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## A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT - NCT ID: NCT06283433 - Study ID: NL83813.078.23 - Status: RECRUITING - Start Date: 2023-10-25 - Completion Date: 2024-11 - Lead Sponsor: Erasmus Medical Center ### Study Description The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population. ### Conditions - Infection, Bacterial ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Finger Prick - Venipuncture ### Outcomes Primary Outcomes - To compare the number of outpatient visits in the control group versus the intervention group at day 28 Secondary Outcomes - Outcomes regarding outpatient visit - Sampling outcomes - Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA) - Cost outcomes - Clinical outcomes - TDM outcomes - Logistical outcomes ### Location - Facility: Erasmus MC, Rotterdam, N/A, N/A, Netherlands @@
## Metabolic Response to Iniciation of Heart Failure Therapy - NCT ID: NCT06283420 - Study ID: CarDia_WP5_P1_IRB:25059/23 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-21 - Completion Date: 2026-12-20 - Lead Sponsor: Vojtech Melenovsky, MD, PhD ### Study Description This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy. ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - hematocrit Secondary Outcomes - HIF response - hepcidin ### Location - Facility: Institute for Clinical end Experimental Medicine - IKEM, Prague, N/A, N/A, Czechia @@
## ICF-based Comparison on Musculoskeletal Health in Poland and Spain - NCT ID: NCT06283407 - Study ID: ICF - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-11-04 - Lead Sponsor: University of Rzeszow ### Study Description Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference. ### Conditions - Musculoskeletal Diseases or Conditions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ICF-based cross-country comparative analysis ### Outcomes Primary Outcomes - Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions Secondary Outcomes - Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities) ### Location - Facility: University of Rzeszow, Rzeszów, N/A, 35-959, Poland @@
## AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives - NCT ID: NCT06283394 - Study ID: 854803 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-06-01 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI \> 30) and diabetes (last A1C\>8 in the last 90 days). The main questions it aims to answer are:Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables). ### Conditions - Obesity - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Storefront Choice Architecture - Fresh Funds - Loss Framing ### Outcomes Primary Outcomes - The primary outcome will be the percentage of food purchasing expenditures spent on eligible healthy foods. Secondary Outcomes - Percentage of the $160 subsidy used each month in the intervention arms. - Change in hemoglobin A1c - Qualitative results ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty - NCT ID: NCT06283381 - Study ID: 4264 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-06-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esomeprazole ### Outcomes Primary Outcomes - The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG) Secondary Outcomes ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules - NCT ID: NCT06283368 - Study ID: 2021/11-06 - Status: COMPLETED - Start Date: 2016-01 - Completion Date: 2021-01 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy. ### Conditions - Thyroid Neoplasms Benign - Thyroid Nodule - Thyroid Cancer - Thyroid Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thyroidectomy, Bilaterally Total - Thyroidectomy, Unilaterally Total - Thyroidectomy, Complementary - Thyroidectomy, Near Total ### Outcomes Primary Outcomes - Determining benign thyroid nodules - Determining malignant thyroid nodules Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome - NCT ID: NCT06283355 - Study ID: IRB00433691 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-12-31 - Lead Sponsor: Johns Hopkins University ### Study Description This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity. ### Conditions - Staphylococcus Aureus - Microbial Colonization - Neonatal Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Nasal Microbiota Transplant (NMT) - Placebo ### Outcomes Primary Outcomes - Neonatal nasal microbiome diversity after intervention Secondary Outcomes ### Location - Facility: Johns Hopkins University, Baltimore, Maryland, 21287, United States @@
## Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency - NCT ID: NCT06283342 - Study ID: Konya Pediatric Hematology - Status: COMPLETED - Start Date: 2018-01-01 - Completion Date: 2019-02-01 - Lead Sponsor: Konya Meram State Hospital ### Study Description This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy. ### Conditions - Iron Deficiency Anemia in Childbirth - Infant Nutrition Disorders - Iron Deficiencies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ferritine level Secondary Outcomes - Hemoglobin level - Prophylactic iron use rate - Iron-sufficient supplementary food intake rate of babies - Breast milk usage rate ### Location - Facility: Konya Training and Research Hospital, Konya, N/A, 42090, Turkey @@
## Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints - NCT ID: NCT06283329 - Study ID: echographic VC curarization - Status: COMPLETED - Start Date: 2023-12-01 - Completion Date: 2023-12-31 - Lead Sponsor: General Administration of Military Health, Tunisia ### Study Description Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC. ### Conditions - Residual Curarization ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - vocal cords echography ### Outcomes Primary Outcomes - Echographic mobility of vocal cords at different times in post extubation Secondary Outcomes ### Location - Facility: Elaskri Haythem, Tunis, N/A, 1008, Tunisia @@
## Systemic Treatments for Alopecia Areata Registry - NCT ID: NCT06283316 - Study ID: 11347 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2099-12-31 - Lead Sponsor: Erasmus Medical Center ### Study Description A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes. ### Conditions - Alopecia Areata - Alopecia Totalis - Alopecia Universalis - Hair Loss - Hair Diseases - Alopecia - Alopecia Drugs - Autoimmune Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Effectiveness of systemic treatments - Safety of systemic treatments Secondary Outcomes - Epidemiological data - Physician Reported - Severity of Alopecia Tool (SALT Score) - Dermatology Life Quality Index (DLQI, 10 items) - Alopecia Areata Symptom Impact Scale (AASIS, 13 items) ### Location - Facility: Erasmus University Medical Center, Rotterdam, N/A, N/A, Netherlands @@
## A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer - NCT ID: NCT06283303 - Study ID: MVR-T3011-HAI-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-11-30 - Lead Sponsor: China Medical University, China ### Study Description This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. ### Conditions - Colorectal Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - T3011 hepatic artery infusion - toripalimab - regorafenib ### Outcomes Primary Outcomes - Treatment Emergent Adverse Event（TEAE） Secondary Outcomes - Objective response rate (ORR) - Overall survival (OS) - Progression-free survival (PFS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PROPE Severe Asthma Study in Egypt - NCT ID: NCT06283290 - Study ID: D3250R00122 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-07-31 - Lead Sponsor: AstraZeneca ### Study Description Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia.While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied. ### Conditions - Severe Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use. Secondary Outcomes - To describe the demographic characteristics of severe eosinophilic asthma patients. - To describe the clinical characteristics of severe eosinophilic asthma patients. - To discover the average OCS dose per year used among severe asthma patients. - To determine the prevalence of the eosinophilic phenotype - To determine the prevalence of the eosinophilic phenotype - To determine the prevalence of the total serum IgE - To determine the annual severe asthma exacerbation rate in the past twelve months among severe asthma patients in Egypt - To evaluate asthma control of severe asthma patients - To evaluate comorbidities related to OCS use ### Location - Facility: Research Site, Mansoura, Dakahlia, N/A, Egypt @@
## Fetal Clavicular Measurement to Predict Fetal Macrosomia - NCT ID: NCT06283277 - Study ID: fetal macrosomia - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-10-30 - Lead Sponsor: Assiut University ### Study Description Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia. ### Conditions - Macrosomia, Fetal - Large for Gestational Age - Shoulder Dystocia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Obstetric Ultrasound ### Outcomes Primary Outcomes - Third trimester clavicle length measurement Secondary Outcomes - Establish the relationship between third-trimester clavicle length and shoulder dystocia - Mode of delivery - Gestational age at the time of delivery. - Neonatal Apgar score. - Neonatal bi-acromial diameter - Neonatal birth weight - Neonatal need for NICU - Neonatal actual clavicle length ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Coeliac Disease in Patients With Type 2 Diabetes - NCT ID: NCT06283264 - Study ID: Coeliac Disease in type2 DM - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-12-30 - Lead Sponsor: Assiut University ### Study Description This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status ### Conditions - Celiac Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PediRISE Feasibility - NCT ID: NCT06283251 - Study ID: 23-590 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12-31 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.The names of the study groups in this research study are:* PediRISE Program Group* Usual Care Group ### Conditions - Pediatric Cancer - Financial Stress - Financial Hardship - Disparities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PediRISE Resource Program ### Outcomes Primary Outcomes - Rate of Participant Consent - 6-Month Follow Up Rate for PediRISE Program Group - 6-Month Follow Up Rate for Usual Care Group Secondary Outcomes ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02215, United States @@
## Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON) - NCT ID: NCT06283238 - Study ID: Pro00115121 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2027-03-25 - Lead Sponsor: Duke University ### Study Description The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy.This study does not include any treatment or investigational drugs.Participants will be asked:* to enroll before beginning standard care of treatment for their cancer* for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene. ### Conditions - GastroEsophageal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Immune checkpoint inhibitor (ICI) or chemotherapy alone ### Outcomes Primary Outcomes - Number of participants with Complete Response (CR) - Number of participants with Partial Response (PR) - Number of participants with Stable Disease - Number of participants with Progressive Disease Secondary Outcomes ### Location - Facility: Duke University, Durham, North Carolina, 27710, United States @@
## Pilot Study to Investigate the Effect of a Dysmenorrhoea App - NCT ID: NCT06283225 - Study ID: RCT004_PilotPia - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-07 - Lead Sponsor: Endo Health GmbH ### Study Description The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants. ### Conditions - Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pia-App ### Outcomes Primary Outcomes - Dysmenorrhea Symptom Interference Scale (DSI) - Moos Menstrual Distress Questionnaire, Form C (MDQ) - Visual analog scale (VAS) - Depression Anxiety Stress Scale mit 21 Items (DASS-21) - German Version of Pain Self-Efficacy Questionnaire (FESS) - Fatigue Severity Scale (FSS) - Pain Disability Index (PDI) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome - NCT ID: NCT06283212 - Study ID: ETX-DS-005 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2029-12 - Lead Sponsor: Encoded Therapeutics ### Study Description EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design. ### Conditions - Dravet Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ETX101 ### Outcomes Primary Outcomes - Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome. - Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52. Secondary Outcomes - Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures. - Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52. ### Location - Facility: Queen Elizabeth Hospital, Glasgow, N/A, G51 4TF, United Kingdom @@
## Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases. - NCT ID: NCT06283199 - Study ID: ORL-ORT-025 - Status: RECRUITING - Start Date: 2021-04-06 - Completion Date: 2027-12-31 - Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona ### Study Description Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month. ### Conditions - Musculoskeletal Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Difference in pain level Secondary Outcomes ### Location - Facility: IRCCS Istituto Ortopedico Rizzoli, Bologna, N/A, N/A, Italy @@
## Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals - NCT ID: NCT06283186 - Study ID: CSEULS-PI-004/2024 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2025-07-31 - Lead Sponsor: Centro Universitario La Salle ### Study Description This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Aerobic exercise - Aerobic exercise ### Outcomes Primary Outcomes - Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle Secondary Outcomes - International Physical Activity Questionnaire (IPAQ) - Fatigue Assessment Scale (FAS) - Heart rate - Rate of perceived exertion (RPE) - Physical Activity Readiness Questionnaire (PAR-Q) ### Location - Facility: CSEU LaSalle, Madrid, N/A, 28023, Spain @@
## HRIPT for Collagen Dressing - NCT ID: NCT06283173 - Study ID: 23-401 - Status: COMPLETED - Start Date: 2024-01-31 - Completion Date: 2024-03-22 - Lead Sponsor: Covalon Technologies Inc. ### Study Description The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site. ### Conditions - Skin Sensitisation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - ColActive Plus Collagen Matrix Dressing ### Outcomes Primary Outcomes - Skin sensitization reaction using Berger and Bowman scale - Skin irritation reaction using Berger and Bowman scale Secondary Outcomes ### Location - Facility: ALS Beauty and Personal Care, Torrance, California, 90501, United States @@
## Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy - NCT ID: NCT06283160 - Study ID: 2023/834 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-05-30 - Lead Sponsor: Centre Hospitalier Universitaire de Besancon ### Study Description Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling). ### Conditions - Pancreatic Fistula - Acute Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy. Secondary Outcomes ### Location - Facility: University Hospital of Besançon, Besançon, N/A, 25000, France @@
## Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care - NCT ID: NCT06283147 - Study ID: 2023.530 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Chinese University of Hong Kong ### Study Description The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):1. RAMP Knee-OA group2. Usual care groupOutcomes will be measured at baseline, week 16, week 32, and week 52. ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Risk assessment and Management Programme - Knee Osteoarthritis ### Outcomes Primary Outcomes - Knee pain Secondary Outcomes - Physical Function - Physical function - Lower limb muscle mass - Level of physical activity - Self-Management efficacy - Level of Anxiety - Level of Depression - Insomnia - Loneliness - Health related Quality of Life - Demographic data ### Location - Facility: Lek Yuen GOPC, Hong Kong, N/A, N/A, Hong Kong @@
## A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer - NCT ID: NCT06283134 - Study ID: BJCT-CMU1H-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2027-12-01 - Lead Sponsor: China Medical University, China ### Study Description This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer. ### Conditions - Colorectal Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BioTTT001 hepatic artery infusion - toripalimab - regorafenib ### Outcomes Primary Outcomes - Incidence of adverse events - MTD Secondary Outcomes - Overall survival(OS) - Progression-free survival (PFS) - Objective response rate (ORR) - Plasma adenovirus (ADV) copies - ADV copies in various sites - Serum IL-12 level - Serum neutralizing antibody level ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer - NCT ID: NCT06283121 - Study ID: BJCT-CMU1H-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2027-11-30 - Lead Sponsor: China Medical University, China ### Study Description This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer. ### Conditions - Gastric Cancer, Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BioTTT001 intraperitoneal infusion - SOX regimen - toripalimab ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Progression-free survival (PFS) - Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gurney Journey: Virtual Reality Distraction - NCT ID: NCT06283108 - Study ID: 23-1183 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06 - Lead Sponsor: Children's Hospital Colorado ### Study Description The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program. ### Conditions - Dental Caries in Children - Dental Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience) - Standard Child Life Preparation and Support ### Outcomes Primary Outcomes - Induction Compliance Checklist - modified Yale Preoperative Anxiety Scale Secondary Outcomes - The Pediatric Behavioral Induction Assessment ### Location - Facility: Children's Hospital Colorado, Aurora, Colorado, 80045, United States @@
## Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty - NCT ID: NCT06283095 - Study ID: OSA - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-11-01 - Lead Sponsor: ET Zarief ### Study Description The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS. ### Conditions - Obstructive Sleep Apnea of Adult ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - expansion palatoplasty ### Outcomes Primary Outcomes - Evaluation the outcome of expansion palatoplasty in management of OSAS. Secondary Outcomes - Expansion palatoplasty in Obstructive sleep apnea patients ### Location - Facility: ASSUIT, Assuit, N/A, 1, Egypt @@
## Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene - NCT ID: NCT06283082 - Study ID: 69HCL23_0617 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption. ### Conditions - Hyperoxaluria (Disorder) ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Lithiasis assessment ### Outcomes Primary Outcomes - Urinary oxalate and glycolate excretion Secondary Outcomes - The prevalence of stones - Lithiasis disease severity - Lithiasis disease severity - Lithiasis disease severity - Lithiasis disease severity - Predisposing conditions for lithiasis disease - Predisposing conditions for lithiasis disease ### Location - Facility: CLIMA, pavillon R, Hôpital Edouard Herriot, Lyon, N/A, 69003, France @@
## Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters - NCT ID: NCT06283069 - Study ID: 45C301 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2033-04-30 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies. ### Conditions - Cardiovascular Diseases - Lifestyle - Nutrition, Healthy - Physical Inactivity - Stress - Sleep ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - compilation of a questionnaire about LifeStyle ### Outcomes Primary Outcomes - weekly physical activity volume Secondary Outcomes - nutrition quality - weight - height - blood pressure - perception of stress, fatigue, and somatic symptoms - glycemia - cholesterol - creatinine - waist circumference - heart rate ### Location - Facility: Istituto Auxologico Italiano, Milan, N/A, N/A, Italy @@
## RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite - NCT ID: NCT06283056 - Study ID: DO611073A - Status: RECRUITING - Start Date: 2022-06-16 - Completion Date: 2025-06-01 - Lead Sponsor: InMode MD Ltd. ### Study Description The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits. ### Conditions - Cellulitis of Leg ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Device treatment ### Outcomes Primary Outcomes - Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale - Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale Secondary Outcomes - Subject assessment of improvement - Subject assessment of improvement - Subject assessment of improvement - Subject assessment of satisfaction - Subject assessment of satisfaction - Subject assessment of satisfaction - Investigator assessment of the skin appearance improvemen - Investigator assessment of the skin appearance improvement - Investigator assessment of the skin appearance - Investigator assessment of the cellulite following subdermal Morpheus8 treatment - Investigator assessment of the cellulite following subdermal Morpheus8 treatment - Investigator assessment of the cellulite following subdermal Morpheus8 treatment ### Location - Facility: Dermatology & Laser Surgery Center of New York, New York, New York, 10028, United States @@
## Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease - NCT ID: NCT06283043 - Study ID: 2022/3749 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2024-03-05 - Lead Sponsor: Inonu University ### Study Description Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements. ### Conditions - Movement Disorders (Incl Parkinsonism) - Parkinsonian Disorders - Attention Impaired - Movement Disorders, Functional ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - TUG - 10 m walking test - 30 sec sit-stand test - berg balance test - one leg stance test - functional reach test - hand dinamometer - mobil application - Pittsburg Sleep Quality İndex - Beck Depression - P300 Secondary Outcomes ### Location - Facility: Inonu University, Malatya, Battalgazi, 44280, Turkey @@
## Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea - NCT ID: NCT06283030 - Study ID: IM-001 - Status: COMPLETED - Start Date: 2021-12-01 - Completion Date: 2023-09-25 - Lead Sponsor: Invicta Medical Inc. ### Study Description This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. ### Conditions - Sleep Apnea - Sleep Apnea, Obstructive - Sleep Apnea Syndromes - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypoglossal nerve stimulation ### Outcomes Primary Outcomes - Identification and access of the target outcomes - Tongue protrusion outcomes - Characterization of electrode array outcomes - Electrode array placement and removal outcomes - Safety outcomes Secondary Outcomes ### Location - Facility: Vanderbilt Bill Wilkerson Centre, Nashville, Tennessee, 37232, United States @@
## Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea - NCT ID: NCT06283017 - Study ID: IM-002 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-06-01 - Completion Date: 2024-03 - Lead Sponsor: Invicta Medical Inc. ### Study Description This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed. ### Conditions - Sleep Apnea - Sleep Apnea, Obstructive - Sleep Disorder - Sleep Apnea Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypoglossal nerve stimulation ### Outcomes Primary Outcomes - Target identification and access outcomes - Tongue protrusion outcomes - Characterization of lead placement outcomes - Lead placement and removal outcomes - Safety outcomes Secondary Outcomes ### Location - Facility: Adelaide Institute for Sleep Health, Flinders University, Adelaide, South Australia, 5042, Australia @@
## Investigation of Walking Training With Different Slope Types in COPD Patients - NCT ID: NCT06283004 - Study ID: 2024-1/30 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-01 - Lead Sponsor: Acibadem University ### Study Description Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill. ### Conditions - Pulmonary Disease, Chronic Obstructive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Downhill walking training - Level walking training - Uphill walking training ### Outcomes Primary Outcomes - 6 Minutes Walking Distance (6MWD) - Spirometric measurements (Forced vital capacity) - Spirometric measurements (First second forced expiratory volume) - Spirometric measurements (FEV1/FVC ratio) - Spirometric measurements (Peak Expiratory Flow) - Spirometric measurements (Maximum Intermediate Expiratory Flow) - Muscle strength measurements (skeletal muscles) - Muscle strength measurements (respiratory muscles) - 30-second sit and stand test - Functional performance inventory Secondary Outcomes - Dyspnea - Fatigue - Level of exertion ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled - NCT ID: NCT06282991 - Study ID: B7461028 - Status: COMPLETED - Start Date: 2020-07-22 - Completion Date: 2021-01-18 - Lead Sponsor: Pfizer ### Study Description The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.This study is seeking participants who:* have lung cancer that could not be controlled.* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.* have received at least 1 treatment before.All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective. ### Conditions - Non-Small Cell Lung Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lorlatinib ### Outcomes Primary Outcomes - The treatment pattern from initial diagnosis to current lorlatinib treatment. Secondary Outcomes - objective response rate (ORR) - overall survival - progression-free survival - 1-year OS rate - time-to-treatment failure for all NSCLC - time-to-treatment failure of lorlatinib - The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile ### Location - Facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch, Kaohsiung City, N/A, 83301, Taiwan @@
## Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes - NCT ID: NCT06282978 - Study ID: GEM-RANTAB - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2029-12 - Lead Sponsor: PETHEMA Foundation ### Study Description The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.Safety refers to the measurement of:i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infectionsThe study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study. ### Conditions - Multiple Myeloma in Relapse ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Elranatamab (PF-06863135) ### Outcomes Primary Outcomes - To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma. Secondary Outcomes - To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma. - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests. - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5). - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements. - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test. - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG. - Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA. - To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value. - To determine serum BCMA levels and its correlation with response. - To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab. - To determine MRD value with alternative methods - To characterize patients' immune system - To define genomic determinants of response/resistance - To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma. - To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma. ### Location - Facility: Hospital Clínico Universitario de Santiago ~ CHUS, Santiago De Compostela, A Coruña, 15706, Spain @@
## Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury - NCT ID: NCT06282965 - Study ID: AngT-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-09 - Lead Sponsor: University of Arizona ### Study Description The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).The main questions this trial aims to answer are:* Is Angiotensin (1-7) safe?* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?Participants will:* Complete 21 days of study treatment consisting of a once-daily injection.* Provide blood samples.* Undergo two magnetic resonance imaging (MRI) scans of the brain.* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Angiotensin (1-7) - Sterile saline ### Outcomes Primary Outcomes - Number of participants with adverse events - Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Secondary Outcomes - Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA) - Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) - Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau) - Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days - Effects of Angiotensin (1-7) on brain white matter integrity - Effects of Angiotensin (1-7) on length of hospital stay - Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM) - Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT - NCT ID: NCT06282952 - Study ID: 198/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-12-31 - Lead Sponsor: Oulu University Hospital ### Study Description The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:* Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant. ### Conditions - Fecal Microbiota Transplantation - Cesarean Section - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Fecal transplant ### Outcomes Primary Outcomes - Microbial composition profiles in fecal sample - Height in centimeters - Height z-score - Weight in kilograms - Weight-for-length (%) Secondary Outcomes - The source of colonization by exclusively shared genes (ESGs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry - NCT ID: NCT06282939 - Study ID: 20234314 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2027-12-01 - Lead Sponsor: HCA Healthcare Research Institute ### Study Description This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures. ### Conditions - Intracranial Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OPTIMA and OPTIMAX Coils manufactured by Balt USA ### Outcomes Primary Outcomes - Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score - Assess coiling alone or in combination with adjunctive devices for approximately 400 patients - Evaluate Coiling with flow diversion for approximately 200 subjects - Subgroup analyses will be performed examining: - Analyze outcomes of small aneurysms defined as smaller than 5mm Secondary Outcomes - Adequate occlusion - Packing density - Complete occlusion - Complete occlusion - Recanalization rate - Retreatment rate - Change in degree of disability - The number of coils used in an aneurysm - Procedural fluoroscopic time ### Location - Facility: Med City Plano, Plano, Texas, 75075, United States @@
## Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD - NCT ID: NCT06282926 - Study ID: 324811 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-09 - Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust ### Study Description The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase. ### Conditions - Tetralogy of Fallot ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography assessment ### Outcomes Primary Outcomes - Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair. - Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS. Secondary Outcomes - Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Mindfulness Meditation - NCT ID: NCT06282913 - Study ID: ---Oncology-Nursing-2024--- - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: Gulhane Training and Research Hospital ### Study Description Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units. ### Conditions - Burnout - Compassion Fatigue - Psychological Well-Being ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mindfulness Meditation ### Outcomes Primary Outcomes - compassion fatigue - burnout - psychological well-being Secondary Outcomes - compassion fatigue - burnout - psychological well-being ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pain and Screen Addiction in University Students - NCT ID: NCT06282900 - Study ID: 2024-1/15 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-06 - Lead Sponsor: Acibadem University ### Study Description One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level. ### Conditions - Student ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - University students ### Outcomes Primary Outcomes - Investigating the use of screen-based devices - Musculoskeletal system evaluation Secondary Outcomes - Physical activity assessment ### Location - Facility: Acibadem University, Istanbul, None Selected, 34752, Turkey @@
## Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator - NCT ID: NCT06282887 - Study ID: 2021-IIT-002 - Status: RECRUITING - Start Date: 2021-11-09 - Completion Date: 2024-11-10 - Lead Sponsor: Guangzhou Concord Cancer Center ### Study Description The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation. ### Conditions - Psycho-Oncology ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Music therapy ### Outcomes Primary Outcomes - Anxiety - Symptom distress - Relaxation Secondary Outcomes - Pulse rates - Respiration rate - Scanning efficiency - Patient satisfaction level - Patient attention to music (only for the music therapy group) ### Location - Facility: GuangZhou Concord Cancer Center, Guangzhou, Guangdong, 510700, China @@
## Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases - NCT ID: NCT06282874 - Study ID: CTONG2303 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-03-01 - Lead Sponsor: Guangdong Association of Clinical Trials ### Study Description This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases. ### Conditions - Carcinoma, Non-Small-Cell Lung - Brain Metastases - Leptomeningeal Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lorlatinib ### Outcomes Primary Outcomes - intracranial objective response rate（iORR） Secondary Outcomes - Progression-free survival (PFS) and intracranial PFS（iPFS） - Obiective response rate (ORR) - Disease control rate (DCR) and intracranial disease control rate (iDCR) - Overall survival - Number of participants with adverse events ### Location - Facility: Guangdong Provincial Perople's Hospital, Guangzhou, Other (Non U.s.), 510080, China @@
## ANTES B+ Clinical Trial - NCT ID: NCT06282861 - Study ID: ANTES B+ - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2025-09 - Lead Sponsor: Fundacio Privada Mon Clinic Barcelona ### Study Description Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:* 1 moderate exacerbation in the previous year* CAT≥10 despite current treatment with LABA -LAMA* Blood eosinophil levels of ≥150 cells/mlthe investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Trelegy Ellipta 100/62.5/25Mcg Inh 30D - Brimica - Duaklir - Ultibro - Ulunar - Xoterna - Anoro - Laventair - Spiolto Respimat - Yanimo - Foradil - Broncoral - Formoterol stada - Oxis - Formatris - Formoterol Aldo - Onbrez - Oslif - Hirobriz - Striverdi - Beglan - Betamican - Inaspir - Serevent - Soltel - Eklira - Bretaris - Seebri - Tovanor - Enurev - Spiriva - Tavulus - Sirkava - Braltus - Gregal - Incruse - Rolufta ### Outcomes Primary Outcomes - Clinical Control (CC) Secondary Outcomes - Clinical Important Deterioration (CID) - Patients persistently controlled - Time to deterioration - Time to no control event of CC - Stability Domain - Time to no control event of CC - Impact Domain - Time to deterioration event of CID-CAT Exacerbations - Time to deterioration event of CID-CAT Spirometry - Exacerbation rate - Time to first Exacerbation - Spirometry changes - Independent predictors ### Location - Facility: Hospital Clínic Barcelona, Barcelona, Catalunya, 08036, Spain @@
## Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate - NCT ID: NCT06282848 - Study ID: HongKongPU_Optometry4 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12 - Lead Sponsor: The Hong Kong Polytechnic University ### Study Description The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid. ### Conditions - Myopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Atropine 0.05% - DIMS lens ### Outcomes Primary Outcomes - Subjective refraction - Axial length Secondary Outcomes - mfERG responses - Retinal and choroidal thickness ### Location - Facility: School of Optometry, Hong Kong Polytechnic University, Hong Kong, N/A, 00000, Hong Kong @@
## Eravacycline Combination Therapy for MRAB - NCT ID: NCT06282835 - Study ID: 2023KY242 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-12-31 - Lead Sponsor: Fujian Medical University Union Hospital ### Study Description The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time ### Conditions - Pulmonary Infection - Pneumonia, Bacterial - Acinetobacter Baumannii ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Eravacycline Injection ### Outcomes Primary Outcomes - Clinical Responded Rate Secondary Outcomes - The microbiological clearance rate - The all-cause mortality rate within 28 days - "Incidence Rate of Adverse Event ### Location - Facility: Fujian Medical University Union hospital, Fuzhou, Fujian, 350000, China @@
## Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction - NCT ID: NCT06282822 - Study ID: HFpEF-SWE - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: First Hospital of China Medical University ### Study Description The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF. ### Conditions - Shear Wave Elastography - Heart Failure With Preserved Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transthoracic echocardiography ### Outcomes Primary Outcomes - Shear wave velocity Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy - NCT ID: NCT06282809 - Study ID: CSP3325 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-01 - Lead Sponsor: HistoSonics, Inc. ### Study Description The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy. ### Conditions - Pancreas Cancer - Adenocarcinoma of the Pancreas - Pancreatic Cancer - Tumor of Pancreas ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy ### Outcomes Primary Outcomes - Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy Secondary Outcomes ### Location - Facility: Hospital de la Santa Creu i Sant Pau, Barcelona, N/A, N/A, Spain @@
## Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy - NCT ID: NCT06282796 - Study ID: EPW-CABC-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2028-12-31 - Lead Sponsor: First Hospital of China Medical University ### Study Description This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography ### Outcomes Primary Outcomes - Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. Secondary Outcomes - Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy. ### Location - Facility: Fujian Cancer Hospital, Fuzhou, Fujian, N/A, China @@
## Studying Topiramate for Re-Activating the HIV-1 Reservoir - NCT ID: NCT06282783 - Study ID: 2024-511532-27-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-08 - Lead Sponsor: Erasmus Medical Center ### Study Description Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone. ### Conditions - HIV-1-infection - Hiv - HIV Infections - HIV I Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Topiramate ### Outcomes Primary Outcomes - Effect of topiramate as measured by cell-associated HIV RNA - Number of treatment-related adverse events as assessed by CTCAE v4.0 Secondary Outcomes - Influence of sex on the primary outcome measures - The effect of topiramate on the size of the HIV reservoir measured by relevant assays ### Location - Facility: Erasmus Medical Centre, Rotterdam, N/A, N/A, Netherlands @@
## Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery - NCT ID: NCT06282770 - Study ID: IRB#23-000444 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2025-07-01 - Lead Sponsor: University of California, Los Angeles ### Study Description After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace. ### Conditions - Spinal Fusion - Chronic Lower Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Laser Diode Brace - Sham Laser Diode Brace ### Outcomes Primary Outcomes - Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS - Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI Secondary Outcomes - Stony Brook Scar Evaluation ### Location - Facility: Semel Institute of Neuroscience at UCLA, Los Angeles, California, 90024, United States @@
## Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP - NCT ID: NCT06282757 - Study ID: 202302 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-05-01 - Lead Sponsor: HAN University of Applied Sciences ### Study Description Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMPStudy design: Web-based randomized controlled trial.Study population: 100 participantsIntervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ). ### Conditions - Communication - Chronic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Video placebo communication - Video nocebo communication ### Outcomes Primary Outcomes - Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ) - Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ) Secondary Outcomes - Change in openness to VR measured using a single question - Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS) ### Location - Facility: HAN University of Applied Sciences, Nijmegen, Overijssel, 6525EN, Netherlands @@
## Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log - NCT ID: NCT06282744 - Study ID: OPTIMAL Arabic version - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-04 - Lead Sponsor: Cairo University ### Study Description Purpose of the study:To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language. ### Conditions - Physical Performance - Outpatients ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Outpatient physical therapy improvement in movement assessment log ### Outcomes Primary Outcomes - validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Changes of Urine Growth Factors Level - NCT ID: NCT06282731 - Study ID: ECKIRB1020407 - Status: COMPLETED - Start Date: 2013-05-31 - Completion Date: 2017-04-27 - Lead Sponsor: En Chu Kong Hospital ### Study Description The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment. ### Conditions - Benign Prostatic Hyperplasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Silodosin ### Outcomes Primary Outcomes - Urine growth factors level Secondary Outcomes - Urine growth factors level ### Location - Facility: En Chu Kong Hospital, New Taipei City, N/A, 23702, Taiwan @@
## A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe - NCT ID: NCT06282718 - Study ID: POS-ARI-PC CORE and AUDIT - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-03 - Lead Sponsor: European Clinical Research Alliance for Infectious Diseases (ECRAID) ### Study Description Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC. ### Conditions - Acute Respiratory Tract Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Age Bands - The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI) - Overall illness severity rating - Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens. - Proportion undergoing POC (with results) and lab-based investigations - Details of prescriptions given on presentation of ARI - Details of tests ordered on presentation of ARI - Return to usual daily activities - Feeling recovered from RTI - Use of prescription medication - Use of over the counter medications - Complications reported associated to ARI presentation - Variation in practice and advice from national guidelines, to be fed back to national teams Secondary Outcomes - Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients. - An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings. - An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials - Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dose Response Effect of Drop Jumps on Bone Characteristics - NCT ID: NCT06282705 - Study ID: 306347 - Status: COMPLETED - Start Date: 2023-01-06 - Completion Date: 2023-12-13 - Lead Sponsor: Nottingham Trent University ### Study Description The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals? ### Conditions - Healthy Participants - Low Activity Level ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Diagonal Drop Jumps 0cm - Diagonal Drop Jumps 40cm - Diagonal Drop Jumps 60cm ### Outcomes Primary Outcomes - BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA). - BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA). - Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA). - Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia. - Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia. - Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia. - Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia. - Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia. - Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia. - Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia. Secondary Outcomes - Peak impact load as assessed by force plates. - Impulse as assessed by force plates. - Load rate as assessed by force plates. - Jump height as assessed by force plates. - Centre of Mass (CoM) velocity as assessed by force plates. - Peak acceleration as assessed by Inertial measurement units (IMU). - Stiffness as assessed by motion capture. - Moments as assessed by motion capture. ### Location - Facility: Nottingham Trent University, Nottingham, Nottinghamshire, Ng11 8NS, United Kingdom @@
## INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old - NCT ID: NCT06282692 - Study ID: UNAIR-MP-INAKTIF-R-005 - Status: RECRUITING - Start Date: 2023-06-19 - Completion Date: 2024-07-19 - Lead Sponsor: Dr. Soetomo General Hospital ### Study Description This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents. ### Conditions - COVID-19 Pandemic - COVID-19 Vaccines ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg ### Outcomes Primary Outcomes - Vaccine Neutralizing Antibody Profile Secondary Outcomes - Incidence of Adverse Events - Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum - Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA - Cellular Immunogenicity Profile - Persistence of Antibody Level - Whole Genome Sequencing (WGS) of SARS-CoV-2 ### Location - Facility: Dr. Soetomo General Hospital, Surabaya, Jawa Timur, 67161, Indonesia @@
## Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea - NCT ID: NCT06282679 - Study ID: KY20220701-03 - Status: RECRUITING - Start Date: 2022-04-01 - Completion Date: 2024-06-28 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea. ### Conditions - Rosacea - Botulinum Toxin ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Botulinum Toxin Type A Injection [Botox] ### Outcomes Primary Outcomes - CEA score Secondary Outcomes - GAIS score ### Location - Facility: Jie Dai, Nanjing, Jiangsu, 210006, China @@
## Lumbar ESPB in Hip Replacement Surgery - NCT ID: NCT06282666 - Study ID: KE-0254/150/2019 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-08-01 - Lead Sponsor: Medical University of Lublin ### Study Description In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed. ### Conditions - Coxarthrosis - Pain, Postoperative - Pain, Acute - Pain, Chronic - Postoperative Pain, Chronic - Analgesia - Quality of Life - Anesthesia - Spinal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spinal anesthesia - lumbar erector spinae plane block - Epidural analgesia - patient-controlled analgesia - Timed Up and Go test - neuropathic pain symptom inventory - Lovett test - Visual analog scale - Quality of Recovery 40 - Ability to sit, stand upright, and walk ### Outcomes Primary Outcomes - Opiod consumtion with PCA Secondary Outcomes - Pain at rest - Pain upon activity - Lovett test - TUG - QoR-40 - NPSI ### Location - Facility: II Department of Anesthesia and Intensive Care, Lublin, N/A, 20-081, Poland @@
## Postural and Muscle Fatigue Analysis of Endodontic Residents - NCT ID: NCT06282653 - Study ID: Endo-ergonomics - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-11-01 - Lead Sponsor: Universidad Europea de Madrid ### Study Description Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA). ### Conditions - Musculoskeletal System Disease - Position Sense Disorders - Symptoms and Signs - Postural; Defect - Endodontic Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Symptom Perception Secondary Outcomes ### Location - Facility: Universidad Europea de Madrid, Villaviciosa De Odón, Madrid, N/A, Spain @@
## Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome - NCT ID: NCT06282640 - Study ID: 567 - Status: COMPLETED - Start Date: 2021-12-30 - Completion Date: 2022-08-30 - Lead Sponsor: Dr. Ayşe Güç ### Study Description Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels. ### Conditions - Carpal Tunnel Syndrome - Vitamin D Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Vitamin D ### Outcomes Primary Outcomes - electrophysiological scale. Secondary Outcomes - monofilament test ### Location - Facility: Kayseri City Hospital, Kayseri, N/A, N/A, Turkey @@
## The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients - NCT ID: NCT06282627 - Study ID: 10430012010023 - Status: COMPLETED - Start Date: 2020-03-20 - Completion Date: 2022-08-30 - Lead Sponsor: University Medical Center Groningen ### Study Description Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status. ### Conditions - COVID-19 - Post-COVID-19 Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational study ### Outcomes Primary Outcomes - SARS-CoV-2 infection Secondary Outcomes - Long-term sequelae ### Location - Facility: University Medical Center Groningen, Groningen, N/A, 9713 GZ, Netherlands @@
## Performance and Safety of MUCOGYNE® Ovule as a Moisturizer - NCT ID: NCT06282614 - Study ID: MUCO245 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-01 - Lead Sponsor: Biocodex ### Study Description The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness. ### Conditions - Vaginal Dryness ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Mucogyne Ovule ### Outcomes Primary Outcomes - Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use Secondary Outcomes - Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation - Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort - Assessment of the local performance of MUCOGYNE® Ovule in reducing itching - Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness - Assessment of the patient's sexual function - Assessment of the patient's satisfaction - Assessment of changes in patient's clinical status - Assessment by investigator of changes in patient's clinical status - Assessment of the safety of MUCOGYNE® Ovule - Assessment of the device deficiencies of MUCOGYNE® Ovule - Assessment of the usability of MUCOGYNE® Ovule ### Location - Facility: JEAN Christian's medical office, Nogent-sur-Marne, N/A, 94130, France @@
## STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS - NCT ID: NCT06282601 - Study ID: GUIGOU - Defaye 2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-03 - Lead Sponsor: Centre Hospitalier Universitaire Dijon ### Study Description Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children. ### Conditions - Presbyacousie ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Audiogram - Musical priming for the syntax test - Test MMSE - Barcelona Music Reward Questionnaire ### Outcomes Primary Outcomes - linguistic performance test focusing on syntax. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers - NCT ID: NCT06282588 - Study ID: CTO21042GZA - Status: RECRUITING - Start Date: 2023-12-13 - Completion Date: 2030-12-31 - Lead Sponsor: Cancer Research Antwerp ### Study Description This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Darolutamide - Darolutamide matched placebo - Radiotherapy - Zoladex 3.6Mg Implant - Zoladex LA - Decapeptyl sustained release 22.5 mg - Decapeptyl sustained release 11.25 mg - Depo-Eligard 45 mg - Depo-Eligard 22.5 mg - Depo-Eligard 7.5 mg - Firmagon 120 MG Injection - Firmagon 80 MG Injection - Docetaxel ### Outcomes Primary Outcomes - Phase 3: PSMA PET metastasis free survival (ppMFS) - Phase 2: quality of life (sexual subdomain) - Phase 2: quality of life (hormonal subdomain) Secondary Outcomes - Overall survival - Prostate-cancer specific survival - Biochemical progression-free survival - Time to next systemic therapy - Frequency and severity of adverse events ### Location - Facility: GZA Sint-Augustinus, Wilrijk, Antwerp, 2610, Belgium @@
## Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer - NCT ID: NCT06282575 - Study ID: JZP598-302 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2029-11-01 - Lead Sponsor: Jazz Pharmaceuticals ### Study Description The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. ### Conditions - Biliary Tract Cancer - HER2 Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Zanidatamab - Cisplatin - Gemcitabine - Pembrolizumab - Durvalumab ### Outcomes Primary Outcomes - Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors Secondary Outcomes - Overall survival (OS) in participants with IHC 3+ tumors - Progression Free Survival for all participants - OS for all participants - Number of participants achieving Confirmed objective response rate (cORR) - Duration of response (DOR) - Number of Patients reporting Treatment-Emergent Adverse Events (TEAE) - Maximum serum concentration of Zanidatamab - Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab - Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30 - TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30 - TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis) - TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis) ### Location - Facility: Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, 80124, United States @@
## FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients - NCT ID: NCT06282562 - Study ID: NL84223.018.23 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2026-08-15 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients. ### Conditions - Brain Tumor, Primary - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - High-Intensity Interval Training (HIIT) ### Outcomes Primary Outcomes - Self-reported physical fitness Secondary Outcomes - Self-reported fitness - VO2max ### Location - Facility: VU University Medical Centers, location VUmc, Amsterdam, N/A, 1081 HV, Netherlands @@
## Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension - NCT ID: NCT06282549 - Study ID: YMC046 - Status: RECRUITING - Start Date: 2022-06-08 - Completion Date: 2027-03-31 - Lead Sponsor: Yuhan Corporation ### Study Description This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination. ### Conditions - Essential Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Telmisartan/Amlodipine/Chlorthalidone(Truset) ### Outcomes Primary Outcomes - Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) Secondary Outcomes - Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage - Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) - Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP) - Percentage of patients who terminated the treatment ### Location - Facility: Busan Veterans Hospital, Busan, N/A, 46996, Korea, Republic of @@
## Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial - NCT ID: NCT06282536 - Study ID: LungMate-018 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2029-12 - Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China ### Study Description Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer. ### Conditions - Potentially Resectable ALK Positive Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Iruplinalkib - surgery ### Outcomes Primary Outcomes - Objective response rate (ORR) Secondary Outcomes - Pathologic complete response (PCR) rate - Major pathologic response (MPR) rate - Overall survival (OS) - Event-free survival (EFS) - Treatment-related adverse event (TRAE) - 5-year overall survival (OS) - 1-year event-free survival (EFS) rate - Health related quality of life (HRQol) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Healthy Minds Comparison Study - NCT ID: NCT06282523 - Study ID: 2023-1773 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-06 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.Participants will complete a four-week well-being program and complete surveys via an app on their phone. Participants can expect to participate in the study for four months. ### Conditions - Depression - Anxiety - Depression/Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HMP app - HMRP web app ### Outcomes Primary Outcomes - Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety Secondary Outcomes - HMP App Utilization: Days - HMP App Utilization: Number of Activities - HMP App Utilization: Minutes - Change in Healthy Minds Index (HM Index): Awareness - Change in Healthy Minds Index (HM Index): Connection - Change in Healthy Minds Index (HM Index): Purpose - Change in Healthy Minds Index (HM Index): Insight - Change in Subjective Happiness Scale - Change in Satisfaction with Life Scale (SWLS) - Change in Perceived Stress Scale (PSS-10) - Change in Flourishing Measure - Change in Digital Working Alliance Inventory (DWAI) - Change in Experiences Questionnaire (EQ) Decentering Subscale - Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale - Change in NIH Toolbox Loneliness - Change in Wellbeing Growth Mindset - Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## Nasal Antisepsis for C. Auris Prevention - NCT ID: NCT06282510 - Study ID: 23053003 - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2028-12 - Lead Sponsor: Mary K Hayden ### Study Description This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris. ### Conditions - Candida Auris Infection - Colonization, Asymptomatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Povidone Iodine Topical ### Outcomes Primary Outcomes - Detection of C. auris from the anterior nares Secondary Outcomes - Detection of C. auris from body sites other than anterior nares - Detection of C. auris from environmental surfaces - Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares - Detection of MRSA from environmental surfaces ### Location - Facility: Rush University Medical Center, Chicago, Illinois, 60612, United States @@
## Xerostomia-optimised IMRT Versus Standard IMRT in NPC - NCT ID: NCT06282497 - Study ID: ZSCPH-003 - Status: RECRUITING - Start Date: 2023-10-23 - Completion Date: 2029-10-23 - Lead Sponsor: Zhongshan People's Hospital, Guangdong, China ### Study Description This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients ### Conditions - Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Optimised neck CTV - standard neck CTV ### Outcomes Primary Outcomes - Regional recurrence free survival Secondary Outcomes - Overall survival - Local recurrence free survival - Distant metastasis-free survival - Progression free survival - Acute toxicities - Late toxicities ### Location - Facility: Zhongshan City People's Hospital, Zhongshan, Guangdong, 528403, China @@
## A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions - NCT ID: NCT06282484 - Study ID: KY20232348-C-1 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-09-29 - Lead Sponsor: Xijing Hospital of Digestive Diseases ### Study Description To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer. ### Conditions - Gastric Xanthoma - Helicobacter Pylori Infection - Gastric Cancer - Intestinal Metaplasia - Precancerous Lesions ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - corelation between the gastric xanthoma and gastric mucosa diseases Secondary Outcomes ### Location - Facility: Xijing Hosipital of Digestive Disease, Xi'an, Shaanxi, 710032, China @@
## EW and Self-Guided PST in Cancer Survivors and Caregivers - NCT ID: NCT06282471 - Study ID: MCC-23-20794 - Status: RECRUITING - Start Date: 2024-02-21 - Completion Date: 2026-03-31 - Lead Sponsor: Virginia Commonwealth University ### Study Description To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers ### Conditions - Cancer Survivors - Informal Caregivers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Expressive Writing and Problem-Solving Therapy (EW+PST) ### Outcomes Primary Outcomes - Consent Rate - Study Retention - Completed Journal Entries - Patient Satisfaction Questionnaire Secondary Outcomes - Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks - Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks - Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks - Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks - Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks - Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks - Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks - Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks - Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks - Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt - NCT ID: NCT06282458 - Study ID: V2000101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2025-04-30 - Lead Sponsor: Veru Inc. ### Study Description The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists. ### Conditions - Muscle Loss - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Enobosarm - Semaglutide ### Outcomes Primary Outcomes - The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days. Secondary Outcomes - The percent change from baseline in total fat mass ### Location - Facility: Pinnacle Trials, Anniston, Alabama, 36207, United States @@
## Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer - NCT ID: NCT06282445 - Study ID: K2024035 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-31 - Lead Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine ### Study Description To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer. ### Conditions - Colorectal Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebrelimab - Oxaliplatin - Capecitabine - Bevacizumab ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Organ retention rate - Overall survival - Disease Control Rate - Surgical conversion rate - TRAEs ### Location - Facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine, Jinhua, Zhejiang, 322000, China @@
## Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) - NCT ID: NCT06282432 - Study ID: RP-L201-0121-LTFU - Status: ENROLLING_BY_INVITATION - Start Date: 2022-03-09 - Completion Date: 2037-03 - Lead Sponsor: Rocket Pharmaceuticals Inc. ### Study Description This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene ### Conditions - Leukocyte Adhesion Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Hematopoietic stem cell transplant (HSCT) free survival Secondary Outcomes - Incidence of hospitalizations - Incidence of significant infections - Resolution of LAD-I-related skin rash - Resolution of LAD-I-related periodontal abnormalities - Event free survival - Overall Survival - Long-term genetic correction in peripheral blood mononuclear cells (PBMCs) - Long-term genetic correction in PB CD15+ granulocytes - Long-term CD18 neutrophil expression by flow cytometry - Long-term CD11 neutrophil expression by flow cytometry - Improvement or resolution of LAD-I related neutrophilia - Improvement or resolution of LAD-I-related leukocytosis. - Incidence of Investigational Product (IP) related serious adverse events (SAEs) - Incidence of hematologic malignancy ### Location - Facility: University of California, Los Angeles (UCLA), Los Angeles, California, 90095-1489, United States @@
## The Effect of Visual and Audio Stimulus Offered to Father-to-be - NCT ID: NCT06282419 - Study ID: B.30.2.ATA.0.01.00/542 - Status: RECRUITING - Start Date: 2023-08-21 - Completion Date: 2025-12-31 - Lead Sponsor: Ataturk University ### Study Description It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program. ### Conditions - Ultrasonography Prenatal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - USE OF MOBILE ULTRASOUND - ultrasound image taken from the internet ### Outcomes Primary Outcomes - Introductory Information Form (For Women) - Spouse Support Scale Perceived by Women During Early Postpartum Period - Breastfeeding Self-Efficacy Scale-Short Form - Breastfeeding Adaptation Scale - Edinburgh Postpartum Depression Scale - Introductory Information Form (For Men) - Fathers' Breastfeeding Attitude and Participation Scale - Edinburgh Postpartum Depression Scale for Men Secondary Outcomes ### Location - Facility: Atatürk University, Erzurum, N/A, N/A, Turkey @@
## Pupil-Indexed Noninvasive Neuromodulation - NCT ID: NCT06282406 - Study ID: N4532-R - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2028-08-05 - Lead Sponsor: VA Office of Research and Development ### Study Description Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning. ### Conditions - Paresis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Electrical Stimulation - Sham ### Outcomes Primary Outcomes - Force Control Change Secondary Outcomes ### Location - Facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh, Pennsylvania, 15240, United States @@
## FibriCheck Data Registry - NCT ID: NCT06282393 - Study ID: Z-2023072 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2026-03 - Lead Sponsor: Qompium NV ### Study Description The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders. ### Conditions - Cardiac Arrhythmia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - FibriCheck recordings ### Outcomes Primary Outcomes - Alignment PPG measurement Secondary Outcomes ### Location - Facility: Ziekenhuis Oost Limburg, Genk, Limburg, 3600, Belgium @@
## Fibricheck Detection cApabilities for Atrial Fibrillation - NCT ID: NCT06282380 - Study ID: FDA-AF study - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Qompium NV ### Study Description Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis. ### Conditions - Atrial Fibrillation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - FibriCheck Mobile Application ### Outcomes Primary Outcomes - Accuracy of the FibriCheck Mobile Application Secondary Outcomes - Sensitivity of the FibriCheck Mobile Application - Specificity of the FibriCheck Mobile Application ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bowel Preparation for Colonoscopy With Oral Lactulose - NCT ID: NCT06282367 - Study ID: JOSE AGURTO TELLO HOSPITAL - Status: COMPLETED - Start Date: 2021-07-01 - Completion Date: 2023-04-01 - Lead Sponsor: Josue Aliaga ### Study Description Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects. ### Conditions - Colonoscopy - Colonoscopy Preparation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Degree of bowel cleansing using the Boston score Secondary Outcomes - adenomas detection rate ### Location - Facility: Jose Agurto Tello Hospital, Lima, N/A, 05001, Peru @@
## Telemedicine for Postoperative Follow-up After Oncological Surgeries - NCT ID: NCT06282354 - Study ID: NP4035/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-15 - Lead Sponsor: Instituto do Cancer do Estado de São Paulo ### Study Description The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form. ### Conditions - Urologic Cancer - Satisfaction, Patient - Surgery - Postoperative Adhesion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Type of post-operative appointment ### Outcomes Primary Outcomes - Patient satisfaction in the post-operative return Secondary Outcomes - unattended arrivals at the institution - Postoperative complications - Appointment's time - Number of exams requested - Total cost involved per service - Environmental impact ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fatigue and Recovery: a Comparison Between Trail and Marathon - NCT ID: NCT06282341 - Study ID: 23CH132 - Status: RECRUITING - Start Date: 2023-12-28 - Completion Date: 2025-09 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Race: Simulated marathon - Race: Simulated trail - Race: Trail in nature ### Outcomes Primary Outcomes - Change in knee extensors maximal isometric torque output Secondary Outcomes - Change in plantar flexor maximal isometric torque output - Recovery of quadriceps maximal isometric torque output the month after the race - Voluntary activation level - Force assessed in dynamic - Velocity assessed in dynamic - Power assessed in dynamic - Muscular power and stretch-shortening cycle assessed through squat jumps - Muscular power and stretch-shortening cycle assessed through countermovement jump - Muscular power and stretch-shortening cycle assessed through drop jump - Muscle electrical activity - The kinetics of energy cost - Racing kinematics - Ground reaction force (in Newton) - Center of pressure (in Newton) - Muscle damage blood markers - Resting heart rate variability parameters - Effort perception - fatigue assessment - Muscular pain ### Location - Facility: Unités de Myologie et de Médecine du Sport, Saint-Étienne, N/A, 42055, France @@
## HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting - NCT ID: NCT06282328 - Study ID: CET 26-2024 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2026-03-01 - Lead Sponsor: Castagna Antonella ### Study Description This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors.This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day. ### Conditions - Hiv - HIV Infections - AIDS ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - HIV test ### Outcomes Primary Outcomes - Prevalence of HIV infection Secondary Outcomes - Number of HIV-IC - Number of Behavioral Risk Factors - CD4+ lymphocytes - HIV-RNA ### Location - Facility: IRCCS San Raffaele Scientific Institute, Milan, N/A, 20127, Italy @@
## Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness - NCT ID: NCT06282315 - Study ID: REALISE - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2026-06 - Lead Sponsor: Insud Pharma ### Study Description An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children. ### Conditions - Soil-Transmitted Helminths ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pre-screening Phase - Screenig Phase - Randomization - Baseline Effectiveness Cohort - Day 0 Trial Intervention - Active Surveillance (study visit Day 1, Day 2 and Day 7) - Passive Surveillance - Post-Treatment Effectiveness Evaluation ### Outcomes Primary Outcomes - AEs and SAEs record of participants treated with FDC compared to ALB. Secondary Outcomes - Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB. ### Location - Facility: Ghana Health Service (GHS), Accra, N/A, N/A, Ghana @@
## Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People - NCT ID: NCT06282302 - Study ID: 6030/22 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2024-04-30 - Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul ### Study Description Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals. ### Conditions - Hypertension,Essential - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group control - Isometric Exercise - Aerobic Exercise ### Outcomes Primary Outcomes - 24-hour Ambulatory Blood Pressure Monitoring Secondary Outcomes ### Location - Facility: Institute of Cardiology, Porto Alegre, RS, 900.620-000, Brazil @@
## Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants - NCT ID: NCT06282289 - Study ID: 2023-077 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09-21 - Lead Sponsor: Institut Pasteur ### Study Description The goal of this study is to investigate the preferential responses of speech neural systems in infants.The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz. ### Conditions - Speech ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Magnetoencephalography (MEG) - Cognition development questionnaire ### Outcomes Primary Outcomes - Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age. Secondary Outcomes - The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs - The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons - NCT ID: NCT06282276 - Study ID: 012922HYMC - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-01-01 - Lead Sponsor: Hillel Yaffe Medical Center ### Study Description Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians. ### Conditions - Weight Stigma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - cross sectional survey ### Outcomes Primary Outcomes - anti fat attitudes - Weight stigma - Therapeutic approach Secondary Outcomes ### Location - Facility: Hillel Yaffe Medical Center, Hadera, N/A, 38000, Israel @@
## The Effect of the Awareness Development Program on Suicide Prevention for Oncology Nurses - NCT ID: NCT06282263 - Study ID: 1292 - Status: COMPLETED - Start Date: 2023-05-25 - Completion Date: 2023-11-02 - Lead Sponsor: Sevda Ozturk ### Study Description The goal of this clinical trial is to investigate the effect of the Awareness Development Programme on Suicide Prevention for Oncology Nurses on the levels of knowledge, stigma and perception of efficacy towards suicide in oncology nurses. The main questions it aims to answer are:1. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the knowledge levels of nurses about suicide according to the pre-programme and control group?2. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the perception of efficacy levels of nurses regarding suicide according to the pre-programme and control group.3. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the stigma levels of nurses towards suicide according to the pre-programme and control group.4. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test and post-test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.5. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test-follow-up test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.Participants will participate the Awareness Development Programme on Suicide Prevention for Oncology Nurses. Oncology Nurses are expected to complete the pre-test, post-test and follow-up tests.Researchers will compare control group to see if effect of "the Awareness Development Programme on Suicide Prevention" ### Conditions - Suicide Prevention - Nurses ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - "Awareness Development Program on Suicide Prevention for Oncology Nurses" ### Outcomes Primary Outcomes - the Literacy of Suicide Scale - Efficacy Perception Scale For Suicide Risk Management - The Stigma of Suicide Scale Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, 06100, Turkey @@
## Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder - NCT ID: NCT06282250 - Study ID: in progress - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2025-12 - Lead Sponsor: Geestelijke Gezondheidszorg Eindhoven (GGzE) ### Study Description In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues. ### Conditions - Bipolar Disorder - Mood Swing - Prodromal Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy - Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy - Psycho-education + Imagery focused Cognitive Therapy ### Outcomes Primary Outcomes - Change in depressive symptom scores on the IDS-SR - Change in hyperactive symptom scores on the ASRM - Change in anxiety symptom scores on the BAI - Change in sleep quality subjective rating on 11-point Likert scale - Change in activity levels subjective rating on 11-point Likert scale Secondary Outcomes ### Location - Facility: Geestelijke Gezondheidszorg Eindhoven (GGzE), Eindhoven, Noord-Brabant, 5626ND, Netherlands @@
## Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study - NCT ID: NCT06282237 - Study ID: 2022.143 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2026-07-01 - Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico ### Study Description The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.Primary objectives:* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).Secondary endpoints will be:1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);• The change in walking performance before and after the rehabilitation treatment. ### Conditions - Sarcoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - survey ### Outcomes Primary Outcomes - Improvement in the Toronto Extremity Salvage Score (TESS) Secondary Outcomes - Pain evaluation - Motor performance evaluation - Evaluation of Quality of Life - Pain evaluation - Pain evaluation - Evaluation of Quality of Life ### Location - Facility: Fondazione Policlinico Campus Biomedico, Roma, N/A, 00128, Italy @@
## Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery - NCT ID: NCT06282224 - Study ID: XMFHIIT-2023SL066 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2026-01-11 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description "For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery." ### Conditions - Pituitary Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DEVICE_FEASIBILITY ### Interventions - Performing endoscopic transnasal skull base surgery with AR-integrated endoscope ### Outcomes Primary Outcomes - Postoperative Recovery of Transnasal Surgery - Postoperative complication Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## the Efficacy and Safety of Ondansetron Oral Soluble Pellicles - NCT ID: NCT06282211 - Study ID: CHASE 005 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-12-29 - Lead Sponsor: The First Affiliated Hospital of Xinxiang Medical College ### Study Description The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy. ### Conditions - Nausea and Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ondansetron Oral Soluble Pellicles ### Outcomes Primary Outcomes - Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups Secondary Outcomes - Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups - Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups ### Location - Facility: Keya Zhi, Weihui, None Selected, 453100, China @@
## Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses - NCT ID: NCT06282198 - Study ID: UCHCEU-13/02/24 - Status: RECRUITING - Start Date: 2018-02-01 - Completion Date: 2024-06-01 - Lead Sponsor: Cardenal Herrera University ### Study Description The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses. ### Conditions - Distal Femoral Musculoskeletal Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Gait Symmetry index measured in percentage (%) Secondary Outcomes - Sagittal range of movement of the knee measured with a goniometer - Muscular strength ### Location - Facility: Universidad CEU Cardenal Herrera, Valencia, N/A, N/A, Spain @@
## SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy - NCT ID: NCT06282185 - Study ID: CanisiusWH - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-01 - Lead Sponsor: Canisius-Wilhelmina Hospital ### Study Description The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:* What is the impact of exercise on quality of life* What is the impact of exercise on physical fitnessParticipants will have an individual training program with supervised training by physiotherapists.Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program. ### Conditions - Prostatic Neoplasms - Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiotherapy ### Outcomes Primary Outcomes - change of quality of life assessed with EPIC26 (0-100 points) - change of quality of life assessed with EPIC26 (0-100 points) - change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) - change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale) Secondary Outcomes - change of physical fitness in maximum uptake of oxygen in ml/kg/min - change of physical fitness in maximum uptake of oxygen in ml/kg/min - change of physical fitness in fat percentage - change of physical fitness in fat percentage - change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) - change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue - NCT ID: NCT06282172 - Study ID: BTL-785_CTUS1600 - Status: COMPLETED - Start Date: 2023-07-25 - Completion Date: 2023-12-18 - Lead Sponsor: BTL Industries Ltd. ### Study Description This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. ### Conditions - Fat Burn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Treatment with BTL-785-7 ### Outcomes Primary Outcomes - Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue. Secondary Outcomes - Investigation of post-treatment adipocyte apoptosis - Incidence of Treatment-related Adverse Events - Comfort Evaluation Assessed by Therapy Comfort Questionnaire ### Location - Facility: Schweiger Dermatology PC, Research Division, Hackensack, New Jersey, 07601, United States @@
## A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC) - NCT ID: NCT06282159 - Study ID: DNTH103-MG-201 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2027-12 - Lead Sponsor: Dianthus Therapeutics ### Study Description The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG). ### Conditions - Myasthenia Gravis, Generalized ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DNTH103 - Placebo ### Outcomes Primary Outcomes - Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)] - Incidence, severity, and relationship of adverse events of special interest (AESI) - Number of participants with changes from baseline in ECG parameters - Number of participants with changes in clinical laboratory values over time Secondary Outcomes - Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score - Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score - Serum concentrations of DNTH103 - Change from baseline in complement total blood test (CH50) - Antidrug antibody (ADA) levels against DNTH103 ### Location - Facility: Bradenton Research Center, Bradenton, Florida, 34205, United States @@
## Testing a Transdiagnostic TMS Treatment Target - NCT ID: NCT06282146 - Study ID: 2024P000252 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function. ### Conditions - Major Depressive Disorder - Depression - Psychiatric Disorder - Mood Disorders - Mental Disorder - Anxiety Disorders - OCD - PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - transcranial magnetic stimulation ### Outcomes Primary Outcomes - Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire - Feasibility as measured by number of the 50 treatments completed Secondary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) - Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC) - World Health Organization Disability Assessment Schedule II (WHODAS 2.0) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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