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## The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU - NCT ID: NCT06353659 - Study ID: M2024077 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-06-30 - Lead Sponsor: Peking University Third Hospital ### Study Description The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury. ### Conditions - Intensive Care Unit - Acute Kidney Injury - Ultrasound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Contrast-enhanced Ultrasound ### Outcomes Primary Outcomes - Acute kidney injury (according to KDIGO 2012 criteria) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer - NCT ID: NCT06353646 - Study ID: XKY-C-004 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Wu Wenming ### Study Description This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - XH001 - Ipilimumab Injection - Chemotherapy ### Outcomes Primary Outcomes - DFS - 1-year DFS rate - MFS - OS Secondary Outcomes - Elispot - Adverse Event - ctDNA - CA19-9 ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China @@
## The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease - NCT ID: NCT06353633 - Study ID: AHekmatdoost - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-25 - Lead Sponsor: National Nutrition and Food Technology Institute ### Study Description In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula. ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - formula - exclusion diet ### Outcomes Primary Outcomes - PCDAI - CRP - ESR - FC - Alb Secondary Outcomes - Arm Circumferance - BMI - Height - weight ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy - NCT ID: NCT06353620 - Study ID: 1018 - Status: RECRUITING - Start Date: 2024-02-13 - Completion Date: 2027-02-28 - Lead Sponsor: IRCCS Eugenio Medea ### Study Description Recent studies have shown that the aperiodic part of the signal (neuronal avalanches) of electroencephalography (EEG) contains important information about the dynamics of neuronal networks. Indeed, this has helped to identify functionally altered areas in patients with temporal epilepsy by simply using the resting EEG signal. Furthermore, it has been seen that the propagation of neuronal avalanches (VNs) correlates with the morphological organization of the cerebral cortex. Therefore, NAs represent a measure with direct utility for studying functional reorganization pre and post drug/surgical treatment. In addition, the aperiodic portion of the signal may represent a noninvasive measure of the excitation/inhibition relationship, which is known of being altered both in epilepsy and in some rare neurodevelopmental syndromes (example: Angelman and Dup15q) ### Conditions - Epilepsy - Angelman Syndrome - Dup15q Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - High Density EEG recording - Rey Complex Figure Test ### Outcomes Primary Outcomes - Differences in the network coherence values in theta and alpha band after treatment - Stability of the alpha frequency band in the EEG activity - Correlation of neural excitation and memory performance Secondary Outcomes ### Location - Facility: IRCCS E.Medea, Conegliano, Treviso, 31015, Italy @@
## Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm. - NCT ID: NCT06353607 - Study ID: 2023-02267; kt23Berdajs - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2028-12-31 - Lead Sponsor: University Hospital, Basel, Switzerland ### Study Description The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection. ### Conditions - Acute Aortic Dissection - Thoracic Aortic Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease. Secondary Outcomes - Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology. - To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD. - To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints. ### Location - Facility: University Hospital Basel, Basel, N/A, 4031, Switzerland @@
## Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI - NCT ID: NCT06353594 - Study ID: COPERNICAN TRIAL - Status: RECRUITING - Start Date: 2024-03-11 - Completion Date: 2035-09 - Lead Sponsor: Jorge Sanz Sanchez ### Study Description The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:* Study group: reduced stent PCI strategy (DCB-based)* Control group: conventional PCI strategy (DES-based). ### Conditions - ST Elevation Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Primary PCI ### Outcomes Primary Outcomes - Target lesion failure (TLF) Secondary Outcomes - Incidence of all-cause death - Incidence of myocardial infarction - Incidence of cardiovascular death - Incidence of target lesion revascularization - Incidence of stent thrombosis - Incidence of acute vessel closure - Incidence of stroke - Incidence of acute kidney injury - Incidence of bleeding ### Location - Facility: Hospital Universitario Y Politecnico La Fe, Valencia, Comunidad Valenciana, N/A, Spain @@
## Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX - NCT ID: NCT06353581 - Study ID: 4-2021-0924 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-02-16 - Completion Date: 2024-05-08 - Lead Sponsor: Yonsei University ### Study Description Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy. ### Conditions - Locally Advanced Pancreatic Cancer - Metastatic Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Neulapeg - Control ### Outcomes Primary Outcomes - Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) - development of neutropenic fever (febrile neutropenia) Secondary Outcomes - relative dose intensity - quality of life assessed according to EORTC QLQ-C30 - Number of patients experiencing Adverse events (AEs) - objective response rate - Progression-free survival - Overall survival - Change in blood cytokine concentrations - G-CSF induced bone pain as assessed by questionnaires ### Location - Facility: Severance Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot - NCT ID: NCT06353568 - Study ID: 5.888.210 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2027-12-30 - Lead Sponsor: University of Nove de Julho ### Study Description This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life). ### Conditions - Diabetic Foot ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Photobiomodulation - Simulation of Photobiomodulation - Therapeutic education ### Outcomes Primary Outcomes - Ulcer Incidence - Ulcer Incidence - Ulcer Incidence Secondary Outcomes - Tactile sensitivity with Semmes-Weinstein monofilament - Tactile sensitivity with Semmes-Weinstein monofilament - Vibratory sensitivity - Vibratory sensitivity - Assessment of Achilles reflex - Assessment of Achilles reflex - Neuropathy Symptom Score (NSS) - Neuropathy Symptom Score (NSS) - Neuropathic Impairment Score (NIS) - Neuropathic Impairment Score (NIS) - Evaluation of the degree of ischemia - Evaluation of the degree of ischemia - Systolic peak velocity - Systolic peak velocity - Resistance Index - Resistance Index - Waveform pattern - Waveform pattern - Evaluation of claudication - Evaluation of claudication - Thermography - Thermography - Quality of Life Assessment - Quality of Life Assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage - NCT ID: NCT06353555 - Study ID: PUMCH-20240311 - Status: RECRUITING - Start Date: 2023-10-11 - Completion Date: 2025-12-31 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism. ### Conditions - Intracerebral Hemorrhage - Low T3 Syndrome - Neurocritical Care - Hormone Replacement Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Euthyrox - Euthyrox ### Outcomes Primary Outcomes - blood pressure - cerebral blood flow dynamics - Whether to use vasoactive vasopressors - neurological function Secondary Outcomes - Days of the patients received intensive care - Mechanical ventilation time ### Location - Facility: Peking union medical college hospital, Beijing, Beijing, 100730, China @@
## Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS) - NCT ID: NCT06353542 - Study ID: HCB/2023/1206 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-02 - Completion Date: 2026-09 - Lead Sponsor: Hospital Clinic of Barcelona ### Study Description Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care.Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP).The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist.In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis.This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them.Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process. ### Conditions - Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Software analysis - Ophthalmologist examination ### Outcomes Primary Outcomes - Diagnostic agreement between the AI software and the ophthalmic examination - Health-Related Quality of Life (HRQoL) - Demographics Secondary Outcomes - Intraocular pressure - Optical coherence tomography (OCT) - Visual field - Cost-effective analysis of both screening methods - Risk score with parameters associated with positive screening of glaucoma ### Location - Facility: Hospital Clínic - ICOF, Barcelona, N/A, 08028, Spain @@
## Sphenopalatine Ganglion Block for Postop Pain Management - NCT ID: NCT06353529 - Study ID: 17065 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-05 - Lead Sponsor: Hamilton Health Sciences Corporation ### Study Description To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. The aim is to improve patient outcomes and reduce the need for pain medication after surgery. ### Conditions - Pituitary - Pain, Postoperative ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution - Placebo ### Outcomes Primary Outcomes - Post-operative pain score Secondary Outcomes - Post-operative bleeding - Post-operative complications - Analgesic requirement - Length of stay ### Location - Facility: Hamilton General Hospital, Hamilton, Ontario, L8L 2X2, Canada @@
## The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients - NCT ID: NCT06353516 - Study ID: 2310-117-126 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2024-12 - Lead Sponsor: Chung-Ang University Gwangmyeong Hospital ### Study Description The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:* \[Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?\]* \[Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?\] Participants will be anesthetized with different categories of anesthetics. * Intravenous anesthetics * Inhalation gas anesthetics ### Conditions - Postoperative Cognitive Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Propofol - Sevoflurane ### Outcomes Primary Outcomes - Concentration of serum S100B levels Secondary Outcomes - Incidence of Delirium - Incidence of Postoperative Cognitive Dysfunction - Concentration of serum albumin - Concentration of serum CRP - Concentration of serum IL6 levels - Concentration of serum TNFα levels - Concentration of cerebrospinal fluid (CSF) albumin ### Location - Facility: Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Gyeonggi-do, 14353, Korea, Republic of @@
## Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment. - NCT ID: NCT06353503 - Study ID: KAZ - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2024-09-27 - Lead Sponsor: abdulmajeed hammadi ### Study Description A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia. ### Conditions - Anterior Cruciate Ligament Tear ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - autologous bone marrow aspirate concentrate ### Outcomes Primary Outcomes - Functional recovery by clinical assessments of the ACL and overall knee joint stability. Secondary Outcomes - magnetic resonance imaging of the knee joint ### Location - Facility: Ministry of Health, Baghdad, N/A, 964, Iraq @@
## The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers - NCT ID: NCT06353490 - Study ID: Geon-111001 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-08-12 - Completion Date: 2024-08-11 - Lead Sponsor: Geon Corporation ### Study Description Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.The main objectives of this study are:1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.2. To verify the consistency of repeated measurements of investigational devices. ### Conditions - Febrile - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Infrared Forehead Thermometer (GE-TF03) - Infrared Ear Thermometer (GE-TE06) - Electronic Thermometer (MT-B321FB) - Electronic Thermometer (MT-B231) ### Outcomes Primary Outcomes - Clinical Bias - Limits of Agreement - Clinical Repeatability Secondary Outcomes ### Location - Facility: Hsinchu MacKay Memorial Hospital, Hsinchu, N/A, N/A, Taiwan @@
## Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option - NCT ID: NCT06353477 - Study ID: EOU 2019-10 - Status: COMPLETED - Start Date: 2019-06-01 - Completion Date: 2023-01-01 - Lead Sponsor: Eskisehir Osmangazi University ### Study Description This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children. ### Conditions - Hand, Foot, and Mouth Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EPs® 7630 ### Outcomes Primary Outcomes - the patient's fever status, restlessness, inappetence, and sleeplessness scores Secondary Outcomes ### Location - Facility: Istinye University Medicine Faculty Hospital, Esenyurt, İstanbul, 34517, Turkey @@
## A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation - NCT ID: NCT06353464 - Study ID: 2306009984 - Status: RECRUITING - Start Date: 2023-10-04 - Completion Date: 2025-09 - Lead Sponsor: Drexel University ### Study Description This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Ensure and Water ### Outcomes Primary Outcomes - Grams of pizza consumed - Baseline medial prefrontal cortex oxygenated hemoglobin - Baseline lateral prefrontal cortex oxygenated hemoglobin - medial prefrontal cortex Oxygenated hemoglobin concentration - lateral prefrontal cortex Oxygenated hemoglobin concentration Secondary Outcomes - medial prefrontal cortex Time to Peak Light Intensity - lateral prefrontal cortex Time to Peak Light Intensity - Preload Oxygenated Hemoglobin Difference ### Location - Facility: Drexel University, Philadelphia, Pennsylvania, 19104, United States @@
## Digital Detox Study: A Randomized Controlled Trial - NCT ID: NCT06353451 - Study ID: EK GZ 67/2021-2024 - Status: COMPLETED - Start Date: 2023-10-23 - Completion Date: 2024-01-21 - Lead Sponsor: Danube University Krems ### Study Description The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students.After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI).The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline. ### Conditions - Health Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Digital Detox ### Outcomes Primary Outcomes - Depressive Symptoms - Stress - Sleep Quality - Well-being Secondary Outcomes - Problematic smartphone use - Body Appreciation - Anxiety Symptoms - Eating Disorder ### Location - Facility: Danube University Krems, Krems, Lower Austria, 3500, Austria @@
## Hydraulic Resistance and Older Adults - NCT ID: NCT06353438 - Study ID: 2024XXXX - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-31 - Lead Sponsor: College of Staten Island, the City University of New York ### Study Description The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:* Does the use of hydraulic exercise equipment decrease fall risk in older adults?* Does the use of hydraulic exercise equipment improve function in older adults?Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric). ### Conditions - Aging - Fall - Old Age; Debility - Muscle Weakness ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Exercise Program ### Outcomes Primary Outcomes - Berg Balance Scale - Timed Up and Go - Tinetti Balance and Gait Assessment Tool - Lower Extremity Functional Scale Secondary Outcomes - Strength ### Location - Facility: Bay Ridge Center, Brooklyn, New York, 11209, United States @@
## Multi-country Survey on Violence Against Women Among Women - NCT ID: NCT06353425 - Study ID: 0562/66 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Chulalongkorn University ### Study Description The goal of this observational study is to explore and learn about violence against women (VAW) among reproductive-aged women in Asia and Oceania countries. The main questions it aims to answer are:* pattern and prevalence of VAW among reproductive-aged women* knowledge, attitude, and practice (KAP) towards VAW among reproductive-aged women* the need of support services for VAW among reproductive-aged womenParticipants will be ever-partnered women aged 15-49 years. The definition of "ever-partnered women" included women who have current and former husbands; current and former cohabiting; or non-cohabiting male intimate partners. ### Conditions - Violence Against Women ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - prevalence of violence against women - KAP towards violence against women Secondary Outcomes - need of support services for violence against women ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Current Treatment Methods of Idiopathic Intracranial Hypertension - NCT ID: NCT06353412 - Study ID: treatment methods of IIH - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-03-09 - Lead Sponsor: Assiut University ### Study Description Aim of the study :1. to determine the response to each treatment plan.2. to determine when to choose specific treatment method.3. to determine complication of each type of treatment method ### Conditions - IIH - Idiopathic Intracranial Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Lumbar puncture ### Outcomes Primary Outcomes - Patient improvement regarding headache, visual symptoms - Patients improvement regarding fundus examination during regular visual assessment - Complication Secondary Outcomes - Other ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations - NCT ID: NCT06353399 - Study ID: 23.0366 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2024-12-31 - Lead Sponsor: University of Louisville ### Study Description The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures. ### Conditions - Ridge Augmentation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intra-marrow penetrations - No Intra-marrow penetrations ### Outcomes Primary Outcomes - Alveolar Ridge Width - Alveolar Ridge Height - Buccal Soft Tissue Thickness Secondary Outcomes - Histomorphometric Measurements ### Location - Facility: University of Louisville, Louisville, Kentucky, 40202, United States @@
## Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) - NCT ID: NCT06353386 - Study ID: 5684-01A - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2028-03-31 - Lead Sponsor: Merck Sharp & Dohme LLC ### Study Description Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study. ### Conditions - Prostatic Neoplasms, Castration-Resistant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Opevesostat - Olaparib - Docetaxel - Cabazitaxel ### Outcomes Primary Outcomes - Number of participants who experience one or more dose-limiting toxicities (DLTs) - Number of participants who experience one or more adverse events (AEs) - Number of participants who discontinue study intervention due to an AE - Prostate-specific antigen (PSA) response rate Secondary Outcomes - Objective response rate (ORR) - Radiographic progression-free survival (rPFS) - Overall survival (OS) - Duration of response (DOR) - Time to first subsequent anticancer therapy (TFST) - Time to pain progression (TTPP) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies - NCT ID: NCT06353373 - Study ID: HZKY-PJ-2024-7 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2025-02-28 - Lead Sponsor: Navy General Hospital, Beijing ### Study Description Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process.In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis. ### Conditions - Venous Thromboembolism - Clinical Decision Support Systems - Digital Health ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Application of the modified DeVTEcare system ### Outcomes Primary Outcomes - In-hospital VTE Secondary Outcomes - Guideline-compliant prescription of VTE prophylaxis - Preventable VTE - Hospital-related VTE death - Major bleeding - Non-major bleeding ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TTField in Combination With TMZ and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma. - NCT ID: NCT06353360 - Study ID: HL-06 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2026-03-09 - Lead Sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd ### Study Description The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM). ### Conditions - Glioblastoma Multiforme ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tumor Treating Fields - Tislelizumab - Temozolomide (TMZ) ### Outcomes Primary Outcomes - Progression-Free Survival (PFS) Secondary Outcomes - Number of participants with adverse events (AEs) - Objective response rate (ORR) - Disease control rate (DCR) - Overall Survival (OS) - PFS rate at 6 months - PFS rate at 1 year - OS rate at 1-year ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin - NCT ID: NCT06353347 - Study ID: HTD1801.PCT106 - Status: RECRUITING - Start Date: 2023-11-13 - Completion Date: 2025-12 - Lead Sponsor: HighTide Biopharma Pty Ltd ### Study Description The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin. ### Conditions - Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HTD1801 - Placebo ### Outcomes Primary Outcomes - Primary Endpoint: mean change in HbA1c Secondary Outcomes - Double-blind (DB) Phase: mean change in fasting plasma glucose - DB Phase: mean change in 2-hour postprandial glucose - DB Phase: proportion of patients achieving HbA1c <7.0% - DB Phase: proportion of patients achieving HbA1c <6.5% - DB Phase: mean change in insulin sensitivity (HOMA-IR) - DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C) ### Location - Facility: Baogang Hospital of Inner Mongolia, Baotou, N/A, N/A, China @@
## Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial) - NCT ID: NCT06353334 - Study ID: 2024-3-22-8 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Tang Ziren ### Study Description Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) by NBP is limited. This study aims to evaluate the safety and efficacy of NBP treatment in improving the neurological function prognosis of patients with ROSC after CA.The study will be a single-center, randomized, double-blind, placebo-controlled trial. The sample size is estimated to be 100 patients. Eligible patients will be randomly allocated in a 1:1 ratio to receive either NBP or placebo treatment daily for a duration of 14 days. The initial administration of NBP or placebo treatment will commence within 6 hours after ROSC following CA. The primary outcome is the proportion of patients with Cerebral Performance Category (CPC) scores of 1-2 at 90 days after randomization in each group. The primary safety outcome is the percentage of severe adverse events occurring during the 14-day treatment period. This trial will determine the efficacy of NBP in providing neuroprotective effects for patients with ROSC after CA. ### Conditions - Butylphthalide - Cardiac Arrest - Neuroprotective Drugs ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Butylphthalide and Sodium Chloride Injection - Saline Solution ### Outcomes Primary Outcomes - The proportion of patients with a CPC score of 1-2 Secondary Outcomes ### Location - Facility: Beijing Chao-Yang Hospital, Beijing, Beijing, 100020, China @@
## Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1 - NCT ID: NCT06353321 - Study ID: STU-2024-0024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-01 - Lead Sponsor: University of Texas Southwestern Medical Center ### Study Description To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) \[68Ga\]-PSMA-11 PET-CT using Illuccix on the same day. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PET-CT imaging subsystem of the RefleXion X1 System Device ### Outcomes Primary Outcomes - Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China - NCT ID: NCT06353308 - Study ID: EA230308 - Status: COMPLETED - Start Date: 2023-05-12 - Completion Date: 2024-03-02 - Lead Sponsor: The University of Hong Kong ### Study Description This paper presents the findings of a clustered randomized controlled trial (cRCT) that evaluated the effectiveness of an online feminist sexual health intervention among Chinese young adults, providing insights into the impacts of this innovative approach and contribute to the growing body of literature on feminist interventions for sexual health and equality promotion. ### Conditions - Sexual Violence ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Sexual Violence Prevention - Sexual health intervention ### Outcomes Primary Outcomes - Rape myth acceptance Secondary Outcomes - Sociocultural Attitudes toward Appearance - Sexual Attitudes Scale - Sexual Desire Inventory ### Location - Facility: The university of Hong Kong, Hong Kong, N/A, 000000, Hong Kong @@
## Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study - NCT ID: NCT06353295 - Study ID: 22-38098 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: University of California, San Francisco ### Study Description The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention. ### Conditions - HIV/AIDS ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - P4P intervention ### Outcomes Primary Outcomes - Uptake of biomedical prevention Secondary Outcomes - Feasibility of delivery of the P4P intervention by peers - Acceptability of the P4P intervention ### Location - Facility: Infectious Diseases Research Collaboration, Kampala, N/A, N/A, Uganda @@
## MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents - NCT ID: NCT06353282 - Study ID: 24-000795 - Status: NOT_YET_RECRUITING - Start Date: 2025-07-01 - Completion Date: 2026-12-31 - Lead Sponsor: University of California, Los Angeles ### Study Description The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms. ### Conditions - PTSD, Post Traumatic Stress Disorder - Adolescents - Psychotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MDMA - Psychotherapy ### Outcomes Primary Outcomes - Changes in heart rhythm via Carnation Ambulatory Heart Monitor - Changes in blood pressure - Change in pulse - Change in body temperature - Mean change in score of visual analog scale to assess potential for misuse of MDMA Secondary Outcomes - Mean change in PTSD symptom severity via the Child PTSD Symptom Scale - Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5) - Mean change in depression symptom severity via the Patient Health Questionnaire-9 (PHQ-9). - Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7) ### Location - Facility: UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, 90095, United States @@
## Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections - NCT ID: NCT06353269 - Study ID: 4255 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-10 - Lead Sponsor: University of California, Irvine ### Study Description * The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed.* Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound.* A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina.Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.* The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.* There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.If a participant is part of the microbiome cohort, they will also be asked to do the following:* a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.* Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.* These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina. ### Conditions - Recurrent Urinary Tract Infection - Hypoestrogenism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Estring Vaginal Product - Vagifem - Estrace 0.01% Vaginal Cream ### Outcomes Primary Outcomes - Adherence to vaginal estrogen treatment Secondary Outcomes - UTI rates - validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6) - validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA) - validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q) - validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I) - validated patient questionnaires - Medication Adherence Report Scale (MARS-5) - optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness - optical coherence tomography measurements for nested OCT cohort - blood vessel density - Vaginal health index for nested microbiome cohort - Vaginal maturation index for nested microbiome cohort - Urologic microbiome results for nested microbiome cohort - Vaginal microbiome results for nested microbiome cohort ### Location - Facility: University of California Irvine Medical Center, Orange, California, 92868, United States @@
## A Community Health Worker Intervention to Address Preeclampsia - NCT ID: NCT06353256 - Study ID: 300012607 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-04-30 - Lead Sponsor: University of Alabama at Birmingham ### Study Description United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with PE to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants. ### Conditions - Preeclampsia Postpartum ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - usual postpartum care ### Outcomes Primary Outcomes - Acceptability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Bilateral Infant Stimulation Study - NCT ID: NCT06353243 - Study ID: STUDY00022901 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-08 - Lead Sponsor: Oregon Health and Science University ### Study Description This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention. ### Conditions - Parent-Child Relations - Preterm Birth - Stress Reaction - Hospitalism in Children ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Bilateral alternating stimulation ### Outcomes Primary Outcomes - Parental anxiety - Physiologic stress response - Parental distress Secondary Outcomes ### Location - Facility: Oregon Health and Science University Neonatal Intensive Care Unit, Portland, Oregon, 97219, United States @@
## Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children - NCT ID: NCT06353230 - Study ID: 0001 - Status: COMPLETED - Start Date: 2019-10-15 - Completion Date: 2021-04-13 - Lead Sponsor: King Edward Medical University ### Study Description Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children. ### Conditions - Rectal Prolapse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - injection 5% phenol in almond oil - injection 15% hypertonic saline - injection 50% dextrose water ### Outcomes Primary Outcomes - Recurrence Secondary Outcomes - fecal incontinence ### Location - Facility: department of pediatric surgery King Edward Medical University, Lahore, Punjab, 54000, Pakistan @@
## Study of a Primary Care Hypoglycemia Prevention Program - NCT ID: NCT06353217 - Study ID: IRB00419034 - Status: RECRUITING - Start Date: 2024-04-14 - Completion Date: 2026-04-14 - Lead Sponsor: Johns Hopkins University ### Study Description This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial. ### Conditions - Diabetes Mellitus - Hypoglycemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Patient Group (Hypoglycemia Prevention Program) - Primary Care Physician Group - Clinic Staff Group ### Outcomes Primary Outcomes - Overall acceptability to patients - Overall acceptability to primary care providers - Overall acceptability to clinic staff Secondary Outcomes ### Location - Facility: Johns Hopkins University School of Medicine, Baltimore, Maryland, 21287, United States @@
## Effectiveness of the Justice Diversion Halt-intervention - NCT ID: NCT06353204 - Study ID: 3325 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-07 - Lead Sponsor: Wetenschappelijk Onderzoek en Datacentrum ### Study Description In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention. ### Conditions - Criminal Recidivism - Delinquency - Antisocial Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Halt-intervention ### Outcomes Primary Outcomes - Criminal Recidivism based on self-report - Criminal Recidivism based on official police records - Criminal Recidivism based on official judiciary records - Truancy based on self-report Secondary Outcomes - Conventional beliefs - Minimizing/mislabeling - Social skills - Taking responsibility for the consequences of behavior - Correct wrongdoing - Support from social network - Experienced legitimacy - Experienced treatment - Receiving adequate information - The right to be informed - Experienced voluntariness - Access to legal assistance - Knowledge of not obtaining a criminal record - Experienced stigmatisation - Experienced re-integration ### Location - Facility: WODC, The Hague, Zuid-Holland, 2500EH, Netherlands @@
## Biomarkers to Predict Cancer Therapy-related Cardiotoxicity - NCT ID: NCT06353191 - Study ID: 19-002566 - Status: RECRUITING - Start Date: 2019-05-03 - Completion Date: 2026-06-01 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy. ### Conditions - Hematopoietic and Lymphatic System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT Secondary Outcomes ### Location - Facility: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States @@
## Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers - NCT ID: NCT06353178 - Study ID: 20240314 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-04-01 - Lead Sponsor: Color Health, Inc. ### Study Description Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program. ### Conditions - Cancer - Caregiving Stress - Caregiver Burnout - Survivorship ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Cancer Connect Program ### Outcomes Primary Outcomes - Quality of Life Secondary Outcomes ### Location - Facility: Color Health, Burlingame, California, 94010, United States @@
## Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva - NCT ID: NCT06353165 - Study ID: CRO-2022-12-BAC-SNF-THA-YPZ - Status: COMPLETED - Start Date: 2023-03-08 - Completion Date: 2023-04-12 - Lead Sponsor: Colgate Palmolive ### Study Description This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use. ### Conditions - Plaque, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Stannous fluoride toothpaste - Colgate Dental Cream ### Outcomes Primary Outcomes - Whole mouth scores of dental plaque - Measurement of total bacterial counts on tongue - Measurement of total bacterial counts on cheek - Measurement of gingivitis - Measurement of total bacterial counts in saliva Secondary Outcomes ### Location - Facility: M U International Oral Science Research, Ltd., Bangkok, Krung Thep Maha Nakhon, 10250, Thailand @@
## Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells for Gastric/Gastroesophageal Junction Adenocarcinoma - NCT ID: NCT06353152 - Study ID: GC506-507 - Status: RECRUITING - Start Date: 2023-11-17 - Completion Date: 2025-11-16 - Lead Sponsor: Peking University ### Study Description A single-arm, open-label early-stage exploratory clinical study to evaluate the safety, tolerability and efficacy of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in subjects with gastric/gastroesophageal junction adenocarcinoma. ### Conditions - Gastric Adenocarcinoma - Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Injection ### Outcomes Primary Outcomes - Occurrence of Dose limiting toxicity. - Incidence of treatment-emergent AEs, AESIs, and SAEs. Secondary Outcomes - Disease control rate (DCR) - Objective response rate (ORR) - Duration of disease control (DDC) - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Proliferation and persistence of Claudin18.2-Targeted Chimeric Antigen Receptor T Cell - Incidence of anti-CAR-T cell antibody in peripheral blood after infusion. ### Location - Facility: Beijing Cancer Hospital, Beijing, Beijing, 100142, China @@
## The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction - NCT ID: NCT06353139 - Study ID: 90591 - Status: RECRUITING - Start Date: 2023-07-01 - Completion Date: 2024-12-31 - Lead Sponsor: Peking University Third Hospital ### Study Description The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:Is it possible that the device can treat olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction? ### Conditions - Olfactory Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Modified olfactory training device ### Outcomes Primary Outcomes - Clinically significant olfactory improvement Secondary Outcomes ### Location - Facility: Dawei Wu, Beijing, Beijing, 100191, China @@
## DEB-TACE Prior to Liver Transplantation in the Treatment of HCC - NCT ID: NCT06353126 - Study ID: DTACESALT - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-07-01 - Lead Sponsor: RenJi Hospital ### Study Description The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral Liver Transplantation) can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for SALT receive DEB-TACE 2 weeks prior to the surgery.The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing SALT; 4) Adverse events related to DEB-TACE. ### Conditions - Liver Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DEB-TACE ### Outcomes Primary Outcomes - Recurrence-free survival (RFS) Secondary Outcomes - Overall survival (OS) - Pathological response rate (Pathological Response) - Proportion of patients completing SALT - Adverse events related to DEB-TACE ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women - NCT ID: NCT06353113 - Study ID: HS-2023-0254 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-09 - Lead Sponsor: San Diego State University ### Study Description The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?2. How does mental and physical health change after using the Down Dog app for 12-weeks?3. What cultural adaptations to the Down Dog app are needed?The study lasts for 12 weeks and participants are asked to:* do prenatal yoga with the app for at least 20 min/day, three days/week, from home* wear a Garmin Vivosmart 5 watch daily* complete four online surveys* complete an optional virtual interviewThis project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes. ### Conditions - Pregnancy Related - Mental Health Issue - Discrimination, Racial - Stress - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Down Dog Prenatal Yoga App ### Outcomes Primary Outcomes - Acceptability of the intervention - Demand of the intervention - Retention - Ease of recruitment Secondary Outcomes - Discrimination - Perceived stress - Perinatal Depression - Self-awareness - Mindfulness - Subjective physical activity - Objective physical activity (steps) - Objective physical activity (intensity) - Cardiac health (heart rate) - Cardiac health (heart rate variability) - Cultural adaptations - Birth outcomes (gestational age) - Birth outcomes (type of delivery) - Birth outcomes (intervention used for delivery) - Birth outcomes (birth weight) - Birth outcomes (maternal weight) - Birth outcomes (pregnancy-related disorders) ### Location - Facility: San Diego State University, San Diego, California, 92182, United States @@
## Chronic Pain in the General Population of Chile - NCT ID: NCT06353100 - Study ID: 230602006 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2024-12-30 - Lead Sponsor: Pontificia Universidad Catolica de Chile ### Study Description The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics.The study objectives are as follows:1. Estimate the prevalence of CP and subtypes in the general population2. Explore the association between mental health indicators, perceived work stress and presence of CP in the population.3. Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP4. Describe the use of management strategies in those who suffer from CP. ### Conditions - Chronic Pain - Migraine Disability - Neuropathic Pain - Fibromyalgia - Depression, Anxiety - Self Harm - Insomnia - Loneliness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Chronic pain (past 3 months) - Depression (2 weeks) - Anxiety (2 weeks) Secondary Outcomes - Migraine Disability - Neuropathic Pain - Fibromyalgia - Self harm (2 weeks) - Insomnia (2 weeks) - Loneliness ### Location - Facility: Pontificia Universidad Catolica de Chile, Santiago, RM, 7550139, Chile @@
## Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry) - NCT ID: NCT06353087 - Study ID: B7451114 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-11-15 - Lead Sponsor: Pfizer ### Study Description This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics. ### Conditions - Dermatitis, Atopic - Dermatitis - Eczema - Skin Diseases - Immune System Diseases - Janus Kinase Inhibitors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52 - Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52 - Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52 Secondary Outcomes - Duration of Abrocitinib Treatment: All Participants - Demographic and baseline characteristics - Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52 - Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52 - Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52 - Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52 - Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52 - Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52 - Change From Baseline in Patient Global Assessment (PtGA) - Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52 - Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 - Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage - NCT ID: NCT06353074 - Study ID: 1335cemre. - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-11-30 - Lead Sponsor: Necmettin Erbakan University ### Study Description This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony. ### Conditions - Uterine Atony With Hemorrhage - Postpartum Hemorrhage ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Postpartum hysterectomy and/or intensive care unit need ratio Secondary Outcomes ### Location - Facility: Cemre Alan, Konya, N/A, N/A, Turkey @@
## Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer - NCT ID: NCT06353061 - Study ID: LACC-MET - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-02-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients. ### Conditions - Cervical Cancer - Radiotherapy - Metformin - Hypoxia - PET/CT ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Metformin - Radiotherapy - Chemotherapy - PET/CT ### Outcomes Primary Outcomes - The degree to which metformin improves the hypoxic index measured by CAIX PET Secondary Outcomes - Progression-free survival（PFS） - Changes in tumor volume during treatment - Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0 - Quality of life assessed by QLQ-C30 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws , Comparative Study - NCT ID: NCT06353048 - Study ID: Soh-Med-24-02-04MS - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2025-02-15 - Lead Sponsor: Sohag University ### Study Description Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression \> 6 mm and/or articular widening \> 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .In general ,tibial plateau fracture are to be operated on , but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues , the patient general condition and the expected limb axis and articular surface restoration.Usual indications for surgical treatment are :1. Intra-articular displacement of ⩾ 2 mm2. Metaphyseal -diaphyseal translation \> 1 cm3. Angular deformity more than 10 degree in the coronal or sagittal view4. Open fracture , compartment syndrome and associated ligament injury require repair.5. Associated fractures of the ipsilateral tibia or fibulaFrequently the depressed articular fragments have to elevated back toward the knee , followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate ### Conditions - Tibial Plateau Fractures Schatzker Type II ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fixation of tibial plateau fractures ### Outcomes Primary Outcomes - range of motion of knee joint using Rasmussen score Secondary Outcomes ### Location - Facility: Sohag university Hospital, Sohag, N/A, N/A, Egypt @@
## Biodiversity Interventions for Well-Being - NCT ID: NCT06353035 - Study ID: NaturalResourcesIFinland - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-30 - Completion Date: 2027-09-30 - Lead Sponsor: Natural Resources Institute Finland ### Study Description Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways. ### Conditions - Microbial Colonization - Immune System Diseases - Well-Being, Psychological - Nature, Human ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Rewilding ### Outcomes Primary Outcomes - Skin Gammaproteobacteria Secondary Outcomes - Salivary cytokines - Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota - Difference in observed species richness of skin, saliva and stool microbiota - Difference in taxonomies of skin, saliva and stool microbiota - Difference in microbial gene pathways of saliva and stool microbiota - Cortisol levels - Perceived Stress Scale - Warwick-Edinburgh Mental Wellbeing Scale - Depression Scale - Nature Relatedness Scale - Metabolites in urine ### Location - Facility: Natural Resources Institute Finland, Helsinki, Uusimaa, 00970, Finland @@
## Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma - NCT ID: NCT06353022 - Study ID: RC23_0267 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2030-06-20 - Lead Sponsor: Nantes University Hospital ### Study Description This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Teclistamab - Talquetamab - Lenalidomide - Bortezomib - Daratumumab - Dexamethasone ### Outcomes Primary Outcomes - Rate of sustained MRD negativity (NGS, 10^-5) - Rate of conversion from positive MRD to negative MRD (NGS, 10^-5) Secondary Outcomes - Number of adverse events - Rate of sustained MRD negativity (NGS, 10^-6) - Rate of conversion from positive MRD to negative MRD (NGS, 10^-6). - Rate of conversion from positive MRD to negative MRD (NGS, 10^-5). - Number of the death - Number of responses - Number of progression-free survival - Percentage of duration of response - Percenatge of time to response ### Location - Facility: CH de la Côte Basque, Bayonne, N/A, 64109, France @@
## Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography - NCT ID: NCT06353009 - Study ID: ICM 2021-2720 - Status: COMPLETED - Start Date: 2020-08-20 - Completion Date: 2023-04-28 - Lead Sponsor: Matthieu Pelletier-Galarneau, MD MSc ### Study Description The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET).The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly.This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries. ### Conditions - Myocardial Endothelial Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - NOVA4 meal - NOVA1-3 meal ### Outcomes Primary Outcomes - Myocardial blood flow values (ml/min/g) at maximum dose of adenosine. Secondary Outcomes - Myocardial blood flow values (ml/min/g) at rest and myocardial reserve. - Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine. ### Location - Facility: Matthieu Pelletier-Galarneau, Montreal, Quebec, H1T 1C8, Canada @@
## Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm - NCT ID: NCT06352996 - Study ID: Dentist Anas Kassas - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-09 - Completion Date: 2024-07-30 - Lead Sponsor: Mansoura University ### Study Description Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction. ### Conditions - Power Arm Canine Retraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm - Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm ### Outcomes Primary Outcomes - Canine tipping - Canine mobility - Implant stability - Pain assessment - canine rotation - canine retraction rate Secondary Outcomes ### Location - Facility: Faculty of dentistry Mansoura University, Mansoura, N/A, N/A, Egypt @@
## Zirconium Dioxide Fixed Dental Prosthesis. - NCT ID: NCT06352983 - Study ID: 2014/11 - Status: COMPLETED - Start Date: 2017-12-20 - Completion Date: 2023-01-20 - Lead Sponsor: Malmö University ### Study Description The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications. ### Conditions - Missing Teeth ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fixed dental prosthesis ### Outcomes Primary Outcomes - Fractures - De-bonding Secondary Outcomes - Caries - Endodontic - Function - Esthetics ### Location - Facility: Malmo university, Malmo, Skane, 214 21, Sweden @@
## Effects of Tuberculosis Infection on Development and Function of the Placenta - NCT ID: NCT06352970 - Study ID: LundU-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Lund University ### Study Description The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.The main questions it aims to answer are:* Does TB infection affect the structure of the placenta?* Does TB infection affect the function of the placenta?Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:* Pathological lesions of the placenta* Gene and protein expression patterns linked to pregnancy-related disorders* Infant outcome at birth and at 6 weeks after birth ### Conditions - Pregnancy Related - Tuberculosis Infection - Placenta Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - TB infection ### Outcomes Primary Outcomes - Proportion of women with pathological placental findings according to the Amsterdam consensus criteria Secondary Outcomes - Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders - Proportions of infants (born to participating women) with adverse outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study - NCT ID: NCT06352957 - Study ID: 23022022CERC - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Istituto di Fisiologia Clinica CNR ### Study Description The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months. ### Conditions - Hemodialysis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Levels of VKDP Secondary Outcomes - Calcium - Phosphate - Magnesium - ALP - PTH - 25(OH)D - P1NP - CTX - TRAP 5b - BSAP - cFGF23 - Klotho - Sclerostin - DKK1 - Fetuin A - Zinc - Irisin - Serum Calcification Propensity T50 test - Hemoglobin (Hb) - Hematocrit (Ht) - Plates (PLTS) - Reticulocytes - Iron - Ferritin - Transferrin - Transferrin Saturation - Albumin - KT/V - Aluminium - C-reactive Protein (CRP) - Cholesterol - Triglycerides - Cholesterol HDL - Cholesterol LDL - Vascular Calcification - Vertebral Fractures - BMD: Bone Mineral Density - Association between Verterbal Fractures and Vascular Calcificatiom - Novel quantitative computer-assisted scoring method for vascular calcifications. - Effect of Etelcalcetide on cardiovascular events and all-cause mortality. - Etelcalcetide Safety: Number of participants with treatment-related adverse events. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children - NCT ID: NCT06352944 - Study ID: AssiutMD - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-07 - Lead Sponsor: Assiut University ### Study Description The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ) ### Conditions - Non-cystic Fibrosis Bronchiectasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - procalcitonin ### Outcomes Primary Outcomes - procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases - NCT ID: NCT06352931 - Study ID: TCD & TCUS in infants - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-07-30 - Lead Sponsor: Assiut University ### Study Description To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging. ### Conditions - Trancranial Doppler ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - transcranial and transcranial dopp;er ### Outcomes Primary Outcomes - To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Peripheral Central Catheter (PICC) Care - NCT ID: NCT06352918 - Study ID: B.30.2.ATA.0.01.00/395 - Status: COMPLETED - Start Date: 2023-05-01 - Completion Date: 2023-12-31 - Lead Sponsor: Ataturk University ### Study Description Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies. ### Conditions - NEWBORN - Pain, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Palmar grasp reflex stimulation ### Outcomes Primary Outcomes - Pain level Secondary Outcomes - Comfort ### Location - Facility: Ataturk University, Erzurum, N/A, 25240, Turkey @@
## Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease - NCT ID: NCT06352905 - Study ID: 2157711 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2025-04 - Lead Sponsor: Baylor University ### Study Description This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Whole body vibration (WBV) - Control ### Outcomes Primary Outcomes - 3-meter backward walk test (3MBWT) Secondary Outcomes ### Location - Facility: Baylor University, Waco, Texas, 76798, United States @@
## A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight - NCT ID: NCT06352892 - Study ID: 20210201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-24 - Completion Date: 2024-09-03 - Lead Sponsor: Amgen ### Study Description The main objective of the study is to assess the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) administration in overweight or obese Chinese participants. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AMG 133 ### Outcomes Primary Outcomes - Maximum Observed Plasma Concentration (Cmax) of AMG 133 - Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133 - AUC from Time Zero Extrapolated to Infinity (AUCinf) of AMG 133 Secondary Outcomes - Number of Participants with Treatment-emergent Adverse Events - Number of Participants with Serious Adverse Events - Number of Participants with Anti-AMG 133 Antibodies ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq. - NCT ID: NCT06352879 - Study ID: 18-Al-KindyCM - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-06-15 - Lead Sponsor: Al-Kindy College of Medicine ### Study Description The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:* What is the prevalence of incontinence among the targeted group?* What are the types of incontinence and what is the frequency of each type among the targeted group?* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors. ### Conditions - Urinary Incontinence - Urge Incontinence - Stress Incontinence ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) Secondary Outcomes - Risk factors for urinary incontinence ### Location - Facility: Baghdad Al- Karkh Health Directorate, Baghdad, N/A, N/A, Iraq @@
## Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM - NCT ID: NCT06352866 - Study ID: CASE3A23 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-12-01 - Lead Sponsor: Jack Khouri ### Study Description The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion. ### Conditions - Multiple Myeloma - Cytokine Release Syndrome - Refractory Multiple Myeloma - Immune Effector Cell Associated Neurotoxicity Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Siltuximab - Teclistamab(FDA-approved) ### Outcomes Primary Outcomes - Change in CRS Rate Secondary Outcomes - Safety assessment of a single dose of siltuximab as CRS prophylaxis - Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis - Incidence of all grade ICANS after siltuximab prophylaxis - Incidence of adverse events after siltuximab prophylaxis - Overall response rate - Progression free survival - Overall survival - Hospitalization rates ### Location - Facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio, Cleveland, Ohio, 44195, United States @@
## Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section - NCT ID: NCT06352853 - Study ID: Diathermy and skin incision cs - Status: COMPLETED - Start Date: 2022-04-01 - Completion Date: 2022-10-01 - Lead Sponsor: Cairo University ### Study Description This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications. ### Conditions - Skin Wound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Skin incision in Cesarean Section by Diathermy - Skin incision in Cesarean Section by Scalpel ### Outcomes Primary Outcomes - Skin incision time in scalpel versus diathermy group - Estimation of incision blood loss in both groups Secondary Outcomes - Postoperative pain in both groups - Postoperative wound healing in both groups ### Location - Facility: Shaimaa El Shemy, Giza, Cairo, 11562, Egypt @@
## Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain - NCT ID: NCT06352840 - Study ID: HUM00231526 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of Michigan ### Study Description The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach. ### Conditions - Chronic Pelvic Pain - Endometriosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - My Pelvic Plan Website - Control Group website ### Outcomes Primary Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups - PROMIS pain intensity 1a between groups - PROMIS Self Efficacy for Managing Symptoms SF 4a between groups Secondary Outcomes - Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups - PROMIS pain intensity 1a between groups - PROMIS Self Efficacy for Managing Symptoms SF 4a between groups ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation - NCT ID: NCT06352827 - Study ID: HUM00228948 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of Michigan ### Study Description The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation. ### Conditions - Constipation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Surveys ### Outcomes Primary Outcomes - Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment - Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment - Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) - Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM) Secondary Outcomes - Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) - Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL) ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy - NCT ID: NCT06352814 - Study ID: 1977152 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2027-05-30 - Lead Sponsor: Baylor University ### Study Description The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy. ### Conditions - Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Activities-based locomotor training (physical therapy) ### Outcomes Primary Outcomes - Gross Motor Function Measure-66 (GMFM) - Pediatric Neuromuscular Recovery Scale (PedsNRS) - Pediatric Evaluation of Disability Inventory (PEDI-CAT) - Pediatric Quality of Life Inventory CP Module (PedsQL-CP) - Functional near-infrared spectroscopy - Electromyography - ActiGraph sensors Secondary Outcomes ### Location - Facility: Baylor University, Waco, Texas, 76798, United States @@
## Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder - NCT ID: NCT06352801 - Study ID: EA230530 - Status: RECRUITING - Start Date: 2023-12-28 - Completion Date: 2026-05-31 - Lead Sponsor: The University of Hong Kong ### Study Description The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.The intervention program includes the following components:Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.Study Objectives:1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong KongHypotheses:1. AD/HD traits negatively predicts psychological well-being2. AD/HD traits positively predicts perceived criticism or rejection sensitivity3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group. ### Conditions - ADHD - Self-Compassion - Psychological Well-Being ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Self-Compassion Intervention ### Outcomes Primary Outcomes - Self-Compassion Scale for Children (SCS-C) - Self-Compassion Scale for Children (SCS-C) - Self-Compassion Scale for Children (SCS-C) - Behavioural ratings on children's executive functions - Behavioural ratings on children's executive functions - Behavioural ratings on children's executive functions - Student's Life Satisfaction Scale (SLSS) - Student's Life Satisfaction Scale (SLSS) - Student's Life Satisfaction Scale (SLSS) - Positive and Negative Affect Schedule for Children (PANAS-C/P) - Positive and Negative Affect Schedule for Children (PANAS-C/P) - Positive and Negative Affect Schedule for Children (PANAS-C/P) Secondary Outcomes ### Location - Facility: The University of Hong Kong, Hong Kong, N/A, N/A, Hong Kong @@
## From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices - NCT ID: NCT06352788 - Study ID: 202007224 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-09-01 - Lead Sponsor: Jason Wilken ### Study Description This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury. ### Conditions - Foot Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Modular Carbon Fiber Custom Dynamic Orthosis (CDO) - Mono Carbon Fiber Custom Dynamic Orthosis (CDO) ### Outcomes Primary Outcomes - PROMIS Physical Function - PROMIS Pain Interference - OPUS Satisfaction with Device and Services - Modified Socket Comfort Score - Comfort - Modified Socket Comfort Score - Smoothness - Numerical Pain Rating Scale - Preference - Ranked - Preference - CDO Configuration - Four Square Step Test (seconds) - Sit to Stand 5 Times (seconds) - Center of Pressure Velocity Magnitude (m/s) - Center of Pressure Velocity Timing (%stance) - Ankle Zero Moment Crossing (%stance) - Peak Ankle Dorsiflexion (degree) - Peak Ankle Plantarflexion Moment (Nm/kg) - Peak Ankle Push-Off Power (W/kg) Secondary Outcomes - PROMIS Satisfaction with Participation in Social Activities - PROMIS Satisfaction with Participation in Discretionary Social Activities - PROMIS Depression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Calcium Carbonate on Labor Induction - NCT ID: NCT06352775 - Study ID: IRB00107112 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Aurora Health Care ### Study Description The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes. ### Conditions - Pregnancy - Uterine Contraction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Calcium Carbonate ### Outcomes Primary Outcomes - Duration of induction time - Rate of labor dystocia Secondary Outcomes - Rate of cesarean deliveries - Total amount of oxytocin after cervical ripening - Gastrointestinal side effects - Blood loss - Rate of postpartum hemorrhage (>/= 500mL) - Neonatal composite adverse outcomes ### Location - Facility: Aurora Sinai Medical Center, Milwaukee, Wisconsin, 53233, United States @@
## The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy - NCT ID: NCT06352762 - Study ID: Izmir Dokuz Eylul University - Status: COMPLETED - Start Date: 2017-02-15 - Completion Date: 2017-12-15 - Lead Sponsor: Izmir Bakircay University ### Study Description Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level. ### Conditions - Spastic Hemiplegic Cerebral Palsy - Upper Extremity Paresis - Robotic Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional physiotherapy - Robotic Rehabilitation ### Outcomes Primary Outcomes - Muscle Tone - Upper Extremity Motor Function - Manual Ability - Functional Independence Secondary Outcomes ### Location - Facility: Nuriye Büyüktaş, Bursa, Nilüfer, 16130, Turkey @@
## Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH) - NCT ID: NCT06352749 - Study ID: BasqueCU2024 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-11-30 - Lead Sponsor: University of the Basque Country (UPV/EHU) ### Study Description The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active. ### Conditions - Physical Function - Cognitive Decline - Psychological Well-Being ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Advice to increase physical activity and reduce sedentary behavior - Online Physical Exercise - Face-to-Face Exercise ### Outcomes Primary Outcomes - Trail Making Test (TMT) - Spanish Version of the Yesavage Depression Scale - 30-seconds Chair Sit to Stand test Secondary Outcomes - MoCA (Montreal Cognitive Assessment) - Wechsler Adult Intelligence Scale III (WAIS-III) - EuroQol-5 dimensions (EQ-5D-5L) - The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008) - Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008) - Satisfaction with Life Scale - Short Physical Performance Battery (SPPB) - The Biceps Curl Test - The 2-minute Walk Test (2-MWT) - The 8 Feet Up-and-Go test - Handgrip strength test - Serum Brain Derived Neurotrophic Factor (BDNF) - Serum Klotho - Serum Glucose - Serum Urea - Serum Creatinine - Serum Uric Acid - Serum Cholesterol - Serum Triglycerides - Serum HDL-Cholesterol - Serum LDL-Cholesterol - Serum Glutamate Pyruvate Transaminase - Serum Glutamate Oxaloacetate Transaminase - Serum gamma glutamyl transferase - Serum Alkaline Phosphatase - Serum Creatin Kinase - Serum Lactate Dehydrogenase - Serum Bilirubin - Serum Sodium - Serum Potassium - Serum Chloride - Serum C Reactive Protein - Serum Albumin - Serum Total Protein - Serum Calcium - Serum Phosphorus - Serum D Vitamin - Erythrocyte count - Hemoglobin - Hematocrit - Mean Corpuscular Volume (MCV) - Mean Corpuscular Hemoglobin (MCH) - Mean Corpuscular Hemoglobin Concentration (MCHC) - Red Cell Distribution Width (RDW) - Leucocyte Count - Neutrophil Count and Percentage - Lymphocyte Count and Percentage - Monocyte Count and Percentage - Eosinophil Count and Percentage - Basophil Count and Percentage - Platelet Count - Platelet Mean Volumen - Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry - Fried's frailty phenotype score - Frail-NH frailty scale - The Pittsburgh Sleep Quality Index - Attendance rate - Dose modification - Adverse Events ### Location - Facility: Residencia Aspaldiko, Portugalete, Bizkaia, 48920, Spain @@
## Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community - NCT ID: NCT06352736 - Study ID: LUTS2023 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-12-31 - Lead Sponsor: Chinese PLA General Hospital ### Study Description This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding. ### Conditions - Lower Urinary Tract Symptoms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - International Prostate Symptom Score(IPSS) - Overactive Bladder Syndrome Score(OABSS) - International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF) - Quality of Life Score（QOL） Secondary Outcomes - Prostatic volume - Maximum urinary flow rate - Residual urine - free prostatic specific antigen(fPSA) - total prostatic specific antigen(tPSA) - fPSA/ tPSA ### Location - Facility: Chinese PLA General Hospital, Beijing, N/A, 100853, China @@
## Cenobamate in the Intensive Care Unit - NCT ID: NCT06352723 - Study ID: 2024P000856 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome. ### Conditions - Epilepsy - Neurologic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cenobamate ### Outcomes Primary Outcomes - Target level - Maintenance level Secondary Outcomes - Seizure cessation - Seizure burden change ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project - NCT ID: NCT06352710 - Study ID: 2022-01510 - Status: RECRUITING - Start Date: 2023-06-12 - Completion Date: 2025-12-31 - Lead Sponsor: Cantonal Hospital of St. Gallen ### Study Description Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making. ### Conditions - Disc Disease - Instabilities Lumbar - Brain Tumor - Aneurysm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OP-Tracker App ### Outcomes Primary Outcomes - Subjective Well-Being (SWI) Secondary Outcomes - EQ-5D-5L - Rate of adverse events - Severity of adverse events - Correlation between TDN/CDG and SWI/QoL - Correlation between baseline factors and TDN grade - Difference between rate of adverse events and TDN distribution between different surgery groups ### Location - Facility: Kantonsspital St.Gallen, St.Gallen, N/A, 9007, Switzerland @@
## Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study) - NCT ID: NCT06352697 - Study ID: DELI_MASLD - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2023-12-31 - Lead Sponsor: Bogomolets National Medical University ### Study Description The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD patients.The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month. ### Conditions - Metabolic Dysfunction Associated Steatotic Liver Disease - Steatotic Liver Disease - Hepatic Steatosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probiotic lysate (postbiotic and metabiotc) - Placebo ### Outcomes Primary Outcomes - changes in fatty liver index (FLI) - hepatic steatosis index (HSI) - TyG index Secondary Outcomes - Concentration of AST - Concentration of ALT - Concentration of Gamma-glutamyl Transferase (GGT) - Concentration of Total Cholesterol (TC) - Concentration of Tryglicerides (TG) - Concentration of LDL-Cholesterol (LDL-C) - Concentration of VLDL-Cholesterol (VLDL-C) - Concentration of HDL-Cholesterol (HDL-C) - Concentration of high sensitivity CRP (hs-CRP) - Concentration of IL-6 - waist circumferences (WC) - body mass index (BMI) - visceral fat content ### Location - Facility: Bogomolets National Medical University, Kyiv, N/A, 01601, Ukraine @@
## Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast - NCT ID: NCT06352684 - Study ID: DP0001-SEV-CAB-II - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-24 - Completion Date: 2025-01-14 - Lead Sponsor: BeamWorks Inc. ### Study Description The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CadAI-B for Breast ### Outcomes Primary Outcomes - Area Under the LROC Curve Secondary Outcomes - Lesion detection sensitivity and specificity ### Location - Facility: Yonsei University Severance Hospital, Seoul, N/A, 03722, Korea, Republic of @@
## Prospective Long-Term Outcomes of a Standardized Ross Procedure - NCT ID: NCT06352671 - Study ID: 023-286 - Status: RECRUITING - Start Date: 2023-10-12 - Completion Date: 2026-01-01 - Lead Sponsor: Baylor Research Institute ### Study Description This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction. ### Conditions - Ross Procedure (Pulmonary Autograft Replacement) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Survival of the patient at 1-, 5- and 10-year intervals Secondary Outcomes - Rate of re-hospitalization - Rate of peri operative morbidity - Rate of re-operation - Rate of re-intervention - NYHA status - Anticoagulant usage - Bleeding events - Post operative infection ### Location - Facility: Baylor Scott and White Heart Hospital, Plano, Texas, 75093, United States @@
## Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea - NCT ID: NCT06352658 - Study ID: #1/2024 - Status: COMPLETED - Start Date: 2023-02-01 - Completion Date: 2024-01-10 - Lead Sponsor: Nourhan M.Aly ### Study Description This was a prospective randomized controlled clinical trial that aimed to compare the efficacy of conventional and CAD CAM mandibular advancement device. ### Conditions - Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conventional mandibular advancement device - CAD CAM mandibular advancement device ### Outcomes Primary Outcomes - Apnea hypopnea index - Epwoth sleeplness scale (ESS) - Oxygen saturation - Snoring index Secondary Outcomes ### Location - Facility: Faculty of Dentistry, Alexandria University, Egypt, Alexandria, N/A, N/A, Egypt @@
## Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser - NCT ID: NCT06352645 - Study ID: STUDY00004879 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Tufts University ### Study Description The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal. ### Conditions - Plaque Induced Gingivitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bixdo Ultra Compact Water Flosser - Manual toothbrush ### Outcomes Primary Outcomes - Inflammation Reduction - Bacterial plaque removal Secondary Outcomes ### Location - Facility: Tufts University School of Dental Medicine, Boston, Massachusetts, 02111, United States @@
## A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke - NCT ID: NCT06352632 - Study ID: ACT-GLOBAL_Master - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-04 - Lead Sponsor: The George Institute ### Study Description Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Standard-dose intravenous tenecteplase - Low-dose intravenous tenecteplase - No intravenous tenecteplase - Conservative Blood Pressure Control - Moderate Blood Pressure Control - Intensive Blood Pressure Control - Placebo - NoNO-42 ### Outcomes Primary Outcomes - modified Rankin scale (mRS) scores Secondary Outcomes - Excellent functional neurological outcome - Independent functional neurological outcome - Health Related Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial - NCT ID: NCT06352619 - Study ID: ACT-GLOBAL_AIS_03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: The George Institute ### Study Description Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management. ### Conditions - Ischemic Stroke, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conservative SBP Control - Moderate SBP Control - Intensive SBP Control ### Outcomes Primary Outcomes - modified Rankin scale Secondary Outcomes - Excellent functional neurological outcome - Independent functional neurological outcome - Health Related Quality of Life - Mortality - Ordinal shift of 7 levels of modified Rankin scale - National Institute of Health Stroke Scale (NIHSS) score - Any intracranial haemorrhage (ICH) - Symptomatic intracerebral haemorrhage (sICH) - Serious Adverse Event (SAE) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy - NCT ID: NCT06352606 - Study ID: 36264PR558/2/24 - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2024-09-01 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy. ### Conditions - Spinal Anesthesia - General Anesthesia - Neonates - Inguinal Herniorrhaphy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Spinal anesthesia - General anesthesia ### Outcomes Primary Outcomes - Heart rate Secondary Outcomes - Heart rate - Mean arterial blood pressure - Incidence of bradycardia - Incidence of hypotension - Incidence of postoperative apnea - The duration of surgery - Need for postoperative O2 supplementation - Hospital stays ### Location - Facility: Tanta University Hospitals, Tanta, ElGharbia, 31527, Egypt @@
## Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage - NCT ID: NCT06352593 - Study ID: 36264PR557/2/24 - Status: RECRUITING - Start Date: 2024-04-06 - Completion Date: 2024-09-01 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage. ### Conditions - Dexmedetomidine - Infusion - Endovascular - Aneurysmal Subarachnoid Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraoperative Dexmedetomidine - Placebo ### Outcomes Primary Outcomes - Incidence of vasospasm Secondary Outcomes - Incidence of morbidity and mortality (M/M) ### Location - Facility: Tanta University Hospitals, Tanta, ElGharbia, 31527, Egypt @@
## Covid-19 Pandemic and Pediatric Dentistry - NCT ID: NCT06352580 - Study ID: COVID-19 Pediatric - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2022-06-30 - Lead Sponsor: Abant Izzet Baysal University ### Study Description Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested. ### Conditions - COVID-19 Pandemic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Survey ### Outcomes Primary Outcomes - Approach to dental treatments Secondary Outcomes ### Location - Facility: Deniz Sıla Özdemir Çelik, Merkez, Bolu, 14030, Turkey @@
## Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy - NCT ID: NCT06352567 - Study ID: BakircayU1394/1414 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2024-08 - Lead Sponsor: Izmir Bakircay University ### Study Description Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.). ### Conditions - Chemotherapy-induced Peripheral Neuropathy - Breast Cancer - Breast Cancer Female ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire ### Outcomes Primary Outcomes - Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms Secondary Outcomes ### Location - Facility: Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology, İzmir, Çiğli, 35620, Turkey @@
## Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections - NCT ID: NCT06352554 - Study ID: 2023/ETH02474:STING - Status: NOT_YET_RECRUITING - Start Date: 2024-04-08 - Completion Date: 2025-01-30 - Lead Sponsor: SpeeDx Pty Ltd ### Study Description This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens. ### Conditions - Diagnosis - Gonorrhea - Resistance Bacterial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics. Secondary Outcomes - To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo. - NCT ID: NCT06352541 - Study ID: SOPH232-1122/I - Status: NOT_YET_RECRUITING - Start Date: 2024-05-30 - Completion Date: 2025-06-30 - Lead Sponsor: Laboratorios Sophia S.A de C.V. ### Study Description This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PRO-232 - Placebo ### Outcomes Primary Outcomes - Incidence Unexpected Related Adverse Reactions - Changes in intraocular pressure (IOP) - Incidence of Stinging Secondary Outcomes - Incidence of Expected Related Adverse Events - Changes in Best Corrected Visual Acuity (BCVA) - Changes in the integrity of the ocular surface (fluorescein staining) - Incidence of ocular symptoms (foreign body sensation and tearing) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment - NCT ID: NCT06352528 - Study ID: CA127-1070 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2025-07-24 - Lead Sponsor: Bristol-Myers Squibb ### Study Description The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function. ### Conditions - Hepatic Impairment - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Repotrectinib ### Outcomes Primary Outcomes - Maximum observed plasma concentration (Cmax) - Time of maximum observed plasma concentration (Tmax) - Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) - Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) Secondary Outcomes - Number of participants with Adverse Events (AEs) - Number of participants with Severe Adverse Events (SAEs) - Number of participants with physical examination abnormalities - Number of participants with vital sign abnormalities - Number of participants with electrocardiogram (ECG) abnormalities - Number of participants with clinical safety laboratory test abnormalities ### Location - Facility: Local Institution - 0003, Miami Lakes, Florida, 33014, United States @@
## T Lymphocyte Subsets in Ulcerative Colitis - NCT ID: NCT06352515 - Study ID: T cells in Ulcerative colitis - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2027-06-01 - Lead Sponsor: Assiut University ### Study Description 1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.2. Correlation of T-cell subsets to therapeutic response/ disease activity.3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC. ### Conditions - Ulcerative Colitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Flow cytometry ### Outcomes Primary Outcomes - Study the distribution of T-cell subsets among ulcerative colitis patients. - Correlation of T-cell subtypes to therapeutic response Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis - NCT ID: NCT06352502 - Study ID: 202112-28 - Status: RECRUITING - Start Date: 2022-01-28 - Completion Date: 2024-09-30 - Lead Sponsor: Tang-Du Hospital ### Study Description EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis. ### Conditions - EGF-R Positive Non-Small Cell Lung Cancer - CNS Metastases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Furmonertinib ### Outcomes Primary Outcomes - Intracranial Objective response rate - Intracranial Disease Control Rate - Intracranial progression-free survival Secondary Outcomes - Progression-free survival - Overall Survival - Safety/Adverse event ### Location - Facility: Tangdu Hopspital, Xi'an, Shanxi, 710038, China @@
## Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia. - NCT ID: NCT06352489 - Study ID: Posterior component separation - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06 - Lead Sponsor: Assiut University ### Study Description * Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.* Detect most common post operative complications related to AWR techniques in a 6 months duration after operation. ### Conditions - Ventral Hernia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Posterior component separation technique. ### Outcomes Primary Outcomes - Hernia recurrence Secondary Outcomes - post operative short term complications ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality - NCT ID: NCT06352476 - Study ID: 10881-669 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-12-01 - Lead Sponsor: Marmara University ### Study Description Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith \& Wagner \& Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced.Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model. ### Conditions - Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Sleep Hygiene Training ### Outcomes Primary Outcomes - Pittsburgh Sleep Quality Index Secondary Outcomes - Pittsburgh Sleep Quality Index ### Location - Facility: Marmara University, Istanbul, N/A, N/A, Turkey @@
## Intervention Social Anxiety: Combining Parent-child Treatment - NCT ID: NCT06352463 - Study ID: 406.XS.03.068 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-07-01 - Lead Sponsor: Leiden University ### Study Description The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously. ### Conditions - Social Anxiety Disorder of Childhood ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Denken + Doen = Durven - Supportive Parenting for Anxious Childhood Emotions ### Outcomes Primary Outcomes - Change in severity of social anxiety in children Secondary Outcomes - Change in anxiety-related symptoms and family accommodation ### Location - Facility: GGZ Delfland, Delft, South-Holland, 2600GA, Netherlands @@
## Comparison of Active Isolated Stretching Versus Myofascial Release of Knee Joint in Office Workers - NCT ID: NCT06352450 - Study ID: DPT/Batch-Fall19/558 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-06-28 - Lead Sponsor: Superior University ### Study Description "Office workers often spend long hours sitting, which can lead to stiffness and reduced mobility. By studying these two techniques AIS and MFR, we can determine which one is more effective in helping office workers to improve their flexibility and range of motion in the knee joint because their sedentary work environment often leads to musculoskeletal issues, including limited knee joint mobility.AIS involves stretching specific muscles while actively engaging opposing muscles to enhance the effectiveness of the stretch. It aims to increase the extensibility of muscles and improve joint mobility. On the other hand, MFR focuses on releasing tension and adhesions in the fascia, the connective tissue surrounding muscles and joints, to restore mobility and reduce pain.Understanding the benefits and effectiveness of these techniques will contribute to evidence-based practices in occupational health and help office workers maintain optimal joint health" ### Conditions - Stiffness; Spine - Mobility Limitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Active isolated stretching (AIS) - Myofascial release (MFR) ### Outcomes Primary Outcomes - Numaric Pain Scale Secondary Outcomes ### Location - Facility: Al-Zahra Medical complex Johar town, Laser spine center Model town, Laser spine center Johar town., Lahore, N/A, N/A, Pakistan @@
## A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity - NCT ID: NCT06352437 - Study ID: 1507-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-07-14 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 3034701 - Placebo matching BI 3034701 ### Outcomes Primary Outcomes - Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator Secondary Outcomes - Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701 - Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701 - Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701 - Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity - NCT ID: NCT06352424 - Study ID: 1458-0006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-12-09 - Lead Sponsor: Boehringer Ingelheim ### Study Description The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BI 456906 - BI 1820237 - Placebo for BI 1820237 - Placebo for BI 456906 ### Outcomes Primary Outcomes - Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems - NCT ID: NCT06352411 - Study ID: 1404-0009 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-08 - Completion Date: 2024-11-26 - Lead Sponsor: Boehringer Ingelheim ### Study Description This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects. ### Conditions - Healthy - Renal Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BI 456906 ### Outcomes Primary Outcomes - Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) - Maximum measured concentration of BI 456906 in plasma (Cmax) Secondary Outcomes - Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) - Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients - NCT ID: NCT06352398 - Study ID: BBTuysuz - Status: COMPLETED - Start Date: 2023-12-20 - Completion Date: 2024-04-01 - Lead Sponsor: Burcu Bozdogan Tuysuz ### Study Description The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded. ### Conditions - Video-Assisted Thoracoscopic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - erector spina plan block - Serratus posterior superior intercostal plan block (SPSIPB) - 0.25% bupivacaine ### Outcomes Primary Outcomes - morphine consumption first 24 hours Secondary Outcomes - NRS pain score ### Location - Facility: Istanbul Medenıyet Unıversıty, Istanbul, Kadıkoy, 34734, Turkey @@
## Epidemiological Investigation of Malocclusion in China - NCT ID: NCT06352385 - Study ID: SH9H-2024-TK16-1.0 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Shanghai Jiao Tong University School of Medicine ### Study Description Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection. ### Conditions - Epidemiological Investigation - Malocclusion ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The Prevalence rate of malocclusion Secondary Outcomes - Dental Aesthetic Index of each age group - Index of Orthodontic Treatment Need of each age group ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Safety and Efficacy of tPBM for Epileptiform Activity in Autism - NCT ID: NCT06352372 - Study ID: tPBM Study - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06 - Lead Sponsor: Richard Frye ### Study Description For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions. ### Conditions - Autism Spectrum Disorder - EEG With Periodic Abnormalities - Epilepsy - Neurodevelopmental Disorders - Neurological Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) ### Outcomes Primary Outcomes - Childhood Autism Rating Scores (CARS) Secondary Outcomes - EEG Delta Power ### Location - Facility: Rossignol Medical Center, Phoenix, Arizona, 85050, United States @@

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