Datasets:

hackint0sh
/

md_dataset

Dataset card Viewer Files Files and versions Community

Split (1)

train · 10k rows

record stringlengths 560 23.9k
## A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour - NCT ID: NCT06380972 - Study ID: HDM6009A-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-10 - Lead Sponsor: AQTIS Medical B.V. ### Study Description A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour ### Conditions - Forehead Contouring ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Polycaprolactone (PCL) Based Facial Injectable ### Outcomes Primary Outcomes - The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS) Secondary Outcomes - The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS) - The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS) - The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS) ### Location - Facility: Guangdong Second Provincial General Hospital, Guangzhou, Guangdong, 510317, China @@
## Art-based Activities in Stroke Patients - NCT ID: NCT06380959 - Study ID: 223K879 - Status: COMPLETED - Start Date: 2023-10-02 - Completion Date: 2024-02-29 - Lead Sponsor: Ege University ### Study Description Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Art Based Activity ### Outcomes Primary Outcomes - Herth Hope Index - Generalized Self-Efficacy Scale - Individual Introduction Form Secondary Outcomes - Art Object Concretization Form ### Location - Facility: Ege University, Bornova, İzmir, 35100, Turkey @@
## Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy - NCT ID: NCT06380946 - Study ID: 978/91 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-06-01 - Completion Date: 2024-11-01 - Lead Sponsor: Al-Azhar University ### Study Description The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy. ### Conditions - Effect of Platelet Rich FibrinDuring Clear Aligner Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - iPRF ### Outcomes Primary Outcomes - Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter Secondary Outcomes ### Location - Facility: AlAzhar university, Cairo, N/A, N/A, Egypt @@
## The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort - NCT ID: NCT06380933 - Study ID: B11103008 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-02-28 - Lead Sponsor: Dalin Tzu Chi General Hospital ### Study Description Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath. ### Conditions - Sleep Quality - Comfort ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - experimental group ### Outcomes Primary Outcomes - Richards-Campbell Sleep Questionnaire Secondary Outcomes - Numerical Rating of Comfort ### Location - Facility: Hsu Mei-Lian, Chiayi City, N/A, N/A, Taiwan @@
## Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example - NCT ID: NCT06380920 - Study ID: Digital Health App - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-12-31 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention. ### Conditions - Weight Loss - Body Fat Rate Loss - Body Composition Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - "AI Mindful Eating" App - Outpatient regular follow-up ### Outcomes Primary Outcomes - weight change Secondary Outcomes - Parameters of Metabolic syndrome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis - NCT ID: NCT06380907 - Study ID: ZL-1102-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-03 - Lead Sponsor: Zai Lab (Hong Kong), Ltd. ### Study Description A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis ### Conditions - Plaque Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ZL-1102 1% w/w gel BID for 16 weeks - ZL-1102 3% w/w gel BID for 16 weeks - ZL-1102 3% w/w gel QD for 16 weeks - Placebo ZL-1102 0% w/w gel BID for 16 weeks - Placebo ZL-1102 0% w/w gel QD for 16 weeks ### Outcomes Primary Outcomes - Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16. Secondary Outcomes - The proportion of patients achieving IGA treatment success. - The proportion of patients achieving IGA score of 0 or 1. - The percent change from baseline in mPASI score. - The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20. - The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20. - Time to achieve mPASI 50/75/90. - Time to achieve IGA score of 0 or 1. - Time to achieve 1- or 2-point improvement in IGA. - Incidence of Treatment Related Adverse Events through Week 20. - Mean local tolerability scores (LTS) - Serum concentration of ZL-1102. - Anti-drug antibody (ADA) of ZL-1102. ### Location - Facility: Zai Lab Site 5013, Phillip, Australian Capital Territory, 2606, Australia @@
## Virtual Reality Cognitive Training for Mild Cognitive Impairment - NCT ID: NCT06380894 - Study ID: 2020/2239 - Status: COMPLETED - Start Date: 2021-01-27 - Completion Date: 2023-01-31 - Lead Sponsor: Changi General Hospital ### Study Description This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Virtual Reality Cognitive Training - Active Control ### Outcomes Primary Outcomes - Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11 - Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11 - Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11 - Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11 - Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11 Secondary Outcomes ### Location - Facility: Changi General Hospital, Singapore, N/A, N/A, Singapore @@
## PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases - NCT ID: NCT06380881 - Study ID: SHR-2017-102 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-07 - Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. ### Study Description To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain. ### Conditions - Patients With Bone Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SHR-2017 ### Outcomes Primary Outcomes - The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax - The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax - The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t - The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞ - The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2 - The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F - The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr - The pharmacodynamic parameter of SHR-2017 after administration include β-CTX - The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time Secondary Outcomes - Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing - Incidence of skeletal-related event - Average daily total opioids consumption ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, 100142, China @@
## IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus - NCT ID: NCT06380868 - Study ID: Nanjing-2 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-06-10 - Completion Date: 2027-07-20 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial. ### Conditions - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intravascular imaging-guided PCI - Angiography-guided PCI group ### Outcomes Primary Outcomes - Rate of target vessel failure (TVF) Secondary Outcomes - Rate of target vessel failure without procedure-related MI - Rate of cardiac death - Rate of all-cause death - Rate of procedure-related myocardial infarction (PMI) - Rate of spontaneous myocardial infarction (SMI) - Rate of clinically-driven revascularization - Rate of stent thrombosis ### Location - Facility: Nanjing First Hospital, Nanjing, Jiangsu, 210006, China @@
## Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME) - NCT ID: NCT06380855 - Study ID: GIHSYSU-34 - Status: RECRUITING - Start Date: 2022-08-24 - Completion Date: 2025-08-24 - Lead Sponsor: Sun Yat-sen University ### Study Description The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury. ### Conditions - Rectal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Flexible colonoscope assisted hybrid transanal total mesorectal resection ### Outcomes Primary Outcomes - Success rate of operation Secondary Outcomes ### Location - Facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510000, China @@
## Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy - NCT ID: NCT06380842 - Study ID: 2023HX1970 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-12-30 - Lead Sponsor: Chunling Jiang ### Study Description The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy. ### Conditions - Necrotizing Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Necrotizing Pancreatitis patients' organ dysfunction progression ### Outcomes Primary Outcomes - Measure organ dysfunction change after open necrosectomy with respect to time Secondary Outcomes - incidence of a composite of major complications - Incidence of ICU mortality - Incidence of hospital mortality - Incidence of 28-day mortality - Incidence of one year mortality - ICU length of hospital stay - Length of hospital stay - The pancreatic symptoms score - The levels of inflammatory factor CRP - The levels of inflammatory cytokines IL-6 - The levels of inflammatory procalcitonin ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form - NCT ID: NCT06380829 - Study ID: Adnan Menderes - Status: COMPLETED - Start Date: 2023-06-05 - Completion Date: 2024-02-10 - Lead Sponsor: Aydin Adnan Menderes University ### Study Description This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale? ### Conditions - Cerebral Palsy - Self Care ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years Secondary Outcomes ### Location - Facility: Bircan Kahraman Berberoğlu, Aydın, N/A, 0900, Turkey @@
## A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer - NCT ID: NCT06380816 - Study ID: CRUKD/24/001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-11 - Lead Sponsor: Cancer Research UK ### Study Description This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.The four main aims of the clinical trial are to find out:1. The best dose of UCB4594 that can be given safely to participants in the trial.2. What the side effects of UCB4594 are and how they can be managed.3. What happens to UCB4594 inside the body and how it affects cancer cells.4. Whether UCB4594 can cause cancer to shrink. ### Conditions - Advanced Solid Tumours - Squamous Cell Carcinoma of Head and Neck - Carcinoma, Non-Small-Cell Lung - Colorectal Neoplasms - Triple Negative Breast Neoplasms - Carcinoma, Renal Cell (Clear Cell Only) - Esophageal Neoplasms - Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors) - Uterine Cervical Neoplasms - Ovarian Neoplasms - Pancreatic Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - UCB4594 ### Outcomes Primary Outcomes - Recommended Phase 2 dose (RP2D) of UCB4594 - Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles). Secondary Outcomes - Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules). - Maximum concentration of UCB4594 (monotherapy modules; Modules A and B). - Minimum concentration of UCB4594 (monotherapy modules; Modules A and B). - Area under the curve of UCB4594 (monotherapy modules; Modules A and B). - Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B). - Clearance of UCB4594 (monotherapy modules; Modules A and B). - Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period). ### Location - Facility: The Christie NHS Foundation Trust, Manchester, N/A, N/A, United Kingdom @@
## Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence - NCT ID: NCT06380803 - Study ID: 4-2020-1385 - Status: RECRUITING - Start Date: 2021-04-29 - Completion Date: 2025-01-26 - Lead Sponsor: Severance Hospital ### Study Description The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery.The main question\[s\]it aims to evaluate :* Satisfaction questionnaire of a educational program* NASA-TLX of a educational program* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiencyParticipants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX.The tutor evaluates GEARS for 15 minutes at the beginning and end of training.After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide. ### Conditions - Breast Neoplasms - Surgery - Educational Problems - Surgical Procedure, Unspecified ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - A educational program ### Outcomes Primary Outcomes - Satisfaction questionnaire of a educational program - NASA-Task Load index of a educational program - Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency Secondary Outcomes - The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide - The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide - The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide ### Location - Facility: Yonsei University College of Medicine, Seoul, N/A, 120-752, Korea, Republic of @@
## Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding - NCT ID: NCT06380790 - Study ID: 8423 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-10 - Lead Sponsor: Cairo University ### Study Description To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment ### Conditions - Orthodontics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laser-aided csf - placebo laser-aided csf ### Outcomes Primary Outcomes - Rate of tooth movement Secondary Outcomes - Pain level - Periodontal health ### Location - Facility: Faculty of dentistry cairo university, Cairo, N/A, N/A, Egypt @@
## Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia - NCT ID: NCT06380777 - Study ID: DDT system for sarcopenia - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2028-12-31 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.Research aims:Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.Participants will:Engage in screening and assessment based on inclusion and exclusion criteria.Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life. ### Conditions - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Appendicular skeletal muscle mass index Secondary Outcomes - Hand grip strength - Gait speed ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache - NCT ID: NCT06380764 - Study ID: RC.11.3.2024 - Status: COMPLETED - Start Date: 2023-03-02 - Completion Date: 2023-12-01 - Lead Sponsor: Benha University ### Study Description Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region. ### Conditions - Postdural Puncture Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Greater Occipital Nerve Block - Bilateral suboccipital intramuscular injection - Epidural Blood Patch - Normal Saline 10 mL Injection - Lidocaine 2% Injectable Solution ### Outcomes Primary Outcomes - The extent of reduction of consumed analgesia Secondary Outcomes ### Location - Facility: Benha university, Banhā, El Qalyoubia, 13511, Egypt @@
## Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer - NCT ID: NCT06380751 - Study ID: D9722C00001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2030-07-18 - Lead Sponsor: AstraZeneca ### Study Description The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. ### Conditions - Advanced Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Saruparib (AZD5305) - Camizestrant - Abemaciclib - Ribociclib - Palbociclib - Fulvestrant - Letrozole - Anastrozole - Exemestane ### Outcomes Primary Outcomes - Progression-Free Survival Secondary Outcomes - Overall Survival - Progression Free Survival 2 - Time to chemotherapy - Objective Response Rate - Duration of Response - Participant-reported tolerability - Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - Plasma concentrations of saruparib (AZD5305) - Plasma concentrations of camizestrant - Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study. ### Location - Facility: Research Site, Toronto, Ontario, M5G 2M9, Canada @@
## Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed) - NCT ID: NCT06380738 - Study ID: D0817R00074 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2027-01-31 - Lead Sponsor: AstraZeneca ### Study Description PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in. ### Conditions - Metastatic Castration-resistant Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Time to treatment discontinuation Secondary Outcomes - Time to first subsequent therapy ### Location - Facility: Research Site, Aschaffenburg, N/A, N/A, Germany @@
## The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease - NCT ID: NCT06380725 - Study ID: jshim8zay6vd - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Anhui Provincial Hospital ### Study Description Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment. ### Conditions - Alzheimer's Disease - Mild Cognitive Impairment - Dementia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial alternating current stimulation(real stimulation) - Transcranial alternating current stimulation(sham stimulation) ### Outcomes Primary Outcomes - Cognitive appraisal - Global Cognitive appraisal - Psychobehavioral assessment Secondary Outcomes - Near-infrared spectroscopy - Event related potential measurement - Peripheral blood biomarkers - Magnetic Resonance Imaging - Incidence of side effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## HYPERTESSA "HyperTessa User Experience Study (HTUX)" - NCT ID: NCT06380712 - Study ID: 6509 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2024-10-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP. ### Conditions - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - User Experience / User Acceptance Indicators for patients Secondary Outcomes - User Experience / User Acceptance Indicators for Healthcare Professionals ### Location - Facility: Fondazione Policlinico Universitario A. Gemelli., IRCCS, Rome, N/A, N/A, Italy @@
## Study to Assess PK, Safety and Tolerability in Healthy Subjects - NCT ID: NCT06380699 - Study ID: HJG-CZQH-QHRD106-I - Status: COMPLETED - Start Date: 2023-03-16 - Completion Date: 2023-12-25 - Lead Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd. ### Study Description The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses. ### Conditions - Acute Ischemic Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - QHRD106 Injection - Yurekline - placebo ### Outcomes Primary Outcomes - Safety as assessed by incidence, severity, and causality of adverse events - Plasma measurements of QHRD106 - Concentration of bradykinin in plasma Secondary Outcomes ### Location - Facility: Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210008, China @@
## Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome - NCT ID: NCT06380686 - Study ID: AIO-KHT-0322/ass - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2030-05 - Lead Sponsor: AIO-Studien-gGmbH ### Study Description Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients. ### Conditions - Squamous Cell Carcinoma of the Oral Cavity - Squamous Cell Carcinoma of the Oropharynx - Squamous Cell Carcinoma of the Hypopharynx - Squamous Cell Carcinoma of the Larynx ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - data collection ### Outcomes Primary Outcomes - Sociodemographic factors - Treatments - Response rates - Treatment decision - Progression-free survival - Time-to-treatment-failure - Overall survival Secondary Outcomes ### Location - Facility: Universitätsklinikum Essen, Essen, N/A, 45147, Germany @@
## Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy - NCT ID: NCT06380673 - Study ID: s68299 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2029-12-30 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only). ### Conditions - Food Allergy - Cow Milk Allergy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Implementation of cow's milk in decreasingly heated forms - Implementation of heated cow's milk - No intervention ### Outcomes Primary Outcomes - Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction Secondary Outcomes - Time to complete tolerance in all three arms - Quality of life in all three arms - Clinical reactions - Side effects - IL-10-producing cow's milk specific regulatory T and B cells - BATs to mimic the outcome of cow's milk provocation tests ### Location - Facility: Imelda Hospital Bonheiden, Bonheiden, N/A, N/A, Belgium @@
## Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors - NCT ID: NCT06380660 - Study ID: ACE-106-001 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2029-03-21 - Lead Sponsor: Acerand Therapeutics (Shanghai) Limited ### Study Description The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors. ### Conditions - Solid Tumor, Adult - BRCA1 Mutation - BRCA2 Mutation - Ovarian Cancer - Breast Cancer - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ACE-86225106 tablet ### Outcomes Primary Outcomes - Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) - The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol - Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) Secondary Outcomes - Objective Response Rate (ORR) - Duration of Response (DoR) and Time to Response (TTR) - Progression Free Survival (PFS) - Overall Survival (OS) - Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change - Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators) ### Location - Facility: Fujian Cancer Hospital, Fuzhou, Fujian, N/A, China @@
## Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns - NCT ID: NCT06380647 - Study ID: 0004 - Status: COMPLETED - Start Date: 2019-10-01 - Completion Date: 2020-09-30 - Lead Sponsor: King Edward Medical University ### Study Description Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients ### Conditions - Herpes Virus Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intravenous Acyclovir ### Outcomes Primary Outcomes - Number of participants with positive Tzanck smear Secondary Outcomes ### Location - Facility: department of pediatric surgery King Edward Medical University, Lahore, Punjab, 54000, Pakistan @@
## The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy - NCT ID: NCT06380634 - Study ID: NYalcinbas - Status: COMPLETED - Start Date: 2023-01-23 - Completion Date: 2024-02-20 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy. ### Conditions - Motivational Interview - Cosmetic Product Causing Toxic Effect ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Experimental group- Motivational Interview ### Outcomes Primary Outcomes - Evaluation Form for Use of Domestic Chemicals and Personal Care Products - Self Efficacy Competence Scale - Endocrine Disruptors Attitude Scale Secondary Outcomes ### Location - Facility: Istanbul University Cerrahpasa, Istanbul, N/A, N/A, Turkey @@
## Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia - NCT ID: NCT06380621 - Study ID: IRC/1386/018 - Status: COMPLETED - Start Date: 2018-03-15 - Completion Date: 2019-03-15 - Lead Sponsor: B.P. Koirala Institute of Health Sciences ### Study Description The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.The main questions it aims to answer are:* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group ### Conditions - Inguinal Hernia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Totally Extra Peritoneal repair (TEP) repair ### Outcomes Primary Outcomes - To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair. - To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair Secondary Outcomes ### Location - Facility: Bikash Kumar Sah, Dharān Bāzār, Koshi, 56700, Nepal @@
## Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia - NCT ID: NCT06380608 - Study ID: 0047-23-ASF - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-12-31 - Lead Sponsor: Zoya Haitov Ben Zikri ### Study Description Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia. ### Conditions - Wisdom Teeth Extraction or Jaw Implant ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Local anesthesia - General anesthesia ### Outcomes Primary Outcomes - Fear and anxiety - Wound heeling Secondary Outcomes ### Location - Facility: Shamir (Asaf Harofe) Medical center, Be'er Ya'aqov, N/A, 60930, Israel @@
## Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms - NCT ID: NCT06380595 - Study ID: 23 -1533 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-21 - Completion Date: 2026-03 - Lead Sponsor: CEVARII ### Study Description Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533. ### Conditions - Inflammatory Abdominal Aortic Aneurysm - Aneurysm, Infected - Aneurysm, Mycotic - Abdominal Aortic Aneurysm - Thoracoabdominal Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Complex endovascular aortic repair (cEVAR) ### Outcomes Primary Outcomes - Primary Graft Patency - Bowel Ischemia - Presence of aortic aneurysm endoleak after surgery - Aneurysm-related mortality (ARM) - Conversion to Open Surgical Repair (OSR) - Aortic rupture - Post-operative infection-related complication (IRC) - The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies. Secondary Outcomes - Assessment of Adverse Events (AEs) described in the protocol. - All Cause Mortality - Continued Aortic sac growth. ### Location - Facility: University of Colorado Healthcare, Aurora, Colorado, 80045, United States @@
## Indoor Air Quality, Temperature and Cognitive Performance - NCT ID: NCT06380582 - Study ID: NL85595.068.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-12-21 - Lead Sponsor: Maastricht University Medical Center ### Study Description Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different.Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years.Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively. ### Conditions - Indoor Air Quality, Temperature and Cognitive Performance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Temperature and Airflow combination ### Outcomes Primary Outcomes - Cognition - Cognition Secondary Outcomes - Heart Rate (bpm) - Metabolic Rate (ml/kg/min) - Blood Pressure (mmHg) - Blood samples - Saliva samples - Breathing rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting - NCT ID: NCT06380569 - Study ID: E-1139-21 Community Setting - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-01 - Lead Sponsor: Kessler Foundation ### Study Description We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - KF-STRIDE® ### Outcomes Primary Outcomes - Mock Job Interview - Employment Status - Time-to-reach Employment - Strength Knowledge and Strengths Use Scale (SKUS) - Youth Interview- Self Efficacy and Anxiety - Job Search Behavior Scale - Work Readiness Scale - Global Assessment of Character Strengths (GACS) Secondary Outcomes - Rosenberg Self-Esteem Scale (RSES) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates - NCT ID: NCT06380556 - Study ID: 25.05.2022/68 - Status: COMPLETED - Start Date: 2022-11-10 - Completion Date: 2023-07-13 - Lead Sponsor: Istanbul Medeniyet University ### Study Description This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants. ### Conditions - Procedural Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ShotBlocker - Mechanical vibration ### Outcomes Primary Outcomes - Procedural pain score- Neonatal Infant Pain Scale (NIPS) Secondary Outcomes - Crying time - Procedure time ### Location - Facility: Istanbul Medeniyet University, Istanbul, Kadıköy, 34720, Turkey @@
## ERCP Biliary Cannulation Success Using ESGE Algorithm - NCT ID: NCT06380543 - Study ID: BILINCE - Status: RECRUITING - Start Date: 2019-12-12 - Completion Date: 2024-12-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis. ### Conditions - Biliary Tract Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Success of ERCP biliary cannulation rate Secondary Outcomes - ERCP complication rates ### Location - Facility: IRCCS OSpedale San Raffaele, Milano, N/A, 20132, Italy @@
## Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities - NCT ID: NCT06380530 - Study ID: SIMULA - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles.At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures. ### Conditions - Musculoskeletal Deformity - Musculoskeletal Abnormalities - Musculoskeletal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Deformity correction ### Outcomes Primary Outcomes - Achieved skeletal corrections - Achieved skeletal corrections Secondary Outcomes - Operating room times - Fluoroscopy times - Blood loss - Intra- and peri-operative complications - Suitability of PSIs - Suitability of GSIs - Suitability of bone graft - Clinical-functional outcome - Clinical-functional outcome ### Location - Facility: IRCCS Istituto Ortopedico Rizzoli, Bologna, BO, 40136, Italy @@
## Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age - NCT ID: NCT06380517 - Study ID: ATS23 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Jaeb Center for Health Research ### Study Description In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks. ### Conditions - Amblyopia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Luminopia - Eye Patch ### Outcomes Primary Outcomes - Change in amblyopic eye logMAR distance VA between randomization and 26 weeks Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia - NCT ID: NCT06380504 - Study ID: RSWITCH-Ethiopia - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2027-06-30 - Lead Sponsor: International Food Policy Research Institute ### Study Description The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness. ### Conditions - Acute Malnutrition, Severe - Malnutrition, Child - Wasting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - R-SWITCH integrated intervention package ### Outcomes Primary Outcomes - Period prevalence of SAM OTP treatment coverage in children 6-59 months of age Secondary Outcomes - Point prevalence of SAM OTP treatment coverage in children 6-59 months of age - Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age - Screening coverage of SAM - Screening coverage of severe underweight - Platform specific screening coverage of SAM - Growth Monitoring Promotion (GMP) consultation attendance - AFD group meeting attendance - AFD home visit coverage - Prevalence of SAM - Prevalence of wasting - Prevalence of stunting - Prevalence of underweight and severe underweight - Mean height-for-age Z-score (HAZ) - Mean weight-for-height Z-score (WHZ) - Mean weight-for-age Z-score (WAZ) - Mean mid-upper arm circumference (MUAC) - Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting - Vaccination coverage - Introduction of (semi) solid and soft complementary foods - Minimum dietary diversity in infants and young children (6-23 mo) - Nr of food groups consumed by infants and young children (6-59 mo) - Minimum meal frequency in infants and young children - Minimum acceptable diet in infants and young children - Continuous breastfeeding 12-23 months - Egg and/or flesh food consumption - Sweet beverage consumption - Zero vegetable or fruit consumption consumption - Minimum milk feeding frequency for non-breastfed children - Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP) - SAM OTP adherence - Weight gain rate during SAM OTP - SAM OTP outcomes (drop-out, death, transfer, non-response rates) - SAM OTP duration ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA) - NCT ID: NCT06380491 - Study ID: REF.2338 - Status: RECRUITING - Start Date: 2023-06-22 - Completion Date: 2025-01-22 - Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ### Study Description The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.The main question it aims to answer is:Does melatonin maintain sleep during night and recover the dipping blood pressure pattern? ### Conditions - Obstructive Sleep Apnea of Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Melatonin 3 MG Oral Tablet ### Outcomes Primary Outcomes - Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure Secondary Outcomes ### Location - Facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ), Mexico City, N/A, N/A, Mexico @@
## Safety and Efficacy of the Bi-Aspheric Monofocal IOL - NCT ID: NCT06380478 - Study ID: CPRO-000012 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-12-25 - Lead Sponsor: ICARES Medicus, Inc. ### Study Description This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination. ### Conditions - Cataract ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - aspicio Monofocal IOL ### Outcomes Primary Outcomes - CDVA - Defocus curve Secondary Outcomes - UDVA - UIVA - CIVA - IOL glistening - PCO - Satisfaction questionnaire - AE ### Location - Facility: Chang Gung University Hospital, Taoyuan, Guishan District, 333, Taiwan @@
## The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease - NCT ID: NCT06380465 - Study ID: 23-11-1838 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-04-30 - Lead Sponsor: Indonesia University ### Study Description Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease.Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo.The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait. ### Conditions - Cerebral Small Vessel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The water extract of "Biang" variety purple sweet potato ### Outcomes Primary Outcomes - Breath Holding Index - Nitric Oxide - L-Arginine - Adiponectin - Cognitive - Gait Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Therapy for Scabies With Two Differently Concentrated Permethrin Creams - NCT ID: NCT06380452 - Study ID: SKABUP - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-12 - Lead Sponsor: Infectopharm Arzneimittel GmbH ### Study Description The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%. ### Conditions - Scabies ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 5% Permethrin Creme - 10% Permethrin Creme ### Outcomes Primary Outcomes - clinical efficacy (yes/no) Secondary Outcomes - effectiveness at Visit 1 - frequency of therapy success - itching - patients with evidence of mites - patients with use of antiscabiosa not compliant with the protocol - patients with new scabies efflorescences - patients with "additional confirmed" treatment failure - AEs, SAEs, ADRs, SUAWs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain - NCT ID: NCT06380439 - Study ID: 23-10-1763 - Status: RECRUITING - Start Date: 2024-04-23 - Completion Date: 2024-07 - Lead Sponsor: Indonesia University ### Study Description Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture ### Conditions - Pain, Postoperative - Hip Osteoarthritis - Hip Fractures - Hip Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - wrist ankle acupuncture ### Outcomes Primary Outcomes - Visual Analog Scale Secondary Outcomes - recovery rate ### Location - Facility: Cipto Mangunkusumo Hospital, Jakarta Pusat, Jakarta, 10430, Indonesia @@
## Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema) - NCT ID: NCT06380426 - Study ID: APHP230441 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-11-30 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways.More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS).The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications.Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches.In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications.GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity.The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity. ### Conditions - Monogenic Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Change in weight and Body Mass Index (BMI) Secondary Outcomes - Change in weight and Body Mass Index (BMI) - Reduction of body weight equal to or above 5% - Change in Hunger score - Change in eating behaviour measured by Food Craving questionnaire - Change in eating behaviour measured by the Binge Eating Scale (BES) - Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ) - Change in eating behaviour measured by the Dykens questionnaire - Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ) - Change in the International physical activity questionnaire (IPAQ - short form) - Change in Digestive disorders (GIQLI ) - Change in sleep disorder (MCTQ score) - Change in score of quality of life scores (patient and parents) - Change in anxiety and depression score - Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) ### Location - Facility: Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP, Paris, N/A, 75013, France @@
## Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults - NCT ID: NCT06380413 - Study ID: 78972024.7.0000.5313 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2025-07-31 - Lead Sponsor: Federal University of Pelotas ### Study Description Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tai Chi Chuan Plus Walking - Walking ### Outcomes Primary Outcomes - Maximal dynamic strength - Functional test - 30-s Chair-stand test Secondary Outcomes - Dynamic muscular endurance - Isometric handgrip strength - Isometric back-leg-chest strength - Functional tests - arm curl - Functional tests - 8-ft Up-and-Go - Functional tests - Chair Sit-and-Reach - Functional tests - Back Scratch - Funcional tests - 6-min Walk - Static balance - 30-second single-leg stance test - Quadriceps muscle thickness - Quadriceps muscle quality - Objective cognitive function - Trail Making Test (TMT) - Objective cognitive function - Controlled Oral Word Association Test (COWAT) - Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref) - Sleep quality - Pittsburgh Sleep Quality Index - Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS) ### Location - Facility: Escola Superior de Educação Física e FIsioterapia, Pelotas, Rio Grande Do Sul, 96055630, Brazil @@
## The Effect of Foot Bath on Birth Pain and Birth Comfort - NCT ID: NCT06380400 - Study ID: 0000-0001-5786-4385 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2024-07-30 - Lead Sponsor: Selcuk University ### Study Description Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women. ### Conditions - Parturition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Foot bath ### Outcomes Primary Outcomes - Visuell analog scale score of the pregnant woman Secondary Outcomes - Birth comfort scale score of the pregnant woman ### Location - Facility: Habibe Bay Ozcalik, Konya, N/A, 42250, Turkey @@
## Whole Body Metabolism in Children Before and After Treatment of CNS Tumor - NCT ID: NCT06380387 - Study ID: H-21046543 - Status: RECRUITING - Start Date: 2023-03-23 - Completion Date: 2026-12 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis. ### Conditions - CNS Tumor, Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Meal ### Outcomes Primary Outcomes - Protein breakdown - Protein synthesis - Phenylalanine concentration - Phe oxidation to TYR - Whole-body protein synthesis - Whole-body protein degradation - Netto protein balance - Glucose Rate of appearance - Total glucose Rate of appearance - Total glucose Rate of disappearance - Endogenous glucose - Oral phenylalanine Rate of appearance - Phenylalanine oxidation - Rate of Appearance of Palmitate in Plasma - Rate of Disappearance of Palmitate - Concentration of ketones Secondary Outcomes - Glucose - Quality of Skeletal Muscle - Protein synthesis rate - Pain score - Life quality score - Muscle biopsy - Incretins - Glucagon - Liver parameters ALT, AST, GGT - Bilirubin - International normalized ratio (INR) - LDH - Insulin - catecholamines - Blood pressure - Waist- and hip circumference - Lipids - Concentration of Plasma Amino Acids - Concentration of Plasma Glucose - Concentration of Plasma Palmitate - Concentration of Plasma Free Fatty Acids - Level of HbA1c ### Location - Facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen, Copenhagen Ø, 2100, Denmark @@
## Gamification in Disaster Nursing Education - NCT ID: NCT06380374 - Study ID: 2024\01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-07-22 - Lead Sponsor: Selcuk University ### Study Description This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group." ### Conditions - Gamification - Nursing Students - Multiple Intelligence Theory - Disaster Nursing ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Gamification in Disaster Nursing Education ### Outcomes Primary Outcomes - Level of knowledge related to disaster nursing services - Volunteer intention to become a disaster nurse - Perception of self-efficacy related to disaster nursing Secondary Outcomes ### Location - Facility: Selcuk University Faculty of Nursing, Konya, Selcuklu, 42000, Turkey @@
## InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology - NCT ID: NCT06380361 - Study ID: SEN-ONCO-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-04-01 - Lead Sponsor: Sensome ### Study Description The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - BioSpy System ### Outcomes Primary Outcomes - The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy. Secondary Outcomes - The ability of BioSpy Sysem to differentiate the lesion from healthy tissue - The ability of BioSpy Sysem to differentiate various lesion types ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations - NCT ID: NCT06380348 - Study ID: JMT101-012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2028-03-26 - Lead Sponsor: Shanghai JMT-Bio Inc. ### Study Description This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1). ### Conditions - Local Advanced or Metastatic NSCLC ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JMT101 Injection - Osimertinib tablet - Cisplatin injection - Pemetrexed injection ### Outcomes Primary Outcomes - Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 Secondary Outcomes - Overall Survival (OS) - Overall Response Rate (ORR) by IRC per RECIST 1.1 - Duration of Response (DoR) by IRC per RECIST 1.1 - PFS by investigator per RECIST 1.1 - ORR by investigator per RECIST 1.1 - DoR by investigator per RECIST 1.1 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study in Patients With Decompensated Liver Cirrhosis - NCT ID: NCT06380335 - Study ID: RTX001-01S - Status: RECRUITING - Start Date: 2023-10-10 - Completion Date: 2026-11-03 - Lead Sponsor: Resolution Therapeutics Limited ### Study Description OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient. ### Conditions - Liver Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Examine the characteristics of patients admitted to hospital with hepatic decompensation. - Examine the characteristics of patients admitted to hospital with hepatic decompensation. - Examine the characteristics of patients admitted to hospital with hepatic decompensation. - Examine the characteristics of patients admitted to hospital with hepatic decompensation. - Examine the characteristics of patients admitted to hospital with hepatic decompensation. - Examine the characteristics of patients admitted to hospital with hepatic decompensation. Secondary Outcomes - Follow the natural history of patients admitted to hospital with hepatic decompensation. - Follow the natural history of patients admitted to hospital with hepatic decompensation. - Follow the natural history of patients admitted to hospital with hepatic decompensation. - Follow the natural history of patients admitted to hospital with hepatic decompensation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. - Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. ### Location - Facility: Bristol Royal Infirmary, Bristol, N/A, BS2 8HW, United Kingdom @@
## Military Health and Nutrition Examination Study - NCT ID: NCT06380322 - Study ID: PBRC 2023-034 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-01 - Lead Sponsor: Pennington Biomedical Research Center ### Study Description The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population. ### Conditions - Hypertension - Type 2 Diabetes - Dyslipidemias - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Dietary intake - Dietary quality Secondary Outcomes - Depression - Anxiety - Resilience - Posttraumatic stress disorder - Self-efficacy - Mood - Physical activity - Physical activity - Physical performance - Physical injuries - Sleep duration and quality - Sleep duration and quality - Eating behavior (Satiety) - Eating behavior (Fast Eating Rate) - Eating behavior (Slow Eating Rate) - Blood pressure - Anthropometric and body composition measures - Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation - Albumin, iodine, and other biomarkers of health - Gut microbiome composition - Prescription and over-the-counter medication and supplement use - Resting metabolic rate (RMR) - Heart rate variability (HRV) - Genomics ### Location - Facility: Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States @@
## A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE - NCT ID: NCT06380309 - Study ID: LY001-I001 - Status: RECRUITING - Start Date: 2024-05-06 - Completion Date: 2027-10-30 - Lead Sponsor: Peking University ### Study Description Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages. ### Conditions - Advanced Malignant Solid Tumor of Digestive System ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IDOV-SAFE ### Outcomes Primary Outcomes - Occurrence of dose-limiting toxicity (DLT) - Incidence of adverse events (AE) Secondary Outcomes - The level of (non-essential) viral DNA in tumor tissue - Tumor markers - Anti-vaccinia virus neutralizing antibody test(VV-Nab) - Levels of viral DNA in blood - Levels of viral DNA in saliva - T cell subsets - Cytokines - ORR - DCR - DOR - PFS - OS ### Location - Facility: Beijing Cancer Hospital, Beijing, N/A, N/A, China @@
## Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars - NCT ID: NCT06380296 - Study ID: 2024-10240 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-03 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications. ### Conditions - Pulp Disease, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Primary molars pulpotomies with NeoMTA - Primary molar pulpotomies with NeoPUTTY ### Outcomes Primary Outcomes - Success rate of a primary molar pulpotomy - Radiographic success of a primary molar pulpotomy Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety - NCT ID: NCT06380283 - Study ID: 2024-10221 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2026-01 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment. ### Conditions - Children, Only - Dental Anxiety - Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Virtual reality headset ### Outcomes Primary Outcomes - Children's pain perception during dental treatment - Children's fear during dental treatment Secondary Outcomes - Children's acceptability of virtual reality intervention during dental care - Oral health care provider's acceptability of virtual reality during dental care ### Location - Facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre, Montreal, Quebec, N/A, Canada @@
## Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12 - NCT ID: NCT06380270 - Study ID: LUMHS/B12/Temp/14.04.2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: Liaquat University of Medical & Health Sciences ### Study Description Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene. ### Conditions - Strep Throat ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Oral probiotic Streptococcus salivarius K12 sachet ### Outcomes Primary Outcomes - Effect on oral health physical condition - Effect on other physical features - Effect on vital signs - Effect on vital signs - Effect on vital signs - Effect on vital signs - Effect on blood biochemistry - Effect on blood biochemistry - Effect on blood biochemistry - Effect on blood biochemistry - Effect on blood electrolytes balance - Effect on hematology - Incidence of inflammation - Incidence of gastrointestinal side effects - Incidence of Adverse events (AEs) Secondary Outcomes ### Location - Facility: Liaquat University of Medical and Health Sciences, Jāmshoro, N/A, 76090, Pakistan @@
## Anorexia Nervosa and Brain in Adolescence - NCT ID: NCT06380257 - Study ID: ANBA - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2030-12 - Lead Sponsor: Kuopio University Hospital ### Study Description Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence. ### Conditions - Anorexia Nervosa ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational study methods ### Outcomes Primary Outcomes - Neuroimaging Secondary Outcomes - Neuroimaging ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery - NCT ID: NCT06380244 - Study ID: 1072.6120.136.2023 - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2025-12-31 - Lead Sponsor: Jagiellonian University ### Study Description Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV). ### Conditions - Analgesics, Opioid - Anesthesia, Endotracheal - Anesthesia, General ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - anesthesia without opioids ### Outcomes Primary Outcomes - Pain level Secondary Outcomes - Total long acting opioid consumption in oxycodone equivalents ### Location - Facility: Jagiellonian University, Kraków, Malopolskie, 31501, Poland @@
## Skin-to-skin Contact Between Premature Infant and Mother - NCT ID: NCT06380231 - Study ID: IRU-YAZILE-001 - Status: COMPLETED - Start Date: 2019-11-01 - Completion Date: 2020-12-01 - Lead Sponsor: Istanbul Rumeli University ### Study Description Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days. ### Conditions - Kangaroo-mother Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - kangaroo mother care (KMC) ### Outcomes Primary Outcomes - power analysis Secondary Outcomes - The effect of kangaroo mother care ### Location - Facility: TC Istanbul Rumeli University, Istanbul, Haliç, 34445, Turkey @@
## Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE) - NCT ID: NCT06380218 - Study ID: 2023-A00249-36 - Status: RECRUITING - Start Date: 2023-07-11 - Completion Date: 2025-08-01 - Lead Sponsor: Institut Pasteur de Lille ### Study Description The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Nutrional and physical activity program ### Outcomes Primary Outcomes - Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" Secondary Outcomes - Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program - Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" - Satisfaction of Primevere products ### Location - Facility: NutrInvest - Institut Pasteur de Lille, Lille, Nord, 59019, France @@
## A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females - NCT ID: NCT06380205 - Study ID: INCB54707-111 - Status: RECRUITING - Start Date: 2024-05-07 - Completion Date: 2024-06-07 - Lead Sponsor: Incyte Corporation ### Study Description The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Povorcitinib - Levonorgestrel/Ethinyl estradiol ### Outcomes Primary Outcomes - Levonorgestrel (LNG) concentration in plasma - Ethinyl estradiol (EE) concentration in plasma Secondary Outcomes - Number of participants with Treatment-emergent Adverse Events (TEAEs) - Additional LNG/EE PK parameters in plasma - Povorcitinib concentration in plasma ### Location - Facility: Celerion Clinical Research Unit, Tempe, Arizona, 85283, United States @@
## Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data - NCT ID: NCT06380192 - Study ID: HJ22-DEE-RETRO - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-31 - Lead Sponsor: Imagine Institute ### Study Description Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent. ### Conditions - Developmental and Epileptic Encephalopathy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies - Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies Secondary Outcomes - Identification of patient subgroups presenting the identified biomarkers - Assessment of patients' quality of life - Assessment of age-related adaptive behavior - Assessment of behavioral disorders - Assessment of autism spectrum disorders ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Photomedicine Project 14: PBMT for Performance Enhancement in SOF - NCT ID: NCT06380179 - Study ID: USUHS.2023-126 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-01 - Lead Sponsor: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) ### Study Description Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.The specific aims of this study are to:1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population. ### Conditions - Photobiomodulation Therapy - Photomedicine - Low-Level Laser Therapy - Performance Enhancement - Quadriceps - Special Operations Readiness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - THOR3 training + Photobiomodulation Therapy (PBMT) - THOR3 training + sham PBMT ### Outcomes Primary Outcomes - Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse - Countermovement Jump (CMJ) initial baseline: peak force production - Countermovement Jump (CMJ) initial baseline: rate of force production - Countermovement Jump (CMJ) initial baseline: unilateral performance comparison - Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse - Countermovement Jump (CMJ) week 1 follow-up: peak force production - Countermovement Jump (CMJ) week 1 follow-up: rate of force production - Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison - Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse - Countermovement Jump (CMJ) week 2 follow-up: peak force production - Countermovement Jump (CMJ) week 2 follow-up: rate of force production - Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison - Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse - Countermovement Jump (CMJ) week 3 follow-up: peak force production - Countermovement Jump (CMJ) week 3 follow-up: rate of force production - Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison - Isometric Quadriceps Strength Testing initial baseline - Isometric Hamstrings Strength Testing initial baseline - Isokinetic Quadriceps Strength Testing initial baseline - Isokinetic Hamstrings Strength Testing initial baseline - Isometric Quadriceps Strength Testing 3-week follow-up - Isometric Hamstrings Strength Testing 3-week follow-up - Isokinetic Quadriceps Strength Testing 3-week follow-up - Isokinetic Hamstrings Strength Testing 3-week follow-up - Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline - Defense and Veteran's Pain Rating Scale (DVPRS) daily reports - Visual Analog Scale (VAS) initial baseline - Visual Analog Scale (VAS) week 1 follow-up - Visual Analog Scale (VAS) week 2 follow-up - Visual Analog Scale (VAS) week 3 follow-up - Borg Modified Rating of Perceived Exertion (RPE) initial baseline - Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up - Elloumi fatigue scale initial baseline - Elloumi fatigue scale 3-week follow-up - Quick Physical Activity Rating scale (QPAR) - Oura Ring Sleep Data: sleep metrics - sleep duration - Oura Ring Sleep Data: sleep metrics - time in bed - Oura Ring Sleep Data: sleep metrics - light sleep length - Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length - Oura Ring Sleep Data: sleep metrics - deep sleep length - Oura Ring Sleep Data: sleep metrics - sleep latency - Oura Ring Sleep Data: sleep metrics - sleep efficiency score - Oura Ring Sleep Data: sleep metrics - sleep quality score - Oura Ring Sleep Data: Readiness trends - body temperature changes - Oura Ring Sleep Data: Readiness trends - heart rate changes - Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV) - Oura Ring Sleep Data: Readiness trends - respiration rate - Oura Ring Sleep Data: Readiness trends - blood oxygen saturation - Oura Ring Sleep Data: Readiness trends - sleep regularity - Oura Ring Sleep Data: Readiness trends - readiness score Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hepatitis C Lab Testing Comparison Study - NCT ID: NCT06380166 - Study ID: A23-356 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: HealthPartners Institute ### Study Description Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories. ### Conditions - Hepatitis C ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Hepatitis C core antigen ### Outcomes Primary Outcomes - Serum on the clot stability - Serum off the clot stability - Plasma on the gel stability - Plasma off the gel stability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment - NCT ID: NCT06380153 - Study ID: HM005PS1S07 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd ### Study Description The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment. ### Conditions - Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hemay005 ### Outcomes Primary Outcomes - Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） - Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） - Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) - Relevant pharmacokinetic parameters，half-life (T1/2) - Relevant pharmacokinetic parameters，clearance (CL/F) - Relevant pharmacokinetic parameters，volume of distribution (Vz/F) - Relevant pharmacokinetic parameters ，Renal clearance rate（CLr） Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study - NCT ID: NCT06380140 - Study ID: cami3zgmxf3vqyc30ndmdqh6gfjid1 - Status: RECRUITING - Start Date: 2023-05-03 - Completion Date: 2025-12-31 - Lead Sponsor: University of Roma La Sapienza ### Study Description Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient. ### Conditions - Post Operative Pain - Inguinal Hernia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Open Tension-free Inguinal Hernia Repair ### Outcomes Primary Outcomes - Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair - Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair - Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair - Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair - Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair Secondary Outcomes ### Location - Facility: Augusto Lauro, Roma, N/A, 000186, Italy @@
## Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes - NCT ID: NCT06380127 - Study ID: CEFADE012021 - Status: COMPLETED - Start Date: 2021-10-01 - Completion Date: 2023-12-15 - Lead Sponsor: Universidade do Porto ### Study Description The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention. ### Conditions - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Exercise training ### Outcomes Primary Outcomes - Change from Baseline on Short Physical Performance Battery (SPBB) Secondary Outcomes - Change from Baseline on Handgrip test - Change from baseline on isokinetic knee strength - Change from Baseline on circulating levels of myostatin - Change from Baseline on circulating levels of Decorin ### Location - Facility: Faculty of Sports, University of Porto, Porto, N/A, 4000, Portugal @@
## Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination - NCT ID: NCT06380114 - Study ID: STUDY00009296 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-11 - Lead Sponsor: University of Rochester ### Study Description Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds. ### Conditions - Hpv ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Communication - Standing Orders ### Outcomes Primary Outcomes - HPV vaccination Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) - NCT ID: NCT06380101 - Study ID: NEAAR-LARC - Status: RECRUITING - Start Date: 2023-09-08 - Completion Date: 2025-06 - Lead Sponsor: University of South Florida ### Study Description This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy. ### Conditions - Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - NEAAR Medical Food ### Outcomes Primary Outcomes - Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea Secondary Outcomes - Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema - Absolute and relative change from baseline of circulating non-essential amino acids - Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food - molecular ctDNA response. ### Location - Facility: University of South Florida, Tampa, Florida, 33606, United States @@
## Improving Motor Skills: The Role of Music and Encouragement - NCT ID: NCT06380088 - Study ID: VEM-DINOGMI-24 - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2024-03-15 - Lead Sponsor: Universita degli Studi di Genova ### Study Description This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Isometric Task ### Outcomes Primary Outcomes - Duration of the task - Biceps Brachii muscle fatigue - Triceps Brachii muscle fatigue - Biceps Brachii activity - Triceps Brachii activity Secondary Outcomes ### Location - Facility: Università degli Studi di Genova, Genova, N/A, 16122, Italy @@
## COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease - NCT ID: NCT06380075 - Study ID: 2024-0480 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).Participants will:* undergo pupillary dilation* have photographs taken of the inside of the eyes using three different cameras ### Conditions - Retinal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Spectralis FAF imaging - Optos imaging - Clarus imaging ### Outcomes Primary Outcomes - Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging - Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging - Compare FAF retinal patterns by Clarus and Optos FAF imaging - Compare Spectralis FAF imaging to Spectralis OCT imaging Secondary Outcomes - Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images - Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging ### Location - Facility: Department of Ophthalmology and Visual Sciences, Madison, Wisconsin, 53705, United States @@
## Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia - NCT ID: NCT06380062 - Study ID: Choline Prostate Cancer - Status: COMPLETED - Start Date: 2012-01-12 - Completion Date: 2015-11-30 - Lead Sponsor: Universität des Saarlandes ### Study Description The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age. ### Conditions - Primary Prostate Urothelial Cancer - Benign Prostatic Hyperplasia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Plasma concentration of choline ### Outcomes Primary Outcomes - Plasma choline concentrations - Whole blood choline concentrations Secondary Outcomes - Plasma and whole blood folate forms - Plasma phospholipids - Plasma S-adenosylmethionine concentrations - Plasma betaine concentrations - Plasma methylmalonic acid concentrations - Plasma homocysteine concentrations ### Location - Facility: University of Saarland, Homburg, Saarland, 66424, Germany @@
## Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data - NCT ID: NCT06380049 - Study ID: 0720242110 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-29 - Completion Date: 2026-04-28 - Lead Sponsor: Seoul National University Hospital ### Study Description The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors. ### Conditions - Stroke - Fall ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - EMG Analysis Software ### Outcomes Primary Outcomes - Sensitivity of the Machine Learning Model Secondary Outcomes - Specificity of the Machine Learning Model ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery - NCT ID: NCT06380036 - Study ID: 003AEstb/EC/01/2022 - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2023-10-31 - Lead Sponsor: Sairah Sadaf ### Study Description A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months ### Conditions - Fistula in Ano ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - video assisted fistula tract surgery ### Outcomes Primary Outcomes - recurrence Secondary Outcomes ### Location - Facility: Sheikh Zayed Medical College, Rahim yar khan, Punjab, 64200, Pakistan @@
## An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices - NCT ID: NCT06380023 - Study ID: 2022.354 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2024-03-03 - Lead Sponsor: North District Hospital ### Study Description The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study.Research Question1. To assess the extent of the environmental contamination during coughing and simulated airway suction2. To measure the air particle count during coughing and simulated open airway suction.3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction. ### Conditions - Airway Aspiration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Enclosure barrier ### Outcomes Primary Outcomes - Air particle count Secondary Outcomes - A fluorescent Dye ### Location - Facility: North District Hospital, Hong Kong, N/A, 000000, Hong Kong @@
## Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome - NCT ID: NCT06380010 - Study ID: IASO HOSPITAL (ATHENS-GREECE) - Status: COMPLETED - Start Date: 2019-12-01 - Completion Date: 2020-06-30 - Lead Sponsor: Iaso Maternity Hospital, Athens, Greece ### Study Description The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial. ### Conditions - Polycystic Ovary Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mediterranean diet group ### Outcomes Primary Outcomes - Adherance to the Mediterranean diet Secondary Outcomes - Improvement of psychological well-being ### Location - Facility: IASO Hospital, Athens, N/A, 15123, Greece @@
## Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies - NCT ID: NCT06379997 - Study ID: SANTA LUCIA IRCCS - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2025-12-31 - Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia ### Study Description The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.Shoulder Disability Questionnaire (SDQ) for functionality.Assessments will be conducted at the following time points:T0) Before the administration of corticosteroid intra-articular injection (baseline).T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0). ### Conditions - Tendinitis of Shoulder - Hyaluronic Acid - Dietary Supplements - Shoulder Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Collagen, Hyaluronic Acid, Vitamin C, and Manganese - Intra-articular infiltration ### Outcomes Primary Outcomes - Numeric rating scale (NRS) Secondary Outcomes - Shoulder Disability Questionnaire (SDQ) for shoulder functionality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use - NCT ID: NCT06379984 - Study ID: 855013 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI).For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8-12 mg twice daily. This is the current standard of care.For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8-12 mg twice daily.The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Buprenorphine ### Outcomes Primary Outcomes - Successful initiation of buprenorphine maintenance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development - NCT ID: NCT06379971 - Study ID: 23-2327 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-04 - Lead Sponsor: University of Colorado, Denver ### Study Description The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development. ### Conditions - Child Development - Cannabis Use ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo - Choline ### Outcomes Primary Outcomes - Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index - Auditory Sensory Gating (P50) - Child Behavior Checklist (CBCL) 1 1/2-5 Secondary Outcomes - Maternal Plasma Choline Levels - Bayley Scales of Infant and Toddler Development ### Location - Facility: UC Health, Aurora, Colorado, 80045, United States @@
## Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects - NCT ID: NCT06379958 - Study ID: IST-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2024-09-30 - Lead Sponsor: Modern Biosciences Ltd ### Study Description A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects. ### Conditions - Pharmacokinetics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - leramistat 40mg - Itraconazole 200 mg - Phenytoin 100 Mg Oral Capsule - Simvastatin 40mg ### Outcomes Primary Outcomes - leramistat: Area under the curve - AUC0 t - leramistat: Area under the curve - AUC0 24 - leramistat: Area under the curve - AUC0 inf - leramistat: Maximum observed concentration - Cmax - leramistat: Time of the maximum observed concentration - Tmax - leramistat:Elimination rate constant -Kel - leramistat: Half life - t½ - leramistat: Plasma Clearance -CL/F - leramistat: Volume of distribution - Vz/F Secondary Outcomes - Incidence of adverse event. ### Location - Facility: Celerion, Belfast, N/A, N/A, United Kingdom @@
## Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA) - NCT ID: NCT06379945 - Study ID: PI23/01103 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Instituto de Investigación Biomédica de Salamanca ### Study Description Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients.On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches. ### Conditions - Myelodysplastic Syndromes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Structural variants and complex rearrangements in MDS - Mutations in MDS - Overall survival and leukemia-free survival in patients with MDS - ISCIII collections of viable samples Secondary Outcomes ### Location - Facility: Fundación Instituto de Investigación Germans Trias i Puyol, Badalona, Barcelona, 08916, Spain @@
## Pain and Muscle Biopsy - NCT ID: NCT06379932 - Study ID: APHP240433 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2024-12-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future. ### Conditions - Neuromuscular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surveys completion ### Outcomes Primary Outcomes - To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale. Secondary Outcomes - To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service - Gather patient feedback on procedures, facilities and reception to improve our service to patients. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Wound Irrigation Comparative Effectiveness Study - NCT ID: NCT06379919 - Study ID: C Acnes in TSA - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-05-31 - Lead Sponsor: Orthopaedic Education and Research Institute (dba Hoag Orthopedics) ### Study Description The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups. ### Conditions - Cutibacterium Acnes Contamination ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Irrisept Irrigation - Saline Irrigation Solution Delivery ### Outcomes Primary Outcomes - C Acnes Presence Secondary Outcomes - American Shoulder and Elbow Surgeons Patient Reported Outcome Measure - Shoulder Range of Motion (ROM) ### Location - Facility: Hoag Orthopedics, Orange, California, 92868, United States @@
## Upper Extremity Muscle Strength, Balance and Functional Skills in DMD - NCT ID: NCT06379906 - Study ID: DMD, UE and Balance - Status: COMPLETED - Start Date: 2023-11-10 - Completion Date: 2024-03-10 - Lead Sponsor: Halic University ### Study Description This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD. ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assessment ### Outcomes Primary Outcomes - Upper Extremity Muscle Strength Measurements - Trunk Control Measurement Scale - Functional Reach Test - Timed Up & Go Test Secondary Outcomes - Pediatric Evaluation of Disability Inventory ### Location - Facility: Haliç University, Istanbul, Eyüpsultan, N/A, Turkey @@
## A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain - NCT ID: NCT06379893 - Study ID: 300128 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-19 - Completion Date: 2024-11-15 - Lead Sponsor: HALEON ### Study Description The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA. ### Conditions - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Voltaren Gel 1% (diclofenac sodium) (US only) - Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) - Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) ### Outcomes Primary Outcomes - Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 - Change from Baseline in the Average Minutes of MVPA at Week 2 - Change from Baseline in the Average Minutes of MVPA at Week 3 Secondary Outcomes - Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21 - Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21 - Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21 - Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21 - Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21 - Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21 - MVPA on Each Day of the Study - WOMAC Physical Function Subscale Score on Days 7,14, and 21 - Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) - Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain - Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness - Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21 - Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution - NCT ID: NCT06379880 - Study ID: 2023-031 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2025-02-25 - Lead Sponsor: Institut de cancérologie Strasbourg Europe ### Study Description FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring. ### Conditions - Prostatic Neoplasms - Lung Neoplasms - Breast Neoplasms - Colorectal Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - CONTINUUM+ CONNECT remote monitoring ### Outcomes Primary Outcomes - Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment Secondary Outcomes - Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings - Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) - Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) - Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group - Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group - Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion - Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion - Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion - Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion - Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning - Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning ### Location - Facility: Sainte-Catherine, Institut du Cancer Avignon-Provence, Avignon, N/A, 84918, France @@
## A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects - NCT ID: NCT06379867 - Study ID: HSK3486-112 - Status: RECRUITING - Start Date: 2024-04-07 - Completion Date: 2024-08-30 - Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd. ### Study Description Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - HSK3486 - Placebo - Moxifloxacin ### Outcomes Primary Outcomes - ΔQTcI Secondary Outcomes - ΔHR, ΔQTcF, ΔPR, and ΔQRS - Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals - AE and SAE - Cmax - AUClast - t1/2 ### Location - Facility: Beijing GoBroad Boren Hospital, Beijing, N/A, N/A, China @@
## Trunk Rotation And Lateral Flexion Exercises In Stroke Patients - NCT ID: NCT06379854 - Study ID: RCRAHS-ISB/REC/MS-PT/01814 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-06 - Lead Sponsor: Riphah International University ### Study Description In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors. ### Conditions - Stroke, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - chest physiotherapy - trunk rotation exercises,deep diaphragmatic also chest physiotherapy ### Outcomes Primary Outcomes - Trunk Impairment Scale: - Peak Flow Meter - Chest Expansion: Secondary Outcomes ### Location - Facility: Shahida Khaliq Health Centre, Islamabad, N/A, 44080, Pakistan @@
## Green Hysteroscopy - NCT ID: NCT06379841 - Study ID: STUDY00007357 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Emory University ### Study Description The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time ### Conditions - Hysteroscopy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Green Draping Procedure - Full Draping Procedure ### Outcomes Primary Outcomes - Difference in operative times Secondary Outcomes - Infection Rate - Post Operative complication Rate - Peri operative Complication Rate - Number of cases of Fluid deficits - Operative room turnover time in Full Draping ### Location - Facility: Emory Hospital, Atlanta, Georgia, 30322, United States @@
## Self-assessment Tool for Implementing the ESCNH - NCT ID: NCT06379828 - Study ID: 2024-0140 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-03 - Completion Date: 2026-09-01 - Lead Sponsor: European Foundation for the Care of Newborn Infants ### Study Description This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability. ### Conditions - Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health - Testing of the Developed Self-assessment Tool in European Hospitals - Self-Assessment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Please note that this is an observational study; not applicable ### Outcomes Primary Outcomes - Online self-assessment tool (including statements and questions) Secondary Outcomes - Response rates - Demographics and characteristics - User-friendliness score of the self-assessment tool - Applicability score of the formulation of the questions - Qualitative feedback on illustration of output - Appraisal on the utilisation of the self-assessment tool - Scalability of the self-assessment tool and dissemination ### Location - Facility: European Foundation for the Care of Newborn Infants (EFCNI), Munich, Bavaria, 81379, Germany @@
## Effect of Oral Lactate Ingestion on Appetite Regulation - NCT ID: NCT06379815 - Study ID: EMRL-23-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08 - Lead Sponsor: Wilfrid Laurier University ### Study Description The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session. ### Conditions - Appetitive Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Sodium Lactate - Sodium Chloride ### Outcomes Primary Outcomes - Blood Lactate - Acylated ghrelin - Total ghrelin Secondary Outcomes - Subjective appetite perception - Free-living energy intake ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lifestyle Intervention With Physical Activity and Diet - NCT ID: NCT06379802 - Study ID: 2023-00546-01 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2027-12-31 - Lead Sponsor: Vastra Gotaland Region ### Study Description The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity.The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited. ### Conditions - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Individualized physical activity and diet ### Outcomes Primary Outcomes - Change in body weight 1 - Change in body weight 2 - Change in body weight 3 - Change in body weight 4 Secondary Outcomes - Length in cm - Weight in kilograms - Cardiovascular disease risk factor change - Body Mass Index (BMI) - Cardiovascular disease risk factor change - Waist-to-hip ratio 1 - Cardiovascular disease risk factor change - Waist-to-hip ratio 2 - Cardiovascular disease risk factor change - Waist-to-hip-ratio 3 - Cardiovascular disease risk factor change - Waist-hip-ratio 4 - Cardiovascular disease risk factor change - Blood pressure 1 - Cardiovascular disease risk factor change - Blood pressure 2 - Cardiovascular disease risk factor change - Blood pressure 3 - Cardiovascular disease risk factor change - Blood pressure 4 - Cardiovascular disease risk factor change - Long-term blood glucose control using glycated haemoglobin (HbA1c) - Cardiovascular disease risk factor change - Serum (total) Cholesterol (S-Cholesterol) - Cardiovascular disease risk factor change - High density lipoprotein (HDL) - Cardiovascular disease risk factor change - Low densitiy lipoprotein (LDL) - Cardiovascular disease risk factor change - Triglycerides - Cardiovascular disease risk factor change - Aerobic fitness (predicted V02 max) - Cardiovascular disease risk factor change - Physical activity level - Change in functional lower extremity muscle strength - Change in upper extremity muscle strength - Hand grip strength - Change in muscle strength - Shoulder flexion - Change in muscle strength - Ankle Plantar - Cardiovascular disease risk factor change - Healthy food intake - Change in resting energy expenditure 1 - Change in resting energy expenditure 2 - Change in resting energy expenditure 3 - Change in resting energy expenditure 4 - Change in respiratory quotient 1 - Change in respiratory quotient 2 - Change in respiratory quotient 3 - Change in respiratory quotient 4 - Change in health-related quality of life - Proportions of problems in five dimensions - Change in health-related quality of life - Index score - Change in health-related quality of life - Visual analog score of present health status - Change in health-related quality of life - Health status categories - Change in self-reported physical activity level - Change in exposure pattern to the food environment - Change in exposure pattern to the built environment - Process evaluation measure 1 - Extent to which intervention was implemented as planned - Process evaluation measure 2 - Number of sessions of each intervention component delivered - Process evaluation measure 3 - Number of sessions of each intervention component received - Process evaluation measure 4 - Satisfaction with individual lifestyle counselling - Process evaluation measure 5 - Satisfaction with the lifestyle school - Process evaluation measure 6A - Perceived facilitators - Process evaluation measure 6B - Perceived barriers - Process evaluation measure 7 - Reach ### Location - Facility: Centre for lifestyle intervention, Gothenburg, N/A, N/A, Sweden @@
## A Trial to Learn if REGV131-LNP1265 is Safe and Works to Help the Body Make Clotting Factor in Pediatric, Adolescent and Adult Patients With Hemophilia B - NCT ID: NCT06379789 - Study ID: R131L1265-HEMB-2318 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-25 - Completion Date: 2032-07-03 - Lead Sponsor: Regeneron Pharmaceuticals ### Study Description Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it.The study is looking at several other research questions including:* How much study drug is in the blood at different times* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body's immune system in response to a foreign substance* Whether the body makes antibodies against the clotting factor replacement therapy* How quality of life is affected by hemophilia B and if it changes after taking study drug* How joint health is affected by hemophilia B and if it changes after taking study drug* How often visits are required for the emergency room, urgent care center, physician's office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug)* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood ### Conditions - Hemophilia B ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - REGV131 - LNP1265 ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events (TEAEs) - Severity of TEAEs - Coagulation Factor IX (FIX) functional activity measured using the chromogenic substrate assay - Change in FIX functional activity in plasma, measured using the chromogenic substrate assay - Annualized bleeding rate (ABR) following sustained FIX functional activity among participants receiving the RDE Secondary Outcomes - Change in FIX functional activity in plasma measured using the chromogenic substrate assay - ABR following sustained FIX functional activity among participants receiving the RDE - FIX functional activity in plasma over time during the study period using the chromogenic substrate assay - Annualized treated bleeding rate (tABR) following sustained FIX functional activity, among participants receiving the RDE - Annualized utilization (IU/kg/year) of FIX replacement therapy following sustained FIX functional activity among participants receiving the RDE - Remaining free of FIX replacement therapy among those receiving the RDE following sustained FIX expression - Remaining zero spontaneous bleeding events among those receiving the RDE over sustained FIX functional activity period - Concentrations of REGV131 components - Concentrations of LNP1265 components - Detection of antibodies to the F9 transgene product FIX protein - Detection of total binding antibodies (TAbs) to the adeno-associated virus 8 (AAV8) capsid proteins - Detection of neutralizing antibodies/transduction inhibitors (NAb/TI) to the adeno-associated virus 8 (AAV8) capsid proteins - Detection of antibodies to LNP1265 - Detection of antibodies to CRISPR-associated protein 9 (Cas9) protein - Detection of vector DNA in blood - Detection of vector DNA in saliva - Detection of vector DNA in nasal secretions - Detection of vector DNA in semen - Detection of vector DNA in urine - Detection of vector DNA in feces - Incidence of TEAEs - Severity of TEAEs - Detection of vector DNA in relevant matrices based on data analysis of Part 1 Dose Confirmation Cohort - Detection of vector DNA in relevant matrices over time based on data analysis from adult cohorts over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 3D Model - Classification of Thoracic and Lumbar Spinal Fractures. - NCT ID: NCT06379776 - Study ID: LabForSIMS-LC1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-25 - Completion Date: 2026-09-30 - Lead Sponsor: Université Paris-Sud ### Study Description The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents.The main questions this study aims to answer are:Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents?Participants will be randomly assigned to either:Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations.Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model.Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method.The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum. ### Conditions - Lumbar Spine Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Education through a 3D model - Education through a traditional pedagogical support ### Outcomes Primary Outcomes - Specific Questionnaire Secondary Outcomes - Objective Structured Assessment of Technical Skills (OSATS) - Subjective questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain - NCT ID: NCT06379763 - Study ID: 170/2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-30 - Lead Sponsor: University of Jordan ### Study Description This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality.RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month. ### Conditions - Non-specific Chronic Neck Pain - Diaphragmatic Breathing Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - diaphragmatic breathing exercise - conventional physiotherapy exercise ### Outcomes Primary Outcomes - neck pain - neck pain Secondary Outcomes - sleep quality ### Location - Facility: The university of Jordan, Amman, N/A, 11942, Jordan @@
## Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania - NCT ID: NCT06379750 - Study ID: STOPNCD - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-03-01 - Lead Sponsor: Queen's University ### Study Description The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. We will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. We will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, we will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which we evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which we use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. We will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change. ### Conditions - Hypertension - Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: OTHER ### Interventions - Nurse-delivered care using WelTel check-ins and BCC SMS - Community-based peer-support model ### Outcomes Primary Outcomes - Systolic blood pressure Secondary Outcomes - Blood pressure control ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial - NCT ID: NCT06379737 - Study ID: 359n/AO/23 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-12-20 - Lead Sponsor: Padua University General Hospital ### Study Description Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction. ### Conditions - Long COVID ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Multi-systemic Rehabilitation ### Outcomes Primary Outcomes - Numerical Rating Scale (NRS) - Hand grip strength - Barthel Dyspnea Scale - Fatigue Assessment Scale - Beck's Depression Inventory (BDI - Beck Anxiety Inventory (BAI) - 12-Item Short Form Health Survey (SF-12) Secondary Outcomes - Patients satisfaction ### Location - Facility: Universityof Padua, Padova, N/A, 35128, Italy @@
## Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft - NCT ID: NCT06379724 - Study ID: 150349 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: University of Kansas Medical Center ### Study Description Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system. ### Conditions - Burns - Skin Graft Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tranexamic acid - Thrombin JMI - skin graft ### Outcomes Primary Outcomes - The number of participants with hematoma occurrence - The rate of percentage of graft take adherence amongst participants - Comparison of number of participants that require re-operation Secondary Outcomes - Difference in cost between two hemostatic agents ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury - NCT ID: NCT06379711 - Study ID: H22-03727 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2028-08-01 - Lead Sponsor: University of British Columbia ### Study Description The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters. ### Conditions - Spinal Cord Injuries - Cardiovascular Diseases - Cardiopulmonary Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Transcutaneous Spinal Cord Stimulation (tSCS) ### Outcomes Primary Outcomes - Circulating endothelial biomarkers in EMV/µL (Park et al., 2023) Secondary Outcomes - Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008) - Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC - Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1 ### Location - Facility: Blusson Spinal Cord Centre, Vancouver, British Columbia, V5Z 1M9, Canada @@
## Rein 3D PRINT PERSONALIZE - NCT ID: NCT06379698 - Study ID: CHUBX 2023/78 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-06-15 - Lead Sponsor: University Hospital, Bordeaux ### Study Description The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers. ### Conditions - Tumoral Kidney ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - personalized 3D model pré-opérative education - generic 3D model pré-opérative education ### Outcomes Primary Outcomes - Qualitative assessment of patient experience 1 - Qualitative assessment of patient experience 2 - Qualitative assessment of patient experience 3 Secondary Outcomes - Description of interactions between carers and patients - Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care. - Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process - To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model) - Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire) - Description of the changes perceived by carers in patients management in both group ### Location - Facility: CHU de Bordeaux, Bordeaux, N/A, N/A, France @@
## Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. - NCT ID: NCT06379685 - Study ID: SOPH190-0923/I - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2025-04-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®. ### Conditions - Dry Eye - Dry Eyes Chronic - Dry Eye Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRO-190 - Systane Ultra® ### Outcomes Primary Outcomes - Incidence Unexpected Related Adverse Reactions Secondary Outcomes - Changes in the ocular comfort index (OCI) score in between interventions - Changes in Best Corrected Visual Acuity (BCVA) - Changes in tear film breakup time - Changes in intraocular pressure (IOP) - Changes in the integrity of the ocular surface (fluorescein staining) - Changes in lissamine green staining ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@