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## Effectiveness of a Resilience-Based Rehabilitation Program for Patients With Coronary Heart Disease - NCT ID: NCT06332859 - Study ID: FOR-0022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-10-14 - Lead Sponsor: Pensionsversicherungsanstalt ### Study Description To handle daily life challenges, one needs to be psychologically resilient. It plays a crucial role in disease development, prognosis, as well as social, occupational, and community participation. Cardiovascular diseases cause physical and psychological stress, which can be linked to individual resilience and the development of such diseases. Stress can trigger TakoTsubo cardiomyopathy and acute coronary events. Individuals who have experienced TakoTsubo cardiomyopathy or an acute coronary event often feel stressed due to emotional or physical triggers. These triggers may include job loss or illness. In medical rehabilitation, therapists consider the individual circumstances of their patients when planning therapy. It may be important to add a special focus on psychological care, including building resilience, which could greatly benefit these individuals. Therefore, the study aims to investigate whether resilience training, as part of an inpatient multidisciplinary rehabilitation program, affects the individual resilience of rehabilitants with TakoTsubo cardiomyopathy or those who have experienced an acute coronary event. ### Conditions - Takotsubo Cardiomyopathy - Acute Coronary Syndrome - Psychological Resilience ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Resilience training ### Outcomes Primary Outcomes - Resilience scale-13 (RS-13) - Brief Resilience scale - German Version (BRS) Secondary Outcomes - European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) - Patient Health Questionnaire-4 (PHQ-4) - Maximal incremental exercise test - Work ability index (WAI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Health in Patients Hospitalized Because of Ischemic Stroke - NCT ID: NCT06332846 - Study ID: KB-0012/06/10 - Status: COMPLETED - Start Date: 2019-10-10 - Completion Date: 2023-12-10 - Lead Sponsor: Pomeranian Medical University Szczecin ### Study Description Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population.The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI). ### Conditions - Oral Disease - Stroke, Ischemic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - oral examination - oral examination ### Outcomes Primary Outcomes - Oral health status - Oral hygiene assessment - Periodontal status- periodontal pockets - Periodontal status-tooth mobility - Periodontal status- bleeding Secondary Outcomes ### Location - Facility: Pomeranian Medical University in Szczecin, Szczecin, N/A, 70-111, Poland @@
## Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery - NCT ID: NCT06332833 - Study ID: 235 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-05-31 - Lead Sponsor: Pirogov Russian National Research Medical University ### Study Description Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. ### Conditions - Varicose Veins - Peripheral Arterial Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - availability of saphenous trunks as possible grafts Secondary Outcomes - presence of varicose veins - type of previous invasive procedure ### Location - Facility: Veronika Golovina, Moscow, Pirogov Russian National Research Medical University, 109044, Russian Federation @@
## In Patients With Obstructive Airway Disease, Investigate the Effects of Different Breathing Strategies and Pedaling Rates on the Physiological Response to Bicycle Exercise - NCT ID: NCT06332820 - Study ID: 202401226RINB - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2030-12-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description The definition of obstructive airway disease is a ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC) of less than 0.7, which includes conditions such as chronic obstructive pulmonary disease, asthma, lymphangioleiomyomatosis, and bronchiolitis obliterans syndrome. For example, lung obstruction adversely affects many aspects of a patient's health, such as lung function and exercise capacity. Pulmonary rehabilitation is widely used in patients with obstructive airway disease, and the prescription of pulmonary rehabilitation depends on exercise capacity parameters such as peak oxygen uptake (peak VO2), peak workload, and anaerobic threshold. However, patients often have difficulty achieving training goals due to severe dyspnea during exercise. Dynamic hyperinflation is a common cause of dyspnea during exercise in patients with obstructive airway disease. Investigators aim to alleviate breathlessness by reducing dynamic hyperinflation, making it easier to achieve training goals. Methods to reduce dynamic hyperinflation include pursed lip breathing, reducing breathing rate to prolong expiratory time, using bronchodilators, and undergoing lung volume reduction surgery. Among these methods, reducing breathing rate to prolong expiratory time may be the most feasible, and investigators aim to change the rhythm and pace of breathing by adjusting the pedal rate of cycling exercise. The pedaling rate is typically set at 60 revolutions per minute. The European Respiratory Society recommended a pedal rate range of 40-70 revolutions per minute in 2019. There is still no consensus on the relationship between pedal rate and respiratory rate. This prospective observational study, using a crossover design, aims to investigate the effects of pedal rate during exercise testing on dynamic hyperinflation and exercise capacity in patients with obstructive airway disease. ### Conditions - Obstructive Airway Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Inspiratory capacity during exercise Secondary Outcomes - Change of FEV1 and symptoms ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## AAV Gene Therapy Clinical Study in Adult Classic PKU - NCT ID: NCT06332807 - Study ID: NGGT002-P-2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-22 - Completion Date: 2030-12-30 - Lead Sponsor: NGGT (Suzhou) Biotechnology Co., Ltd. ### Study Description This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU). NGGT002 is an rAAV8 based vector carrying a functional copy of the human PAH gene.Participants will receive a single administration of NGGT002 and will be followed for safety and efficacy for 5 years. ### Conditions - Phenylketonurias ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NGGT002 ### Outcomes Primary Outcomes - Incidence and severity of Adverse Events (AEs) - Change from baseline in clinical laboratory values - Change from baseline in 12-lead electrocardiograms (ECGs), vital signsand physical examinations - Change from baseline in Plasma Phe Concentration Secondary Outcomes - Incidence of sustained plasma Phe concentration of ≤360 μmol/L at Week 12, Week 28, Week 52 and during Year 1 to 5 post dose - Change from baseline in total protein intake at at Week 28, Week 52 and during Year 1 to 5 post dose - Change in PKU Profile of Mood States (POMS) - Change in Phenylketonuria Quality of Life Questionnaire (PKU-QOL) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Keep On Keep Up for Parkinson's - NCT ID: NCT06332794 - Study ID: H-2201 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2025-06-30 - Lead Sponsor: Northumbria University ### Study Description The goal of this mixed methods, user research study is to evaluate the Keep On Keep Up programme for people with Parkinson's (KOKU4PD).The main aims of the study are to:1. To explore the usability and acceptability of the PD specific KOKU programme from a user and health care professional perspective.2. To produce a KOKU4PD digital program that is ready for National Health Service (NHS) approval and a future effectiveness evaluation.Participants will use the KOKU4PD app at home for 4 weeks. They will be assessed at baseline and after the 4 weeks to measure aspects of their disease status, mobility, thinking, mood and quality of life. They will also be asked to complete some questionnaires about the usability of the app. ### Conditions - Parkinson's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - KOKU4PD ### Outcomes Primary Outcomes - Usability of the KOKU app Secondary Outcomes - Executive clock drawing task (CLOX 1, 2) (mean Change from baseline) - Trail Making Test (mean Change from baseline) - Freezing of Gait Questionnaire (mean Change from baseline) - Falls Efficacy scale (mean Change from baseline) - Parkinson's disease quality of life questionnaire - PDQ-39 (mean Change from baseline) - Mini-BESTest (mean Change from baseline) - Two minute walk test, single and dual task (mean Change from baseline) - EuroQol-5 Dimension Quality of Life tool - EQ5D-5L (mean Change from baseline) - Activities-specific Balance Confidence (ABC) Scale (mean Change from baseline) - Multidimensional Fatigue Inventory (MFI) (mean Change from baseline) - Technology Acceptance questionnaire ### Location - Facility: Northumbria University, Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom @@
## Intravesical Gentamicin to Prevent Recurrent UTI - NCT ID: NCT06332781 - Study ID: 2126175 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-07-31 - Lead Sponsor: Women and Infants Hospital of Rhode Island ### Study Description Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI) ### Conditions - Recurrent Uti ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Gentamicin - Nitrofurantoin ### Outcomes Primary Outcomes - UTIs Secondary Outcomes - Patient reported outcome measures - Patient reported outcome measures - Patient reported outcome measures - Patient reported outcome measures - Patient reported outcome measures - Patient reported outcome measures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients - NCT ID: NCT06332768 - Study ID: WEAN_2021 - Status: COMPLETED - Start Date: 2017-09-01 - Completion Date: 2022-03-01 - Lead Sponsor: Northern State Medical University ### Study Description The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support. ### Conditions - Mechanical Ventilation Complication - Weaning Failure - Acute Respiratory Distress Syndrome - High-flow Oxygenation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Respiratory support ### Outcomes Primary Outcomes - Weaning failure Secondary Outcomes ### Location - Facility: City hospital # 1, Arkhangelsk, Arkhangelsk Region, 163000, Russian Federation @@
## Study to Evaluate LB-LR1109 for the Treatment of Solid Tumors - NCT ID: NCT06332755 - Study ID: LG-LRCL001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-02 - Lead Sponsor: LG Chem ### Study Description This is a Phase 1, first-in-human (FIH), multi-center, open-label, non-randomized, dose escalation study, designed to determine the Maximum tolerated dose(MTD)/Recommended Phase 2 dose(RP2D) of LB-LR1109 and to evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, immunogenicity, pharmacodynamics of LB-LR1109, and its impact on quality of life in participants with unresectable and metastatic nonsmall cell lung cancer(NSCLC), head and neck squamous cell carcinoma(HNSCC), renal cell carcinoma(RCC), urothelial carcinoma, or malignant melanoma and no available standard of care treatment options. ### Conditions - Non-small Cell Lung Cancer(NSCLC) - Head and Neck Squamous Cell Carcinoma(HNSCC) - Renal Cell Carcinoma(RCC) - Urothelial Carcinoma - Malignant Melanoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LB-LR1109 ### Outcomes Primary Outcomes - MTD and/or RP2D of LB-LR1109 in participants with advanced or metastatic solid tumors - Incidence of Treatment-Emergent Adverse Events of LB-LR1109 Secondary Outcomes - Preliminary efficacy of LB-LR1109 - Anti-tumor efficacy of LB-LR1109 - Pharmacokinetic profile of LB-LR1109 - Characterize PK of LB-LR1109 - Immunogenicity of LB-LR1109 - Quality of life of participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased - NCT ID: NCT06332742 - Study ID: QXZS for DOR - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-12-31 - Lead Sponsor: Yun Chen ### Study Description A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction ### Conditions - Decreased Ovarian Reserve ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Traditional Chinese medicine syndrome score - serum sex hormone levels - serum AMH levels - transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC) Secondary Outcomes - Seven items of thyroid function - natural pregnancy rate ### Location - Facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210023, China @@
## Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy - NCT ID: NCT06332729 - Study ID: EG,KFS,lab reserach 6 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-06-15 - Lead Sponsor: Mahmoud Reda Elsharkawy ### Study Description Summary:Inclusion Criteria:* Children aged four to eight years.* Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.* Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).* Ability to follow verbal commands and instructions.Exclusion Criteria:* Previous neurological or orthopedic surgery in the lower extremities.* Botox injection in the lower extremities within the past six months.* Fixed deformity in the joints of the lower limb.* Genu recarvatum secondary to surgery.* Severe hearing and visual defects.Materials for Subject Selection and Evaluation:* Modified Ashworth Scale for muscle tone assessment.* Gross Motor Functional Classification System (GMFCS) for functional activity classification.* Digital goniometer for measuring the angle of knee hyperextension.* Lafayette Manual Muscle Tester for quantifying muscle strength.Methods:* Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.* Evaluation of gross motor function using the GMFCS.* Assessment of genu recarvatum using a digital goniometer.* Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.* Assessment of range of motion in the knee joint using Kinovea software.* Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).Group A Treatment:- Designed physical therapy program combined with pulley therapy for muscle strengthening.Group B Treatment:- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy. ### Conditions - Cerebral Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - universal exercis unit - functional electrical stimulation ### Outcomes Primary Outcomes - muscle strength using muscle tester device - Range of motion using kinoviea software and digital goniometer - range of motion for the joint using digital geniometer Secondary Outcomes ### Location - Facility: Physical Therapy, Kafr Ash Shaykh, N/A, N/A, Egypt @@
## Research on the Correlation Between Organoid Drug Sensitivity Testing and Precise Treatment of Gastrointestinal Tumors - NCT ID: NCT06332716 - Study ID: KY20222234 - Status: RECRUITING - Start Date: 2022-08-26 - Completion Date: 2025-12 - Lead Sponsor: Jianjun Yang,MD ### Study Description Study the correlation between in vitro drug sensitivity screening of digestive tract tumor organoids and their clinical efficacy in anti-tumor treatment, evaluate the use of digestive tract tumor organoid drug sensitivity to predict the therapeutic effect of anti-tumor drugs, and explore new methods for personalized and precise treatment of esophageal cancer, gastric cancer, colorectal cancer, and gastrointestinal stromal tumors. ### Conditions - Gastrointestinal Tumors，3D Organoids，Drug Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Based on diagnostic and treatment guidelines/expert consensus, as well as clinical treatment experience, it is recommended that no more than 9 drugs be used for drug sensitivity testing each time. ### Outcomes Primary Outcomes - Progression-free survival（PFS） Secondary Outcomes - Overall survival（OS） ### Location - Facility: XijingH, Xi'an, Shaanxi, N/A, China @@
## Acanthamoeba and Artificial Intelligence - NCT ID: NCT06332703 - Study ID: IACA - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: IRCCS Ospedale San Raffaele ### Study Description Acanthamoeba keratitis, caused by the pathogen Acanthamoeba spp, is recognized worldwide as a severe ocular infection that can pose potential risks to vision.This observational retrospective and single-center study, of exploratory nature, aims to determine the possibility of identifying patterns that may be useful for future rapid diagnosis of Acanthamoeba keratitis from confocal images, leveraging the normality of corneal examination and the high specificity and sensitivity of computational models.The data will be based on patients who have been confirmed positive through laboratory tests with proven effectiveness in detecting the infection.The laboratory tests considered for the division of patients into their respective groups are bacterial examination, PCR examination, and culture examination.Patients were divided into two groups, the first comprising patients positive for Acanthamoeba infection, while the second comprised patients negative for Acanthamoeba but positive for other pathogens. The study will last for 18 months.The cohort under study includes 151 patients from the IRCCS San Raffaele Hospital who underwent the aforementioned examinations, of which 76 cases will be included in the group of patients positive for Acanthamoeba and 75 in the group of controls positive for other pathogens.The confocal images of this cohort will be fed into artificial intelligence software. To evaluate the model, the test set will be used, and the AI model's ability will be assessed using the most commonly used metrics in the field of computer vision such as accuracy, specificity, sensitivity, and f1-score; culminating in a comprehensive evaluation of the model. ### Conditions - Acanthamoeba Keratitis - Artificial Intelligence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determination of the potential presence of significant patterns of Acanthamoeba infection in in-vivo confocal microscopy (IVCM) images. Secondary Outcomes - Correlation assessment between IVCM images and laboratory results. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## OCT and OCT-Angiography Biomarkers of Treatment Response to Dexamethasone Implant in Macular Edema Due to Retinal Vascular Diseases - DME and RVO - NCT ID: NCT06332690 - Study ID: 514.2021 - Status: RECRUITING - Start Date: 2023-10-17 - Completion Date: 2025-12 - Lead Sponsor: IRCCS Multimedica ### Study Description The purpose of this pilot study is to evaluate different imaging parameters in patients with previously treatment-naive DME and ME due to RVO before and after treatment with dexamethasone implant, in order to find specific retinal inflammatory and microvascular biomarkers that may be predictive of treatment outcome. ### Conditions - Diabetic Macular Edema - Macular Edema Due to Diabetes Mellitus - Retinal Vein Occlusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dexamethasone implant ### Outcomes Primary Outcomes - Modification of inflammatory biomarkers on OCT and perfusion density parameters on OCT-A at 4 months after surgery (Change measure) Secondary Outcomes - Initial clinical characteristics in patients with a gain in BCVA (Best Corrected Visual Acuity) of ≥ 5, ≥ 10, and ≥ 15 ETDRS (Early Treatment Diabetic Retinopathy Study) letters. ### Location - Facility: MultiMedica IRCCS Multimedica, Milan, N/A, 20123, Italy @@
## Target of Suv420h1/2 in Hepatocytes - NCT ID: NCT06332677 - Study ID: TERS - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2026-02 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description Nonalcoholic fatty liver disease (NAFLD) is globally the leading cause of liver disease and frequently progresses to cirrhosis and liver cancer. The identification of effective drugs is the main unmet clinical need. Changes in liver histones methylation accompanies the development and progression of NAFLD. Our preliminary data demonstrate that inactivation of the methyltransferases SUV420H1/2 in hepatocytes protects mice against NAFLD. In this project we propose to examine the relevance of these findings by evaluating the impact of genetic deletion of hepatic SUV420H1/2 in mice fed a steatogenic diet. To further evaluate the potential for clinical translation of these results, we will next 1) evaluate the expression of SUV420H1/2 in human liver transcriptomic data and 2) analyze the impact of genetic variations on disease outcomes in population-based cohorts; 3) test an innovative therapeutic approach based on hepatocyte-targeted antisense oligonucleotides downregulating SUV420H1/2 in human liver organoids/assembloids. ### Conditions - NAFLD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - the main genes and expression by comparing the transcriptomic lipidomic profile ### Outcomes Primary Outcomes - the main genes and expression by comparing the transcriptomic lipidomic profile - the main genes and expression by comparing the transcriptomic lipidomic profile Secondary Outcomes ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica, Milano, N/A, 20122, Italy @@
## Early Nutrition Intervention for M1 Stage Cancer Patients - NCT ID: NCT06332664 - Study ID: 2023-2330 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-07-01 - Lead Sponsor: Xingchen Peng ### Study Description In China, the treatment of advanced-stage cancer often follows a pattern where the management of patients is primarily overseen by oncologists who focus on addressing the main clinical symptoms and intervening accordingly.However, symptoms such as appetite loss, weight loss, and anxiety are often overlooked. It is common for clinical nutritionists to passively enter oncology wards to conduct comprehensive nutritional assessments and develop nutrition plans only when patients exhibit significant malnutrition, upon request from oncologists or patients and their families.Against this background, the investigators integrated clinical nutritionists into the oncology treatment team and established a proactive nutritional intervention team specifically targeting M1 advanced-stage cancer patients. This initiative aims to conduct a single-center, open-label, randomized parallel-group prospective study, with the following objectives: 1) to evaluate the impact of this model on the nutritional status, survival, and quality of life of advanced-stage cancer patients, and 2) to further optimize this model for widespread replication in clinical practice. ### Conditions - Nutrition - Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Early Nutrition Intervention ### Outcomes Primary Outcomes - the incidence of cachexia Secondary Outcomes - overall survival ；progression-free survival - Physical Fitness Status - BMI - Nutritional risk and malnutrition status - Patient's emotional changes - Caregiver psychological burden - Patient's physical, social, and cognitive functioning - incidence of Sarcopenia - Nutritional risk and malnutrition status - Patient's emotional changes ### Location - Facility: West China Hospital, Sichuan Universit, Chengdu, Sichuan, 610041, China @@
## Metabolic Availability in Older and Younger Men - NCT ID: NCT06332651 - Study ID: NL84684.091.23 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-04-01 - Lead Sponsor: Wageningen University ### Study Description The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men. ### Conditions - Ageing ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Black beans - Milk - Sorghum ### Outcomes Primary Outcomes - Metabolic availability of methionine in black beans and lysine in milk and sorghum measured with the indicator amino acid oxidation method. Secondary Outcomes ### Location - Facility: Wageningen University & Research, Wageningen, Gelderland, 6708PB, Netherlands @@
## PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects - NCT ID: NCT06332638 - Study ID: IN_APA_124 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-19 - Completion Date: 2024-07-31 - Lead Sponsor: HK inno.N Corporation ### Study Description The primary objective of this study is to explore pharmacokinetics, pharmacodynamics, and safety of tegoprazan 12.5 mg in healthy subjects when orally administered as a single dose or as multiple doses twice daily. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tegoprazan 12.5mg - Tegoprazan 25mg - Famotidine 20mg ### Outcomes Primary Outcomes - Cmax of tegoprazan and tegoprazan's metabolite M1 - AUC0-t of tegoprazan and tegoprazan's metabolite M1 - AUC0-∞ of tegoprazan and tegoprazan's metabolite M1 - Tmax of tegoprazan and tegoprazan's metabolite M1 - t1/2β of tegoprazan and tegoprazan's metabolite M1 - CL/F of tegoprazan - Vd/F of tegoprazan - Css,max of tegoprazan and tegoprazan's metabolite M1 - Css,min of tegoprazan and tegoprazan's metabolite M1 - Css,avg of tegoprazan and tegoprazan's metabolite M1 - AUCtau,ss of tegoprazan and tegoprazan's metabolite M1 - Tmax,ss of tegoprazan and tegoprazan's metabolite M1 - t1/2β,ss of tegoprazan and tegoprazan's metabolite M1 - CLss/F of tegoprazan - Vdss/F of tegoprazan - Accumulation index of tegoprazan - Fluctuation of tegoprazan Secondary Outcomes - 24-hour, daytime and nighttime mean pH - 24-hour, daytime and nighttime median pH - 24-hour, daytime and nighttime TpH>3(%) - 24-hour, daytime and nighttime TpH>4(%) - 24-hour, daytime and nighttime Δ TpH>3(%) - 24-hour, daytime and nighttime Δ TpH>4(%) - 24-hour, daytime and nighttime Δ mean pH - 24-hour, daytime and nighttime Δ median pH ### Location - Facility: Inje University Busan Paik Hospital, Busan, N/A, 47392, Korea, Republic of @@
## The Fingerprinting of Inherited Leukoencephalopathies: A New Brain Imaging, Genetic and Clinical Assessment - NCT ID: NCT06332625 - Study ID: PNRR-MR1-2022-12375648 - Status: RECRUITING - Start Date: 2023-05-22 - Completion Date: 2025-11-22 - Lead Sponsor: IRCCS Fondazione Stella Maris ### Study Description Inherited leukoencephalopathies are a broad spectrum of genetically determined disorders, characterized by specific involvement of the white matter of the central nervous system. These pathologies are almost as common as other acquired white matter disorders, such as acute disseminated encephalomyelitis and multiple sclerosis. The onset can occur at any age, from prenatal life to adulthood, and the clinical picture is mostly progressive, but can also be non-evolving or, rarely, improve over time. Thanks to new diagnostic approaches, including next-generation genetic sequencing and recognition of magnetic resonance imaging patterns, in recent years the investigators have witnessed a significant increase in the number of genetically defined leukoencephalopathies. However, despite advances in genetic studies, inherited leukoencephalopathies include a large number of inherited white matter diseases in children and adults and remain of unknown cause in many patients (about 40%). This significant percentage of cases of unknown etiology represents a major challenge for public health, both in prognostic terms and, consequently, economically. However, even in leukoencephalopathies of genetically determined cause, the absence of specific biomarkers can be a limiting factor in the design and execution of clinical studies in search of promising therapies. As in other fields of neurology, the integration of clinical and genetic data with brain MRI data plays a fundamental role in the diagnostics of subjects affected by these pathologies. Currently, the methodologies commonly used in magnetic resonance imaging are qualitative, and evaluate brain lesions through the contrast between white and gray matter. The lack of specific biomarkers is therefore a limiting factor in the design of therapeutic challenges. In this regard, the development of new multiparametric quantitative magnetic resonance imaging (qMRI) methods could allow the investigators to identify new biomarkers to assess the etiology behind leukodystrophies, increasing diagnostic power and understanding the progression or improvement of leukoencephalopathy for both future trials and existing therapies. In this perspective, recent rapid "transient-state" magnetic resonance imaging methods, such as MR Fingerprinting (MRF), have proven effective in efficiently separating different components of brain tissue. These techniques consist of rapid and highly undersampled acquisitions performed by continuously changing the MR sequence parameters, thus obtaining a signal evolution that is unique for each combination of underlying tissue properties. Furthermore, if these techniques have already shown their validity at 3 Tesla, they could be even more informative in 7T MRI where the use of qMRI could provide more details thanks to the high image resolution.The project's objective is to evaluate and validate new and innovative quantitative magnetic resonance imaging (qMRI) methodologies at both clinical and ultra-high fields in inherited leukodystrophies and those of unknown etiology.This is a national, multi-institutional, multicenter exploratory study on the potential identification and predictability of early structural and metabolic markers in quantitative MRI at 3T and 7T in the diagnosis and follow-up of leukodystrophy and leukoencephalopathy in adults and during development.The study will include multiple sub-studies:1. A cross-sectional study in leukoencephalopathies at clinical fields.2. A longitudinal study in leukoencephalopathies at 3T: natural history and therapy outcomes.3. A cross-sectional and longitudinal study at 7T: The added value of ultra-high-field Magnetic Resonance Imaging in leukoencephalopathies. ### Conditions - Leukoencephalopathies ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Brain quantitative magnetic resonance imaging ### Outcomes Primary Outcomes - Quantitative Susceptibilty Mapping, QSM - Fractional Anisotropy, FA - Mean Diffusivity, MD - Relaxation times - Myelin water fraction, MWF - Neuromotor skills - Neuromotor skills Secondary Outcomes - Epilepsy symptoms - Electroencephalography features - Neuro-psychological profile ### Location - Facility: IRCCS Associazione Oasi Maria SS Troina, Troina, Enna, 94018, Italy @@
## Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial - NCT ID: NCT06332612 - Study ID: 8420224AROM - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Ziauddin University ### Study Description OSF is a widespread health issue in Asian countries, notably Pakistan, linked to the consumption of pan, chalia, and gutka, affecting a rising number of young individuals as an epidemic. This condition significantly impairs oral function, resulting in ulcers and chronic lesions, often progressing to oral cancer. Current treatments focus on symptom relief and halting disease progression. This study explores the repurposing of metformin, an FDA-approved drug with antifibrotic properties, for OSF treatment. Our objective is to unveil its therapeutic potential and comprehend its impact on the dysregulated signaling pathways associated with OSF. This research offers promising insights for an enhanced management approach, providing hope for those grappling with this debilitating condition ### Conditions - Oral Submucous Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin Hydrochloride - betamethasone dipropionate - Pentoxifylline ### Outcomes Primary Outcomes - Cell Viability - Cytotoxicity - Morphological Changes Cell Shape - Morphological Change Cell Density - Morphological Change Extracellular Matrix (ECM) Structure - Cell Migration Assays - Cell Invasion Assays - Apoptosis Analysis - Assess Signaling pathway with optimal metformin concentration Secondary Outcomes - Clinical Oral Mucosal Characteristics - Patient Burning sensation pain - Patient Mouth Opening ### Location - Facility: Ziauddin University, Karachi, Sindh, 74700, Pakistan @@
## Minocycline for Helicobacter Pylori Rescue Treatment - NCT ID: NCT06332599 - Study ID: rjhy20240001 - Status: RECRUITING - Start Date: 2021-10-01 - Completion Date: 2034-06-30 - Lead Sponsor: Shanghai Jiao Tong University School of Medicine ### Study Description Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting. ### Conditions - Helicobacter Pylori Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - BQT - EBM4M4 - EBM3M3 - EBM2M4 - EBM2M3 ### Outcomes Primary Outcomes - Helicobacter pylori eradication rate Secondary Outcomes - Rate of adverse effects - Compliance rate ### Location - Facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, None Selected, 200127, China @@
## The Learning Effect of Applying Diversified Teaching in Emergency Injury Classification -Taking the Emergency Nurse of a Regional Hospital in Yunlin County as an Example - NCT ID: NCT06332586 - Study ID: 202311087RINA - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-25 - Completion Date: 2024-05-05 - Lead Sponsor: National Taiwan University Hospital ### Study Description "Triage" is the first process of emergency treatment. It is mainly based on the severity of the disease and the appropriate allocation of limited people, time, place, and medical resources. It is very important and related to the quality of medical care. In order to accurately judge the severity of patients, reduce the individual errors of artificial memory and increase the consistency of the judgment of triage levels, the new emergency five-level triage classification standard (Taiwan Triage and Acuity Scale) was implemented in 2010. , TTAS), the purpose is to allocate medical resources in the most appropriate manner at the appropriate time. It has been revised many times so far, so correct injury classification can maximize the safety of people's lives. This article reviews the relevant literature and finds that to have an efficient injury classification so that each patient receives appropriate medical allocation, an organized, effective and systematic injury inspection process structure is needed to enable the injury nurse to perform correct inspections. Injury skills and cognition should be actively promoted, and this policy must require traumatization nurses to continuously update their traumatization cognition and skills, and must also continue to conduct regular assessments and reviews to continuously improve the quality of traumatization grading by traumatization nurses. It can be seen that triage nurses must have skills, knowledge, attitudes and systems to improve the accuracy of triage levels and ensure the treatment of patients who need priority treatment . Therefore, this study can be used to understand the learning effectiveness of trauma care before and after diversified teaching, which can be used as a basis for teaching new trauma care nurses. ### Conditions - Triage ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Diversified teaching ### Outcomes Primary Outcomes - Improving the injury diagnosis ability of triage diagnosis nurses through diversified teaching Secondary Outcomes ### Location - Facility: Taiwan, Taipei, N/A, Taiwan, Taiwan @@
## Impact of Onco-sexology Support on the Quality of Life of Patients Newly Diagnosed for Cancer - NCT ID: NCT06332573 - Study ID: 24-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Hôpital Européen Marseille ### Study Description Onco-sexology as a supportive care for patients treated for cancer is still rarely discussed or even non-existent in 2022. However, it's recommended to integrate the preservation of sexual health throughout the treatment and post-cancer process, given the impact of cancer, treatments and the importance of intimate life for a majority of patients.Onco-sexology is one of the supportive care services validated by The French National Cancer Institute (INCa). It is also an objective of the 2014-2019 cancer plan and the 2017-2030 national sexual health strategy plan.Although sexuality is one of the fundamental needs of the human being, including in the case of a chronic disease or cancer diagnosis, the lack of training of health professionals to deal with intimate life, the difficulty to exchange on this subject between caregivers and patients, the lack of financial support for onco-sexology consultations, are all obstacles to the global management of oncology patients. However, it's a request from patients to be able to discuss the subject in an intimate way with a professional.While onco-sexology is already recommended as supportive care, a study on the impact of the delay in the management of sexual difficulties on quality of life could provide a sufficient level of evidence to change the practices and the care pathway of the oncology patient. Our objective is to study whether early management in onco-sexology has an impact on quality of life compared to late management (ie onco-sexology consultation before vs. after introduction of systemic oncological treatment). ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Onco-sexology support - Onco-sexology support ### Outcomes Primary Outcomes - Rate of patients with improved quality of life as measured by the 36-Item Short Form Survey (SF-36) at the end of onco-sexology support Secondary Outcomes - Evaluation of the quality of life of patients at 6 and 12 months after the end of onco-sexology support through the 36-Item Short Form Survey (SF-36) questionnaire - Evaluation of the quality of sexual life at the end of the onco-sexology support in both groups through specific questionnaires (The sexual quality of life-female and men) - Evaluation of the quality of sexual life at 6 and 12 months after the end of the onco-sexology support through specific questionnaires (The sexual quality of life-female and men) - Evaluation of the body image, at the end of the onco-sexology support through the "Body Image Scale ". - Evaluation of the body image, of the patient at 6 and 12 months after the last consultation with the onco-sexologist through the "Body Image Scale". - Evaluation of the satisfaction of the patient at the end of the care in onco-sexology care - Rate of patients expressing sexual difficulties during the consultation of announcement ### Location - Facility: Hôpital Européen Marseille, Marseille, N/A, N/A, France @@
## Pain in Endometriosis And the Relation to Lifestyle - NCT ID: NCT06332560 - Study ID: NL86247.091.24 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-05 - Lead Sponsor: Radboud University Medical Center ### Study Description The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet intervention on health related quality of life and pain symptoms in women with endometriosis. And whether the addition of CBT enhancing this effect. The secondary objective is to investigate the effect of an anti-inflammatory diet on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome.Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy.Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet. ### Conditions - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Anti-inflammatory diet (DI) - Cognitive behavioral therapy (CBT) ### Outcomes Primary Outcomes - Change in Pain intensity assessed by the Numerical Rating Scale - Change in inflammatory characteristics in menstruum Secondary Outcomes - Change in Health Related Quality of Life assessed by the Endometriosis Health Profile 30 - Change in general Quality of Life assessed by the Short Form 36 - Change in the composition of vaginal and intestinal microbiome - Change in Objective stress assessed by measuring scalp hair cortisol levels - Adherence and anti-inflammatory status of the diet ### Location - Facility: Radboud University Medical Center, Nijmegen, N/A, N/A, Netherlands @@
## Transfusion in Cardiac Valve Surgery - NCT ID: NCT06332547 - Study ID: TICVS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-30 - Lead Sponsor: Guangdong Provincial People's Hospital ### Study Description This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups. ### Conditions - Cardiac Surgery With Cardiopulmonary Bypass - Valve Heart Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Restrictive Transfusion Strategy - Liberal Transfusion Strategy ### Outcomes Primary Outcomes - A composite of postoperative morbidity and mortality Secondary Outcomes - Rate of reoperation - Length of ICU Stays - Length of Postoperative Hospital Stay - Number of Blood Transfusion - Duration of mechanical ventilation - Postoperative thoracic fluid volume in the first 24 hours - Number of participants with postoperative atrial fibrillation - Number of participants with new-onset renal failure with dialysis - Number of participants with acute kidney injury - Number of participants with delirium - Hospitalization expense ### Location - Facility: Guangdong Provincial People's Hospital, Guangzhou, Guangdong, 510145, China @@
## Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease - NCT ID: NCT06332534 - Study ID: M14-671 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-26 - Completion Date: 2034-12-20 - Lead Sponsor: AbbVie ### Study Description Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and/or biologic therapy.Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. ### Conditions - Crohn's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Upadacitinib ### Outcomes Primary Outcomes - Percentage of participants who achieved clinical response per the Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12, with clinical remission per the PCDAI at Week 64 - Achievement of endoscopic response at Week 64 in participants who achieved clinical response per PCDAI at Week 12. - Number of Participants with Adverse Events Secondary Outcomes - Achievement of clinical remission per PCDAI - Achievement of endoscopic response - Achievement of endoscopic remission - Achievement of clinical response per PCDAI - Achievement of clinical response per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 - Achievement of endoscopic remission at Week 64 in participants who achieved clinical response per PCDAI at Week 12 - Achievement of corticosteroid (CS)-free clinical remission per PCDAI at Week 64 in participants who achieved clinical response per PCDAI at Week 12 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Infant Crying, a Bioacoustic Prognostic Signal for Neurodevelopment - NCT ID: NCT06332521 - Study ID: 23CH296 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2029-04-01 - Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne ### Study Description Crying is a vital communication signal for the baby. Product of a complex physiological process, it reflects not only the organization and functioning of the cortical central nervous system and the function of sympathetic and parasympathetic autonomic regulation but also the integrity of three entities: the lungs responsible for ventilatory mechanics and respiratory rhythm, the larynx and its vocal cords as a phonatory organ, and the oropharyngeal tract guaranteeing the resonance of the sound emitted by the vocal cords.Crying is usually caused by pain, discomfort, hunger, or separation from parents or other caregivers. Crying carries essential information from birth, the expression of which depends closely on the neuroanatomical and functional brain integrity of the child. On a bioacoustic level, crying consists of sequences of complex acoustic signals produced by the vocal folds and filtered by the vocal tract. The vibration frequency of the vocal cords determines the cry's fundamental frequency f0 (and the harmonic frequencies), which is responsible for its more or less low or high pitch. Other acoustic cues also characterize each baby's cry. ### Conditions - Newborn; Vitality - Premature Infants - Infant Development ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Acoustic signal analysis method ### Outcomes Primary Outcomes - Fundamental frequency f0 (Hz) - Bailey-4 quantitative scale Secondary Outcomes - Percentage voiced frames - Harmonics of f0 (Hz) - Median pitch f0 (Hz) - Harmonicity (dB) - Jitter (Percentage), - Q25 (Percentage) - Median Cepstral Peak Prominence (CPP) (dB) ### Location - Facility: Chu de Saint-Etienne, Saint-Étienne, N/A, 42055, France @@
## Pulsed Electromagnetic Fields (PEMFs) - A Highly Selective Breast CAncer Treatment pLatform (PASCAL) - NCT ID: NCT06332508 - Study ID: 2022/00406 - Status: RECRUITING - Start Date: 2022-12-30 - Completion Date: 2025-12 - Lead Sponsor: National University Hospital, Singapore ### Study Description To assess the safety and tolerability of combined PEMFs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pulsed electromagnetic fields (PEMFs) - Anthracycline-based chemotherapy ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 Secondary Outcomes - Treatment response as assessed by clinical measurement of tumor size using calipers ### Location - Facility: National University Hospital, Singapore, N/A, 119074, Singapore @@
## Research Project on the Risk of Discomfort, Pain, Alteration of Skin Condition in Bedpan Use by Patients and Caregivers - NCT ID: NCT06332495 - Study ID: RC23_0573 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-03 - Lead Sponsor: Nantes University Hospital ### Study Description the hypothesis is that the current bedpan is not adapted to the diversity of patients encountered. It is necessary to collect the opinions of patients themselves on the current pool in different departments in order to validate our hypothesis.The objective is to evaluate pain in patients with reduced or very reduced mobility caused by the bedpan currently used in current practice through an observational study. ### Conditions - Nurse-Patient Relations ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questioning the patient during hygiene care ### Outcomes Primary Outcomes - Assessment of pain in a patient with reduced or very reduced mobility when using a bedpan. Secondary Outcomes - Assess the proportion of patients with a MCID of the pain felt by the patient in pre-installation > 1.3 - Assess the maximum pain felt by the patient pre/post and per/post use of the bedpan. - Assess patient discomfort on the bedpan - Assess alteration of skin condition at the seat of the patient using the bedpan - Assess the caregiver's pain when handling the bedpan, placing the bedpan in position and removing the bedpan. - Assess the risk factors associated with the onset of pain when placing a bedpan. - Assess the difficulty of positioning and removing the bedpan. - Assess bedpan stability during use - Evaluate the effect of time spent on the bedpan on: pain, skin alteration and discomfort ### Location - Facility: Nantes University Hospital, Nantes, Loire Atlantique, 44093, France @@
## Complete Digital Workflow for Construction of Full Arch Implant Supported Screw Retained Restoration - NCT ID: NCT06332482 - Study ID: M0303023RP - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-30 - Completion Date: 2024-09-15 - Lead Sponsor: Mansoura University ### Study Description This study will compare the occlusal accuracy of different techniques for recording maxillomandibular relationships in a Complete digital workflow to construct full arch implant-supported screw-retained restoration. ### Conditions - Prosthesis Durability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Implant supported screw retained prosthesis ### Outcomes Primary Outcomes - measurement of occlusal prematurity - prosthestic complications Secondary Outcomes ### Location - Facility: Mansoura University ,Faculty of dentistry, Mansoura, N/A, P.O.Box:35516, Egypt @@
## Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation - NCT ID: NCT06332469 - Study ID: INSERT feasibility - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-10-31 - Lead Sponsor: Linkoeping University ### Study Description The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Internet based education and support program for patients awaiting kidney transplantation ### Outcomes Primary Outcomes - Kidney transplant understanding tool (K-TUT) - Self-care in chronic illness inventory v.4c - The Self-Efficacy for Managing Chronic Disease 6-item Scale (SES6G - Pearlin Mastery Scale - The Depression Anxiety Stress Scales 21 (DASS-21) - Acceptance of chronic health conditions scale (ACHC) - EQ-5D-5L Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Renal Microcirculation With Rubidium Positron Emission Tomography - NCT ID: NCT06332456 - Study ID: ICM 2023-3169 - Status: RECRUITING - Start Date: 2023-07-04 - Completion Date: 2024-12 - Lead Sponsor: Matthieu Pelletier-Galarneau, MD MSc ### Study Description The aim of this study is to demonstrate that positron emission tomography imaging with Rubidium-82 (radioactive tracer) can non-invasively detect and quantify changes in renal blood flow (renal perfusion) and renal vascular resistance in both healthy subjects and patients with renal insufficiency. Ultimately, the results of this study will contribute to a better understanding of the role of positron emission imaging in the evaluation of patients with renal diseases. ### Conditions - Renal Microcirculation With Rubidium Positron Emission Tomography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Renal blood flow in units of mL/min/100g Secondary Outcomes - Renal vascular resistance in units of mmHg/mL/min/100g - Correlation between renal vascular resistance measured with PET and measured with echography - Coefficient of repeatability of renal blood flow ### Location - Facility: Montreal Heart Institute, Montréal, Quebec, H1T 1C8, Canada @@
## Randomized, Controlled Trial Comparing the Effectiveness of Sedation-Epidural Anesthesia to Spinal Anesthesia in Outpatient Hip or Knee Arthroplasty. - NCT ID: NCT06332443 - Study ID: CER-CEMTL-2023-3086 - Status: RECRUITING - Start Date: 2023-03-15 - Completion Date: 2026-03-15 - Lead Sponsor: Maisonneuve-Rosemont Hospital ### Study Description To our knowledge, no study has compared the difference between these two NA techniques. Early postoperative adverse events like uncontrolled pain, orthostatic hypotension, urinary retention, and prolonged motor block are linked to late patient mobilization, prolong hospitalization and failure to discharge in outpatient setting. The type of anesthesia used may have an important impact. Therefore, this study has the potential to improve the already established ERAS program and improve patients care perioperative and postoperative. Showing that SED-EA and SA are equivalent will allow for a more efficient and reliable technique for THA/TKA ERAS program that can be further translated into other lower limb surgeries. ### Conditions - Knee Injuries and Disorders - Hip Injuries - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Spinal anesthesia - Sedation epidural anesthesia ### Outcomes Primary Outcomes - Adverse Events Secondary Outcomes - Time needed by the anesthesiologist to perform the technique - Time needed for the SA or SED-EA to achieve adequate sensory block - Intraoperative blood loss - intraoperative muscle tension - Extra Lidocaine needed - Conversion to GA - Total dose of the sedation - Hemodynamic stability measured - Time to return of motor and sensory function - Post-operative nausea - PONV and anti-emetics - Urinary retention - Opioid consumption - Length of stay - Failed discharded - Complications related to the technique performed. - Adverse event ### Location - Facility: Hopital Maisonneuve Rosemont, Montreal, Quebec, H1T 2M4, Canada @@
## Intratumoral CAN2109 in Subjects With Solid Tumors or Lymphomas - NCT ID: NCT06332430 - Study ID: CW-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2026-05-30 - Lead Sponsor: Canwell Biotech Limited ### Study Description A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas. ### Conditions - Solid Tumor - Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CAN2109 ### Outcomes Primary Outcomes - Safety and tolerability - Recommended Phase 2 Dose (RP2D) Secondary Outcomes - To determine the efficacy of CAN2109 - To evaluate the pharmacodynamics of CAN2109 ### Location - Facility: Sun Yat-Sen University Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, 510535, China @@
## Combined Effects of Ba-Duan-Jin Based Deep Breathing Exercises and Forced Expiratory Technique - NCT ID: NCT06332417 - Study ID: REC/RCR&AHS/23/0364 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-06-15 - Lead Sponsor: Riphah International University ### Study Description This study will be a randomized control trial. A total of 68 patients will be recruited and randomly assign to the experimental group or the control group in a 1:1 ratio. Participants in the experimental group will receive a 8-week Ba-duan jin exercise training intervention along with Forced Expiratory Technique at least 3 days a week and 30 minutes a day, while participants in the control group will be only given Forced Expiratory intervention and will be told to maintain their original lifestyle for 8 weeks along with standard COPD treatment. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ba-Duan-Jin Based Deep Breathing Exercises - FET (Forced Expiratory Technique) ### Outcomes Primary Outcomes - 36-Item Short Form Survey (SF-36) - FEV1/FVC ratio - Exercise Tolerance : 6 minute walk test - Forced vital capacity (FVC) - Forced expiratory volume (FEV1) Secondary Outcomes ### Location - Facility: Social Security Teaching Hospital, Lahore, Punhab, 42000, Pakistan @@
## Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry - NCT ID: NCT06332404 - Study ID: B3002024000047 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2034-04 - Lead Sponsor: University Hospital, Antwerp ### Study Description Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved.The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital. ### Conditions - Obstructive Sleep Apnea - Sleep Apnea - Apnea ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Hypoglossal nerve stimulation Inspire system (Inspire Medical Systems Inc., USA) ### Outcomes Primary Outcomes - Delta apnea-hypopnea index (AHI) as measured by a polysomnography Secondary Outcomes - % of patients that reach treatment success defined by a 50% reduction in AHI and an on therapy AHI of < 20 events/h OR an on therapy AHI of < 15 events/h - Therapy adherence defined by the amount of hours therapy usage per night. - Delta oxygen desaturation index (ODI) as measured by a polysomnography - Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire - Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire - Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire ### Location - Facility: Antwerp University Hospital, Edegem, Antwerp, 2650, Belgium @@
## Paced Heart Rate Acceleration for Cardiac Conditioning - NCT ID: NCT06332391 - Study ID: 202308349 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-11-30 - Lead Sponsor: Denice Hodgson-Zingman, MD ### Study Description A clinical trial of exercise-similar heart rate acceleration delivered via cardiac pacing vs. sham intervention in subjects at rest will be performed. The study population comprises subjects with guideline-directed medically managed severe left ventricular dysfunction due to ischemic or non-ischemic cardiomyopathy and an existing implantable cardioverter defibrillator or biventricular implantable cardioverter defibrillator. The purpose of the study is to understand how the heart rate pattern of exercise contributes to the considerable cardiac conditioning effects of exercise and estimate whether the pacing approach may have translational clinical applicability. Fifty-two subjects will be randomized, single-blinded, to either the pacing intervention or a sham intervention which they will receive once daily, 3 days/week for 6 weeks. Baseline symptoms and clinical test results will be compared to the same measures at 2 weeks, 4 weeks and 6 weeks of intervention/sham and at 3 months and one-year post-intervention. The primary endpoint will be the change in left ventricular ejection fraction from baseline in intervention vs. sham groups (mixed effects linear regression with time and treatment arm as fixed effects and pre-specified covariates of sex and cardiomyopathy type as random effects). Secondary endpoints will include changes in quality of life, 6-minute walk distance, cardiopulmonary exercise test (CPET) measures, daily activity and major adverse cardiac events (MACE) at 3 and 12 months between pacing and sham groups. A "dose-response" analysis of outcomes at 2, 4, and 6 weeks of the intervention vs. sham compared with baseline will be performed. ### Conditions - Heart Failure, Systolic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise-similar cardiac pacing - Sham cardiac pacing ### Outcomes Primary Outcomes - Change in left ventricular ejection fraction by echocardiogram Secondary Outcomes - Quality of Life score on the Minnesota Living with Heart Failure questionnaire - Quality of Life score on the Kansas City Cardiomyopathy Questionnaire - 6-minute walk distance - Cardiopulmonary exercise test maximum oxygen consumption - Cardiopulmonary exercise test metabolic equivalents achieved - Cardiopulmonary exercise test peak power output achieved - Cardiopulmonary exercise test total exercise time - daily minutes of sedentary activity - daily minutes of low activity - daily minutes of moderate activity - daily minutes of vigorous activity - major adverse cardiac events - symptom score during the intervention/sham procedure - maximum achieved pacing rate during the intervention/sham procedure - presence of significant arrhythmia during the intervention/sham procedure - vital signs - systolic blood pressure during the intervention/sham procedure - vital signs - oxygen saturation in the blood during the intervention/sham procedure - tolerability - vital signs - cardiac output - vital signs - cardiac output during the intervention/sham procedure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Exercise Therapy on Type II Diabetic Neuropathic Patients - NCT ID: NCT06332378 - Study ID: sHasan - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-08-15 - Lead Sponsor: Dr. Sobia Hasan ### Study Description The goal of this Randomized control trial (clinical trial) is to learn about the effect of Exercise therapy on Type II Diabetic Neuropathic Patient in Pakistan ,40-70 year's old patient, will be refer by physicians.Exclusion criteria of the study will lower extremity complications such as fracture, having experience dislocation at least six months prior to the study, having any history of surgical operations in muscles, bones, and joints of lower extremities, suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy, middle ear and vestibular impairments (patients' self-report), knee joint flexion contracture, and interruption of the intervention sessions for more than two days..The main question it aims to answer are:1. To compare the effects of two therapeutic exercises on clinical balance measures on type II diabetic peripheral neuropathy patients.2. Effectiveness of exercises using Swiss ball in lowering waist circumference, and BMI.3. Effectiveness of exercises on fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and glycosylated Hemoglobin (HbA1c) among Type II diabetic patients.4. Effectiveness of exercises on autonomic nervous system activity on type II diabetic peripheral neuropathy patients.By using random allocation, the participants will divided into three groups: an intervention group (N=30) that receive ball training exercise, another intervention group (N=30) that receive Frenkel training exercise and a control group (N=30).Each exercise session contain 5 min warm-up (stationary bike), 45 min exercise training (with 1 minute rest for every 5 minutes of exercise), and 5 min of cool down activities including stretching of the muscles involved in balance exercise (gluteal, erector spine, hamstring, rectus femorus, gastro soleus, and pectoral muscles). This make the participants' heart rate stable and prepare their muscles for optimal activity. ### Conditions - Diabetic Neuropathies ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental group 1 :Ball training - Experimental group 2 :Frenkel Exercises - Control Group ### Outcomes Primary Outcomes - One Leg Stance - Berg Balance Scale - Timed Up and Go Test: - Diabetic Neuropathy Symptom Score - Hemoglobin A1C Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers - NCT ID: NCT06332365 - Study ID: ID: 3938/2022 - Status: COMPLETED - Start Date: 2022-01-03 - Completion Date: 2024-02-19 - Lead Sponsor: Pia Lopez Jornet ### Study Description Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus ### Conditions - Oral Lichen Planus - Oral Lichen Planus Related Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acetonide triamcinolone 0.2% +hyaluronicacid 1% - Corticoid Acetonide triamcinolone 0.2% - Hyaluronic acid 1% ### Outcomes Primary Outcomes - Pain assessment scale Secondary Outcomes - OHIP-14 questionnaire - reduction of clinical signs measure - Salivary level of oxidative stress biomarker ### Location - Facility: Pia Lopez Jornet, Murcia, N/A, 30004, Spain @@
## Intra-articular Platelet-Rich Plasma for Acetabular Labral Tears - NCT ID: NCT06332352 - Study ID: 00173470 - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2026-01-25 - Lead Sponsor: University of Utah ### Study Description Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function.Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants. ### Conditions - Acetabular Labrum Tear ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PRP ### Outcomes Primary Outcomes - Pain & Function Improvements Secondary Outcomes - Visual Analog Scale (VAS) - Harris Hip Scores (HHS) - International Hip Outcome Tool (iHOT-12) - EQ-5D (EuroQual 5D) ### Location - Facility: University of Utah - Department of Orthopaedics, Salt Lake City, Utah, 84108, United States @@
## Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 16055 NFL Delta Gly4 Env Protein Trimer and Trimer 4571 Combined With 3M-052-AF + Alum Adjuvant and Ad4-Env145NFL Viral Particles as Heterologous Prime-boost Regimens in Adult Participants Without HIV. - NCT ID: NCT06332339 - Study ID: HVTN 313 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2026-11-11 - Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) ### Study Description The goal of this clinical trial is to test 16055 NFL delta Gly4 Env protein trimer and Trimer 4571 combined with 3M-052-AF + Alum adjuvant and Ad4-Env145NFL viral particles as heterologous prime-boost regimens in adult participants without HIV.The main question\[s\] it aims to answer are:* Are these vaccine regimens safe and well tolerated?* Are the prime-boost vaccine regimens that include Ad4-Env145NFL and Trimer 4571 as heterologous boosts going contribute to the development of B-cell and antibody responses?Participants will attend scheduled study visits to receive their vaccine and will record symptoms on a daily eDiary. ### Conditions - HIV ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 16055 NFL delta Gly4 trimer - Trimer 4571 - Ad4-Env145NFL, 5 x 108 viral particles (vp) ### Outcomes Primary Outcomes - Local reactogenicity signs and symptoms - Systemic reactogenicity signs and symptoms - Number of adverse events (AEs) reported for 30 days after receipt of any study product - Number of Serious Adverse Reactions (SAEs) leading to early participant withdrawal or permanent discontinuation - Number of Medically Attended Adverse Event (MAAEs) leading to early participant withdrawal or permanent discontinuation - Number of Adverse Events of Special Interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) leading to early participant withdrawal or permanent discontinuation - Number of Adverse Events (AEs) leading to early participant withdrawal or permanent discontinuation - Occurrence of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc) - Magnitude of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) - Response Rate of serum IgG binding antibodies to vaccine-matched HIV-1 Env trimers and specific epitopes (e.g., CD4 binding site, V2, base of trimer, etc.) Secondary Outcomes - Occurrence of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) - Magnitude of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) - Response Rate of serum antibody neutralization of the autologous pseudovirus HIV-1 strains (including vaccine-matched deglycosylated 16055, WT 16055, BG505, 1086) - Occurrence of serum antibody neutralization of HIV-1 strains - Magnitude of serum antibody neutralization of HIV-1 strains - Response Rate of serum antibody neutralization of HIV-1 strains - Flow cytometry analysis of the frequency of Env-specific IgG+ B cells - Occurrence of serum IgG binding antibodies as measured by BAMA - Magnitude of serum IgG binding antibodies as measured by BAMA - Response Rate of serum IgG binding antibodies as measured by BAMA - Number of Isolation of CD4bs bnAb specific VH and VL alleles and characteristic mutations - Flow cytometry analysis of the frequency of Env-specific IgG+ B cells at 26 weeks and 52 weeks after the fifth vaccination - Occurrence of serum IgG binding antibodies - Magnitude of serum IgG binding antibodies - Response Rate of serum IgG binding antibodies - Occurrence of serum antibody neutralization to tier 2 HIV-1 strains - Magnitude of serum antibody neutralization to tier 2 HIV-1 strains - Response Rate of serum antibody neutralization to tier 2 HIV-1 strains - Epitope specific response rates as measured by electron microscopy polyclonal epitope mapping (EMPEM) ### Location - Facility: Alabama CRS, Birmingham, Alabama, 35222, United States @@
## Investigation of the Efficacy of Non-Invasive Vagus Nerve Stimulation and Physiotherapy in Unilateral Vestibular Hypofunction Patients - NCT ID: NCT06332326 - Study ID: E-10840098-772.02-4966 - Status: RECRUITING - Start Date: 2022-10-23 - Completion Date: 2024-05 - Lead Sponsor: Medipol University ### Study Description The purpose of this study: To investigate the effectiveness of non-invasive vagus nerve stimulation and vestibular rehabilitation applications in patients diagnosed with Unilateral Vestibular Hypofunction (UVH). ### Conditions - Vestibular Diseases - Vestibular Vertigo - Vertigo ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - non-invasive vagus nerve stimulation - vestibular rehabilitation ### Outcomes Primary Outcomes - Modified-CTSIB - Semitandem test - tandem test - one-leg standing test - Unterberger test - VAS Visual Analogue Scale (dizziness severity) - Dynamic visual acuity test Secondary Outcomes - Dizziness Handicap Inventory Scale - Tampa Kinesiophobia Scale - Hospital Anxiety and Depression Scale (HAD) ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, N/A, Turkey @@
## Erector Spina Plane Block Volume Comparison - NCT ID: NCT06332313 - Study ID: 2023/10/05 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-12 - Completion Date: 2024-12-05 - Lead Sponsor: Kahramanmaras Sutcu Imam University ### Study Description After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded ### Conditions - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - erector spina plane block ### Outcomes Primary Outcomes - The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Exploratory Clinical Study of Adebelimumab in Combination With Famitinib and Chemotherapy in Patients With NSCLC - NCT ID: NCT06332300 - Study ID: ADBL-LC-003 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2026-02-01 - Lead Sponsor: Jiangsu Province Nanjing Brain Hospital ### Study Description This study was a single-arm design to explore the efficacy and safety of Adebelimumab in combination with famitinib and lateral ventricular chemotherapy in patients with floppy meningeal metastases from non-squamous NSCLC who have failed EGFR-TKI therapy, and included patients with pathologically confirmed non-squamous non-small cell lung cancer. ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Adebelimumab+Famitinib + FOLFIRI+Ariely ### Outcomes Primary Outcomes - ORR Secondary Outcomes - iPFS - iDoR - PFS - OS ### Location - Facility: Shengcun Fang, Nanjing, Jiangsu, N/A, China @@
## A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Advanced NSCLC With Leptomeningeal Metastasis - NCT ID: NCT06332287 - Study ID: 2023-NSCLC - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: Jiangsu Province Nanjing Brain Hospital ### Study Description To observe the efficacy of Trilaciclib combined with lateral ventricular chemotherapy in the treatment of non-small cell lung cancer with leptomeningeal metastasis。 ### Conditions - NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - combination of Trilaciclib and Pemetrexed ### Outcomes Primary Outcomes - Duration of severe neutropenia (DSN) Secondary Outcomes - Incidence of Treatment-Emergent Adverse Events - Incidence of grade 3 and 4 hematologic toxicity - Incidence of G-CSF treatment - Incidence of platelet transfusion ### Location - Facility: Fang Shencun, Suzhou, Jiangsu, 210029, China @@
## tislelizUMaB in canceR Patients With molEcuLar residuaL Disease - NCT ID: NCT06332274 - Study ID: 2023-503316-33-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-04 - Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris ### Study Description Numerous studies have shown that even when imaging does not reveal the presence of cancer cells, traces of tumor DNA (i.e. originating from cancer cells) can be detected in the blood of certain patients: this is called molecular residual disease (MRD). When such traces are detected (we speak of MRD+ status), the risk of relapse is much higher than when there is no circulating tumor DNA (MRD - status). Given the success of immunotherapy in treating patients with metastatic disease in a variety of tumor types, there is enormous enthusiasm for expanding the use of immunotherapy to people with cancer at an early stage.UMBRELLA is a biology-driven trial designed to study the impact of systemic treatment with tislelizumab monotherapy after detection of MRD+ status after completion of surgery and perioperative treatments in patients with cancer of a solid tumor. Residual disease (MRD) will be determined by optimized detection and precise monitoring of circulating tumor DNA, enabling early detection of recurrence and disease monitoring, including in patients without MRD \[MRD(-)\]. ### Conditions - Cancer - Lung Cancer - Colo-rectal Cancer - Pancreas Cancer - Soft Tissue Sarcoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tislelizumab - Blood sampling - Placebo ### Outcomes Primary Outcomes - Efficacy of tislelizumab compared to placebo as measured by DFS (Disease-free survival) Secondary Outcomes - Estimation of DFS in subjects without MRD - Estimation of overall survival (OS) - Percentage of MRD (+) subject's completion of standard curative-intent therapy - Time between detection of MRD and detection of relapse at imaging. - Percentage of subjects with MRD assessment failure. - Estimation of the time to become MRD (-) for MRD(+) patients - Evaluation of Health-Related Quality of Life (QLQ) by QLQ-C30 - Evaluation of Health-Related Quality of Life (QLQ) by EQ-5D-5L - Cost effectiveness analysis: incremental cost - Cost effectiveness analysis: QALY - Cost effectiveness analysis: ICER ### Location - Facility: Gustave Roussy, Villejuif, Val De Marne, 94800, France @@
## Standardized Assessment in Depression Treatment in Routine Psychiatric Services - NCT ID: NCT06332261 - Study ID: 2024-BB-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-04 - Lead Sponsor: Karolinska Institutet ### Study Description The goal of this observational study is to evaluate current practices in depression treatment in psychiatric services in Stockholm, Sweden.The main questions it aims to answer are:* Are current practices consistent with local clinical guidelines in terms of standardized assessment and the treatments provided?* What are the present conditions for implementing measurement-based care in depression treatment in this setting?Data will be collected retrospectively from medical records of patients having received psychological or pharmacological treatment for depression from 2020 to 2023. Frequency of standardized assessments (not scores) using the Montgomery-Åsberg Depression Rating Scale, the Montgomery-Åsberg Depression Rating Scale-Self Assessment, and the Patient Health Questionnaire-9 is collected, together with information on patient, clinician, and treatment characteristics. ### Conditions - Major Depressive Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale Secondary Outcomes - Montgomery-Åsberg Depression Rating Scale-Self Assessment - The Patient Health Questionnaire-9 ### Location - Facility: Stockholm Health Care Services, Region Stockholm, Stockholm, N/A, N/A, Sweden @@
## Possible Effects of the Dietary Supplement Magnesium Compared to Placebo - NCT ID: NCT06332248 - Study ID: 2014/1023-31/4 & 2014/274-31/5 - Status: COMPLETED - Start Date: 2014-09-15 - Completion Date: 2015-05-28 - Lead Sponsor: Dan Hasson ### Study Description The goal of this clinical trial was to investigate possible outcomes of the nutritional supplement magnesium compared to placebo in healthy, working adults. The main questions it aimed to answer were:* Are there differences in ratings of health, stress, well-being and work environment indicators between individuals intaking 375 mg magnesium (daily for 3 months) compared to placebo?* Are there differences in hearing, measured with hearing tests between those receiving 375 mg magnesium compared to placebo?Participants were asked to ingest 375 mg magnesium or placebo daily for 3 months.Researchers compared the group ingesting magnesium with the group ingesting placebo pills to see if there were any differences in for example self-rated health, recovery, wellbeing, etc. ### Conditions - Health Promotion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Magnesium - Placebo ### Outcomes Primary Outcomes - Time x group difference in HealthWatch-11 (questionnaire) Secondary Outcomes - Intervention compliance measure 1 (objective, number of pills left) - Intervention compliance measure 2 (subjective, marked days in calendar) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Silodosin in the Treatment of Lower Urinary Tract Symptoms in Taiwanese Population. - NCT ID: NCT06332235 - Study ID: KMUHIRB-F(I)-20220023 - Status: RECRUITING - Start Date: 2022-02-18 - Completion Date: 2024-12-31 - Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital ### Study Description To evaluate the therapeutic effects and safety of silodosin in the patients of acute brain injury with lower urinary tract symptoms. ### Conditions - Human Trichinellosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Silodosin 8 mg ### Outcomes Primary Outcomes - Assessment criteria Efficacy - Assessment criteria Safety Secondary Outcomes - Assessment criteria Efficacy ### Location - Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Sanmin District, 807, Taiwan @@
## Recovery With Tart Cherry Supplementation Following a Marathon. - NCT ID: NCT06332222 - Study ID: 1987 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-10-11 - Lead Sponsor: Northumbria University ### Study Description The goal of this clinical trial is to compare recovery in healthy, active runners.The main questions it aimed to answer were whether 7 day supplementation with Vistula TC attenuated:* muscle function* inflammation* soreness following a marathon run.Participants will either consume a spray-dried tart cherry supplement or a calorie-matched placebo-control for 7 days, and complete a marathon. Participants will perform functional tests, be assessed for their perceptual recovery and markers of inflammation and muscle damage via:* maximal voluntary contractions* counter movement jumps* visual analog scales to assess soreness* blood samples ### Conditions - Exercise Recovery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Tart Cherry - Placebo ### Outcomes Primary Outcomes - Maximal Voluntary Contraction Secondary Outcomes - Counter Movement Jump - Active Muscle Soreness - Serum Concentration of High-Sensitive C-Reactive Protein - Serum Concentration of Creatine Kinase - Perceptual Measures ### Location - Facility: Northumbria University, Newcastle Upon Tyne, Tyne And Wear, NE1 8ST, United Kingdom @@
## Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico - NCT ID: NCT06332209 - Study ID: Pro00135303 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-09-30 - Lead Sponsor: Medical University of South Carolina ### Study Description The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery. ### Conditions - Post-Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Trauma Focused Cognitive Behavioral Therapy ### Outcomes Primary Outcomes - Traumatic Stress Symptoms - Traumatic Stress Symptoms Secondary Outcomes - Anxiety and Depression Symptoms - Anxiety and Depression Symptoms ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunodeficiency and Cancer: Identification of Congenital Immune System Defects Underlying Paediatric Lymphomas - NCT ID: NCT06332196 - Study ID: L-IEI - Status: RECRUITING - Start Date: 2023-10-18 - Completion Date: 2025-10-18 - Lead Sponsor: Meyer Children's Hospital IRCCS ### Study Description Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas. ### Conditions - Immune Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Analysis of biological sample and clinical data ### Outcomes Primary Outcomes - To unravel inborn error of immunity behind Lymphoid neoplasm in children Secondary Outcomes - Identification of lymphoma-specific biomarkers ### Location - Facility: AOU Malpighi IRCCS, Bologna, N/A, N/A, Italy @@
## GWAS and EWAS in Patients With Erdheim-Chester Disease - NCT ID: NCT06332183 - Study ID: ECDGWAS - Status: RECRUITING - Start Date: 2019-07-17 - Completion Date: 2024-10-01 - Lead Sponsor: Augusto Vaglio ### Study Description Erdheim-Chester Disease (ECD) is a rare form of histiocytosis characterized by the proliferation of blood cells, known as histiocytes, which infiltrate various organs and tissues, often causing irreversible damage. The causes of the condition are still unknown, and although some mutations in genes involved in cell proliferation have been identified, other factors may be involved. Susceptibility to developing rare diseases like ECD is typically associated with genetic factors, including DNA polymorphisms and epigenetic modifications.This study aims to analyze the entire genome of a large cohort of patients with ECD and healthy controls to determine whether there are polymorphisms and epigenetic variants associated with susceptibility to developing the disease. The study could thus clarify the genetic predisposition to ECD development, provide insights into disease pathogenic mechanisms, and identify proteins or cellular mechanisms potentially targeted by specific treatments. ### Conditions - Erdheim-Chester Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Presence of polymorphisms ### Outcomes Primary Outcomes - Polymorphisms and genetic variants correlated with disease development - Methylation in Erdheim-Chester disease - Gene expression in Erdheim-Chester disease Secondary Outcomes ### Location - Facility: Hopital Pitié Salpetrière, Paris, N/A, N/A, France @@
## ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors - NCT ID: NCT06332170 - Study ID: HS-20093-103 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2028-05-30 - Lead Sponsor: Hansoh BioMedical R&D Company ### Study Description HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - HS-20093 - Adebrelimab - Cisplatin/ Carboplatin - Cetuximab - Enzalutamide ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) for combination-treatments Secondary Outcomes - Incidence and severity of adverse events (AEs) - Objective response rate (ORR) determined by investigators - Disease control rate (DCR) determined by investigators - Duration of response (DoR) determined by investigators - Progression-free survival (PFS) determined by investigators according to RECIST 1.1 - Overall survival (OS) - Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 - Time to PSA progression (TTPP) - Prostate-specific cancer antigen (PSA) response rate - Time to first subsequent therapy (TFST) - Observed maximum plasma concentration (Cmax) of HS-20093advanced solid tumor - Time to reach maximum plasma concentration (Tmax) of HS-20093 - Terminal half-life (T1/2) of HS-20093 following the first dose - Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093 - Percentage of participants with antibodies to HS-20093 in serum ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Postoperative Quality of Recovery After General Anesthesia With Remimazolam - NCT ID: NCT06332157 - Study ID: 2023-ke-715-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Beijing Chao Yang Hospital ### Study Description 126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital were selected. In the intervention group, anesthesia was induced with remimazolam besylate at a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by continuous pump. Control group: anesthesia induction, intravenous injection of propofol 2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients were routinely monitored for vital signs and anesthesia depth after entering the operating room. The patients were followed up after surgery, and the quality of recovery score at 24 hours after surgery was the main study outcome. ### Conditions - Anesthesia Recovery Period ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Remimazolam besylate - Propofol Injection Emulsion ### Outcomes Primary Outcomes - 15-item quality of recovery scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning - NCT ID: NCT06332144 - Study ID: 1R56DC020208-01A1 - Status: RECRUITING - Start Date: 2024-01-13 - Completion Date: 2024-08-31 - Lead Sponsor: Northeastern University ### Study Description The goal of this observational study is to test a reciprocal relationship between statistical learning and the development of language and literacy in first-graders with autism and their non-autistic peers. The main questions it aims to answer are:1. whether children's statistical learning abilities can predict their long-term improvement of language and literacy skills in school;2. how children's brains automatically learn patterns from speech and prints;3. whether children's learning in the lab reflects the language patterns they have learned over the years from their native language.First-grade students will participate in the study twice across three months.During Time 1, children will complete* a battery of language, reading, and cognitive assessments* a series of computer-based statistical learning games both inside and outside of functional MRI scanner.During Time 2, children will complete a battery of language and reading assessments to detect the growth in three months.Researchers will compare the autistic and the non-autistic groups to see if statistical learning plays a similar or different role in predicting children's language and literacy growth. ### Conditions - Autism Spectrum Disorder - Language Development - Literacy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Structural vs. Random sequences of stimuli - Intact vs. Degraded speech - Repeating 5-syllable nonwords or 2-syllable nonwords - Recall letter or syllable strings that either contain highly frequent bigram/trigram items or infrequent items according to English Corpus data. ### Outcomes Primary Outcomes - Language Composite Score - Reading Composite Score - Language/Literacy Disorder Status - Neural similarity between language and statistical learning tasks - Orthographic statistical sensitivity - Phonological statistical sensitivity Secondary Outcomes - Linguistic SL composite scores - Neural sensitivity to statistical regularities during the statistical learning tasks ### Location - Facility: Northeastern University, Boston, Massachusetts, 02115, United States @@
## Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature - NCT ID: NCT06332131 - Study ID: UPCC07623 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: Abramson Cancer Center at Penn Medicine ### Study Description This is an observational study that includes patients with melanoma who will be treated with adjuvant immune checkpoint inhibitor (ICI) therapy. The investigators will use echocardiograms, blood draws, and PET stress tests to understand how ICI therapy affects the heart and circulatory system. ### Conditions - Melanoma - Coronary Microvascular Dysfunction - Cardiotoxicity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of new abnormal myocardial blood flow reserve (MBFR) Secondary Outcomes - Incidence of major cardiovascular events - Coronary calcium score - All cause mortality - Cardiovascular specific mortality ### Location - Facility: Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## The Effect of Ice Massage on Pain, Ecchymosis, Hematoma and Patient Satisfaction - NCT ID: NCT06332118 - Study ID: avf ice massage - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-30 - Lead Sponsor: Erzurum Technical University ### Study Description The research was planned to measure pain, ecchymosis, hematoma and patient satisfaction with ice massage applied to the fistula before the arteriovenous fistula procedure in hemodialysis patients. Patients who agree to participate in the study will be given ice massage before the procedure and the relevant parameters will be measured. ### Conditions - Hemodialysis Complication ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - ice massage group ### Outcomes Primary Outcomes - Pain score Secondary Outcomes - Ecchymosis degree - Hematoma degree - Patient satisfaction score ### Location - Facility: Ercan Bakır, Erzurum, Yakutiye, 25010, Turkey @@
## Evaluation of Low Phenylalanine Formulas - NCT ID: NCT06332105 - Study ID: CUK001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-30 - Completion Date: 2025-04 - Lead Sponsor: Ajinomoto Co., Inc. ### Study Description Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes. ### Conditions - Phenylketonurias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Glytactin - L-AA ### Outcomes Primary Outcomes - Change in blood Phe in Secondary Outcomes ### Location - Facility: Birmingham Women and Children's Hospital, Birmingham, West Midlands, B4 6NH, United Kingdom @@
## FID-007 and Cetuximab in Treating Patients With Advanced Head and Neck Squamous Cell Carcinoma - NCT ID: NCT06332092 - Study ID: FID-007-003 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-12-31 - Lead Sponsor: Fulgent Pharma LLC. ### Study Description The goal of this FID-007 Clinical Trial is to compare the efficacy of different dosing regimens of FID-007 in combination with Cetuximab in patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The main questions it aims to answer are: to evaluate the efficacy, and to characterize the safety and tolerability. Eligible participants will be enrolled and randomized to 1 of 2 arms of FID-007 with fixed-dose Cetuximab in each 28-day cycle. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - FID007 ### Outcomes Primary Outcomes - ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Secondary Outcomes - BOR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) - Duration of Response (DoR) measurement - Progression-free Survival (PFS) measurement - Overall Survival (OS) measurement - Disease Control Rate (DCR) analysis - Adverse Events (AEs) graded according to the CTCAE version 5.0 - Vital Signs safety assessments - Clinical Laboratory safety assessments - ECGs safety assessment - Area Under the Plasma Concentration Versus Time Curve (AUC) of FID-007 - Peak Plasma Concentration (Cmax) - Terminal/elimination half-life (t1/2) - Clearance (CL) - Volume of Distribution (Vd) ### Location - Facility: Gabrail Cancer Center Research, Canton, Ohio, 44718, United States @@
## Holmium-166 TARE in Liver Limited Unresectable Colorectal Cancer Patients - NCT ID: NCT06332079 - Study ID: HAITI 2023-505356-22-00 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2027-02 - Lead Sponsor: Gruppo Oncologico del Nord-Ovest ### Study Description The aim of this study is to assess the efficacy of 166Ho-TARE followed by maintenance therapy with fluoropyrimidine and anti-EGFR or bevacizumab in liver-limited unresectable colorectal cancer patients, in terms of progression free rate 9- and 8-months for cohort A and B, respectively. ### Conditions - Colorectal Cancer Metastatic ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 166Holmium TARE - Cetuximab - Panitumumab - 5-Fluorouracil - Bevacizumab - Capecitabine ### Outcomes Primary Outcomes - Progression-free survival (PFS) Rate Secondary Outcomes - Overall Toxicity rate - Grade 3/ Grade 4 Toxicity rate - Post-treatment Disease Control Rate (DCR) - Progression free survival - Overall Survival - Dose-response relationships - Quality of Life (QoL) assessed using the EORTC QLQ-CR29 questionnaire - Quality of Life (QoL) assessed using the EORTC QLQ-CR30 questionnaire - Quality of Life (QoL) assessed using the EuroQol EQ-5D questionnaire ### Location - Facility: Azienda Ospedaliero Universitaria Pisana, Pisa, N/A, 56126, Italy @@
## Oxytocin Administration to Therapists and Its Effects on Patient-perceived Attunement and Responsiveness - NCT ID: NCT06332066 - Study ID: 0046-24-COM - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-06-30 - Lead Sponsor: Shalvata Mental Health Center ### Study Description In recent years there is a great interest in the possible role of Oxytocin (OT) as a facilitator for enhancing psychotherapeutic processes in patients with mental illnesses. Specific studies explored OT administration to patients, and the effect on psychotherapy on interaction within the therapeutic dyad. Nonetheless, studies exploring OT's effects of the therapists' side of the therapeutic dyad on the psychotherapy session and outcome, have not been conducted. The current study aims to assess the effect of OT administration to the therapists of psychiatric outpatients, on treatment process and outcome and specifically on the patient and therapist experience of the attunement and responsiveness toward the patient in the therapeutic encounter. Twenty staff members from Teradion Mental health Clinic of Clalit Health Services will be recruited, as well as 100 patients treated by these staff members. Therapists agreeing to participate will receive OT and PLC in a random order, at the same day they are seeing the same patients and the consecutive week. Patients agreeing to participate will complete a demographic questionnaire and all study measures, and will be scheduled to perform two consecutive research sessions with their therapists. The therapist will receive either OT or PLC in each of these two sessions, and right after the session the patients will complete the assessment scales. Multilevel models will be performed by the investigators to assess the effects of OT administration in therapists receiving OT versus receiving placebo. This research will be performed in accordance with ethical principles of Helsinki WMA Declaration. This study is the first to assess the effectiveness of hormonal augmentation for therapists and its influence on therapeutic process with patients suffering from acute distress in the public mental health domain. ### Conditions - Mental Health Therapists ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Oxytocin nasal spray ### Outcomes Primary Outcomes - Attunement and Responsiveness towards patients Secondary Outcomes - Attachment with Therapist - Working Alliance with Therapist - Patient Symptoms ### Location - Facility: Mental Health Clinic, Teradion, Misgav, N/A, N/A, Israel @@
## A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects - NCT ID: NCT06332053 - Study ID: SY-5007-I-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-01 - Lead Sponsor: Shouyao Holdings (Beijing) Co. LTD ### Study Description This study is a single-center, open-lable and fixed sequence test conducted in healthy subjects to evaluate the pharmacokinetic effects of Itraconazole and Rifampicin on a single dose of SY-5007 Oral administration. It is planned to enroll 28 healthy subjects and assign them to two parallel test groups, Group A (SY-5007 combined with Itraconazole) and Group B (SY-5007 combined with Rifampicin). ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SY-5007 - Itraconazole - SY-5007 - Rifampin ### Outcomes Primary Outcomes - Cmax for SY-5007 - Tmax for SY-5007 - AUC0-t for SY-5007 - AUC0-∞ for SY-5007 - t½ for SY-5007 - CL/F for SY-5007 - Vz/F for SY-5007 Secondary Outcomes - Safety of SY-5007 ### Location - Facility: West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China @@
## Gentamicin Bladder Instillation on CAUTI - NCT ID: NCT06332040 - Study ID: 22-500-243-50-35 - Status: RECRUITING - Start Date: 2023-10-09 - Completion Date: 2026-10-08 - Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix ### Study Description Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs. ### Conditions - Catheter Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Gentamicin ### Outcomes Primary Outcomes - CAUTI as primary outcome Secondary Outcomes ### Location - Facility: St. Jpseph's Hospital and Medical Center, Phoenix, Arizona, 85013, United States @@
## Accuracy of Hystro-Salpingo-Foam-Sonography (HYFOSY) as Tubal Patency Test in Comparison to Laparoscopy in Infertile Patients - NCT ID: NCT06332027 - Study ID: Soh-Med-24-03-03MD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Sohag University ### Study Description Tubal patency testing is an essential part of female subfertility evaluation . Tubal abnormalities are seen in 30-40% of female subfertility patients . Laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure .Laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia.Traditionally, Hysterosalpingography(HSG) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain.Hysterosalpingo-Contrast Sonography (HyCoSy) was introduced as an alternative using either contrast media or saline. The accuracy of HyCoSy is comparable to that of HSG and LSC being reference standards for tubal patency testing.However, hyperechogenic contrast media such as Echovist_ (Schering AG, Berlin) and SonoVue_ (Bracco, Milan)are either no longer available or not licensed for tubal patency testing.Hysterosalpingo-Foam Sonography (HyFoSy) was developed as an alternative for contrast HyCoSy and was introduced in 2010 as a first-line office tubal patency test.Foam is used in the HyFoSy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlExEm_-gel (containing hydroxyethyl cellulose and glycerol,IQMedical Ventures BV, Rotterdam, TheNetherlands) with 5ml purified ExEm_-water.The ExEm_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. In a review on safety aspects and side effects of ExEm-gel it was considered to be appropriate and safe for tubal patency testing.In 2017, HyLiFoSy combined with power Doppler (PD)(HyLiFoSy-PD) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto HyFoSy and HyCoSy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive Ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (HyCoSy), hysterosalpingo-foam sonography (HyFoSy), and hysterosalpingo-lidocaine-foam sonography (HyLiFoSy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with HSG, and from 78.1 to96.91% with lap-and-dye test.In addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. Finally, some studies have shown an increase in the rate of post-procedure gestation. ### Conditions - Infertility, Female ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Hystro-Salpingo-Foam-Sonography (HYFOSY) ### Outcomes Primary Outcomes - the accuracy of HyFoSy in the assessment of tubal patency Secondary Outcomes ### Location - Facility: Sohag University Hospital, Sohag, N/A, N/A, Egypt @@
## Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China - NCT ID: NCT06332014 - Study ID: 20210123 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2026-07-29 - Lead Sponsor: Amgen ### Study Description The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months. ### Conditions - Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Prolia ### Outcomes Primary Outcomes - Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 Secondary Outcomes - Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12 - Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12 - Percent change from baseline in total hip and femoral neck BMD at month 6 and 12 - Percent change from baseline in lumbar spine BMD at month 6 - Number of participants with adverse events (AE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of a Music and Interaction Intervention on Patient Distress During Whole Body Magnetic Resonance - NCT ID: NCT06332001 - Study ID: IEO 1403 - Status: RECRUITING - Start Date: 2020-12-31 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a randomized controlled trial for the evaluation of the acceptability of Whole-Body-Magnetic Resonance Imaging (WB-MRI) based on music and comunication intervention compared to a standard care condition.Subjects will be randomized into two groups: the experimental group or arm that receives the music and interaction interventions, and the control group or arm that receives a standard care condition. ### Conditions - Neoplasm Malignant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Experimental Group - Control Group ### Outcomes Primary Outcomes - Acceptability of WB-MRI based on music and comunication intervention compared to a standard care condition. Secondary Outcomes - Measure the level of patient's distress pre and post WB-MRI in the two groups using Distress Thermometer (V2.2020) ### Location - Facility: IEO Istituto Europeo di Oncologia, Milan, N/A, 20141, Italy @@
## Microbiome, Immune-system and Tumor Interaction in Colorectal Cancer - NCT ID: NCT06331988 - Study ID: IEO 1341 - Status: RECRUITING - Start Date: 2022-07-21 - Completion Date: 2029-07-31 - Lead Sponsor: European Institute of Oncology ### Study Description Colorectal cancers represent the second leading cause of cancer-related death in the United States Western world. In Italy they represent the second most frequent neoplasm (49,000 cases in 2019). Despite the advancement of surgical techniques and medical therapy programs systemic, it is estimated that approximately 40-50% of colorectal cancers recur after being treated for a limited loco-regional disease. Patients who develop metastases throughout their history clinic have a 5-year overall survival of just over 10%.Adjuvant systemic chemotherapy can reduce the risk of disease recurrence in patients with colorectal adenocarcinomas, however, the standard drugs used to date for this use (fluoropyrimidines and oxaliplatin) have not undergone substantial changes in the last 20 years or so.A crucial point is the need to have more precise information regarding risk factors above all biomolecular to base therapeutic choices.It has now become urgent to overcome the T-tumor N-node M- metastasis (TNM) staging, to have more modern knowledge on the factors capable of impacting significantly on the prognosis, influence the real risk of disease recurrence, Identify new prognostic categories and subcategories, therefore being able to predict the clinical benefit of treatments that can be more targeted, personalized and effective. In this panorama it has developed in recent years an ever-growing literature also regarding the role of bacterial flora intestinal (microbiota) in patients with colorectal cancer. In particular, recent discoveries have highlighted the immunoregulatory role of the microbiota in the anti-tumor response. This study aims of evaluating how the molecular characteristics of the tumor, of the infiltrating immune system cells and of the associated intestinal microbiota correlate with the development of colorectal cancer, its progression and response to treatments. ### Conditions - Colorectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Relapse free survival Secondary Outcomes - Overall survival ### Location - Facility: European Institute of Oncology, Milan, N/A, 20141, Italy @@
## Radiomics and Radiogenomics of Non-small Cell Lung Cancer - NCT ID: NCT06331975 - Study ID: IEO 0836 - Status: COMPLETED - Start Date: 2018-06-12 - Completion Date: 2023-09-14 - Lead Sponsor: European Institute of Oncology ### Study Description In this study, the radiomic characteristics and a broad range of genetic aberrations in lung adenocarcinomas will be evaluated. Investigators will assess changes in the radiomic and genetic profiles during targeted therapies in a subset of patients harboring treatable mutations. Patients undergoing targeted therapies will also be evaluated for variations in genomic profile and radiomic signature during follow-up ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Radiomic signature ### Outcomes Primary Outcomes - Evaluation of the association between the status of Epidermal Growth Factor Receptor (EGFR), Anaplastic Lymphoma Kinase (ALK), Kirsten Rat Sarcoma Virus (KRAS) and nodal status - Evaluation of the association between the status of EGFR, ALK, KRAS and overall survival (OS) - Evaluation of the association between the status of EGFR, ALK, KRAS and disease free survival (DFS) Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Digestive Tract Cancer and CIPN - NCT ID: NCT06331962 - Study ID: B-ER-112-010 - Status: RECRUITING - Start Date: 2023-05-19 - Completion Date: 2025-07-31 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description According to the incidence rate of cancer, the digestive tract cancer accounts for two of the top ten cancers. It also accounts for half of the top ten causes of cancer death. Chemotherapy remains one of the most common forms of cancer treatment, and chemotherapy-induced peripheral neuropathy (CIPN) is one of the common adverse effects of cancer treatment in cancer survivors. To date, there is no exercise guideline established for patients with CIPN; therefore, CIPN remains quite threatening to cancer survivors. Due to limited studies on effects of exercise on improvement of CIPN symptoms in patients with digestive tract cancers, this study aims to investigate the effects of exercise and different intervention delivery modes (remote home exercise and exercise under supervision) at different time points on the CIPN symptoms, body inflammatory index, physical function, and quality of life of gastrointestinal cancer survivors with chemotherapy-induced peripheral neuropathy. ### Conditions - Digestive Tract Cancer - Chemotherapy-induced Peripheral Neuropathy - Remote Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - remote home-based exercise therapy group - supervised exercise therapy group - regular care group ### Outcomes Primary Outcomes - Basic information - gene - body height - body weight - body mass index - blood data - Questionnaire of Quality of Life - Questionnaire of Chemotherapy-Induced Peripheral Neuropathy Secondary Outcomes - Muscle Strength - Dynamic Balance - Sensation Test - Cardiovascular Endurance ### Location - Facility: Department of Physical Therapy, National Cheng-Kung University, Tainan, N/A, 701, Taiwan @@
## Video Supported Training on Non-Stress Test Application to Pregnant Women - NCT ID: NCT06331949 - Study ID: TR TOKAT02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-11-01 - Lead Sponsor: Hilal Özbek ### Study Description Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided ### Conditions - First Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - video assisted training ### Outcomes Primary Outcomes - State-Trait Anxiety Scale - Prenatal Attachment Inventory (PAI) Secondary Outcomes - State-Trait Anxiety Scale - Prenatal Attachment Inventory (PAI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Improving Emotional Regulation Skills of Children in Difficulty in Shenzhen - NCT ID: NCT06331936 - Study ID: Shenzhen Project - Status: RECRUITING - Start Date: 2024-01-06 - Completion Date: 2024-09 - Lead Sponsor: City University of Hong Kong ### Study Description The study aims to 1) improve the emotional regulation strategies of children in difficulty in Shenzhen, and 2) develop and publish a set of evidence-based intervention manuals for professional use. Based on the intervention manual design of the researchers' previous study conducted in Hong Kong, the current research revised the intervention manual to adapt to the context of mainland China. This study adopts a randomized wait-list control trial design. The researchers aim to recruit 200 children in difficulty aged 8 to 14 as participants and randomly assign them to an experimental and a wait-list control group with a ratio of 3:2. Each participant will attend four sessions of intervention and one booster session, and each session requires around 1.5 to 2 hours to complete. The participants will complete assessments before the first session of the intervention (T1), immediately after the fourth session of the intervention (T2), and one month after the completion of the intervention (T3). A qualitative assessment will also be conducted after the booster session. ### Conditions - Emotion Regulation - Parent-Child Relations - Happiness - Positive Affect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Emotion regulation ### Outcomes Primary Outcomes - 10-item Emotional Management Strategy Questionnaire - 10-item Positive and Negative Affect Schedule - Patient Health Questionnaire-9 - Generalized Anxiety Disorder Scale - Subjective Happiness Scale - Connor-Davidson Resilience Scale 10-Item - Child-Parent Relationship Scale - Family Harmony Scale Secondary Outcomes ### Location - Facility: City University of Hong Kong, Hong Kong, N/A, N/A, China @@
## Assessing the Effectiveness of Continuous Glucose Monitoring in Enhancing Surgical Outcomes for Diabetic Patients - NCT ID: NCT06331923 - Study ID: U1111-1305-0484 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2025-12-31 - Lead Sponsor: Beijing Tsinghua Chang Gung Hospital ### Study Description The goal of this multi-center, pragmatic, randomized controlled trial is to assess the effectiveness of continuous glucose monitoring (CGM) compared with conventional monitoring in enhancing surgical outcomes for diabetic patients. The main questions it aims to answer are:* To assess the effectiveness of CGM compared with conventional monitoring in reducing the comprehensive complication index (CCI) for patients with diabetes or impaired glucose tolerance (IGT) within 30 days after surgery.* To analyze the impact of different age groups, types of surgery, preoperative levels of HbA1c, and preoperative 24h glycemic variations on the improvement of surgical outcomes under the CGM model.Participants will receive CGM prescribed by the attending physician for at least 6 hours before surgery. Glucose monitoring should be continued until the 7th day after surgery or discharge.The investigators will compare conventional monitoring group to see if CGM could reduce the CCIs for patients with diabetes or impaired glucose tolerance within 30 days after surgery. ### Conditions - Comprehensive Complication Index ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Continuous glucose monitoring (CGM) device ### Outcomes Primary Outcomes - Comprehensive complication index Secondary Outcomes - Postoperative complications - Morality - The length of the stay in the intensive care unit - The length of hospital stay - The overall hospitalization cost - Perioperative glucose level ### Location - Facility: Zhifeng Gao, Beijing, Beijing, 102218, China @@
## Efficacy and Safety of Topical Insulin for Neurotrophic Corneal Ulcers - NCT ID: NCT06331910 - Study ID: TITNCUES - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Assiut University ### Study Description To evaluate Safety and efficacy of topical insulin in treatment of neurotrophic corneal ulcers ### Conditions - Neurotrophic Keratopathy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - insulin eye drops ### Outcomes Primary Outcomes - Decrease in ulcer size and the increase in visual acuity . Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bronchial Asthma & Its Exacerbation - NCT ID: NCT06331897 - Study ID: Bronchial asthma - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2026-06-01 - Lead Sponsor: Assiut University ### Study Description Our goals is to assess :1¬_ the role of spirometer in case of asthma exacerbation 2_hematological parameters (N/L ratio \& platelet indices \&CRP )in asthma exacerbation for diagnosing and classifying asthma severity and its exacerbation ### Conditions - Bronchial Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of Broncial asthma & its exacerbation : the utility of laboratory investigation , chest imaging , pulmonary function tests Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) - NCT ID: NCT06331884 - Study ID: PCZ_Phase1 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2024-07-31 - Lead Sponsor: 4TEEN4 Pharmaceuticals GmbH ### Study Description Dipeptidyl peptidase 3 (DPP3) is a protease involved in the degradation of several cardiovascular mediators. During cardiogenic shock, upregulation of the vasoconstrictive molecule angiotensin II is a physiologic and potentially life-saving response aimed at maintaining adequate tissue perfusion. As circulating (c)DPP3 is able to effectively cleave angiotensin II, it may represent a novel factor contributing to hemodynamic instability during cardiogenic shock.Recently, a cDPP3-antagonizing antibody called AK1967 (commonly referred to as Procizumab) has been developed. In animal models of cardiogenic- and septic shock, inhibition of cDPP3 by AK1967 resulted in improved cardiac function and survival. Furthermore, AK1967 has shown an excellent safety record in different preclinical studies. In the current study the safety, tolerability and pharmacokinetics/-dynamics of AK1967 will be investigated in healthy male subjects. ### Conditions - Safety and Tolerability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK1967 (Procizumab) - Placebo ### Outcomes Primary Outcomes - Reported number of adverse events from baseline (start of Procizumab administration) up until the last follow-up visit after Procizumab administration Secondary Outcomes ### Location - Facility: Radboud University Medical Center, Nijmegen, Gelderland, 6525, Netherlands @@
## Effectiveness of US-PENS for Patients With Post-surgical Shoulder Pain - NCT ID: NCT06331871 - Study ID: 2004202111621 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2025-10-30 - Lead Sponsor: Universidad Rey Juan Carlos ### Study Description The aim of this clinical trial was to demonstrate the effectiveness of the application of ultrasound-guided percutaneous nerve stimulation (US-PENS) directed at the axillary nerve and the suprascapular nerve, in patients with post-surgical shoulder pain.This is a randomized, longitudinal, prospective and quasi-experimental clinical trial in which a total of 70 patients divided into two groups; physiotherapy protocol group (n=35) and experimental group to which the same protocol was practiced and a US-PENS session was added (n=35).The intervention and follow-up period of the participants took place over 12 weeks. ### Conditions - Ultrasound-Guided Percutaneous Electrical Nerve Stimulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ultrasound Guied Percutaneus Electrical Nerve Stimulation (US-PENS) and Manual physiotherapy protocol based on available evidence. - Manual physiotherapy protocol based on available evidence. ### Outcomes Primary Outcomes - The Numeric Pain Rating Scale (NPRS) - Disabilities of the Arm, Shoulder and Hand (DASH) - The Shoulder Pain and Disability Index (SPADI) - GONIOMETRY - DINAMOMETRY - PAIN THRESHOLD ON PRESSURE Secondary Outcomes ### Location - Facility: Clinica Cemtro, Madrid, N/A, 28049, Spain @@
## The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis - NCT ID: NCT06331858 - Study ID: KutahyaHSU-DRGOKPINARDROMER-43 - Status: RECRUITING - Start Date: 2023-09-20 - Completion Date: 2024-03-29 - Lead Sponsor: Kutahya Health Sciences University ### Study Description The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA). ### Conditions - Knee Osteoarthritis - Pain - Physical Disability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - hip device-assisted concentric abductor strengthening (HDACAS) - knee device-assisted concentric flexor-extensor strengthening (KDACFES) ### Outcomes Primary Outcomes - Western Ontario and McMaster Universities (WOMAC) - The Lequesne Algofunctional index - TIME UP AND GO TEST - 30 SECOND CHAIR TEST - 40 METER SELF PACED WALK TEST - SIX MINUTES WALK TEST - STAIR CLIMB TEST Secondary Outcomes - Visual Analog Scale (VAS) - Mini Osteoarthritis Knee and Hip Quality of Life Scale ### Location - Facility: Kutahya Health Sciences University, Kutahya, N/A, 43100, Turkey @@
## Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma - NCT ID: NCT06331845 - Study ID: NPC012 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: Fujian Cancer Hospital ### Study Description This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC). ### Conditions - Metastatic Nasopharyngeal Carcinoma - Intermittent Systematic Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Gemcitabine - Cisplatin - Paclitaxel protein-bound - Capecitabine - Tislelizumab ### Outcomes Primary Outcomes - progression-free survival Secondary Outcomes - progression-free survival 2 - overall survival ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL - NCT ID: NCT06331832 - Study ID: 2323-EAP - Status: NO_LONGER_AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: IGM Biosciences, Inc. ### Study Description Expanded Access of Imvotamab (IGM-2323) in Patients with Relapsed/Refractory Non-Hodgkin Lymphomas from IGM-2323-001 clinical trial. ### Conditions - Relapsed/Refractory Non-Hodgkin Lymphomas ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - IGM2323 ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: Sir Charles Gairdner Hospital, Nedlands, Western Australia, N/A, Australia @@
## Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms. - NCT ID: NCT06331819 - Study ID: 7-3-2024 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-03-01 - Lead Sponsor: Jordan Collaborating Cardiology Group ### Study Description The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital. The main aims are:* To prospectively obtain demographic and clinical information of patients referred for a sleep study.* To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition.* To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders.* To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking. ### Conditions - Obstructive Sleep Apnea - Vasovagal Syncope - Smoking - Acanthosis Nigricans ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - In-lab polysomnography - Continuous positive airway pressure ### Outcomes Primary Outcomes - Clinical association between obstructive sleep apnea and presence of facial pigmentation - Clinical association between obstructive sleep apnea and severity of facial pigmentation - Relation between obstructive sleep apnea and vasovagal symptoms - Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms Secondary Outcomes - Relation between obstructive sleep apnea and the effect of treatment on facial discolouration - Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms - Relation between obstructive sleep apnea and the effect of treatment on smoking habits ### Location - Facility: The University of Jordan, Amman, N/A, 11942, Jordan @@
## Myocardial Fibrosis Identification in Patients With Anthracycline-induced Cardiotoxicity - NCT ID: NCT06331806 - Study ID: IEO 398 - Status: RECRUITING - Start Date: 2018-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is an interventional study for patients who had developed Anthracycline-Induced Cardiotoxicity (AIC) during or after anthracycline-containing therapy, referred to the Cardioncology Unit for heart failure treatment ### Conditions - Cardiomyopathy Due to Drug ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Evaluation of myocardial fibrosis ### Outcomes Primary Outcomes - Evaluation of blood levels of Suppression Of Tumorigenicity 2 (ST2) - Evaluation of blood levels of Galectin-3 (Gal-3) - Evaluation of Enhanced Liver Fibrosis score (ELF) - Evaluation of CMR imaging marker of fibrosis Secondary Outcomes - Evaluation of response to heart failure treatment - Evaluation of levels of Troponin I (TnI) and B-type Natriuretic Peptide (BNP) - Evaluation of levels of cytochrome C ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Pulsed Electromagnetic Fields for Analgesia Post Mastectomy - NCT ID: NCT06331793 - Study ID: IEO 1849 - Status: RECRUITING - Start Date: 2023-05-09 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Study aim is to test AlgoCare, a device that uses the technology PEMF (Pulsed ElectroMagnetic Fields) for the treatment of postoperative pain in oncological breast surgery, in order to demonstrate that the use of Algocare in the postoperative period allows for a reduction in pain intensity in terms of Numerical Rating Scale (NRS) score and use of analgesic drugs. ### Conditions - Female Breast Cancer - Post Operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active AlgoCare - Non-active AlgoCare ### Outcomes Primary Outcomes - Pain intensity Secondary Outcomes - Need for analgesic drugs - Patient reported pain characteristics - Number of participants with other symptoms - Need for other drugs - Wound healing timing ### Location - Facility: European Institute of Oncology, Milan, N/A, 20141, Italy @@
## Refractive Status and Accommodation Response Under Different Experimental Conditions. - NCT ID: NCT06331780 - Study ID: WS10370 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2024-12-31 - Lead Sponsor: Essilor International ### Study Description Eye Care Professionals (ECPs) massively use auto-refractors during the patient journey to measure the objective refractive error: starting point of the subjective eye refraction. These devices provide objective information about the refractive and accommodative state of the eye, useful for the ECP to perform a complete eyesight test. Auto-refractor data for the distance vision are repeatable and accurate but near vision information are not enough reliable to build an accurate near vision routine exam. Previous internal studies, with auto refractors currently on the market, have shown that, during accommodation measurements, a large proportion of participants had a lower accommodative response than expected. ### Conditions - Accommodation Disorder - Accommodative Fatigue - Accommodative Inertia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Visual acuity - Objective refraction - Objective monocular accommodation amplitude measurement - Subjective monocular accommodation amplitude measurement with the "Push-Up" method - Subjective monocular accommodation facility measurement with the "Rock" method: - CISS Questionnaire - Difficulty assessment questionnaire - Subjective evaluation questionnaire ### Outcomes Primary Outcomes - Accommodative response measured with closed-field aberrometer with different target displacement methods - Accommodative response measured with closed-field aberrometer with different displayed targets - Objective refraction measured with closed-field aberrometer and two camera exposure times Secondary Outcomes ### Location - Facility: Essilor International - Ci&T 2, Créteil, N/A, 94000, France @@
## Development of a Multilevel HIV Prevention Intervention for the Emergency Department - NCT ID: NCT06331767 - Study ID: 2024P000654 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2029-04 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits. ### Conditions - HIV - Drug Use - Mental Health - Psychological Distress - Social Marginalization - Problems With Access to Health Care ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - mSYNC ### Outcomes Primary Outcomes - Acceptability - Acceptability - Acceptability - Appropriateness - Appropriateness - Appropriateness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Technology-Enabled Remote Hypertension Management To Advance Health Equity - NCT ID: NCT06331754 - Study ID: ATMANHEALTH001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-03-17 - Lead Sponsor: Atman Health, Inc ### Study Description The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization. ### Conditions - Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Technology-enabled blood pressure management ### Outcomes Primary Outcomes - Difference in SBP change Secondary Outcomes - HEDIS proportion - Difference in DBP change ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Collagen for Treatment of Musculoskeletal Injuries - NCT ID: NCT06331741 - Study ID: 0403 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: I.M. Sechenov First Moscow State Medical University ### Study Description The purpose of the study:Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales ### Conditions - Anterior Cruciate Ligament Injuries - Hallux Rigidus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane - Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group) - Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity ### Outcomes Primary Outcomes - The International Knee Documentation Committee score - The Knee injury and Osteoarthritis Outcome Score - Modified Lysholm scale - Anterior Cruciate Ligament OsteoArthritis Score - American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score - 36-Item Short Form Survey Secondary Outcomes ### Location - Facility: university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery, Moscow, N/A, 119991, Russian Federation @@
## Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001 - NCT ID: NCT06331728 - Study ID: IGNX-T1 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2025-10 - Lead Sponsor: IgGenix Australia Pty Ltd ### Study Description The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents. ### Conditions - Peanut Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IGNX001 - Placebo ### Outcomes Primary Outcomes - Incidence and Severity of Treatment Emergent Adverse Events - Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions - Number of Participants with Clinically significant Changes from Baseline - Hematology - Number of Participants with Clinically Significant Changes from Baseline - Chemistry - Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves - Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations Secondary Outcomes - Concentration of IGNX001 in the Plasma - Measurement of Area under the Plasma/Serum Concentration Curve (AUC) - Peak Serum Concentration (Cmax) - Time to Peak Serum Concentration (Tmax) - Elimination Half-life (t1/2) - Changes Over Time to Anti-drug Antibodies ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg - NCT ID: NCT06331715 - Study ID: ML1005 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-06 - Completion Date: 2024-08-31 - Lead Sponsor: Megalabs ### Study Description An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition. ### Conditions - Bioequivalence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Palbociclib 125mg ### Outcomes Primary Outcomes - AUC 0-t - Cmax Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR) - NCT ID: NCT06331702 - Study ID: CDBJEIV2023001 - Status: RECRUITING - Start Date: 2024-03-02 - Completion Date: 2024-12-31 - Lead Sponsor: Liaoning Chengda Biotechnology CO., LTD ### Study Description This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately. ### Conditions - Japanese Encephalitis - Measles - Mumps - Rubella ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Vero cell-drived inactive Japanese encephalitis vaccine - Measles-Mumps-Rubella Vaccine ### Outcomes Primary Outcomes - Antibody Titer for Post Vaccination - Seroconversion Rate for Post Vaccination Secondary Outcomes - Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination - Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination - Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination ### Location - Facility: Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, 210009, China @@
## EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE - NCT ID: NCT06331689 - Study ID: HP-epidemıology - Status: COMPLETED - Start Date: 2021-02-01 - Completion Date: 2021-07-01 - Lead Sponsor: Kutahya Health Sciences University ### Study Description Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation. ### Conditions - Hip Fracture - Mortality Rate ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - mortalite ratio Secondary Outcomes ### Location - Facility: Kütahya Health Sciences University, Kütahya, N/A, 43100, Turkey @@
## Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care - NCT ID: NCT06331676 - Study ID: 69HCL23_1120 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-10 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments. ### Conditions - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Tissue collection - Data collection ### Outcomes Primary Outcomes - Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering. Secondary Outcomes - Change in protein expression - Change in gene expression - Change in inflammation - Change in histological tissue structure - Change in histological tissue structure - Change in tissue elasticity - Change in steroid hormone physiology - Steroid hormones in peritoneal fluid ### Location - Facility: Hôpital Femme Mère Enfant / GHE, Bron, N/A, 69500, France @@
## SPI and Remifentanil in Skull Pin Fixation - NCT ID: NCT06331663 - Study ID: KMUHIRB-F(II)-20240055 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06-20 - Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital ### Study Description Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed. ### Conditions - Pain, Procedural ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Remifentanil ### Outcomes Primary Outcomes - 50% effect concentration of remifentanil - 90% effect concentration of remifentanil Secondary Outcomes ### Location - Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, N/A, N/A, Taiwan @@
## A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer - NCT ID: NCT06331650 - Study ID: CROC202314 - Status: RECRUITING - Start Date: 2023-08-09 - Completion Date: 2025-10 - Lead Sponsor: Guangzhou Institute of Respiratory Disease ### Study Description To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC). ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - cadonilimab ### Outcomes Primary Outcomes - Safety assessments and ORR Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangdong, Guangzhou, 510000, China @@
## Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis - NCT ID: NCT06331637 - Study ID: 3782 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-31 - Completion Date: 2026-12-31 - Lead Sponsor: Istituto Clinico Humanitas ### Study Description This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA) ### Conditions - Ulcerative Colitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Transanal Transection and Single-Stapled anastomosis (TTSS) - Double-stapled anastomosis ### Outcomes Primary Outcomes - Pouch Function Score (PFS) Secondary Outcomes - Pouch Function Score (PFS) - Pouch Function Score (PFS) - Postoperative complications - Anastomotic leak - Patients fit for stoma closure - Healthcare costs - Rectal cuff lenght - Pouch complications ### Location - Facility: IRCCS Humanitas Research Hospital, Rozzano, MI, 20089, Italy @@
## Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF - NCT ID: NCT06331624 - Study ID: GRI-0621-IPF-02 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2025-01 - Lead Sponsor: GRI Bio Operations, Inc. ### Study Description This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects complete 6 weeks of treatment (approximately 8 placebo subjects). ### Conditions - Idiopathic Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tazarotene (GRI-0621) - Placebo ### Outcomes Primary Outcomes - Safety and Tolerability of oral GRI-0621 Secondary Outcomes - Change from baseline biomarkers - Plasma concentrations of GRI-0621 - Pharmacodynamics of GRI-0621 in blood (Study Population) - Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study) ### Location - Facility: Newport Native MD, Inc., Newport Beach, California, 92663, United States @@
## MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA - NCT ID: NCT06331611 - Study ID: Motor - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Istituto Giannina Gaslini ### Study Description To date there is still little scientific evidence regarding neuromuscular block monitoring in pediatric anesthesia and indications for safe reversal. Although the use of rocuronium and sugammadex is becoming wide, qualitative monitoring or clinical practice are applied instead of quantitative monitoring (acceleromyography-electromyography EMG). The use of neuromuscular monitoring leads to better control of intraoperative paralysis, proper timing of extubation, and reduced risk of residual postoperative paralysis-paralysis (PORC) and related complications.The main objective of the study is to analyse the incidence of sugammadex use and the total dose/kg, with and without the aid of quantitative neuromuscular monitoring.Secondary objectives are:* the time required to extubate different patients,* the incidence of respiratory complications at extubation,* the need to administer additional doses of sugammadex. A prospective RCT. Patients will be divided into two study groups; in the first group, quantitative neuromuscular monitoring based on electromyography (EMG) will be used, while in the second group, the same monitoring will be applied but covered (blinded to the anesthetist) and the pharmacological strategy is based exclusively on the clinical practice All children aged between 2 months and 6 years, scheduled to undergo elective non-cardiac surgical procedures, lasting approximately from one to two hours(anesthesia time), with general anesthesia and tracheal intubation receiving a non-depolarizing blockade agent.* Children between 2 months and 6 years* Children who will undergo elective non cardiac surgery (maximum two hours of anesthesia time with tracheal intubation receiving a non depolarizing blockade agent),* Acquisition of informed consent by a legally recognized representative capable of understanding the document and providing consent on behalf of the participant. * Children under 2 months of age or over 12 years of age, * Children with an ASA classification \> 3, * Presence of neuromuscular disease, channelopathy, or any clinical condition that contraindicates the administration of neuromuscular muscle relaxants, * Confirmed or suspected allergy to sugammadex or rocuroniumt, * Presence of amputation or limb malformations that make placement of neuromuscular monitoring impossible, * Any specific contraindication to any aspect of the protocol. 12 months The randomization process will performed using numbers randomized by a computer-generated random number sequence. The randomization list will be prepared by independent statistician . The subjects will be assigned to the treatment arm in a sequence as per the randomization code provided in a closed envelope in a 1:1 ratio. The investigator will administered the treatment as per the randomization codes.One hundred children undergo in the clinically guided group and 100 children in the neuromuscular monitoring groups with the aim to include 200 children in total.Demographics and baseline characteristics with mean, median, standard deviation, and range (minimum, maximum) will generated for each arm. Subject disposition, including the number of subjects withdrawn or discontinued from the study, for each arm will summarized. The study will follow the CONSORT guidelines for statistical analysis and reporting. Chi squared test or Fisher's exact test and Student's t-test or Mann Whitney test will applied to categorical and continuous data, respectively, with a significance level of 5% by two-sided test. Statistical analysis was performed using SPSS software (ver. 21.0) (IBM, Armonk, NY, USA). ### Conditions - Anesthesia,General - Neuromuscular Blockade - Tracheal Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - TOF monitoring ### Outcomes Primary Outcomes - Sugammadex administration Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors With Resectable Disease With Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H) - NCT ID: NCT06331598 - Study ID: ML43332 - Status: RECRUITING - Start Date: 2024-05-30 - Completion Date: 2029-09-20 - Lead Sponsor: Hoffmann-La Roche ### Study Description This study is being conducted to evaluate efficacy parameters (disease free survival \[DFS\] and overall survival \[OS\]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence. ### Conditions - Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Atezolizumab - Tiragolumab ### Outcomes Primary Outcomes - Disease Free Survival (DFS) Rate at 24 Months Secondary Outcomes - DFS Rate at 36, 48 and 60 Months - OS (Overall Survival) - Percentage of Participants With Adverse Events ### Location - Facility: Hospital Universitari Vall dHebron; Oncology, Barcelona, N/A, 08035, Spain @@
## Effect of Low-dose Radiotherapy on Tumor Immune Microenvironment in Oligometastases of NSCLC After Immunotherapy - NCT ID: NCT06331585 - Study ID: KY-2024004 - Status: WITHDRAWN - Start Date: 2024-03-18 - Completion Date: 2026-03-18 - Lead Sponsor: Hetian District People's Hospital ### Study Description The purpose of this phase Ⅱ trial was to investigate the effect of low-dose radiotherapy (LDRT) on the tumor immune microenvironment (TME) in oligometastasis, oligoprogression, and oligopersistence of non-small cell lung cancer (NSCLC) after immunotherapy. At least 20 participants will be enrolled in this study. All will take part at Hetian District People's Hospital. ### Conditions - Low-dose Radiotherapy - Tumor Microenvironment - Non-Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - low dose radiotherapy ### Outcomes Primary Outcomes - Analysis of the tumor immune microenvironment Secondary Outcomes - Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measurement of Safety and Tolerability of Low Dose Radiotherapy - Progression Free Survival (PFS) - Overall Survival (OS) ### Location - Facility: Hetian District People's Hospital, Hetian, Xinjiang Uygur Autonomous Region, 848000, China @@
## Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression - NCT ID: NCT06331572 - Study ID: 1stChongqingMU-TRD - Status: COMPLETED - Start Date: 2021-08-01 - Completion Date: 2023-12-20 - Lead Sponsor: First Affiliated Hospital of Chongqing Medical University ### Study Description This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD. ### Conditions - Psychiatric Disorder - Major Depressive Disorder - Metabolic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 17-HAMD ### Outcomes Primary Outcomes - 17 items Hamilton Depression Scale Secondary Outcomes - Hamilton Anxiety Scale ### Location - Facility: The First Affiliated Hospital of Chongqing Medical University, Chongqing, Province, 400000, China @@

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