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## Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees - NCT ID: NCT06284733 - Study ID: P.T.REC/012/004874 - Status: COMPLETED - Start Date: 2023-11-05 - Completion Date: 2024-04-20 - Lead Sponsor: MTI University ### Study Description This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data. ### Conditions - Amputation; Traumatic, Leg, Lower ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Whole-body vibration plus conservative care - conservative care ### Outcomes Primary Outcomes - Prosthetic leg stability test Secondary Outcomes - Sway Index - Limits of Stability Test ### Location - Facility: Ahmed Mohamed Ahmed Abdelhady, Cairo, N/A, N/A, Egypt @@
## Transcranial Alternating Current Stimulation for the Improvement of Episodic Memory in Healthy Older Adults - NCT ID: NCT06284720 - Study ID: Project number 144 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10-31 - Lead Sponsor: Universidade Católica Portuguesa ### Study Description Memory complaints are a common symptom among Subjective Cognitive Decline, Mild Cognitive Impairment and Alzheimer disease. Indeed, episodic memory and Alzheimer disease are highly sensitive to aging. Many brain areas become active when we remember an event from the past. The precuneus, part of the posterior system of default mode network, has been identified as a central node of episodic memory retrieval and a central node in various psychiatric and neurological disorders, such as Alzheimer disease. Age-related changes have been consistently found in the default mode network connectivity, occurring within its posterior areas and with the reduction of connectivity between anterior and posterior subnetwork. It has also been found that aging is associated with decreased functional connectivity in the precuneus and posterior cingulate of the default mode network. Furthermore, γ-Aminobutyric acid (GABA), which plays an essential role in regulating brain activity and modulating the default mode network, shows a decrease throughout the normal course of aging, in Mild Cognitive Impairment and Alzheimer disease. It was also verified a link between cognitive decline and the dysfunction of the inhibitory activity of GABAergic interneurons, particularly parvalbumin-positive interneurons, that play a role in control local circuitry, brain networks and memory processing. Parvalbumin interneurons are the fast-spiking interneurons that generate and maintain gamma frequency. Gamma band has been associated with the encoding and retrieval of episodic memory. Impairments of gamma oscillations have been observed in healthy aging, Mild Cognitive Impairment and Alzheimer disease.By identifying these functional connectivity changes, non-invasive neuromodulation techniques may offer a new strategy for improving cognitive functions. Transcranial Alternating Current Stimulation (tACS) is a form of non-invasive brain stimulation that modulates cortical activity by applying weak, oscillating electrical currents to the cortex via two or more scalp electrodes. By using alternating currents, it is possible to simulate the rhythmic pattern of electrophysiological activity of the brain. tACS can interact with neural firing at behaviorally relevant frequencies linked to memory.In this randomized, double-blind, sham-controlled, cross-over study, the investigators will evaluate whether stimulation with gamma tACS on the precuneus can improve episodic memory in healthy older adults. ### Conditions - Healthy Older Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Gamma tACS (40 Hz) over the precuneus - Sham tACS over the precuneus ### Outcomes Primary Outcomes - Changes in immediate and delayed free recall Auditory Verbal Learning Test scores - Changes in immediate free recall and delayed recognition Face-Name Memory Test scores Secondary Outcomes - Change in functional connectivity ### Location - Facility: Filipa Ribeiro, Lisbon, N/A, N/A, Portugal @@
## Effect of Rhythmic Gymnastics Training in Children With Down Syndrome - NCT ID: NCT06284707 - Study ID: Rhythmic_PAU_2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-05 - Lead Sponsor: University of Castilla-La Mancha ### Study Description Some of the clinical characteristics of people with Down syndrome (DS) are orthopedic, cardiovascular, neuromuscular, visual, cognitive and perceptual disorders, which directly affect the quality of their movements. Children with DS often have a sedentary lifestyle or low levels of physical activity which exacerbates problems related to obesity and overall physical health. Therefore, the practice of physical exercise in this type of population is essential to improve their health-related physical fitness. The aim of this study was to analyze the influence of an adapted rhythmic gymnastics training program on body composition, tendon architecture and stiffness, and physical capacity in children with DS. ### Conditions - Physical Conditioning, Human ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - swimming training - rhythmic gymnastics training ### Outcomes Primary Outcomes - Body composition - Tendon thickness - Stiffness tendon - Hamstrings flexibility - body mass index - visceral fat area - metabolism - tendon elastography - balance - functional capacity Secondary Outcomes ### Location - Facility: Universidad de Castilla La Mancha, Toledo, N/A, 45071, Spain @@
## Treatment of Neuropathic Pain Following Spinal Cord Injury - a rTMS Approach - NCT ID: NCT06284694 - Study ID: REB23-0120 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: University of Calgary ### Study Description This study aims to determine if repetitive transcranial magnetic stimulation (rTMS) can improve pain symptomology in adults with neuropathic pain (NP) following a spinal cord injury (SCI). ### Conditions - Neuropathic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Repetitive Transcranial Magnetic Stimulation (rTMS) ### Outcomes Primary Outcomes - International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) v3.0 - Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Neuropathic Pain Quality 5a Secondary Outcomes - Quality of Life Index Spinal Cord Injury version (QLI-SCI) - Pain Catastrophizing Scale (PCS) - World Health Organization Disability Assessment Schedule (WHODAS) 2.0 - Generalized Anxiety Disorder scale-7 (GAD-7) - Patient Health Questionnaire-9 (PHQ-9) ### Location - Facility: Foothills Medical Centre, Calgary, Alberta, T2N 2T9, Canada @@
## Weight Inclusive and Adaptive Strategies to Enhance Cardiometabolic Health in Black Adults - NCT ID: NCT06284681 - Study ID: IRB-300012557 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The proposed 6-month pilot Sequential Multiple Assignment Randomize Trial (SMART) has two aims. The first and primary aim is to determine the feasibility of conducting a full-scale SMART to compare weight-focused (i.e., weight loss) and weight-neutral (i.e., weight loss is not an explicit goal) adaptive biobehavioral interventions for improving cardiometabolic health in Black adults with overweight or obesity (BMI ≥27 kg/m2) plus at least one weight-related cardiometabolic condition (high blood pressure, prediabetes or diabetes, and/or high cholesterol). Biobehavioral interventions are treatment strategies that combine lifestyle-based behavioral interventions such as eating a healthy diet and exercise with medications. In this study, participants will be randomly assigned to receive either weight-focused or weight-neutral health coaching for 7 weeks. At week 8, participants will be identified as either "responders" or "nonresponders" to the initial interventions. The threshold for response in the weight-focused condition is greater than or equal to 3% weight loss. The threshold for response in the weight-neutral condition is engaging in greater than or equal to 150 minutes of moderate physical activity for the 7 days prior to the week 8 study visit. Responders to the initial interventions will continue with health coaching on a biweekly basis for weeks 9-26 of the intervention. Nonresponders will be re-randomized to either intensify the lifestyle-based intervention by receiving a membership to the YMCA and enrolling in group fitness classes or augmenting the health coaching with enhanced medical management in partnership with their established primary care provider. The second aim is to use clinical data from the pilot SMART to estimate treatment effects and the between-person variability in these effects. Because this is a pilot study, these estimates will not be used to make comparisons or draw conclusions on the comparative effectiveness of intervention conditions. Rather, these data will be used to generate preliminary effect sizes that can be used to estimate the sample size required for a full-scale trial. Clinical trial feasibility data will be collected on an ongoing basis throughout the study and clinical data will be collected prior to initiating the intervention (baseline) and at week 8 (response visit) and week 26 (post-intervention visit). ### Conditions - Obesity - Prehypertension - Hypertension - PreDiabetes - Type 2 Diabetes - Dyslipidemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Weight-focused health coaching - Weight-neutral health coaching - Intensify lifestyle approach - Augment with enhanced medical management ### Outcomes Primary Outcomes - Recruitment rate - Retention rate - Response/Non-response rate to initial interventions - Attendance to health coaching sessions - Treatment Credibility and Expectancy Questionnaire (CEQ) - Treatment Credibility and Expectancy Questionnaire (CEQ) - Treatment Preference - Treatment Preference - Family medicine clinic capacity for research - Study visit duration - Time required for surveys completion - Response to weight-focused health coaching - Response to weight-neutral health coaching measurement Secondary Outcomes - Change in blood pressure - Change in glucose - Change in insulin - Change in insulin sensitivity - Change in HbA1c - Change in total cholesterol - Change in LDL-cholesterol - Change in HDL-cholesterol - Change in triglycerides - Change in Metabolic Syndrome Severity Score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety - NCT ID: NCT06284668 - Study ID: GWang027 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-07-10 - Lead Sponsor: Tianjin Medical University General Hospital ### Study Description To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval ### Conditions - Sleep Disturbance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - normal Saline - Esketamine - Remimazolam ### Outcomes Primary Outcomes - The incidence of postoperative sleep disturbance on the first night after surgery Secondary Outcomes - The incidence of sleep disturbance one day before surgery - The incidence of postoperative sleep disturbance on the second and third postoperative nights - Postoperative anxiety - Postoperative depression - Pain Score (NRS) - Mean intraoperative blood pressure - Oxygen saturation - Somatokinetic reaction - Operation time - Duration of anesthesia - Time to walking down - Adverse event ### Location - Facility: Tianjin Medical University General Hospital, Tianjin, N/A, 300052, China @@
## The Effect of a Brief Educational Intervention for Adults With ADHD - NCT ID: NCT06284655 - Study ID: 635362 a - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2030-12 - Lead Sponsor: St. Olavs Hospital ### Study Description This RCT-study proposes the evaluation of an intensive educational intervention tailored for adults with Attention Deficit Hyperactivity Disorder (ADHD) in community mental health centers (CMHCs). Given the prevalent challenges of prolonged waiting lists and low patient engagement in CMHCs, the research seeks to assess the efficacy of this intervention in enhancing patient engagement, self-efficacy, satisfaction with the information and overall health outcomes. The intervention, developed collaboratively with user representatives, combines a brief group-based educational sessions with standard clinical care. The primary hypotheses posit that this approach will lead to increased patient satisfaction with the treatment, patient self-efficacy, and activation compared to conventional treatment. Additionally, it aims to improve patients' satisfaction with information received. The study will employ a ITT analysis to assess the intervention's effects against usual treatment practices in outpatient settings. The anticipated outcome is a significant improvement in level of patient satisfaction, level of self-efficacy and level of satisfaction with the received information for patients with ADHD, potentially informing clinical practices and optimizing care for adults with ADHD. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - group-based combined with innovative technology education - Standard treatment ### Outcomes Primary Outcomes - Change in client satisfaction using CSQ - Change in general self-efficacy using GSE-6 - Change in satisfaction with the information - Knowledge and treatment preferences Secondary Outcomes - Change in patient activation using PAM - Change in ADHD-related symptoms using ASRS - Change in ADHD-related symptoms using SCL-9 - Change in depression and anxiety symptoms using PHQ-4 - Change in patient enablement using PEN-13 - Change in stress level using PSS-4 - Change in level of functioning using WSAS - Change in ADHD Quality of life using AAQoL - Change in Health-related Quality of life using EQ-5D-5L ### Location - Facility: St Olav's Hospital, Trondheim, N/A, N/A, Norway @@
## Early Lumbar Drainage Combined With Intrathecal Urokinase Injection for Treatment of Severe Aneurysmal SAH (LD-ITUK) - NCT ID: NCT06284642 - Study ID: LD-ITUK-2024-001 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2026-06-30 - Lead Sponsor: Second Affiliated Hospital of Nanchang University ### Study Description The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the placebo group. Patients in the treatment group will receive standard treatment with the addition of lumbar drainage combined with intrathecal urokinase injection started within 24 hours after aneurysm treatment with 30000 IU urokinase, once a day for 3 consecutive days. Patients in the control group will receive standard treatment with the addition of lumbar drainage combined with intrathecal placebo (0.9%NaCl) injection. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 2 on the modified Rankin Scale (mRS), at 6 months after aneurysmal SAH. Primary outcome will be determined by a member of the Independent Committee on Terminal events. ### Conditions - Aneurysmal Subarachnoid Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Urokinase - Placebo ### Outcomes Primary Outcomes - Modified Rankin Scale (mRS) Secondary Outcomes - Modified Rankin Scale (mRS) - Relative Modified Rankin Scale (mRS) - Modified Rankin Scale (mRS) distribution - Glasgow Outcome Scale (GOS） - Questionnaire EuroQol Five Dimensions Questionnaire (EQ-5D) - Barthel Index for Activities of Daily Living (BI) - Total hospitalized time - Total hospitalized costs - Cerebral vasospasm (CV) - Delayed cerebral ischemia (DCI) - Death - Hydrocephalus - Rebleeding ### Location - Facility: The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China @@
## Enhancing Referral Decision-making for Advanced Treatment in Parkinson's Disease Through Objective Measurements and Patient Reported Outcomes. - NCT ID: NCT06284629 - Study ID: PD-DigiCare - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-09-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The overall aim of the trial is to compare the efficacy of using wearables and patient-reported outcome measures versus standard care in enhancing the timeliness of referrals to advanced monitoring of treatments for people with Parkinson's Disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Neptune - Standard clinical care ### Outcomes Primary Outcomes - Differences between groups in algorithm-based motor symptom burden (time spent in the ON state without dyskinesias) at referral to evaluation for advanced treatment. Secondary Outcomes - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. - Changes in type of, frequency and dose of medication (calculated Levodopa Equivalent Dose, LED, by use of Tomlinson's scale) - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. - Differences in questionnaire data from baseline (inclusion visit) to end-of-intervention. ### Location - Facility: Rigshospitalet Glostrup, Glostrup, N/A, 2600, Denmark @@
## JASP-1 for Children Recently Diagnosed and Their Parents - NCT ID: NCT06284616 - Study ID: K2019-0392 - Status: COMPLETED - Start Date: 2019-08-15 - Completion Date: 2023-12-31 - Lead Sponsor: Region Stockholm ### Study Description To implement and evaluate a patient-and family-centered Juvenile Arthritis Support Program during one year (JASP-1) for children recently diagnosed with JIA and their parents and after 12 months compare satistaction with care and health outcomes with a control group receiving standard care. ### Conditions - JIA - Support Program - Patient Satisfaction - Patient Outcome Assessment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - JASP-1 ### Outcomes Primary Outcomes - Rate of Patient Reported Experienced Measures (PREM) Secondary Outcomes - Rate of Overall perceived health - Rate of Child Health Activity Questionnaire (CHAQ) - Number of active joints ### Location - Facility: Astrid Lindgren Children´s Hospital, Stockholm, Region Stockholm, 17176, Sweden @@
## Effectiveness of Hyperbaric Oxygen Therapy in Adults - NCT ID: NCT06284603 - Study ID: AWF_LA_HBOT - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-12-20 - Lead Sponsor: Poznan University of Physical Education ### Study Description The goal of this controlled, experimental study is to learn about the effects of 10 sessions of hyperbaric oxygen therapy on physical performance, vascular circulation, biochemical parameters, and composition of the intestinal microbiota in young healthy men depending on the frequency of single treatments.The main questions it aims to answer are:1. Do 10 treatments of hyperbaric oxygen therapy induce significant changes in physical performance levels, vascular circulation, and concentrations of biochemical parameters in young, healthy men?2. Does the body's response to 10 treatments of hyperbaric oxygen therapy differ depending on the frequency of treatments?3. Does a series of hyperbaric oxygen therapy treatments induce significant changes in the composition of the intestinal microbiota, metabolome, and functional status of the intestines?Participants are exposed to hyperoxia under hyperbaric conditions or form a control group with no treatment. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hyperbaric Oxygen Therapy - HBOT ### Outcomes Primary Outcomes - Volume of oxygen and carbon dioxide - Heart rate - Vascular circulation measures Secondary Outcomes - Body composition (body mass, fat mass, lean body mass, muscle mass) - Inflammatory cytokine profile - Oxidative stress indicators - F2-Isoprostanes (F2-IsoP) - Brain-derived neurotrophic factor concentration (BDNF) - Nicotinamide (NAD) metabolites - Gut microbiome and metabolome - Indicators of intestinal inflammation (fecal calprotectin, claudin, occludin, zonulin, sIgA) - endothelial nitric oxide synthase (eNOS) - Vascular endothelial growth factor (VEGF) - Hypoxia inducible factor-1 (HIF-1alfa) ### Location - Facility: Poznan University of Physical Education, Poznan, Wielkopolska, 61-871, Poland @@
## Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination With Pembrolizumab, in Unresectable Melanoma Patients - NCT ID: NCT06284590 - Study ID: PH-ICKPD1-02/21 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-19 - Completion Date: 2028-07 - Lead Sponsor: Philogen S.p.A. ### Study Description The trial aims to evaluate the efficacy of single agent L19IL2, single agent L19TNF, and combination L19IL2+L19TNF given concurrently with anti-PD1 therapy compared to historical control of anti-PD-1 re-challenge alone for anti-PD1 refractory unresectable stage III-IV melanoma. ### Conditions - Melanoma Stage III - Melanoma Stage IV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - L19IL2 - L19TNF - L19IL2/L19TNF - KEYTRUDA® ### Outcomes Primary Outcomes - Confirmed Objective Response Rate (ORR) Secondary Outcomes - Best overall response (BOR) - Duration of Response (DoR) - Pathological response - Confirmed ORR - Progression-free survival (PFS) - Overall survival (OS) - Serious Adverse Event (SAEs) - Drug-Induced Liver Injury (DILI) - Number of patients with Adverse Events of Special Interest (AESI) - Number of patients with Immune-Related Adverse Events (IRAEs) - Number of participants with abnormal hematology laboratory tests results - Number of participants with abnormal hematology laboratory tests results - Number of participants with abnormal hematology laboratory tests results - Number of participants with abnormal hematology laboratory tests results - Number of participants with abnormal serum chemistry laboratory tests results - Number of participants with abnormal serum chemistry laboratory tests results - Number of participants with abnormal serum chemistry laboratory tests results - Number of participants with abnormal serum chemistry laboratory tests results - Number of participants with abnormal serum chemistry laboratory tests results - Number of participants with abnormal coagulation laboratory tests results - Number of participants with abnormal body temperature - Number of participants with abnormal blood pressure - Number of participants with abnormal Electrocardiogram (ECG) readings - Number of participants with abnormal Echocardiogram (ECHO) readings - Number of participants with abnormal physical examination results - Concomitant medication usage - Assessment of the formation of human anti-fusion protein antibodies (HAFA) against L19IL2 and L19TNF ### Location - Facility: Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States @@
## Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis - NCT ID: NCT06284577 - Study ID: 677186 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2027-07-01 - Lead Sponsor: Oslo University Hospital ### Study Description The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients. ### Conditions - Cystic Fibrosis in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Multistrain Probiotic - Placebo - maltodextrin ### Outcomes Primary Outcomes - Changes in GI related QoL using the questionnaire PedsQL GI Secondary Outcomes - Changes in microbiota - Changes in intestinal inflammation ### Location - Facility: Oslo University Hospital, Oslo, N/A, N/A, Norway @@
## A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) - NCT ID: NCT06284564 - Study ID: 2023-0538 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2026-10-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if evolocumab and nivolumab can control metastatic and refractory renal cell carcinoma. The safety of this drug combination will also be studied. ### Conditions - Metastatic Renal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Evolocumab - Nivolumab ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## The Relationship Between Internet-use Behavior and Mental Health in Youth - NCT ID: NCT06284551 - Study ID: 202111069RINB - Status: ENROLLING_BY_INVITATION - Start Date: 2022-02-08 - Completion Date: 2025-01-27 - Lead Sponsor: National Taiwan University Hospital ### Study Description Introduction: WHO defines youth as 15-24 years age group. At this stage, the brain is still under development, with high impulsiveness, being fond of stimulation and yearning for peer life. Compared with traditional interpersonal interaction, modern youths use the Internet as a main interpersonal interaction platform and conduct lots of leisure activities on the Internet. Poor cognitive emotion regulation strategies and personal traits may extend to new types of mental health issues; and are associated with depression, anxiety, suicidal/self-injurious behaviors, and cyberbullying.Objectives: (1) To investigate whether emotion regulation strategies while facing stressful events are highly related to with cyberbullying, social media, and internet gaming disorder. (2) To investigate the relation between cyberbullying and depression, anxiety, suicide/self-injury among Taiwanese youths. (3) To investigate the probability of cyberbullying, social media addiction, and internet gaming disorder occurring at the same time.Method: This cross-sectional study recruits cases of youths from 15 to 24 years old and collects data through questionnaires survey. In addition to collection of basic data, Internet using habits, and medical history, self-rated questionnaires include Suicide/Self-Injury Ideation Questionnaire, The Beck Depression Inventory 2nd Edition, Multidimensional Anxiety Scale for Children-Taiwan version, Cognitive Emotion Regulation Questionnaire, Cyberbullying Questionnaire, and Internet Gaming Disorder Scale-Short Form. ### Conditions - Mental Health Issue ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Cyberbullying Questionnaire Secondary Outcomes - Beck's Depression Inventory (BDI-II) ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, N/A, Taiwan @@
## Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds - NCT ID: NCT06284538 - Study ID: NA-01-23 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-09-30 - Lead Sponsor: Nova Argentia S.r.l. ### Study Description The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events. ### Conditions - Wound Healing Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - NOVA.EMOSTOP RE-EPITHELIZING ### Outcomes Primary Outcomes - improvement in Clinical Healing score at visit 3 Secondary Outcomes ### Location - Facility: Casa di cura riabilitativa Villa Sofia, Acireale, Catania, 95024, Italy @@
## Ankle Assistance and Resistance in Older Adults - NCT ID: NCT06284525 - Study ID: 2137420 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2025-01 - Lead Sponsor: Northern Arizona University ### Study Description The goal of this research protocol is to improve mobility in older individuals through advances in wearable assistive devices by focusing on two specific aims. The first aim is to study if targeted ankle resistance gait training improves walking performance in older individuals. The second aim is to evaluate the potential of wearable assistance at the ankle, knee, and/or hip joints to increase walking performance in older individuals. ### Conditions - Sarcopenia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Ankle resistance and biofeedback ### Outcomes Primary Outcomes - 6MWT - Metabolic power - Plantar flexor strength Secondary Outcomes ### Location - Facility: Northern Arizona University, Flagstaff, Arizona, 86011, United States @@
## Uveal Melanoma - Comparative Study - NCT ID: NCT06284512 - Study ID: Uveal Melanoma 1942/2022 - Status: RECRUITING - Start Date: 2023-10-15 - Completion Date: 2024-12-31 - Lead Sponsor: Medical University of Vienna ### Study Description The progress of uveal melanoma is typically monitored with sonography by experienced onco-ophthalmologists. However, there is evidence that twodimensional measurements in color fundus photography match precisely with sonography measurements. This study aims to compare sonography and color fundus photography measurements in order to evaluate the feasibility of monitoring of uveal melanoma with color fundus photography. ### Conditions - Uveal Melanoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Sonography, color fundus photography ### Outcomes Primary Outcomes - Largest Basal Diameter Secondary Outcomes ### Location - Facility: Medical University of Vienna, Department of Ophthalmology and Optometry, Vienna, N/A, 1090, Austria @@
## Effect of Different Fixed Lingual Retainers on Tooth Stability - NCT ID: NCT06284499 - Study ID: 26308819120 - Status: WITHDRAWN - Start Date: 2020-01-16 - Completion Date: 2023-10-13 - Lead Sponsor: Mustafa Kemal University ### Study Description Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests. ### Conditions - Effect of Lingual Retainers on Tooth Stability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - measuring tooth stability after orthodontic treatment using a Periotest® device. ### Outcomes Primary Outcomes - Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device Secondary Outcomes ### Location - Facility: Hatay Mustafa Kemal University, Faculty of Dentistry, Hatay, N/A, 31060, Turkey @@
## A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib - NCT ID: NCT06284486 - Study ID: 2023-0794 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2028-12-30 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Venetoclax - Revumenib ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Ketamine as a Supplement to Local Anesthesia for Minor Procedures - NCT ID: NCT06284473 - Study ID: 212154 - Status: RECRUITING - Start Date: 2022-05-25 - Completion Date: 2025-05-31 - Lead Sponsor: Loyola University ### Study Description This trial is a double-blind randomized controlled clinical trial of adults and children (ages 7 to less than 70 years). Patients who present to the ED and who undergo minor bedside procedures that require local anesthesia will be divided into two groups: The first group will be treated with 0.7 mg/kg intranasal ketamine as well as standard local anesthesia for the procedure (treatment cohort). The second group will be treated with a volume-based dose of intranasal saline solution as well as standard local anesthesia for the procedure (control cohort). The primary aim is to assess whether patients in the treatment cohort report lower pain scores on the Numerical Rating Scale (NRS-100) when compared to patients in the control cohort. For adult patients, a secondary aim is to compare agitation between the two cohorts using the Richmond Agitation Sedation Scale (RASS) and, for pediatric patients, a secondary aim is to compare alertness between the two cohorts using the University of Michigan Sedation Scale (UMSS).Results obtained from specific procedures will be analyzed on a spectrum of complexity and general length of recovery time. Scientific achievements may include finding a safe and effective way to reduce pain and discomfort during minor procedures in the Emergency Department. Additionally, it would provide opportunities for more research on sub-dissociative doses of ketamine during minor procedures: a topic in which there is still a gap in the published research ### Conditions - Pain, Procedural - Minor Laceration - Abscess ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ketamine - Saline ### Outcomes Primary Outcomes - Immediate pain - Acute pain - Delayed pain Secondary Outcomes - Immediate agitation - Acute agitation - Delayed agitation - Immediate alertness - Acute alertness - Delayed alertness ### Location - Facility: Loyola University Medical Center, Maywood, Illinois, 60153, United States @@
## Phase I/II Study of a Combination of Decitabine and Cedazuridine (ASTX727) and ASTX029, an ERK Inhibitor, for Patients With RAS Pathway Mutant Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Neoplasms - NCT ID: NCT06284460 - Study ID: 2022-0622 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2027-12-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description The goal of Part 1 of this clinical research study is to find the highest tolerable dose of ASTX029 that can be given in combination with ASTX727 to participants who have RAS-mutant MDS or MDS/MPN. The goal of Part 2 of this clinical research study is to learn if the dose of ASTX029 found in Part 1 can help to control the disease when used in combination with ASTX727. ### Conditions - Pathway Mutant Myelodysplastic Syndromes - Myelodysplastic Neoplasm - Myeloproliferative Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ASTX029 - ASTX727 ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Cente, Houston, Texas, 77030, United States @@
## Barriers to Cervical Cancer Screening - NCT ID: NCT06284447 - Study ID: 22-004500 - Status: RECRUITING - Start Date: 2023-03-23 - Completion Date: 2025-03-31 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates barriers to cervical cancer screening among non-compliant women. ### Conditions - Cervical Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Identify barriers to cervical cancer screening Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Liposomal Bupivacaine Use in Alveolar Bone Graft Patients - NCT ID: NCT06284434 - Study ID: CHI2311 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Kerry O'Rourke ### Study Description The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:* pain scores at hip and jaw sites* opioid use in amount and frequency* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine. ### Conditions - Cleft Lip and Palate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Liposomal Bupivacaine - Bupivacain - Epinephrine ### Outcomes Primary Outcomes - Visual Analog Pain Scores - Opioid Use - PROMIS Pediatric Mobility Questionnaire Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Durometer for Measuring Uterine Tone - NCT ID: NCT06284421 - Study ID: IRB23-1068 - Status: RECRUITING - Start Date: 2024-02-08 - Completion Date: 2024-09-30 - Lead Sponsor: University of Chicago ### Study Description This study will evaluate the use of a durometer to measure uterine tone in parturients undergoing cesarean delivery. ### Conditions - Uterine Tone Disorders - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Shore durometer ### Outcomes Primary Outcomes - feasibility of a durometer Secondary Outcomes - durometer reading - durometer reading - durometer reading - correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") - correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") - correlation of durometer reading with a 0-10 uterine tone rating score (0= "no tone"; 10= "excellent tone") ### Location - Facility: University of Chicago, Chicago, Illinois, 60637, United States @@
## Centralized Screening Unit (CSU) at Montefiore-Einstein - NCT ID: NCT06284408 - Study ID: 2024-15683 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-12 - Lead Sponsor: Albert Einstein College of Medicine ### Study Description This study proposes to increase Lung-cancer screening (LCS) in the Bronx, New York. Despite strong evidence that Lung-cancer screening (LCS) can reduce Lung cancer (LCa) deaths, low-dose computed tomography (LDCT) referral rates by clinicians are very low and there is poor adherence with LCS by patients. Both provider and patient barriers may be amenable to systemic improvements in support, coordination and infrastructure for screening. The investigator team hypothesizes that the implementation of a Central Screening Unit (CSU) that shifts routine workflow attributed to LCS (e.g., collection of smoking history, determination of eligibility, shared decision making and arranging follow-up) away from busy practices (usual care) and that offers patients an array of navigation and support services will increase the uptake of LCS guidelines and subsequent low-dose computed tomography (LDCT) screening scans in a low-income, predominately Hispanic and Black catchment area. The proposed study represents a unique opportunity to test this hypothesis in the context of the roll out of a CSU as a significant new component of the Montefiore-Einstein health system. The investigator team will examine whether and how the CSU facilitates LCS uptake and retention of patients. This study is powered to test whether CSU reduces proportion of late-stage lung cancer diagnoses in the Bronx, New York. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Centralized Screening Unit Implementation ### Outcomes Primary Outcomes - Participant Referrals - Proportion of participants with early stage lung cancer (LCa) Secondary Outcomes ### Location - Facility: Montefiore Medical Center's New York City Research and Improvement Networking Group (NYC RING), Bronx, New York, 10467, United States @@
## Two Schemes Response in Multiple Myeloma - NCT ID: NCT06284395 - Study ID: HGM1471-002/24 - Status: RECRUITING - Start Date: 2023-11-20 - Completion Date: 2024-03-30 - Lead Sponsor: Hospital General de Mexico ### Study Description Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination. ### Conditions - Response, Acute Phase - Survivorship ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bortezomib ### Outcomes Primary Outcomes - Favorable Response - Time to next treatment Secondary Outcomes - Overall survival ### Location - Facility: Hospital General de Mexico Dr. Eduardo Liceaga, Mexico City, Cdmx, 06720, Mexico @@
## Interaction Between Early Trauma and Odor-induced Dopamine Release - NCT ID: NCT06284382 - Study ID: 2022-A02736-37 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Hôpital le Vinatier ### Study Description This prospective, double-blind, parallel-group controlled trial aims to investigate the consequence of early trauma on dopamine release evoked by positive valence odors. ### Conditions - Trauma, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - High score at Childhood Trauma Questionnaire. - Low score at Childhood Trauma Questionnaire. ### Outcomes Primary Outcomes - Dopamine transmission measured with positron emission tomography Secondary Outcomes - Odor hedonic appreciation. - Functional brain connectivity. - Effective brain connectivity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Video Messages for Smoking Cessation Campaign - NCT ID: NCT06284369 - Study ID: Mongolia - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-04 - Lead Sponsor: Loma Linda University ### Study Description 240 adult smokers will be recruited. Subjects will be asked to view video messages that encourage smoking cessation. The effect of these videos will be assessed. ### Conditions - Smoking Cessation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Developing, Evaluating and Testing Video Messages for a Smoking Cessation Campaign - Health Message Framing ### Outcomes Primary Outcomes - Message Engagement Secondary Outcomes - Readiness to Quit Smoking ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pan Immune Inflammation Value for Perioperative Complications of Laparoscopic Sleeve Gastrectomy - NCT ID: NCT06284356 - Study ID: IRB Session 2022/14 Protocol 6 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2023-05-01 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description Morbid obesity emerges as a problem that causes serious complications and increased mortality rates. The most effective treatment for morbid obesity today is surgical treatment. The most preferred type of surgery in morbid obesity surgery in Turkey and around the world is Laparoscopic Sleeve Gastrectomy (LSG).While postoperative complications are divided into early and late complications, complications that develop during surgery and in the postoperative period before discharge are defined as perioperative complications. Early surgical complications after LSG include complications such as staple line bleeding, leaks, pulmonary thromboembolism, and torsion of the remnant stomach. It is important to detect these complications, which can be controlled with early intervention in the perioperative period.Monitoring blood parameters and monitoring inflammation are methods that are easily accessible and provide rapid evaluation. Platelet lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), which are used in the evaluation and detection of postoperative complications, have shed light on studies in this direction. Pan immune inflammation value (PIV) is calculated from blood parameters and has been used to evaluate prognosis and chemotherapy results in colorectal cancer.In this study, the diagnostic importance of changes in NLR, PLR, and PIV values in the preoperative and postoperative periods will be investigated in detecting complications that develop in the perioperative period before discharge in patients who underwent LSG. ### Conditions - Morbid Obesity - Laparoscopic Sleeve Gastrectomy - Post Operative Complicaiton ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Laparoscopic Sleeve Gastrectomy ### Outcomes Primary Outcomes - Complication prediction after LSG with complete blood cell parameters Secondary Outcomes ### Location - Facility: Kahramanmaras SIU, Kahramanmaraş, N/A, 46000, Turkey @@
## Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study - NCT ID: NCT06284343 - Study ID: 6414 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-09-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk.GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded.The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population.The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population. ### Conditions - Cancer-associated Thrombosis - Venous Thromboembolism - Gynecologic Cancer - Ovarian Cancer - Cervix Cancer - Endometrial Cancer - Vaginal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anticoagulant ### Outcomes Primary Outcomes - Venous thromboembolism Secondary Outcomes - Bleeding ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, N/A, 00168, Italy @@
## CHARGE Study: CHoice ARchitecture Genetic tEsting - NCT ID: NCT06284330 - Study ID: STU-2023-0881 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2025-08 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care. ### Conditions - Hereditary Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Enhanced cascade testing ### Outcomes Primary Outcomes - Rate of cascade genetic testing Secondary Outcomes - Change in probands' family communication about genetic test results as measured by Proband survey - Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months - Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale - Proband's reaction to intervention materials as measured by proband survey. ### Location - Facility: UT Southwestern Medical Center, Dallas, Texas, 75390, United States @@
## A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. - NCT ID: NCT06284317 - Study ID: ETOP 25-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2030-03 - Lead Sponsor: ETOP IBCSG Partners Foundation ### Study Description ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations. ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adjuvant durvalumab ### Outcomes Primary Outcomes - Disease-free survival (DFS) Secondary Outcomes - Response rate as per investigator assessment. - Proportion of patients undergoing surgery - Proportion of patients with surgical outcome R0 and R1 - pCR rate - Proportion of patients eligible for randomisation - Proportion of patients effectively randomised - Toxicity according to CTCAE v5.0 - DFS in patients with pCR - Overall survival (OS) in patients with/without pCR - DFS in patients with/without ctDNA clearance - Time to recurrence (TTR) in patients with/without pCR - Time to treatment discontinuation (TTD) in patients with/without pCR - Toxicity according to CTCAE v5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL - NCT ID: NCT06284304 - Study ID: N22DES - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2027-04-01 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description Trial design: A single centre phase II non-randomised studyTrial population: Men with intermediate risk localised prostate cancerRecruitment target: 20 patients in totalTrial objectives:* Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects* Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 yearsTrial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - De-escalated radiotherapy ### Outcomes Primary Outcomes - Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac Secondary Outcomes - Acute GU toxicity - Acute GI toxicity - Late GU toxicity - Late GI toxicity - PROMs - Biochemical free survival ### Location - Facility: Netherlands Cancer Institute, Amsterdam, N/A, 1066CX, Netherlands @@
## Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies - NCT ID: NCT06284291 - Study ID: TMSpath - Status: RECRUITING - Start Date: 2023-11-22 - Completion Date: 2026-03-01 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments. ### Conditions - Epilepsy - Genetic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - transcranial magnetic stimulation (TMS) ### Outcomes Primary Outcomes - Resting motor threshold - SICI - ICF - LICI - TEP amplitude - TEP latency Secondary Outcomes ### Location - Facility: Meyer Children's Hospital IRCCS, Firenze, N/A, N/A, Italy @@
## Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain - NCT ID: NCT06284278 - Study ID: NCKU_PPGP_diaphragm - Status: RECRUITING - Start Date: 2023-10-20 - Completion Date: 2024-07-31 - Lead Sponsor: YI-JU TSAI ### Study Description The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain. ### Conditions - Postpartum - Pregnancy Related - Pelvic Girdle Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Diaphragmatic breathing retraining - Pelvic stabilization exercise - pelvic anatomy education ### Outcomes Primary Outcomes - Muscle function measures of lumbopelvic muscles - Diaphragm thickness - Diaphragm mobility - Diaphragm strength - Mechanical Property of Thoracolumbar Fascia - Functional performance of ASLR fatigue task - Functional performance of timed up and go test - Functional performance of 6m timed walk test - pain intensity measure of Numeric Rating Scale (NRS) - Disability Level: measure of pelvic girdle questionnaire(PGQ) - Health-related Quality of Life: Short Form-36 (SF36) - Fear Avoidance Belief: Tampa Scale of Kinesiophobia - Self-Efficacy: Pain Self-efficacy Questionnaire - Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF) - Self-perceived Change: Global Rating of Change Scale (GROC) Secondary Outcomes ### Location - Facility: National Cheng Kung University, Tainan, N/A, 701, Taiwan @@
## Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis - NCT ID: NCT06284265 - Study ID: MMH-407-007 - Status: RECRUITING - Start Date: 2023-10-16 - Completion Date: 2026-12-31 - Lead Sponsor: Materia Medica Holding ### Study Description Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis ### Conditions - Cystitis Chronic - Cystitis Bacterial - Recurrence of Chronic Bacterial Cystitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Raphamin - Placebo ### Outcomes Primary Outcomes - Time to the first recurrence of chronic bacterial cystitis Secondary Outcomes - Percentage of patients with a reduction of recurrences of chronic bacterial cystitis ### Location - Facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department, Irkutsk, N/A, 664003, Russian Federation @@
## Virtual Game Simulation on Nursing Students' Physical Examination Skills - NCT ID: NCT06284252 - Study ID: TÜBİTAK-323S135 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-15 - Completion Date: 2025-02-15 - Lead Sponsor: Necmettin Erbakan University ### Study Description The project is unique in that it will use virtual game simulation, a new learning method, and it will address the physical examination skills of nursing students, an area that has not been researched before. In the project, a randomized controlled research design with a pretest-posttest control group will be used. The population will consist of 200 second-year students enrolled in the Physical Examination in Nursing course at Necmettin Erbakan University, Faculty of Nursing, Department of Nursing, in the 2024-2025 Fall Semester. 120 students from the population who meet the research inclusion criteria will be randomly assigned to control (n=60) and experimental (n=60) groups according to their general academic success score. In collecting data; Introductory characteristics form, skill checklist for physical examination of the heart, skill checklist for physical examination of the abdomen, skill checklist for physical examination of the respiratory system and an evaluation form for the effect of virtual game simulation on skill practice for physical examination will be used. In the project, three different virtual game simulations will be developed for physical examinations of the heart, abdomen and respiratory system. During the fall semester, theoretical and laboratory demonstration applications will be carried out by the project team. A pre-test will be administered to all students, and then virtual game simulations will be made available to students in the experimental group for three weeks. Then, the virtual games will be closed to the students and a post-test will be administered to the experimental and control group students. After the final test application, virtual game simulations will be made available to students in the control group. In pre- and post-test applications, students will practice physical examination skills on simulated patients at three different stations (heart, abdomen and respiratory system) and will be evaluated by the project team according to skill checklists. After the skill evaluations, the students in the experimental group will be given a form to evaluate the effect of the virtual game simulation for physical examination on skill practice and will be asked to fill it out. ### Conditions - Simulation of Physical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Virtual Gaming Simulation ### Outcomes Primary Outcomes - Skill assessment for physical examination of the abdomen (Pretest) - Skill assessment for physical examination of the heart(Pretest) - Evaluation of physical examination skills of the respiratory system(Pretest) Secondary Outcomes - Skill assessment for physical examination of the abdomen (Posttest) - Skill assessment for physical examination of the heart(Posttest) - Evaluation of physical examination skills of the respiratory system(Posttest) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using Games in Teaching Nursing History - NCT ID: NCT06284239 - Study ID: Tell Me Game - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Necmettin Erbakan University ### Study Description Innovative learning methods can be used in teaching nursing history. One of the most preferred among these methods is learning through games. It is known that today's Generation Z students prefer active learning methods and want to learn by having fun instead of learning by rote. It is reported that learning through games improves students' knowledge and skills and increases retention. One of the methods of learning through games is the "tell me" game. The "Tell Me" game involves the narrator explaining the words prepared specifically for the subject to a group of students without using prohibited words. Other students in the group try to know the word explained. Thus, both the student narrator and the student trying to know actively use their critical thinking and decision-making skills. This research aims to determine the effect of the tell-all game used in teaching nursing history on students' learning and opinions. ### Conditions - Education Nursing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Tell me about the game. ### Outcomes Primary Outcomes - Nursing History Knowledge Test Secondary Outcomes - Nursing History Teaching Evaluation Form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients - NCT ID: NCT06284226 - Study ID: CCT-ANK-11 - Status: WITHDRAWN - Start Date: 2022-03-25 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Kejing Biotechnology Co., Ltd. ### Study Description An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients ### Conditions - Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Allogeneic NK（CCT-ANK-11) ### Outcomes Primary Outcomes - To evaluate the safety and the efficacy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium - NCT ID: NCT06284213 - Study ID: 5U24NS100591 - Status: RECRUITING - Start Date: 2021-09-29 - Completion Date: 2027-07 - Lead Sponsor: Massachusetts General Hospital ### Study Description Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss.Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated.The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function. ### Conditions - Cognitive Impairment - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No interventions ### Outcomes Primary Outcomes - SVD progression as measured by decline in global cognition Secondary Outcomes - SVD progression as measured by decline in executive function ### Location - Facility: University of Southern California, Los Angeles, California, 90033, United States @@
## Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis - NCT ID: NCT06284200 - Study ID: sarcopenia eRA - Status: RECRUITING - Start Date: 2023-06-23 - Completion Date: 2024-06-23 - Lead Sponsor: Kayseri City Hospital ### Study Description introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study. ### Conditions - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluation of Muscle Mass - Evaluation of Muscle Strength - Evaluation of Muscle Performance Secondary Outcomes - Rheumatoid Arthritis Quality of Life Scale - Health Assessment Questionnaire (HAQ) - Hospital Anxiety and Depression Scale (HADS) ### Location - Facility: Health Sciences University, Kayseri Medicine Faculty, Kocasinan, Kayseri, 38125, Turkey @@
## Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis - NCT ID: NCT06284187 - Study ID: KhonKaenH - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Khon Kaen Hospital ### Study Description BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture. ### Conditions - Tuberculosis - Pulmonary ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of participants with pulmonary TB by Allplex™ MTB/MDRe Secondary Outcomes ### Location - Facility: Thananit Sangkomkamhang, Khon Kaen, N/A, 40000, Thailand @@
## Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking. - NCT ID: NCT06284174 - Study ID: B-BR-109-054-T - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation. ### Conditions - Spine Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Povidone-iodine solution; chlorhexidine gluconate ### Outcomes Primary Outcomes - Bacteria culture and Polymerase chain reaction exam Secondary Outcomes - Post operative infection ### Location - Facility: National Cheng Kung University Hospital, Tainan, N/A, 704, Taiwan @@
## QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up - NCT ID: NCT06284161 - Study ID: RBHP 2020 GUY - Status: RECRUITING - Start Date: 2022-06-28 - Completion Date: 2026-02-28 - Lead Sponsor: University Hospital, Clermont-Ferrand ### Study Description Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis. ### Conditions - Amyotrophic Lateral Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Quadriceps Combined Test ### Outcomes Primary Outcomes - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) - Parameters from the QCT (Quadriceps Combined Test) Secondary Outcomes - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data - Clinical and paraclinical likely course data ### Location - Facility: CHU de Clermont-Ferrand, Clermont-Ferrand, N/A, 63000, France @@
## Confidential IPV Screening Tool - NCT ID: NCT06284148 - Study ID: Pro00093964 - Status: COMPLETED - Start Date: 2010-10-06 - Completion Date: 2023-07-31 - Lead Sponsor: Medical University of South Carolina ### Study Description Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care. ### Conditions - Violence, Domestic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SCREENING ### Interventions - Screening for intimate partner violence - Assessment and referral ### Outcomes Primary Outcomes - IPV positive (Yes/No) - Screening completed (Yes/No) Secondary Outcomes - Severity of risk - Physician compliance with IPV management tools ### Location - Facility: Biomedical Informatics Center, Charleston, South Carolina, 29403, United States @@
## MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles - NCT ID: NCT06284135 - Study ID: 2017-PS-03 - Status: COMPLETED - Start Date: 2017-06-19 - Completion Date: 2021-05-31 - Lead Sponsor: Martini-Klinik am UKE GmbH ### Study Description A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. ### Conditions - Lymphocele After Surgical Procedure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Michl-stitch ### Outcomes Primary Outcomes - rate of lymphoceles requiring intervention after RARP Secondary Outcomes - total lymphocele rate after RARP - other complications ≥ grade IIIa according to Clavien-Dindo after RARP - continence rates after RARP ### Location - Facility: Martini-Klinik am UKE GmbH, Hamburg, N/A, 20246, Germany @@
## Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 - NCT ID: NCT06284122 - Study ID: MorningLyte - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-04 - Lead Sponsor: The Lymphoma Academic Research Organisation ### Study Description This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma. ### Conditions - Follicular Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mosunetuzumab - Lenalidomide - Rituximab - Obinutuzumab - Cyclophosphamide - Doxorubicin - Vincristin - Prednisone - Rituximab - Obinutuzumab - Bendamustin ### Outcomes Primary Outcomes - Progression Free Survival (PFS) - Progression Free Survival (PFS) Secondary Outcomes - Overall Response (OR) - Complete Metabolic Rate (CMR) - Overall Response (OR) - Complete Metabolic Rate (CMR) - Best Overall Response (CMR + PMR) rate - Best Overall Response (CMR + PMR) rate - Progression of disease within 2 years (POD24) - PFS - PFS - Event Free Survival (EFS) by Lugano 2014 - Event Free Survival (EFS) by Lugano 2014 - Time to Next Anti-Lymphoma Treatment (TTNLT) - Time to Next Anti-Lymphoma Treatment (TTNLT) - Duration of response - Duration of response - Overall Response (OR) - Complete Metabolic Rate (CMR) - Duration of complete response - Duration of complete response - Overall Survival (OS) - Overall Survival (OS) - Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs) - Incidence and severity of AEs including SAEs and AESIs - Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation - Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation - Incidence of Second Primary Malignancies (SPM) - Incidence of Second Primary Malignancies (SPM) - anti-drug antibodies (ADA) to mosunetuzumab - Time to deterioration in physical functioning - Time to deterioration in lymphoma symptoms - Maximum serum concentration of mosunetuzumab - Cmax - Minimum serum concentration of mosunetuzumab - Cmin - Area under the curve of serum concentration of mosunetuzumab - AUC - Maximum serum concentration of lenalidomide - Cmax - Minimum serum concentration of lenalidomide - Cmin - Area under the curve of serum concentration of lenalidomide - AUC ### Location - Facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie, Brugge, N/A, 8000, Belgium @@
## Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain - NCT ID: NCT06284109 - Study ID: 23-1036 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: The Cleveland Clinic ### Study Description Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cryoanalgesia - Sham Cryoanalgesia ### Outcomes Primary Outcomes - Phantom limb pain score Secondary Outcomes - Mobility - General physical and emotional disability - Opioid consumption ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Personal Recovery Based Psychoeducation For Schizophrenia - NCT ID: NCT06284096 - Study ID: 2023/391 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-06 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated.Research Question:1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission?Hypotheses:H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission.H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission.H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission.H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission.H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission.H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission. ### Conditions - Mental Health Recovery - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Psychoeducation ### Outcomes Primary Outcomes - Personal Recovery levels of individuals diagnosed with schizophrenia Secondary Outcomes - Psychological resilience levels of individuals diagnosed with schizophrenia - Hope levels of individuals diagnosed with schizophrenia ### Location - Facility: Umraniye Community Mental Health Center affiliated with the Ministry of Health., Istanbul, Umraniye, 34760, Turkey @@
## Measuring Various Variables in Obstructive Sleep Apnea - NCT ID: NCT06284083 - Study ID: Cumhuriyet University Hospital - Status: COMPLETED - Start Date: 2018-12-18 - Completion Date: 2022-02-07 - Lead Sponsor: Cumhuriyet University ### Study Description This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma. ### Conditions - Obstructive Sleep Apnea-hypopnea Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - taking a blood sample ### Outcomes Primary Outcomes - Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity. Secondary Outcomes - Polysomnographic measurement ### Location - Facility: Sivas Cumhuriyet University, Sivas, Centre, 58140, Turkey @@
## Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer - NCT ID: NCT06284070 - Study ID: 202433 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2029-12-31 - Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University ### Study Description Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic efficacy Secondary Outcomes - SUV ### Location - Facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, Chongqing, Chongqing, 400010, China @@
## Lower Silesia Culotte Bifurcation Registry (LSCBR). - NCT ID: NCT06284057 - Study ID: CopperHealthCentre3 - Status: RECRUITING - Start Date: 2013-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Regional Cardiology Center, The Copper Health Centre (MCZ), ### Study Description The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis. ### Conditions - Safety Issues - Efficacy, Self ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte ### Outcomes Primary Outcomes - Target lesion failure (TLF) Secondary Outcomes - MACE ### Location - Facility: Department of Cardiology, Provincial Specialized Hospital in Legnica,, Legnica, Lower Silesia, 59-220, Poland @@
## Facilitating Safe Transition to Home for Preterm Infants - a National Database Study - NCT ID: NCT06284044 - Study ID: NIHR204885 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-11-30 - Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust ### Study Description Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight.Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge.This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays. ### Conditions - Premature Birth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Age and postmenstrual age when each of three physiological barriers are reached - Final barrier to discharge home Secondary Outcomes - Number of days in hospital after surpassing all physiological discharge barriers ### Location - Facility: University Hospitals of Derby and Burton, Derby, Derbyshire, DE22 3DT, United Kingdom @@
## Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions - NCT ID: NCT06284031 - Study ID: Brachy Study - Status: RECRUITING - Start Date: 2023-06-26 - Completion Date: 2026-12 - Lead Sponsor: National University Hospital, Singapore ### Study Description Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient settingPrimary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5 ### Conditions - Cervical Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 3 fractions HDR brachytherapy ### Outcomes Primary Outcomes - Local control rate - Loco-regional control rate - Progression-free survival (PFS) - Overall survival (OS) Secondary Outcomes - Long term toxicities ### Location - Facility: National University Hospital, Singapore, N/A, 119074, Singapore @@
## Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain - NCT ID: NCT06284018 - Study ID: postnatal low back pain - Status: NOT_YET_RECRUITING - Start Date: 2024-02-24 - Completion Date: 2024-12-31 - Lead Sponsor: Cairo University ### Study Description This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Progressive Muscle Relaxation Exercises - Pilates Exercises ### Outcomes Primary Outcomes - Pressure Algometer Secondary Outcomes - Oswestry Disability Index ### Location - Facility: faculty of physical therapy: Cairo university, Giza, N/A, 12662, Egypt @@
## Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level - NCT ID: NCT06284005 - Study ID: MOTU ATP - Studio clinico - Status: COMPLETED - Start Date: 2020-07-27 - Completion Date: 2022-12-22 - Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus ### Study Description The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.The main question it aims to answer are:* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.Participants will perform:* walking tests inside parallel bars on flat and/or inclined terrain;* walking tests on treadmill;* stair climbing/descent tests. ### Conditions - Amputation - Amputation; Traumatic, Leg, Lower ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - WRL ATP ### Outcomes Primary Outcomes - ad hoc check-list Adverse Event - ad hoc check-list Adverse Event - ad hoc check-list Adverse Event - ad hoc check-list Adverse Event - ad hoc check-list Adverse Event Secondary Outcomes ### Location - Facility: IRCCS Fondazione Don Carlo Gnocchi, Firenze, FI, 50143, Italy @@
## Digital Health Navigation for Latino Patients With Type II Diabetes - NCT ID: NCT06283992 - Study ID: 2024p000095 - Status: RECRUITING - Start Date: 2024-03-31 - Completion Date: 2027-05-31 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Digital Navigation ### Outcomes Primary Outcomes - Proportion of Participants Who Login to the Portal Secondary Outcomes - Proportion of Participants that Perform Distinct Portal Functions - Proportion of participants that complete a telehealth - Proportion of participants that are re-admitted ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States @@
## A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. - NCT ID: NCT06283979 - Study ID: 199723 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: Biocomposites Ltd ### Study Description The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers. ### Conditions - Pressure Ulcer, Stage IV - Osteomyelitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - STIMULAN VG - Standard of Care ### Outcomes Primary Outcomes - Individual patient success and findings at the 8 week follow-up visit Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease - NCT ID: NCT06283966 - Study ID: D5989C00001 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2028-03-06 - Lead Sponsor: AstraZeneca ### Study Description This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk. ### Conditions - COPD (Chronic Obstructive Pulmonary Disease) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BGF MDI 320/14.4/9.6 μg - GFF MDI 14.4/9.6 μg ### Outcomes Primary Outcomes - Time to first severe cardiac or COPD event Secondary Outcomes - Time to first severe COPD exacerbation event - Time to first severe cardiac event - Time to cardiopulmonary death - Moderate/severe COPD exacerbation rate - Time to Myocardial Infarction (MI) hospitalization or cardiac death - Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death ### Location - Facility: Research Site, Athens, Alabama, 35611, United States @@
## Boosting Resources for Tracheostomy Care at Home - NCT ID: NCT06283953 - Study ID: 2023P001695 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-10-01 - Lead Sponsor: Massachusetts General Hospital ### Study Description The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:* How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?* How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm. ### Conditions - Tracheostomy - Caregiver Burden ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Trach@Home - Trach Me Home ### Outcomes Primary Outcomes - Caregiver Burden Secondary Outcomes - Medical Complications Associated with Tracheostomy - 6-month Readmission Rate - Frequency of pediatrician communication - Primary care pediatrician satisfaction ### Location - Facility: University of San Diego Rady Children's Hospital, La Jolla, California, 92093, United States @@
## Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation - NCT ID: NCT06283940 - Study ID: 281694 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2026-01 - Lead Sponsor: Vastra Gotaland Region ### Study Description Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life. ### Conditions - Aortic Valve Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiotherapist-led exercise based cardiac rehabilitation (PT-X) ### Outcomes Primary Outcomes - Exercise capacity in watt - Rating of perceived exertion Borg RPE scale 6-20 - Exercise capacity in Watt - Rating of perceived exertion Borg RPE scale 6-20 - Muscular endurance test, shoulder flexion - Muscular endurance test, shoulder flexion - Muscle endurance test, shoulder abduction - Muscle endurance test, shoulder abduction - Muscle endurance test, unilateral heel-lift - Muscle endurance test, unilateral heel-lift - Lower extremity function - Lower extremity function - Physical activity - Physical activity - Self-assessed level of physical activity - Self-assessed level of physical activity - Health Related Quality of Life - Health Related Quality of Life Secondary Outcomes - Frailty - Frailty - Hospital admission - Hospital admission ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) - NCT ID: NCT06283927 - Study ID: MEC-2020-0812-5 - Status: RECRUITING - Start Date: 2023-01-01 - Completion Date: 2028-01-01 - Lead Sponsor: Jasper Gerritsen ### Study Description Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. ### Conditions - Glioblastoma - Glioblastoma Multiforme - Glioblastoma, IDH-wildtype - Glioblastoma Multiforme of Brain - Glioblastoma Multiforme, Adult - Recurrent Glioblastoma - Astrocytoma, Malignant - Astrocytoma of Brain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Re-resection - Temozolomide - Lomustine - Re-irradiation - Experimental therapy - Best supportive care ### Outcomes Primary Outcomes - Overall survival - Neurological morbidity at 6 weeks Secondary Outcomes - Neurological morbidity at 3 months - Neurological morbidity at 6 months - Progression-free survival - Residual tumor volume - Quality of life at 6 weeks (EORTC QLQ C30) - Quality of life at 3 months (EORTC QLQ C30) - Quality of life at 6 months (EORTC QLQ C30) - Quality of life at 6 weeks (EORTC QLQ BN20) - Quality of life at 3 months (EORTC QLQ BN20) - Quality of life at 6 months (EORTC QLQ BN20) - Quality of life at 6 weeks (EQ-5D) - Quality of life at 3 months (EQ-5D) - Quality of life at 6 months (EQ-5D) - Serious Adverse Events ### Location - Facility: University of California, San Francisco, San Francisco, California, 94143, United States @@
## Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry - NCT ID: NCT06283914 - Study ID: BIO-2024-0011 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-01 - Lead Sponsor: American University of Beirut Medical Center ### Study Description The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age \>18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded. ### Conditions - Oxygen Saturation - Respiratory Distress Syndrome - Anesthesia, General ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PaO2 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness - NCT ID: NCT06283901 - Study ID: NL82013.018.22 - Status: RECRUITING - Start Date: 2023-01-02 - Completion Date: 2025-09-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome. ### Conditions - Traumatic Brain Injury - Intracranial Hemorrhages - Subarachnoid Hemorrhage - Meningitis - Encephalitis - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Glasgow Outcome Scale Extended Secondary Outcomes - Glasgow Outcome Scale Extended ### Location - Facility: Radboud UMC, Nijmegen, Gelderland, 6525 GA, Netherlands @@
## CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention - NCT ID: NCT06283888 - Study ID: PRECISE-PCI - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-01 - Lead Sponsor: Zunyi Medical College ### Study Description In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice. ### Conditions - ACS - Acute Coronary Syndrome - CYP2C19 Polymorphism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CYP2C19 Genotype Guided DAPT - Conventional DAPT ### Outcomes Primary Outcomes - NACE (net adverse clinical event) Secondary Outcomes - Incidence of clinically significant bleeding - Incidence of MACCE ### Location - Facility: Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, 563003, China @@
## The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer - NCT ID: NCT06283875 - Study ID: PROMISEPLUS-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-01-30 - Lead Sponsor: Geneplus-Beijing Co. Ltd. ### Study Description This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS. ### Conditions - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - DFS of enrolled patients for 2 years Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China @@
## MIVetsCan: Can-Coach Trial (Phase 2) - NCT ID: NCT06283862 - Study ID: HUM00231159b - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-02 - Lead Sponsor: University of Michigan ### Study Description The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. ### Conditions - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Educational Session ### Outcomes Primary Outcomes - Patient Global Impression of Change (PGIC) score Secondary Outcomes - Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 - Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1 - Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 - Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 - Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation - Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48105, United States @@
## Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study - NCT ID: NCT06283849 - Study ID: SON-2024-32671 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: University of Minnesota ### Study Description The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting. ### Conditions - Cardiovascular Diseases - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - strategies to break up SB ### Outcomes Primary Outcomes - sedentary time Secondary Outcomes ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy - NCT ID: NCT06283836 - Study ID: Dexrem ATI 4-6 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-15 - Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy ### Study Description Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trialThe goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:* to assess the patient's satisfaction with each sedation regimen* the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered. ### Conditions - Otosclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dexmedetomidine - Remifentanil ### Outcomes Primary Outcomes - Patient satisfaction - Surgeon satisfaction Secondary Outcomes - mean arterial pressure - Heart Rate ### Location - Facility: Cluj County Clinical Emergency Hospital, Cluj Napoca, Cluj, 400006, Romania @@
## Morphological Changes of Removable Orthodontic Retainers During the Use - NCT ID: NCT06283823 - Study ID: 41821 - Status: RECRUITING - Start Date: 2021-12-21 - Completion Date: 2024-12-21 - Lead Sponsor: University of L'Aquila ### Study Description The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage. ### Conditions - Orthodontic Retainer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thermoformed orthodontic retainer ### Outcomes Primary Outcomes - Peer Assessment Rating (PAR) index - Volumetric superimposition of digital models Secondary Outcomes - Thickness ### Location - Facility: University of L'Aquila, L'Aquila, N/A, 67100, Italy @@
## The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy - NCT ID: NCT06283810 - Study ID: 2023/168 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-09-30 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.Translated with DeepL.com (free version) ### Conditions - Midwifery Students ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - psychotherapy of interpersonal relationships - laughter therapy - Plasebo ### Outcomes Primary Outcomes - self-reflection skills - problem solving skills - interpersonal relationship skills Secondary Outcomes ### Location - Facility: Istanbul University-Cerrahpasa, Istanbul, N/A, 34320, Turkey @@
## Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes - NCT ID: NCT06283797 - Study ID: RECHMPL22_0346 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-05 - Lead Sponsor: University Hospital, Montpellier ### Study Description The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use.The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.An optional 1-year extension aims at assessing: (1) Sustainability of above mentioned parameters over a second year of HCL use in the group who started HCL early after diagnosis, (2) Efficacy on glucose control according to the above mentioned parameters when HCL is initiated early after diagnosis vs. after 1 year in the control group of the randomized phase. ### Conditions - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OmniPod 5 - Dexcom G6 - PAID questionnaires ### Outcomes Primary Outcomes - Glycated hemoglobin (HbA1c) level Secondary Outcomes - Percent of time spent in the 70-180 mg/dl glucose range - Percent of time spent in the 70-140 mg/dl glucose range - Mean glucose level - Percent of time spent with glucose level below 70 mg/dl - Percent of time spent with glucose level below 54 mg/dl - Percent of time spent with glucose level above 180 mg/dl - Percent of time spent with glucose level above 250 mg/dl - Coefficient of glucose variability - Score of PAID questionnaire for parents - Score of PAID questionnaire for children - Stimulated plasma C-peptide level 10-min after 1mg IV glucagon - Number of needed interventions by the parents/guardians or care providers ### Location - Facility: University Hospital, Angers, Angers, N/A, N/A, France @@
## Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients - NCT ID: NCT06283784 - Study ID: YOVIS Capsules - Status: COMPLETED - Start Date: 2021-09-05 - Completion Date: 2022-05-18 - Lead Sponsor: Biofarma ### Study Description This is a double blind, randomized, placebo-controlled study. One-hundred subjects are randomized to receive either YOVIS or placebo over a period of 10 days.The purpose is to determinate the efficacy of the treatment in subjects treated with antibiotic therapy, by measuring occurrence of Antibiotic Associated Diarrhoea (AAD) from baseline to the end of the observation period (28±2 days) ### Conditions - Diarrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yovis Capsules - Placebo ### Outcomes Primary Outcomes - Efficacy of YOVIS in preventing the incidence of AADD in subjects under antibiotic therapy Secondary Outcomes - Severity and duration of AAD - Severity and duration of AAD - Evaluation of duration and severity of gastrointestinal symptoms - Evaluation of duration and severity of gastrointestinal symptoms - Evaluation of duration and severity of gastrointestinal symptoms - Impact of bowel habits on QoL - Effects of YOVIS, versus placebo, at each visit on the overall health status - Assessment of acceptability, safety and satisfaction grade of YOVIS versus placebo - Global Patient's self-reported acceptance at the end of study - Global acceptability (investigator) at the end of study ### Location - Facility: General Practitioner Ambulatory, Sanremo, Italy/Imperia, 18038, Italy @@
## The Effect of Heated Socks Developed With Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering - NCT ID: NCT06283771 - Study ID: TU-BOZKUL-007 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-05-15 - Lead Sponsor: Tarsus University ### Study Description In this study, it is aimed to reveal the effect of the use of heated socks to be developed as wearable technology by providing temperature control on body temperature, comfort perception level and shivering development in healthy volunteers and this purpose constitutes the unique value of the project. The research was planned as a prospective, two-arm (1:1), randomized controlled, double-blind study. The population of the study will consist of 4th year nursing students consisting of an average of 250 people who will enroll in the fall semester of the 2024-2025 academic year. As a result of the power analysis performed in the G\Power program, the sample will consist of 70 healthy volunteers, at least 35 in each group. In the study, data will be collected with the "Descriptive Characteristics Form" and "Hypothermia Monitoring Form (Shivering Level Diagnosis Form and Temperature Comfort Perception Scale)" which includes the descriptive information of healthy volunteers. Healthy volunteers will fill out the "Introductory Characteristics Form" and "Hypothermia Monitoring Form" before being taken to the Faculty of Nursing Skills Laboratory for the application. Before the volunteers are taken to the single rooms in the laboratory, the environment will be cooled for 30 minutes with the air conditioner in the room so that the temperature is 21oC. The study group will wear socks developed with wearable technology and the control group will wear socks with the same appearance. The healthy volunteer will be asked to lie motionless on the bed for 60 minutes in a single room. Body temperature (with Braun tympanic thermometer), shivering level and temperature comfort perception will be recorded on the "Hypothermia Monitoring Form" when all healthy volunteers are taken to the Skills Laboratory, at 15 minutes, 30 minutes and 60 minutes, and when they leave the laboratory. The research data will be analyzed in a computer environment. Descriptive variables of healthy volunteers included in the study will be expressed as mean±standard deviation and median (maximum minimum), percentage and frequency. Changes in body temperature measurements obtained after wearing socks to be developed with wearable technology, repeated measurements, analysis of variance (Repeated ANOVA) if parametric, Friedman test if non-parametric, and post-hoc test will be used in intra-group multiple comparison analysis as further analy ### Conditions - Wearable Technology - Hypothermia - Shivering - Thermal Comfort Perception ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Heated socks to be developed with wearable technology ### Outcomes Primary Outcomes* - Body temperature - Shivering level - Thermal comfort perception - Descriptive Characteristics Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Focused Power Ultrasound Mediated Inferior Perirenal Adipose Tissue Modification Therapy for Essential Hypertension (PARADISE HTN-III) - NCT ID: NCT06283758 - Study ID: PARADISE HTN-III - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-10 - Lead Sponsor: Suzhou Municipal Hospital ### Study Description This seamless two-stage phase II/III clinical trial aims to evaluate the efficacy and safety of a novel focused power ultrasound mediated inferior perirenal adipose tissue modification therapy for essential hypertension. Stage 1 is a phase II, multicenter, open-label, randomized trial to determine the optimal treatment strategy. Stage 2 is a phase III, multicenter, randomized, double-blind trial investigating the efficacy and safety of optimal treatment strategy compared to sham control. ### Conditions - Hypertension - Blood Pressure - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - focused power ultrasound mediate inferior perirenal adipose tissue modification - Sham-control group ### Outcomes Primary Outcomes - Ambulatory Blood Pressure Secondary Outcomes - Ambulatory Blood Pressure - Office Systolic Blood Pressure - Office Systolic Blood Pressure - Ambulatory Blood Pressure - Ambulatory Blood Pressure - Home Blood Pressure - Home Blood Pressure - Blood pressure control rate - Antihypertensive drug load index ### Location - Facility: The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China @@
## Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia - NCT ID: NCT06283745 - Study ID: 73225 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-23 - Completion Date: 2027-03-22 - Lead Sponsor: Stanford University ### Study Description This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia. ### Conditions - Paraosmia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Platelet-rich Plasma (PRP) - Saline ### Outcomes Primary Outcomes - Change in Sniffin Sticks Parosmia Test (SSParoT) - Change in questionnaire of olfactory disorders (QOD) scale score Secondary Outcomes ### Location - Facility: Stanford Sinus Center / Stanford University School of Medicine, Palo Alto, California, 94304, United States @@
## A Clinical Study to Assess the Effect of a Supplement on Digestive Health, Overall Well-being, and Participant Experience. - NCT ID: NCT06283732 - Study ID: 20392 - Status: COMPLETED - Start Date: 2023-11-15 - Completion Date: 2024-02-15 - Lead Sponsor: Amway Corp ### Study Description The study aims to evaluate the effectiveness of a dietary supplement (greens powder), on improving digestive health, quality of life, energy levels, and satiety over a 14-day period. Participants, aged 18-65 and experiencing mild digestive issues, will consume the greens powder daily and report outcomes through diaries and questionnaires. ### Conditions - Digestive System Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Greens powder ### Outcomes Primary Outcomes - Digestive Health Improvement Secondary Outcomes - Quality of Life and Well-being Enhancement ### Location - Facility: Citruslabs, Santa Monica, California, 90404, United States @@
## Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer - NCT ID: NCT06283719 - Study ID: ZG006-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd ### Study Description This is a multicenter, open-label phase I/II study, divided into 2 parts:Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic (PK) results for use in Part 2.Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with advanced small cell lung cancer. ### Conditions - Small Cell Lung Cancer - Neuroendocrine Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ZG006 ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Number of participants with adverse events (AEs) - Number of participants with serious adverse events (SAEs) - Duration of response (DOR) - Disease control rate (DCR) ### Location - Facility: Shanghai Chest Hospital, Shanghai, Shanghai, N/A, China @@
## The Tryptophan Requirement in Healthy Adults - NCT ID: NCT06283706 - Study ID: 1000081113 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: The Hospital for Sick Children ### Study Description The aging population is growing rapidly. For the first time ever, Canadian seniors outnumbered young adults in 2016. Aging is associated with many physical and metabolic deteriorations including the loss of muscle mass and strength, insulin resistance, increased inflammation and oxidative stress.The muscles of our bodies are composed of proteins and proteins are made of small building blocks called amino acids. Our bodies have the ability to make some amino acids which are called the non-essential amino acids. However, there are certain amino acids that our body's need to make protein but can only be supplied from the foods that we consume. These are called essential amino acids. Tryptophan is one of the essential amino acids that the body needs. Tryptophan is required for protein synthesis and acts as a precursor for serotonin and nicotinic acid. Therefore, there may be a need for more threonine in the diet of older adults. However, the current requirement for threonine is based on studies conducted exclusively in young adults. Thus, the purpose of this study is to find out how much tryptophan older adults need. ### Conditions - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Tryptophan ### Outcomes Primary Outcomes - Determination of tryptophan requirement in adults >60 years of age. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Mindfulness-based Stress Reduction Programme Given to Infertile Women - NCT ID: NCT06283693 - Study ID: RojdaBAYARYILDIRIM - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-06-10 - Lead Sponsor: Saglik Bilimleri Universitesi ### Study Description Purpose of the Study This study aims to determine the effect of mindfulness-based stress reduction program given to infertile women on perceived stress, anxiety, depression and salivary cortisol.Materials and Method It will be conducted in a randomized controlled experimental design. This randomized controlled trial will follow the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. ### Conditions - Dependent Variables of the Study: Anxiety, Depression, Stress and Salivary Cortisol Levels - Independent Variables of the Study: Women's Socio-demographic Characteristics, Mindfulness-based Stress Reduction Program ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - mindfulness-based stress reduction ### Outcomes Primary Outcomes - Informed Voluntary Consent Form (Annex 1) - Identifying Characteristics Information Form (Annex 2) - Perceived Stress Scale (Appendix 3): - Depression-Anxiety-Stress Scale (Appendix 4) - Collection and study of salivary cortisol samples Secondary Outcomes - Perceived Stress Scale (Appendix 3): - Depression-Anxiety-Stress Scale (Appendix 4) - Collection and study of salivary cortisol samples ### Location - Facility: Saglık Bilimleri Universitesi, Istanbul, N/A, N/A, Turkey @@
## The Effect of Nutrition and BMI on on Lung Capacity, Functional Capacity and Mortality in End-Stage Lung Patients - NCT ID: NCT06283680 - Study ID: 2024 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-28 - Completion Date: 2024-05-31 - Lead Sponsor: Aylin Seylam Küşümler ### Study Description The aim of this study was to investigate the effect of nutritional risk index, BMI and body fat, muscle ratio on functional capacity, lung capacity, exercise capacity index, all-cause mortality, post-transplant intensive care unit stay and survival time in end-stage lung patients on the lung transplant list. ### Conditions - Lung Transplant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lung transplantation ### Outcomes Primary Outcomes - BMI Secondary Outcomes - Nutrition risk index ### Location - Facility: OkanU, Istanbul, N/A, N/A, Turkey @@
## Special Use - Results Surveillance on Long-term Use With Wegovy® - NCT ID: NCT06283667 - Study ID: NN9536-4872 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-22 - Completion Date: 2028-01-31 - Lead Sponsor: Novo Nordisk A/S ### Study Description The purpose of the study is to investigate the safety and effectiveness of Wegovy® in patients with obesity disease under real-world clinical practice in Japan. Participants will get Wegovy® as prescribed by the study doctor. The study will last for about 4 years. Participant will be in the study for about 2 years (104 weeks). ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Semaglutide ### Outcomes Primary Outcomes - Number of Adverse Reactions (ARs) Secondary Outcomes - Number of Adverse Events (AEs) - Number of serious adverse events (SAEs) - Number of Serious Adverse Reactions (SARs) - Change in body weight (Percent (%)) - Change in body weight (Kilograms (Kg)) - Change in waist circumference - Change in BMI (Body Mass Index) - Change in body weight after treatment discontinuation ### Location - Facility: Novo Nordisk Investigational Site, Tokyo, Chiyoda City, 100-0005, Japan @@
## Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation - NCT ID: NCT06283654 - Study ID: VUmc 2018.539 - Status: COMPLETED - Start Date: 2018-09-30 - Completion Date: 2023-01-31 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description In this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. The goal was to see if using a simple handheld ECG device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ED) after undergoing a common procedure known as pulmonary vein isolation (PVI). This procedure is often used to treat AF, but following it patients frequently visit the ED due to concerns about their heart rhythm, which can strain healthcare resources. The researchers proved a group of patients with a 1-lead ECG device , which allowed users to check their heart rhythm at any time. The researchers compared the ED utilization over a year with that of patients who received standard care after PVI. The hope was that by using the 1-lead ECG device, patients could better manage their condition from home and only seek medical help when truly necessary. ### Conditions - Atrial Fibrillation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 1-lead ECG ### Outcomes Primary Outcomes - number of ED visits Secondary Outcomes - ratio of the number of cardioversions emergency vs planned ### Location - Facility: Amsterdam UMC -vumc, Amsterdam, N/A, N/A, Netherlands @@
## Study to Evaluate the Safety and Effectiveness of Saxenda® for Weight Management in Routine Clinical Practice in Taiwan. - NCT ID: NCT06283641 - Study ID: NN8022-7780 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-23 - Completion Date: 2025-02-28 - Lead Sponsor: Novo Nordisk A/S ### Study Description This is a non-interventional study to evaluate the safety and effectiveness of Saxenda® in obese adults and adolescents in Taiwan. The participants will recieve Saxenda® treatment which is a medicine that doctors can already prescribe.The study will last for about 26 weeks. ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Liraglutide ### Outcomes Primary Outcomes - Incidence of adverse events (AEs) by preferred term (PT) Secondary Outcomes - Number of adverse drug reaction (ADRs) - Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) - Number of unexpected AEs and unexpected ADRs - Number of unexpected SAEs and unexpected SADRs - Dose and exposure of liraglutide after initiation and reasons if not escalate to liraglutide 3.0 miligram (mg) for maintenance as specified in the product label - Body weight loss Percent (%) (Adult) - Body weight loss (%) (Adult) - Body weight loss Kilogram(Kg) (Adult) - Body weight loss (kg) (Adult) - The proportion of adult subjects losing at least 5% of baseline body weight - The proportion of adult subjects losing at least 5% of baseline body weight - The proportion of adult subjects losing more than 10% of baseline body weight - The proportion of adult subjects losing more than 10% of baseline body weight - The proportion of losing at least 5% of baseline body weight from adult subjects whose maintenance dose of 3 mg, 12- week Saxenda® - Change in body mass index (BMI) (kg/m^2) (Adolescent) - Change in body mass index (BMI) (kg/m^2) (Adolescent) - Change in body mass index (BMI) (%) (Adolescent) - Change in body mass index (BMI) (%) (Adolescent) - Change in body mass index standard deviation score (BMI SDS) (Adolescent) - Change in body mass index standard deviation score (BMI SDS) (Adolescent) - Body weight loss (%) (Adolescent) - Body weight loss (%) (Adolescent) - Body weight loss (kg) (Adolescent) - Body weight loss (kg) (Adolescent) - The proportion of adolescent subjects losing at least 4% of baseline BMI - The proportion of adolescent subjects losing at least 4% of baseline BMI - The proportion of adolescent subjects losing at least 10% of baseline BMI - The proportion of adolescent subjects losing at least 10% of baseline BMI - The proportion of losing at least 4% of baseline BMI from adolescent subjects whose maintenance dose of 3 mg or maximum tolerated dose, 12- week Saxenda® ### Location - Facility: National Taiwan University Hospital, Taipei City, N/A, 100229, Taiwan @@
## Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves - NCT ID: NCT06283628 - Study ID: STUDY00023737 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Milton S. Hershey Medical Center ### Study Description The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation. ### Conditions - Lumbar Spondylosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiofrequency ablation of lumbar medial branch nerves. ### Outcomes Primary Outcomes - The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). - The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). - The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). Secondary Outcomes - Oswestry Disability index (ODI) - Oswestry Disability index (ODI) - Oswestry Disability index (ODI) ### Location - Facility: Penn State Hershey College of Medicine, Hershey, Pennsylvania, 17033, United States @@
## Effect of Vitamin D on Skeletal Muscle Function and Qol in Patients With Chronic Intestinal Failure/Insufficiency - NCT ID: NCT06283615 - Study ID: 2024-01-01 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-11-30 - Lead Sponsor: Jinling Hospital, China ### Study Description Eligible patients were randomized into two groups: Vitamin D group and Control group. Control group: routine treatment only, no additional vitamin D intervention therapy. Vitamin D group: In addition to the conventional treatment, additional intramuscular injection of vitamin D2 was given once every two weeks, each dose of 600,000 units, and the treatment lasted for 12 weeks.The primary and secondary outcomes will be collected. ### Conditions - Intestinal Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vitamin D ### Outcomes Primary Outcomes - Quality of life score - Muscle function status Secondary Outcomes - Serum vitamin D levels - Hepatic and renal function - Bone mineral density - Thyroid and parathyroid-related hormones - Nutritional status indicators - Number of participants with treatment-related adverse events ### Location - Facility: Xinying Wang, Nanning, Jiangsu, 210002, China @@
## Oral Health in Children and Adolescents With Obesity and Normal Weight - NCT ID: NCT06283602 - Study ID: 2020/17 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2021-04-29 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description We aimed to compare the oral health status (dmft/DMFT index, IDCAS-II, BEWE, plaque index, gingival index, probing depth) between normal-weight (NW) and obese (OW) children/adolescents.82 participants aged 6-16 years were concluded in this cross-sectional study. The children/adolescents were classified according to the body mass index (BMI): NW (n=41) and OW (n=41). Caries experience was assessed by the International Caries Detection and Assessment System (ICDAS-II), decay, missing, filling teeth (dmft) for the primary teeth and (DMFT) for the permanent teeth, erosive tooth wear using Basic Erosive Wear Examination (BEWE), Plaque Index (PI) and Gingival Index (GI), Probing Depth (PD). ### Conditions - Pediatric Obesity - Pediatric Dentistry ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - oral health status ### Outcomes Primary Outcomes - the results of DMFT, plaque and gingival indies - the results of dmft, BEWE, ICDAS-II, probing dept - Comparison of demographic attributes between obese and normal weights Secondary Outcomes - biochemical parameters of obese individuals - other biochemical parameters of obese individuals ### Location - Facility: Aslı Soğukpınar Önsüren, Mersin, N/A, N/A, Turkey @@
## The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis - NCT ID: NCT06283589 - Study ID: INZ701-401 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2024-08-19 - Lead Sponsor: Inozyme Pharma ### Study Description The purpose of this study is to determine if multiple doses of INZ-701, given once per week over 4 weeks are safe and increase pyrophosphate (PPi) levels in hemodialysis-dependent (HD) end stage kidney disease (ESKD) study participants who have low PPi levels. In addition, the effect of hemodialysis on the PK of INZ-701 and PPi levels will be evaluated. ### Conditions - Calciphylaxis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - INZ-701 ### Outcomes Primary Outcomes - Determine if INZ-701 increases PPi levels Secondary Outcomes - Assess the Time to Maximum Serum Concentration (Tmax) - Assess the Maximum Serum Concentration (Cmax) of INZ-701 - Assess the Area under the concentration-time curve over the dosing interval (AUCtau) - Assess the Clearance after extravascular administration of drug (CL/F) ### Location - Facility: South Florida Nephrology Research, Coral Springs, Florida, 33071, United States @@
## Pancreatic Cancer Initial Detection Via Liquid Biopsy - NCT ID: NCT06283576 - Study ID: PANCAID-00-08 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Karolinska University Hospital ### Study Description The overall rationale of PANCAID is to provide a diagnostic blood test for early diagnosis of pancreatic cancer. With a set of different liquid biopsy methods, it is the aim to measure these markers in well-defined patient cohorts. For the entire series of these studies, the following groups are planned: 1) Histologically proven early-stage pancreatic cancer (e.g. T1a/b and T2 carcinomas \[N0M0\]); 2) Intraductal papillary mucinous neoplasia (IPMN) that were operated with verification of the benign, premalignant or malignant histology; 3) ordinary branched-duct IPMN; 4) individuals at risk (IAR) with and without IPMN, with and without known hereditary cancer gene (e.g. BRCA2); 5) a high risk group of patients with chronic pancreatitis, aged 55-65, who are heavy smokers (≥40 PY), with newly onset diabetes mellitus (NODM). ### Conditions - Pancreatic Cancer - IPMN, Pancreatic - Individuals at Risk - Chronic Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Liquid biopsy ### Outcomes Primary Outcomes - Cancer detection Secondary Outcomes - Overall survival ### Location - Facility: Gastrocentrum, KarolinskaUniversity Hospital, Stockholm, N/A, 14186, Sweden @@
## Online Physical Activity Tracking in Patients With Multiple Sclerosis - NCT ID: NCT06283563 - Study ID: 2023/5474 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-28 - Completion Date: 2025-02-28 - Lead Sponsor: Inonu University ### Study Description This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical activity tracking - No physical activity tracking ### Outcomes Primary Outcomes - Smartphone pedometer - Smartphone pedometer - International Physical Activity Questionnaire - Short Form - International Physical Activity Questionnaire - Short Form Secondary Outcomes - Beck Depression Inventory II - Beck Depression Inventory II - Beck Anxiety Inventory - Beck Anxiety Inventory - Fatigue Severity Scale - Fatigue Severity Scale - Multiple Sclerosis Quality of Life-54 - Multiple Sclerosis Quality of Life-54 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy, Safety, and Tolerability of Abrocitinib in Subjects With Moderate to Severe Chronic Hand Eczema Refractory to Corticosteroid Therapy - NCT ID: NCT06283550 - Study ID: INNO-6052 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-08 - Lead Sponsor: Innovaderm Research Inc. ### Study Description This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping. ### Conditions - Chronic Hand Eczema ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Abrocitinib 200 mg - Abrocitinib 100 mg - Placebo ### Outcomes Primary Outcomes - Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) Secondary Outcomes - Change from baseline in hand modified Total Lesion Symptom Score (mTLSS) - Reduction from baseline in hand Physician's Global Assessment (PGA) - Change from baseline in Hand Eczema Severity Index (HECSI) - Change from baseline in Extent of Disease affected with moderate to severe chronic hand eczema (CHE) - Patient Global Assessment (PaGA) measurements - Change from baseline in hand Dermatology Life Quality Index (DLQI) - Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) - Change from baseline in pain Numerical Rating Scale (NRS) - Change from baseline in itch Numerical Rating Scale (NRS) ### Location - Facility: Innovaderm Research Inc., Montréal, Quebec, H2X 2V1, Canada @@
## Online Episiotomy Simulation Training for Midwifery Students - NCT ID: NCT06283537 - Study ID: KÜBAP-01/2023-39 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-05-30 - Lead Sponsor: Kastamonu University ### Study Description Purpose: To determine the effect of online episiotomy simulation training to midwifery students on their episiotomy application skills, satisfaction with the teaching method and self-confidence.Method: This study is a randomized controlled experimental study. It will be conducted with third-year students studying at Kastamonu University Midwifery Department in the 2023-2024 period. In the research, all third-year students in the midwifery department (n=60) will be divided into 30 students into the online education group and 30 students into the face-to-face education group using a random sampling model. "Student Information Form", "Episiotomy Skill Evaluation Form" and "Student Satisfaction and Self-Confidence in Learning Scale" will be used to collect data. ### Conditions - Training Group, Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Effect of training method ### Outcomes Primary Outcomes - episiotomy skill performances Secondary Outcomes - Satisfaction with education ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Eye-tracking Investigation of Clinical Measures in Multiple Sclerosis - NCT ID: NCT06283524 - Study ID: ETNA-TrainMS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-03-18 - Lead Sponsor: Innodem Neurosciences ### Study Description The overarching goal of this research protocol is to acquire eye-tracking, cognitive, and disease-severity metrics in MS patients to train machine learning algorithms that will support the development and performance assessment of a sensitive and non-invasive eye-tracking software application. The training of our machine learning classifying algorithms to identify which eye-tracking metrics-or combination thereof-can serve as reliable markers of MS disease severity and cognitive status. ### Conditions - Multiple Sclerosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Eye-Tracking ### Outcomes Primary Outcomes - Predictive power of eye-movement biomarkers (EMBs) for MS severity in relationship to Expanded Disability Status Scale (EDSS) Secondary Outcomes - Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Symbol Digit Modalities Test (SDMT) as part of the Brief International Cognitive Assessment for MS (BICAMS). - Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Rey Auditory Verbal Learning Test (RAVLT) as part of the Brief International Cognitive Assessment for MS (BICAMS). - Predictive power of eye-movement biomarkers (EMBs) for cognitive status in relationship to the Brief Visuospatial Memory Test-Revised (BVMT-R) as part of the Brief International Cognitive Assessment for MS (BICAMS). - Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the Timed 25-foot walk as part of the Multiple sclerosis functional composite (MSFC). - Predictive power of eye-movement biomarkers (EMBs) for physical disability in relationship to the 9-Hole Peg Test (9-HPT) as part of the Multiple sclerosis functional composite (MSFC). ### Location - Facility: Genge Partners, Inc., Montréal, Quebec, H4A 3T4, Canada @@
## Evaluation of the RESTART Survival Programme - NCT ID: NCT06283511 - Study ID: IJB-RESTART - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-12 - Lead Sponsor: Jules Bordet Institute ### Study Description The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme. ### Conditions - Invasive Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - educational workshops ### Outcomes Primary Outcomes - Assessment of satisfaction with participation in the Restart programme and its various components via Likert scale and open questions. Secondary Outcomes - assessment of quality of life - assessemnt of health literacy via HLQ questionnaire - assessment of professional status - assessment of level of physical activity - assessment of emotionnal distress - assessment of the intensity of residual fatigue - assessment of sleep quality - Measuring the rate of participation in the programme - assessment of quality of life - assessment of emotionnal distress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transvaginal Detrusor Nerve Radiofrequency Ablation for Treatment of Overactive Bladder - NCT ID: NCT06283498 - Study ID: DO612574A - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-10 - Completion Date: 2026-07 - Lead Sponsor: InMode MD Ltd. ### Study Description The goal of this Safety and efficacy of transvaginal Detrusor Nerve Ablation for treatment of overactive bladder symptoms, including refractory overactive bladderThe main questions it aims to answer are:•Change from baseline to the end of treatment in a 3-day diary analysis to assess the reduction of urgency incontinence episodes. \[Time Frame: 3 months\]Subjects will undergo one treatment session and be reassessed at 4 weeks post-treatment. If less than a 50% improvement is noted, a second and third treatment session will be performed at 4-week intervals. If more than a 50% improvement is noted, patients will be followed longitudinally to assess the durability of the treatment. Investigators will have the ability to initiate a second and or third treatment on an individual basis.Follow-up will occur at 3- months, 6-months and 12 months after the subject's last treatment. ### Conditions - Overactive Bladder Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Device Morpheus8V ### Outcomes Primary Outcomes - Change in urgency incontinence episodes after 3 month Secondary Outcomes - Change in urgency incontinence episodes after 1 month - Change in urgency incontinence episodes - Change in urgency incontinence episodes - Analysis to assess the urinary frequency - Analysis to assess urinary frequency - Analysis to assess the urinary frequency. - Analysis to assess the urinary frequency. - Assessment of the impact of the treatment on Overactive Bladder symptoms - Assessment of the impact of the treatment on Overactive Bladder symptoms - Assessment of the impact of the treatment on Overactive Bladder symptoms - Assessment of the impact of the treatment on Overactive Bladder symptoms - Patient-reported Pain assessment - Patient-reported outcome measure - Patient-reported outcome measure - Patient-reported outcome measure - Patient-reported outcome measure ### Location - Facility: Mickey Karram MD, Corona Del Mar, California, 92625, United States @@
## Real-time Anatomy Recognition Tool Accuracy Research for Ultrasound-guided PENG and Suprainguinal Fascia Iliaca Blocks - NCT ID: NCT06283485 - Study ID: Study Artificial intelligence - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-05-25 - Lead Sponsor: Konya City Hospital ### Study Description Background and rationale: Ultrasound-guided regional anesthesia is a widely used pain control method today. A critical aspect of the procedure is accurate visualization of anatomical structures on ultrasound to precisely define target areas. Distinguishing surrounding tissues with an imaging model that automatically recognizes sonoanatomy in ultrasound images will reduce unintended intraneural injections or injury to other anatomical structures in close proximity and increase patient safety.Research question; How can we improve the ultrasound images we frequently use in regional blocks by integrating them with artificial intelligence to reduce complications and improve applications? And what is the accuracy of the developed artificial intelligence support during imaging?Research purpose; This work; We aim to further increase the safety of different regional block positions, minimize the risk of complications, and improve ultrasound visualization by developing an artificial intelligence model (AI Model-Artificial Intelligence) that automatically identifies and segments anatomical landmarks, provides visual guidance for inexperienced colleagues, and improves the performance of the developed model during application. aims to demonstrate its accuracy.Hypothesis; Numerous studies have shown that the use of ultrasound and neurostimulators in practice increases the success, onset and quality of nerve blocks, but due to the low incidence of major complications and the absence of comparable randomized studies, no definitive statement can be made as to whether ultrasound reduces the overall rate of nerve damage. An imaging model that automatically marks sonoanatomy with artificial intelligence in ultrasound images can reduce unintended intraneural injections or injury to other anatomical structures in close proximity and improve patient safety. ### Conditions - Artificial Intelligent - Ultrasound Therapy; Complications - Nerve Block ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ultrasound examination ### Outcomes Primary Outcomes - Artificial intelligence Program size - Score of assessment the pictures Secondary Outcomes ### Location - Facility: Yasin Tire, Konya, Meram, 42140, Turkey @@
## Enhancing Prospective Thinking in Early Recovery (BEAM) - NCT ID: NCT06283472 - Study ID: 1805574553; Aims 14-16 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-02-01 - Lead Sponsor: Indiana University ### Study Description The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:* Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?* Will high-intensity EFT cues effect greater treatment-seeking interest?* Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)* Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?* Will the novel behavioral SS decision-making task activate the nucleus accumbens?Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - High-Intensity Cue - Low-Intensity Cue ### Outcomes Primary Outcomes - Increase Prospective Thinking - Delayed Rewards Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2 - NCT ID: NCT06283459 - Study ID: 301-23-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-30 - Lead Sponsor: Imunon ### Study Description This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365). ### Conditions - SARS CoV 2 Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - IMNN-101 ### Outcomes Primary Outcomes - Number of participants with local and systemic reactogenicity adverse events and all adverse events - Number of participants with geometric mean titer (GMT) of the serum neutralizing antibody (Nab) against the Omicron XBB.1.5 strain. Secondary Outcomes - Number of participants with GMT of serum spike binding IgG antibodies - Number of participants with a magnitude and phenotype of cytokine producing S protein-specific T cells, as measured by flow cytometry and/or ELISpot. - Number of participants with seroresponse rate (SRR). ### Location - Facility: Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States @@
## Enhancing Prospective Thinking in Early Recovery - NCT ID: NCT06283446 - Study ID: 1805574553; Aims 11-13 - Status: RECRUITING - Start Date: 2023-12-20 - Completion Date: 2024-07-31 - Lead Sponsor: Indiana University ### Study Description The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues? Will high-intensity EFT cues effect greater treatment-seeking interest? Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS? Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above. ### Conditions - Alcohol Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - High-Intensity Cue - Low-Intensity Cue ### Outcomes Primary Outcomes - Increase Prospective Thinking - Delayed Rewards Secondary Outcomes ### Location - Facility: Indiana University School of Medicine - Goodman Hall, Indianapolis, Indiana, 46202, United States @@