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## Video-respiratory Polygraphy in Children - NCT ID: NCT06287333 - Study ID: 2023PI221 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-02-28 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The diagnosis of obstructive sleep apnea-hypopnea syndrome in children (OSAS) requires a polysomnography (PSG) in a sleep lab with video surveillance and monitoring by a nurse. But PSG is a cumbersome exam, sometimes difficult to perform in children. Simplified exams as respiratory polygraphy (RP) which uses only respiratory signals can be used for the diagnosis of OSAS but studies show that it underestimates the obstructive apnea-hypopnea index (OAHI) because the total sleep time cannot be accurately estimated. The use of a video camera with software synchronous with the RP software could compensate for this disadvantage, by estimating when the child is sleeping or not. ### Conditions - Sleep Apnea, Obstructive ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Polysomnography in routine care ### Outcomes Primary Outcomes - OAHI in video-RP significantly correlated with OAHI in PSG Secondary Outcomes - Diagnostic ability of video-RP to identify OSAS in children - Diagnostic ability of video-RP to identify moderate-severe OSAS in children ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer - NCT ID: NCT06287320 - Study ID: Bioplc - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-02-28 - Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences ### Study Description This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs). ### Conditions - Locally Advanced Non-small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - concurrent or sequential chemoradiotherapy - Immunotherapy ### Outcomes Primary Outcomes - Adverse Event Secondary Outcomes - Progression-free survival (PFS) - Overall survival (OS) - Objective Response Rate (ORR) - Disease control rate (DCR) ### Location - Facility: Chinese Academy of Medical Science and Peking Union Medical College, Beijing, Beijing, 100021, China @@
## Semaglutide 2.4mg for Low Responders After Bariatric Surgery - NCT ID: NCT06287307 - Study ID: NOK000024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-09 - Lead Sponsor: Zuyderland Medisch Centrum ### Study Description In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight. ### Conditions - Obesity - Obesity, Morbid - Weight Gain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - Semaglutide 2.4 MG/0.75 ML Subcutaneous Solution [WEGOVY] ### Outcomes Primary Outcomes - Weight change from start study at 3 months post operative until 15 months later - Difference between placebo group and treatment group in weight change Secondary Outcomes - Weight loss 3 months after surgery - Weight loss 6 months after surgery - Weight loss 12 months after surgery - Weight loss 18 months after surgery - Metabolic health before surgery (bloodpressure) - Metabolic health before surgery (HbA1c) - Metabolic health before surgery (glucose) - Metabolic health before surgery (triglyceride) - Metabolic health before surgery (LDL) - Metabolic health before surgery (HDL) - Metabolic health before surgery (total cholesterol) - Metabolic health 3 months after surgery (Bloodpressure) - Metabolic health 3 months after surgery (HbA1c) - Metabolic health 3 months after surgery (glucose) - Metabolic health 3 months after surgery (triglyceride) - Metabolic health 3 months after surgery (LDL) - Metabolic health 3 months after surgery (HDL) - Metabolic health 3 months after surgery (total cholesterol) - Metabolic health at 6 months after surgery (bloodpressure) - Metabolic health at 6 months after surgery (HbA1c) - Metabolic health at 6 months after surgery (glucose) - Metabolic health at 6 months after surgery (triglyceride) - Metabolic health at 6 months after surgery (LDL) - Metabolic health at 6 months after surgery (HDL) - Metabolic health at 6 months after surgery (total cholesterol) - Metabolic health at 12 months after surgery (bloodpressure) - Metabolic health at 12 months after surgery (HbA1c) - Metabolic health at 12 months after surgery (glucose) - Metabolic health at 12 months after surgery (triglyceride) - Metabolic health at 12 months after surgery (LDL) - Metabolic health at 12 months after surgery (HDL) - Metabolic health at 12 months after surgery (total cholesterol) - Metabolic health at 18 months after surgery (bloodpressure) - Metabolic health at 18 months after surgery (HbA1c) - Metabolic health at 18 months after surgery (glucose) - Metabolic health at 18 months after surgery (triglyceride) - Metabolic health at 18 months after surgery (LDL) - Metabolic health at 18 months after surgery (HDL) - Metabolic health at 18 months after surgery (total cholesterol) - Health-related quality of life also related to gastro intestinal symptoms before surgery - Health-related quality of life also related to gastro intestinal symptoms 3 months after surgery - Health-related quality of life also related to gastro intestinal symptoms 6 months after surgery - Health-related quality of life also related to gastro intestinal symptoms - Health-related quality of life also related to gastro intestinal symptoms - Cardiorespiratory fitness level before surgery - Cardiorespiratory fitness level 3 months after surgery - Cardiorespiratory fitness level 6 months after surgery - Cardiorespiratory fitness level 12 months after surgery - Cardiorespiratory fitness level 18 months after surgery - Change in liver fat and liver stiffness at start of treatment - Change in liver fat and liver stiffness 15 months after semaglutide start - To describe the persistence of therapy - To describe the average weekly dose ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer - NCT ID: NCT06287294 - Study ID: RS23-042 - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2024-12-31 - Lead Sponsor: Our Lady's Hospice and Care Services ### Study Description Taste problems and xerostomia (dry mouth) are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. This study will explore the relationship between dry mouth and taste problems in patients with advanced cancer. ### Conditions - Taste, Altered - Xerostomia - Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To measure the prevalence of taste problems in patients with advanced cancer with a dry mouth using the Oral Symptom Assessment Scale (questionnaire) - To identify an association of any other oral symptoms present in patients with taste problems and dry mouth who have advanced cancer using the Oral Symptom Assessment Scale (questionnaire) - To characterise the taste disturbances i.e. to identify reduced taste, heightened taste, altered taste or no taste using the Taste Questionnaire in Palliative Care (questionnaire) and Waterless Empirical Taste Test (objective taste test) - To identify what impact taste problems are having on patients dietary intake using the Taste Questionnaire in Palliative Care (questionnaire). - To identify what impact taste problems are having on patients quality of life using the Taste Questionnaire in Palliative Care (questionnaire). Secondary Outcomes ### Location - Facility: Our Lady's Hospice and Care Services, Dublin, N/A, D6WRY72, Ireland @@
## High-heeled Shoes in a Sample of Young Women - NCT ID: NCT06287281 - Study ID: Heel01 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-02-28 - Lead Sponsor: Manusapiens ### Study Description At a postural level, many doctors, physiotherapists and chiropractors are convinced that lower back pain induced by heels is due to an increase in lumbar lordosis associated with an anterior pelvic tilt; this thought is even shared by the American Chiropractic Association and the American Physical Therapy Association.Furthermore, in most of the websites consulted, even by non-experts, the reason for the onset of spinal pain is attributed to hyperlordosis and pelvic anteversion. However, this thought is not entirely in agreement with other scientific publications. Therefore it is necessary to pay attention to online searches which often answer these questions without taking EBM into account.None of the studies reported above take into consideration the time factor. In fact, all the studies have evaluated the immediate changes brought about by heel raising. Women who complain of lower back pain when wearing high-heeled shoes rarely experience pain as soon as they start wearing them.The objective of the research arises from these considerations. The aim of this study (primary outcome) is to investigate whether wearing high-heeled shoes for at least 2 hours modifies the spinopelvic parameters compared to the barefoot condition and as soon as the shoes are worn.The secondary outcome will be to verify in the sample analyzed whether there are different behaviors between the subgroups of those who have complained in their anamnesis and those who have never complained of lower back pain when using high-heeled shoes for a few hours. ### Conditions - Low Back Pain - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - heel hight shoes ### Outcomes Primary Outcomes - effect of high-heeled shoes on trunk inclination - effect of high-heeled shoes on pelvic inclination - effect of high-heeled shoes on lordotic angle - effect of high-heeled shoes on kyphotic angle - effect of high-heeled shoes on lumbar arrow - effect of high-heeled shoes on cervical arrow Secondary Outcomes - different response on trunk inclination between the subgroups (suffering from back pain and asymptomatic) - different response on pelvic inclination between the subgroups (suffering from back pain and asymptomatic) - different response on lordotic angle between the subgroups (suffering from back pain and asymptomatic) - different response on kyphotic angle between the subgroups (suffering from back pain and asymptomatic) - different response on lumbar arrow between the subgroups (suffering from back pain and asymptomatic) - different response on cervical arrow between the subgroups (suffering from back pain and asymptomatic) ### Location - Facility: Spine Center, Bologna, N/A, 40128, Italy @@
## Revolade Tablets Specified Drug-use Survey - NCT ID: NCT06287268 - Study ID: CETB115G1401 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2028-10-31 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA). ### Conditions - Aplastic Anemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - eltrombopag ### Outcomes Primary Outcomes - Occurrence of serious adverse events Secondary Outcomes - Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation - Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) - Occurrence of clonal evolution - Hematologic response status - Change over time from baseline in platelet count - Change over time from baseline in hemoglobin - Change over time from baseline in neutrophil count - Change over time from baseline in reticulocyte count - Change over time from baseline in transfusion dependence - Change over time from baseline in transfusion volume ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals - NCT ID: NCT06287255 - Study ID: 2023H0314 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-09-30 - Lead Sponsor: Ohio State University ### Study Description The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels. ### Conditions - Physical Inactivity - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - EIM+ ### Outcomes Primary Outcomes - Feasibility of EIM+ - Acceptability of EIM+ Secondary Outcomes - Change in physical activity - Change in weight - Change in BMI - Change in hip circumference - Change in waist circumference - Change in blood pressure - Change in heart rate variability - Change in hemoglobin A1c - Change in perceived stress - Change in depressive symptoms - Change in diet - Change in activity minutes per week - Change in daily steps total - Change in measured steps per minute - Change in sleep quality - Change in sleep duration - Change in estimated energy expenditure - Change in heart rate - Change in distance moved - Change in minutes of vigorous activity - Change in minutes of moderate activity - Change in minutes of light activity - Change in minutes of sedentary time - Change in number of manually entered and automatically detected physical activities (walking, running, etc.) - Change in quality of life measures ### Location - Facility: The Ohio State University, Columbus, Ohio, 43202, United States @@
## Validation of the Cervicothoracic Differentiation Test - NCT ID: NCT06287242 - Study ID: 24-01-282 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-02 - Lead Sponsor: University of Hartford ### Study Description The goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. The main question it aims to answer is: • Does matched or unmatched region of manipulation based on the CTDT result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? Participants will be asked to:* rate their pain with neck movement, complete brief questionnaires about their pain,* have their neck range of motion measured,* perform a test known as the cervico-thoracic differentiation test (CTDT),* receive either a cervical or thoracic manipulation,* repeat the range of motion measurements.* A second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated.Researchers will compare the effects of manipulation matched to CTDT test result to individuals in the unmatched CTDT manipulation group to see if the CTDT may indicate which region will provide a greater treatment effect for individuals with neck pain. ### Conditions - Neck Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - spinal manipulation ### Outcomes Primary Outcomes - pain with motion Secondary Outcomes - pain at rest - range of motion - neck disability index ### Location - Facility: University of Hartford, West Hartford, Connecticut, 06117, United States @@
## Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab - NCT ID: NCT06287229 - Study ID: 2023-0627 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2030-12-31 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease. ### Conditions - Relapsed/Refractory - B-cell Acute Lymphocytic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Blinatumomab - Inotuzumab Ozogamicin - Hyper-CVAD - Mini-hyper-CVD ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Preliminary Evaluation of a Mental Health Program: a Comparison Study - NCT ID: NCT06287216 - Study ID: 2024001 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-04-30 - Lead Sponsor: The Royal Ottawa Mental Health Centre ### Study Description The mental hygiene challenge is a Royal Ottawa Health Care Group led initiative to engage the staff, clients and community members to attend to their mental well-being by way of practicing mental hygiene activities for 10 min on a daily basis, throughout the month of March. Participants are encouraged to choose one or many of the practices recommended and do them for about 10 minutes a day. Participants are encouraged to make it their own, in that they can combine the practice or tailor them in a way that suits them best. When signing up for the challenge, participants receive free access to a toolkit with brief outlines and instructional videos on various mental hygiene practices.We also encourage participants to divide the 10 minutes in whatever way best works for them, such as 10 minutes all at once, 5 minutes twice, or even 2 minutes five times. This study aims to expand on the work that was done in 2022 and 2023, when the World Health Organization - 5 Wellbeing Index (WHO-5) and the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) were collected from participants to ascertain the impact of mental hygiene, by way of including a control group. ### Conditions - Mental Wellbeing ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Mental Hygiene - Self-Care ### Outcomes Primary Outcomes - Change in level of mental wellbeing as measured by the WHO-5 index. - Change in level of mental wellbeing as measured by the WEMWBS. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Novel Prevention Intervention Program to Reduce Risky Patterns of Substance Use Among Emerging Adults - NCT ID: NCT06287203 - Study ID: Pro2023001498 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-11-20 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description The purpose of this research study is to test whether completion of a new personalized feedback program is associated with reductions in risky substance use among emerging adults (18-25 years of age). ### Conditions - Substance Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Addiction Risk Feedback Program ### Outcomes Primary Outcomes - Alcohol Consumption - Alcohol Problems - Drug Use Problems - Readiness to change - Future substance use intentions Secondary Outcomes - Worry About Substance Use Disorders - Perceived Susceptibility - Well-Being - Anxiety and Depressive Symptoms - Addiction Risk Program Satisfaction - Feelings About Results - Satisfaction with the Assigned Conditions ### Location - Facility: Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey, 08854, United States @@
## Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures - NCT ID: NCT06287190 - Study ID: Self-confidence assessment - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-11-30 - Lead Sponsor: Cairo University ### Study Description This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation ### Conditions - Self Confidence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dental interns ### Outcomes Primary Outcomes - Self-confidence regarding treatment Secondary Outcomes - difficulties in dental practice through this period ### Location - Facility: Cairo University, Cairo, N/A, N/A, Egypt @@
## Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - NCT ID: NCT06287177 - Study ID: Protocol 28/2023 - Status: RECRUITING - Start Date: 2022-11-01 - Completion Date: 2024-11-01 - Lead Sponsor: Federico II University ### Study Description Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population ### Conditions - Hypercholesterolemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Inclisiran ### Outcomes Primary Outcomes - Description of adherence to treatment with Inclisiran in a real-life Italian population - Description of persistence to treatment with Inclisiran in a real-life Italian population - Description of efficacy of treatment with Inclisiran in a real-life Italian population Secondary Outcomes ### Location - Facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, Napoli, N/A, 80131, Italy @@
## Management of Heart Failure in Italian Outpatients Clinics: Observational Study - NCT ID: NCT06287164 - Study ID: 101 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Federico II University ### Study Description OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.Aim of the Optimization of Therapy in the Italian Management of Heart Failure \[OpTIMa-HF\] Registry is to collect data on HF patients followed in different Italian outpatients' settings to describe the current Italian population of HF patients, in terms of demographic characteristics and disease features, with a specific focus on guideline-directed medical therapy (GDMT) prescription, assessing its improvement after educational activities. In the present analysis we report the baseline data on the general enrolled population with a specific focus on HFrEF treatment adherence and prescription rates, according to the most recent European Guidelines. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection ### Outcomes Primary Outcomes - HF treatment adherence according to the most recent European Guidelines Secondary Outcomes ### Location - Facility: Federico II University of Naples, Department of Advanced Biomedical Sciences, Napoli, N/A, 80131, Italy @@
## Regional Anesthesia EMG Study - NCT ID: NCT06287151 - Study ID: STUDY00002844 - Status: RECRUITING - Start Date: 2023-08-09 - Completion Date: 2024-12 - Lead Sponsor: Nationwide Children's Hospital ### Study Description This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. ### Conditions - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - BlockSynop surface electromyography device - Clonidine - Sevoflurane ### Outcomes Primary Outcomes - Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. - Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. . - Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. - Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. Secondary Outcomes - Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude. - Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude. - Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude. - Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude. - Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes. ### Location - Facility: Nationwide Children's Hospital, Columbus, Ohio, 43205, United States @@
## The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients - NCT ID: NCT06287138 - Study ID: KY2023-182-03 - Status: RECRUITING - Start Date: 2023-05-10 - Completion Date: 2025-03-31 - Lead Sponsor: Capital Medical University ### Study Description Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients. ### Conditions - Mechanical Ventilation - Sedation and Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ciprofol ### Outcomes Primary Outcomes - Explore the effect of ciprofol on tidal volume - Explore the effect of ciprofol on respiratory rate - Explore the effect of ciprofol on minute ventilation - Explore the effect of ciprofol on P0.1 - Explore the effect of ciprofol on PMI - Explore the effect of ciprofol on ΔPocc Secondary Outcomes - Explore the effect of ciprofol on tidal volume - Explore the effect of ciprofol on respiratory rate - Explore the effect of ciprofol on minute ventilation - Explore the effect of ciprofol on P0.1 - Explore the effect of ciprofol on PMI - Explore the effect of ciprofol on ΔPocc - Explore the effect of ciprofol on systolic blood pressure - Explore the effect of ciprofol on diastolic blood pressure - Explore the effect of ciprofol on mean arterial pressure - Explore the effect of ciprofol on heart rate - Explore the effect of ciprofol on saturation of pulse oxygen - Explore the effect of ciprofol on end-tidal carbon dioxide pressure - Explore the effect of ciprofol on RASS score ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100071, China @@
## Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients - NCT ID: NCT06287125 - Study ID: Renal assess in SSc and SLE - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Assiut University ### Study Description * Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment.* Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment.* Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment.* Correlation between detected markers and other assessment tools. ### Conditions - Systemic Sclerosis and Systemic Lupus Erythematous ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Renal multi-parametric MRI, Renal doppler ultrasound, Serum CD147 ### Outcomes Primary Outcomes - Evaluate serum levels of CD147 in SSc and SLE patients - Evaluate renal resistive index in SSC and SLE patients - Evaluate Multiparametric MRI in SSC and SLE Secondary Outcomes - Utility of CD 147 in ssc and SLE patients - Utility of renal resistive index in SSC and SLE patients - Utility of Multiparametric MRI in SSC and SLE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevention of Acute Cholecystitis With ETGBD - NCT ID: NCT06287112 - Study ID: PAC-ETGBD - Status: NOT_YET_RECRUITING - Start Date: 2024-03-02 - Completion Date: 2025-03-30 - Lead Sponsor: Seoul National University Hospital ### Study Description The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility. ### Conditions - Biliary Obstruction - Acute Cholecystitis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Endoscopic transpapillary gallbladder drainage (ETGBD) ### Outcomes Primary Outcomes - Incidence rate of acute cholecystitis Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease - NCT ID: NCT06287099 - Study ID: 2023-BRL-101-SCD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-05-10 - Lead Sponsor: Bioray Laboratories ### Study Description This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101). ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BRL-101 ### Outcomes Primary Outcomes - Proportion of stem cell engrafted subjects - Time to neutrophil engraftment - Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease - NCT ID: NCT06287086 - Study ID: 2024-BRL-101-SCD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-14 - Completion Date: 2026-06-10 - Lead Sponsor: Bioray Laboratories ### Study Description This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101) ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BRL-101 autologous hematopoietic stem and progenitor cells injection ### Outcomes Primary Outcomes - Proportion of stem cell engrafted subjects - Time to neutrophil engraftment - Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion.. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) - NCT ID: NCT06287073 - Study ID: 1245-0323 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2025-11-22 - Lead Sponsor: Boehringer Ingelheim ### Study Description The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment. ### Conditions - Kidney Disease, Chronic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - JARDIANCE® ### Outcomes Primary Outcomes - Number of subjects with adverse events - Number of subjects with serious adverse event - Number of subjects with non-serious adverse events - Number of subjects with adverse drug reaction - Number of subjects with serious adverse drug reactions - Number of subjects with unexpected adverse events - Number of subjects with adverse events of special interest - Number of subjects with specific adverse events - Number of subjects with adverse events leading to temporary or permanent discontinuation - Number of subjects with adverse events by intensity - Number of subjects with adverse events by outcome of the events - Number of subjects with adverse events by causality - Number of subjects with adverse events leading to death Secondary Outcomes - Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment ### Location - Facility: Samsung Medical Center, Seoul, N/A, 03181, Korea, Republic of @@
## Bleaching Effect of Strawberry Extract Versus Hydrogen Peroxide in Patients With Extrinsic Staining - NCT ID: NCT06287060 - Study ID: Strawberry extract - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-12 - Lead Sponsor: Cairo University ### Study Description with limited evidence based information in literature about using Strawberry extract for teeth bleaching in patients with extrinsic staining , it is beneficial to evaluate this new material using a randomized controlled clinical trial to test the null hypothesis that this extract will have the same effect as Hydrogen peroxide regarding the bleaching effect and hypersensitivity. ### Conditions - Bleaching Effect and Postoperative Sensitivity of Strawberry Extract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - strawberry extract. ### Outcomes Primary Outcomes - Bleaching effect of strawberry extract versus Hydrogen peroxide. Secondary Outcomes - post operative sensitivity. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Using Different Spinal Needle Sizes on the Efficacy of the Dural Puncture Epidural Block - NCT ID: NCT06287047 - Study ID: spinal needle sizes and DPE - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-01-01 - Completion Date: 2024-04-15 - Lead Sponsor: Cairo University ### Study Description The aim of this study is to compare the dural puncture epidural technique (DPET) with either 25-gauge spinal needle or 27-gauge spinal needle versus conventional epidural technique and evaluate whether DPET improves onset and spread of labor analgesia and if there is a role of the usage of different sized needles as regards block efficiency and complications. ### Conditions - Dural Puncture Epidural Technique ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Epidural analgesia ### Outcomes Primary Outcomes - Onset of analgesia Secondary Outcomes - Degree of analgesia ### Location - Facility: Faculty of Medidcne, Cairo Univerisity, Cairo, N/A, N/A, Egypt @@
## The Role of the Free/Pedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF) - NCT ID: NCT06287034 - Study ID: RS1833/23 - Status: RECRUITING - Start Date: 2023-03-21 - Completion Date: 2025-09-21 - Lead Sponsor: Regina Elena Cancer Institute ### Study Description Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT) ### Conditions - Larynx Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Primary suture ### Outcomes Primary Outcomes - questionnaires for evaluation of the quality of life Secondary Outcomes - Identification of risk factors - Evaluation of swallowing function - Evaluation of vocal rehabilitation ### Location - Facility: "Regina Elena" National Cancer Institute, Rome, N/A, 00144, Italy @@
## Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty - NCT ID: NCT06287021 - Study ID: TRASERBMD2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-02 - Lead Sponsor: Permedica spa ### Study Description The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up. ### Conditions - Total Hip Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Jump System Traser® cup - Jump System HAX-Pore® cup ### Outcomes Primary Outcomes - BMD - ROI 1 Secondary Outcomes - BMD - ROI 2,3,4 - Harris hip score - Moore's osseointegration signs ### Location - Facility: IRCCS Istituto Clinico San Siro, Milan, N/A, 20148, Italy @@
## ABO-Incompatible Kidney Transplants Between Robot-Assisted vs. Open Surgery - NCT ID: NCT06287008 - Study ID: 2023-0085 - Status: COMPLETED - Start Date: 2020-10-01 - Completion Date: 2024-01-31 - Lead Sponsor: Asan Medical Center ### Study Description While robot-assisted kidney transplantation (RAKT) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in ABO-incompatible (ABO-i) KT compared to open KT (OKT) remains understudied. This study aims to compare ABO-i KT outcomes between RAKT and OKT.The study utilized data from 29 ABO-i RAKT and 210 ABO-i OKT cases performed at Asan Medical Center from October 2020 to February 2023. Univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (BPAR), de novo donor-specific antibodies (DSA), and overall graft failure. ### Conditions - Kidney Transplantation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - robot-assisted kidney transplantation ### Outcomes Primary Outcomes - Graft survival - renal function Secondary Outcomes - . A composite of biopsy-proven acute rejection, graft failure, and the development of de novo donor-specific antibodies ### Location - Facility: Asan Medical Center, Seoul, N/A, 05505, Korea, Republic of @@
## Postoperative Pain Assessment After Canal Preparation by Different NiTi File Systems - NCT ID: NCT06286995 - Study ID: 6280 - Status: COMPLETED - Start Date: 2023-10-14 - Completion Date: 2024-02-14 - Lead Sponsor: Ain Shams University ### Study Description The participants were divided into two groups : group one ( Trunatomy file group)(n=10) was mechanically prepared the canals by Trunatomy file and group two ( Edgeendo x7 file group) ( n=10) was prepared the canals by Edgeendo x7 file, the participants were assessed pain preoperatively and postoperatively by Visual Analog Scale(VAS) ### Conditions - Post Operative Pain - Inflammation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chemomechanical preparation for root canals ### Outcomes Primary Outcomes - Level of post operative pain using 10-cm visual analogue scale ( VAS) Secondary Outcomes - Level of inflammatory mediators substance P in apical fluid samples ### Location - Facility: Ain Shams university, Cairo, N/A, N/A, Egypt @@
## The Oral Symptom Assessment Scale in Older Patients With Frailty - NCT ID: NCT06286982 - Study ID: OASIS III - Status: RECRUITING - Start Date: 2023-06-06 - Completion Date: 2024-07-06 - Lead Sponsor: Our Lady's Hospice and Care Services ### Study Description Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months. ### Conditions - Frailty - Older Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Oral Symptom Assessment Scale ### Outcomes Primary Outcomes - To determine the prevalence of oral symptoms in older patients with frailty - To determine the clinical features of these oral symptoms in this group (i.e. frequency, severity and level of distress) - To determine the relationship between oral symptoms and Clinical Frailty Score / Cumulative Illness Rating Scale for Geriatrics/Medications - To provide initial validation of OSAS in older patients with frailty Secondary Outcomes ### Location - Facility: St James's Hospital, Dublin, N/A, D8, Ireland @@
## Clinical Study on Intensive Multi-acupuncture in the Treatment of Lumbar Muscle Strain. - NCT ID: NCT06286969 - Study ID: ZSLL-ZN-2024-007-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Xu Xinnan ### Study Description Acupuncture is widely used as a routine treatment for lumbar muscle strain. The aim of this randomized controlled trial is to evaluate the effectiveness of the intensive multi-acupuncture method. This trial will include 108 patients with lumbar muscle strain injury from two outpatient clinics. All participants will be randomized in a 1:1 ratio to the intensive multi-acupuncture method group and the normal needling group. Outcomes will be assessed before the intervention, after one treatment, after five treatments, and at follow-up 2 weeks after the end of treatment. The primary outcome indicator will be the clinical efficacy evaluation criteria, and the secondary outcome indicators will be the pain visual analog scale (VAS) score, the Japanese Orthopaedic Association Assessment Treatment Score (JOA) score, the lumbar joint mobility measurement scale, and the Modified Ashworth Grading Scale. This study will provide evidence as to whether the intensive multi-acupuncture method is safe and effective. ### Conditions - Lumbar Muscle Strain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - acupuncture ### Outcomes Primary Outcomes - clinical efficacy evaluation criteria Secondary Outcomes - Pain visual analog scale (VAS) score - Japanese Orthopaedic Association Scores - Lumbar Joint Mobility Measurement Scale - Improvement of the Ashworth Rating Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rectal Tumor Resection Using the UNI-VEC Multichannel Transanal Access Device - NCT ID: NCT06286956 - Study ID: vec-pr-1901 - Status: RECRUITING - Start Date: 2021-04-19 - Completion Date: 2024-09-07 - Lead Sponsor: Vecmedical Spain, S.L. ### Study Description The aim of the clinical trial is to investigate whether the use of a new multichannel endoscopic transanal access device (named UNI-VEC) is safe and effective in the resection of a rectal polyp or tumor that sits in the distal part of the colon (up to about 20 cm from the anal margin). This is the first study to test the device in humans, after proving its good performance in preclinical development (preclinical development has included functional laboratory tests and an animal trial). ### Conditions - Rectal Polyp - Rectal Polyps - Rectal Lesion - Sessile Colonic Polyp - Pedunculated Colorectal Polyps ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Treatment of rectal lesions with UNI-VEC ### Outcomes Primary Outcomes - Assess that the use of the device meet the established functional requiremnt of allowing the removal of polyps Secondary Outcomes - Rate of anorectal hemorrhagic events - Rate of injuries to the anorectal canal and perianal region - Assessment of anorectal continence ### Location - Facility: Hospital Universitario de Cabueñes, Gijón, Asturias, 33394, Spain @@
## The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions - NCT ID: NCT06286943 - Study ID: S68124 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate).A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory \[WM\], cognitive flexibility \[CF\], response inhibition \[RI\]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment.First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress.Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively ### Conditions - Executive Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Short Chain Fatty Acids (SCFAs). - Placebo - Maastricht Acute Stress Task - No-stress control task ### Outcomes Primary Outcomes - Working memory Secondary Outcomes - Cognitive Flexibility - Response Inhibition ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder - NCT ID: NCT06286930 - Study ID: STU-2023-0470 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-01-02 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description Hypothesis: Will the use of tDCS brain modulation in the cerebellum assist in restricted behaviors, social cognition and cognitive flexibility in women with anorexia nervosa in addition to other therapies?Primary Outcomes:1. To observe the impacts and outcomes of cerebellar transcranial direct current stimulation (tDCS) on social behaviors measured by Cyberball and Trust Game.2. To observe the neuropsychological impacts of cerebellar tDCS through fMRI imaging as well as looking at the Region of Interest (ROI) of changes in the Default Mode Network and Cerebellum circuits and their activation levels in those networks.Secondary Outcomes:1.To observe the impacts and outcome of cerebellar transcranial direct current stimulation (tDCS) measuring the differences between anodal and cathodal stimulation. To observe potential increases in responses to social stimuli, decreases in eating disorder/depressive symptomology via cathodal stimulation. To also observe potential little to no changes in social stimuli and eating disorder/depressive symptomology via anodal stimulation. ### Conditions - Anorexia Nervosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - anodal trans cranial direct current stimulation (tDCS) - cathodal trans cranial direct current stimulation (tDCS) ### Outcomes Primary Outcomes - tDCS impact on social behaviors using Cyberball - tDCS impact on social behaviors using the Trust Game - neurological impacts of tDCS as measured by fMRI imaging Secondary Outcomes - measure the differences of social stimuli and eating disorder/depressive symptomology - measure the differences of social stimuli and eating disorder/depressive symptomology - measuring the differences of social stimuli and eating disorder/depressive symptomology measuring using the Food Rating Task. - measure the differences of social stimuli and mental flexibility with Trail Making Task - measure the differences of social stimuli and eating disorder/depressive symptomology utilizing Patient Health Questionnaire-9. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Initiation of Noninvasive Ventilation in ALS Patients With Chronic Respiratory Insufficiency - NCT ID: NCT06286917 - Study ID: R24001 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2029-12 - Lead Sponsor: Tampere University ### Study Description This research will study whether noninvasive ventilation (NIV) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (ALS) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are. ### Conditions - Ventilation Therapy - ALS - Chronic Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - NIV initiation in patients with ALS ### Outcomes Primary Outcomes - NIV usage hours according to different initiation locations in patients with ALS - Compliance with NIV according to NIV initiation setting in patients with ALS - Decrease in blood carbon dioxide levels in patients with ALS depending on the place of NIV initiation. Secondary Outcomes ### Location - Facility: Tampere University Hospital, Tampere, N/A, 33520, Finland @@
## Sleep Position Pattern Recording - NCT ID: NCT06286904 - Study ID: McMaster-Myant 16633 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-30 - Lead Sponsor: Myant Medical Corp. ### Study Description The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants. This is a first step towards examining the association between maternal sleep position and fetal growth. ### Conditions - Pregnant Women ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Skiin Garment system ### Outcomes Primary Outcomes - Accuracy of Skiin Garment system for detecting sleep position of pregnant women Secondary Outcomes - Questionnaire on wearable device invasiveness and satisfaction - Participant recruitment rate - Participant retention rate ### Location - Facility: McMaster University, Hamilton, Ontario, L8S 4K1, Canada @@
## Frailty, Physical Capacity and Lung Function in Postoperative Pulmonary Endarterectomy Patients - NCT ID: NCT06286891 - Study ID: CAAE: 73520523.7.0000.0068 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-09-30 - Lead Sponsor: University of Sao Paulo General Hospital ### Study Description The goal of this observational and prospective study is to investigate changes in physical performance, lung function, respiratory and peripheral muscle strength in patients during the postoperative period following pulmonary endarterectomy (PET). ### Conditions - Chronic Thromboembolic Pulmonary Hypertension - Physical Disability - Fragility ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To investigate changes in physical performance measured by Six-Minute Walk Test. - To investigate changes in physical performance measured by Short Physical Performance Battery (SPPB). - To investigate changes in physical performance by 1-minute sit-to-stand test (1-MSTST). - To investigate changes in peripheral muscle strength. - To investigate changes in respiratory muscle strength: - To investigate changes in lung function test measure by spirometry: - To investigate frailty by Clinical Frailty Scale (CFS) Secondary Outcomes - To explore potential preoperative and immediate postoperative risk factors as predictors of functional loss. - To investigate changes in hemodynamic and respiratory variables during the funcional tests. ### Location - Facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, 05403-000, Brazil @@
## Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes - NCT ID: NCT06286878 - Study ID: SDC 4620/17/120 - Status: RECRUITING - Start Date: 2021-12-08 - Completion Date: 2025-07-30 - Lead Sponsor: University of Sao Paulo ### Study Description Type 2 diabetes mellitus (T2DM) is one of the most important risk factors for atherosclerotic heart disease. Strategies focused solely on glycemic control have failed to demonstrate vascular events reduction in this population. On the other hand, new antidiabetic drugs recently have demonstrated significant decrease of cardiovascular mortality, raising the hypothesis that possible effects beyond glycemia control could explain this benefit. Aim: This study is intended to evaluate possible pleiothropic effects of dapaglifozin, a SGLT-2 (sodium glucose cotransporter 2) inhibitor, in individuals admitted with a diagnosis of Acute Myocardial Infarction (AMI). Methods: This is a prospective, randomized, double-blind, placebo controlled trial. Individuals presenting with AMI whithin the first seven days of evolution will be randomized to dapaglifozin or placebo. The investigators's goal is to analyze platelet aggregability 48 hours after randomization (primary endpoint), as well as glycemic control, cardiac biomarkers, corrected QT interval electrocardiographic analysis, autonomic modulation through spectral analysis of the RR interval and inflammatory biomarkers at inclusion and 30 days after starting study drug (secondary endpoints). Sample size calculation resulted in 80 individuals (40 per group). Expected results: This study will seek to aggregate new insights to the current knowledge about this new antidiabetic drug class. Previous randomized clinical trials have demonstrated that SGLT-2 inhibitors significantly reduced the composite endpoint of cardiovascular death, AMI or stroke, as well as Heart Failure (HF) hospitalization. Therefore, this study is supposed to clarify possible mechanisms that could explain these results aforementioned. ### Conditions - Myocardial Infarction - Acute Coronary Syndrome - Diabetes - Ventricular Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - Dapagliflozin ### Outcomes Primary Outcomes - Platelet aggregation using ADP Secondary Outcomes - Platelet aggregation using ADP at 30 (± 5) days after study therapy - Platelet aggregation using ASPI at 30 (± 5) days after study therapy ### Location - Facility: Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, N/A, 05403-900, Brazil @@
## Improving Quality of ICD-10 Coding Using AI: Protocol for a Crossover Randomized Controlled Trial - NCT ID: NCT06286865 - Study ID: 260972(REK) - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2024-04 - Lead Sponsor: University Hospital of North Norway ### Study Description The goal of this randomised trial is to learn about the role of AI in clinical coding practice. The main question it aims to answer is:Can the AI-based CAC system reduce the burden of clinical coding and also improve the quality of such coding? Participants will be asked to code clinical texts both while they use our CAC system and while they do not. ### Conditions - Gastrointestinal Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: DIAGNOSTIC ### Interventions - Easy-ICD ### Outcomes Primary Outcomes - Time - Accuracy Secondary Outcomes ### Location - Facility: Norwegian Centre for E-health Research, Tromso, Troms, 9019, Norway @@
## Italian Language Validation of The Eating Disorder Examination (EDE) - Child Version - NCT ID: NCT06286852 - Study ID: EDE BA - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-11-01 - Completion Date: 2024-06-30 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Although eating disorders often occur during or after puberty, it is likely that critical antecedent conditions can be established before adolescence. The Eating Disorder Examination has been adapted for children and is described by Bryant - Waugh, Cooper, Taylor and Lask (1996). The EDE is considered the gold standard of measures of eating disorder psychopathology (Wilson, 1993), and this adaptation, which allows its use with a younger age group, is a potentially important addition to the assessment of eating disorders in children. The latest version of EDE, the l7th edition, has now surpassed its predecessors.The aim of the study is to evaluate the psychometric properties of the Child vers ion EDE (chEDE) translated into Italian, in a sample of patients with eating disorder ### Conditions - Feeding and Eating Disorders of Childhood ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Administration of K-SADS-PL- Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version (Kaufmann, 2002) - Administration of ChEDE- Child Version of the EatingDisorder Examination ### Outcomes Primary Outcomes - K-SADS-PL (Kiddie-Schedule for Affective Disorder and Schizophrenia-Present and Lifetime version) questionnaire - ChEDE (Child Version of the EatingDisorder Examination) Secondary Outcomes ### Location - Facility: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy @@
## Study of Cannabidiol (CBD) in Healthy Volunteers - NCT ID: NCT06286839 - Study ID: AFCRO-150 - Status: COMPLETED - Start Date: 2022-05-12 - Completion Date: 2022-12-14 - Lead Sponsor: NextEvo Inc. ### Study Description This was a prospective, single-centre, open label, randomized, two-arm, parallel design study to evaluate the effect of four-weeks consumption of active study product on primary endpoint in healthy adults ### Conditions - Immune System and Related Disorders - Immune System Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cannabidiol (CBD) ### Outcomes Primary Outcomes - Plasma CBD pharmacokinetics of twice daily intake of 2 different doses of CBD over three days - Evaluate the safety of twice daily intake of 2 different doses of CBD over three 3 days Secondary Outcomes - Plasma CBD maximal concentration (Cmax, ng/ml) - Plasma CBD time to peak (Tmax, minutes) - Percentage Change between groups on whole blood LPS stimulated cytokines (% change) ### Location - Facility: Altantia Clinical Trials, Chicago, Illinois, 60611, United States @@
## A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia - NCT ID: NCT06286826 - Study ID: ATRESO - Status: RECRUITING - Start Date: 2023-10-12 - Completion Date: 2026-01-12 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation ### Conditions - Atresia Esophagus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Postero-lateral thoracotomy - Minithoracotomy ### Outcomes Primary Outcomes - incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically Secondary Outcomes - incidence of musculoskeletal abnormalities in the short term - incidence of musculoskeletal abnormalities in the medium term - Evaluation of severity of outcomes in the medium, short and long term - Predective Facotrs evaluation ### Location - Facility: Spedali Civili di Brescia, Brescia, N/A, 25123, Italy @@
## The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates - NCT ID: NCT06286813 - Study ID: Akarakoc - Status: RECRUITING - Start Date: 2024-03-02 - Completion Date: 2024-05-30 - Lead Sponsor: Marmara University ### Study Description This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.Interventional research with two parallel groups and no control group ### Conditions - Skin Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Plant (natural) oils ### Outcomes Primary Outcomes - Neonatal skin condition score - Skin moisture meter(DMM): Secondary Outcomes ### Location - Facility: Bakırköy Dr. Sadi Konuk Training and Research Hospital, Istanbul, N/A, 34854, Turkey @@
## Personalized Transcranial Direct Current Stimulation in Stroke Recovery - NCT ID: NCT06286800 - Study ID: PRO00036824 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-09-14 - Lead Sponsor: The Methodist Hospital Research Institute ### Study Description The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial direct current stimulation (tDCS) with OT - Sham tDCS with OT ### Outcomes Primary Outcomes - fMRI functional connectivity biomarker Secondary Outcomes - Wolf Motor Function Test - Fugl-Meyer assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Mountain Craft Training at Enhancing the Resilience and Physio-psychological Well-being of Children From Low-income Families - NCT ID: NCT06286787 - Study ID: HSEARS20221110002 - Status: RECRUITING - Start Date: 2023-11-16 - Completion Date: 2024-11-01 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description It is imperative to offer adequate community resources and psychosocial support, with a particular focus on enhancing resilience for children from low-income families. This study aims to determine the feasibility, acceptability, and preliminary efficacy of mountain craft training in enhancing resilience and self-esteem, reducing depressive symptoms, and improving the physical health of children from low-income families. ### Conditions - Resilience - Well-being - Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Intervention - Placebo ### Outcomes Primary Outcomes - Resilience Scale-14 (RS-14) Secondary Outcomes - Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC) - Chinese version of Rosenberg's Self-Esteem Scale (RSES) - The children's peak expiratory flow rate ### Location - Facility: The Asbury Methodist Social Service, Hong Kong, N/A, N/A, China @@
## Sleep as a Mechanism of Change in Alcohol Use - NCT ID: NCT06286774 - Study ID: 2096884 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-04-01 - Lead Sponsor: University of Missouri-Columbia ### Study Description This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes. ### Conditions - Insomnia - Alcohol; Harmful Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy for Insomnia ### Outcomes Primary Outcomes - Insomnia Symptoms - Drinking quantity - Alcohol-related consequences Secondary Outcomes - Treatment willingness (alcohol) - Alcohol craving - Negative emotionality - Response inhibition - Working memory - Delay discounting - Alcohol to help with sleep - Heartrate variability - Dysfunctional Beliefs and Attitudes about Sleep Scale ### Location - Facility: University of Missouri-Columbia, Columbia, Missouri, 65212, United States @@
## Routine Validation and Reproducibility Testing of Laboratory Measures and Research Techniques Used for Metabolism Research (VAL) - NCT ID: NCT06286761 - Study ID: 2100332 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2028-03 - Lead Sponsor: Bettina Mittendorfer ### Study Description The purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the University of Missouri. As technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. Reproducibility means performing the same test more than once to see if the same results can be achieved each time. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - endothelial cell collection ### Outcomes Primary Outcomes - Validation and reproducibility testing for blood assays - Validation and reproducibility testing for endothelial cell collection - Validation and reproducibility testing for mixed meal ingestion - Validation and reproducibility testing for glucose tolerance testing - Validation and reproducibility testing for DEXA - Validation and reproducibility testing for MRI - Validation and reproducibility testing for MRS Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients - NCT ID: NCT06286748 - Study ID: DeniseMafra19 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-10 - Lead Sponsor: Universidade Federal Fluminense ### Study Description Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Beetroot juice - Placebo ### Outcomes Primary Outcomes - Change individual quality of life - Change physical activity level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients - NCT ID: NCT06286735 - Study ID: DeniseMafra18 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-22 - Completion Date: 2024-12-22 - Lead Sponsor: Universidade Federal Fluminense ### Study Description Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - cinnamomum - Placebo ### Outcomes Primary Outcomes - Concentration of Nuclear factor kappa B (NF-KB) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Optimized Rehabilitation of Older Adults With Hip Fracture and Signs of Cognitive Impairment - Feasibility Study - NCT ID: NCT06286722 - Study ID: LollandCD - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2025-06-30 - Lead Sponsor: Lolland Community, Denmark ### Study Description Older adults suffering from a hip fracture are a significant concern, with higher incidence rates among women. Mortality rates post-hip fracture are alarming, with up to 8-fold increased risk within 3 months and significant percentages within 30 days and 12 months. Older adults with hip fracture face challenges in regaining pre-fracture level of function, especially those with cognitive impairment, which affects 25% to 40% of cases and increases mortality risk. While interventions exist, such as progressive strength training and structured exercise programs, patients with hip fracture don't consistently restore pre-fracture function, particularly in cognitively impaired patients, who are often excluded from studies. Limited evidence exists on effective management for this subgroup, with a lack of clarity on community-based rehabilitation. Although guidelines suggest exercise interventions for patients with mild to moderate cognitive impairment, the specifics remain uncertain due to insufficient research focused solely on this population.This feasibility study aims to assess the practicality and safety of implementing a 12-week individualized, progressive exercise program for older adults with hip fracture and cognitive impairment in an outpatient setting. Additionally, the investigators seek to gather qualitative insights through observations and interviews regarding participants' experiences and the perceived value of rehabilitation post-hip fracture, particularly focusing on the exercise intervention provided. ### Conditions - Hip Fractures - Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Progressive, individualized and structured exercise program ### Outcomes Primary Outcomes - The New Mobility Score Secondary Outcomes - Mini Mental State Examination - Height - Weight - Tandem balance test - The Barthel-20 - 30 sec chair raise test - Brief Assessment of Impaired Cognition Questionaire - Handgrip strength measurement - The Cumulated Ambulation Score - Four meter walk test - Euroqol 5 dimensions - Clinical Frailty Scale - The Verbal Rating Scale - Activity accelerometers ### Location - Facility: Stevns Healthcare Center, Stevns Municipality, Hårlev, N/A, 4652, Denmark @@
## FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis - NCT ID: NCT06286709 - Study ID: RG_22-063 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-29 - Completion Date: 2026-07-29 - Lead Sponsor: University of Birmingham ### Study Description FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease. ### Conditions - Primary Sclerosing Cholangitis - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Faecal Microbiota Transplant - FMT Placebo ### Outcomes Primary Outcomes - Serum Alkaline Phosphatase (ALP) Secondary Outcomes - Patient-reported outcome (PRO) measures - Patient-reported outcome (PRO) measures - Patient-reported outcome (PRO) measures - Patient-reported outcome (PRO) measures - Surrogate biomarkers of liver fibrosis - Surrogate biomarkers of liver fibrosis - Routine liver laboratory parameters - Routine liver laboratory parameters - Routine liver laboratory parameters - Routine liver laboratory parameters - Routine liver laboratory parameters - PSC specific prognostic scores - PSC specific prognostic scores - Quantitative assessment of Inflammatory Bowel Disease (IBD) activity - Quantitative assessment of IBD activity - Quantitative assessment of IBD activity - The incidence of clinical non-trial endpoint events - The incidence of trial endpoint events - Occurrence of adverse events ### Location - Facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, N/A, B15 2TH, United Kingdom @@
## Optic Nerve Sheath Diameter in Hypertensive Emergency - NCT ID: NCT06286696 - Study ID: NL84914.058.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-07-01 - Lead Sponsor: Leiden University Medical Center ### Study Description This prospective observational study investigates the potential of point-of-care ultrasonography of the optic nerve sheath diameter (ONSD) to rule out papilledema in patients with suspected hypertensive emergency. The primary focus is on assessing ONSD sensitivity in identifying papilledema (hypertensive retinopathy grade 4), while secondary endpoints include hypertensive retinopathy grade 3, hypertensive encephalopathy, and the need for intravenous rapid-acting medications to lower elevated blood pressure. This study aims to determine the diagnostic characteristics of this procedure for the diagnosis of hypertensive retinopathy, thus assessing its potential as a screening tool to rule out hypertensive retinopathy by the acute internal medicine doctor. ### Conditions - Hypertensive Emergency - Papilledema - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Optic Nerve Sheath Diameter ### Outcomes Primary Outcomes - Papilledema Secondary Outcomes - Hypertensive retinopathy grade 3 & 4 combined - Hypertensive encephalopathy - Rapid acting medications administered intravenously to lower the elevated blood pressure - Presence of a bulging optic nerve disc and/or crescent sign found by ultrasonography of the optic nerve ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Early Mobilization on SAH Patients Physiological Parameters - NCT ID: NCT06286683 - Study ID: APHP231706 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-02 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. More specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters. ### Conditions - Subarachnoid Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lung ultrasound - Transcranial Doppler - near-infrared spectroscopy (NIRS) - clinical examination ### Outcomes Primary Outcomes - Impact on lung aeration Secondary Outcomes - Impact on cerebral blood flow - Impact on cerebral tissue oxygenation - Impact on heart rate - Impact on arterial pressure - Impact on Saturation - Impact on neurological examination - Impact on patient comfort ### Location - Facility: Adéla FOUDHAÏLI, Paris, N/A, 75010, France @@
## Single Versus Dual Implant Fixation of Distal Femur Fractures - NCT ID: NCT06286670 - Study ID: IRB00108312 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-12 - Lead Sponsor: Wake Forest University Health Sciences ### Study Description The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities. ### Conditions - Articular Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single Implant Fixation - Dual Implant Fixation ### Outcomes Primary Outcomes - Return to Work - International Physical Activity Questionnaire (IPAQ) Scores - Return to Work - International Physical Activity Questionnaire (IPAQ) Scores - Return to Work - International Physical Activity Questionnaire (IPAQ) Scores - Return to Work - International Physical Activity Questionnaire (IPAQ) Scores Secondary Outcomes - Number of Unions - Number of Resource Utilizations - Number of Reoperations - Number of Complications - Time to Walking Without an Assistive Device - Prescribed Weight Bearing Status - Fear of Movement - Change in Tampa Scale for Kinesiophobia (TSK) Scores - Health Related Quality of Life - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Scores - Global Health Status - Change in Veterans RAND 12 Item Health Survey (VR12) Scores - Change in the Work Productivity and Activity Impairment Questionnaire Scores - Change in Numeric Pain Rating - Change in Pain Inventory (BPI) - Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Subscale--Pain Interference - Presence of Post-Traumatic Arthritis (PTOA) - Kellgren Lawrence (KL) classification - Presence of Post-Traumatic Arthritis (PTOA) - Paley Grading System (PGS - Isokinetic Knee Flexion/Extension Strength Testing - Counter-Movement Jump measurement - Single Leg Static and Dynamic Postural Stability Index - Triple Hop Performance Assessment ### Location - Facility: Atrium Health Musculoskeletal Institute, Charlotte, North Carolina, 28204, United States @@
## Xanthohumol and Viral Infections (XL) - NCT ID: NCT06286657 - Study ID: UVienna23a - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-12-30 - Lead Sponsor: University of Vienna ### Study Description The aim of the present study is to determine if a regular oral supplementation of xanthohumol attenuate the severity of symptoms and duration of´viral infections. ### Conditions - Infection Viral ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Xanthohumol - Placebo ### Outcomes Primary Outcomes - Changes in severity and duration of viral infections Secondary Outcomes - Changes in blood lipid levels - Changes in cognitive skills ### Location - Facility: University of Vienna, Vienna, N/A, 1090, Austria @@
## Hop Compounds on the Immune System (VH) - NCT ID: NCT06286644 - Study ID: UVienna23 - Status: RECRUITING - Start Date: 2022-05-30 - Completion Date: 2024-12-30 - Lead Sponsor: University of Vienna ### Study Description The aim of the present study is to determine the effect of Iso-alpha-Acids and Xanthohumol from hops on the immune response of healthy participants over a timeframe of 6 hours. ### Conditions - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Xanthohumol - Iso-alpha-Acids - Xanthohumol + Iso-alpha-Acids ### Outcomes Primary Outcomes - Changes in parameters of immune response - Changes in parameters of immune response Secondary Outcomes ### Location - Facility: University of Vienna, Vienna, N/A, 1090, Austria @@
## Prediction of Lymph Node Metastasis in Patients With Thyroid Malignancy by a New Scale - NCT ID: NCT06286631 - Study ID: Rating scale-202402 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2026-10-01 - Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University ### Study Description The incidence of papillary thyroid cancer (PTC) has been on the rise in recent years, and 20%-50% of PTC patients will have lymph node metastasis. Lymph node involvement in PTC patients is usually related to the recurrence of PTC after surgery, and 30% of patients recur without lymph node dissection, with the risk of central cervical lymph node metastasis being the greatest, so it seems to be a good choice to perform lymph node dissection on patients after thyroidectomy, but in fact, there are controversies at home and abroad as to whether to perform lymph node dissection or not. The 2021 Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of differentiated thyroid cancer state that prophylactic central lymph node dissection (PCND) may increase the incidence of postoperative complications, but due to the high metastatic rate of PTC and the ability of PCND to effectively prevent recurrence and reoperation, countries in the East Asian region perform prophylactic lymph node dissection on almost all patients with PTC. However, for more countries in Europe and the United States, performing PCND has become a non-essential, individualized option. The aim of this study is to collect multifactorial data from more than 1,000 patients who have undergone previous thyroidectomy from 2021 to 2023, and to develop a novel scoring scale that can be used to individualize patients' scores based on a variety of factors prior to surgery, so that patients can be more accurately predicted to have lymph node metastasis and need prophylactic lymph node dissection prior to surgery, and patients who do not need dissection can avoid surgery. For patients who do not need lymph node dissection, complications caused by surgery can be avoided, while for patients who do have lymph node metastasis, recurrence of their cancer can be prevented. This will change the status quo of not being able to accurately determine the actual situation through simple preoperative examination or performing prophylactic lymph node dissection for all PTC patients. ### Conditions - Papillary Thyroid Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Height - Weight - Age - Genders - BMI - Whether lymph node dissection was performed during previous surgery - Tumor Diameter Size - Tumor limitation of the primary focus - Extratumoral invasion - Pathologic lymph node metastasis - Tumor cystic solidity on preoperative ultrasound - Preoperative ultrasound tumor echo intensity - Preoperative ultrasound tumor boundaries - Preoperative ultrasound tumor for the presence of calcifications - Preoperative ultrasound tumor aspect ratios - Preoperative ultrasound for enlarged cervical lymph nodes - TSH - TPOAb - TgAb - Calcium - B-raf gene mutation Secondary Outcomes ### Location - Facility: The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710000, China @@
## Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians - NCT ID: NCT06286618 - Study ID: HHSN268201800015I - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-08-31 - Lead Sponsor: University of Southern Mississippi ### Study Description The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi. ### Conditions - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Psychosocial Intervention - Structural Intervention - Traditional Psychosocial+Structural - Integrated Psychosocial+Structural ### Outcomes Primary Outcomes - Participant Burden Secondary Outcomes - Diet Quality - cost effectiveness ### Location - Facility: The University of Southern Mississippi, Hattiesburg, Mississippi, 39406-0001, United States @@
## RCT GBR One Stages Comparing A-Oss and Autogenous Bone Versus A-Oss and LCR-A - NCT ID: NCT06286605 - Study ID: UNISS_PHD_Osstem_4 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-12-30 - Lead Sponsor: Università degli Studi di Sassari ### Study Description The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group). ### Conditions - Guided Bone Regeneration - Dental Implant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - A-oss and autogenous bone - A-oss an LCR-A ### Outcomes Primary Outcomes - Rate of Implants survival - Number of Participants with prosthesis failure - Number of complications Secondary Outcomes - Horizontal and volumetric dimensional changes - Rate of peri-implant marginal bone level - Plaque Index and bleeping on probing - Valuation of patient satisfaction - Valuation of soft tissue thickness and amount of keratinized tissue - Rate of pes score ### Location - Facility: Marco Tallarico, Sassari, N/A, 07100, Italy @@
## LUNGevity: Lung Cancer Stigma Community Based Participatory Research - NCT ID: NCT06286592 - Study ID: Pro2023002053 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-11 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description Lung cancer survival rates are low for intersectional underserved groups. Lung cancer stigma and intersectional stigma related to minoritized group status leads to increased morbidity and mortality and health disparities. Mindfulness interventions have been shown to decrease stigma and the negative impacts of stigma, however, these interventions have never been tested to decrease lung cancer stigma specifically. In this study, the investigators will use Community Based Participatory Research framework and MOST methodology to build and optimize a brief virtual mindfulness intervention to decrease lung cancer stigma, through first building a diverse coalition of lung cancer patients on a participatory action council. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Ultra-brief mindfulness intervention video - Forgiveness video - ACT values video ### Outcomes Primary Outcomes - Lung Cancer Stigma Inventory (LCSI) - Tobacco use quit likelihood Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SOI Immediately vs Delayed - NCT ID: NCT06286579 - Study ID: UNISS_PHD_Osstem_3 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-01-31 - Lead Sponsor: Università degli Studi di Sassari ### Study Description The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface ### Conditions - Dental Implant - Dental Implant-Abutment Design ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Immediately implant placement - Delayed ### Outcomes Primary Outcomes - Number of prosthesis failure - Number of implant failure - Number of complications Secondary Outcomes - Rate of peri-implant marginal bone level changes - Valuation of patient satisfaction - Rate of implant stability quotient (ISQ) - Valuation of soft tissue thickness and amount of keratinized tissue - Number of PES score ### Location - Facility: Marco Tallarico, Sassari, N/A, 07100, Italy @@
## Soi TS3 Surface in Patients With and Without Type 2 Diabetes - NCT ID: NCT06286566 - Study ID: UNISS_PHD_Osstem_2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-01-31 - Lead Sponsor: Università degli Studi di Sassari ### Study Description The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes. ### Conditions - Dental Implant - Dental Implant-Abutment Design ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Implant placement with soi surface in diabetic subjects - Implant placement with soi surface in healthy subjects ### Outcomes Primary Outcomes - Number of prosthesis failure: - Number of implant failure - Number of complication Secondary Outcomes - Rate of peri-implant marginal bone level changes - Valuation of patient satisfaction ### Location - Facility: Marco Tallarico, Rome, Sassari, 07100, Italy @@
## Rehabilitation of Abdominal Diastasis After Childbirth: Trunk and Inspiratory Muscle Training - NCT ID: NCT06286553 - Study ID: DRA Rehab TEG & IMT - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-08-30 - Lead Sponsor: University of Patras ### Study Description Diastasis Recti Abdominis (DRA) is the separation of the rectus muscles caused by stretching and thinning of the linea alba during pregnancy and childbirth. It's a common condition, affecting 66-100% of women post-birth and can persist for many years, leading to abdominal protrusion, discomfort, and aesthetic concerns. It might also contribute to back pain, urinary issues, and reduced abdominal strength, impacting quality of life. Recent guidelines propose that conservative management, such as rehabilitation interventions, should be prioritized for DRA. However, there is a lack of consensus among researchers regarding the most effective exercise regimen, resulting in diverse rehabilitation programs. Recent evidence advocates not only for closing the gap but also for achieving optimal function. Current studies often neglect to address functional rehabilitation, underscoring the necessity for robust clinical trials, which is the primary focus of this study.Additionally, although breathing exercises are commonly prescribed for DRA, the precise role of the diaphragm, the primary respiratory muscle, in rehabilitation hasn't been fully examined. The diaphragm forms the upper boundary of the abdominal cavity and plays a key role in the stability of the trunk, working together with the abdominal and pelvic floor muscles. A recent study found reduced diaphragm excursion in postpartum women with lumbopelvic pain during a low postural demanding task, while previous studies suggest that diaphragm training could alleviate such symptoms influencing factors such as diaphragm thickness and excursion, which may be linked to improved trunk stability. Hence, training the diaphragm and accessory inspiratory muscles through Inspiratory Muscle Training (IMT) could potentially play a crucial role in managing DRA.In summary, the goal of this study is to develop and assess a comprehensive rehabilitation program aimed at effectively reducing DRA and addressing associated dysfunctions. The program will integrate evidence-based rehabilitation interventions, such as trunk stabilization exercises and IMT, targeting all related dysfunctions caused by DRA, and introducing a novel therapeutic protocol not previously implemented. The study will take the form of a prospective, randomized controlled trial (RCT). ### Conditions - Diastasis Recti And Weakness Of The Linea Alba - Diastasis, Muscle ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trunk exercise - Inspiratory Muscle Training (IMT) - Control Group ### Outcomes Primary Outcomes - Inter-recti distance (IRD) Secondary Outcomes - Diaphragmatic Thickness - Diaphragmatic Excursion - Maximum Inspiratory Pressure (MIP) - Strength Index (S-Index) - Peak Inspiratory Flow (PIF) - Trunk flexion test - Plank test - Side plank test - McGill's trunk flexor endurance test - Body Image States Scale (BISS) - Activities Assessment Scale (AAS) - Hernia-Related Quality-of-Life Survey (HerQLes) ### Location - Facility: Laboratory of Clinical Rehabilitation and Research (CPRlab), University of Patras, Patras, Achaia, Greece, 26504, Greece @@
## Evaluation of the Efficacy and Safety of Surgical Device "Lymphoblock" for Prevention of Lymphorrhea in Patients With Thoracoabdominal Aorta Repair. - NCT ID: NCT06286540 - Study ID: 26031993 - Status: RECRUITING - Start Date: 2023-02-22 - Completion Date: 2026-05 - Lead Sponsor: Petrovsky National Research Centre of Surgery ### Study Description Randomized, double-blind, placebo-controlled study will determine the clinical efficacy and safety of Lymphoblock in the prevention of postoperative retroperitoneal chylo-/lymphorrhoea in patients with open surgical treatment of the thoracoabdominal aorta. It is planned to recruit 138 clinical observations. Efficacy will be evaluated based on clinical and laboratory data. ### Conditions - Aorta Abdominalis; Aneurysm - Aorta Thoracic; Aneurysm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lymphoblock - Placebo ### Outcomes Primary Outcomes - Number of Participants with Chylous Effusion (Сhilo-/lymphorrhea) - Number of Participants with Lymphocele Secondary Outcomes - The amount of drainage discharge 1 - The amount of drainage discharge 2 - The amount of drainage discharge 3 - Concentration of triglycerides in the drainage discharge - Concentration of triglycerides in blood plasma - Concentration of cholesterol in the drainage discharge - Concentration of cholesterol in the blood plasma - Concentration of protein in the drainage discharge - Concentration of protein in the blood plasma - Concentration of albumin in the drainage discharge - Concentration of albumin in the blood plasma - Concentration of lactate dehydrogenase in the drainage discharge - Concentration of lactate dehydrogenase in the blood plasma - Concentration of glucose in the drainage discharge - Concentration of glucose in the blood plasma - Number of Participants with Pleural effusion within 10 days - Number of Participants with Lymphocele 3 months after the surgery - Number of Participants with Pleural effusion 3 months after the surgery ### Location - Facility: Petrovsky NRCS, Moscow, N/A, 119991, Russian Federation @@
## Quality of Sexual Life of PrEP Users - NCT ID: NCT06286527 - Study ID: EssaiClinique_PREP-QUAL-VS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-09-06 - Lead Sponsor: University Hospital, Grenoble ### Study Description The study will recruit participants on the occasion of their visit in a sexual health center or another HIV pre-exposure prophylaxis (PrEP) facility in France.PrEP users will be proposed to fill a self-administered, online, anonymous questionnaire regarding how they perceive different fields of their sexual life, and how they perceive that PrEP has an impact on the quality of sexual life. ### Conditions - HIV Pre-exposure Prophylaxis Use - Adult ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - anonymous self-administered online questionnaire ### Outcomes Primary Outcomes - quality of sexual life as assessed by a set of questions - perceived influence of PrEP use on the quality of sexual life Secondary Outcomes ### Location - Facility: Olivier EPAULARD, Grenoble, Is, 38043, France @@
## Food at Home Study - NCT ID: NCT06286514 - Study ID: STUDY00019996 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-30 - Lead Sponsor: University of Minnesota ### Study Description The study objective is to develop an accessible home food environment assessment toolkit that includes valid and reliable paper and electronic tools targeting foods known to impact diet-related health that can be user-administered across literacy levels in English and Spanish. ### Conditions - Obesity - Diet, Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Usability of HFI core - Acceptability of HFI core - Concurrent criterion validity of HFI core - Concurrent criterion validity of HFI core - Convergent construct validity of HFI core - Convergent construct validity of HFI core - Test-retest reliability of HFI core - Usability of eHFI - Acceptability of eHFI - Concurrent criterion validity of eHFI - Concurrent criterion validity of eHFI - Convergent construct validity of eHFI - Convergent construct validity of eHFI Secondary Outcomes ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases - NCT ID: NCT06286501 - Study ID: R23060L - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-12-31 - Lead Sponsor: Wellbeing Services County of Pirkanmaa ### Study Description The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging. ### Conditions - Dental Caries in Children - Dental Plaque - Tooth Decay - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lumoral Treatment - Standard, personalized oral health care ### Outcomes Primary Outcomes - Bleeding on probing (BOP) - Bleeding on probing (BOP) Secondary Outcomes - Active matrix metalloproteinase 8 (aMMP-8) - Probing Pocket Depth (PPD) - Probing Pocket Depth (PPD) - Visible plaque index (VPI) - Visible plaque index (VPI) - Decayed tooth assessment (DT) - Clinical attachment level (CAL) - Clinical attachment level (CAL) - Microbiological evaluation/16S rRNA analysis - Microbiological evaluation/16S rRNA analysis - Oral-related quality of life measurement (OHIP-14) - Absence of adverse effects ### Location - Facility: Wellbeing Services of County Pirkanmaa, Tampere, Pirkanmaa, 33520, Finland @@
## Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza - NCT ID: NCT06286488 - Study ID: KB/96/2020 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2020-09-15 - Completion Date: 2026-05-01 - Lead Sponsor: Medical University of Warsaw ### Study Description The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant). ### Conditions - Influenza - Obesity - Pregnancy; Infection - Elderly Infection - Vaccine Reaction - Vaccine Adverse Reaction - Tolerance ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vaxigrip ### Outcomes Primary Outcomes - influenza vaccine immunogenicity, seroconversion and seroprotection Secondary Outcomes - assessment of vaccination tolerance ### Location - Facility: Department of Social Medicine and Public Health, Medical University of Warsaw, Warsaw, N/A, 02-077, Poland @@
## A Study of VRG50635 in Healthy Volunteers - NCT ID: NCT06286475 - Study ID: VGCS-50635-003 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-05 - Lead Sponsor: Verge Genomics ### Study Description The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VRG50635 - Placebo ### Outcomes Primary Outcomes - Number of Participants with Adverse Events - Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf) - Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast) - Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24) - Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau) - Maximum Observed Concentration (Cmax) - Half-life (t1/2) - Time of Maximal Plasma Concentration (tmax) Secondary Outcomes ### Location - Facility: Site 001, Lincoln, Nebraska, 68502, United States @@
## Evaluation of the Cancer Tracking System (CATSystem) - NCT ID: NCT06286462 - Study ID: R01CA278617 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2028-01-31 - Lead Sponsor: University of Kansas Medical Center ### Study Description Cervical cancer contributes to significant preventable mortality in Kenya where less than 20% of women are screened. The Cancer Tracking System (CATSystem) is a web-based, algorithm generated tool to promote guideline adherent cervical cancer screening and retention through treatment. The goal of this project is to rigorously evaluate the efficacy, implementation, and cost-effectiveness of the CATSystem to improve rates of screening, treatment, referral, and follow-up care in a matched, cluster randomized controlled trial in 10 Kenyan government hospitals (5 intervention, 5 standard of care). ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Cancer Tracking System (CATSystem) ### Outcomes Primary Outcomes - Guideline adherent treatment for a positive screen - Cost-effectiveness of the CATSystem Intervention on screening and treatment outcomes Secondary Outcomes - Cervical cancer screening ### Location - Facility: Akala Health Center, Akala, N/A, N/A, Kenya @@
## Identification of Cellular and Molecular Mechanisms Involved in the Pathophysiology of Alcohol Use Disorder by Examination of Cerebrospinal Fluid - NCT ID: NCT06286449 - Study ID: CSV_AUD - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Vastra Gotaland Region ### Study Description BACKGROUNDThe brain and spinal cord are enveloped by cerebrospinal fluid (CSF), which extends down to the base of the spine, a few centimeters below the termination of the spinal cord. Here, it can be collected through a minor needle puncture. This procedure enables the gathering of information about otherwise concealed molecular and cellular processes in the brain. Analyzing various specific molecules in the CSF has yielded crucial insights into the underlying mechanisms of many neurological and psychiatric disorders, such as multiple sclerosis (MS) and dementia, significantly enhancing the prospects for its treatment. However, for several brain disorders, including Alcohol Use Disorder (AUD) and substance use disorders, CSF studies are absent. AUD, a brain disease affecting the reward system, is characterized by an inability to limit alcohol consumption. High levels of alcohol intake, as seen in AUD, are a leading cause of morbidity and premature mortality. Yet, there is a lack of effective medications for its treatment. Analyzing molecules in CSF, believed to be significant for the development and maintenance of AUD, could enhance the development of effective pharmacological treatments. At present, there are no CSF studies on individuals with AUD, that explore the underlying mechanisms of the disease. Additionally, several CSF studies lack a representative control group of truly healthy controls (i.e. have not presented any neurological or psychiatric symptoms), which is crucial for drawing accurate conclusions.OBJECTIVESub-study 1 aims to collect CSF from individuals with AUD across various ages to analyze brain molecules that contribute to the development and maintenance of the disease.Sub-study 2 aims to gather CSF from healthy controls across various ages to study molecules involved in neurological and psychiatric conditions, including AUD, substance dependency, brain inflammation, and narcolepsy. The goal is to create a reference group of CSF from healthy controls for comparison with CSF collected from individuals with the aforementioned conditions.We hypothesize that levels of certain molecules, such as dopamine, differ between healthy controls and those with e.g. AUD. This study may provide insights into cellular and molecular mechanisms underlying brain disorders, which is in turn crucial for developing new, effective treatments.Sub-study 3 will examine how the incubation of nerve cells in CSF collected in sub-study 1 and 2 affects their excitability and ability to form new synapses, essential for communication in the brain.We hypothesize that the excitability and synaptogenesis of nerve cells will vary depending on whether they are incubated in CSF from neurologically and psychiatrically healthy individuals versus those with AUD, substance use disorders, brain inflammation, and narcolepsy. Understanding how CSF composition influences brain function in these conditions could be instrumental in creating new therapeutic drugs.METHODSIndividuals with AUD, as well as psychiatrically and neurologically healthy volunteers, will be successively recruited for CSF collection and analyses. Recruitment will be performed through media advertisements and posters within healthcare facilities (The Sahlgrenska University Hospital) and the University of Gothenburg. Additional participants will be recruited from parallel research projects performed within the group (IV-ASA BO10 dnr: 2019-04120, COMB BO8 dnr 431-18, GlycinA BO5 dnr 806-14, PI Bo Söderpalm and NordAlc BO9 dnr: 430-18, PI Andrea de Bejczy) CSF will be obtained through lumbar puncture (spinal tap), a procedure where a thin needle is inserted below the end of the spinal cord. Local anesthesia will be administered in order to mitigate potential discomfort. The lumbar puncture will be performed by an experienced physician, minimizing the risk of injury. Blood samples will also be collected to correlate molecule levels in CSF with those in the blood. Participants will be interviewed about their medical history including their alcohol consumption, and a comprehensive medical examination will be performed.SIGNIFICANCECSF studies offers unique insights into the cellular and molecular processes within the brain. This approach has been utilized for exploring the mechanisms behind several psychiatric and neurological disorders, but not for certain brain diseases like AUD. AUD inflicts significant suffering for affected individuals, contributes to high mortality rates, and imposes considerable burdens on the society. Moreover, a deeper understanding of the cellular and molecular underpinnings of brain diseases such as AUD, can facilitate the development of novel, more effective medications for its treatment. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Spinal tap ### Outcomes Primary Outcomes - CSF-DA levels Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Dual-task Training on the Number of EEG Band in Stroke Patients - NCT ID: NCT06286436 - Study ID: IR.SBMU.RETECH.REC.1401.842 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-05-29 - Lead Sponsor: Universidad de Zaragoza ### Study Description Stroke is a prevalent global health concern, causing widespread disability as it disrupts blood supply to the brain, leading to functional impairments. Upper limb dysfunction affects over 80% of stroke survivors acutely and becomes permanent in approximately 60%, hindering daily activities and autonomy. Dual-task training (DTT), involving simultaneous cognitive and motor tasks resembling daily activities, is proposed as an effective intervention.The study suggests using electroencephalogram (EEG) analysis, particularly the Fast Fourier Transform (FFT), to assess changes in brain signals pre- and post-DTT intervention. EEG provides real-time insights into brain function, and FFT analyzes signal frequencies. The intervention involves three tasks performed concurrently with mental calculations, such as sorting blocks and manipulating objects. This 12-session, four-week intervention aims to improve upper limb function. The study explores EEG's role in evaluating DTT effects on stroke patients, particularly using FFT to analyze brain signal frequencies. ### Conditions - Stroke - Electroencephalography ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dual-task training ### Outcomes Primary Outcomes - EEG Data Secondary Outcomes - Upper limb function - Elbow flexor muscle tone - Wrist extension range of motion - ADLs ### Location - Facility: Shahid Beheshti University of Medical Sciences, Tehran, Velenjak, N/A, Iran, Islamic Republic of @@
## Colchicine in Acutely Decompensated HFREF - NCT ID: NCT06286423 - Study ID: HSR220446 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2028-02 - Lead Sponsor: University of Virginia ### Study Description This is a double blind, placebo-controlled pilot trial randomizing patients admitted to the hospital with acutely decompensated heart failure (ADHF) and inflammation to receive either colchicine or matching placebo.Upon enrollment, patients will be randomized 1:1 to receive either the experimental drug (Colchicine) or matching placebo. The regimen in the active arm will consist of 14 days of Colchicine 0.6 mg bid followed by 76±14 days of Colchicine 0.6 mg once per day. Placebo regimen will be analogous, with one pill bid for 14 days followed by one pill once per day for 76 days. Dose reduction for patients with Stage III chronic kidney disease is allowed as detailed in the protocol. At the same time, dose reduction can also be elected in case of GI symptoms. The study team will transiently stop the experimental medication in case of acute kidney injury (AKI), defined per Kidney Disease Improving Global Outcomes (KDIGO) Stage I, as specified in the protocol.These patients will continue with their standard of care for the management of heart failure which consists of a combination of medications that relieve congestion, normalize blood pressure and heart rate, and block the effects of hormones on the heart. The proposed treatment will be in addition to standard of care. No standard of care medications will be withheld. While inflammation is a known risk factor in heart failure, there are no standard anti-inflammatory drugs used in patients with heart failure, as the benefit is not established. The study team will study colchicine, an anti-inflammatory drug, as compares with placebo.Blood will be obtained from the patients in order to measure hsCRP and IL-6. Blood samples will be collected at baseline, 24±6h, 48±6h and 72±6h after treatment initiation, and subsequently at 14±7 days and at study closure. The first four blood samples will be obtained while the subject is still admitted to the hospital. The blood sample at 14±7 days will be obtained during an outpatient encounter. A study closure visit with clinical assessment and experimental drug collection for capsule counting to assess compliance will be conducted at 90±14; the final blood sample will be collected at that time. ### Conditions - Heart Failure - Decompensated Heart Failure - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Colchicine 0.6 mg - Control/Placebo group ### Outcomes Primary Outcomes - Difference in the change in high sensitivity C-reactive protein (hsCRP) between colchicine arm and placebo arm in the first 72 hours of treatment Secondary Outcomes - Difference in hsCRP area under curve between colchicine and placebo arm at 14 days - Difference in change in plasma IL-6 concentration between colchicine arm and placebo arm in the first 72 hours of treatment ### Location - Facility: UVA Health, Charlottesville, Virginia, 22908, United States @@
## Accommodation Response in Hypermetropic Anisometropia (ARIHA Study) - NCT ID: NCT06286410 - Study ID: 184950 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-12 - Lead Sponsor: University of Sheffield ### Study Description Anisometropic amblyopia is when one eye has a much stronger glasses prescription than the other, causing poor vision in one eye, even with glasses, because the brain favours the better-seeing eye.With standard care treatment (glasses plus either patching or atropine drops given to the better seeing eye), 35% of children with anisometropic amblyopia do not have any significant visual improvements, and will have reduced vision in one eye for life. There is no consensus for the reasons why some children do not respond as well as others.Recent research using the Plusoptix PowerRefractor (PR3), which quickly measures eye focusing (accommodation), suggested that in children with anisometropic amblyopia, the focusing of the amblyopic eye might influence treatment success. However, such measurements weren't previously common due to equipment limitations in clinics.The investigators aim to use the non-invasive PR3 to assess accommodation in hypermetropic anisometropic amblyopia, at the University of Sheffield. This will be a two-phase study of children aged 4-10 years who have hypermetropic anisometropia. The investigators will recruit participants attending the Ophthalmology Department at Sheffield Children's NHS Foundation Trust (SCH). The investigators will take repeated measurements of accommodation at points during standard care treatment (phase 1) and conduct a pilot intervention study (phase 2) to determine whether adjusting glasses prescriptions based on accommodation responses with amblyopia treatment can improve vision in the weaker eye. The goal is to gather evidence to inform a future larger multicentre RCT to improve the visual outcomes for anisometropic amblyopic children in the future. ### Conditions - Anisometropic Amblyopia - Accommodation Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bespoke glasses prescription worn during amblyopia treatment. ### Outcomes Primary Outcomes - Change in visual acuity Secondary Outcomes - Change in PR3 accommodation measurements ### Location - Facility: Division of Ophthalmology & Orthoptics, School of Allied Health Professions, Nursing and Midwifery, The University of Sheffield, Sheffield, South Yorkshire, S10 2RX, United Kingdom @@
## Topical Anti-Androgens in Pilonidal Sinus Disease - NCT ID: NCT06286397 - Study ID: 855173 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-01 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:* Does clascoterone improve the severity of pilonidal disease as scored by a physician?* Does clascoterone improve patient symptoms due to pilonidal disease?* Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.Researchers will compare participants who received clascoterone treatment to those who received placebo. ### Conditions - Pilonidal Disease - Pilonidal Disease of Natal Cleft - Pilonidal Sinus - Pilonidal Cyst ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 1% Clascoterone - Vehicle Cream ### Outcomes Primary Outcomes - Physician-Assessed Disease Severity Assessment - Dermatology Life Quality Index Secondary Outcomes - Subcutaneous Inflammation ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19103, United States @@
## Evaluating the Long-term Effects of Microfocused Ultrasound on Facial Tightening Using Quantitative Instruments - NCT ID: NCT06286384 - Study ID: LEMU47 - Status: RECRUITING - Start Date: 2023-07-03 - Completion Date: 2025-03-15 - Lead Sponsor: First Affiliated Hospital of Jinan University ### Study Description By utilizing standardized photographs in conjunction with quantification detection instruments, data analysis before and after treatment is conducted, along with long-term efficacy observations. This approach aims to provide more comprehensive scientific evidence for the clinical application of ultrasound treatment in anti-aging therapy. ### Conditions - Facial Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Total Volume Change of Nasolabial Folds - Change in Maximum Depth of Nasolabial Folds - Vertical Elevation Value of Nasolabial Fold Curve Projection Curve - Elevation Value of Nasolabial Fold Curve Projection Curve (Along the Nasal Wing Method - Change in Mid-Facial Volume - Brow Lift Height Secondary Outcomes ### Location - Facility: First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, 510000, China @@
## Pelvic Neuro-Angiogenesis in Deep Endometriosis - NCT ID: NCT06286371 - Study ID: 2023-13/37 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-04 - Lead Sponsor: Uludag University ### Study Description Endometriosis is observed in one out of every ten women in society, causing endometrial cells to be found outside their normal location in the body and proliferate in other locations, leading to fibrosis in the tissue due to the secretion of various factors from the cells. Additionally, the substances secreted by the cells can cause various other changes in the tissue besides fibrosis. Increased neurogenesis and neovascularization are among the primary changes, which occur as a result of the secretion of substances from the cells. Increased neovascularization, neurogenesis, and fibrosis in the tissue lead to the formation of nodular structures in the pelvic region, resulting in pain development in women.Nodular formations in the pelvic region due to endometriosis are especially observed in the rectovaginal space. Despite being small in size, they can induce increased neovascularization and neurogenesis even in healthy peritoneal tissue due to the microenvironment they create, leading to different clinical symptoms clinically. However, it is not known how far these changes occur around the endometriotic nodule in the presence of endometriosis.In this project, in patients operated on due to endometriosis, the density of nerve and vascular structures in the surgical margins of the peritoneal tissue excised along with the nodule, and the synthesis and release of chemical mediators causing pain (e.g., Bradykinin, Substance-P) are evaluated. The aim is to determine the minimum surgical margin where excision should be applied in surgery and to demonstrate any endometriotic changes that may exist in the tissues, even though they may appear macroscopically healthy. ### Conditions - Endometriosis-related Pain - Endometriosis - Deep Endometriosis - Endometriosis; Peritoneum ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Laparoscopic Endometriosis Surgery ### Outcomes Primary Outcomes - Density of Neuro-Angiogenesis - Density of Pain Mediators in Pelvic Peritoneum Secondary Outcomes - Relationship between Neuro-Angiogenesis Density and Pelvic Pain Scores ### Location - Facility: Uludag University Faculty Hospital, Bursa, Gorukle, 16285, Turkey @@
## Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK) - NCT ID: NCT06286358 - Study ID: P2023/346 / CCB : B40620230001 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-09-30 - Lead Sponsor: Université Libre de Bruxelles ### Study Description Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.The goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable us to diagnose aortic valve disease and aortic aneurysm.In patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and/or cardiac magnetic resonance imaging and KCG recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG. ### Conditions - Aortic Valve Disease - Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Kinocardiography ### Outcomes Primary Outcomes - Understand and assess the complex mechanisms underlying the modifications of KCG signals in patients with AVD and/or TAA Secondary Outcomes - Comparing KCG to clinical assessment - Asses the clinical application of KCG to diagnose AVD and TAA ### Location - Facility: Erasme hospital, Brussels, N/A, 1070, Belgium @@
## Lifestyle InterVEntion Study in General Practice: LIVES - GP - NCT ID: NCT06286345 - Study ID: 17644 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2025-07-01 - Lead Sponsor: University Medical Center Groningen ### Study Description Patients with depression are at a substantially increased risk of chronic physical disease including cardiovascular disease. This may be attributed primarily to an unhealthy lifestyle related to their disorder. Interestingly, the unhealthy lifestyle feeds back to decreased quality of life and increased depressive symptoms, thus creating a hazardous vicious circle. Consequently, there is a great potential for 'Lifestyle Medicine' for depression. Yet, it is known that patients with depression often have motivational and self-management problems. Therefore an 18 session multimodal lifestyle intervention (MLI) specifically tailored to the needs of depressed patients was developed and piloted in mental health care, with promising results. This research aims to investigate using a process evaluation the feasibility of this MLI in general practice because this is the setting where the majority of patients with depression are treated and results from mental health care are unlikely to apply. ### Conditions - Depression, Unipolar - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - GLI-LEEF ### Outcomes Primary Outcomes - Reach of GLI-LEEF - General practice adoption of GLI-LEEF - General practitioner adoption of GLI-LEEF - Lifestyle coach adoption of GLI-LEEF - Adherence to GLI-LEEF - Drop-out from GLI-LEEF - Barriers and facilitators of the GLI-LEEF implementation Secondary Outcomes - Body weight of the participant as assessed by a medical weight scale - Body height of the participant as assessed by a stadiometer - Waist circumference of the participant as assessed using a tape meter line - Diastolic and systolic blood pressure as assessed using a sphygmomanometer - Treatment success on several domains by according to the Outcome Questionnaire-45 (OQ-=45) - Recovery of the participant according to the Individual Recovery Outcomes - Counter (I.ROC) - Wellbeing as assessed by the Mental Health Continuum Short Form (MHC-SF) - Self esteem according to the Rosenberg Self-Esteem Scale (RSES) - Insomnia according to the Insomnia Severity Index (ISI) - Quality of life according to the Recovering Quality of Life (ReQol) - Health care consumption and productivity loss according to the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) ### Location - Facility: University Medical Center Groningen, Groningen, N/A, 9700 AD, Netherlands @@
## Music Therapy in Acute Leukemia Patients With Fatigue - NCT ID: NCT06286332 - Study ID: Interventional - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Chang Gung University ### Study Description The objective of this study is to assess the efficacy of employing music therapy in alleviating fatigue and medical laboratory values among patients with acute myeloid leukemia. ### Conditions - Acute Myeloid Leukemia - Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Music Therapy ### Outcomes Primary Outcomes - Change from baseline in fatigue on the Tang Fatigue Rating Scale (TFRS) and 11-point Numeric Rating Scale (NRS-11) at day 21. Secondary Outcomes - Change from baseline in neutrophil, hemoglobin, abumin at day 21. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler" - NCT ID: NCT06286319 - Study ID: 23-00726 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: NYU Langone Health ### Study Description The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period. ### Conditions - Lung Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Angel Cooler ### Outcomes Primary Outcomes - Proportion of Devices Deemed "Functional" Secondary Outcomes ### Location - Facility: NYU Langone Health, New York, New York, 10016, United States @@
## Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure - NCT ID: NCT06286306 - Study ID: 2022_0232 - Status: RECRUITING - Start Date: 2023-02-24 - Completion Date: 2025-05-25 - Lead Sponsor: University Hospital, Lille ### Study Description Acute respiratory failure represents a frequent cause of admission to intensive care units (ICUs). In the absence of tailored interventions, it poses an imminent threat to patients' lives. Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function.This practice is grounded in the concept of " preload responsiveness ". However, the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality.Consequently, preload unresponsiveness assumes a pathological character, potentially indicative of fluid overload or right ventricular dysfunction, both deleterious conditions linked to unfavorable outcomes.Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation.The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic, non-hypercapnic respiratory failure.* Main objective: To evaluate the association between fluid responsiveness, assessed by the inferior vena cava collapsibility index (cIVC) with trans-thoracic echocardiography within the initial 48 hours post-ICU admission, and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic, non-hypercapnic acute respiratory failure.* Secondary objectives: To evaluate the association between fluid responsiveness and mortality at day 28 and day 90, the need of invasive mechanical ventilation, and the number of days free from organ support (vasopressors, mechanical ventilation and renal replacement therapy) by day 28.Upon receipt of both oral and written information, patients will provide non-objection to participate in the study. This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval (No. 2022-A02813-40). ### Conditions - Hypoxemic Without Hypercapnia Acute Respiratory Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association between fluid responsiveness and death or the need of invasive mechanical ventilation Secondary Outcomes - All cause mortality - Need of invasive mechanical ventilation - Days alive without vasopressor agents - Days alive without mechanical ventilation or oxygen support - Days alive without renal replacement therapy - Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy ### Location - Facility: Hopital Roger Salengro, Lille, N/A, 59037, France @@
## YOD-RiSoCo: Social Cognition and Risky Decision-making in Patients With Young-onset Dementia - NCT ID: NCT06286293 - Study ID: 18171 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-03-31 - Lead Sponsor: University Medical Center Groningen ### Study Description The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.* Examine if there is a relation between social cognition tests and measures of risky behaviour.Participants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited. ### Conditions - Young-onset Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological assessment, driving simulator task ### Outcomes Primary Outcomes - Social cognitive performance Secondary Outcomes - Association between social cognition and risky decision-making ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery - NCT ID: NCT06286280 - Study ID: AZ221/21 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: University of Giessen ### Study Description Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell (EPCs) activation during extracorporeal circulation (ECC) is lacking.This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation. ### Conditions - Inflammatory Response ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - cytokine adsorber (CytoSorb®) ### Outcomes Primary Outcomes - correlation of endothelial progenitor cells with cytokine levels with and without adsorber use Secondary Outcomes - Overall mortality rate - Days on ventilator, vasopressor and renal replacement therapy - incidence of stroke - length of ICU and in-hospital stay - Echocardiographic changes - Influence of Cytokine on endothelial progenitor cells ### Location - Facility: Universityhospital Giessen, Department of Cardiovascular Surgery, Giessen, N/A, 35392, Germany @@
## AI-Assisted System for Accurate Diagnosis and Prognosis of Breast Phyllodes Tumors - NCT ID: NCT06286267 - Study ID: SYSKY-2023-351-02 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2027-12-31 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Breast phyllodes tumor (PT) is a rare fibroepithelial tumor, accounting for 1% to 3% of all breast tumors, categorized by the WHO into benign, borderline, and malignant, based on histopathology features such as tumor border, stromal cellularity, stromal atypia, mitotic activity and stromal overgrowth. Malignant PTs account for 18%-25%, with high local recurrence (up to 65%) and distant metastasis rates (16%-25%). Benign PT could progress to malignancy after multiple recurrences. Therefore, Early, accurate diagnosis and identification of therapeutic targets are crucial for improving outcomes and survival rates.In recent years, there has been growing interest in the application of artificial intelligence (AI) in medical diagnostics. AI can integrate clinical information, histopathological images, and multi-omics data to assist in pathological and clinical diagnosis, prognosis prediction, and molecular profiling.AI has shown promising results in various areas, including the diagnosis of different cancers such as colorectal cancer, breast cancer, and prostate cancer. However, PT differs from breast cancer in diagnosis and treatment approach. Therefore, establishing an AI-based system for the precise diagnosis and prognosis assessment of PT is crucial for personalized medicine.The research team, led by Dr. Nie Yan, is one of the few in Guangdong Province and even nationally, specializing in PT research. Their team has been conducting research on the malignant progression, metastasis mechanisms, and molecular markers for PT. The team has identified key mechanisms, such as fibroblast-to-myofibroblast differentiation, and the role of tumor-associated macrophages in promoting this differentiation. They have also identified molecular markers, including miR-21, α-SMA, CCL18, and CCL5, which are more accurate in predicting tumor recurrence risk compared to traditional histopathological grading.The project has collected high-quality data from nearly a thousand breast PT patients, including imaging, histopathology, and survival data, and has performed transcriptome gene sequencing on tissue samples. They aim to build a comprehensive multi-omics database for breast PT and create an AI-based model for early diagnosis and prognosis prediction. This research has the potential to improve the diagnosis and treatment of breast PT, address the disparities in breast PT care across different regions in China, and contribute to the development of new therapeutic targets. ### Conditions - Phyllodes Breast Tumor - Artificial Intelligence - Multiomics - Prognostic Cancer Model - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - imaging ### Outcomes Primary Outcomes - Sensitivity - False-negative Rate - Specificity - False-positive Rate - Receiver Operating Characteristic Curve - Area under roc Curve Secondary Outcomes ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510050, China @@
## Study of Safety and Efficacy of the Drug Cycloferone in Patients With Acute Respiratory Viral Infection - NCT ID: NCT06286254 - Study ID: CYCL-NTTF-2023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-20 - Completion Date: 2024-07-30 - Lead Sponsor: POLYSAN Scientific & Technological Pharmaceutical Company ### Study Description The study will collect the information on clinical effects and safety of the basic therapy of acute respiratory viral infection (ARVI) + Cycloferone® and basic therapy of ARVI1 + Arbidol® in real-life clinical settings. ### Conditions - Acute Respiratory Viral Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cycloferone ### Outcomes Primary Outcomes - Average fever duration according to the data of the Patient's Diary Secondary Outcomes - Dynamics of symptom severity parameter according to WURSS-21* questionnaire by visit 2, 3 and 4 (AUC value of change in symptom severity according to WURSS-21 questionnaire) - Dynamics of symptom severity parameter according to CCQ scale by visit 2, 3 and 4 - Time (days) till disappearance of disease symptoms according to WURSS-21 scale. - Number of patients with symptoms of disease and everyday activity disturbance of different severity degree according to WURSS-21 scale. - Number of patients with symptoms of disease of different severity degree according to CCQ scale. - Number of patients with complete disappearance of symptoms according to WURSS-21 questionnaire per each day of the therapy. - Frequency of the need to administer the systemic antibacterial therapy - Percentage of patients who needed hospitalization - Average duration of the temporary incapacity period. - Frequency of revealing ARVI pathogen before beginning of the therapy (at visit 1) for each pathogen among those patients who underwent the qualitative investigation for ARVI pathogen. - Percentage of patients with negative result of the qualitative investigation for ARVI pathogen by visits 3 and 4 among those patients in whom the pathogen was revealed at visit 1. ### Location - Facility**: Clinic Zvezdnaya, Saint Petersburg, N/A, N/A, Russian Federation @@
## Comparison of the Complications in Multiple Myeloma Patients Who Received Autologous Stem Cell Transplantation Between in HEPA-filtered Room and Non-HEPA-filtered Room - NCT ID: NCT06286241 - Study ID: 877/2564(IRB2) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-07-30 - Lead Sponsor: Siriraj Hospital ### Study Description The goal of this observational study is to comparison of the complications in multiple myeloma patients who received autologous stem cell transplantation between in HEPA-filtered room and non-HEPA-filtered room. The main questions it aims to answer are:* The incidence of febrile neutropenia, infection, and duration of hospital stay* 2-year progression free survival Participants will be collected the data of baseline diagnosis, treatment, treatment results and complications during admission and follow-up visits from hospital medical record. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - febrile neutropenia - Infection - duration of admission - progression free survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease - NCT ID: NCT06286228 - Study ID: 751/2563(IRB4) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-04-01 - Lead Sponsor: Siriraj Hospital ### Study Description The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:* 1-year progression free survival rate* 1-year overall survival rate* Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year* Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year* Rate of Neutrophil and platelet engraftment* Efficacy of donor specific antibody desensitization* Relapsed rate* Primary and late graft failure* Safety and complication of haploHSCT* Complication of viral, bacterial, and fungal infection* Viral reactivation* Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT* Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - register hematologic patients with haploidentical hematopoietic stem cell transplantation Secondary Outcomes - progression free survival rate - overall survival rate - Chronic Graft-versus-host free relapsed free survival - Relapsed rate - Primary and late graft failure - Rate of Neutrophil and platelet engraftment - Efficacy of donor specific antibody desensitization - Safety and complication of haploHSCT - Complication of viral, bacterial, and fungal infection - Viral reactivation - outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT - cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Registry of Patients With Plasma Cell Disorders - NCT ID: NCT06286215 - Study ID: 586/2564(IRB2) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2035-04-01 - Lead Sponsor: Siriraj Hospital ### Study Description The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:* The incidence of plasma cell disorders both before and after malignancy* Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)* Progression free survival (PFS)* overall survival* factors influencing overall survival, progression-free survival, and time to progression* Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.* genetic characteristics of plasma cell disorder* cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record. ### Conditions - Plasma Cell Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - register the plasma cell disorder patients Secondary Outcomes - incidence of plasma cell disorders - Time to progression - Progression free survival - overall survival - influencing factors - Symptoms and signs - genetic characteristics - cost-effectiveness ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Integrative Neuro-social Cognitive Strategy Programme for Instilling REcovery (INSPIRE) a Community-Based Cognitive Remediation Trial - NCT ID: NCT06286202 - Study ID: RECAS-0306 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-07 - Lead Sponsor: Singapore Institute of Technology ### Study Description Adults with serious mental illnesses (such as schizophrenia and schizoaffective disorders) often experience a range of cognitive difficulties (such as memory, problem solving difficulties) that affect their ability to lead meaningful life roles. Cognitive remediation is an intervention to address cognitive difficulties in this group of mental health service users. Its implementation in less well-resourced community-based settings is less well-studied.Therefore, the aims of the study are:* To investigate the effects of cognitive remediation on various cognitive skills (such as attention, memory, problem-solving, facial expression recognition, taking others' perspectives etc), for participants with schizophrenia or schizoaffective disorders in community mental health settings.* To investigate if factors such as participants' motivation for engagement and social interaction can affect changes in cognitive skills and functional ability.Participants in the treatment group will attend computer-based cognitive exercises to improve their cognitive skills. They will also participate in group sessions facilitated by therapists to learn how to utilize strategies learned from the computer sessions in their daily lives. Participants in the control group will attend the usual rehabilitation activities in their respective community-based psychiatric rehabilitation centers.This research study will compare the differences in their cognitive performance, functional ability and recovery immediately after the intervention and 8 weeks later. ### Conditions - Schizophrenia - Schizoaffective Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Remediation: Adapted Neuropsychological and Education Approach to Remediation (NEAR) - Standard Psychiatric Rehabilitation at Anglican Care Centers ### Outcomes Primary Outcomes - Brief Assessment of Cognition in Schizophrenia (BACS) - Penn Emotion Recognition Task (ER40) - The Awareness of Social Inference Test (TASIT)- Part 3 - Goal Attainment Scale - Social and Occupational Functioning Assessment Scale (SOFAS) - Recovery Assessment Scale-Domain and Stages (RAS-DS) Secondary Outcomes - Positive and Negative Syndrome Scale (PANSS) - Brief Negative Symptom Scale (BNSS) - Brief Regulation of Motivation Scale (BRoMS) ### Location - Facility: Anglican Care Center-Bukit Batok, Singapore, N/A, N/A, Singapore @@
## Trazodone on OSA Endotypes - NCT ID: NCT06286189 - Study ID: 2020P002760-t - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Placebo oral tablet - Trazodone Hydrochloride ### Outcomes Primary Outcomes - Effect of trazodone on arousal threshold (%eupnea) Secondary Outcomes - Effect of trazodone on apnea hypopnea index (events/h) ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Breastfeeding Promotion in Lebanon Through a Salutogenic Intervention - NCT ID: NCT06286176 - Study ID: LIUIRB-200311-NR1 - Status: COMPLETED - Start Date: 2022-11-17 - Completion Date: 2023-06-30 - Lead Sponsor: Nabiha Ramadan ### Study Description The study is a randomized control trial to assess the effect of a salutogenic intervention on breastfeeding initiation and duration of exclusive breastfeeding in Lebanon. In this Salutogenic intervention, infant feeding helpers will provide subjects of the intervention group breastfeeding related information , and will support these subjects by counseling and guiding them to find general resistance resources. This aims to increase sense of coherence and its parameters: comprehensibility, manageability and meaningfulness, which are the base of salutogenesis. ### Conditions - Breast Feeding - Exclusive Breastfeeding - Salutogenesis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Videos with breastfeeding education material and encouraging messages - Whatsapp group ### Outcomes Primary Outcomes - breastfeeding initiation - Duration of Exclusive breastfeeding Secondary Outcomes - Mean change in Self- esteem in participants from baseline to 6 months postpartum - The Change in Sense of Coherence (SOC) scores from baseline to 6 months postpartum ### Location - Facility: Lebanese International University, Beirut, N/A, 146404, Lebanon @@
## Neuroinflammatory Interactions of ATP and P2X3 Receptor in the Airways of Chronic Cough Patients - NCT ID: NCT06286163 - Study ID: PA4099 - Status: RECRUITING - Start Date: 2023-10-01 - Completion Date: 2025-06-30 - Lead Sponsor: Imperial College London ### Study Description This study is being done in order to understand what causes people to have a chronic cough, which is defined as a cough lasting for more than 8 weeks. The research team wish to find out whether there is any inflammation in the lungs of patients with chronic cough. The research team will also determine whether a suspected chemical produced in the body, called adenosine triphosphate (ATP) can be responsible for causing the chronic cough. In order to be able to find out what is abnormal in those who have a chronic cough, The research team will need to compare their results with those that do not have a chronic cough.In this study, the research team will examine 10 participants who suffer from chronic cough and 8 individuals who do not have a chronic cough and are healthy. ### Conditions - Chronic Cough ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Presence of ATP in airways of idiopathic chronic cough patients and the localisation of P2X2/3 receptors in the airways - Cough sensitivity and laryngeal sensitivity to exogenous ATP - Examine the effects of exogenous ATP on the inflammatory response in the upper and lower airways. Secondary Outcomes ### Location - Facility: Royal Brompton & Harefield NHS Trust,, London, N/A, SW3 6HP, United Kingdom @@
## Efficacy and Safety of Single-port Surgical Robot System in Thoraic Surgery - NCT ID: NCT06286150 - Study ID: EC-2023-087(QX)-03 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2027-07-15 - Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University ### Study Description Robotic surgical systems have become a promising surgical assistance system, with unique advantages such as 3D high-definition visual system, highly flexible wrist-jointed instruments, and automatic fitering of hand tremors. Robotic surgical systems is applied in various fields including urology, general surgery, cardiothoracic surgery, head and neck surgery, and gynecology. Currently, the Da Vinci surgical robot system is the most widely used robot system globally. However, the Da Vinci robot system for single-port laparoscopic surgery has not yet been launched in China. Therefore, the investigators conduct a prespective, single-center study to evaluate the efficacy and safety of single-port surgical robot system in thoracic surgery. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surgical robot system ### Outcomes Primary Outcomes - Intraoperative conversion rate - Surgical complications rate Secondary Outcomes - Intraoperating bleeding volume - Surgical time - Length of hospital admissions - Postoperative wound pain score - Surgeon satisfaction - Adverse events - Rate of re-admission to hospital - Rate of reoperation - Postoperative mortality ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510000, China @@
## Duration of Music Interventions and Pain Tolerance (DOMINANT) - NCT ID: NCT06286137 - Study ID: NL82922.078.22 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Erasmus Medical Center ### Study Description This study will investigate the effect of different durations of music interventions (1, 5 and 20 minutes of music) on pain tolerance. ### Conditions - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Listening to music for 1 minute - Listening to music for 5 minutes - Listening to music for 20 minutes - Not listening to music ### Outcomes Primary Outcomes - Pain tolerance Secondary Outcomes - Heart rate variability (HRV) - Level of perceived anxiety, Spielberger State-Trait Anxiety Inventory (STAI)-6 questionnaire - Valence and arousal, Self-Assessment manikin (SAM) questionnaire - Music listening Questionnaire - Pain intensity - Pain unpleasantness ### Location - Facility: Erasmus Medical Center, Rotterdam, N/A, 3015 GD, Netherlands @@
## Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA) - NCT ID: NCT06286124 - Study ID: 8612 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Erasmus Medical Center ### Study Description The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine. ### Conditions - Incisional Hernia of Midline of Abdomen ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hybrid Surgery ### Outcomes Primary Outcomes - Mean peak torque 1 year Secondary Outcomes - Mean peak torque 2 years - Recurrent Incisional Hernia - Severity of surgical complications - Surgical complications - General Quality of Life - Mesh specific Quality of Life - Scar satisfaction - Pain in the abdominal region ### Location - Facility: Alrijne Hospital, Leiden, N/A, N/A, Netherlands @@
## Red Cell Distribution Width as a Predictor for Post Operative Atrial Fibrillation After Open Heart Surgries - NCT ID: NCT06286111 - Study ID: ASU MD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-08-01 - Lead Sponsor: Ain Shams University ### Study Description In this study we investigate the correlation between RDW and POAF, as we use the RDW as a predictor for inflammation for prediction of POAF ### Conditions - Atrial Fibrillation - Inflammatory Marker - Heart; Surgery, Heart, Functional Disturbance as Result ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Red cell distribution width as a predictor for Post-operative Atrial fibrillation after Open Heart Surgeries Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Alpha Lipoic Acid in Pediatrics on Hemodialysis - NCT ID: NCT06286098 - Study ID: ALA in Pediatrics on HD - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-10-20 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to test alpha lipoic acid in children undergoing hemodialysis. The main questions it aims to answer are:* Will the use of alpha lipoic acid lower cardiovascular events in that population?* Is the incidence of those cardiovascular events linked to the oxidative stress and endothelial dysfunction in that population?* Will the drug cause side effects?Participants will:* take either one dose daily of 600mg tablet Alpha lipoic acid orally or a look-alike tablet containing no drug.* be monitored for the occurrence of cardiovascular events (stroke, angina, etc.)* be monitored for the occurrence of side effects* give blood samples for testing serum levels of E-selectin biomarker and superoxide dismutase enzyme* undergo clinical examinations (Echocardiogram, Duplex ultrasonography, Intima-Media-Thickness) Researchers will compare between the group taking alpha lipoic acid and the group taking the look-alike tablet. ### Conditions - Hemodialysis Complication - Pediatric Kidney Disease - Cardiovascular Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Alpha lipoic acid - Placebo ### Outcomes Primary Outcomes - Serum level of E-Selectin Secondary Outcomes - Serum levels of superoxide dismutase (SOD) - Number of cardiovascular events - Number of Adverse effects ### Location - Facility: New Pediatrics Hospital, Faculty of Medicine, Ain Shams University, Cairo, El Weili, 11381, Egypt @@
## A Comparison of Diagnostic Testing Modalities in the Assessment of Asthma - NCT ID: NCT06286085 - Study ID: 337788 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-07-24 - Lead Sponsor: Portsmouth Hospitals NHS Trust ### Study Description This study aims to assess the concordance of international asthma guidelines in the diagnosis of asthma and explore the presence of airways disease using additional non-guideline physiologic criteria, such as IOS (impulse osciollometry), not included in the guidelines, but available in the Portsmouth lung function service. ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lung function tests ### Outcomes Primary Outcomes - International asthma guidelines scores - non-guideline physiologic criteria Secondary Outcomes - non-guideline physiologic criteria for asthma. - Comparison of the diagnostic outcomes of each guideline with a "reference standard". ### Location - Facility: Portsmouth Hospitals University NHS Trust, Portsmouth, N/A, N/A, United Kingdom @@
## The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD - NCT ID: NCT06286072 - Study ID: YCEYHANS - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-03-30 - Lead Sponsor: Kirsehir Ahi Evran Universitesi ### Study Description COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.The main questions it aims to answer are:1. Does the training given in COPD affect the level of fatigue?2. Do the education given and text messages sent regarding COPD affect the level of fatigue?In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.The initial information of all groups was taken again at the end of the 8th week.Main outcomes:* Dyspnea severity,* COPD general conditions and* Fatigue level. The results obtained will be interpreted by comparing between 3 groups. ### Conditions - Copd - Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Education and message ### Outcomes Primary Outcomes - Fatigue Level - Dyspnea Severity Secondary Outcomes - COPD general condition ### Location - Facility: Yasemin CEYHAN, Kırşehir, Center, 40100, Turkey @@
## Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI - NCT ID: NCT06286059 - Study ID: Phentolamine for CA-AKI - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-01-31 - Lead Sponsor: Helwan University ### Study Description To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI. ### Conditions - CA-AKI - Contrast-Associated Acute Kidney Injury - Coronary Artery Disease - Acute Coronary Syndrome - Adrenergic Receptor Antagonist Adverse Reaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Phentolamine ### Outcomes Primary Outcomes - Rate of CA-AKI Secondary Outcomes - Peak of serum creatinine elevation - Duration of CA-AKI - Change in HR - Change in SBP - Change in DBP - Urine output - Rate of RRT - Rate of MACE - Rate of rehospitalization - Duration of hospitalization ### Location - Facility: Badr university hospital, Badr, Cairo, N/A, Egypt @@
## A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy - NCT ID: NCT06286046 - Study ID: AG348-C-026 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2027-09 - Lead Sponsor: Agios Pharmaceuticals, Inc. ### Study Description The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy. ### Conditions - Sickle Cell Disease - Nephropathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Mitapivat ### Outcomes Primary Outcomes - Percentage of Participants With Albumin Creatinine Ratio (ACR) Response Secondary Outcomes - Change From Baseline in Cystatin C and Creatinine-based Estimated Glomerular Filtration Rate (eGFRcr-cys) - Change From Baseline in Albumin Creatinine Ratio (ACR) - Percentage of Participants With Stable ACR - Annualized Rate of Emergency Room (ER) Visits - Annualized Rate of Days of Hospitalizations - Type, Frequency, Severity, and Relationship to Study Drug of Adverse Events (AEs) and Serious Adverse Events (SAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@