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## Effect of Intestinal Microecology After HDDT Combined With Probiotics for Helicobacter Pylori Eradication - NCT ID: NCT06292546 - Study ID: ZYC-Hp2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-09-01 - Lead Sponsor: Zhongshan Hospital (Xiamen), Fudan University ### Study Description The aim of this study was to evaluate the effect of Intestinal microecology after high dose dual therapy combined with probiotics for Helicobacter pylori eradication ### Conditions - H Pylori Infection Eradication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vonorason - Amoxicillin - Bacillus subtilis enteric-coated capsules ### Outcomes Primary Outcomes - Gut Microbiota Secondary Outcomes - Fecal metabolites - Eradication rate - Frequency of the adverse events - Compliance rate of the drugs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study - NCT ID: NCT06292533 - Study ID: UTAR-30-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Universiti Tunku Abdul Rahman ### Study Description The goal of this study is to to evaluate the effectiveness of Ultrapulse for the treatment of androgenic alopecia among Malaysian. The main questions it aims to answer are:* the efficacy of Ultrapulse in treatment of androgenic alopecia among Malaysian* the safety and adverse effect of Ultrapulse treatment.* the quality of life of androgenic alopecia among Malaysian. ### Conditions - Androgenic Alopecia - Alopecia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Er:YAG laser ### Outcomes Primary Outcomes - Global assessment of hair growth Secondary Outcomes - Patient satisfaction - Quality of Life of Patient - Adverse effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of ABLLS-R and Portage Guide in the Development of Receptive Language Skills Autism Spectrum Disorder. - NCT ID: NCT06292520 - Study ID: 4847 - Status: COMPLETED - Start Date: 2023-06-10 - Completion Date: 2023-12-10 - Lead Sponsor: Riphah International University ### Study Description Language is the system someone uses to communicate with another person. This covers the origins and construction of words, their definitions, and the use of language in various contexts. In normally developing children, receptive language skills are typically much more advanced than expressive language skills. However, some studies found that toddlers and kids with ASD had a relatively greater impairment in receptive language skills than in expressive language skills. The study will evaluate the ABLLS-R (Assessment of Basic Language and Learning Skills test) and Portage guidance and compare their effectiveness in developing the Receptive Language Skills in children with Autism Spectrum Disorder (N=12).The study will follow the Randomized control trial study design and a purposive sampling technique will be used. Data will be collected from a special education centre BASES (Behaviour and special education services), Lahore. Children with autism spectrum disorder with mild to moderate severity level will be included in the study. The age range of the children will be from three years to seven years. Children with other neurological disorders or any comorbid conditions will be excluded from the study. The consent form will be filled out by parents of children who meet the inclusion criteria. The autism screening tool will apply by the speech and language pathologist. Half of the total number of children will receive therapeutic intervention under ABLLS-R protocol and other will receive Interventions under portage guide protocol. The data will be analysed by using SPSS 22 statistical software. The results of the study of both the groups will be compared and conclusion will be made on the basis of results. Receptive language skills are crucial for communication and social interaction. Research comparing these assessment tools can contribute to the development of more effective early intervention programs for children with ASD. By identifying the most appropriate assessment tool and intervention strategies, these programs can be better designed to support early language development and promote better long-term outcomes. By understanding the strengths and limitations of each assessment tool, professionals can create more individualized treatment plans for children with ASD ### Conditions - Autism Spectrum Disorders - Non-verbal Learning Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Portage Guide Protocol - ABLLS-R protocol ### Outcomes Primary Outcomes - ABLLS-R for the development of receptive language in children with Autism - Portage Guide for the development of receptive language in children with Autism Secondary Outcomes ### Location - Facility: Bases Institute, Lahore, Punjab, 05309, Pakistan @@
## Comparative Effects of Myofascial Stretch and Contract-relax in Children With Spastic cp - NCT ID: NCT06292507 - Study ID: REC/RCR&AHS/23/0734 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-03-25 - Lead Sponsor: Riphah International University ### Study Description Cerebral palsy (CP) is primarily a neuromotor disorder that affects the development of movement, muscle tone and posture.It is one of the three most common lifelong developmental disabilities, the other two being autism and mental retardation causing considerable hardship to affected individuals and their families. CP is a common problem, the worldwide incidence being 2 to 2.5 per 1000 live births. Myofascial therapy is definable by "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". The PNF contract-relax technique consists of stretching the target muscle, keeping it in position while the patient isometrically contracts it and relaxes in sequence, producing effects such as maintenance and gain in joint mobility, increased muscle strength, and better motor control whereas The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone This study will be randomized clinical trial and will be conducted in Rasool medical centre Gujrat and City hospital Gujrat. This study will be completed within duration of 6 months after the approval of synopsis.Convenience sampling technique will be used to collect the data. A sample size of total 20 patientswill be taken in the study. 20participants will be equally divided into two group's myofascial stretch and contract-relax stretching techniques having 10participants in each group. Informed consent will be sought from them and they will be clearly explained about the purpose of study.Myofascial Stretching will be applied to Group A and Contract-Relax stretching will be applied to Group B.Results will be analyzed on SPSS. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - MYOFASCIAL STRETCH - CONTRACT-RELAX TECHNIQUE ### Outcomes Primary Outcomes - Manual Ability Classification system Secondary Outcomes ### Location - Facility: Mirza Muhammad Farooq, Gujrāt, Punjab, 50700, Pakistan @@
## Focused Ultrasound for Drug-resistant Epilepsy - NCT ID: NCT06292494 - Study ID: 1129052082 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-12-31 - Lead Sponsor: Taipei Veterans General Hospital, Taiwan ### Study Description Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy. ### Conditions - Focused Ultrasound - MR-guided FUS - Drug Refractory Epilepsy - Drug Resistant Epilepsy - Medication Resistant Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exablate 4000 Transcranial MRgfUS System ### Outcomes Primary Outcomes - pulse rate [Safety] - blood oxygen saturation level [Safety] - MRI [Safety] - Incidence of Treatment-Emergent Adverse Events [Tolerability] Secondary Outcomes - seizure frequency [efficacy] - scalp EEG [efficacy] - No. of seizure-free days [efficacy] ### Location - Facility: Taipei Veterans General Hospital, Taipei, N/A, N/A, Taiwan @@
## Combine Effects of Brunnstorm Movement Therapy and LLLT in Chronic Stroke Patient - NCT ID: NCT06292481 - Study ID: REC/RCR&AHS/23/0240 - Status: COMPLETED - Start Date: 2023-08-01 - Completion Date: 2023-10-10 - Lead Sponsor: Riphah International University ### Study Description The primary objective of this study is to determine the combined effects of Brunnstorm movement therapy and low level laser therapy on upper limb function in chronic stroke patient. ### Conditions - Chronic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Brunnstorm movement therapy - Combined Brunnstorm Movement therapy and low level laser therapy ### Outcomes Primary Outcomes - Fugle meyer Assessment test - Box and block test - Nine peg hole test - to check Muscle tone - to measure grip Strength Secondary Outcomes ### Location - Facility: Govt. Mian Munshi DHQ Teaching hospital, Lahore, Punjab, 54000, Pakistan @@
## Plantar Cutaneous Sensory Stimulation in Patients With Diabetic Neuropathy - NCT ID: NCT06292468 - Study ID: REC/RCR&AHS/23/0238 - Status: COMPLETED - Start Date: 2023-07-07 - Completion Date: 2023-09-18 - Lead Sponsor: Riphah International University ### Study Description To determine the effects of plantar cutaneous sensory stimulation on foot tactile sensitivity, postural control, and spatiotemporal gait parameters in patients with diabetic neuropathy. ### Conditions - Diabetic Neuropathies ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional physical therapy - Plantar cutaneous sensory stimulation ### Outcomes Primary Outcomes - Foot tactile sensitivity - Postural control - Spatiotemporal gait parameters Secondary Outcomes ### Location - Facility: PhysioFit, Faisalabad, Punjab, 38000, Pakistan @@
## Association of Anthropometrics With Grip Strength and Smash Quality Post Six Week Elastic Resistance Training - NCT ID: NCT06292455 - Study ID: RIPHAH/RCRS/REC/00713 - Status: COMPLETED - Start Date: 2020-07-10 - Completion Date: 2020-12-15 - Lead Sponsor: Riphah International University ### Study Description To determine the association of hand and forearm anthropometrics on grip strength and forehand smash quality of badminton players after six-weeks of elastic resistance training. ### Conditions - Anthropometric Measurements and Elastic Resistance Training - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Elastic resistance training - Conventional Resistance Training ### Outcomes Primary Outcomes - Smash quality (Power) - Smash quality (Speed) - Smash quality (Distance) Secondary Outcomes ### Location - Facility: Riphah international University, Islamabad, ICT, 44000, Pakistan @@
## Effects of HIIT on Muscle Strength, Atrophy and Aerobic Capacity in Stroke Patients. - NCT ID: NCT06292442 - Study ID: REC/RCR&AHS/23/0237 - Status: COMPLETED - Start Date: 2023-09-01 - Completion Date: 2023-11-01 - Lead Sponsor: Riphah International University ### Study Description To determine the effects of High-Intensity Interval Training on muscle strength, atrophy, and aerobic capacity in stroke patients. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - traditional physical therapy - High intensity interval training ### Outcomes Primary Outcomes - Muscle strength - Muscle Atrophy - 6-Minute Walk Test (6MWT) - Aerobic Capacity Secondary Outcomes - Fastest Gait Speed ### Location - Facility: Jinnah Hospital, Lahore, Lahore, Punjab, 54000, Pakistan @@
## Effects of Complex Training in Cricket Fast Bowlers - NCT ID: NCT06292429 - Study ID: REC/RCR & AHS/23/1104 - Status: RECRUITING - Start Date: 2023-06-16 - Completion Date: 2024-06 - Lead Sponsor: Riphah International University ### Study Description This study will be a randomized controlled trial and the data will be collected from National Cricket Academy and domestic cricket clubs. The sample size will be calculated by conducting a pilot study. There will be three groups. Group-A will be receiving Complex training, Group-B will be receiving Conventional training and Group C as a Control Group. Athletes with same physical fitness level will be recruited. There will be parallel assignment of the participants. Assessor will be kept blinded. All the parameters would be assessed at Baseline, 6 Weeks, 12 Weeks. Physical fitness will be assessed through Field Testing. Bowling performance will be assessed through speed machine and Kinovea Software. Work capacity will be assessed through step testing. Muscle strength will be assessed through Dynamometer. Lastly, BMD will be assessed though Bone Densitometer. ### Conditions - Resistance Training - Plyometric Exercise - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Complex Training - Conventional Training - Control Group ### Outcomes Primary Outcomes - Physical fitness (linear speed capability) - Physical fitness (lower limb explosive power) - Physical fitness (upper body strength test) - Physical fitness (lower body strength test) - Physical fitness (upper body muscular endurance) - Physical fitness (aerobic capacity) - Bowling performance (Ball speed) - Bowling performance (run-up time) - Bowling performance (accuracy) - Bowling performance (RPE) Secondary Outcomes - Work capacity - Muscle Strength - Bone Density ### Location - Facility: Pakistan Sports Board Coaching Center, Lahore, Punjab, 54000, Pakistan @@
## Mirror Therapy With Sensory Motor Training in Children With CP - NCT ID: NCT06292416 - Study ID: REC/0257Huma Saleem - Status: RECRUITING - Start Date: 2023-12-30 - Completion Date: 2024-05-14 - Lead Sponsor: Riphah International University ### Study Description The study compares two interventions in CP children: mirror therapy with sensory motor training versus mirror therapy with motor training. Mirror therapy works by manipulating the brain out of pain, ultimately improving movement in patients with one-sided paralysis. It can be used in combination with other therapies to assist patients with cerebral palsy in retraining the brains, restoring function, and enhancing the overall quality of life. The purpose of this study is to use a combination of Mirror therapy with sensory motor training and motor training and observe which one of these combinations has the most desirable effects in improving movement and quality of life in CP Children ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: Mirror therapy with sensory motor training. - Experimental: Mirror Therapy with motor training - Experimental: Motor Training ### Outcomes Primary Outcomes - The Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment) - Jebsen Taylor Hand dysfunction test Secondary Outcomes ### Location - Facility: Eliya care Centre Faisalabad, Lahore, Punjab, N/A, Pakistan @@
## Effects of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy - NCT ID: NCT06292403 - Study ID: Farwa Akhtar - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-01-01 - Lead Sponsor: Riphah International University ### Study Description The aim of this study is to find the effects of strength training with or without mirror therapy of non-paralytic upper limb for functional activities and in lower limb for gait pattern, balance and stability, and ADLs of paralytic side in patients with acute and sub-acute stroke. A randomized controlled trial that will include total 44 participants .The control group will undergo usual rehabilitation training along with strength training. The trial group will undergo strength training and mirror therapy of NHS on the basis of usual rehabilitation training. For the control group, training time will be 30 minutes, once a day, 3 days a week for 8 weeks. IN trial group, training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks. were allowed to rest for 3-5 min during each training. Data collected will be analyzed through SPSS 25. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Strength Training - Mirror therapy ### Outcomes Primary Outcomes - Modified Barthel Index - Dynamic Gait Index - Berg Balance Scale Secondary Outcomes ### Location - Facility: Fatima Hospital, Rawalpindi, Punjab, N/A, Pakistan @@
## The Effect Of Pet Therapy Applıed To Elders's Sleep And Qualıty Of Lıfe - NCT ID: NCT06292390 - Study ID: AIBU-SBF-CY-09 - Status: COMPLETED - Start Date: 2021-11-15 - Completion Date: 2023-06-22 - Lead Sponsor: Tokat Gaziosmanpasa University ### Study Description Quality of life is defined as functional abilities that include the ability to fulfill an individual social role, the degree and quality of social interaction, mental health, physical competence, somatic senses such as pain, and satisfaction with life. The World Health Organization (WHO) defined quality of life in 1947 as a decrease not only in disease, disorder or disability, but also in physical, mental and social well-being. Old age is one of the situations in which the quality of life decreases. It is reported that the poor social and financial situation of individuals, low educational level, gender, lack of physical movement, decreased daily life activity level, decreased mobility ability, fall anxiety, sleep problems and other conditions that cause disability are determinants of the quality of life. According to the results of Bloom et al.'s study, elderly people wake up at night due to health problems.According to the literature, the sleep and life of pet therapy applied to elderly individuals living in a nursing home there have not been any studies examining the effect on quality. For this reason, it was aimed to conduct this study in order to determine the effect of pet therapy applied to elderly individuals living in a nursing home on sleep and quality of life.The study was planned to be conducted in a randomized controlled manner in order to determine the effect of pet therapy applied for one hour twice a week for 6 weeks to elderly people living in a nursing home in Tokat province on sleep pattern and quality of life. In the study, gender, age group and the presence of chronic diseases were taken as equivalence criteria. Since conducting the study single-blind will increase the reliability of the study, the application of the scales was applied by another researcher/surveyor other than the main researcher. ### Conditions - Pet Therapy Effect of Sleep and Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pet Therapy ### Outcomes Primary Outcomes - PUKI Secondary Outcomes - CASP-19 QUALITY OF LIFE ### Location - Facility: Nursing Home, Tokat, Center, 60000, Turkey @@
## Better Understanding of Fatigue After STroke - NCT ID: NCT06292377 - Study ID: BRUFAST - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Brugmann University Hospital ### Study Description Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\< 3 months) and late (\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted.Autonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices.Autonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated.Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke.Cardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism.Based on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF.To confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF.There will also be an investigation into following elements:* the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty.* the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - ECG - Transthoracic echography (TTE) - Blood sampling ### Outcomes Primary Outcomes - Heart rate variability (HRV) - Heart rate variability (HRV) - Heart rate variability (HRV) - Transthoracic echography (TTE) - Transthoracic echography (TTE) - Transthoracic echography (TTE) - Fatigue Severity Scale - Fatigue Severity Scale - Fatigue Severity Scale - N-terminal pro-brain natriuretic peptide (NT-proBNP) - N-terminal pro-brain natriuretic peptide (NT-proBNP) - N-terminal pro-brain natriuretic peptide (NT-proBNP) - cardiac troponin (cTnT) Secondary Outcomes - Blood CRP level - Blood neutrophil-to-lymphocyte ratio (NLR) - Stroke localization in the brain - Fazekas scale - Global cortical atrophy scale - Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) - Presence for pre-existing fatigue (yes/no) - Duration of pre-existing fatigue - Patient Health Questionnaire-2 (PHQ-2) - Patient Health Questionnaire-2 (PHQ-2) - Patient Health Questionnaire-2 (PHQ-2) - Montreal Cognitive Assessment (MoCA) questionnaire - Montreal Cognitive Assessment (MoCA) score - Insomnia Severity Index (ISI) - Insomnia Severity Index (ISI) - Insomnia Severity Index (ISI) - Complete blood count abnormalities: yes/no - Renal insufficiency: yes/no - Electrolyte imbalance: yes/no - Abnormal liver enzymes: yes/no - Dyslipidemia: yes/no - Diabetes: yes/no - Thyroid disorder: yes/no - Iron deficiency: yes/no ### Location - Facility: CHU Brugmann, Brussels, N/A, 1020, Belgium @@
## Comparison of Retention Characteristics of Immediate vs Delayed Retainer Delivery Using 3D Digital Model Analysis - NCT ID: NCT06292364 - Study ID: PGIDS/BHRC/23/106 - Status: RECRUITING - Start Date: 2023-11-05 - Completion Date: 2024-12-05 - Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak ### Study Description Retention has been defined as "the holding of teeth following orthodontic treatment in the treated position for the period of time necessary for the maintenance of the result". Controversies regarding retention regime exist due to lack of high quality evidence regarding duration, type and timing of different type retainer.The present randomised controlled trial will be undertaken to assess the changes and compare if there is any difference in movement of teeth in post orthodontic treatment cases with immediate and delayed (post 7 days) delivery using beggs retainer and change in level of bone biomarker over 6 months period of retention . ### Conditions - Relapse ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - immediate orthodontic retainer delivery - delayed orthodontic retainer delivery ### Outcomes Primary Outcomes - overjet - overjet - overjet - Overjet - contact point displacement - contact point displacement - contact point displacement - contact point displacement - overbite - overbite - overbite - overbite - intermolar width - intermolar width - intermolar width - intermolar width - intercanine width - intercanine width - intercanine width - intercanine width Secondary Outcomes - GCF - elisa - GCF - elisa - GCF - elisa - GCF - elisa ### Location - Facility: Pgids Rohtak, Rohtak, Haryana, 124001, India @@
## DMB-I in the Treatment of Alzheimer Type Dementia - NCT ID: NCT06292351 - Study ID: DMBN_ALZH-2022-II - Status: RECRUITING - Start Date: 2023-12-27 - Completion Date: 2024-12-21 - Lead Sponsor: Bigespas LTD ### Study Description The purpose of this study is to assess the efficacy and safety of DMB-I for the treatment of patients with Alzheimer type dementia. ### Conditions - Alzheimer Disease - Dementia of Alzheimer Type ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DMB-I (Dimebon) - Placebo ### Outcomes Primary Outcomes - Mean change in Alzheimer's Disease Assessment Scale score after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) in patients receiving the study drug or placebo Secondary Outcomes - Mean change in cognitive impairment score on the Alzheimer's Disease Assessment Scale after 12 weeks of therapy compared to baseline - Mean change in Mini-Mental State Examination score after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 0) - Change in the quality of life of patients according to the Quality of Life - Alzheimer's Disease questionnaire after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) - Change in the general clinical impression in accordance with the Clinical Global Impressions Scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) - Dynamics on the Lawton's Instrumental activities of daily living scale after 12 weeks of therapy (Visit 4) and after 26 weeks of therapy (Visit 6) compared to baseline (Visit 1) ### Location - Facility: State autonomous healthcare institution "Transregional Clinical Diagnostic Center", Kazan, N/A, 420101, Russian Federation @@
## Lung Sonar in Neonatal Respiratory Disorders - NCT ID: NCT06292338 - Study ID: AUCHAU - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: Gehad Adel Mohammed Hussein ### Study Description This study aimed to determine the value of chest ultrasonography in comparison to other tools as chest x-ray and ABG in diagnosis and follow up of neonates with respiratory disorders. ### Conditions - Neonatal Respiratory Distress ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparing between LUS and Chest xRay in neonatal respiratory disorders assessment Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Psychological Aspects in OSA - NCT ID: NCT06292325 - Study ID: FDG_88-17 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-05-08 - Completion Date: 2024-05-31 - Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus ### Study Description The research project consists of an observational study. Obstructive Sleep Apnea (OSA) is a condition characterized by recurrent episodes of upper airway collapse during sleep, leading to decreased blood oxygen levels and disruptions of normal sleep patterns. Estimates of its prevalence vary, but its impact on patients' quality of life is evident.The research aims to explore the perception and awareness of the disease and its impact on the individual and couple's lives of patients with OSA and their bed partners, to assess patients' perceptions of the disease and symptoms, as well as their bed partners' perceptions. Moreover, psychological aspects of living with OSA, such as perceived stress, depression, anxiety, sleep quality, daily sleepiness will be studied to observe the association with Continuous Positive Airway Pressure (CPAP) adherence. ### Conditions - Osa Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Continuous Positive Airway Pressure (CPAP) ### Outcomes Primary Outcomes - Brief Illness Perception Questionnaire (Brief IPQ) - CPAP therapy adherence (hours/night) - Dyadic Adjustment Scale (DAS) Secondary Outcomes - The experience in close relationships-revised (ECR-R) Scale - The Psychological General Well-Being Index (PGWB-S) - The Patient Health Questionnaire - 9 (PHQ-9) - The Generalized Anxiety Scale -7 (GAD-7) - The Mannheim Dream Questionnaire (MADRE) - The EP worth scale (ESS) - Pittsburgh Sleep Quality Index (PSQI) ### Location - Facility: IRCCS Fondazione Don Carlo Gnocchi, Milan, MI, 20148, Italy @@
## Investigation of the Effectiveness of Craniosacral Therapy in Patients With Multiple Sclerosis. - NCT ID: NCT06292312 - Study ID: 19.12.2023/10-483 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-05-15 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description Although the cause of Multiple Sclerosis (MS), one of the common demyelinating diseases of the central nervous system, has not yet been fully elucidated, autonomic nervous system dysfunction has been suggested in its etiology. Symptoms such as fatigue, problems with bladder, bowel, cardiovascular, sleep, sexual and sweating functions, abnormal sympathetic skin response or decreased heart rate variation support this hypothesis.In the treatment of many neurological diseases such as Multiple Sclerosis, complementary medicine practices and non-traditional therapies have recently been shown to be effective in addition to conventional practices. One of these practices, craniosacral therapy (CST), uses manual palpation and manipulation of the craniosacral system to influence sensory, motor, cognitive and emotional processes in the nervous system. In addition, it is thought that applying external force to certain bone elements can have a positive effect on various symptoms in patients with MS, based on the knowledge that it can be transmitted within the system. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Craniosacral therapy - Conventional physiotherapy ### Outcomes Primary Outcomes - Dynamic posturography - Heart rate variability Secondary Outcomes - Pain level - Central sensitization - Fatigue - Sleep quality - Life quality ### Location - Facility: Ankara Yıldırım Beyazıt University, Ankara, N/A, 06010, Turkey @@
## The PARS Study: Paediatric Advanced Respiratory Service Study - An Observational Diagnostic Feasibility Study - NCT ID: NCT06292299 - Study ID: INGN22RM471P - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12 - Lead Sponsor: NHS Greater Clyde and Glasgow ### Study Description Diagnostic investigations in paediatric respiratory and sleep medicine are often challenging due to patient size (due to prematurity), tolerability, and compliance with "gold standard equipment". Children with sensory/behavioural issues, at increased risk of sleep disordered breathing (SDB), often find tolerating standard diagnostic equipment difficult. There is a need to develop non-invasive, wireless, devices designed for the paediatric population. Devices must address health in-equalities as high-risk children, with low birth weights, genetic syndromes, or complex neuro-disabilities, are often unable to undergo current investigations, particularly in sleep medicine. Prompt and accurate diagnosis of SDB is important to facilitate early intervention and improve outcomesInfants in the neonatal period can have immature breathing control which manifests as excessive central breathing pauses, apnoea's, whilst asleep requiring oxygen therapy. There is also a risk to newborn term infants of sudden unexpected neonatal collapse, even in "low risk" babies. Diagnosis of breathing issues in babies can be challenging since babies are often too small for standard monitoring equipment. Effective monitoring and appropriate treatment of apnoea's has been shown to improve prognosis in terms of 5-year mortality and neurodevelopmental outcomes.This observational study is part of a phased clinical program of research that aims to validate a small wearable biosensor developed by PneumoWave Ltd in a paediatric clinical setting with the overall primary endpoints of monitoring and assessing respiratory pattern as an aid to sleep diagnostics, and as a device to monitor apnoea in neonatal patients. ### Conditions - Sleep Disordered Breathing - Apnea of Prematurity - Respiratory Rate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pneumowave ### Outcomes Primary Outcomes - Assess the feasibility of collecting respiratory waveform data using Pneumowave device in patients who have (1) attended the sleep laboratory for CR- polysomnography and (2) are inpatient in neonatal unit Secondary Outcomes - Collate respiratory data in patients who have attended the sleep laboratory for CR- poly or inpatient in neonatal unit. Respiratory data will observe: (1) Normal respiratory effort (2) Response to treatments - Collate waveform and motion artefact data in patients who have attended overnight CR-polysomnography - Collate waveform and motion artefact data in neonatal patients at risk of central apnoea - Assess the useability of Pneumowave in the opinion of the clinician, nurse and patient ### Location - Facility: Royal Hospital for Children, Glasgow, Glasgow, Glasgow City, G51 4TF, United Kingdom @@
## Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer - NCT ID: NCT06292286 - Study ID: UW 22-704 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-07-01 - Lead Sponsor: The University of Hong Kong ### Study Description About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known. ### Conditions - Recurrent Ovarian Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Carboplatin or cisplatin - Paclitaxel, gemcitabine or liposomal doxorubicin with or without bevacizumab or biosimilar - Bevacizumab or biosimilar - Cytoreductive surgery ### Outcomes Primary Outcomes - Complete resection rate Secondary Outcomes - 12-month progression-free survival rate - 12-month overall survival rate - Surgical complication rate - Quality of life scale ### Location - Facility: The University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section - NCT ID: NCT06292273 - Study ID: ANET19 - Status: COMPLETED - Start Date: 2023-10-10 - Completion Date: 2024-02-20 - Lead Sponsor: Menoufia University ### Study Description Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block. ### Conditions - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Transversus Abdominis Plane Block with bupivacain Plus dexamethasone - Transversus Abdominis Plane Block with bupivacain ### Outcomes Primary Outcomes - Post operative pain Secondary Outcomes - Sedation - Heart rate - Total analgesic consumption - Side effects ### Location - Facility: Faculty of Medicine Menoufia University, Cairo, Governorate, 32511, Egypt @@
## Digital Toolkit for Skin Diseases in LMICs: Part 2 - NCT ID: NCT06292260 - Study ID: 2020-2054-2 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-05-31 - Lead Sponsor: Tulane University ### Study Description Impact evaluation of eSkinHealth in improving case detection of skin NTDs and treatment outcomes in rural and urban settings ### Conditions - Skin Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - mHealth app ### Outcomes Primary Outcomes - Number of cases of each skin NTD (neglected tropical disease) and other skin conditions as compared to the pre-intervention Secondary Outcomes - Case confirmation rate for each skin NTD (neglected tropical disease) and other skin conditions by dermatologists - Number of days from registry to confirmatory diagnosis - Feasibility, usability, and effectiveness of the surveillance approach using eSkinHealth app - Capacity building and effectiveness of training ### Location - Facility: Hope Commission International, Abidjan, N/A, N/A, Côte D'Ivoire @@
## Effectiveness of CBT and APT on Managing Child Anxiety in Dental Office - NCT ID: NCT06292247 - Study ID: A0503023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-05-01 - Lead Sponsor: Mansoura University ### Study Description This study was conducted to the Effectiveness of Cognitive Behavioral Therapy and Auricular Plaster Therapy on Managing Child Anxiety in Dental Office. ### Conditions - Dental Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Cognitive behavioral therapy - Auricular plaster therapy - Tell Show Do ### Outcomes Primary Outcomes - Venham Clinical Anxiety Scale - Heart Rate to detect the anxiety. - RMS-Self Pictorial scale to detect the anxiety. Secondary Outcomes - Parental acceptance of the behavior management technique ### Location - Facility: Faculty of dentistry, Mansoura, Dakahlia, 35511, Egypt @@
## Patient Specific Implant Versus Miniplates for Advancement of Hypoplastic Maxilla - NCT ID: NCT06292234 - Study ID: OMFS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-03-01 - Lead Sponsor: Cairo University ### Study Description Distraction osteogenesis is the treatment of choice in management of severe maxillary anteroposterior deficiency allowing for a progressive bone generation and simultaneous expansion of the surrounding scarred soft tissue \& better long-term stability \& less relapse rate. ### Conditions - Cleft Lip and Palate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PSI - Conventional miniplates ### Outcomes Primary Outcomes - Distraction effectiveness Secondary Outcomes - Velopharyngeal insufficiency - Speech - Operative time - Wound dehiscence - Infection - Nerve affection - Screw loosening - Overall complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Depression Treatment Supported by Mobile Sensor Analytics - NCT ID: NCT06292221 - Study ID: H19-078 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: UConn Health ### Study Description The current best practice guidelines for treating depression call for close monitoring of patients, and periodically adjusting treatment as needed. This present study seeks to develop and investigate an innovative digital system, DepWatch, that leverages mobile health technologies and machine learning tools to provide clinicians objective, accurate, and timely assessment of depression symptoms to assist with their clinical decision making process. Specifically, DepWatch collects sensory data passively from smartphones and wristbands, without any user interaction, and uses simple user-friendly interfaces to collect ecological momentary assessments (EMA), medication adherence and safety related data from patients. The collected data will be fed to machine learning models to be developed in the project to provide weekly assessment of patient symptom levels and predict the trajectory of treatment response over time. The assessment and prediction results are then presented using a graphic interface to clinicians to help them make critical treatment decisions. The main question the present clinical trial aims to answer are as follows:1. Feasibility of the digital tool, DepWatch, to assist clinicians in depression treatment and inform their clinical decision process2. Effectiveness of the digital tool, DepWatch, to improve depression treatment outcomes All study participants will carry the DepWatch app on their smartphones and wear a Fitbit provided by the study team during the study period. They will also complete brief questionnaires via the app at specific time intervals throughout the study period. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - A mobile Health (mHealth) tool called 'DepWatch' ### Outcomes Primary Outcomes - Feasibility and Usability Secondary Outcomes - Depression outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors - NCT ID: NCT06292208 - Study ID: IBD0333-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-02 - Completion Date: 2030-12-31 - Lead Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. ### Study Description Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT).Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma.Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333. ### Conditions - MTD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IBD0333 ### Outcomes Primary Outcomes - MTD - DRDE - Dose limiting toxicity (DLT) - RP2D - ORR Secondary Outcomes - pharmacokinetic parameters - pharmacokinetic parameters - pharmacokinetic parameters - pharmacokinetic parameters - ADA - ORR - DCR - DoR - PFS - Frequency of adverse events (AEs) and SAEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Vitamin D on Health Promotion During Pregnancy and Its Impact on Prematurity-Related Outcome - NCT ID: NCT06292195 - Study ID: VitDTracking - Status: RECRUITING - Start Date: 2023-11-03 - Completion Date: 2025-12-31 - Lead Sponsor: University of Évora ### Study Description The VitDTracking study focuses on the relevance of maternal vitamin D levels and their association with prematurity, aiming to improve maternal and child health outcomes, particularly by reducing avoidable preterm births. In Portugal, vitamin D levels during pregnancy have never been studied. Epidemiological data from other countries reveal a high prevalence of vitamin D deficiency/insufficiency, especially in pregnant women.The hypovitaminoses prevalence remains high even with a supplementation dosage of 400 to 600 IU/day during pregnancy (dosage used in Portugal), which is considered as a suboptimal dose. This phenomenon is associated with adverse maternal and child outcomes, such as intrauterine growth restriction, preeclampsia, cholestasis, hypertension, and gestational diabetes as major causes of prematurity.Additionally, the Portuguese population has a higher prevalence of genome alterations that confer a lower capacity to produce vitamin D from sunlight exposure. These genetic characteristics are present in about 19% of the population, representing a prevalence four times higher than the European average (19% versus 4.75%), leading to a higher predisposition to vitamin D deficiency. ### Conditions - Vitamin D Deficiency - Pregnancy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Exposure ### Outcomes Primary Outcomes - Differences in the rate of Prematurity with different maternal Vitamin D levels - Differences in Birth Weight with different maternal Vitamin D levels - Differences in Apgar Scores with different maternal Vitamin D levels - Differences in the number of admissions to the Neonatal Intensive Care Unit with different maternal Vitamin D levels - Differences in the Neonatal Morbidity rate with different maternal Vitamin D levels - Differences in the Neonatal Mortality rate with different maternal Vitamin D levels - Differences in the number of Neonatal Infections with different maternal Vitamin D levels - Differences in the Number of Congenital Malformation diagnoses with different maternal vitamin D levels - Differences in the presence of vitamin D-related polymorphisms with different maternal levels of vitamin D Secondary Outcomes - Differences in maternal vitamin D levels between the three groups/cohorts related to prematurity - Differences in maternal vitamin D levels between the three groups/cohorts related to birth weight - Differences in maternal vitamin D levels between the three groups/cohorts related to Apgar scores - Differences in maternal vitamin D levels between the three groups/cohorts related to admission to the Neonatal Intensive Care Unit - Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal morbidity - Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal mortality - Differences in maternal vitamin D levels between the three groups/cohorts related to neonatal infections. - Differences in maternal vitamin D levels between the three groups/cohorts related to the diagnosis of congenital malformations - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with prematurity - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with birth weight - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with Apgar scores - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with admission to the Neonatal Intensive Care Unit. - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal morbidity - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal mortality - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with neonatal infections - Differences in the presence of vitamin D-related polymorphisms between the three groups/cohorts associated with the diagnosis of congenital malformations ### Location - Facility: Unidade Local de Saúde do Baixo Alentejo, Beja, N/A, 7801-849, Portugal @@
## Red Light Ptosis Proof-of-Concept - NCT ID: NCT06292182 - Study ID: 160802 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2025-11-30 - Lead Sponsor: University College, London ### Study Description This study tests a new treatment to help with droopy eyelids (ptosis) and eye movement problems (squint) in children and young people with genetically confirmed mitochondrial conditions - using red-light.We use a torch to shine a red light through the closed eyelid for 3 minutes a day. The study will run for 18 months.We believe that this treatment could help strengthen the muscle in the eyelid to make it easier to open the eyes, and could also help some children with squint. ### Conditions - Mitochondrial Diseases - Blepharoptosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Near-infrared light ### Outcomes Primary Outcomes - Palpebral fissure width Secondary Outcomes ### Location - Facility: Moorfields Eye Hospital NHS Foundation Trust, London, N/A, EC1V 2PD, United Kingdom @@
## Pectoralis Minor Release Versus Non-release in RSA - NCT ID: NCT06292169 - Study ID: STUDY00007201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-01 - Lead Sponsor: Emory University ### Study Description The goal of this clinical trial is to assess if concomitant open pectoralis minor release would improve pain and outcomes after Reverse Shoulder Arthroplasty (RSA). The main questions it aims to answer are:* whether releasing the pectoralis minor prophylactically could have better pain relief* whether releasing the pectoralis minor prophylactically could have increased Range of motion (ROM) outcomes* whether releasing the pectoralis minor prophylactically could have higher final Patient Reported Outcome Measurements (PROMs) Participants will be randomized to either undergo RSA with pectoralis minor release or RSA without pectoralis minor release. ### Conditions - Reverse Total Shoulder Arthroplasty - Rotator Cuff Tear Arthropathy - Advanced Glenohumeral Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pectoralis Minor Release - RSA ### Outcomes Primary Outcomes - Visual analog Scale (VAS) pain scores Secondary Outcomes ### Location - Facility: Emory Clinic, Atlanta, Georgia, 30322, United States @@
## tACS Treatment for Cognitive Impairments in Methamphetamine Addicts - NCT ID: NCT06292156 - Study ID: CASPsy7 - Status: RECRUITING - Start Date: 2023-02-20 - Completion Date: 2024-08 - Lead Sponsor: Beijing HuiLongGuan Hospital ### Study Description 1. To evaluate the cognitive function of methamphetamine Patients.2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients ### Conditions - Methamphetamine Abuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Theta treatment group - Alpha active control group - Sham control group ### Outcomes Primary Outcomes - The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - ERP components associated with cognitive function - Condition stop signal task - Neural oscillations associated with cognitive function - Functional connection of brain region associated with cognitive function - Microstate associated with cognitive function - The effect of oxidative stress system on cognitive function - The effect of immune system on cognitive function - The effect of brain derived neurotrophic factor(BDNF) on cognitive function - Genetic mechanism of cognitive function Secondary Outcomes - Reverse learning task - Beck Depression Scale - Barrett impulse Scale - Degree of insomnia - The Sensitivity to Punishment and Reward Questionnaire - Visual analog scale - The Desires for Drug Questionnaire - Obsessive compulsive drug use scale - Obsessive-compulsive inventory - Thought Control Ability Questionnaire - Thought Suppression Questionnaire - Rumination Questionnaire - Anger Rumination Questionnaire - Beck Anxiety Scale - Emotional Regulation Difficulty Scale - Aggressive questionnair ### Location - Facility: Xin Hua Drug Rehabilitation Center, Mianyang, N/A, N/A, China @@
## AI4HOPE Dementia Care Planning Pilot Study 2 ( AI4HOPE2) - NCT ID: NCT06292143 - Study ID: EU101136769-CLIN2 - Status: NOT_YET_RECRUITING - Start Date: 2025-07 - Completion Date: 2026-12 - Lead Sponsor: University of Bonn ### Study Description This pilot study will test a digital care planning decision support system for patients with dementia. ### Conditions - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Advance Care Planning Toolkit ### Outcomes Primary Outcomes - Ease of use of digital platform - Effect of digital platform on documentation of advance care planning Secondary Outcomes ### Location - Facility: University Hospital Bonn, Bonn, N/A, 53127, Germany @@
## Health-Kit Enabled Mobile App for Tobacco Cessation - NCT ID: NCT06292130 - Study ID: 156588-01 - Status: COMPLETED - Start Date: 2022-03-21 - Completion Date: 2023-09-21 - Lead Sponsor: Pro-Change Behavior Systems ### Study Description Tobacco use remains the leading preventable cause of death in the US, contributing to more than 480,000 premature deaths each year. The Tobacco Treatment Guidelines underscore the need to offer patients who use tobacco products brief interventions that include prescriptions for proven pharmacological smoking cessation aids and proactive connections to evidence-based behavioral support. The rapid expansion of smart phone capabilities enhances the potential for tobacco cessation apps to personalize behavior change guidance and to send contextually relevant tailored behavior change nudges based on readiness to quit and electronic heath record (EHR) data. Rich data from EHRs are now available to third-party apps from the Health app (iOS) via Fast Healthcare Interoperability Resources standard Application Programming Interface (API).This Phase I SBIR will explore the acceptability and effects of one such innovative health IT solution. Refresh is a highly individualized tobacco cessation HealthKit enabled app that will 1) implement a full range of best practices in tailored health behavior change communications based on readiness to change; 2) individualize behavior change guidance based on Health app data; and 3) concisely provide data and documentation of key actionable insights in the EHR on the patient's smoking status, app usage, and brief micro-message clinicians can deliver to reinforce and accelerate a patient's behavior change progress. This interoperability will provide value to both patients and clinicians; empower and support successful and lasting behavior change; and enable the implementation and evaluation of a best-in-class approach to tobacco and nicotine treatment.Extensive end user and stakeholder input will ensure refresh is designed for rapid dissemination. Patients of an integrated delivery system with an upcoming appointment (n=100) will be recruited to participate in a 30-day pilot test. Pilot participants will provide quantitative and qualitative data, and utilization and acceptability data will be examined. Pre-post comparisons of PROMIS measure for tobacco (psychosocial expectancies) will provide preliminary data on the effects of the program. Acceptability data from participating clinicians (n=10) who receive and deliver EHR prompts will also be gathered. The hypothesis is that the patients who utilize refresh will have significantly higher psychosocial expectancies regarding tobacco at follow-up. Secondary outcomes will be examined. ### Conditions - Cigarette Smoking ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - refresh ### Outcomes Primary Outcomes - Psychosocial Expectancies (PROMIS Smoking Initiative) Patient Reported Outcome Secondary Outcomes - Confidence ### Location - Facility: Pro-Change Behavior Systems, Inc, South Kingstown, Rhode Island, 02879, United States @@
## Implementation of Onsite Rapid CYP2C19 Assay for Genotype Guided Dual Antiplatelet Therapy After Acute Ischemic Stroke - NCT ID: NCT06292117 - Study ID: 230247 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: University of Virginia ### Study Description The goal of this observational study is to use a genetic test to help doctors prescribe the most effective medications after a patient has a stroke. One type of stroke is caused by a blood clot in brain vessels. After a patient has this kind of stroke, they are often given a combination of two blood thinners to prevent it from happening again. One of these blood thinners, called clopidogrel, is less effective in some people due to differences in their DNA. Clopidogrel needs to be activated by a specific enzyme in the body known as CYP2C19. This enzyme does not work as well if there are variations in the section of DNA that tells the body how to make CYP2C19. It can be predicted who has less CYP2C19 enzyme activity with a genetic test. If these patients are given a different blood thinner, it can reduce their risk of another stroke compared to if they are given clopidogrel.The main questions this study aims to answer are:* What are the best strategies to implement this genetic test in the hospital?* Does implementation of this genetic test change providers' decisions on which medication to prescribe after a participant has a stroke?Participants in this study will have a genetic test done onsite looking for variations in the section of DNA that tells the body how to make CYP2C19. This genetic test will only look for 11 known variations; the genome will not be sequenced. The investigators will alert the doctor of the patient's test results so they can prescribe the appropriate blood thinner. Through this, the investigators will learn the best practices for successful implementation of this genetic test. ### Conditions - Ischemic Stroke - CYP2C19 Polymorphism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CYP2C19 Genotype ### Outcomes Primary Outcomes - Percentage of patients discharged from University of Virginia (UVA) Health on dual antiplatelet therapy with a diagnosis of AIS/TIA meeting eligibility criteria upon presentation that are successfully genotyped - Average turnaround time of genotype result from time of collection of blood sample to time result is entered into the electronic health record Secondary Outcomes - Number of CYP2C19 LOF carriers for whom a genotype-guided modification to DAPT is made - Number needed to genotype (NNG): number of patients who would need to undergo genotyping to have a recommended change in DAPT based on genotype - Stroke-free status via the Questionnaire to Verify Stroke-Free Status (QVSFS) of participants at 90 days in participants who received DAPT - Major adverse cardiovascular events at 90 days in participants who received DAPT - Correlation between P2Y12 reaction units (PRUs) measured via P2Y12 assay and CYP2C19 genotype in patients who received DAPT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS) - NCT ID: NCT06292104 - Study ID: STU-2023-0589 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2029-01 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities. ### Conditions - Postural Orthostatic Tachycardia Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - multimodal diagnostic testing ### Outcomes Primary Outcomes - Phenotyping POTS - Natural history - Natural history Secondary Outcomes ### Location - Facility: UT Southwestern Medical Center, Dallas, Texas, 75208, United States @@
## A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril - NCT ID: NCT06292091 - Study ID: Ur_ABD_PK - Status: COMPLETED - Start Date: 2024-02-28 - Completion Date: 2024-04-01 - Lead Sponsor: Seoul National University Hospital ### Study Description The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Captopril 12.5 Mg - Sodium bicarbonate 4 G - Torsemide 20 MG ### Outcomes Primary Outcomes - AUClast of captopril - Cmax of captopril Secondary Outcomes - AUCinf of captopril - Tmax of captopril - t1/2 of captopril - CL/F of captopril - Vd/F of captopril - fe of captopril - urine pH - Safety parameters ### Location - Facility: Seoul National University Hospital, Seoul, N/A, 03080, Korea, Republic of @@
## Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA) - NCT ID: NCT06292078 - Study ID: 1R01DA059401-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-08 - Lead Sponsor: University of Oregon ### Study Description This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states. ### Conditions - Opioid Misuse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Instructional Skill-Building Learning Approach (ISLA) ### Outcomes Primary Outcomes - Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension - Engagement vs. Disaffection with Learning Student-report - Inclusive Teaching Practices - School Climate Survey- Student - School Climate- Teacher - Student-Teacher Relationships - Opioid and Other Substance Misuse - Student Internalizing Behaviors - Student Externalizing Behaviors - ISLA Acceptability - ISLA Implementation Fidelity Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gastric Ultrasound To Assess Gastric Contents In Patients On Semaglutide Therapy - NCT ID: NCT06292065 - Study ID: Project ID 6171 - Status: RECRUITING - Start Date: 2024-04-14 - Completion Date: 2024-12-31 - Lead Sponsor: Nils Vlaeminck ### Study Description Glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1-RA) such as semaglutide (Ozempic™, Rybelsus™, Wegovy™) were first introduced as a therapeutic agent for type 2 diabetes mellitus but they are being increasingly used to target weight loss in obesity.One of the mechanisms by which weight loss is achieved, is increased satiety and significantly delayed gastric emptying. Tachyphylaxis for this effect has been reported with chronic use of long acting GLP-1-RA (e.g. semaglutide) but this was based on the paracetamol absorption technique or 13C breath test. Recent clinical data suggests semaglutide use does increase perioperative gastric content.This creates uncertainty for anaesthetists who are, anecdotally, more frequently faced with patients who may or may not have full stomachs despite adhering to conventional fasting guidelines.To address this issue the American Society of Anesthesiologists (ASA) has recently released guidelines in which it advises to hold GLP-1-RA for one day (if administered daily) or one week (if administered weekly).However, these recommendations are based on sparse empirical evidence and they do not necessarily follow from the known pharmacokinetic properties of these drugs. Typically, GLP-1-RA are administered in increasing doses over several weeks until a therapeutic steady state is achieved. Meanwhile the elimination half-life of e.g. semaglutide is 7 days. This means that holding semaglutide for one day or even one week might not be enough to attenuate its therapeutic effect of delayed gastric emptying. On the other hand if semaglutide were to be held for e.g. 5 terminal half-lifes, this would mean an unpractical 5 weeks during which glycemic control may be worsened and after which semaglutide doses would have to be incrementally increased again. Besides, hyperglycaemia secondary to semaglutide cessation can also delay gastric emptying.Further confounding the assessment of these patients there can be 'background' delayed gastric emptying in diabetic patients and more pronounced delayed gastric emptying in patients recently started on GLP-1-RA. The presence of gastro-intestinal symptoms (nausea, vomiting, dyspepsia, abdominal distension) might offer clinical information regarding increased gastric residue in this population.Gastric ultrasound is a point-of-care clinical and research tool that has steadily gained popularity to assess gastric content in patients not compliant with fasting rules or with certain comorbidities. Clinical decisions can be made based on the visualised content (e.g. solids, fluids or nothing) or through calculation of gastric volume by measuring antral circumference. In this study the investigators will examine gastric contents in patients who are taking semaglutide and in patients who are not. The investigators will then evaluate whether there is a difference in the incidence of full stomachs and whether gastric ultrasound influenced the anaesthetic plan of the treating anaesthetist. ### Conditions - Gastroparesis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Point-of-care gastric ultrasound ### Outcomes Primary Outcomes - Prevalence of full stomach Secondary Outcomes - Frequency of changes to the anaesthetic plan - Calculated gastric content - Prevalence of solid gastric content - Association between fasting time for solids and 'full stomach' - Association between fasting time for liquids and 'full stomach' - Frequency of perioperative aspiration - Prevalence of gastric symptoms - Association between nausea and 'full stomach' - Association between vomiting and 'full stomach' - Association between dyspepsia and 'full stomach' - Association between abdominal distension and 'full stomach' - association between semaglutide dose and calculated gastric content - association between semaglutide dose and 'full stomach' - Association between frequency of semaglutide administration and calculated gastric content - Association between frequency of semaglutide administration and 'full stomach' - Association between duration of semaglutide therapy and calculated gastric content - Association between duration of semaglutide therapy at current dose and calculated gastric content - Association between duration of semaglutide therapy and 'full stomach' - Association between duration of semaglutide therapy at current dose and 'full stomach' - Association between duration of cessation of semaglutide and calculated gastric content - Association between duration of cessation of semaglutide and 'full stomach' - Association between preoperative blood glucose levels and calculated gastric content - Association between preoperative blood glucose levels and 'full stomach' - Association between HbA1c levels and calculated gastric content - Association between HbA1c levels and 'full stomach' - Association between time since onset of diabetes mellitus and calculated gastric content - Association between time since onset of diabetes mellitus and 'full stomach' ### Location - Facility: Antwerp University Hospital, Edegem, Antwerp, 2650, Belgium @@
## Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness - NCT ID: NCT06292052 - Study ID: NSCLC-TDLN-001 - Status: RECRUITING - Start Date: 2017-01-01 - Completion Date: 2024-04-01 - Lead Sponsor: Sun Yat-sen University ### Study Description The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Immunotherapy ### Outcomes Primary Outcomes - Complete pathologic response Secondary Outcomes - Major pathologic response - Complete pathologic response in lymph nodes ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Human-centered Injury Thrivorship Pathway for Survivors of Physical Trauma - NCT ID: NCT06292039 - Study ID: P0555788 - Status: NOT_YET_RECRUITING - Start Date: 2025-07 - Completion Date: 2026-06 - Lead Sponsor: University of California, San Francisco ### Study Description The goal of this clinical trial is to pilot and evaluate a human-centered injury thrivorship pathway in injury survivors. The main question it aims to answer is:• Is the pathway appropriate, acceptable, and feasible to meet the medical and social needs of injury survivors?Injury survivors will be purposively sampled to enroll in the pathway and asked to participate in in-depth interviews and their use of pathway resources will be tracked. ### Conditions - Injury Traumatic - Survivorship - Trauma Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Human-Centered Injury Thrivorship Pathway ### Outcomes Primary Outcomes - Early Implementation Outcomes - Acceptability, Appropriateness, Feasibility Secondary Outcomes - Participant pathway resource utilization - type - Participant pathway resource utilization - frequency - Participant pathway resource utilization - duration - Participant pathway resource utilization - % utilized ### Location - Facility: Zuckerberg San Francisco General Hospital, San Francisco, California, 94110, United States @@
## Efficacy of ProgenaMatrix™ in the Management of DFUs - NCT ID: NCT06292026 - Study ID: DFU/1 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-14 - Completion Date: 2026-09 - Lead Sponsor: ProgenaCare Global, LLC ### Study Description This multicenter study will collect data to determine closure time for diabetic ulcers when following protocol parameters and treatment with ProgenaMatrix™. ### Conditions - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ProgenaMatrix Keratin graft - standard of care ### Outcomes Primary Outcomes - time to wound closure Secondary Outcomes ### Location - Facility: United Wound Healing, Puyallup, Washington, 98371, United States @@
## A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a) - NCT ID: NCT06292013 - Study ID: 18812 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2029-03 - Lead Sponsor: Eli Lilly and Company ### Study Description The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). ### Conditions - Atherosclerotic Cardiovascular Disease (ASCVD) - Elevated Lp(a) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lepodisiran Sodium - Placebo ### Outcomes Primary Outcomes - Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint Secondary Outcomes - Change from Baseline in Lipoprotein(a) [Lp(a)] at Week 4 - Time to First Occurrence of Any of the Component of MACE-3 Composite Endpoint - Time to First Occurrence of Fatal or Non-Fatal Myocardial Infarction - Time to Cardiovascular Death - Time to Occurrence of All-Cause Death - Time to First Occurrence of Any Component of the MACE-4 Composite Endpoint (In the Population with Established ASCVD and CV Event, or Revascularization) - Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population At Risk for First CV event) - Time to First Occurrence of any Component of the MACE-4 Composite Endpoint (In the Population with Lp(a) ≥ 200 nmol/L) - Time to First Occurrence of Any Component of MACE-3 + MALE Composite Endpoint - Time to First Occurrence of Any Component of Coronary MACE-3 Composite Endpoint ### Location - Facility: Birmingham Clinical Research, Birmingham, Alabama, 35209, United States @@
## Examining the Effects of Morning and Evening Exercise on Glucose Regulation in Adults With Prediabetes - NCT ID: NCT06292000 - Study ID: 23-1721 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-06 - Lead Sponsor: University of Colorado, Denver ### Study Description Purpose of the Study: This study is to learn more about how exercising at different times of the day (morning versus evening) affects metabolism of glucose in the body, sleep, activity outside of exercise, and other factors.Procedures:* 2 screening visits to make sure you are eligible to be in the study. This will include a fasting blood draw and heart tracing (EKG).* If you are eligible, you will complete both exercise conditions in a random order. All participants in the study will complete the following separated by 3-4 weeks: * Baseline condition of NO exercise * Morning exercise for 3 days in a row * Evening exercise for 3 days in a row* You will be provided with an example diet to follow for the days you are completing the baseline and exercise conditions (three days total for each condition). This diet will be a "traditional" diet with a controlled amount of carbohydrates, protein, and fat per day. The investigators will provide you with examples of meals to eat during this time.* You will be asked questions and complete questionnaires about your health history, sleeping and awakening habits, and sleepiness levels.* You will undergo one x-ray scan to measure your level of body fat.* You will be asked to wear an activity monitor and sleep monitor for 6 days in a row three times during this study.* You will be asked to wear a continuous glucose monitor (CGM) for 6 days in a row three times during this study.* You will be asked to measure your saliva melatonin levels three times in the study. This will be done once per hour for 5 hours (a total of 6 saliva samples).* You will be asked to complete a procedure called a "hyperinsulinemic-euglycemic clamp" where you will have an IV placed and insulin and glucose infused with frequent lab and finger stick blood sugars monitored closely. This will be done 3 times during the study. ### Conditions - PreDiabetes - Obesity - Inactivity/Low Levels of Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - AM Exercise - PM Exercise ### Outcomes Primary Outcomes - Peripheral insulin sensitivity Secondary Outcomes - Free Living Glucose - Melatonin offset - AM Cortisol - Physical activity and sedentary behavior - Sleep outcomes ### Location - Facility: University of Colorado, Aurora, Colorado, 80045, United States @@
## Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation - NCT ID: NCT06291987 - Study ID: IRB23-1681 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2026-05 - Lead Sponsor: University of Chicago ### Study Description The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs. ### Conditions - Myeloproliferative Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Ivosidenib - Ruxolitinib ### Outcomes Primary Outcomes - Maximum tolerated dose Secondary Outcomes - Overall Survival (OS) - Overall Response Rate (ORR) - Time to Response (TTR) - Duration of response (DOR) - Progression free survival (PFS) ### Location - Facility: University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, 60637, United States @@
## Ankle Foot Orthosis on Muscle Activity in Cerebral Palsy - NCT ID: NCT06291974 - Study ID: delta2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-11-30 - Lead Sponsor: Delta University for Science and Technology ### Study Description To compare the effect of solid ankle foot orthosis and ground reaction foot orthosis on the muscle activity in children with spastic diplegic cerebral palsy (Gross Motor Functional Classification Scale III). ### Conditions - Cerebral Palsy Spastic Diplegia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - electromyography ### Outcomes Primary Outcomes - muscle activity by Electromyography device Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia Major - NCT ID: NCT06291961 - Study ID: CS-101-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-07 - Lead Sponsor: CorrectSequence Therapeutics Co., Ltd ### Study Description The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating patients with β-thalassemia major anemia. ### Conditions - Beta-Thalassemia Major ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CS-101 injection ### Outcomes Primary Outcomes - AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-101 infusion - Overall survival rate - Proportion of subjects with engraftment - Time to neutrophil engraftment - Time to platelet engraftment - Incidence of transplant-related mortality - Change in fetal hemoglobin(HbF) concentration over time - Change in total hemoglobin(Hb) concentration over time Secondary Outcomes - Chimerism level in Peripheral blood and bone marrow - Proportion of subjects achieving transfusion independence for at least 6 consecutive months - Proportion of subjects achieving fetal hemoglobin(HbF) increase≥2.0 g/dL - Proportion of subjects achieving fetal hemoglobin(HbF) increase≥7.0 g/dL ### Location - Facility: The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, N/A, China @@
## A Clinical Study With Adalimumab Biosimilar - NCT ID: NCT06291948 - Study ID: 0225 - Status: COMPLETED - Start Date: 2022-08-01 - Completion Date: 2023-10-20 - Lead Sponsor: Laboratorios Richmond S.A.C.I.F. ### Study Description The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) \[Test Product\] vs. Humira® AC Pen \[Reference Product\] ### Conditions - Pharmacokinetics - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Humira® (adalimumab) AC Pen [Reference Product] - Adalimumab Richmond [Test Product] ### Outcomes Primary Outcomes - Peak Serum Concentration of adalimumab (Cmax) - Area Under the Serum Concentration-time Curve of adalimumab (ABC0-t) - Area Under the Serum Concentration- Time Curve ob adalimumab (ABC0-∞) Secondary Outcomes - Number of samples with positive Anti-adalimumab serum antibodies ### Location - Facility: FP Clinical Pharma S.R.L., Buenos Aires, N/A, C1425BAA, Argentina @@
## Safety and Tolerability of Intravitreal Administration of VG901 in Patients With Retinitis Pigmentosa Due to Mutations in the CNGA1 Gene - NCT ID: NCT06291935 - Study ID: VG901-2021 A - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-12 - Lead Sponsor: ViGeneron GmbH ### Study Description The goal of this phase 1 clinical trial is to learn about the safety and efficacy of a gene therapy, VG901, in patients with a rare disorder of the eye called Retinitis Pigmentosa. The main questions the study aims to answer are:* What is the best tolerated dose and are there any side effects, in particular any inflammatory reactions post drug administration?* Are there any early signs of efficacy on visual function?Participants will be administered a single intravitreal dose of VG901 into the most affected eye through a syringe and followed up for a year to monitor safety and efficacy. There will be two cohorts of participants in this study. Study Cohort 1 will receive the low dose and Study Cohort 2 will receive the high dose as specified in the Protocol. ### Conditions - Retinitis Pigmentosa ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VG901 ### Outcomes Primary Outcomes - Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary Outcomes - Physical Examination - Pulse rate - Blood pressure - Body temperature - Respiratory rate - Slit lamp examination - Fundus biomicroscopy - Optical coherence tomography (OCT) - Fundus autofluorescence - Tonometry - Adeno-associated virus (AAV) spread - Immunopathology ### Location - Facility: Center for Ophthalmology, University of Tuebingen, Tuebingen, N/A, 72076, Germany @@
## Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation - NCT ID: NCT06291922 - Study ID: 853181 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-06 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life. ### Conditions - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise Intervention - Usual Care ### Outcomes Primary Outcomes - Effects of exercise intervention on physical activity and capacity (step count) - Effects of exercise intervention on physical activity and capacity (distance) Secondary Outcomes - Effects of exercise intervention on frailty and muscle mass (frailty status) - Effects of exercise intervention on frailty and muscle mass (muscle quantity) - Effects of exercise intervention on quality of life - Cost-effectiveness of the exercise intervention vs. usual care ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia - NCT ID: NCT06291909 - Study ID: 205989 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2027-01 - Lead Sponsor: University of South Australia ### Study Description This is a randomised controlled study aiming to evaluate the implementation of a website ('Small Steps') to support the modification of participants' time-use behaviour to reduce the risk factors for dementia. 'Small Steps' website provides the tools for this with a visual representation of the participant's current use of time and allowing manipulation to demonstrate how small lifestyle changes may improve and meet sleep and physical activity needs. Participants will be assisted to make changes to current behaviours with the aim to reduce the time they spend sitting (sedentary behaviour), increase physical activity, and improve sleep duration and quality.Participants (aged 65 or older) will be randomly allocated to one of two groups, the 'Extended Program' (intervention) group or the 'Condensed Program' (control) group.There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this program and in total the program is 36-weeks long. Participants will use a tailored website to help support them in making progressive changes over the first 12 weeks. They will then try to maintain these behaviour changes for as long as possible. There will be in-person health testing during each phase and information about sleep habits, sleep quality, and motivation will be assessed using online surveys. Physical activity levels and sleep duration will also be assessed. ### Conditions - Dementia - Alzheimer Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Small Steps Program - Comparator Program ### Outcomes Primary Outcomes - Number of participant logins onto the "Small Steps" website - Number of participant check-ins on the "Small Steps" dashboard - Number of participant behavioural change choices on the "Small Steps" website during the Introduction Phase. The greater number of choices indicates a greater engagement with the intervention and use of the website. - Time participants spent on the "Small Steps" website - Duration of each participant behavioural change choice during the Introductory Phase - Holden's Simplified System Usability Scale - Health Care Climate Questionnaire - Behavioural Automaticity Questionnaire - (Behavioural Regulation in Exercise Questionnaire - Self-efficacy and Intention Questionnaire - Perceived Competence Scale - Exit interview - Daily activity - Sleep quality - Sleep Hygiene - Sleep quantity Secondary Outcomes - Addenbrooke's Cognitive Exam III - Trail Making Test - Digit Span Test ### Location - Facility: University of South Australia, Adelaide, South Australia, 5001, Australia @@
## A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection - NCT ID: NCT06291896 - Study ID: UBT 2023-01 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-15 - Lead Sponsor: Umbria Bioengineering Technologies ### Study Description This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs. ### Conditions - Women's Health: Neoplasm of Breast ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - MammoWave ### Outcomes Primary Outcomes - MammoWave® sensitivity - MammoWave® specificity Secondary Outcomes - Detection rates by type of lesion - Recall rate - Positive-predictive value - Program screening rate - BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density - MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study - Agreement between different evaluator (i.e. local versus central) - Volunteers' satisfaction questionnaire ### Location - Facility: Ospedale San Giovanni Battista - USL Umbria 2, Foligno, Perugia, 06034, Italy @@
## Evaluation of KGR Prescriptions in Suppressing COVID-19 Infection. - NCT ID: NCT06291883 - Study ID: CHUH112-REC2-008 - Status: COMPLETED - Start Date: 2023-02-09 - Completion Date: 2024-02-08 - Lead Sponsor: Sheng-Teng Huang ### Study Description These studies offer valuable insights into the potential development of KGR as a novel herbal-based preventive and therapeutic strategy against COVID-19. ### Conditions - Coronavirus Disease 2019 - Severe Acute Respiratory Syndrome Coronavirus 2 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Kang Guan Recipe (Treat) - Kang Guan Recipe (Placebo) ### Outcomes Primary Outcomes - Serum Infection rate of pseudocells Secondary Outcomes ### Location - Facility: China Medical University Hospital, Taichung, North District, 404, Taiwan @@
## Predictors of Post-COVID Clinical and Cognitive Consequences - NCT ID: NCT06291870 - Study ID: F4396-P - Status: RECRUITING - Start Date: 2023-01-19 - Completion Date: 2025-12-30 - Lead Sponsor: VA Office of Research and Development ### Study Description The CDC describes Post-acute sequelae of SARS-COV-2 infection (PASC) for the wide range of physical and mental health consequences experienced by some patients. These sequelae may be present four or more weeks after SARS-COV-2 infection, including patients who had initial mild or asymptomatic acute infection. However, there is complete absence of data whether chronic sleep changes due to COVID-19 infection may influence these physical and mental health consequences. While fatigue is one of the common post-COVID conditions, there are no systematic examinations of sleep disturbances in COVID-19 survivors. This will be a pilot observational retrospective and prospective cohort study, to systematically assess if sleep disturbances and severity of sleep apnea comprise a modifiable facet of PASC as well as the short-term and longer-term effects of COVID-19 infection itself on sleep, cognitive function, exercise capacity and lung function. ### Conditions - Post Acute Sequelae of SARS CoV 2 Infection - Obstructive Sleep Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Neurocognitive function Trails A and Trails B - Neurocognitive function PASAT - Neurocognitive function Stroop color-word interference - Neurocognitive function DIGIT - Neurocognitive function WASI - Neurocognitive function WMS - Neurocognitive function PVT - Neurocognitive function HVLT-R - Sleepiness ESS - Sleep quality PSQI - Quality of life SF-36v2 - Quality of life FOSQ - Quality of life SGRQ - Fatigue Severity - PROMISE Sleep Disturbance - Horne and Osteberg Morningness/Eveningness Questionnaire - Mini Mental State Examination (MMSE) - Borg Scale - Dyspnea: Six-minute walk test (6MWT) distance Secondary Outcomes ### Location - Facility: John D. Dingell VA Medical Center, Detroit, MI, Detroit, Michigan, 48201-1916, United States @@
## A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine - NCT ID: NCT06291857 - Study ID: CIC-E-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-30 - Completion Date: 2025-04-09 - Lead Sponsor: Novavax ### Study Description The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant - Novavax COVID-19 Vaccine - Comparator Influenza Vaccine - Fluarix - Comparator Influenza Vaccine -Fluarix High Dose - Placebo 0.9% sodium chloride for injection ### Outcomes Primary Outcomes - Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs - Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs). - Safety-Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis) over 6 months Secondary Outcomes - Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT - Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMFR - Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as SCR - Immunogenicity- HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR - Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMT - Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMFR - Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as SCR - Influenza NAb responses: neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, is expressed as GMTR - SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMT - SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMFR - SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as SCR - SARS-CoV-2 NAb responses: neutralizing antibody titers specific to the homologous SARS-CoV-2 strain Expressed as GMTR ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ocular Trauma and COVID-19 in Indonesia - NCT ID: NCT06291844 - Study ID: Cohort-Mata-2023-1 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-06-01 - Lead Sponsor: Prof. R. D. Kandou General Hospital ### Study Description Ocular injuries, a significant contributor to avoidable blindness globally, impact approximately 55 million individuals each year. Prompt initial treatment is vital for improving vision, yet the scarcity of skilled eye specialists often results in overcrowding at advanced medical centers. Moreover, the COVID-19 outbreak has introduced distinct factors into the management of ocular trauma. This research investigated the epidemiology of ocular injuries during the pandemic and offered observations on the distinctive hurdles and trends encountered. ### Conditions - Ophthalmological Disorder - Ocular Injury - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ocular Trauma Secondary Outcomes ### Location - Facility: Department of Ophthalmology, Prof. R. D. Kandou General Hospital - Faculty of Medicine, Sam Ratulangi University, Manado, North Sulawesi, N/A, Indonesia @@
## A Study to Learn About the Use of Paxlovid in Patients With COVID-19 in the Kingdom of Bahrain. - NCT ID: NCT06291831 - Study ID: C4671050 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-05-13 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to collect information on the:* general information of a group of people such as their age, sex* clinical information of the patients such as any other illness before having COVID 19.* the number of COVID-19 patients who meet and follow the most up to date World Health Organization (WHO) recommendations for medication to treat COVID-19 (such as version 14, published 10Nov2023) compared to Kingdom of Bahrain national recommendations* adult COVID-19 patients' health care resource use and outcomes within the 28-day period In adult patients with COVID-19 who have been prescribed nirmatrelvir and ritonavir treatment.This study will be conducted in the Kingdom of Bahrain. The study will capture information of the adult COVID-19 outpatients and inpatients who have been prescribed nirmatrelvir, ritonavir treatment and those not treated with nirmatrelvir, ritonavir.This study will have about 3000 patients treated with Paxlovid™ therapy and 1000 were not. The study will involve collection of patient information from medical records. The information collected can be either from papers or from computers.The study will include patient information of those who:* had COVID-19 infection during the study period from 16 February 2022 to 30 November 2022.* are 18 years of age or older. This study will help to inform decision-making on use of Paxlovid at the national level. ### Conditions - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - nirmatrelvir, ritonavir - Controls ### Outcomes Primary Outcomes - Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Age - Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Gender - Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Ethnicity - Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Education - Demographic characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Employment status - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Height - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Weight - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Body Mass Index (BMI) - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Smoking status - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Pre-existing Comorbidities - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Concomitant medications for comorbidities at index date - Clinical characteristic of COVID-19 patients who have been Prescribed nirmatrelvir, ritonavir treatment and those not treated COVID antiviral: Medications used to treat COVID-19 Secondary Outcomes - Assessment of all Participants HRU: Inpatient setting - Assessment of all Participants HRU ### Location - Facility: Pfizer Gulf FZ, Busaiteen, N/A, N/A, Bahrain @@
## Self-Adhering Magnetic Device to Treat Corneal Exposure - NCT ID: NCT06291818 - Study ID: 2023-0917 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: University of Illinois at Chicago ### Study Description Paralytic lagophthalmos can be difficult to treat and manage. It has a host of causes and effects, one of which (for the latter) is exposure keratopathy. Untreated, this can lead to corneal ulceration, inflammation, and potentially blindness. Despite a variety of attempts at treating this complex condition, none have satisfactorily reduced complications ranging from ease of use to aesthetics. With improvement in magnetic technology, however, that may change. Barmettler et al (2014) have demonstrated preliminary success of externally affixed magnets in closing both model and patient eyelids. As such, we hypothesize that magnetic devices can be used to treat corneal exposure by controlling eyelid position. ### Conditions - Paralytic Lagophthalmos - Corneal Exposure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - temporary magnetic system for tarsorrhaphy (MST) ### Outcomes Primary Outcomes - Number of participants with success of a temporary magnetic system for tarsorrhaphy Secondary Outcomes ### Location - Facility: University of Illinois - Specialty Care Building, Chicago, Illinois, 60612, United States @@
## Phenotyping and Characterization of wtATTR-CM (TRACE 1) - NCT ID: NCT06291805 - Study ID: 1-10-72-189-23 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-12 - Lead Sponsor: Steen Hvitfeldt Poulsen ### Study Description Descriptive cross-sectional study on 100 consecutive ATTRwt-CM patients reflecting all NAC stages aiming primarily to investigate ATTRwt-CM patient's quality of life (QoL) measures and their relation to ATTRwt-CM severity. Secondarily aiming to investigate the possibility to measure misTTR and fragTTR in plasma and urine and to detect fragTTR in endomyocardial biopsies from ATTRwt-CM patients. To investigate whether misTTR and fragTTR levels are correlated with ATTRwt-CM severity. ### Conditions - Transthyretin Amyloidosis - Transthyretin Amyloid Cardiomyopathy - Wild-Type Transthyretin-Related (ATTR)Amyloidosis - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Investigation of cardiac amyloidosis severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. - Investigation of the relations between cardiac amyloid severity and patient quality of life in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy. - Assessment of transthyretin and pathogenic fragments and relation to cardiac amyloid severity in patients with Wild-type Transthyretin Amyloidosis Cardiomyopathy Secondary Outcomes - Validation of a new amyloid specific questionnaire (ATTR-QoL) in comparison with Kansas City Cardiomyopathy Questionnaire (KCCQ) ### Location - Facility: Aarhus University Hospital, Aarhus, Arrhus N, 8200, Denmark @@
## Otago Exercise Program Applied By Telerehabilitation - NCT ID: NCT06291792 - Study ID: FTR001 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-03-01 - Lead Sponsor: Sinop University ### Study Description The aim of this study is to examine the effects of Otago Exercise Program (OEP) on pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life and balance with the telerehabilitation method in individuals with a history of falling, which is frequently seen in elderly individuals due to aging.45 people between the ages of 65 and 78 participated in the study. They were randomly divided into 3 groups as control, telerehabilitation otago exercise program (TOEG) and face-to-face otago exercise program (FOEG). 45 minutes of OEP was applied 3 times a week for 8 weeks. Pain, walking speed, lower extremity muscle strength, fear of falling, anxiety, quality of life, and balance were evaluated before the Otago Exercise Program, at the 4th week, at the 8th week, and 4 weeks after the end of the exercise program. Significance was evaluated at the p\<0.05 level in the study. ### Conditions - Older People--Abuse of - Falling - Balance; Distorted ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - telerehabilitation otago exercise program - face to face otago exercise program ### Outcomes Primary Outcomes - Numerical Pain Scale - Walking Speed - lower extremity muscle strength - Fall effectiveness scale - Beck anxiety scale - Tinetti balance and walking test - World Health Organization Quality of Life Scale: Secondary Outcomes ### Location - Facility: Bahçeşehir University research application center, Istanbul, N/A, N/A, Turkey @@
## Diagnosis of Pancreatic Cancer by Purine Metabolite (Hypoxanthine, Xanthine) in Urine - NCT ID: NCT06291779 - Study ID: SNUBH-GS- HBP5 - Status: RECRUITING - Start Date: 2022-11-30 - Completion Date: 2024-05-31 - Lead Sponsor: Ho-Seong Han ### Study Description * This study aim to develope a diagnostic method of pancreatic cancer by using a reagent for analyzing purine metabolite (Hypoxanthine, Xanthine) in urine.* It is safe and cost effective compare to radiologic or blood test. It can be used for initial screening test for healty population. ### Conditions - Pancreas Cancer - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Purine metabolite (Hypoxanthine, Xanthine) in urine by CubeBio ### Outcomes Primary Outcomes - Urine Secondary Outcomes ### Location - Facility: Ho-Seong Han, Seongnam, Gyeonggi-do, N/A, Korea, Republic of @@
## Gestational Diabetes After Gastric Bypass Surgery - NCT ID: NCT06291766 - Study ID: 2022-05498-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2035-12 - Lead Sponsor: Region Skane ### Study Description The goal of this trial is to compare different means of glucose monitoring in women with gestational diabetes and a history of gastric bypass surgery.The main question it aims to answer is:How does continous glucose monitoring impact the treatment and affect pregnancy outcome in these women.Participants will be randomized to either continous glucose monitoring or regular capillary glucose measurements during the last trimester of their pregnancy. Researchers will compare the glucose measurement outcomes, the glucose lowering treatment given and pregnancy outcomes between groups. ### Conditions - Diabetes, Gestational - Gastric Bypass Status for Obesity Complicating Pregnancy, Childbirth, or the Puerperium - Pregnancy in Diabetic - Blood Glucose Self Monitoring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FreeStyle Libre 2, continous glucose monitoring ### Outcomes Primary Outcomes - Adverse Pregnancy Outcome Secondary Outcomes - Glucose values - Glucose values - Glucose values - Glucose values - Glucose values - Pharmacological treatment - Pharmacological treatment - Pharmacological treatment - Pharmacological treatment - Birthweight - Week of delivery ### Location - Facility: Region Skane, Lund, N/A, 221 85, Sweden @@
## Characteristics and Tumor Staging Proposal for Primary Malignant Melanoma of the Esophagus - NCT ID: NCT06291753 - Study ID: SL-B2023-478-01 - Status: COMPLETED - Start Date: 2023-09-22 - Completion Date: 2024-02-18 - Lead Sponsor: Sun Yat-sen University ### Study Description Background: Primary malignant melanoma of the esophagus (PMME) is a malignant tumor originating from esophageal melanocytes with a poor prognosis. No international clinical guidelines or tumor staging systems have been proposed for PMME. This study aimed to analyze the clinical characteristics and treatment outcomes of patients with PMME and propose a tumor staging system in PMME.Materials and Methods: The clinical characteristics of 25 patients with PMME at our cancer center were summarized, and 21 patients were enrolled in a pooled analysis with 162 cases (extracted from 74 eligible articles in PubMed) for further survival analysis and proposal of PMME tumor staging. ### Conditions - Primary Malignant Melanoma of the Esophagus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Overall Survival(OS) - Disease-free survival (DFS) Secondary Outcomes ### Location - Facility: Qianwen Liu, Guangzhou, Guangdong, N/A, China @@
## Continuous Versus Intermittent Nebulization Therapy in Acute Asthma Exacerbation at Emergency Department - NCT ID: NCT06291740 - Study ID: MTU-EC-EM-2-008/67 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Thammasat University ### Study Description The goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ED). Participants will random assign to either continuous or intermittent nebulization. In the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. In the intermittent group, the same medications are administer every 20 minutes for an hour. Measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. Primary endpoints are ED stay length, hospital admission, and ED revisit within 48 hours post-discharge. Adverse events are documented. ### Conditions - Asthma Exacerbation - Emergency Department - Nebulization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - continuous nebulization - Intermittent nebulization ### Outcomes Primary Outcomes - Length of ED stay Secondary Outcomes - pulmonary function test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA - NCT ID: NCT06291727 - Study ID: Prisma Upstate - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-07-01 - Lead Sponsor: Prisma Health-Upstate ### Study Description This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization. ### Conditions - Anesthesia, Spinal - Arthroplasty, Replacement, Knee ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mepivacaine - Bupivacaine ### Outcomes Primary Outcomes - Same day discharge rate Secondary Outcomes - Post-operative pain score as assessed by numeric rating scale (NRS) - Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively - Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity - Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively - Pain Medications as evaluated by medical morphine equivalents - Patient satisfaction levels as assessed by a 5-item Likert response scale ### Location - Facility: Prisma Health Patewood Hospital, Greenville, South Carolina, 29615, United States @@
## Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension - NCT ID: NCT06291714 - Study ID: Clearsight - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03-31 - Lead Sponsor: University of Giessen ### Study Description In order to reduce the incidence of IOH, various goal-directed therapy (GDT) protocols have already been introduced with success regarding the reduction of postoperative AKI and MINS. However, these studies used an invasive hemodynamic monitoring which offered a continuous surveillance of the blood pressure. In contrast, standard non-invasive blood pressure monitoring results in a blind gap between two measurements (mostly three or five minutes). In order to address this limitation, different continuous non-invasive blood pressure monitoring devices have been introduced. The next evolutional step of non-invasive cardiac output monitoring was to prevent IOH before their onset by using the Hypotension Prediction Index (HPI). Based on the Edward ́s monitoring platform, HPI is a monitoring tool which aims to predict IOH (defined as MAP\<65 mmHg for at least one minute) up to 15 min before its onset. The underlying machine learning based algorithm uses analyses features from the pressure waveform and was first calculated from a large retrospective data set of surgical patients and subsequently validated in a prospective cohort. In this study HPI showed a sensitivity of 88% and specificity of 87% for predicting IOH 15 min before its onset. Since then, own and studies of other working groups confirmed the effective prevention of IOH by the use of HPI-based GDT. Until today the arterial waveform analysis was dependent on invasive arterial measurement but since Edwards Lifesciences already promoted the start of the HPI on the ClearSight platform a non-invasive measurement will soon be possible.Further, until now it has not yet been proven that the perioperative use of a continuous non-invasive blood pressure monitoring has a beneficial effect on the patient´s outcome.Study objectives The aim of the study is to investigate whether a hemodynamic protocol based on continuous non-invasive cardiac output monitoring (ClearSight system) compared to standard care can reduce the incidence of IOH, postoperative AKI, and MINS in patients undergoing major trauma and orthopedic surgery. ### Conditions - Intraoperative Hypotension - Acute Kidney Injury - Myocardial Injury After Non-cardiac Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - GDT-based hemodynamic management based on Clearsight device ### Outcomes Primary Outcomes - Change of the frequency of intraoperative hypotension - Change of the absolute duration of of intraoperative hypotension - Change of the relative duration of intraoperative hypotension Secondary Outcomes - AKI - MINS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Relationship Between Scapular Endurance, Core Endurance, and Functional Performance in Adolescent Tennis Players - NCT ID: NCT06291701 - Study ID: ODUSBFFTR-ELIFAYGUNPOLAT-002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-04-15 - Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ ### Study Description This study aims to examine the relationship between scapular endurance, core endurance, and upper extremity performance in adolescent tennis players. The hypothesis of this study is that better scapular/core endurance in adolescent tennis players is associated with better upper extremity performance. Establishing this relationship will contribute to identifying the exercise training necessary to improve upper extremity performance in tennis players. ### Conditions - Athletic Injuries - Sports Physical Therapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessment of scapular endurance - Prone Bridge Test - Side Bridge Test - Closed Kinetic Chain Upper Extremity Stability Test - Seated Medicine Ball Throw Test ### Outcomes Primary Outcomes - Prone Bridge Test - Side Bridge Test - Scapular Endurance Values - Closed Kinetic Chain Upper Extremity Stability Test - Seated Medicine Ball Throw Test Secondary Outcomes ### Location - Facility: Ordu University, Ordu, N/A, 52200, Turkey @@
## Applying Mobile Healthcare Education to Improve Cutaneous Self-care Capability - NCT ID: NCT06291688 - Study ID: 202312004RIND - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2026-01-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description The goal of this clinical interventional study is to compare the efficacy of mobile healthcare education in two ways (game-based or text-based) to improve cutaneous self-care capability in cancer patients receiving EGFR-based target therapy. The main questions it aims to answer are:Impact of different mobile healthcare education ways on cutaneous self-care capability of patients Impact of different mobile healthcare education ways on learning motivation of patients towards cutaneous self-care knowledge and skillsParticipants will be randomly divided into two groups. Both groups will download a healthcare education application on their phone. One group will accept the education about the knowledge and self-care skills of cutaneous adverse drug reaction by playing game. In contrast, the other group will accept the same education content by reading text on the phone. Subjects will be asked to use the application at home for two weeks after giving consent to participate this study, and then completed questionnaire three times during study period. The timepoints of completing questionnaire are listed following:Baseline / pre-intervention test (after signing informed consent form, D1) First post-intervention test (after finishing intervention, D15) Second post-intervention test (D30) Researchers will compare game group and text group to see if game group has better performance on cutaneous self-care capability and learning motivation. ### Conditions - EGFR Gene Mutation - Drug-Related Side Effects and Adverse Reactions - Cancer, Treatment-Related - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Mobile healthcare education game - Mobile healthcare education application ### Outcomes Primary Outcomes - Change from baseline in the score of cutaneous adverse drug reaction (CADR) knowledge on researcher-designed questionnaire at Day 15 and Day 30. Secondary Outcomes - Investigate the learning motivation towards CADR by self-designed questionnaire at Day 15 - Change from baseline in the score of the quality of life on DLQI questionnaire at Day 15 and Day 30 - Investigate the user-experience of the mobile healthcare education APP by researcher-designed questionnaire at Day 15. - Change from baseline in the score of the self-care measurement adherence on researcher-designed questionnaire at Day 15 and Day30. ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100225, Taiwan @@
## Gender-Affirming Hormone Therapy and Its Impact on Myocardial Mass and Cardiac Function, Heart, Liver and Pancreatic Fat Content - NCT ID: NCT06291675 - Study ID: 2083/2022 - Status: RECRUITING - Start Date: 2023-03-03 - Completion Date: 2033-03-03 - Lead Sponsor: Medical University of Vienna ### Study Description Background: Gender affirming hormone therapy (GAHT) leads to profound changes in sex hormone levels, carrying a wide range of implications for major physiological processes in the body. GAHT has been shown to be associated with changes in cardiovascular parameters, the insulin system, body composition, and the psychological state. However, despite the fact that GAHT is usually a long-term intervention, the majority of the research concerns itself with an overall short duration of the therapy and the data on the mid- to long-term effects of GAHT is scarce.Objectives: The study aims to investigate the effects of gender affirming hormone therapy on the cardiovascular risk profile, insulin system, body composition, various metabolic parameters, and the psychological state after 2, 5, and 10 years of the treatment.Study design: The study is designed as an observational longitudinal monocentric study, which includes transgender men and transgender women who have been taking gender affirming hormone therapy during the past 2 years and took part in our pilot study. Our probands will undergo a magnetic resonance scan, extensive bloodwork, an oral glucose tolerance test, and a psychological self-assessment after 2, 5, and 10 years of the treatment.Materials and methods: The magnetic resonance imaging and spectroscopy will be performed with a 3-Tesla magnetic resonance device. We will also perform an extensive blood analysis and an 75g- 2h oral glucose tolerance test. Additionally, the psychological state of the probands will be assessed with 3 questionnaires.Study population: 30 transgender men 30 transgender women who participated in our pilot study and have been taking the gender affirming hormone therapy for the past 2 years.Relevance and implications of the study: The majority of previous research has focused on the short-term effects of gender affirming hormone therapy. Contrastingly, our study aims to focus on the effects of hormone therapy at 2, 5 and 10 years after the beginning of the treatment. Moreover, our study group utilizes measurements of myocardial, hepatic, and pancreatic fat content as well as an MR-assisted measurement of cardiac function, which is a topic that has not been present in research into the effects of gender affirming hormone therapy outside of our pilot study. ### Conditions - Gender Dysphoria - Hormone Therapy Induced Morphologic Change ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - gender-affirming hormone therapy ### Outcomes Primary Outcomes - Myocardial mass - Cardiac function - LVEF - cardiac function - cardiac output index - Organ lipid content - Subcutaneous to visceral fat ratio Secondary Outcomes ### Location - Facility: Chiari Stoffwechselambulanz, Medical University of Vienna, Vienna, N/A, 1090, Austria @@
## Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing - NCT ID: NCT06291662 - Study ID: PRECISE_IC - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2025-06-30 - Lead Sponsor: Kathleen McGreevy ### Study Description Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. ### Conditions - Sarcoma - Intracranial Neoplasm - Pelvic Bone Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 3D printer applications ### Outcomes Primary Outcomes - 3D model feasibility for pre-surgical making decisions - Surgical time - Device feasibility Secondary Outcomes ### Location - Facility: Azienda Ospedaliero-Universitaria Careggi (AOUC), Firenze, N/A, N/A, Italy @@
## Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age - NCT ID: NCT06291649 - Study ID: AMIETOX - Status: RECRUITING - Start Date: 2023-04-05 - Completion Date: 2033-08-05 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room). ### Conditions - Acute Intoxication ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determination of Incidence of intoxication in paediatric children - Determination of Prevalence of intoxication in paediatric children Secondary Outcomes ### Location - Facility: Ospedale Santa Maria Annunziata, Bagno A Ripoli, Firenze, 50139, Italy @@
## Re- Admission Rate Among Survived Patients With Acute Respiratory Failure - NCT ID: NCT06291636 - Study ID: R.24.01.2451 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-01-20 - Lead Sponsor: Mansoura University ### Study Description Readmission to the intensive care unit (ICU) results in increased consumption of medical resources and costs, and has been proposed as a marker for quality of care. ICU readmission rates have been estimated at 4 to 14% and different risk factors have been proposed by various studies Readmitted patients mostly carry poor prognosis compared to newly admitted ones, in addition to the bad psychological impact for both patient and his family ### Conditions - Respiratory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Length of hospital and ICU stay and Cause of readmission Secondary Outcomes ### Location - Facility: Tamer Awad Elsayed, Mansoura, Dakhlia, 050, Egypt @@
## Molecular Analysis of Intracanal Microbes After Chemomechanical Procedure and Root Canal Medication: Clinical Study - NCT ID: NCT06291623 - Study ID: Molecular Analysis - Status: COMPLETED - Start Date: 2022-05-03 - Completion Date: 2024-01-15 - Lead Sponsor: Mansoura University ### Study Description This study aimed to evaluate clinically the intracanal microbes at molecular level after using established root canal medicament Calcium hydroxide and potential root canal medicament Glycyrrhizin.and Decontamination Analysis of Controls samples. ### Conditions - Bacterial Viability of Necrotic Pulp With Asymptomatic Apical Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Glycyrrhizin ### Outcomes Primary Outcomes - minimizing of viable bacteria which showed by Real time PCR Secondary Outcomes ### Location - Facility: Mansoura University, Mansoura, Dakahliya, 35511, Egypt @@
## Feasibility Testing a Decision-support Intervention for Clinical Trials - NCT ID: NCT06291610 - Study ID: Aarhus University Hospital - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2026-12-31 - Lead Sponsor: University of Aarhus ### Study Description A decision-support intervention are developed for a Danish nationwide randomised controlled trial (RCT) among patients with laryngeal and pharyngeal cancer referred to curative intended radiotherapy. The primary endpoints in this RCT are levels of dysphagia and xerostomia.The decision-support intervention consists of three components, including (1) a patient decision aid tailored to clinical trial participation and (2) decision coaching consultations carried out by trained healthcare professionals. Finally, (3) a training program in decision coaching will be an integrated part of the intervention.To feasibility test (beta test) the intervention, 60 patient participants will be included, separated into pre- (n=30) and post- (n=30) intervention groups. Pre-intervention to complete the survey based on current clinical practice. Post-intervention to complete the survey following engagement in the decision support intervention.A total of 12 physicians will be recruited and trained in decision coaching. To assess the acceptability of the intervention, the physicians will be interviewed. Additionally, they will be asked to audio-record two decision coaching sessions to test the fidelity of the intervention. ### Conditions - Head and Neck Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Clinical trial decision support intervention ### Outcomes Primary Outcomes - Decisional conflict scale - The decision preparation scale Secondary Outcomes - The stages of decision making measure - Items on health literacy ### Location - Facility: Aarhus University Hospital, Aarhus, N/A, 8200, Denmark @@
## Vaping Adverse Lung and Heart Events Cohort - NCT ID: NCT06291597 - Study ID: 22071 - Status: RECRUITING - Start Date: 2021-10-14 - Completion Date: 2032-06 - Lead Sponsor: Laval University ### Study Description This prospective study assesses the pulmonary and cardiovascular effets of vaping in adult electronic cigarette users with biannual visits and a 5-year follow-up. ### Conditions - Vaping - Electronic Cigarette Use ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vaping ### Outcomes Primary Outcomes - Number of participants who vape daily with impaired lung volumes. - Number of participants who vape daily with impaired lung diffusion capacity. - Number of participants who vape daily with impaired spirometry. - Number of participants who vape daily with airway hyperresponsiveness. - Number of participants who vape daily with changes in blood cell count. - Number of participants who vape daily with changes in sputum cell count. - Vaping, tobacco and cannabis smoking habits of participants. Secondary Outcomes ### Location - Facility: IUCPQ-UL, Québec, N/A, G1V 4G5, Canada @@
## Effects of Exercises on Functional Capacity - NCT ID: NCT06291584 - Study ID: P20230001 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-10-01 - Lead Sponsor: Kırklareli University ### Study Description In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity. ### Conditions - Nicotine Addiction - Respiratory Disease - Sedentary Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise ### Outcomes Primary Outcomes - International Physical Activity Questionnaire - Short Form - Six-Minute Walk Test- (6MWT) Secondary Outcomes ### Location - Facility: Kirklareli University, Kırklareli, Kayalı, 39000, Turkey @@
## Assessment of Microorganisms and Host Response In Liver Diseases - NCT ID: NCT06291571 - Study ID: 324543 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2030-03-01 - Lead Sponsor: University of Aberdeen ### Study Description The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease. ### Conditions - Gut Microbiome - Liver Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To identify the bacterial, fungal, and virological agents present in patients with liver disease as opposed to controls Secondary Outcomes - To assess the host immune response against specific microbes isolated from patients with liver disease and controls - To characterise the changes in the liver immune microenvironment by analysing liver biopsies from patients ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exercise Training for Smoking Students - NCT ID: NCT06291558 - Study ID: P202200027 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2024-10-01 - Lead Sponsor: Kırklareli University ### Study Description Smoking can damage lung functions as a result of high carbon monoxide and low hemoglobin oxygen carrying capacity in the blood. Smoking between young people continues to increase, which can cause respiratory function problems and lung diseases at an early age. In the studies, it has been seen that smoking may reduce the oppression and exercise ability. ### Conditions - Nicotine Dependence - Smoking - Physical Inactivity - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exercise ### Outcomes Primary Outcomes - International Physical Activity Questionnaire (Short) - Six-Minute Walk Test - Scoring the Fagerstrom Test for Nicotine Dependence (FTND) - Beck's Depression Inventory (BDI) - Lung Function Test Secondary Outcomes ### Location - Facility: Kirklareli University, Kırklareli, Kayalı, 39000, Turkey @@
## Effectiveness and Safety of Coronary Scoring Balloon Dilation Catheter in the Pretreatment of Coronary Stenosis Lesions - NCT ID: NCT06291545 - Study ID: JW-SBC202202 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-06-30 - Lead Sponsor: JW Medical Systems Ltd ### Study Description This trial adopts a prospective, multicenter, randomized controlled, and non-inferiority comparison trial design, and plans to recruit 200 eligible subjects who will be randomly assigned to the experimental group or the control group in a 1:1 ratio. All randomly enrolled subjects will be followed up until 30 days after the surgery. ### Conditions - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Coronary artery scoring balloon dilation catheter（JW Medical Systems Ltd） - ScoreFlex NC Coronary Dilatation Catheter ### Outcomes Primary Outcomes - Rate of successful device usage Secondary Outcomes - Rate of success of the surgery - Incidence of in-hospital MACE - Incidence of PoCE within 30 days after surgery - The lumen is obtained immediately ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility and Usability of a Virtual Reality System - NCT ID: NCT06291532 - Study ID: VRRS01 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-04-01 - Completion Date: 2025-09-30 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults. ### Conditions - Autism Spectrum Disorder - Intellectual Disability ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rehabilitation with VRRS ### Outcomes Primary Outcomes - Usability questionnaire - Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time - Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises. - Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise. Secondary Outcomes ### Location - Facility: IRCCS Centro Neurolesi Bonino Pulejo, Messina, N/A, 98124, Italy @@
## The Effect of Multisensory Stimulus Method on Pain and Physiological Parameters in Infants - NCT ID: NCT06291519 - Study ID: SHN50343434 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-30 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description This study aimed to investigate the impact of employing the multi-sensory stimulation technique by both the mother and the nurse on the pain and physiological responses of infants aged 2-6 months during vaccination. The significance of pain experienced during vaccination in children is emphasized, potentially leading to avoidance behaviors toward healthcare services. There is growing evidence supporting the efficacy of non-pharmacological interventions. Multi-sensory stimulation, which integrates various stimuli such as taste, touch, and speech, alleviates infant pain. However, there has been a lack of studies assessing the effectiveness of this approach during vaccination administered by different healthcare providers. Hence, this study sought to explore the effects of multi-sensory stimulation by both mother and nurse applied to pain and physiological parameters. It is anticipated that the findings of this study will contribute to both pain management strategies and healthcare practices. ### Conditions - Multisensory Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Multi-sensory Stimulation Method-Mother Applying the Method to the Baby - Multi-sensory Stimulation Method-Nurse Applying the Method to the Baby - Breastfeeding Applied Group ### Outcomes Primary Outcomes - The Effect of Multiple Sensory Stimulus Method Secondary Outcomes - Comparison of the group in which the mother applied multiple sensory stimuli and the group in which the nurse applied multiple sensory stimuli ### Location - Facility: Istanbul University-Cerrahpasa, Istanbul, None Selected, 34381, Turkey @@
## SUbstrate Ablation in Persistent Atrial Fibrillation for Elimination of Recurrences (SUPAFER). - NCT ID: NCT06291506 - Study ID: 6270 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Hospital Universitario La Paz ### Study Description Antecedents: electrical isolation of pulmonary veins is the standard treatment for patients with atrial fibrillation. However, its efficacy is lower in persistent and chronic forms of this arrhythmia compared to paroxysmal atrial fibrillation. Many complementary techniques have been proposed, that added to pulmonary veins isolation, may reduce the recurrence rate of atrial fibrillation. However, none of them has obtained consistent results. Linear ablation aims to parcellate and modify the left atrial substrate responsible for atrial fibrillation maintenance. Previous studies have offered contradictory results using linear ablation.Methods: SUPAFER is a multicenter, 1:1 randomized clinical trial that compares the efficacy of pulmonary veins isolation alone vs pulmonary vein isolation plus an specific protocol of left atrial linear ablation. Contrary to previous studies, the specific SUPAFER linear ablation is systematic, homogeneous and target atrial areas that have not been systematically ablated in previous trials. The trial aims at demonstrating the superiority of the combined ablative approach during 1-year follow-up. Daily transtelephonic ECG samples a 30 days continuous ECG monitoring are used to maximize de detection of recurrences, even asymptomatic. ### Conditions - Persistent and Long Lasting or Chronic Atrial Fibrillation - Atrial Fibrillation Ablation - Linear Left Atrial Ablation - Daily Transtelephonic Electrocardiogram ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiofrequency ablation of heart atrial tissue. ### Outcomes Primary Outcomes - Recurrences of sustained >30 secons atrial arrhythmias measured by daily ECG samples (Kardia Alivecor) and 30 days continuous Holter. Secondary Outcomes - Acute intraprocedure efficacy. - Complications. ### Location - Facility: La Paz University Hospital - IdiPaz, Madrid, N/A, N/A, Spain @@
## Precision Study Measuring Potassium (K) in Capillary Specimens - NCT ID: NCT06291493 - Study ID: CS-2024-0002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: Abbott Point of Care ### Study Description Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer. ### Conditions - Precision of Potassium (K) Test in Capillary Whole Blood ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Fingerstick blood draw ### Outcomes Primary Outcomes - Precision for Potassium (K) Test Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Music Therapy After Stroke (Subacute Phase) - NCT ID: NCT06291480 - Study ID: NL78853.058.22 / STRUM - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12 - Lead Sponsor: Universiteit Leiden ### Study Description The goal of this longitudinal, single-subject study is to investigate the role of motivation in music therapy for stroke patients within the subacute phase, who experience upper limb and/or attention deficits. The main questions it aims to answer are:* Does music therapy increase patient's motivation to rehabilitate?* Do increases in motivation correlate with functional improvements, in particular upper limb and/or attention skills?Participants will receive up to 9 music therapy sessions within 3-5 weeks, with functional assessments before and after each period. Each participant serves as their own comparison: researchers will compare a period with standard care only (control phase) to a period with music therapy plus standard care (intervention phase), the order of which will be randomized in advance. ### Conditions - Stroke (CVA) or TIA - Stroke/Brain Attack ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Neurologic Music Therapy ### Outcomes Primary Outcomes - Motivation: Brain Injury Rehabilitation Trust Motivation Questionnaire (BMQ-S) [self-reported] Secondary Outcomes - Motor Function: Action Research Arm Test (ARAT) - Motor Function: Barthel Index (BI) - Cognition: Cancellation Wechsler Adult Intelligence Scale (WAIS-IV) - Cognition: Color-Word Interference Test, also known as Stroop test - Cognition: WAIS IV Digit Span Test - Forward and Backward - Cognition: Verbal Fluency Test - Cognition: Trail Making Test (TMT) ### Location - Facility: Leo Polak Rehabilitation centre, Amsterdam, Nederland, 1069BW, Netherlands @@
## Plasma Beta-endorphin Levels and Suicidal Behavior - NCT ID: NCT06291467 - Study ID: RECHMPL23_0121 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: University Hospital, Montpellier ### Study Description It is an interventional research, monocentric, which involves only minimal risks and constraints.Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA. ### Conditions - Suicide - Depression - Beta Endorphin ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Blood samples - questionnaires ### Outcomes Primary Outcomes - Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt. Secondary Outcomes - - The kinetics of β-endorphin levels between two measurement points (inclusion and D7+/-2 days) in patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any history of suicide attempt. - The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS) - The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16) - To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion, - To assess the association between β-endorphin levels and Anhedonia - To assess the association between β-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion - To assess the association between β-endorphin levels and Anxiety, ### Location - Facility: University hospital, Montpellier, N/A, 34295, France @@
## GCF Levels of Chemokines in Periodontitis - NCT ID: NCT06291454 - Study ID: 741100 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-01 - Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ ### Study Description This study aimed to determine CCL19/MIP3beta(β) and CCL20/MIP3alpha(α) in the gingival crevicular fluid (GCF) of the patients with different periodontitis phenotypes.A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA. ### Conditions - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Routine periodontal examination ### Outcomes Primary Outcomes - CCL19/MIP3beta(β) levels - CCL20/MIP3alpha(α) levels Secondary Outcomes - CCL19/MIP3beta(β) levels and clinical parameters - CCL20/MIP3alpha(α) levels and clinical parameters ### Location - Facility: Ordu University, Faculty of Dentistry, Ordu, N/A, 52100, Turkey @@
## Women Urinary Incontinence Prevalence Study (WUIPS) - NCT ID: NCT06291441 - Study ID: WUIPS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: IRCCS San Raffaele ### Study Description The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG). ### Conditions - Female Urinary Incontinence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Prevalence of middle-aged women with urinary incontinence Secondary Outcomes - Predictors of urinary incontinence in middle-aged women - Quality of life of middle-aged women with urinary incontinence - Social impact of middle-aged women with urinary incontinence - Costs of urinary incontinence for middle-aged women ### Location - Facility: Policlinico San Marco Zingonia, Osio Sotto, Bergamo, 24040, Italy @@
## Raman Spectroscopy Compared to Flow Cytometry - NCT ID: NCT06291428 - Study ID: F-CNIC-2024-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-15 - Completion Date: 2026-12-30 - Lead Sponsor: Hospital Regional de Alta Especialidad del Bajio ### Study Description The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).Objectives:MAIN OBJECTIVE:To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy.SPECIFIC OBJECTIVES:* To assess the presence of MRD using flow cytometry in patients with ALL.* To assess the presence of MRD using Raman spectroscopy in patients with ALL.* To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.* To establish the validation of using Raman spectroscopy as a method for MRD evaluation.Study Design:An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48.Inclusion Criteria:Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy. ### Conditions - Acute Lymphoblastic Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Raman spectroscopy ### Outcomes Primary Outcomes - measurable residual disease Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) - NCT ID: NCT06291415 - Study ID: 2022-523-GLOB1 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2026-11 - Lead Sponsor: Hutchmed ### Study Description This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP. ### Conditions - Immune Thrombocytopenia - Blood Platelet Disorder - Hematologic Diseases - Purpura, Thrombocytopenic - Purpura - Blood Coagulation Disorder - Thrombotic Microangiopathies - Hemorrhagic Disorders - Autoimmune Diseases - Immune System Diseases - Hemorrhage - Pathologic Processes - Skin Manifestations - Thrombocytopenia - Purpura, Thrombocytopenic, Idiopathic - Primary Immune Thrombocytopenia - ITP - Immune Thrombocytopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HMPL-523 ### Outcomes Primary Outcomes - Safety and tolerability of HMPL-523 in adult subjects with primary ITP - Dose Limiting Toxicities Secondary Outcomes - Cmax (maximum plasma drug concentration) - AUCtau (area under the concentration-time curve over a dosage interval) - Tmax (time to reach maximum plasma drug concentration) - Cmin (minimum plasma drug concentration) ### Location - Facility: Center for Cancer and Blood Disorders, Bethesda, Maryland, 20817, United States @@
## Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery - NCT ID: NCT06291402 - Study ID: RC 34-1-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-06-15 - Lead Sponsor: Al-Azhar University ### Study Description Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis. ### Conditions - Rhinitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sore throat Secondary Outcomes - Dysphagia - Throat irritation ### Location - Facility: Neveen Kohaf, Tanta, N/A, 11865, Egypt @@
## Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication - NCT ID: NCT06291389 - Study ID: RC.2.8.2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-05-15 - Lead Sponsor: Al-Azhar University ### Study Description An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function. ### Conditions - Abdominal Compartment Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Intraoperative peak airway pressure (PAP) Secondary Outcomes - Duration of oxygen therapy - Post operative Tidal Volume (Vt) (Measured by spirometer) - Post operative Respiratory Rate (RR) - Hospital stay. ### Location - Facility: Neveen Kohaf, Tanta, N/A, 11865, Egypt @@
## Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) - NCT ID: NCT06291376 - Study ID: D928FC00001 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2029-10-25 - Lead Sponsor: Alexion Pharmaceuticals, Inc. ### Study Description The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression. ### Conditions - Immunoglobulin A Nephropathy - IgAN ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ravulizumab - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 - Glomerular Filtration Rate (eGFR) Over 106 Weeks Secondary Outcomes - Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106 - Change From Baseline in eGFR at Weeks 34, 50, and 106 - Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106 - Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106 - Number of Participants With Partial Remission at Weeks 34, 50, and 106 - Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106 - Number of Participants With Composite Kidney Failure Endpoint - Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106 - Number of Participants With Kidney Hierarchical Composite Endpoint ### Location - Facility: Research Site, Alabaster, Alabama, 35007, United States @@
## Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception. - NCT ID: NCT06291363 - Study ID: 2024-3612 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-03-04 - Lead Sponsor: Ciusss de L'Est de l'Île de Montréal ### Study Description This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit. ### Conditions - Opioid Use, Unspecified - Anesthesia - Nociceptive Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esmolol Hydrochloride - Saline ### Outcomes Primary Outcomes - Intra operative remifentanil administration Secondary Outcomes - The NOL Index variation before and after orotracheal intubation and first surgical incision - The mean intraoperative blood pressure and heart rate - doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg) - Total time with NOL value above > 25 - The total time and time weighted average of hypotension and/or bradycardia - The time to first analgesic requirement in PACU - The amount of morphine equivalent consumption - The intensity of pain at rest and under stress - Postoperative nausea and vomiting (PONV) and antiemetics use - The time spent in PACU ### Location - Facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montréal-Est, Quebec, H1T2M4, Canada @@
## Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid - NCT ID: NCT06291350 - Study ID: 23-AOI-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-09-15 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists. ### Conditions - Pemphigoid, Benign Mucous Membrane - Gingivitis Hyperplastic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Plaque sampling and stool collection - periodontal examination ### Outcomes Primary Outcomes - composition of the periodontal microbiota Secondary Outcomes - Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3). - Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3). - Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe) - Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3) ### Location - Facility: Nice University Hospital, Nice, N/A, 06000, France @@
## Ibuprofen Inhibits Human Sweet Taste - NCT ID: NCT06291337 - Study ID: Pro2019001483 - Status: COMPLETED - Start Date: 2020-06-01 - Completion Date: 2023-09-30 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases. ### Conditions - Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants - Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Inhibition of Sweet Taste by Ibuprofen Oral Rinses - Inhibition of Sweet Taste by Naproxen Oral Rinses ### Outcomes Primary Outcomes - Sweet taste ratings - Sugar detection thresholds Secondary Outcomes ### Location - Facility: Food Science and Nutritional Sciences, New Brunswick, New Jersey, 08901, United States @@
## WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment - NCT ID: NCT06291324 - Study ID: IRB00103472 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12-15 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients. ### Conditions - Pancreatic Cancer - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Adherence and acceptability Secondary Outcomes - Theme - Heart rate variability (HRV) ### Location - Facility: Levine Cancer Institute, Charlotte, North Carolina, 28204, United States @@
## Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants - NCT ID: NCT06291311 - Study ID: MT_NIPP-HPV_ERBE - Status: RECRUITING - Start Date: 2023-12-27 - Completion Date: 2025-12 - Lead Sponsor: University Hospital Tuebingen ### Study Description This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen. ### Conditions - HPV Infection - Cervical Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cold physical Plasma - Control group ### Outcomes Primary Outcomes - HPV eradication rate Secondary Outcomes - Correlation of HPV Genotyping - HPV-Quality-of-Life (HPV-QoL) - Tissue Tolerance and Compatibility of NIPP Treatment - Detection of Intracellular Molecular Plasma Mechanisms ### Location - Facility: University Hospital Tuebingen, Department of Women's Health, Tuebingen, N/A, 72076, Germany @@
## Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia - NCT ID: NCT06291298 - Study ID: STUDY006542 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: University of South Florida ### Study Description The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity. ### Conditions - Autism Spectrum Disorder - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - COGMUSE-AUT ### Outcomes Primary Outcomes - Objective Cognition-National Institute of Health Toolbox Secondary Outcomes - Objective Slee-Daily Actigraphy - Subjective Sleep- Electronic Daily Sleep Diaries - Insomnia Severity Index - Sleep Habits Questionnaire - Pre-Sleep Arousal - WHO Quality of Life-BREF - Mood - Depression - Adaptive Behavior Assessment System (ABAS-III) - Game-related experience (completed during intervention) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People - NCT ID: NCT06291285 - Study ID: NN7533-7587 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-07-11 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Decitabine-THU - Decitabine-THU ### Outcomes Primary Outcomes - AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose Secondary Outcomes - AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose - Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose - Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose - t½,DEC,SD: Terminal half-life for decitabine after a single dose - t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose - tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose - tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose - Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose - Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose ### Location - Facility: ICON-Salt Lake City, Millcreek, Utah, 84124, United States @@
## Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI - NCT ID: NCT06291272 - Study ID: FMHS 328-0723 - Status: RECRUITING - Start Date: 2023-10-15 - Completion Date: 2024-10-30 - Lead Sponsor: University of Nottingham ### Study Description Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme. ### Conditions - Colon, Irritable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Psyllium - Methylcellulose - Inulin - Maltodextrin ### Outcomes Primary Outcomes - colonic gas volume Secondary Outcomes - colonic gas volume at 6 hours - Breath hydrogen - Oro-cecal transit time - 24 hour breath hydrogen ### Location - Facility: Nottingham Digestive Disease Centre, Nottingham, Nottinghamshire, NG7 2UH, United Kingdom @@
## Mpox Prospective Observational Cohort Study - NCT ID: NCT06291259 - Study ID: CTO 4081 - Status: RECRUITING - Start Date: 2022-06-21 - Completion Date: 2024-09 - Lead Sponsor: Unity Health Toronto ### Study Description The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada3. The transmissibility of Mpox infection4. Viral shedding over time in infected individualsThe study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):1. Collection of clinical data through chart review and research staff interviews with study participants2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies. ### Conditions - Monkeypox ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Description of clinical manifestation - Psychosocial impact - Transmission-related aspects of mpox infection - Virologic aspects of mpox infection over time Secondary Outcomes ### Location - Facility: BC Centre For Excellence, Vancouver, British Columbia, V6Z 1Y6, Canada @@

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