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## Comparisons Of Different Antiplaque Agents On Gingivitis In Orthodontic Patients - NCT ID: NCT06305546 - Study ID: 2911 - Status: COMPLETED - Start Date: 2023-04-01 - Completion Date: 2023-10-31 - Lead Sponsor: Anam Sattar ### Study Description Fixed orthodontic treatment affects the periodontium by allowing plaque accumulation on teeth if the oral ecosystem is unfavorable which initially causes gingivitis to progress into periodontitis, and later enamel demineralization occurs. Yáñez-Vico et al observed that regular modifications per checkups were painful and unpleasant for the patient thus the patients undergoing fixed orthodontic treatments compromised their oral hygiene. This creates plaque retention sites which can lead to developing white spot lesions, caries, and periodontitis ### Conditions - Gingivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Chlorhexidine Gluconate - Metronidazole - combination gel (chlorhexidine and metronidazole) - Placebo ### Outcomes Primary Outcomes - gingival index - bleeding index - orthodontic plaque index Secondary Outcomes ### Location - Facility: Dow University of Health Sciences, Karachi, Sindh, N/A, Pakistan @@
## Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis - NCT ID: NCT06305533 - Study ID: 854623 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-10 - Lead Sponsor: University of Baghdad ### Study Description The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is:Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens.Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline.All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids.All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LASER disinfection - Photodynamic therapy - Root surface debridement ### Outcomes Primary Outcomes - Probing Pocket Depth (PPD) Secondary Outcomes - Bleeding on probing (BOP) - Plaque index (PI) - Clinical attachment loss (CAL) - Change in bacterial load of F. nucleatum and Fretibacterium fastidiosum ### Location - Facility: College of Dentistry, University of Baghdad, Baghdad, N/A, 10047, Iraq @@
## Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds - NCT ID: NCT06305520 - Study ID: BPLUS-NASAL-02 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-03-10 - Completion Date: 2024-10-31 - Lead Sponsor: Bioplus ### Study Description Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory designTreatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)Population: Number of subject 100\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design). ### Conditions - Nasal Disease - Nasal Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Investigational medical device (SkinPlus-HYAL Implant Lidocaine) - Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine) ### Outcomes Primary Outcomes - Difference in the mean values of the Wrinkle Severity Rating Scale (WSRS) between the treatment and control groups as evaluated by an independent evaluator at 24 weeks after the application of the investigational medical device Secondary Outcomes - Difference in the mean values of the WSRS between the treatment and control groups as evaluated by the investigator at 8, 16, 24, and 48 weeks after device application - Difference in the mean Global Aesthetic Improvement Scale (GAIS) values between the treatment and control groups as evaluated by the investigator at weeks 8, 16, 24, and 48 of the first post-device application phase compared to before application - Difference in the mean values of the WSRS between the treatment and control groups as evaluated by an independent evaluator at 48 weeks after device application. ### Location - Facility: Seoul National University Hospital, Seoul, Jongnogu, 03080, Korea, Republic of @@
## Differents Laser Applications on Plantar Fasciitis - NCT ID: NCT06305507 - Study ID: 30923-N - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-07 - Lead Sponsor: University of Seville ### Study Description The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled \"Effect of different laser applications on Plantar Fasciitis\", is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep mode in the reduction of pain associated with plantar fasciitis.The main questions it seeks to answer are:* What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis?* What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis?Participants in this study will perform the following tasks:* Undergo low-level laser therapy sessions in local spot mode or sweep mode.* Comply with the instructions on the duration and frequency of the sessions.* Record the pain levels experienced before and after each session.The investigators will compare the group undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects. ### Conditions - Fasciitis, Plantar ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Focussed laser therapy - Shower laser therapy ### Outcomes Primary Outcomes - Pain Reduction in Patients with Plantar Fasciitis Treated with Laser Therapy (LLLT): Comparison between Local Spot Mode and Sweep Mode" Secondary Outcomes - Fascia thickness ### Location - Facility: Área Clínica de Podología, Sevilla, Andalucía, 41004, Spain @@
## Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors - NCT ID: NCT06305494 - Study ID: HE671008 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-12 - Lead Sponsor: Khon Kaen University ### Study Description Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues.Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues.Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult.The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life. ### Conditions - Atrophic Vaginitis - Gynecologic Cancer - Lower Urinary Tract Symptoms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prevalence of genitourinary syndrome of menopause Secondary Outcomes - Severity of genitourinary syndrome of menopause - Quality of life of gynecologic cancer survivor - Attitude toward genitourinary syndrome of menopause in gynecologic cancer survivor ### Location - Facility: Faculty of Medicine, Khon Kaen University, Khon Kaen, N/A, 40002, Thailand @@
## Glaucoma Evaluation With the P200TE - NCT ID: NCT06305481 - Study ID: OPT1099 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2024-09-30 - Lead Sponsor: Optos, PLC ### Study Description Images captured on the P200TE device on glaucoma patients ### Conditions - Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - P200TE ### Outcomes Primary Outcomes - Number of images collected Secondary Outcomes ### Location - Facility: Werner Optometry, Cajon, California, 92019, United States @@
## Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis - NCT ID: NCT06305468 - Study ID: APHP240055 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients.This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression. ### Conditions - Toxoplasmosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality rate in intensive care. Secondary Outcomes - Hospital mortality rate - Length of stay in intensive care - Duration of mechanical ventilation ### Location - Facility: Cochin hospital, Paris, N/A, 75014, France @@
## Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship - NCT ID: NCT06305455 - Study ID: HSD135 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: José Raimundo Araujo de Azevedo ### Study Description The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit. ### Conditions - Antimicrobial Resistance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Escherichia coli ESBL ### Outcomes Primary Outcomes - Prevalence of Escherichia coli resistance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Microbiota Directed Food for Children With Moderate Acute Malnutrition - NCT ID: NCT06305442 - Study ID: PR-24031 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-02-28 - Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh ### Study Description Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food. The investigator propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF. ### Conditions - Moderate Acute Malnutrition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Microbiota-Directed Food - Ready-to-Use Supplementary Food ### Outcomes Primary Outcomes - Mean change in Weight-for-Length Z-score (WLZ) Secondary Outcomes - Microbial community repair - Validated plasma and faecal biomarkers of health status (prioritized Luminex/ELISA panel including mediators of growth, systemic inflammation, gut inflammation/entero-pathogen burden) - Mean change in Weight-for-Age Z-score (WAZ) - Mean change in Length-for-Age Z-score (LAZ) - Mean change in body composition (% body fat mass and % fat-free mass) - Bayley Scales of early childhood development (cognitive, motor, language development) ### Location - Facility: Mirpur Study site, Dhaka, N/A, N/A, Bangladesh @@
## Encouraging Positive Parenting Habits - NCT ID: NCT06305429 - Study ID: HABITE - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: D'Or Institute for Research and Education ### Study Description This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study. ### Conditions - ADHD ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HabitE (effective parenting habit) program (in Brazilian Portuguese) ### Outcomes Primary Outcomes - Number of videos viewed - Percentage of completed daily ratings - Participant satisfaction Secondary Outcomes - Parent-rated child's difficulties with daily transitions - Parent-rated child's impairment related to transition difficulties - Inconsistent parenting - Use of physical control - Hostility toward child - Parent Stress ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema - NCT ID: NCT06305416 - Study ID: 2023/CT/01 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-04 - Lead Sponsor: Incepta Pharmaceuticals Ltd ### Study Description Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema.Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus.The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid. ### Conditions - Diabetic Macular Edema - Diabetic Retinopathy - Macular Edema - Macular Degeneration - Retinal Disease - Retinal Degeneration ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ranibizumab 10mg/ml Injection - Lucentis ### Outcomes Primary Outcomes - Changes in Best Corrected Visual Acuity (BCVA) from Baseline - Changes in Central Subfield Thickness (CST) from Baseline Secondary Outcomes - Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity - Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity - Evaluation and comparison of safety between reference vs. test drug. ### Location - Facility: Bangladesh Eye Hospital & Institute, Dhaka, N/A, 1209, Bangladesh @@
## VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury - NCT ID: NCT06305403 - Study ID: VEXUS1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-05-18 - Lead Sponsor: Inonu University ### Study Description In this prospective observational study, patients hospitalized in mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included.To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO.According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not.By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined. ### Conditions - Sepsis - Acute Kidney Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - serum creatinin level ### Outcomes Primary Outcomes - ngal - VEXUS Secondary Outcomes - MORTALİTY ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer. - NCT ID: NCT06305390 - Study ID: 2022-003905-31 - Status: RECRUITING - Start Date: 2023-12-04 - Completion Date: 2025-07 - Lead Sponsor: IRCCS San Raffaele ### Study Description This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa. ### Conditions - Clinical Suspicion of Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PET/MRI ### Outcomes Primary Outcomes - To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of clinically significant prostate cancer (csPCa) Secondary Outcomes - To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone To report the reduction in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET ### Location - Facility: U.O. of Nuclear Medicine, ,Ospedale San Raffaele, Milano, N/A, 20132, Italy @@
## Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems - NCT ID: NCT06305377 - Study ID: DESPED-T1 study - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-03-30 - Lead Sponsor: Giulio Frontino ### Study Description The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control. ### Conditions - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tandem Control IQ ### Outcomes Primary Outcomes - Glucometric data Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue - NCT ID: NCT06305364 - Study ID: CL-1001 - Status: RECRUITING - Start Date: 2023-08-01 - Completion Date: 2024-12-01 - Lead Sponsor: Jubaan Ltd. ### Study Description This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance. ### Conditions - Colorectal Neoplasms - Gastrointestinal Microbiome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Gixam ### Outcomes Primary Outcomes - Primary Safety Endpoint - Number of device related adverse events and serious adverse events - Primary Efficacy Endpoint - Gixam's diagnostic accuracy Secondary Outcomes ### Location - Facility: Westside GI, New York, New York, 10019, United States @@
## A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes - NCT ID: NCT06305351 - Study ID: K-757 P008 - Status: RECRUITING - Start Date: 2023-12-07 - Completion Date: 2024-07 - Lead Sponsor: Kallyope Inc. ### Study Description This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM) ### Conditions - Obesity - Type 2 Diabetes Mellitus (T2DM) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - K-757 and K-833 QD - K-757 and K-833 BID - Matching placebo to K-757 and K-833 QD - Matching placebo to K-757 and K-833 BID ### Outcomes Primary Outcomes - Proportion of participants who experienced 1 or more treatment-emergent AEs - Proportion of participants who discontinued study medication due to an AE Secondary Outcomes - Area under the concentration-time curve [AUC] of plasma K-757 - AUC of plasma K-833 - Maximum concentration [Cmax] of plasma K-757 - Cmax of plasma K-833 - Time of maximum concentration [Tmax] of plasma K-757 - Tmax of plasma K-833 - Clearance [Cl] of plasma K-757 - Cl of plasma K-833 - Volume of distribution at steady-state [Vdss] of plasma K-757 - Vdss of plasma K-833 - Half-life [t1/2] of plasma K-757 - t1/2 of plasma K-833 ### Location - Facility: QPS Miami, Miami, Florida, 33143, United States @@
## Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling - NCT ID: NCT06305338 - Study ID: KUK-Ophthalmology-009 - Status: COMPLETED - Start Date: 2022-04-12 - Completion Date: 2023-04-26 - Lead Sponsor: Johannes Kepler University of Linz ### Study Description During cataract surgery an artificial intraocular lens (IOL) is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt, one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric, or multifocal optics.Various methods to measure IOL misalignments have been described. Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess IOL decentration and tilt. The subjective grading at the slitlamp may display considerable variability between examiners. This method is more qualitative than quantitative and does not allow fine resolution when reporting IOL tilt. The fact that the patient has no standardized target to focus on makes the method even less reliable. Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the IOL position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. Scheimpflug camera images have been used for assessing IOL tilt previously, but erroneous results, often due to corneal magnification, have diminished their widespread use. Another possibility to assess tilt is the use of Purkinje reflexes. The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized. Since light is reflected at all interfaces of media with a difference in refractive index, these reflections, called Purkinje images, can be used to assess tilt and decentration of IOLs. Two different clinically applicable Purkinjemeter system provide the measurement of IOL decentration and tilt. The main problem with Purkinje meters is accessibility, as there are only a few prototypes available worldwide.The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: OCT based devices are available in most clinics, the resolution of modern OCT devices is high, and the measurements are reproducible.Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression. This method was developed by Wold and introduced to ophthalmology previously. ### Conditions - Intraocular Lens - Cataract ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Optical Coherence Tomography ### Outcomes Primary Outcomes - post operative IOL tilt Secondary Outcomes - Comparison of tilt prediction - comparion of three measurement methods - Comparison of tilt pre- versus post operative ### Location - Facility: Matthias Bolz, Linz, Oberösterreich, 4020, Austria @@
## Coparenting Intervention to Prevent Postpartum Depression - NCT ID: NCT06305325 - Study ID: 35957 - Status: COMPLETED - Start Date: 2018-09-23 - Completion Date: 2020-02-22 - Lead Sponsor: Brock University ### Study Description The goal of this pilot randomized controlled trial was to examine the feasibility and acceptability of an ehealth antenatal coparenting intervention (eACoP) in primiparous Pakistani women. The secondary purpose of the study was to see the effectives of the intervention in prevention postpartum depression in women. Two hundred and twelve primiparous couples were randomized into an intervention or a control group from the Aga Khan University Hospital. Couples were randomized using consecutively numbered sealed envelopes. Couples in the intervention group received the eACoP intervention during pregnancy, consist of eight online videos in addition to the standard care provided at the center. Both the intervention group and control group received standard care. ### Conditions - Postpartum Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - eHealth Antenatal Coparenting Intervention ### Outcomes Primary Outcomes - feasibility-recruitment rate, adherence, and follow-up rate - Acceptability- Participants satisfaction Secondary Outcomes - Depressive Symptoms - anxiety - Coparenting Relationship - Relationship Satisfaction- couple relationship satisfaction to discriminate between distressed and non-distressed relationship. - Postpartum Childcare Stress - Infant Development - partner support ### Location - Facility: Aga Khan University, Karachi, SinDH, N/A, Pakistan @@
## Community Services Navigation to Advance Health Equity in Breast Cancer Screening - NCT ID: NCT06305312 - Study ID: HCI166685 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-09 - Lead Sponsor: University of Utah ### Study Description The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Community Service Navigation - Usual Care ### Outcomes Primary Outcomes - Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener - Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed. Secondary Outcomes ### Location - Facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences, Salt Lake City, Utah, 84112, United States @@
## Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells - NCT ID: NCT06305299 - Study ID: LCCC2152-ATL - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-03 - Lead Sponsor: UNC Lineberger Comprehensive Cancer Center ### Study Description The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated.There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy. ### Conditions - Ovary Neoplasm - Ovarian Cancer - Epithelial Ovarian Cancer - Recurrent ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - iC9-CAR.B7-H3 T cells - Cyclophosphamide - Fludarabine ### Outcomes Primary Outcomes - Toxicity: NCI-CTCAE - Toxicity: Cytokine Release Syndrome (CRS) - Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) Secondary Outcomes - The recommended phase 2 dose (RP2D) - Progression Free Survival (PFS) - Overall Survival (OS) - The disease control rate (DCR) ### Location - Facility: Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, 27599, United States @@
## Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) - NCT ID: NCT06305286 - Study ID: IRB23-1367 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2029-03 - Lead Sponsor: University of Chicago ### Study Description AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells. ### Conditions - Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AT-1501 ### Outcomes Primary Outcomes - Number of Participants who are insulin-independent post- first and final transplant Secondary Outcomes - Number of Participants with glycosylated hemoglobin (HbA1c) <7.0% ### Location - Facility: University of Chicago, Chicago, Illinois, 60637, United States @@
## Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients - NCT ID: NCT06305273 - Study ID: 23-0150-A - Status: NOT_YET_RECRUITING - Start Date: 2024-03-25 - Completion Date: 2025-03-01 - Lead Sponsor: Mount Sinai Hospital, Canada ### Study Description It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Head position for face mask ventilation during induction supine - Head position for face mask ventilation during induction head elevated ### Outcomes Primary Outcomes - Average tidal volume Secondary Outcomes - Predictors for difficult mask ventilation like BMI - Predictors for difficult mask ventilation like presence of beard - Predictors for difficult mask ventilation like Mallampati classification III or IV - Predictors for difficult mask ventilation like age of 57 yo or older. - Predictors for difficult mask ventilation like severely limited mandibular protrusion - Predictors for difficult mask ventilation like history of snoring. - Oropharyngeal airway - Insufficient mask ventilation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## LOTUS Trial: Lumbar Ultrasound in Obstetric Patients With BMI > 40 - NCT ID: NCT06305260 - Study ID: STUDY00000324 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-11-01 - Completion Date: 2024-12-30 - Lead Sponsor: MetroHealth Medical Center ### Study Description The goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (BMI \>40) obstetric patient population. The main questions it aims to answer are:* Is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement?* Is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? Participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement. ### Conditions - Obesity, Morbid - Labor Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Lumbar Ultrasound ### Outcomes Primary Outcomes - Epidural Redirects Secondary Outcomes - Total time to epidural space - Number of attempts at a different level - Epidural replacement rate - Patient satisfaction ### Location - Facility: MetroHealth Hospital, Cleveland, Ohio, 44109, United States @@
## A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours - NCT ID: NCT06305247 - Study ID: CLIN-01194-450 - Status: RECRUITING - Start Date: 2024-04-03 - Completion Date: 2028-03-20 - Lead Sponsor: Ipsen ### Study Description The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours.The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.In this study, all participants will receive the study drug, which will be taken by mouth (orally). ### Conditions - Melanoma - Head and Neck Squamous Cell Carcinoma - Pancreatic Ductal Adenocarcinoma - Colorectal Cancer - Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - IPN01194 - IPN01194 ### Outcomes Primary Outcomes - Phase 1: Percentage of participants with dose limiting toxicity (DLT) - Phase 1: Percentage of participants experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TE SAEs) - Phase 1: Percentage of participants with dose interruptions and permanent treatment discontinuations - Phase 2a: Objective response rate (ORR) Secondary Outcomes - Phase 1: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01194 - Phase 1: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01194 - Phase 1: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01194 - Phase 1: Geometric mean ratio of Cmax of IPN01194 administered in fed state relative to fasted state - Phase 1: Geometric mean ratio of AUClast of IPN01194 administered in fed state relative to fasted state - Phase 1: Geometric mean ratio of AUCinf administered in fed state relative to fasted state - Phase 1: Prolongation of corrected QT interval (QTc) - Phase 1: Objective response rate (ORR) - Phase 2a: Duration of response (DoR) - Phase 2a: Progression-free survival (PFS) - Phase 2a: PFS rate at 4 months - Phase 2a: Disease control rate (DCR) - Phase 2a: Percentage of participants with TEAEs and TE SAEs - Phase 2a: Percentage of participants with dose interruptions and permanent treatment discontinuations ### Location - Facility: The Angeles Clinic and Research Institute - California, Los Angeles, California, 90025, United States @@
## A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade) - NCT ID: NCT06305234 - Study ID: 165-503 - Status: RECRUITING - Start Date: 2024-01-20 - Completion Date: 2033-11-18 - Lead Sponsor: BioMarin Pharmaceutical ### Study Description This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503. ### Conditions - Phenylketonuria (PKU) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pegvaliase ### Outcomes Primary Outcomes - To evaluate immunologic and inflammatory responses associated with occurrences of Secondary Outcomes - Evaluation of immunologic and/or inflammatory responses over time - Evaluation of immunologic responses over time ### Location - Facility: Tulane University School of Medicine, New Orleans, Louisiana, 70112, United States @@
## Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy - NCT ID: NCT06305221 - Study ID: opioid-free analgesia - Status: RECRUITING - Start Date: 2024-03-09 - Completion Date: 2025-03-31 - Lead Sponsor: Beijing Friendship Hospital ### Study Description The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain. ### Conditions - Opioid-Free Anesthesia - Laparoscopic Sleeve Gastrectomy - Postoperative Vomiting - Postoperative Recovery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Opioid-free Analgesics (esketamine, dexmedetomidine) - Opioid Anesthetics (sufentanil and remifentanil) ### Outcomes Primary Outcomes - 15-item recovery quality scale score 48 hours after surgery - 15-item recovery quality scale score 24 hours before surgery Secondary Outcomes - Dosage of postoperative analgesics - Duration of until postoperative PACU Aldrete score> 9 points - anesthesia-related complication - time to first exhaust gas after surgery - time of first postoperative mobilization - Overall benefit of analgesic score satisfaction in pain treatment - Acute pain numeric rating scale score - Rhodes Index of Nausea, Vomiting, and Retching - Rhodes Index of Nausea, Vomiting, and Retching ### Location - Facility: bijia Song, Beijing, N/A, N/A, China @@
## A UK Registry for Metabolic and Bariatric Endoscopic Interventions - NCT ID: NCT06305208 - Study ID: CCLR-23-018 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2039-02-01 - Lead Sponsor: Cleveland Clinic London ### Study Description In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments. ### Conditions - Obesity - Diabetes Mellitus, Type 2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Endoscopic gastric suturing - Endoscopic gastric plication - Revisional gastroplasty - Transoral outlet reduction endoscopy (TORe) - Duodenal mucosal resurfacing (DMR) - Intragastric balloon(s) ### Outcomes Primary Outcomes - Total body weight loss percentage (TBWL%) - Change in glycated haemoglobin (HbA1c; mmol/mol) - Change in the number and dose of anti-diabetic medications Secondary Outcomes - Procedure time (mins) - Inpatient stay (days) - Adverse events - Change in systolic blood pressure measurements (mmHg) - Change in diastolic blood pressure measurements (mmHg) - Changes in number and dose of anti-hypertensive medications (n) - Changes in low-density lipoprotein cholesterol (mmol/L) - Changes in triglycerides (mmol/L) - Changes in high-density lipoprotein cholesterol (mmol/L) - Changes in total cholesterol (mmol/L) - Changes in alanine transaminase (IU/L) - Changes in aspartate aminotransferase (IU/L) - Changes in Fibrosis-4 Index for Liver Fibrosis - Changes in non-alcoholic fatty liver disease fibrosis score - Changes in weight (kg) - Changes in body mass index (kg/m2) - Changes in glycated haemoglobin (HbA1c; mmol/mol) - Changes in number and dose of anti-diabetic medications (n) - Changes in number and dose of anti-obesity medications (n) - Changes in health-related quality of life scores (EuroQol-5D-5L) ### Location - Facility: Cleveland Clinic London, London, N/A, SW1X 7HY, United Kingdom @@
## Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome - NCT ID: NCT06305195 - Study ID: 0107766 - Status: RECRUITING - Start Date: 2023-08-23 - Completion Date: 2026-10-21 - Lead Sponsor: Alexandria University ### Study Description The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals.Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators. ### Conditions - Diabetes Mellitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - heart rate variability test ### Outcomes Primary Outcomes - Beat-to-beat Heart rate variability - body mass index - Valsalva ratio - Stand 30:15 ratio - deep breath test interpretation Secondary Outcomes - Framingham risk score (FRS) ### Location - Facility: Alexandria university, Alexandria, N/A, N/A, Egypt @@
## Metreleptin in Anorexia Nervosa - NCT ID: NCT06305182 - Study ID: BASEC 2022-01328 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-02-01 - Lead Sponsor: Gabriella Milos ### Study Description The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight. ### Conditions - Anorexia Nervosa ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metreleptin - Sodium chloride ### Outcomes Primary Outcomes - Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up Secondary Outcomes - Subjective depression by the Beck Depression Inventory-II (BDI-II) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Hematology in the Metreleptin treatment group compared to placebo group between - Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up - Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up ### Location - Facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Zurich, N/A, 8091, Switzerland @@
## Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer - NCT ID: NCT06305169 - Study ID: 1.4 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Sandwell & West Birmingham Hospitals NHS Trust ### Study Description Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis.The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad.To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy.A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gastropanel ### Outcomes Primary Outcomes - Measurement of the specificity and negative predictive value of serum biomarkers in gastric cancer Secondary Outcomes - Creating a scoring system for patients that warrant urgent endoscopy on the cancer pathway ### Location - Facility: Sandwell General Hospital, Birmingham, West Midlands, B71 4HJ, United Kingdom @@
## Protocol Optimization in CT for the Quantification of BMD - NCT ID: NCT06305156 - Study ID: CT_BMD_1 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2025-03 - Lead Sponsor: Hatem Alkadhi ### Study Description Bone mineral density is an important measurement to detect osteoporosis.The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA* How can we optimize the CT scan for bone mineral densityParticipants will undergo:* Clinically indicated CT scan on day of inclusion* Study related DXA scan on a separate appointment ### Conditions - Osteoporosis, Osteopenia - Bone Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Bone Mineral Density quantification ### Outcomes Primary Outcomes - Bone mineral density CT - Bone mineral density Dual-energy x-ray absorptiometry (DXA) Secondary Outcomes - Correlation between age and bone mineral density - Correlation between sex and bone mineral density - Correlation between height and bone mineral density - Correlation between weight and bone mineral density - Correlation between body mass index (BMI) and bone mineral density ### Location - Facility: Diagnostic and Interventional Radiology, University Hospital Zurich, Zürich, N/A, 8091, Switzerland @@
## Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy - NCT ID: NCT06305143 - Study ID: YFZXYDK202402 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-01 - Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center ### Study Description The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR).The main questions it aims to answer are:* mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment* proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment* proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment* mean changes in BCVA and CMT from baseline to monthly follow-up time point* complications and adverse effects ### Conditions - Diabetic Macular Edema ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Conbercept ### Outcomes Primary Outcomes - improvement of visual acuity Secondary Outcomes ### Location - Facility: Shanghai Eye Diseases Prevention &Treatment Center, Shanghai, Shanghai, 201103, China @@
## Prognostic Value of Performance Scores in Patients Undergoing Surgery for Upper Tract Urothelial Carcinoma - NCT ID: NCT06305130 - Study ID: KMUHIRB-E(I)-20180214 - Status: COMPLETED - Start Date: 1988-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Kaohsiung Medical University ### Study Description Aim: to comprehensively evaluate the prognostic value of preoperative ECOG-PS scores and ASA scores in patients undergoing radical nephroureterectomy (RNU) for upper tract urothelial carcinoma.Methods: multicentered cohort study ### Conditions - Carcinoma, Transitional Cell (RENI) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Overall survival - Cancer-specific survival - Disease-free survival - Bladder recurrence-free survival Secondary Outcomes - Number of patients with major postoperative complication - Number of patients with postoperative renal failure ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1 - NCT ID: NCT06305117 - Study ID: PP202304-37-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2025-05 - Lead Sponsor: International Agency for Research on Cancer ### Study Description The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life.The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting.In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Distraction strategy ### Outcomes Primary Outcomes - Patients' acceptance rate regarding the use of the distraction strategy. Secondary Outcomes - Accessibility of the strategy - Duration of use of the strategy by patients - Type of video content chosen by participants - Type of music content chosen by participants - Patients' perception of factors limiting the use of the strategy - Healthcare providers' perception of factors limiting the use of the strategy - Workload for strategy administrators - Strategy administrators ability to use the strategy - Patients' satisfaction regarding the use of the strategy - Healthcare providers' satisfaction regarding the strategy - Prevalence of adverse events related to the use of the strategy - Type of adverse events related to the use of the strategy - Severity of adverse events related to the use of the strategy ### Location - Facility: Centre Léon Bérard, Lyon, N/A, N/A, France @@
## Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old. - NCT ID: NCT06305104 - Study ID: KN-EEC-II - Status: RECRUITING - Start Date: 2023-07-18 - Completion Date: 2024-06-30 - Lead Sponsor: Chengdu CoenBiotech Co., Ltd ### Study Description This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old.In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis.In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old. ### Conditions - Tuberculosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - 2.5μg/ml EEC - 5μg/ml EEC - 5 unit（U） EC ### Outcomes Primary Outcomes - Sensitivity of different doses of EEC and control EC in pulmonary tuberculosis patients aged 18 to 65 years ; - specificity of different doses of EEC and control EC in healthy subjects aged 18 to 65 years and patients with non-tuberculous lung disease ; - The skin test site specific reaction at 4h,8h (only for stage 2);24h, 48h, 72h, 96h, and 7 days after skin test. Those with average diameter of induration/redness is ≥5 mm will be considered to positive. Secondary Outcomes - Receiver operator characteristic curve(ROC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. - Area under the curve(AUC) of different doses of EEC to evaluate the optimal diagnostic test cut-off value of the test drug. - In healthy people, patients with tuberculosis and patients with non-tuberculous lung diseases, the consistency rates of the three detection reagents EEC , EC and IGRA were evaluated respectively. - Incidence of adverse events and serious adverse events at injection and non-injection sites，abnormal incidence of laboratory indicators and vital signs during the study period. ### Location - Facility: Beijing Chest Hospital, Beijing, Beijing, 101149, China @@
## DNA Methylation Markers in Veterans Exposed to Open Burn Pits - NCT ID: NCT06305091 - Study ID: 1681559 - Status: RECRUITING - Start Date: 2023-03-13 - Completion Date: 2027-03-31 - Lead Sponsor: Central Arkansas Veterans Healthcare System ### Study Description Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations.Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems.Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems.Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates.Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high. ### Conditions - Open Burn Pit Exposure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Health survey for physical and mental health comorbidities, epigenetic marker and heavy metals in blood and urine samples ### Outcomes Primary Outcomes - DNA methylation markers and heavy metals Secondary Outcomes - Physical and mental health comorbidities ### Location - Facility: Central Arkansas Veterans Healthcare System (3J/NLR), North Little Rock, Arkansas, 72114, United States @@
## Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study - NCT ID: NCT06305078 - Study ID: 2023-0528 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2024-12-31 - Lead Sponsor: Children's Hospital Medical Center, Cincinnati ### Study Description The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial. ### Conditions - Attention Deficit Hyperactivity Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Personalized ADHD Medication Experiment ### Outcomes Primary Outcomes - Decision-Making Involvement Scale - Decisional Conflict Scale (DCS) - Behavioral Intention Questions - System Usability Scale - Implementation of Decision Secondary Outcomes ### Location - Facility: Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45220, United States @@
## Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty - NCT ID: NCT06305065 - Study ID: 2024.089 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-05 - Lead Sponsor: Chinese University of Hong Kong ### Study Description REAL INTELLIGENCE™ CORI™ (CORI Surgical System) is a computer-assisted orthopedic surgical system. CORI Surgical System is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures.CORI Surgical System is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Surgical System software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module.Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model.The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments. ### Conditions - Knee Osteoarthritis - Total Knee Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KUNWU Navigation TKA procedure - CORI Surgical System TKA procedure - Conventional TKA procedure ### Outcomes Primary Outcomes - Post-operative leg alignment - Hip-knee-ankle axis (HKA axis) Secondary Outcomes - Lateral View - Standard Radiographic Evaluation - Femoral coronal alignment (FCA) - Standard Radiographic Evaluation - Femoral sagittal alignment (FSA) - Standard Radiographic Evaluation - Femoral component rotation (FCR) - Standard Radiographic Evaluation - Tibial coronal alignment (TCA) - Standard Radiographic Evaluation - Tibial slope - Standard Radiographic Evaluation - Joint line distance - Knee Society Score (KSS) - Oxford Knee Score (OKS) - HEALTH ECONOMICS/QUALITY OF LIFE - EQ-5D-5L - Forgotten Joint Score (FJS) ### Location - Facility: The Chinese University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## Effects of Olfactory and Gustatory Stimulus on the Nutrition of Premature Babies - NCT ID: NCT06305052 - Study ID: estimulation-taste-olfactory - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-04 - Completion Date: 2024-04 - Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute ### Study Description The objective of this clinical trial is to test the effects of olfactory and taste stimulation with milk or water in premature newborns with a gestational age between 28 and 32 weeks.The main question researchers want to resolve is: • Does olfactory and gustatory stimulation in these newborns reduce the time spent with an oral or nasogastric feeding tube and bring forward oral feeding? Participants will be stimulated with milk or water depending on the randomly chosen group. 1: the olfactory stimulus (with smell) will be performed with a sterile cotton swab close to the nostrils immediately before feeding through the tube, 2: the gustatory stimulus (taste) will be performed with a sterile cotton swab on which a drop of milk or water will be applied on the newborn's tongue if they are awake or on their lips if they are sleeping, and is performed immediately before tube feeding. ### Conditions - Weight, Birth - Premature Birth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Milk - Water ### Outcomes Primary Outcomes - Comparison of the period between the beginning of the intervention and enteral feeding. Secondary Outcomes - Describe the gestational age of the newborn - Describe the sex of the newborn. - Describe the type of birth. - Describe the APGAR score. - Describe birth weight and birth weight z-score. - Describe head circumference at birth and head circumference z-score at birth - Describe birth length and birth length z-score. - Determine the frequency of rupture of membranes >24h, chorioamnionitis, antepartum hemorrhage, gestational hypertension, pre-eclampsia and prenatal steroids >24h. - Compare the time, in days, of feeding via oral/nasal gastric tube. - Compare the total duration, in days, of parenteral nutrition (TPN) use. - Compare the type of food at discharge (natural, artificial or mixed). - Compare weight gain and weight Z score, at 28 days of life and at discharge from the neonatal ICU, as well as anthropometric parameters: head circumference and length with their respective Z score at discharge from the NICU. - Compare gestational age (GA) at the time of removal of the oro/nasogastric tube and at discharge from the NICU. - Compare the frequency of diagnosis of patent ductus arteriosus requiring treatment, bronchopulmonary dysplasia (BPD), retinopathy of prematurity, intraventricular hemorrhage and necrotizing enterocolitis. - Determine the association of treatment time with oxygen therapy (nasal catheter, nasal prong - nasal CPAP, intermittent positive pressure or endotracheal ventilation) in hours. ### Location - Facility: Instituto de Medicina Integral Professor Fernando Figueira, Recife, Pernambuco, 50070-550, Brazil @@
## Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments - NCT ID: NCT06305039 - Study ID: 2089705 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-12-19 - Completion Date: 2028-05-31 - Lead Sponsor: University of Maryland, College Park ### Study Description Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also "single-sided deafness" (SSD) CI users who use one CI together with good acoustic hearing in their opposite ear. The goal is to measure and understand the impact of large input asymmetries across the two ears. These asymmetries are common in BI-CI listeners and always present in SSD-CI users. Although most CI listeners benefit from a second source of auditory input, this project measures how these asymmetries limit speech understanding and spatial hearing. The long-term goal is countering or compensating for input asymmetries. Electrophysiological measures are used to describe the health of the auditory system. Behavioral measures are used to assess if training improves performance. CT imaging is utilized to describe the placement of the CIs. ### Conditions - Hearing Loss - Hearing Loss, Sensorineural - Cochlear Hearing Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Diagnostic tests of cochlear implant or acoustic hearing function - Targeted aural rehabilitation of the poorer performing ear ### Outcomes Primary Outcomes - Perceptual responses to sound level - Speech understanding in the presence of masking sounds - Computed-tomography scan - Electrode impedance (transelectrode impedance matrix) - Electrically evoked compound action potentials (ECAPs) Secondary Outcomes - Sound Localization - Perceptual Fusion - Spectrotemporal ripple sensitivity ### Location - Facility: Walter Reed National Military Medical Center, Bethesda, Maryland, 20889, United States @@
## Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia - NCT ID: NCT06305026 - Study ID: S-20190160 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-08-31 - Lead Sponsor: Hospital of South West Jutland ### Study Description Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM.Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria).Data collection: Will be done as study subjects are included and stored in REDCAP.Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests.Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series.Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia.Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test. ### Conditions - Rheumatoid Arthritis - Fibromyalgia, Secondary - Widespread Chronic Pain - Muscle Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Muscle- and skin biopsies ### Outcomes Primary Outcomes - Muscle pathology - Skin biopsies Secondary Outcomes - Cold pressure test - Pain pressure threshold (PPT) - Computerized Cuff pressure algometry (CPA) ### Location - Facility: Esbjerg Hospital, Esbjerg, N/A, 6700, Denmark @@
## PEA: The Ability of Nurses To Recognize It (PEA: ANTRI) - NCT ID: NCT06305013 - Study ID: SIMU PEA 2024 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-01 - Lead Sponsor: Brno University Hospital ### Study Description The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals should be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowledge of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk university and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized. ### Conditions - Pulseless Electrical Activity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pulseless electrical activity recognition ### Outcomes Primary Outcomes - Pulseless electrical activity recognition, Secondary Outcomes ### Location - Facility: Faculty hospital Brno, Brno, Jihomoravský Kraj, 62500, Czechia @@
## Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis - NCT ID: NCT06305000 - Study ID: 2015-KAEK-80-23-25 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-05-10 - Lead Sponsor: Biruni University ### Study Description This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is:Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone?Our study consists of 4 groups:Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (\< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples.Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis. ### Conditions - Peri-implant Mucositis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-surgical treatment - Free gingival graft ### Outcomes Primary Outcomes - Inflammatory parameter levels in peri-implant crevicular fluid - Inflammatory parameter levels in peri-implant crevicular fluid - Inflammatory parameter levels in peri-implant crevicular fluid - Inflammatory parameter levels in peri-implant crevicular fluid Secondary Outcomes - Plaque index (Silness & Löe, 1964) - Plaque index (Silness & Löe, 1964) - Plaque index (Silness & Löe, 1964) - Plaque index (Silness & Löe, 1964) - Gingival Index ( Löe & Silness,1963) - Gingival Index ( Löe & Silness,1963) - Gingival Index ( Löe & Silness,1963) - Gingival Index ( Löe & Silness,1963) - Bleeding on probing (Ainamo & Bay 1975) - Bleeding on probing (Ainamo & Bay 1975) - Bleeding on probing (Ainamo & Bay 1975) - Bleeding on probing (Ainamo & Bay 1975) - Keratinized mucosa width - Keratinized mucosa width - Keratinized mucosa width - Keratinized mucosa width - Probing depth - Probing depth - Probing depth - Probing depth ### Location - Facility: Biruni University, Istanbul, N/A, N/A, Turkey @@
## Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer - NCT ID: NCT06304987 - Study ID: BFH-niCRT-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Beijing Friendship Hospital ### Study Description This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer. ### Conditions - Locally Advanced Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor - Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor ### Outcomes Primary Outcomes - CR - AE rate Secondary Outcomes - NAR score - OPR - ORR - immune-related adverse event rate ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, 100050, China @@
## A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma - NCT ID: NCT06304974 - Study ID: BL-B01D1-305 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy. ### Conditions - Esophageal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-B01D1 - Irinotecan - paclitaxel - docetaxel ### Outcomes Primary Outcomes - Progression-free survival (PFS) - Overall survival (OS) Secondary Outcomes - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Cmax - T1/2 - Anti-drug antibody (ADA) ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, N/A, China @@
## A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers - NCT ID: NCT06304961 - Study ID: D9180C00011 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-09-05 - Lead Sponsor: AstraZeneca ### Study Description The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tozorakimab ### Outcomes Primary Outcomes - Area under the concentration-time curve from time 0 to infinity (AUCinf) - Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast) - Maximum observed drug concentration (Cmax) Secondary Outcomes - Time to reach peak or maximum observed concentration following tozorakimab administration (tmax) - Terminal elimination half-life (t1/2) - Terminal rate constant (λz) - Apparent total body clearance (CL/F) - Apparent volume of distribution based on the terminal phase (Vz/F) - Number of participants with adverse events (AEs) - Number of participants with presence of Anti-Drug Anitbodies (ADAs) ### Location - Facility: Research Site, Berlin, N/A, 14050, Germany @@
## The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency - NCT ID: NCT06304948 - Study ID: Vitamin D and migraine - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-02 - Lead Sponsor: Assiut University ### Study Description 1. To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks2. To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine.3. To correlate the serum level of glutamate with gene expression of in migraine ### Conditions - Migraine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Link between human cytomegalovirus gene expression and glutamate levels in Migraine :relationship to the Vit D Deficiency Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Injectable Platelet Rich Fibrin Post Tonsillectomy - NCT ID: NCT06304935 - Study ID: IPRF effect post tonsillectomy - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-01 - Lead Sponsor: Assiut University ### Study Description To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy ### Conditions - IPRF Post Tonsillectomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Use of injectable platelet rich fibrin after tonsillectomy by injection of IPRF in one tonsillar bed and use of other side as control ### Outcomes Primary Outcomes - IPRF effect on healing - IPRF effect on post tonsillectomy pain and bleeding Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary - NCT ID: NCT06304922 - Study ID: BRCA 1/2 in cancer ovary - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Assiut University ### Study Description The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer. ### Conditions - Ovarian Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer ### Outcomes Primary Outcomes - Objective response rate. - Progression free survival Secondary Outcomes - Overall survival and toxicity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block - NCT ID: NCT06304909 - Study ID: 2080278 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-03 - Lead Sponsor: Assiut University ### Study Description Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block. ### Conditions - Trauma Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine injection ### Outcomes Primary Outcomes - The incidence of rebound pain. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy - NCT ID: NCT06304896 - Study ID: #18240343 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-12-01 - Lead Sponsor: Arab Contractors Medical Centre ### Study Description BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality. ### Conditions - Chemotherapy Induced Systolic Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Carvedilol - Ramipril - Rosuvastatin - Colchicine - Placebo ### Outcomes Primary Outcomes - Chemotherapy-induced cardiomyopathy - Chemotherapy-induced cardiomyopathy Secondary Outcomes - Major Adverse Cardiovascular Events - All-Cause Mortality ### Location - Facility: Arab Contractors Medical Centre, Cairo, N/A, N/A, Egypt @@
## Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects - NCT ID: NCT06304883 - Study ID: ALZ-801-AD351 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-01 - Lead Sponsor: Alzheon Inc. ### Study Description This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801. ### Conditions - Early Alzheimer's Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Experimental: ALZ-801 ### Outcomes Primary Outcomes - Primary cognitive efficacy endpoint 1 - Primary cognitive efficacy endpoint 2 - Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs) - Primary imaging biomarker endpoint 1 - Primary imaging biomarker endpoint 2 Secondary Outcomes - Secondary functional efficacy endpoint - Secondary global assessment efficacy endpoint - Secondary cognitive efficacy endpoint 1 - Secondary cognitive efficacy endpoint 2 - Secondary cognitive efficacy endpoint 3 - Secondary imaging biomarker endpoint - Secondary fluid biomarker endpoint ### Location - Facility: Xenoscience, Inc., Phoenix, Arizona, 85004, United States @@
## Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease - NCT ID: NCT06304870 - Study ID: SYB-reflux - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rehabilitation therapy - Lidocaine - Injection ### Outcomes Primary Outcomes - Rosenbek penetration-aspiration scale Secondary Outcomes - Gastroesophageal Reflux Disease Questionnaire - Pressure pain threshold ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL - NCT ID: NCT06304857 - Study ID: 2022/ABM/01/00039 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-12-31 - Lead Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland ### Study Description The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment. ### Conditions - Breast Cancer - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Dapagliflozin - Placebo ### Outcomes Primary Outcomes - Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. Secondary Outcomes - Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months. - Change in left ventricular ejection fraction at 6 and 12 months. - Change in left ventricular diastolic function at 6 and 12 months. - Change in Troponin I after 6 and 12 months. - Change in NTproBNP levels at 6 and 12 months. - Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire. - Occurrence of death from any cause. - Composite endpoint of cardiovascular events. - Occurrence of death from any cardiovascular reasons. - Occurrence of non-fatal myocardial infarction. - Occurrence of non-fatal stroke. - Occurrence of hypoglycaemia. - Occurrence of ionic disorders. - Occurrence of renal failure. - Occurrence of hypersensitivity to investigated drug. - Occurrence of allergic reactions. - Occurrence of infection. ### Location - Facility: 4th Military Clinical Hospital with Polyclinic, Wrocław, Dolnośląskie, 50-981, Poland @@
## Risk of CKD in Diabetic Patients With MAFLD - NCT ID: NCT06304844 - Study ID: Soh-Med-24-02-06MD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2025-02-01 - Lead Sponsor: Sohag University ### Study Description This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions. ### Conditions - Type 2 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - transient elastography (Fibroscan) ### Outcomes Primary Outcomes - Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of Facility Ratings to Improve Satisfaction With Heath Care for Children - NCT ID: NCT06304831 - Study ID: SwissTI - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2024-09-06 - Lead Sponsor: Swiss Tropical & Public Health Institute ### Study Description Despite increasing options for public and private health care providers in Laos, choosing a high-quality health provider or a facility is difficult because timely and reliable information about providers is not readily available. People rely on social networks or previous experiences to select providers. However, in Laos, only 28% describe their recent visit to a health care provider as high-quality suggesting that while there are increasing options for care, people may need support to find providers that meet their quality needs. Rapid adoption of mobile phones in Laos, particularly in urban areas, offer opportunities to enhance people's access to timely quality information about health care providers. The study team will use mobile phones to collect and disseminate quality information about providers - known to be valued by Laotians - to improve their access to quality care as well as their overall satisfaction with care. ### Conditions - Quality of Health Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Quality ratings of health care providers for children ### Outcomes Primary Outcomes - Proportion of mothers that change their preferred health care providers for children for non-urgent care Secondary Outcomes - Proportion of mothers satisfied with health care for their children of their most recent visit - Number and type of health care providers used in the past 3 months - Proportion of mothers that change their most recently visited health care providers for children - Proportion of mothers choosing the preferred facility for non-urgent care because of online or digital information sources - Proportion of mothers that change their preferred health care providers for children for urgent care - Proportion of mothers confident they can identify the best place for getting care for sick children ### Location - Facility: Lao Tropical and Public Health Institute, Vientiane, Vientiane Capital, N/A, Lao People's Democratic Republic @@
## Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours. - NCT ID: NCT06304818 - Study ID: SCTB14-X101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2028-12-30 - Lead Sponsor: Sinocelltech Ltd. ### Study Description This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial. ### Conditions - Advanced Malignant Solid Tumours ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SCTB14 ### Outcomes Primary Outcomes - Dose-Limiting toxicity(DLT) - Objective response rate (ORR) Secondary Outcomes - Disease control rate (DCR) - Progression-free survival (PFS) - Overall survival (OS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TGRX-326 Phase I/II Pharmacokinetic Study - NCT ID: NCT06304805 - Study ID: TGRX-326-1002 - Status: COMPLETED - Start Date: 2023-12-13 - Completion Date: 2024-01-19 - Lead Sponsor: Shenzhen TargetRx, Inc. ### Study Description A study evaluating the effects of food intake on the pharmacokinetic (PK) profiles of TGRX-326 and the effect of different drug specifications on human bioavailability for TGRX-326, a drug indicated for non-small cell lung cancer treatment ### Conditions - Non Small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - cycle 1: treatment drug - cycle 1: reference drug - cycle 1: fasted - cycle 1: food - cycle 2: treatment drug - cycle 2: reference drug - cycle 2: fasted - cycle 2: food - cycle 3: treatment drug - cycle 3: reference drug - cycle 3: fasted - cycle 3: food ### Outcomes Primary Outcomes - Plasma Cmax - Plasma AUC(0-t) - Plasma AUC(0-inf) Secondary Outcomes - Plasma Tmax - terminal elimination rate constant (lambda-z) - Elimination half-life (T1/2-Z) - AUC(%Extrap) - Plasma volume of distribution (Vz/F) - Plasma clearance (CL/F) - Adverse events/serious adverse events ### Location - Facility: First Affiliated Hospital Bengbu Medical College, Bengbu, Anhui, 233004, China @@
## Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer - NCT ID: NCT06304792 - Study ID: H-22030591 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2028-08-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate. ### Conditions - Infertility - IVF ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Immediate FET in a stimulated or programmed cycle ### Outcomes Primary Outcomes - Live birth rate Secondary Outcomes - Live birth rate per blastocyst transfer - Ongoing pregnancy rate - Miscarriage rate - Cancelled cycle rate and reason for cancelled cycles - Endocrinology of the luteal phase - Number of ovarian follicular structures >10 mm - Time-to-pregnancy - Time-to-live-birth - Pregnancy related complications - Neonatal outcomes (weight in kilograms) - Neonatal outcomes (length in cm) - Neonatal outcomes (apgar score at 1, 5 and 10 minutes postpartum) - Quality of life based on the Copenhagen Multicenter Psychosocial Infertility (COMPI) stress scale questionnaires ### Location - Facility: Fertility Departmen, Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## The Effect of Continuous Intravenous Infusion of Lidocaine on PPCs and Prognosis in Emergency Surgical Patients With IAI - NCT ID: NCT06304779 - Study ID: V3.0.2023.11.29 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-10-31 - Completion Date: 2026-06-30 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description The main purpose of this study is to evaluate the impact of continuous 24-hour intravenous infusion of lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for intra-abdominal infection (IAI).The secondary objectives of this study are to assess the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period, length of hospital stay, and outcomes within 30 days postoperatively. ### Conditions - Postoperative Pulmonary Complications - Intra-abdominal Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Lidocaine - Placebo ### Outcomes Primary Outcomes - The impact of continuous 24-hour intravenous lidocaine on the incidence of PPCs in patients undergoing emergency laparotomy for IAI. Secondary Outcomes - the impact of continuous 24-hour intravenous lidocaine infusion on the proportion of patients requiring mechanical ventilation, protection of important organ function during the perioperative period ### Location - Facility: Zhongshan Hospital,Fudan university, Shanghai, Shanghai, 200032, China @@
## Open Versus Laparoscopic Ablation of Liver Malignancies - NCT ID: NCT06304766 - Study ID: H-23015954 - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2025-12 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery. ### Conditions - Hepatocellular Carcinoma - Cholangiocarcinoma - Liver Metastases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Laparoscopic ablation - Open ablation ### Outcomes Primary Outcomes - Complications measured by the comprehensive complication index. Secondary Outcomes - Tumor ablation completeness. - Quality of Recovery score (QoR) - Quality of Life score (QoL) - Overall survival ### Location - Facility: Rigshospitalet, Copenhagen, N/A, 2100, Denmark @@
## ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction - NCT ID: NCT06304753 - Study ID: BOT119435 - Status: RECRUITING - Start Date: 2023-10-27 - Completion Date: 2025-12-01 - Lead Sponsor: I.M. Sechenov First Moscow State Medical University ### Study Description BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes. ### Conditions - Chronic Heart Failure With Low Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telebot ### Outcomes Primary Outcomes - All-cause mortality - Heart failure decompensation Secondary Outcomes - Change in NT-proBNP - Change in Quality of life - Changes in medical adherence ### Location - Facility: Hospital Therapy No. 1 Department, University Clinical Hospital No. 1, Sechenov University, Moscow, N/A, 119435, Russian Federation @@
## Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants - NCT ID: NCT06304740 - Study ID: IMG-007-102 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2024-09 - Lead Sponsor: Inmagene LLC ### Study Description This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - IMG-007 - Placebo ### Outcomes Primary Outcomes - Adverse Event Evaluation Secondary Outcomes - Pharmacokinetic Parameters, Cmax - Pharmacokinetic Parameters, Tmax - Pharmacokinetic Parameters, AUC0-t ### Location - Facility: Linear Clinical Research, Perth, N/A, N/A, Australia @@
## Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment - NCT ID: NCT06304727 - Study ID: 23-5064 - Status: RECRUITING - Start Date: 2022-11-21 - Completion Date: 2024-06-30 - Lead Sponsor: Hospices Civils de Lyon ### Study Description The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization.A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections.A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management. ### Conditions - Bronchiolitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - clinical data review ### Outcomes Primary Outcomes - Feasibility of the short enteral feeding protocol Secondary Outcomes ### Location - Facility: Hopital Femme Mere Enfant, Bron, N/A, N/A, France @@
## Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana - NCT ID: NCT06304714 - Study ID: 20_RIPH3-16 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-08 - Lead Sponsor: University Hospital Center of Martinique ### Study Description In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage.Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated.The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes.The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena.This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients. ### Conditions - Snake Envenomation - Thrombi - Coagulopathy - Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patients suffering from envenomation by Bothrops ### Outcomes Primary Outcomes - Plasma Willebrand factor (VW:Act) activity prior to administration of the anti-venom (Bothrofav® or Antivipmyn-tri®). Secondary Outcomes - Plasma VW factor activity (VW:Act/VW:Ag ratio) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Handwritten Text Production in Adults With Autism - NCT ID: NCT06304701 - Study ID: PI-2023-08 - Status: RECRUITING - Start Date: 2023-11-29 - Completion Date: 2025-05 - Lead Sponsor: Centre Hospitalier de Niort ### Study Description The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.The secondary objectives are:* Identifying links between specific deficits of ASD and difficulties in written production.* Identifying links between the severity of ASD and difficulties in written production.The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).The secondary evaluation criteria are:* Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).* Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).* Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC). ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Cognitive and writing tests ### Outcomes Primary Outcomes - Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd) Secondary Outcomes - Identifying links between specific deficits of ASD and difficulties in written production - Identifying links between the severity of ASD and difficulties in written production ### Location - Facility: Centre Hospitalier de Niort, Niort, N/A, 79000, France @@
## Yoga and Diet on Cognitive, Nutritional Status, Mental and Functional Abilities in Older Adults - NCT ID: NCT06304688 - Study ID: University of Jaén_24 - Status: COMPLETED - Start Date: 2023-11-13 - Completion Date: 2024-02-12 - Lead Sponsor: University of Jaén ### Study Description Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted. Also, Nutrition plays a fundamental role in the health and well-being of individuals at all stages of life, but it is especially crucial in old age due to the physiological and metabolic changes that occur during the aging process. Maintaining a healthy and balanced diet is essential for providing the necessary nutrients for proper body function, strengthening the immune system, and maintaining the health of bone and cardiovascular structures. Specifically, the Mediterranean diet is a traditional dietary pattern based on foods commonly consumed in Mediterranean regions such as Greece, Italy, and Spain. It is characterized by high consumption of fruits, vegetables, legumes, nuts, whole grains, fish, and olive oil, along with moderate intake of dairy and red wine, and limited con-sumption of red meat and processed products. This eating style has been the subject of numerous scientific studies highlighting its multiple health benefits. Apart from the physical health benefits for older adults, the Mediterranean diet has consistently been associated with positive effects such as reduced risk of cardiovascular pathologies, de-creased chronic diseases and pro-inflammatory factors, as well as contributing to the prevention of obesity and cognitive decline. ### Conditions - Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yoga and Mediterranean Diet intervention ### Outcomes Primary Outcomes - TMT (Trail Making Test) - SFT (Senior Fitness Test) - Handgrip Strength - Mindful Attention Awareness Scale (MAAS) - Digit symbol substitution test (DSST) - D2 test - Isaac test - Anxiety and Depression - Sleep quality - Balance - Nutritional status Secondary Outcomes ### Location - Facility: Agustín Aibar Almazán, Jaén, N/A, 23007, Spain @@
## Manageable Environmental Factors in Migraine - NCT ID: NCT06304675 - Study ID: 905055423985 - Status: COMPLETED - Start Date: 2023-09-30 - Completion Date: 2024-03-04 - Lead Sponsor: Samsun University ### Study Description There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups. ### Conditions - Migraine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - 1. Environmental factors/triggers affecting the chronicity of migraine Secondary Outcomes - 2.Environmental factors/triggers and migraine treatment ### Location - Facility: Samsun University, Samsun, N/A, 55100, Turkey @@
## Yoga for Physical and Mental Health - NCT ID: NCT06304662 - Study ID: University of Jaén - Status: COMPLETED - Start Date: 2023-11-13 - Completion Date: 2024-02-19 - Lead Sponsor: University of Jaén ### Study Description In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future. ### Conditions - Stress ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yoga intervention ### Outcomes Primary Outcomes* - D2 test - Mindful Attention Awareness Scale (MAAS) - Handgrip Strength - Anxiety and Depression - Sleep quality - Stress level - The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) - State Anxiety Inventory (STAI) - Attentional Control: Shifting and Distraction (AC-S and AC-D) - Positive and Negative Affect Schedule - Difficulties in Emotion Regulation Scale (DERS) Secondary Outcomes ### Location - Facility: Agustín Aibar Almazán, Jaén, N/A, 23007, Spain @@
## Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures - NCT ID: NCT06304649 - Study ID: Cast21CHLA2023Study1SAP - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12 - Lead Sponsor: Cast21 ### Study Description The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product. ### Conditions - Fractures, Closed - Fractures Bone - Fracture - Fractures - Radius; Fracture, Lower or Distal End - Ulna Fractures - Radius Distal Fracture ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cast or brace alternative ### Outcomes Primary Outcomes - Clinical determination of healing (standard of care) - Range of Motion (standard of care) Secondary Outcomes - Patient Reported Outcomes - Pain - Patient Reported Outcomes - Satisfaction - Physical Therapy Referral ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma - NCT ID: NCT06304636 - Study ID: DC15-MM-01 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2027-10-01 - Lead Sponsor: Cartesian Therapeutics ### Study Description This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15 ### Conditions - Refractory Multiple Myeloma - Relapsed Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Descartes-15 ### Outcomes Primary Outcomes - Determine the safety of Descartes-15 in patients with relapsed/refractory multiple myeloma (R/R MM) Secondary Outcomes - To assess the anti-myeloma activity of Descartes-15, as measured by IMWG response criteria and progression-free survival ### Location - Facility: Center for Cancer and Blood Disorders (AON), Bethesda, Maryland, 20817, United States @@
## SVF for Treating Pulmonary Fibrosis Post COVID-19 - NCT ID: NCT06304623 - Study ID: CIRE.112 - Status: COMPLETED - Start Date: 2020-05-05 - Completion Date: 2024-03-01 - Lead Sponsor: Michael H Carstens ### Study Description General description of the studyThis is a prospective, multicenter, expanded access interventional study of subjects recovered from COVID-19 pneumonia to assess their response to intravenous administration of adipose-derived autologous SVF.Primary objectiveThe purpose of this study was to evaluate the safety of single intravenous injections of autologous adipose-derived SVF produced using the GID SVF-2 device system for the treatment of secondary respiratory distress associated with COVID-19.Secondary objectiveTo evaluate the efficacy of the initial treatment with SVF IV. ### Conditions - Pulmonary Fibrosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Autologous adipose-derived SVF IV administration ### Outcomes Primary Outcomes - Safety of treatment with SVF IV Secondary Outcomes - Efficacy of the initial treatment with SVF IV ### Location - Facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA), León, Leon, 21000, Nicaragua @@
## Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador - NCT ID: NCT06304610 - Study ID: ONZ-2024-0044 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: University Hospital, Ghent ### Study Description ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations.In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer.At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests.Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador):* AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test* ELISA protein detection: only available comparison testIn order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium):• HPV DNA Mole Bioscience testConcordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes. ### Conditions - Cervical Cancer - HPV Infection ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Questionnaire - HPV self-sample - Endocervical sample ### Outcomes Primary Outcomes - Clinical validation Secondary Outcomes - Concordance - HPV DNA test validation - Protein test validation ### Location - Facility: Ghent University Hospital, Ghent, East-Flanders, 9000, Belgium @@
## Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy - NCT ID: NCT06304597 - Study ID: 17651 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-06-01 - Lead Sponsor: University Medical Center Groningen ### Study Description Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy. ### Conditions - Locally Advanced Rectal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Imfinzi - Opdivo ### Outcomes Primary Outcomes - Safety of nivolumab-800CW in combination with durvalumab-680LT - To investigate the feasibility of using fluorescence molecular endoscopy (FME) and ex vivo FMI to detect nivolumab-800CW and durvalumab-680LT signals indicating PD1 and PD-L1 expression. - Heart rate - Blood pressure systolic and diastolic - Temperature Secondary Outcomes - Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. - Determine the PD-1 and PD-L1 expression and the changes in PD-1 and PD-L1 expression before and after nCRT in patients with LARC. - Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression - Quantify in vivo fluorescence signals of nivolumab-800CW and durvalumab-680LT before and after CRT by using MDSFR/SFF spectroscopy/UNSB/SFF spectroscopy and correlate these measurements to, in vivo fluorescence intensities and PD1/PD-L1 expression - Perform real-time polymerase chain reaction (qPCR) and western blot on biopsies to determine whether there is genetic downregulation or protein degradation of PD-1 and PD-L1 after chemoradiotherapy - Compare immune cell composition between the radiated and non-radiated area of the bowel. - Evaluate targeted detection with nivolumab-800CW and durvalumab-680LT of the tumor by ex vivo visualization of the resection specimen with PEARL Trilogy ### Location - Facility: University Medical Center Groningen, Groningen, N/A, 9713 GZ, Netherlands @@
## Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture - NCT ID: NCT06304584 - Study ID: P-2023-143 - Status: RECRUITING - Start Date: 2023-05-15 - Completion Date: 2025-05-15 - Lead Sponsor: University Hospital Bispebjerg and Frederiksberg ### Study Description The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip.The main questions aim to answer:* how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered* what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fractureParticipants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation. ### Conditions - Hip Fractures - Rehabilitation - Recovery of Function ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Recovery of pre-fracture function Secondary Outcomes - Basic mobility - 30 second chair stand test (CST) - Timed Up & Go test (TUG) - Hip related pain - Hand Grip Strength (HGS) - Health questionnaire - Physical activity (weekly) - Physical activity / upright time (time standing and walking) - Frailty - Fear of falling - Comorbidity - Cognitive status - Number of falls - Residential status / discharge destination - Length of stay in acute hospital - Number of weekly exercise sessions with therapist in all settings - Number of rehab weeks - Type of training in Municipality - Training after discharge from 24-hour setting - Home care, nurse/other health assistance, times pr week - Data 30 days post-discharge - Data 3 months post-discharge - Data 1 year post-discharge ### Location - Facility: Department of Physio- and Occupational Therapy and Othopedic Surgery, University Hospital Bispebjerg and Frederiksberg, Copenhagen, N/A, 2400, Denmark @@
## A Study of HC006 in Subjects With Advanced Solid Tumors - NCT ID: NCT06304571 - Study ID: HC006-001 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2026-07-16 - Lead Sponsor: HC Biopharma Inc. ### Study Description The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors. ### Conditions - Advanced Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - HC006 ### Outcomes Primary Outcomes - Incidence of Dose Limiting Toxicities(DLTs) - Incidence of adverse events(AEs) - Incidence of Serious adverse events(SAEs) - Clinically Significant changes in safety assessments Secondary Outcomes - Pharmacokinetic (PK) Parameter:Maximum serum concentration (Cmax) - PK Parameter:Time to reach Cmax (Tmax) - PK Parameter:Area Under the Concentration-time Curve (AUC) - Immunogenicity - Objective Response Rate (ORR) per RECIST 1.1 - progression-Free Survival (PFS) per RECIST 1.1 - Overall Survival (OS) - Disease Control Rate (DCR) per RECIST 1.1 - Duration of response (DOR) per RECIST 1.1 - Time to progression (TTP) per RECIST 1.1 - Time To Response (TTR) per RECIST 1.1 ### Location - Facility: Shanghai East Hospital, Shanghai, Shanghai, 200120, China @@
## "Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects. - NCT ID: NCT06304558 - Study ID: CI 240228, 2024-480 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2024-06 - Lead Sponsor: Universidad Europea de Madrid ### Study Description The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results. ### Conditions - Sexual Satisfaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Non-Invasive Neuromodulation (NESA) ### Outcomes Primary Outcomes - Sexual satisfaction Secondary Outcomes - Stress levels - Blood Pressure (Sistolic and diastolic) - Heartbeats per minute - Sleep Quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab - NCT ID: NCT06304545 - Study ID: SHR-1210-HLJ-081 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-03-15 - Lead Sponsor: Harbin Medical University ### Study Description This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation. ### Conditions - Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Camrelizumab - Chemotherapy - Radiotherapy ### Outcomes Primary Outcomes - Pathological Complete Response rate Secondary Outcomes - Objective Response Rate - Disease Control Rate - Anal preservation rate - Disease-free Survival - Overall Survival - AEs - 3-years Overall Survival rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Efficacy and Safety Assessment of Alsareen Capsule for the Management of H. Pylori Infection - NCT ID: NCT06304532 - Study ID: HU123 - Status: COMPLETED - Start Date: 2023-08-15 - Completion Date: 2024-03-06 - Lead Sponsor: Hamdard University ### Study Description Helicobacter pylori infection is a major cause of morbidity and mortality worldwide. More than 50% of the global population is estimated to be infected. In 2015, there were approximately 4.4 billion individuals with H pylori infection worldwide. In Pakistan the prevalence of H. pylori infection, highest (63%) in middle age (41-60 years) group while lowest (33%) in teens and pre-teens (\<20 years) group. In young age (20-40) and old age (\>60 years) groups, the prevalence of H. pylori was 55% and 60% respectively.In conventional system of medicine H. pylori infection is treated by triple regimen antibiotic therapy that are amoxicillin, clarithromycin and metronidazole along with acid reducing proton pump inhibitor. Due to recurrence of infection this therapy is repeated multiple times resulting in drug resistance and long term side effects. These side effects \& a long term impact of H. pylori in patient general health necessitates development of a safe and long term effective therapy. ### Conditions - H. Pylori Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - H. pylori stool for antigen test will screened before and after treatment. Secondary Outcomes ### Location - Facility: Shifa Ul Memorial Hospital-Hamdard University, Karachi, Sindh, N/A, Pakistan @@
## Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke - NCT ID: NCT06304519 - Study ID: 1986626-1 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2026-02-28 - Lead Sponsor: University of Delaware ### Study Description Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Dynamic ankle-foot orthosis ### Outcomes Primary Outcomes - Mechanical Cost of Transport of the Lower Extremities - Sagittal plane ankle moment during stance - Sagittal plane ankle angle during stance - Self-selected walking speed - a candidate set of clinical outcome measures Secondary Outcomes ### Location - Facility: University of Delaware STAR Campus, Newark, Delaware, 19713, United States @@
## Effect of Obesity on Extracellular Matrix Composition - NCT ID: NCT06304506 - Study ID: 514-0894/23-3000 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-12-30 - Lead Sponsor: University of Copenhagen ### Study Description The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.The main questions to answer,- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men ### Conditions - Adipose Tissue ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Cross sectional study ### Outcomes Primary Outcomes - The effect of obesity and age on adipose tissue extracellular matrix composition Secondary Outcomes ### Location - Facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, N/A, 2200, Denmark @@
## REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU) - NCT ID: NCT06304493 - Study ID: 23-2470 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: University of Colorado, Denver ### Study Description The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders. ### Conditions - Postoperative Atelectasis - Postoperative Hypoxemia - Postoperative Pneumonia - Postoperative Pulmonary Complications - Patient Adherence - Incentive Spirometry - Respiratory Therapy - Respiratory Insufficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Alarms ### Outcomes Primary Outcomes - Rate of adequate IS breaths achieved in PACU Secondary Outcomes - Rate of IS breaths attempted in PACU - Time to first adequate IS breath - Duration of postoperative O2 therapy - Presence of postoperative pulmonary complications - Individual postoperative pulmonary complications - Need for ICU Admission after PACU - PACU Length of Stay ### Location - Facility: CU Anschutz, Aurora, Colorado, 80045, United States @@
## Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome - NCT ID: NCT06304480 - Study ID: AFCRO-179 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-07-31 - Lead Sponsor: University College Cork ### Study Description There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods.As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens. ### Conditions - Gut Microbiome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - 100g fermented Tofu ### Outcomes Primary Outcomes - To evaluate the effect of replacing animal protein in a typical Western diet with plant-derived protein delivered in a (soy-based) tofu on gut microbiome composition. Secondary Outcomes - To evaluate the functional activity of the gut microbiome, and any alterations caused by the soya replacement. - To evaluate the metabolome of urine and faecal samples and any alterations caused by the soya replacement. - To measure the effect of the meat substitution on a panel of proinflammatory cytokines, based on the observation that particular taxa are associated with an inflammatory phenotype. - To measure the effect of the meat substitution on cholesterol and serum triglycerides. - To measure the effect of the meat substitution on blood pressure. - To measure the effect of the meat substitution on body mass index (BMI). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## CM for Patients With ALD After Liver Transplant - NCT ID: NCT06304467 - Study ID: IRB#23-001133 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-01 - Lead Sponsor: Arpan A. Patel, MD ### Study Description Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use.The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility. ### Conditions - Alcohol Use Disorder - Alcohol; Liver - Post Liver Transplant - Contingency Management - Alcohol Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Contingency Management ### Outcomes Primary Outcomes - Number of Non-Drinking Days Secondary Outcomes - Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr)) - Client Satisfaction Questionnaire-8. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes - NCT ID: NCT06304454 - Study ID: P5_BG - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-03-15 - Lead Sponsor: Brain In Game scientific-technical service ### Study Description Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group. ### Conditions - Kindergarten Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Board game intervention ### Outcomes Primary Outcomes - Visual Memory - Processing speed and inhibition - Affect recognition Secondary Outcomes - Hollingshead Index (Hollingshead, 1975) - CHEXI (Giménez et al. 2022) ### Location - Facility: Faculty of Education, Psychology and Social Work; University of Lleida, Lleida, N/A, 25001, Spain @@
## Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer - NCT ID: NCT06304441 - Study ID: IPVO - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: Guangzhou Medical University ### Study Description Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined. ### Conditions - Leptomeningeal Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osimertinib - Pemetrexed ### Outcomes Primary Outcomes - Clinical response rate Secondary Outcomes - Overall survival - Incidence of treatment-related adverse events ### Location - Facility: The Third People's Hospital of Huizhou (Huizhou Hospital of Guangzhou Medical University), Huizhou, Guangdong, N/A, China @@
## Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications - NCT ID: NCT06304428 - Study ID: Pro00114580 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2028-07-01 - Lead Sponsor: Duke University ### Study Description The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone.The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders.The main questions this study aims to answer are:* Which of the three models is more effective in preventing falls with fractures?* What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling.* What are the differences in osteoporosis treatment and medication burden?The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services.42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team.This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol. ### Conditions - Accidental Falls/Prevention and Control - Osteoporosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Deprescribing Care Model - Bone Health Service Model - Injury Prevention Service Model ### Outcomes Primary Outcomes - Injurious falls Secondary Outcomes - Number of patients who initiate treatment for osteoporosis - Medication Possession Ratio during follow-up, as measured by EHR and Medicare claims - Number of patients who had deprescribing ordered - Modified Drug Burden Index during follow-up, as measured by EHR and Medicare claims - Patient medication side effect burden, measured via Living with Medicines Questionnaire (LMQ3). - Patient falls self-efficacy (i.e. fear of falling), measured via Falls Efficacy Scale - Patient pain, measured via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form - Patient depression, measured via Patient Health Questionnaire survey (PHQ-8) - Patient anxiety, measured via PROMIS anxiety short form survey - Patient sleep, measured via PROMIS sleep disturbance short form ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Elevated Lipoprotein(a) in Hospital Staff - NCT ID: NCT06304415 - Study ID: CIRB2023/2651 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2036-12-31 - Lead Sponsor: Changi General Hospital ### Study Description The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population. ### Conditions - Hypercholesterolemia - Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Distribution and prevalence of elevated Lipoprotein(a) Secondary Outcomes - Correlation of lipoprotein(a) with cardiovascular outcomes - Genetic variants of lipoprotein(a) and cardiovascular outcomes atherosclerotic events ### Location - Facility: Clinical Trials & Research Unit, Singapore, N/A, 529889, Singapore @@
## Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players - NCT ID: NCT06304402 - Study ID: 7978-GOA - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-06-01 - Lead Sponsor: Dokuz Eylul University ### Study Description This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications. ### Conditions - Sports Physical Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - The Percussive Massage Treatment - The Proprioceptive Neuromuscular Facilitation Stretching ### Outcomes Primary Outcomes - Shoulder internal rotation range of motion Secondary Outcomes - Attack Speed ### Location - Facility: Dokuz Eylul University, School of Physical Therapy and Rehabilitation, İzmir, Balçova, 35340, Turkey @@
## Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy - NCT ID: NCT06304389 - Study ID: BLUELIGHT-VNS - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2026-04 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS. ### Conditions - Refractory Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration - transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration ### Outcomes Primary Outcomes - Effect of blue light on VNS biomarkers - Effect of blue light on VNS biomarkers - Effect of blue light on VNS biomarkers Secondary Outcomes ### Location - Facility: Cliniques Universitaires Saint Luc, Woluwe-Saint-Lambert, N/A, 1200, Belgium @@
## Evaluation of Shell Technique in Secondary Alveolar Cleft Grafting - NCT ID: NCT06304376 - Study ID: OMFS/FSDC002 - Status: COMPLETED - Start Date: 2022-03-12 - Completion Date: 2024-02-22 - Lead Sponsor: October 6 University ### Study Description This study aims to evaluate the sufficiency of Khoury shell technique for reconstruction of alveolar cleft. Khoury technique was carried out using cortical bone shell fixed away from alveolar bone using two micro-screws, which was harvested from anterior iliac bone crest. The gap between the shell cortical bone and the native alveolar bone was filled by cancellous bone which was harvested from anterior iliac crest bone. The whole graft was covered by collagen membrane. The volumetric bone gain of the defect was determined via CBCT. ### Conditions - Alveolar Cleft - Alveolar Ridge Cleft ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Alveolar ridge grafting ### Outcomes Primary Outcomes - Volumetric bone gain Secondary Outcomes - Eruption of the tooth in the cleft ### Location - Facility: Ministry of Health, Farwaniya Hospital, Al Farwānīyah, N/A, 81004, Kuwait @@
## Braining - Evaluation of Acute Effects of Physical Exercise - NCT ID: NCT06304363 - Study ID: Braining booster - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-31 - Lead Sponsor: Region Stockholm ### Study Description "Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period.The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes. ### Conditions - Psychiatric Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Braining ### Outcomes Primary Outcomes - Anxiety Visual Analogue Scale (VAS) Secondary Outcomes - Beck Anxiety Inventory BAI - Montgomery-Åsberg Depression Rating Scale MADRS - High sensitivity C-reactive protein hsCRP - Brain-derived neurotrophic factor BDNF - Telomerase activity - Motivational factors of continued exercise ### Location - Facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest), Stockholm, N/A, 14186, Sweden @@
## Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma - NCT ID: NCT06304350 - Study ID: SGHDOT-24-20 - Status: RECRUITING - Start Date: 2024-02-17 - Completion Date: 2026-12-31 - Lead Sponsor: Tongji University ### Study Description This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study ### Conditions - Esophageal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Combination of pembrolizumab and platinum containing dual drugs ### Outcomes Primary Outcomes - Pathological complete remission (pCR) Secondary Outcomes - Major pathological remission (MPR) - R0 resection rate - Progression free survival (PFS) - Total survival time (OS) - Safety (incidence of adverse drug reactions) ### Location - Facility: Shanghai General Hospital, Shanghai, Shanghai, 200080, China @@
## Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy - NCT ID: NCT06304337 - Study ID: YXLL-KY-2023(162) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-03 - Completion Date: 2025-03-03 - Lead Sponsor: Qianfoshan Hospital ### Study Description The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2\<90%, t\>10s) and severe hypoxia (Spo2\<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients. ### Conditions - Airway Management ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - New oropharyngeal airway group ### Outcomes Primary Outcomes - Incidence of hypoxia (Spo2<90%,t>10s) and severe hypoxia (Spo2<85%) during anesthetic sedation Secondary Outcomes - The incidence of choking, reflux aspiration and laryngeal spasm were recorded - The dose of additional drugs during the operation - Endoscopist satisfaction - Record adverse events that occur throughout the process ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block - NCT ID: NCT06304324 - Study ID: 18/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-30 - Lead Sponsor: Poznan University of Medical Sciences ### Study Description Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery. ### Conditions - Ankle Disease - Ankle Injuries and Disorders - Foot Injury - Foot Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 0.9% Sodium chloride - 0.1mg/kg Dexamethasone - 0.05ug/kg Dexmedetomidine ### Outcomes Primary Outcomes - time to the first need of opiate following the procedure Secondary Outcomes - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale - Neutrophil-to-lymphocyte ratio - Platelet-to-lymphocyte ratio - Platelet-to-lymphocyte ratio - Time to mobilization ### Location - Facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland, Poznań, Wielkopolska, 61-545, Poland @@
## Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida - NCT ID: NCT06304311 - Study ID: MAHSA/PHD/SON/2024/01 - Status: COMPLETED - Start Date: 2022-10-02 - Completion Date: 2024-01-04 - Lead Sponsor: University of Lahore ### Study Description The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes. ### Conditions - Labor Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Routine Obstetrics care & Lamaze breathing techniques and backside massage ### Outcomes Primary Outcomes - Labour pain intensity - Anxiety level - Duration of Labour - Maternal self-efficacy Secondary Outcomes ### Location - Facility: Lady Wallingdon Hospital, Lahore, Punjab, 54000, Pakistan @@
## NLR and PLR Levels Following iPACK Block in Knee Arthroplasty - NCT ID: NCT06304298 - Study ID: 10/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-01 - Lead Sponsor: Poznan University of Medical Sciences ### Study Description Effect of iPACK block on NLR and PLR following knee arthroplasty ### Conditions - Knee Arthropathy - Knee Osteoarthritis - Knee Pain Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 0.9% Sodium Chloride Injection - Ropivacaine 0.2% Injectable Solution ### Outcomes Primary Outcomes - Neutrophil-to-lymphocyte ratio - Neutrophil-to-lymphocyte ratio - Neutrophil-to-lymphocyte ratio Secondary Outcomes - PLR - PLR - PLR - first need of opiate - Opioid Consumption - Pain score - Pain score - Pain score - Pain score - Pain score - Pain score - Pain score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis - NCT ID: NCT06304285 - Study ID: 2023-ky421 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: The First Affiliated Hospital of University of Science and Technology of China ### Study Description The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD ### Conditions - Parkinson's Disease - Chronic Appendicitis - Acupuncture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture treatment - Sham acupuncture treatment ### Outcomes Primary Outcomes - Score of MDS Unified-Parkinson Disease Rating Scale III Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, 230001, China @@
## Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound - NCT ID: NCT06304272 - Study ID: Irrigation - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-12 - Lead Sponsor: Patan Academy of Health Sciences ### Study Description There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference. ### Conditions - Trauma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Irrigating Traumatic Wound with Drinking Water ### Outcomes Primary Outcomes - Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis - NCT ID: NCT06304259 - Study ID: 24428 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10-01 - Lead Sponsor: October 6 University ### Study Description Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. ### Conditions - Endodontic Disease - Endodontically Treated Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Saline - Saline ### Outcomes Primary Outcomes - postoperative pain - postoperative pain - postoperative pain Secondary Outcomes - Substance P level - Substance P level - Substance P level ### Location - Facility: Faculty of Dentistry, Ain shams University, Cairo, N/A, 4543070, Egypt @@

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