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## TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD - NCT ID: NCT06271733 - Study ID: 21110503 - Status: ENROLLING_BY_INVITATION - Start Date: 2022-01-11 - Completion Date: 2027-01-31 - Lead Sponsor: Rush University Medical Center ### Study Description The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program. ### Conditions - PTSD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TMS - Sham ### Outcomes Primary Outcomes - PTSD Checklist for DSM-5 (PCL-5) Secondary Outcomes - Patient Health Questionnaire-9 (PHQ-9) ### Location - Facility: Rush University Medical Center, Chicago, Illinois, 60612, United States @@
## Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome - NCT ID: NCT06271720 - Study ID: faculty of physical therapy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Noha Elserty ### Study Description This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome ### Conditions - Shoulder Impingement ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - visceral manipulation - integrated neuromuscular inhibition ### Outcomes Primary Outcomes - pain intensity - pain pressure threshold - shoulder range of motion - shoulder functional level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stellate Ganglion Block - NCT ID: NCT06271707 - Study ID: ANES-2024-32720 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-09-30 - Lead Sponsor: University of Minnesota ### Study Description The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care. ### Conditions - Esophagectomy - Pneumonectomy - Lobectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - 0.5% bupivacaine - Saline ### Outcomes Primary Outcomes - an ultrasound guided left stellate ganglion block with 5 mL of saline. - Atrial fibrillation; Other arrhythmias; Adverse events. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Activity and Participation in Vestibular Disorders - NCT ID: NCT06271694 - Study ID: STUDY22020027 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-01-31 - Lead Sponsor: University of Pittsburgh ### Study Description This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation. ### Conditions - Vestibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Vestibular Rehabilitation ### Outcomes Primary Outcomes - Late-life Function and Disability Instrument - Dizziness Handicap Inventory Secondary Outcomes ### Location - Facility: UPMC-Rehab Institute, Pittsburgh, Pennsylvania, 15206, United States @@
## Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans - NCT ID: NCT06271681 - Study ID: 2120135-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-02-01 - Lead Sponsor: VA Sierra Nevada Health Care System ### Study Description The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster series of 15-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine 8 weeks later. Immune response will be assessed by opsonophagocytic assay reactivity and IgG Geometric mean concentration changes. ### Conditions - Pneumococcal Vaccines - Immunosuppression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 15-valent pneumococcal conjugate vaccine - 23-valent pneumococcal polysaccharide vaccine ### Outcomes Primary Outcomes - Change in opsonophagocytic assay (OPA) geometric mean titers (GMT) - Change in Immunoglobulin G (IgG) geometric mean concentrations (GMC) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Decision Support to Improve System Naloxone Co-prescribing - NCT ID: NCT06271668 - Study ID: 23-2356 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-09 - Lead Sponsor: University of Colorado, Denver ### Study Description The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months. ### Conditions - Medication Abuse - Harm Reduction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Naloxone Co-prescribing Clinical Decision Support (CDS) ### Outcomes Primary Outcomes - Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone Secondary Outcomes - Clinical decision support (CDS) acceptance rate - Subsequent opioid overdose/poisonings rates - Naloxone dispensed rate ### Location - Facility: University of Colorado Hospital, Aurora, Colorado, 80045, United States @@
## Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE) - NCT ID: NCT06271655 - Study ID: BFD-RST-23-004 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-09-30 - Lead Sponsor: Christopher Payette ### Study Description The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests. ### Conditions - Acute Respiratory Infection - Viral Infection - Upper Respiratory Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - SPOTFIRE R Panel ### Outcomes Primary Outcomes - Antibiotic Use Secondary Outcomes - Emergency Department Length of Stay - Utilization of Alternative Tests - Patient Confidence in Diagnosis - Provider Confidence in Diagnosis ### Location - Facility: George Washington University Hospital, Washington, District of Columbia, 20037, United States @@
## Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators - NCT ID: NCT06271642 - Study ID: 73822 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-05-31 - Lead Sponsor: Stanford University ### Study Description This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli. ### Conditions - Pain - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only - Bluetooth Haptic Device (Control Frequency) + Needle Sham only ### Outcomes Primary Outcomes - Mechanical Pain Threshold Secondary Outcomes - Mechanical pain sensitivity - Anxiety scores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients - NCT ID: NCT06271629 - Study ID: 2204-042-1314 - Status: COMPLETED - Start Date: 2022-02-26 - Completion Date: 2024-02-29 - Lead Sponsor: Seoul National University Hospital ### Study Description The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates.However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications.Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them. ### Conditions - Rectal Cancer - Low Anterior Resection Syndrome - Insomnia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Insomnia severity index ### Outcomes Primary Outcomes - Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS). Secondary Outcomes - European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) - European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29) ### Location - Facility: Seoul National University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant - NCT ID: NCT06271616 - Study ID: MC1873 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-31 - Lead Sponsor: Mayo Clinic ### Study Description This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD. ### Conditions - Chronic Graft Versus Host Disease - Hematopoietic and Lymphatic System Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Biospecimen Collection - Echocardiography - Ibrutinib ### Outcomes Primary Outcomes - Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD) Secondary Outcomes - Cumulative incidence of non-relapse mortality (NRM) - Cumulative incidence of relapse - Cumulative incidence of moderate/severe chronic GVHD - Cumulative incidence of moderate/severe chronic GVHD - Cumulative incidence of chronic GVHD of all grades - Cumulative incidence of late acute GVHD - Overall survival (OS) - NIH moderate/severe GVHD and relapse free survival (CRFS) - Type and duration of immune suppressive therapy - Cumulative incidence of complete immune suppression (IS) discontinuation - Incidence of adverse events (AE) ### Location - Facility: Mayo Clinic in Florida, Jacksonville, Florida, 32224-9980, United States @@
## Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas - NCT ID: NCT06271603 - Study ID: 23.02645.000357-MS01 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-02 - Lead Sponsor: Damae Medical ### Study Description This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas. ### Conditions - Basal Cell Carcinoma of the Skin ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - diagnosis based on deepLive™ LC-OCT device - diagnosis based on skin biopsy ### Outcomes Primary Outcomes - The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. - The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. - The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management. Secondary Outcomes - Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm. - Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm. - Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm. - Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm. - Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm - Estimate the actual cost of conducting the diagnosis with LC-OCT technology. - Compare healthcare consumption between the two groups at 1 year. - Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management. ### Location - Facility: Hôpital Ambroise Paré, Boulogne-Billancourt, N/A, 92100, France @@
## MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels - NCT ID: NCT06271590 - Study ID: CM-US-R03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2031-04 - Lead Sponsor: Concept Medical Inc. ### Study Description This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees. ### Conditions - Coronary Artery Disease - Native Coronary Artery Stenosis - Cardiovascular Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sirolimus Drug Coated Balloon - Drug eluting stents (DES) ### Outcomes Primary Outcomes - Target lesion failure (TLF) Secondary Outcomes - Procedural success - Target lesion failure (TLF) - Ischemia driven target vessel revascularization (ID-TVR) - Target vessel revascularization (TVR) - Any revascularization - Target vessel failure (TVF) - Q-wave myocardial infarction (MI) - Non Q-wave myocardial infarction (MI) - Any myocardial infarction (MI) - Target vessel myocardial infarction (TV MI) - Spontaneous myocardial infarction (MI) - Procedural myocardial infarction (MI) - Cardiovascular mortality - All-cause mortality - Cardiovascular mortality or myocardial infarction (MI) - All-cause mortality or MI - All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR) - Any probable or definite stent thrombosis - Probable stent thrombosis - Definite stent thrombosis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II - NCT ID: NCT06271577 - Study ID: PRO-0013 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2024-12 - Lead Sponsor: AliveCor ### Study Description AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices. ### Conditions - Myocardial Infarction - Ischemia - Myocardial Ischemia - Heart Diseases - Cardiovascular Diseases - Vascular Diseases - Heart Attack - Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - AliveCor 12-lead ECG ### Outcomes Primary Outcomes - Inter-rater variability for Standard 12-lead ECG readings - Inter-rater variability for AC 12L ECG readings - Number of standard 12-lead ECG readings requiring a consensus consultation - Number of AC 12L ECG readings requiring a consensus consultation - Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI - Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI - Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI - Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI - Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI - Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI - Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs Secondary Outcomes ### Location - Facility: Mayo Clinic, Rochester, Minnesota, 55905, United States @@
## Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions - NCT ID: NCT06271564 - Study ID: FDASU-Rec IM012415 - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2024-12 - Lead Sponsor: Ain Shams University ### Study Description ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell. ### Conditions - Oral Potentially Malignant Lesions ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Magnetite ZnO Composite Nanoparticles - Topical Placebo Gel ### Outcomes Primary Outcomes - Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient Secondary Outcomes - Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy ### Location - Facility: Faculty of Dentistry Ain shams University, Cairo, N/A, N/A, Egypt @@
## Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy - NCT ID: NCT06271551 - Study ID: ESTRACISE - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2029-12 - Lead Sponsor: Central Finland Hospital District ### Study Description The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transdermal estrogen - Active Comparator: Androgen deprivation therapy - Resistance training ### Outcomes Primary Outcomes - The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy. Secondary Outcomes - The occurrence of androgen deprivation therapy induced adverse effects. - Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events). - Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer. - Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ). - Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity). - Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity). - Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition. - Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density. - Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass. - Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass. - Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status. - Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides). - Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content - Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins) - Number of participants with resistance training induced adverse events. - The World Health Organization Quality of Life Brief Version (WHOQOL-BREF). - The Patient Health Questionnaire score (PHQ-9) overall and subdomain score. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome - NCT ID: NCT06271538 - Study ID: EP-USM-122023-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2025-03-30 - Lead Sponsor: EP Plus Group Sdn Bhd ### Study Description The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention. ### Conditions - Irritable Bowel Syndrome - Gastrointestinal Diseases - Colonic Diseases, Functional - Intestinal Disease - Digestive System Disease - Pathologic Processes - Colonic Disease - Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Skal Pro - Placebo ### Outcomes Primary Outcomes - Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS) Secondary Outcomes - Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary - Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary - Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ) - Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire - Change in Visceral Sensitivity Index - Assessment of psychological dysfunction suing Catastrophizing Questionnaire ### Location - Facility: Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, 16150, Malaysia @@
## Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis - NCT ID: NCT06271525 - Study ID: P.T.REC/012/002532 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-05-20 - Lead Sponsor: Shady Abdelsattar Refaat ### Study Description this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis ### Conditions - Cervical Spondylosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - cupping therapy ### Outcomes Primary Outcomes - the nitric oxide level Secondary Outcomes - cervical range of motion - pain intensity ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel - NCT ID: NCT06271512 - Study ID: REG-501 - Status: RECRUITING - Start Date: 2024-01-23 - Completion Date: 2043-12 - Lead Sponsor: bluebird bio ### Study Description The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel. ### Conditions - Beta-Thalassemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs) Secondary Outcomes - Number of Participants with Serious Adverse Events (SAEs) - Number of Participants with beti-cel related AEs - Event-Free Survival - Percentage of Participants Achieving Transfusion Independence ### Location - Facility: UCSF Benioff Children's Hospitals, Oakland, California, 94609, United States @@
## The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization - NCT ID: NCT06271499 - Study ID: AnkaraU-Smart-cannulation - Status: COMPLETED - Start Date: 2022-08-01 - Completion Date: 2023-02-14 - Lead Sponsor: Ankara University ### Study Description The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG. ### Conditions - Catheterization - Cannulation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Radial artery catheterization with USG - Radial artery catheterization with smart glasses integrated UGG ### Outcomes Primary Outcomes - The success rate - The anesthesiologist's satisfaction Secondary Outcomes - The cannulation time - Complications ### Location - Facility: Ankara University Medical Faculty, Ankara, N/A, N/A, Turkey @@
## Pregabalin in Treatment of Postdural Puncture Headache - NCT ID: NCT06271486 - Study ID: RC. 40.5.2023 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-08-15 - Lead Sponsor: Al-Azhar University ### Study Description Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders ### Conditions - Postdural Puncture Headache ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pregabalin 75mg - An epidural blood patch (EBP) - conservative treatment. ### Outcomes Primary Outcomes - the incidence of complete relief Secondary Outcomes - The intensity of the headache ### Location - Facility: Neveen Kohaf, Tanta, N/A, 11865, Egypt @@
## Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME - NCT ID: NCT06271473 - Study ID: AinShamsU3 - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2025-06-30 - Lead Sponsor: Ain Shams University ### Study Description To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema. ### Conditions - Efficacy - Safety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. ### Outcomes Primary Outcomes - change in CMT by OCT at final visit Secondary Outcomes - change in BCVA at final visit ### Location - Facility: Ain Shams university, Cairo, N/A, N/A, Egypt @@
## Disability in Patients With Non-specific Chronic Low Back Pain - NCT ID: NCT06271460 - Study ID: 2023-21-728 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-10 - Lead Sponsor: Acibadem University ### Study Description To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population. ### Conditions - Chronic Nonspecific Low Back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Traditional physiotherapy ### Outcomes Primary Outcomes - Visual Analog Scale - The Roland-Morris Disability Questionnaire - The Quebec Back Pain Disability Scale - The Oswestry Disability Index - The Perceived Global Impact Secondary Outcomes ### Location - Facility: Acıbadem Health Group, Istanbul, None Selected, 34752, Turkey @@
## Answerability and Minimal Clinical Significance of the Pain Questionnaires - NCT ID: NCT06271447 - Study ID: 2023-21-705 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-08 - Lead Sponsor: Acibadem University ### Study Description To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation. ### Conditions - Chronic Low-back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Traditional therapy ### Outcomes Primary Outcomes - Visual Analog Scale - Fear-Avoidance Beliefs Questionnaire - Tampa Scale for Kinesiophobia - The Pain Catastrophizing Scale - The Perceived Global Impact Secondary Outcomes ### Location - Facility: Elif Esma Safran, Istanbul, None Selected, 34752, Turkey @@
## Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers. - NCT ID: NCT06271434 - Study ID: Olej z kryla/jelita - Status: NOT_YET_RECRUITING - Start Date: 2024-03-23 - Completion Date: 2024-06-24 - Lead Sponsor: Poznan University of Physical Education ### Study Description The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.Hypotesis:The krill oil will infleunce the gut barier integrity. ### Conditions - Endothelial Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - THYROX (Atlantic krill oil - Placebo ### Outcomes Primary Outcomes - I-FABP (intestinal fatty acid binding protein) - CLDN-3 - LBP (lipopolysaccharide binding protein) - Catechyloamines, cortisol - CD14 Secondary Outcomes - Food intake ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme - NCT ID: NCT06271421 - Study ID: 01/24 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2027-09-01 - Lead Sponsor: Poznan University of Medical Sciences ### Study Description Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.The main questions it aims to answer are:1. how NanoTherm therapy influences overall survival, and progression free survival;2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.Participants will undergo:* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;* after the first activation (10th day), the catheter will be removed;* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects. ### Conditions - Glioblastoma Multiforme ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NanoTherm therapy - Glioma Resection - radiotherapy according to Stupp protocol - chemotherapy according to Stupp protocol ### Outcomes Primary Outcomes - Survival following the surgery [units months 1-24] - Progression free survival [units months 1-24] Secondary Outcomes - Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease] - EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best] - Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst] - modified Rankin scale [0-best; 6-worst] - Barthel index [range 0-100; 0-best, 100-worst] ### Location - Facility: University Hospital, Poznań, N/A, 60-355, Poland @@
## Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging - NCT ID: NCT06271408 - Study ID: POL-Xe-005 - Status: RECRUITING - Start Date: 2024-02 - Completion Date: 2024-04 - Lead Sponsor: Polarean, Inc. ### Study Description The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.Participants will:Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation). ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution - Vibrating Mesh Nebulizer - Metered Dose Inhaler - Jet Nebulizer ### Outcomes Primary Outcomes - Ventilation Defect Percent Secondary Outcomes - Distribution of ventilated space - Membrane uptake of Xe 129 - Red blood cell Xe 129 transfer ### Location - Facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit, Charlottesville, Virginia, 22947, United States @@
## Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction - NCT ID: NCT06271395 - Study ID: Chaoshengqiunang - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2024-10 - Lead Sponsor: Zeng Changhao ### Study Description Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations. ### Conditions - Cricopharyngeal Achalasia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Injectable Type A Botulinum Toxin ### Outcomes Primary Outcomes - functional oral intake scale Secondary Outcomes - Penetration-Aspiration Scale - The Fiberoptic Endoscopic Dysphagia Severity Scale - Murray secretion scale ### Location - Facility: Xinzhu Rehabilitation Hospital, Xinzhu, N/A, N/A, Taiwan @@
## The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes - NCT ID: NCT06271382 - Study ID: AIBU-SBF-SA-05 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-02-15 - Lead Sponsor: Abant Izzet Baysal University ### Study Description This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes. ### Conditions - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Acupressure Group - Sham Acupressure Group - Foot Ankle Exercise Group ### Outcomes Primary Outcomes - Ankle Brachial Index Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study. - NCT ID: NCT06271369 - Study ID: CCTL019CUS13 - Status: COMPLETED - Start Date: 2022-08-11 - Completion Date: 2023-02-15 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier. ### Conditions - Diffuse Large B-cell Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Number of patients with IP admission - Number of IP admissions - IP days - Number of ICU stays - ICU days - Number of patients with OP visit - Number of OP visits - Number of patients with ER visit - Number of ER visits - Healthcare reimbursement costs - Overall survival (OS) - Time to next treatment (TTNT) or death Secondary Outcomes ### Location - Facility: Novartis, East Hanover, New Jersey, 07936, United States @@
## Breast Cancer - Navigate - Prospective Cohort - NCT ID: NCT06271356 - Study ID: STU00220278 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Northwestern University ### Study Description The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach. ### Conditions - Breast Cancer - Quality of Life - Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - BC-Navigate ### Outcomes Primary Outcomes - Demand of BC-Navi: Recruitment Rate - Demand of BC-Navi: Rentention Rate - Acceptability of BC-Navi - Preliminary Efficacy: Chemotherapy Initiation Secondary Outcomes ### Location - Facility: Northwestern University, Chicago, Illinois, 60611, United States @@
## Kidney Graft Tolerance KTOL - NCT ID: NCT06271343 - Study ID: RC23_0394 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-06-01 - Lead Sponsor: Nantes University Hospital ### Study Description Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens. ### Conditions - Kidney Transplant Tolerance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. Secondary Outcomes - Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones. - Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. ### Location - Facility: Nantes University Hospital, Nantes, Loire-Atlantique, 44093, France @@
## Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD. - NCT ID: NCT06271330 - Study ID: AP_JBD_FarWest_004 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-09 - Lead Sponsor: Nantes University Hospital ### Study Description Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication. ### Conditions - AMD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Faricimab ### Outcomes Primary Outcomes - Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment. Secondary Outcomes - Difference between time to recurrence before switch and after switch. ### Location - Facility: Ducloyer, Nantes, N/A, 44000, France @@
## Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study - NCT ID: NCT06271317 - Study ID: AP_CL_001 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2027-03 - Lead Sponsor: Nantes University Hospital ### Study Description The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique ### Conditions - Obesity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Study postoperative morbidity after nissen sleeve gastrectomy in Nantes - postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder - NCT ID: NCT06271304 - Study ID: BLUES - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-06-01 - Lead Sponsor: Mental Health Services in the Capital Region, Denmark ### Study Description The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime). ### Conditions - Bipolar Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Blue blocking eyewear - Low filtration eyewear ### Outcomes Primary Outcomes - Manic symptoms Secondary Outcomes - Mood instability - Objective sleep quality - Objective sleep quality - Subjective sleep quality - Subjective sleep quality ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts - NCT ID: NCT06271291 - Study ID: 23-000161 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2029-05-01 - Lead Sponsor: Mayo Clinic ### Study Description This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured. ### Conditions - Pancreatic Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer - Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes Secondary Outcomes ### Location - Facility: City of Hope, Duarte, California, 91010, United States @@
## The Effect of Emotional Freedom Techniques Application on Nurses - NCT ID: NCT06271278 - Study ID: 2023-17 - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2024-02-28 - Lead Sponsor: Gurkan KAPIKIRAN ### Study Description Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units. ### Conditions - Occupational Stress - Alert Fatigue, Health Personnel ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Freedom Technique ### Outcomes Primary Outcomes - Subjective Units of Disturbance Scale - Alarm Fatigue Scale - The General Work Stress Scale Secondary Outcomes ### Location - Facility: Inonu University Turgut OzaL Medical Center, Malatya, N/A, 44090, Turkey @@
## Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery - NCT ID: NCT06271265 - Study ID: 402-C-125 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2025-07 - Lead Sponsor: Pacira Pharmaceuticals, Inc ### Study Description This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA). ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - EXPAREL - bupivacaine ### Outcomes Primary Outcomes - The following model-predicted PK endpoint will be determined: - The following model-predicted PK endpoint will be determined: - The following model-predicted PK endpoint will be determined: - The following model-predicted PK endpoint will be determined: - The following model-predicted PK endpoint will be determined: - The following model-predicted PK endpoint will be determined: Secondary Outcomes - Vitals change from Baseline: - Vitals change from Baseline: - Vitals change from Baseline: - Vitals change from Baseline: - Vitals change from Baseline: - Incidence of treatment-emergent adverse events (TEAEs) - Incidence of adverse events of special interest (AESIs) - Incidence of serious adverse events (SAEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study - NCT ID: NCT06271252 - Study ID: OriCAR-017 US-P1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-01 - Lead Sponsor: OriCell Therapeutics Co., Ltd. ### Study Description The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.RIGEL Study ### Conditions - Neoplasms, Plasma Cell - Neoplasms by Histologic Type - Neoplasms - Hemostatic Disorders - Vascular Diseases - Cardiovascular Diseases - Paraproteinemias - Blood Protein Disorders - Hematologic Diseases - Hemorrhagic Disorders - Lymphoproliferative Disorders - Immunoproliferative Disorders - Immune System Diseases - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - OriCAR-017 ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) of OriCAR-017 US-P1 - Dose-limiting toxicity (DLT) Secondary Outcomes - Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM - Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM - Assessment of Duration of Response (DOR) of treatment in patients with RR/MM - Progress-Free Survival (PFS) of treatment in patients with RR/MM - Assessment of Overall Survival (OS) of treatment in patients with RR/MM - Assessment of MRD negative Rate - Assessment of Overall Response Rate (ORR) - Assessment of Disease Control Rate (DCR) - Assessment of Clinical Benefit Rate (CBR) ### Location - Facility: Northside Hospital, Atlanta, Georgia, 30342, United States @@
## Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults - NCT ID: NCT06271239 - Study ID: U1111-1299-9167 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2025-03-30 - Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul ### Study Description This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months. ### Conditions - Frailty - Aging - Physical Disability ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intervention group (ViviFrail) - Group Suggestions for a Healthy Life (CG) ### Outcomes Primary Outcomes - Short physical performance battery Secondary Outcomes - Barthel Index - ICOPE questionnaire - Lawton Scale - 4-meter gait speed - Five Times Sit-to-Stand - Balance test in three positions - Self-perceived health - Adverse health outcomes - falls - Adverse health outcomes - hospitalization - Adverse health outcomes - institutionalization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters - NCT ID: NCT06271226 - Study ID: OMUKAEK 2022/75 - Status: RECRUITING - Start Date: 2023-03-20 - Completion Date: 2024-12-31 - Lead Sponsor: Ondokuz Mayıs University ### Study Description The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).The main questions that the study aims to answer are:Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.Acupressure applied to intensive care patients has an effect on physiological parameters.Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain. ### Conditions - Intensive Care Patients - Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - acupressure - placebo acupressure - control group ### Outcomes Primary Outcomes - neurological evaluation - evaluation of pain - evaluation of physiological parameters Secondary Outcomes - evaluation of physiological parameters ### Location - Facility: Giresun Eğitim Araştırma Hastanesi, Giresun, N/A, 28000, Turkey @@
## The Gut-Lung Axis and Respiratory Illness in Children - NCT ID: NCT06271213 - Study ID: 303841 - Status: RECRUITING - Start Date: 2024-02-04 - Completion Date: 2028-05-01 - Lead Sponsor: NHS Greater Glasgow and Clyde ### Study Description The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:* What does a healthy gut-lung axis look like?* Do children with respiratory issues show an altered gut microbiome?* Do children with GI issues show an altered lung microbiome?Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).Participants will provide:* airway samples (to investigate the lung microbiome)* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care* stool samples (to assess gut microbiome)* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis. ### Conditions - Respiration Disorders - Respiratory Disease - Asthma in Children - Wheezing - Gastro-Intestinal Disorder - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - observational only - no interventions as part of study ### Outcomes Primary Outcomes - Assess differences in gut and lung microbiota diversity between groups - Assess changes in gut and lung microbiota in children with asthma receiving biologics - Determine mediators of gut-lung axis in health and disease Secondary Outcomes - Nutritional influence in gut-lung axis - Multi-omics integration ### Location - Facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow, Glasgow, N/A, N/A, United Kingdom @@
## Intervention on Metabolism and Related Chronic Diseases - NCT ID: NCT06271200 - Study ID: MG-113-GP-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2027-12-31 - Lead Sponsor: National Health Research Institutes, Taiwan ### Study Description This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks. ### Conditions - Metabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Intermittent fasting and 10,000 steps per day ### Outcomes Primary Outcomes - Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks Secondary Outcomes ### Location - Facility: Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes, Zhunan, Miaoli County, 350, Taiwan @@
## Dynamic-orthosis Programs for Stroke Hand Function - NCT ID: NCT06271187 - Study ID: A-ER-110-507 - Status: RECRUITING - Start Date: 2023-01-22 - Completion Date: 2024-12-31 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dynamic-orthosis - Traditional stroke occupational therapy training ### Outcomes Primary Outcomes - Fugl-Meyer Assessment- Upper Extremity - Box and Block Test - Motor Activity Log Secondary Outcomes - Modified Ashworth scale - Upper limb joint range of motion ### Location - Facility: National Cheng Kung University, Tainan, N/A, 701, Taiwan @@
## Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children - NCT ID: NCT06271174 - Study ID: RC23_0009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Nantes University Hospital ### Study Description Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia". ### Conditions - Persistent Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Carbocaine - Profofol and/or Suxaméthonium and/or Sévoflurane ### Outcomes Primary Outcomes - Persistent Postoperative Pain Secondary Outcomes - Screening of neuropathic pain if persistent postoperative pain - 3 months - Screening of neuropathic pain if persistent postoperative pain - 6 months - Screening of neuropathic pain if persistent postoperative pain - 12 months - 1st EN score in immediate post-operative ICU before morphine titration - Persistent postoperative pain at 6 months. - Persistent postoperative pain at 12 months. - Postoperative nausea and vomiting - Time in Post Interventional Care Unit - Opioïd dose received - Per-operative - Opioïd dose received - in Post Interventional Care Unit - Opioïd dose received - Intravenous Morphine dose received in Post Interventional Care Unit ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting - NCT ID: NCT06271161 - Study ID: F002 - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-01-01 - Lead Sponsor: Selcuk University ### Study Description The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting? ### Conditions - Postoperative Pain - Postoperative Nausea and Vomiting - Throat, Sore - Anesthesia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used. Secondary Outcomes - Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded. ### Location - Facility: Funda Arun, Selçuklu, Konya, 42000, Turkey @@
## Career and Lifestyle Among Female Surgeons in Jordan - NCT ID: NCT06271148 - Study ID: Mutah University - Status: COMPLETED - Start Date: 2023-02-03 - Completion Date: 2023-12-31 - Lead Sponsor: Mohammad Abu-Jeyyab ### Study Description A study conducted to evaluate the female surgeons in Jordan from different lifestyle ### Conditions - Surgery - Lifestyle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Interview ### Outcomes Primary Outcomes - Career and Lifestyle Among Female Surgeons in Jordan - Working Hours - Sex Bias - inadequate mentorship - having 30 days of leave - salary Secondary Outcomes ### Location - Facility: Mutah University, Al-Karak, N/A, 61710, Jordan @@
## Assessing the Quality of Life of Patients With Rosacea - NCT ID: NCT06271135 - Study ID: LU20170508 - Status: COMPLETED - Start Date: 2017-05-08 - Completion Date: 2018-11-30 - Lead Sponsor: Medical University of Bialystok ### Study Description The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires. ### Conditions - Rosacea ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - CAPILLARY REPAIR SERUM 30ml ### Outcomes Primary Outcomes - Elements influenced on quality of life of participants with rosacea Secondary Outcomes - Self-reported questionnaire - Dietary Questionnaire - The Physical Activity Questionnaire - DLQI (Dermatology Life Quality Index) - SWLS (Satisfaction With Life Scale) - BDI (Beck Depression Inventory) ### Location - Facility: Medical University of Bialystok, Białystok, N/A, 15-089, Poland @@
## Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients - NCT ID: NCT06271122 - Study ID: COMPET-1 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2025-05-16 - Lead Sponsor: Korian ### Study Description Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders). ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Voluntary activation assessed by magnetic stimulation ### Outcomes Primary Outcomes - Central voluntary activation assessed by transcranial magnetic stimulation (TMS) Secondary Outcomes - Muscle excitability assessed by femoral magnetic stimulation (FMS) - Contractile properties assessed by femoral magnetic stimulation (FMS) - Corticospinal excitability assessed by transcranial magnetic stimulation (TMS) - Intra-cortical inhibitions transcranial magnetic stimulation (TMS) - Voluntary activation assessed by femoral magnetic stimulation (FMS) ### Location - Facility: Clinique du Souffle La Vallonie, Lodève, N/A, 34700, France @@
## Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors - NCT ID: NCT06271109 - Study ID: Soh-Med-24-01-04MD - Status: ENROLLING_BY_INVITATION - Start Date: 2021-12-01 - Completion Date: 2025-06-01 - Lead Sponsor: Sohag University ### Study Description aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors. ### Conditions - Liver Neoplasms ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Anatomical laparoscopic liver resection for liver neoplasms - Non-Anatomical laparoscopic liver resection for liver neoplasms ### Outcomes Primary Outcomes - complete resection of the neoplasm Secondary Outcomes - residual liver tissue - recurrence rate ### Location - Facility: Sohag University, Sohag, N/A, N/A, Egypt @@
## Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children - NCT ID: NCT06271096 - Study ID: 638/ADR/KMC - Status: COMPLETED - Start Date: 2019-11-01 - Completion Date: 2024-01-01 - Lead Sponsor: Arooj Khan ### Study Description IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures ### Conditions - Seizures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intra muscular Midazolam - Intravascular Diazepam ### Outcomes Primary Outcomes - Fits Controlled Secondary Outcomes ### Location - Facility: Khyber Teaching Hospital, Peshawar, N/A, 25000, Pakistan @@
## Internet-based Behavior Therapy for Adults With Tourette Syndrome - NCT ID: NCT06271083 - Study ID: 2023-06541-01 - Status: RECRUITING - Start Date: 2024-02-02 - Completion Date: 2028-05 - Lead Sponsor: Karolinska Institutet ### Study Description This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention. ### Conditions - Tourette Syndrome - Chronic Tic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exposure with response prevention - Brief psychoeducation with general psychological support ### Outcomes Primary Outcomes - Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) Secondary Outcomes - Yale Global Tic Severity Scale (YGTSS) - impairment scale - Clinical Global Impression (CGI) - Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL) - Montgomery-Asberg Depression Rating Scale (MADRS) - Adult Tic Questionnaire (ATQ) - Work and social adjustment scale (WSAS) - Treatment Inventory of Costs in Psychiatric Patients (TIC-P) - Assessing Quality of Life 6 Dimensions (AQoL-6D) ### Location - Facility: Karolinska Institutet, Stockholm, N/A, 14157, Sweden @@
## Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study - NCT ID: NCT06271070 - Study ID: 2023-R23 - Status: RECRUITING - Start Date: 2024-01-16 - Completion Date: 2024-12-31 - Lead Sponsor: KAGOME CO., LTD. ### Study Description To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam. ### Conditions - Lifestyle Risk Reduction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-intervention ### Outcomes Primary Outcomes - Skin carotenoid level - Blood markers of lifestyle-related diseases - BMI - Body fat percentage - Blood pressure Secondary Outcomes - Questionnaire ### Location - Facility: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited, Hanoi, N/A, 11612, Vietnam @@
## Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse - NCT ID: NCT06271057 - Study ID: CARMOD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2027-10-20 - Lead Sponsor: The Lymphoma Academic Research Organisation ### Study Description This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator. ### Conditions - Diffuse Large B-cell Lymphoma Refractory - Refractory Primary Mediastinal Large B-Cell Lymphoma - Refractory Transformed B-cell Non-Hodgkin Lymphoma - Refractory High Grade B-Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - golcadomide ### Outcomes Primary Outcomes - Complete metabolic response rate (CMR rate) Secondary Outcomes - Objective response rate (ORR) - Objective response rate (ORR) - Complete response rate (CRR) - Duration of response (DR) - Event-free survival (EFS) - Progression-free survival (PFS) - Time To Next anti-Lymphoma Treatment (TTNLT) - Overall survival (OS) - Incidence of Adverse Events and Serious Adverse events ### Location - Facility: Hopital Henri Mondor, Créteil, N/A, 94010, France @@
## a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS - NCT ID: NCT06271044 - Study ID: RAILESS - Status: ACTIVE_NOT_RECRUITING - Start Date: 2014-10 - Completion Date: 2027-12-31 - Lead Sponsor: Helsinki University Central Hospital ### Study Description To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level. ### Conditions - to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - With radioiodine treatment - With postoperative radioiodine treatment ### Outcomes Primary Outcomes - Event free situation during follow-up event free /disease free Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection - NCT ID: NCT06271031 - Study ID: LHS0211 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-03-31 - Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust ### Study Description The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:* Interviews with healthcare staff to understand patient care pathways.* Analysis of historical data on bacteria causing infections and antibiotic treatments.* A 30-day observational study to observe patient treatment for bloodstream infections. ### Conditions - Sepsis - Bloodstream Infection - Bacteraemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Generation of a software simulation model that is fine tuned to the observed data. Secondary Outcomes - Exploration of the performance of the model in different hypothesised scenarios. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TocILizumab in aorTitis in GCA (TILT) - NCT ID: NCT06271018 - Study ID: GMIO-2024-0001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: GMIOFrance ### Study Description This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA. ### Conditions - Giant Cell Arteritis - Aortitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To evaluate the proportion of patients with remission of GCA Secondary Outcomes - To assess the cumulative incidence of relapse - To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start - To assess the cumulative dose of prednisone - To assess the cumulative incidence of severe adverse events - To assess the proportion of radiological vascular progression - To assess the cumulative incidence of vascular revascularization procedures ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves - NCT ID: NCT06271005 - Study ID: 000824 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Genetic Disease Investigators ### Study Description This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves. ### Conditions - Dry Eye Disease - Dry Eye ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - NeuroTears - Placebo ### Outcomes Primary Outcomes - OSDI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Microbiome Diagnostics of Lung Cancer - NCT ID: NCT06270992 - Study ID: 123R030 - Status: RECRUITING - Start Date: 2023-11-15 - Completion Date: 2026-05-15 - Lead Sponsor: TC Erciyes University ### Study Description The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis. ### Conditions - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NCCN (National Comprehensive Cancer Network) diagnosis ### Outcomes Primary Outcomes - Diagnostics accuracy assessment Secondary Outcomes ### Location - Facility: Erciyes University Hospital, Kayseri, N/A, 38039, Turkey @@
## Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing. - NCT ID: NCT06270979 - Study ID: ISHA - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Prof. Ivan Bautmans ### Study Description In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.The aims of the study are:1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.2. to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.3. to explore individual trajectories of intrinsic capacity with the ISHA system. ### Conditions - Frailty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - ISHA ### Outcomes Primary Outcomes - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Potential technical problems of the ISHA system - Experiences with ISHA (usability, feasibility and acceptability outcome) Secondary Outcomes - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol) - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). - The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). - The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT - NCT ID: NCT06270966 - Study ID: 28287 08/11/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-07 - Completion Date: 2025-12-01 - Lead Sponsor: University of Cagliari ### Study Description The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI) ### Conditions - Mild Cognitive Impairment - Cognitive Remediation - Virtual Reality - Psychiatric Rehabilitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual Reality Cognitive Remediation ### Outcomes Primary Outcomes - Side effects; Dropout rates; Proportion of recruited participants among those considered eligible Secondary Outcomes - Short Form Health Survey, 12 items (SF-12) - Brief Social Rhythms Scale (BSRS) - Patient Health Questionnaire (PHQ-9) - Generalized Anxiety Disorder-7 item (GAD-7) - Addenbrooke's Cognitive Examination (ACE-R) - Matrix test - Rey's Word Test - Trail Making Test (TMT) - Digit Span - Stroop Test - Frontal Assessment Battery (FAB) - Cognitive Estimates Test (CET) - Rey Figure Test ### Location - Facility: San Giovanni di Dio Hospital, Cagliari, CA, 09100, Italy @@
## Non-invasive Monitoring: Impact on Patient Management and Outcomes - NCT ID: NCT06270953 - Study ID: DZ_NX_US - Status: RECRUITING - Start Date: 2024-01-19 - Completion Date: 2024-06-30 - Lead Sponsor: Turtle Shell Technologies Pvt. Ltd. ### Study Description Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery. ### Conditions - No Specific Medical Conditions or Disease States ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dozee Pro NX ### Outcomes Primary Outcomes - Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions), Secondary Outcomes - HCP experience response data - Care pathway mapping ### Location - Facility: Oak Village Healthcare, Lake Jackson, Texas, 77566, United States @@
## Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy - NCT ID: NCT06270940 - Study ID: 2023.0922 - Status: RECRUITING - Start Date: 2024-03-04 - Completion Date: 2026-02-28 - Lead Sponsor: Amsterdam UMC, location VUmc ### Study Description Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes. ### Conditions - Neuropathic Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pulsed Radiofrequency (PRF) Treatment ### Outcomes Primary Outcomes - Duration PRF - Type of PRF - Pain intensity - Health Related Quality of life - Patient Global Impression of Change: PGIC - Use of opioids - PROMIS-29 - PROMIS Global-10 Secondary Outcomes ### Location - Facility: Amsterdam UMC, Amsterdam, N/A, 1081 HV, Netherlands @@
## A Feasibility Study for Randomization of Code Stroke Imaging Strategies - NCT ID: NCT06270927 - Study ID: 00003830 - Status: RECRUITING - Start Date: 2023-10-23 - Completion Date: 2024-07-10 - Lead Sponsor: University of Texas at Austin ### Study Description The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort. ### Conditions - Brain Ischemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI - CT ### Outcomes Primary Outcomes - compliance Secondary Outcomes ### Location - Facility: Ascension Seton, Austin, Texas, 78712, United States @@
## Inclusive Positive Behaviour Supports - NCT ID: NCT06270914 - Study ID: IBIS - Status: RECRUITING - Start Date: 2023-08-25 - Completion Date: 2025-12-31 - Lead Sponsor: Uppsala University ### Study Description Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups. ### Conditions - Behavior Problem - Social Skills ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Inclusive Positive Behavior Interventions and Supports ### Outcomes Primary Outcomes - Social emotional skills - Classroom environment - Students' achievement Secondary Outcomes - Collective self-efficacy - Problem behavior in classroom and school ### Location - Facility: Department of Education, Uppsala, Uppland, 752 37, Sweden @@
## Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk - NCT ID: NCT06270901 - Study ID: BMEL: 2822EPS008 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-30 - Lead Sponsor: University of Bonn ### Study Description The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated. ### Conditions - Cardiovascular Diseases - Metabolic Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - High Protein Planetary Health Diet - Low Protein Planetary Health Diet - High Protein Western Diet - Low Protein Western Diet ### Outcomes Primary Outcomes - Parameters of lipid metabolism in blood Secondary Outcomes - Parameters of lipid metabolism in blood - Parameters of lipid metabolism in blood - Parameters of lipid metabolism in blood - Parameters of lipid metabolism in blood - Parameters of glucose metabolism in blood - Parameters of glucose metabolism in blood - Parameters of glucose metabolism in blood - Parameters of glucose metabolism in blood - Parameters of glucose metabolism in blood - Blood amino acid profile - Blood urea - Uric acid in blood - Parameters of hunger and satiety in blood - Parameters of endothelial function in blood - Parameters of inflammation in blood - Endothelial function - Neuropsychological parameters - Neuropsychological parameters - Neuropsychological parameters ### Location - Facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology, Bonn, North-Rhine Westphalia, 53115, Germany @@
## Hypofractionation (Radiation) Trial for Multiple Myeloma - NCT ID: NCT06270888 - Study ID: IRB23-1011 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: University of Chicago ### Study Description This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma. ### Conditions - Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Radiation ### Outcomes Primary Outcomes - Maximum Tolerated Dose of Radiation of Per Fraction Secondary Outcomes - Rate of Grade 3 or Higher Adverse Events - Rate of Long-Term Adverse Events - Overall Response Rate - Progression-free Survival - Local Control of the treated Lesion ### Location - Facility: The University of Chicago Comprehensive Cancer Center, Chicago, Illinois, 60637, United States @@
## Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF) - NCT ID: NCT06270875 - Study ID: PROJECT ADAPT-HF - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-03 - Lead Sponsor: University of Alabama at Birmingham ### Study Description Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components). ### Conditions - Heart Failure NYHA Class III - Heart Failure NYHA Class IV - Chronic Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - ADAPT HF ### Outcomes Primary Outcomes - Feasibility of Intervention Delivery and Data Collection - Acceptability of Intervention Measure (AIM) - PROMIS Pain Intensity Scale - Pain Interference Scale Short Form 6b - Feasibility of Intervention Measure Secondary Outcomes - Edmonton Symptom Assessment Scale (ESES-r) - Kansas City Cardiomyopathy Questionnaire- Short Form - Hospital Anxiety and Depression Scale (HADS) - PROMIS General Self-efficacy - Self-care of Heart Failure Index - Multidimensional Scale of Perceived Social Support (MSPSS) - Patient Activation Measure (PAM) Short Form - Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q - Connor-Davidson Resilience Scale (CD-RISC-10) - Discrimination in Medical Settings Scale Scale - Cost/Resource Utilization Form - SF Global Health Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Digital Active Aging Training Program for Older Adults - NCT ID: NCT06270862 - Study ID: SSHRC-PEG2023-AAT - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-12-31 - Lead Sponsor: Toronto Metropolitan University ### Study Description The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics. ### Conditions - Healthy Aging - Cognitive Change - Psychological Stress - Loneliness - Social Interaction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Resilience training - cognitive training - physical exercise - social interaction - workshop series ### Outcomes Primary Outcomes - Exercise Self-efficacy level (ESES) - the 5-item World Health Organization WellBeing Index (WHO-5) - Kessler Psychological Distress Scale (K10) - Multidimensional Scale of Perceived Social Support (MSPSS) - Conner-Davidson Resilience Scale 10-item (CD RISC-10) - Emotional regulation Questionnaire (ERQ) - Positive and Negative Affect Schedule (PANAS) - Visual working memory test - Divided attention test - Visual memory test - Stroop test - Sustained attention to response test Secondary Outcomes - Satisfaction with life scale (SWLS) - Instrumental Activities of Daily Living(IADL) - The 6-item De Jong Gierveld Loneliness Scale - The Brief Approach/Avoidance Coping Questionnaire (BACQ) ### Location - Facility: Cognitive Aging Lab, Toronto, Ontario, M5B 2K3, Canada @@
## Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS - NCT ID: NCT06270849 - Study ID: MTU-EC-SU-0-002/66 - Status: COMPLETED - Start Date: 2023-02-24 - Completion Date: 2024-01-20 - Lead Sponsor: Thammasat University Hospital ### Study Description The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis. ### Conditions - Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire - Reliability of Thai Version of the ICIQ-FLUTS LF ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity. - The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency. - The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability. Secondary Outcomes - The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity. ### Location - Facility: Thammasat University Hospital, Khlong Luang, Pathumthani, 12120, Thailand @@
## A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) - NCT ID: NCT06270836 - Study ID: KS301P108 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2025-12-30 - Lead Sponsor: Kodiak Sciences Inc ### Study Description This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR. ### Conditions - Non-proliferative Diabetic Retinopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tarcocimab - Sham injection ### Outcomes Primary Outcomes - Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) Secondary Outcomes - Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy - Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) ### Location - Facility: Retina Consultants of Orange County, Fullerton, California, 92835, United States @@
## Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial - NCT ID: NCT06270823 - Study ID: NIMR/HQ/R.8a/Vol.IX/4331 - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-02-14 - Lead Sponsor: Kilimanjaro Clinical Research Institute ### Study Description Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care ### Conditions - Transient Tachypnea of the Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Knee-to-chest-flexion manoeuvre ### Outcomes Primary Outcomes - respiratory distress Secondary Outcomes - adverse outcome of knee-to-chest flexion maneuver ### Location - Facility: Kilimanjaro Christian Medical Centre, Moshi, Kilimanjaro, P.O.Box 3010, Tanzania @@
## Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity - NCT ID: NCT06270810 - Study ID: Aero-PA - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-06-01 - Lead Sponsor: Kastamonu University ### Study Description The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.The main question it aims to answer is:• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables. ### Conditions - Overweight ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Aerobic Exercise - Increasing non-Exercise Physical Activity ### Outcomes Primary Outcomes - Low Density Lipoprotein (LDL) Cholesterol - High Density Lipoprotein (HDL) Cholesterol - Total Cholesterol - Glycated Hemoglobin (HbA1C) - Serum Triglycerides - Maximal Oxygen Consumption - Systolic Blood Pressure - Diastolic Blood Pressure Secondary Outcomes - Body Fat Percentage - Fat-free Mass - Waist Circumference - Hip Circumference ### Location - Facility: Kastamonu University, Çatalzeytin Vocational School, Çatalzeyti̇n, Kastamonu, 37, Turkey @@
## Pre-anesthesia Imaging-based Respiratory Assessment and Analysis - NCT ID: NCT06270797 - Study ID: KMUHIRB-E(I)-20230184 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital ### Study Description This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system. ### Conditions - Clinical Decision Support System ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - intubation for general anesthesia ### Outcomes Primary Outcomes - A pre-anesthesia evaluation - Perform non-invasive imaging capture. - difficult intubation prediction Secondary Outcomes - time to successfully extubate the nasotracheal tube after anesthesia - safely discharged from post-anesthesia care unit (postoperative recovery room) - side effects and adverse events ### Location - Facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Sanmin Dist, 80756, Taiwan @@
## Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve - NCT ID: NCT06270784 - Study ID: 09.2024.122 - Status: RECRUITING - Start Date: 2024-01-17 - Completion Date: 2024-09-17 - Lead Sponsor: Marmara University ### Study Description The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?Participants will:* undergo either traditional or orthodontic extraction* be monitored for postoperative paresthesia.Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage. ### Conditions - Inferior Alveolar Nerve Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Traditional Extraction - Orthodontic Extraction ### Outcomes Primary Outcomes - The effect of the extraction method on nerve injury Secondary Outcomes - 2-point discrimination test ### Location - Facility: Marmara University, Istanbul, Basibuyuk, 34854, Turkey @@
## OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study - NCT ID: NCT06270771 - Study ID: 5823 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-02-01 - Lead Sponsor: Sunnybrook Health Sciences Centre ### Study Description A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months. ### Conditions - MDS - Myelodysplastic Syndromes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OURA Ring ### Outcomes Primary Outcomes - Feasibility of patients with MDS wearing the OURA ring Secondary Outcomes - Exploratory correlations between physiologic changes captured by the wearable device and physical functioning ### Location - Facility: Sunnybrook Health Sciences Research Centre, Toronto, Ontario, M4N 3M5, Canada @@
## Clinical Validation of BBCT-hip - NCT ID: NCT06270758 - Study ID: 453/2023/Sper/IOR - Status: RECRUITING - Start Date: 2023-11-07 - Completion Date: 2030-11-06 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study. ### Conditions - Osteoporosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CT scan at the femur ### Outcomes Primary Outcomes - Femoral fracture event - BBCT-hip risk prediction Secondary Outcomes - T-score ### Location - Facility: Rizzoli Orthopaedic Institute, Bologna, N/A, 40136, Italy @@
## ICG Anastomotic Control in Digestive System Surgery - NCT ID: NCT06270745 - Study ID: sdycllyy001 - Status: RECRUITING - Start Date: 2018-01-01 - Completion Date: 2024-06-01 - Lead Sponsor: Shandong Linglong Yingcheng Hospital ### Study Description This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery. ### Conditions - Surgical Anastomosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - indocyanine green ### Outcomes Primary Outcomes - Anastomotic leak at 30 days Secondary Outcomes - Post-operative morbidity ### Location - Facility: Shandong Linglong Yingcheng Hospital, Yantai, Shandong, 264000, China @@
## Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population. - NCT ID: NCT06270732 - Study ID: PID2021-125444OB-100-II-iM - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2025-03-03 - Lead Sponsor: Universitat Autonoma de Barcelona ### Study Description OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efﬁcacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group). ### Conditions - Emotional Intelligence - Social Interaction - Mental Health Wellness 1 - Well-Being, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iMentalize Program (iMentalize) - Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) - Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) ### Outcomes Primary Outcomes - Parental Reﬂective Function Questionnaire (PRFQ) - Trait Meta-Mood Scale (24 items) (TMMS-24) - Basic Empathy Scale (BES) - Movie for the Assessment of Social Cognition (MASC) - Stirling Children's Wellbeing Scale (SCWBS) - Child Well-Being Level (CWBL) - Strengths and Difﬁculties Questionnaire (SDQ) - Achenbach System for Empirically Assessment (ASEBA) Secondary Outcomes - Observing Mediational Interaction (OMI) - Parental Stress Questionnaire (PSI) - Goldberg Health Questionnaire (28 items) (GHQ-28) - Difﬁculties in Emotional Regulation Scale (DERS) - Oxford Happiness Questionnaire (OHQ) - Rosenberg's Self-Esteem Scale (RSES) - Parental Sense of Competence Scale (PSOC) - Self-Other Mentalization Scale (SOMS) - Reﬂective Functioning Scale - Youth (5 items version) (RFQ-Y5) - Trait Meta-Mood Scale - Children version (TMMS-C) - Big Five Questionnaire for Children and Adolescents (BFQ-NA) - BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn) - Rosenberg's Self-Esteem Scale - Child version (RSES-C) - Battery of Socialization (BAS) ### Location - Facility: Sergi Ballespí, Barcelona, N/A, 08193, Spain @@
## An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy - NCT ID: NCT06270719 - Study ID: SRP-9001-401 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2038-12-31 - Lead Sponsor: Sarepta Therapeutics, Inc. ### Study Description This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies. ### Conditions - Duchenne Muscular Dystrophy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - delandistrogene moxeparvovec - Standard of Care ### Outcomes Primary Outcomes - All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12 Secondary Outcomes - All Cohorts: Time to Rise From Floor (Supine to Stand) - All Cohorts: Loss of Ambulation (LOA) - All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item Score - All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue - All Cohorts: Pulmonary Function, as Measured Forced Vital Capacity (FVC) (% Predicted) - All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO) - All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) - Delandistrogene Moxeparvovec Cohorts: Time to Walk/Run 10 Meters (Calculated Velocity) - Delandistrogene Moxeparvovec Post-trial Cohort: North Star Ambulatory Assessment (NSAA) ### Location - Facility: Arkansas Children's Hospital, Little Rock, Arkansas, 72202, United States @@
## A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors - NCT ID: NCT06270706 - Study ID: PLN-101095-ONC-101 - Status: RECRUITING - Start Date: 2023-08-30 - Completion Date: 2025-12 - Lead Sponsor: Pliant Therapeutics, Inc. ### Study Description This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab.The study will consist of 2 main parts:* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design* Part 2: Dose-expansion cohorts using Simon's 2-stage design ### Conditions - Metastatic Solid Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - PLN-101095 - Pembrolizumab ### Outcomes Primary Outcomes - Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0. - Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications. Secondary Outcomes - Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK). - Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK). - Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK). - Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1. - Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1. ### Location - Facility: South Texas Accelerated Research Therapeutics (START), Grand Rapids, Michigan, 49546, United States @@
## hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis - NCT ID: NCT06270693 - Study ID: Dr Sushma - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-11-01 - Completion Date: 2024-04-01 - Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak ### Study Description Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure. ### Conditions - Apical Periodontitis - Coronary Artery Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endodontic treatment ### Outcomes Primary Outcomes - Serum hsCRP - complete hemogram indices Secondary Outcomes - Periapical index SCORE CHANGE ### Location - Facility: PGIDS, Rohtak, Haryana, 124001, India @@
## Carotenoids for Collision Athletes - NCT ID: NCT06270680 - Study ID: STUDY00023019 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2024-12-20 - Lead Sponsor: Penn State University ### Study Description This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo. ### Conditions - Head Injury - Carotenoids ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Vision Edge Pro - Placebo ### Outcomes Primary Outcomes - Blood and saliva biomarkers via venous blood draw and spitting into sterile cup. - Visual Performance: Speed of visual processing - Visual Performance: Contrast Sensitivity - Skin carotenoid concentration - Retinal Nerve Fiber Layer Thickness - Macular Pigment Optical Density - Visual Quality of Life Scores - Visual Quality of Life Scores Secondary Outcomes - Demographic information - Demographic information ### Location - Facility: The Pennsylvania State University, University Park, Pennsylvania, 16802, United States @@
## Effects of Exercise Training in Survivors of Lymphoma - NCT ID: NCT06270667 - Study ID: LYMfit - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2028-09-01 - Lead Sponsor: Norwegian School of Sport Sciences ### Study Description This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases. ### Conditions - Lymphoma - Physical Exercise - Cardiotoxicity - Cardiovascular Diseases - Chemotherapeutic Toxicity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Aerobic Exercise - Combined Aerobic and Resistance Exercise ### Outcomes Primary Outcomes - VO2peak Secondary Outcomes - Systolic- and diastolic heart chamber dimensions - Systolic- and diastolic longitudinal strain - Lean body mass - Fat mass - Forced Vital Capacity - Forced Expiratory Volume 1 sec - Maximal voluntary ventilation - Diffusion capacity - Physical activity - Physical activity - Global Health related Quality of life - Blood volume - Muscle fiber area - Muscle fiber type - Muscle mitochondria mass ### Location - Facility: Norweigan School of Sport Sciences, Oslo, N/A, N/A, Norway @@
## Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery - NCT ID: NCT06270654 - Study ID: 2023322-12280 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2024-06-01 - Lead Sponsor: University of Malaya ### Study Description The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery. ### Conditions - Lumbar Spine Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Erector spinae plane block - Skin infiltration LA ### Outcomes Primary Outcomes - Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery - Total opioid consumption intraoperative - Total opioid consumption post-operative - Timing of first rescue dose of iv morphine Secondary Outcomes - The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation - Hemodynamic changes intraoperative - Hemodynamic changes intraoperative - Length of hospital stays - Time to ambulation after surgery ### Location - Facility: Universiti Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, 51100, Malaysia @@
## Increasing Physical Activity for Adults With Multiple Sclerosis (MS) - NCT ID: NCT06270641 - Study ID: STUDY00018628 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2026-09-30 - Lead Sponsor: University of Washington ### Study Description This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS). ### Conditions - Multiple Sclerosis (MS) - Fatigue - Physical Inactivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ExerciseRx intervention ### Outcomes Primary Outcomes - Physical activity: daily average step count Secondary Outcomes - Activity volume - Minutes/week of moderate intensity aerobic activity - Fatigue - PROMIS Fatigue-MS Short Form 8a - Pain intensity - PROMIS Pain Intensity Short Form 3a - Depressive symptom severity - PROMIS Depression Short Form 8a - Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a - Physical functioning - PROMIS Physical Function 10a - Pain interference - PROMIS Pain Interference Scale Short Form 6a - Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a - Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a ### Location - Facility: UW Medicine, Seattle, Washington, 98133, United States @@
## Personalized Live-remote Exercise Training for Cancer Survivors - NCT ID: NCT06270628 - Study ID: NL85029.018.23 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-20 - Completion Date: 2027-10-31 - Lead Sponsor: UMC Utrecht ### Study Description BackgroundMany people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.Goal of the study:The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.Design of the studyIn the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.MeasurementsThe main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.Conclusion:This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively. ### Conditions - Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise group ### Outcomes Primary Outcomes - Health-Related Quality of Life - A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline - A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline - A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline - A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline Secondary Outcomes - Health-related quality of life - Fatigue - Anxiety and Depression - CIPN_1 - CIPN_2 - Sleep - Pain - Cognitive problems - Work limitations - Body image - Fear of cancer recurrence - Habitual physical activity - Aerobic capacity on bike - Aerobic capacity on step - Handgrip strength - Upper body muscle strength - Lower body muscle strength - Sit to stand test - Physical function - Balance - Physical activity - Blood pressure - Resting heart rate - Weight - Height - Waist circumference - Hip circumference - Body composition - Inflammatory state - Growth factors - CRP - Hemoglobin - Leucocyte counts - Quality-adjusted life years - Health-care, patient and family costs - Productivity losses - Exercise-related (serious) adverse events ### Location - Facility: University Medical Center Utrecht, Utrecht, N/A, N/A, Netherlands @@
## Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model - NCT ID: NCT06270615 - Study ID: CRCBDD1712 - Status: RECRUITING - Start Date: 2022-07-01 - Completion Date: 2024-06 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions. ### Conditions - Wounds and Injuries - Traumatic Shock - Hemorrhagic Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Ambispective validation of machine learning-based predictive model ### Outcomes Primary Outcomes - Fβ-score, with β = 4 Secondary Outcomes - Common binary classification metrics ### Location - Facility: Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department, Clichy, N/A, 92110, France @@
## The ONCOCAMP Study - NCT ID: NCT06270602 - Study ID: ONCOCAMP - Status: RECRUITING - Start Date: 2023-07-14 - Completion Date: 2026-07 - Lead Sponsor: National Cancer Institute, Naples ### Study Description The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study. ### Conditions - Oncology ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Data collection (retrospective) - Data collection (prospective) ### Outcomes Primary Outcomes - Incidence for each tumor of the patients included in the ROC platform - Evaluation of the time interval between GOM activities - Evaluation of the time interval between GOM activities - Evaluation of the time interval between GOM activities - Evaluation of the time interval between GOM activities - Evaluation of the time interval between GOM activities - Frequency of use of the services of the ROC platform - Descriptive analysis of each subgroup of patients (subdivision by tumor type) - Spatial analysis for each patient - Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) - Percentage of patient included in clinical trial - Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate - Prevalence for each tumor of the patients included in the ROC platform Secondary Outcomes - Description of pharmacological strategies - Description of diagnostic activities - Description of surgical strategies - Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) - Description of each surgical approach - Description of the different surgical techniques among the centers - Patients' quality of life - Patients' reported outcome - Patients' satisfaction and evaluation of the diagnostic / therapeutic path - Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis - Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit - Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path - Survival analysis for each tumor - Life status assessment for each patient ### Location - Facility: Asl Napoli 2 Nord, Casavatore, Napoli, 80020, Italy @@
## Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children - NCT ID: NCT06270589 - Study ID: IRB-2023-1684 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-05 - Lead Sponsor: Purdue University ### Study Description The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restQuestion 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restParticipants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities.Participants will complete the testing and/or receive treatments below:Day 1:* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)Days 2-5* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)* Participants' heart rate and self-reported affect and rating of physical exertion will be measured* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performanceResearcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - MF-HIIT - MF-only - HIIT-only - Sitting rest ### Outcomes Primary Outcomes - Inhibition speed - Inhibition accuracy - Shifting speed - Shifting accuracy - N2-ERP - P3-ERP Secondary Outcomes - State Mindfulness Scale for Physical Activity (SMSPA) - Rating of perceived exertion - Heart Rate ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma - NCT ID: NCT06270576 - Study ID: HS3131 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-06 - Lead Sponsor: National Jewish Health ### Study Description A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma. ### Conditions - Asthma; Eosinophilic - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Lipopolysaccharides ### Outcomes Primary Outcomes - Neutrophil heterogeneity using single cell RNA sequencing Secondary Outcomes ### Location - Facility: National Jewish Health, Denver, Colorado, 80206, United States @@
## High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture - NCT ID: NCT06270563 - Study ID: P.T.REC/012/003967 - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-12-01 - Lead Sponsor: Cairo University ### Study Description The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients ### Conditions - Forward Head Posture ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Postural advice - Traditional exercise treatment - Scapular stabilization exercises - High intensity Laser therapy ### Outcomes Primary Outcomes - Forced vital capacity (FVC) - Forced expiratory volume at one second (FEV1) - FEV1/FVC - Maximum voluntary ventilation (MVV) - Craniovertebral angle (CVA) - Neck Disability Index (NDI) Secondary Outcomes - Upper thoracic chest expansion - Middle thoracic chest expansion - Lower thoracic chest expansion - Visual analogue scale (VAS) ### Location - Facility: Cairo University, Giza, N/A, N/A, Egypt @@
## Role of Dynamic Movement Intervention in Children With Spastic Diplegia - NCT ID: NCT06270550 - Study ID: DMI in Spastic Diplegia - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: Cairo University ### Study Description The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy. ### Conditions - Spastic Diplegia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dynamic Movement Intervention ### Outcomes Primary Outcomes - Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System. Secondary Outcomes ### Location - Facility: Cairo University, Cairo, N/A, N/A, Egypt @@
## Post-market Clinical Trial of the Dominus® Stent-Graft - NCT ID: NCT06270537 - Study ID: Dominus PMCF - Status: RECRUITING - Start Date: 2023-10-24 - Completion Date: 2029-02-28 - Lead Sponsor: Braile Biomedica Ind. Com. e Repr. Ltda. ### Study Description Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use ### Conditions - Thoracic Aortic Dissection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Stent-Graft Dominus® Endoprosthesis ### Outcomes Primary Outcomes - Early occurrence of adverse events (Safety Outcome) Secondary Outcomes - Device Success - Absence of endoprosthesis fracture - Endoleak - Reintervention-free - Adverse Events ### Location - Facility: Hospital Evangélico de Vila Velha, Vila Velha, Espirito Santo, 29118-060, Brazil @@
## Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target - NCT ID: NCT06270524 - Study ID: RCAPHM21_0433 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-12-31 - Lead Sponsor: Assistance Publique Hopitaux De Marseille ### Study Description This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission. ### Conditions - Immunoglobulin G4-Related Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Blood sampling ### Outcomes Primary Outcomes - Serum C5a concentration Secondary Outcomes - frequency of C5aR1+ monocytes among total monocytes - frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants - NCT ID: NCT06270511 - Study ID: 2222T1412 - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-06-19 - Lead Sponsor: Shionogi ### Study Description The aim of this study is to investigate different formulations of S-337395. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - S-337395 - Placebo ### Outcomes Primary Outcomes - Part A: Plasma Concentration of S-337395 - Part B: Number of Participants Experiencing Treatment-emergent Adverse Events Secondary Outcomes - Part A: Number of Participants Experiencing Treatment-emergent Adverse Events - Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples) - Part B: Plasma Concentration of S-337395 ### Location - Facility: ICON Lenexa, Lenexa, Kansas, 66219, United States @@
## Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure - NCT ID: NCT06270498 - Study ID: 24811 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-06-01 - Lead Sponsor: Raffaele De Caterina ### Study Description The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo. ### Conditions - Chronic Heart Failure - Iron-deficiency - Left Ventricular Systolic Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sucrosomial iron - Placebo ### Outcomes Primary Outcomes - Exercise capacity Secondary Outcomes - Quality of life - 6MWT distance improvement - Quality of life improvement - Exercise capacity (peak oxygen consumption) - F2-isoprostanes - Soluble NOX2-derived peptide (sNOX2-dp) - H2O2 - Phosphate - Fibroblast growth factor (FGF)-23 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children - NCT ID: NCT06270485 - Study ID: EA2/224/23 - Status: RECRUITING - Start Date: 2023-11-27 - Completion Date: 2025-06 - Lead Sponsor: Charite University, Berlin, Germany ### Study Description Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age ### Conditions - Ventilation Therapy; Complications - Congenital Heart Disease - Children, Only - Hemodynamic Instability ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - PEEP ### Outcomes Primary Outcomes - Cardiac Output Secondary Outcomes - TAPSE (cm) - respiratory mechanics - TAPSV (cm/s) - Global Strain RV (%/sec) - Lung Compliance (ml/Min/kg) - Esophageal Pressure (mbar) - EIT ### Location - Facility: Deutsches Herzzentrum der Charité, Berlin, N/A, 13353, Germany @@
## Transinguinal Periperitoneal Technique in Inguinal Hernioplasty - NCT ID: NCT06270472 - Study ID: tipp technique - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-04-01 - Lead Sponsor: Assiut University ### Study Description evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals ### Conditions - Hernia, Inguinal ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - hernioplasty ### Outcomes Primary Outcomes - Recurrence rate of inguinal hernia 2 years follow up . - Numerical rating score of pain Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke - NCT ID: NCT06270459 - Study ID: DSRB 2023/00954 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-15 - Completion Date: 2025-08-14 - Lead Sponsor: Tan Tock Seng Hospital ### Study Description There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - HMAN Robot ### Outcomes Primary Outcomes - Compliance Rates Secondary Outcomes - Fugl Meyer Motor Assessment (FMA) - Action Research Arm Test (ARAT) - Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded) - System Usability Scale (SUS) - Intrinsic Motivation Inventory (IMI) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Community Based Rehabilitation Model After Total Knee Replacement - NCT ID: NCT06270446 - Study ID: DSRB 2019/01135 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2022-07-01 - Lead Sponsor: Tan Tock Seng Hospital ### Study Description To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Community based physiotherapy - Outpatient physiotherapy ### Outcomes Primary Outcomes - TUG - 30 sec chair stand test - Pain intensity Secondary Outcomes - Knee flexion and extension - Passive range of motion - Presence of lag ### Location - Facility: Tan Tock Seng Hospital, Singapore, N/A, N/A, Singapore @@