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## Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors - NCT ID: NCT06331559 - Study ID: SIM0501-101 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2027-12-31 - Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. ### Study Description This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - SIM0501 Tablets - SIM0501 Tablets - SIM0501 in combination with olaparib - SIM0501 in combination with olaparib ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - Adverse events will be evaluated according to the CTCAE v5.0 Secondary Outcomes ### Location - Facility: Shandong Cancer Hospital, Jinan, Shandong, 250117, China @@
## Gut Oxalate Absorption in Calcium Oxalate Stone Disease - NCT ID: NCT06331546 - Study ID: IRB300004693 - Status: RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-12-31 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate.The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.Participants will* ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time* ingest a soluble form of oxalate and sugar preparations to test gut permeability* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test ### Conditions - Kidney Stone - Kidney Calculi - Urolithiasis - Urolithiasis, Calcium Oxalate - Nephrolithiasis - Nephrolithiasis, Calcium Oxalate - Oxalate Urolithiasis - Oxaluria - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Low-oxalate diet - High-oxalate diet - soluble oxalate gut absorption test ### Outcomes Primary Outcomes - Net Gastrointestinal absorption of food-bound oxalate Secondary Outcomes - Absorption of soluble 13C2-oxalate - Estimated endogenous oxalate synthesis (oxalate mg/day) ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea - NCT ID: NCT06331533 - Study ID: IstanbulTRH1 - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2023-06-01 - Lead Sponsor: Istanbul Training and Research Hospital ### Study Description Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy. ### Conditions - Erythematotelangiectatic Rosacea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Botulinum toxin A - Placebo ### Outcomes Primary Outcomes - Assessment of erythema with Clinician's Erythema Assessment scale - Evaluation of erythema using mexameter - Evaluation of erythema by dermatoscopy Secondary Outcomes - Evaluation of the change in vascular structure using videocapillaroscopy ### Location - Facility: Istanbul Training and Research Hospital, Istanbul, N/A, 34098, Turkey @@
## NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens - NCT ID: NCT06331520 - Study ID: Desineo - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Fudan University ### Study Description The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy. ### Conditions - Chemotherapy-induced Nausea and Vomiting - Highly Emetogenic Chemotherapy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Netupitant / Palonosetron Oral Capsule [Akynzeo] - Olanzapine - Dexamethasone Oral ### Outcomes Primary Outcomes - Percentage of patients with complete response (CR) Secondary Outcomes - Percentage of Patients With CR (acute and delayed) - Percentage of patients with overall complete protection(OCP) - Percentage of patients with overall total control (OTC) - incidence of adverse events - quality of life questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch - NCT ID: NCT06331507 - Study ID: HUM00176904 - Status: TERMINATED - Start Date: 2021-09-02 - Completion Date: 2023-06-29 - Lead Sponsor: University of Michigan ### Study Description This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED). ### Conditions - Cardiomyopathies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - CMR patch ### Outcomes Primary Outcomes - Scan speed: Secondary Outcomes ### Location - Facility: Michigan Medicine - University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery - NCT ID: NCT06331494 - Study ID: SICAS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2026-08-31 - Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University ### Study Description Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis. ### Conditions - Ischemic Stroke, Acute - Intracranial Atherosclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Butylphthalide - Placebo ### Outcomes Primary Outcomes - Changes in stenosis degree in the responsible artery Secondary Outcomes - Stroke recurrence - Change in plaque volumes the responsible artery - Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery - Changes in National Institutes of Health Stroke Scale (NIHSS) - Proportion of patients with modified Rankin Scale score (mRS) 0-2 - Change in the value of cerebral blood flow (CBF) in the responsible artery territory - Change in concentrations of serum lipid profiles ### Location - Facility: The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510080, China @@
## The Effect of Over Weight on Oocytes Quality in IVF Patients - NCT ID: NCT06331481 - Study ID: 0005-22-HYMC - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-02-01 - Completion Date: 2024-07 - Lead Sponsor: Hillel Yaffe Medical Center ### Study Description Obesity is an increasing worldwide problem and a risk factor for many diseases. The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. They present with higher incidence of infertility compared to normal weight women.This study is prospective observational cohort study performed between February 2022 until June 2022 in a single university-affiliated hospital. ### Conditions - IVF - Overweight ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Fullicular fluid for cytology and biocemical analysis ### Outcomes Primary Outcomes - Impact of obesity on oocyte's mtDNA expression in Cumulus Cells - Impact of obesity on oocyte quality through levels of protein BMP-15 - Impact of obesity on oocyte quality through levels of protein HSPG2 Secondary Outcomes - Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression - Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15 - Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2 ### Location - Facility: Hillel Yaffe Medical Center - IVF Unit, Hadera, N/A, 38100, Israel @@
## Hypofractionated Radiochemotherapy - NCT ID: NCT06331468 - Study ID: MCC-23-GYN-10 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-08-01 - Lead Sponsor: Denise Fabian ### Study Description The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?* What is the proportion of patients who complete the treatment in prescribed timeframe?* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:* Complete history and physical exam, GOG performance status evaluation* Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.Treatment will be administered on an outpatient basis.The main difference between the proposed regimen in the trial and standard of care is as follows:1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.IMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.After active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.Following the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment. ### Conditions - Uterine Cervix Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cisplatin - intensity modulated radiation therapy (IMRT) - high-dose-rate (HDR) brachytherapy ### Outcomes Primary Outcomes - MRI assessed rate of complete response Secondary Outcomes - MRI assessed rate of complete response - progression-free survival (PFS) - overall survival (OS) - Treatment Completion - Treatment Tolerability ### Location - Facility: Markey Cancer Center, Lexington, Kentucky, 40506, United States @@
## Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection - NCT ID: NCT06331455 - Study ID: 23-5501 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-04 - Lead Sponsor: Marc de Perrot ### Study Description The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery. ### Conditions - Lung Cancer Patients - Non-small Cell Lung Cancer (NSCLC) ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Durvalumab - Non-ablative oligofractionated radiation (NORT) ### Outcomes Primary Outcomes - To Measure CD8 TILs density & Major Pathological Response (MPR) Secondary Outcomes - To explore the efficacy and safety of NORT-durvalumab ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients - NCT ID: NCT06331442 - Study ID: 006503905 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-11 - Lead Sponsor: University of Zagreb ### Study Description This randomized controlled trial will be conducted on 40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia. Respondents will be randomly allocated into 4 groups (n=10). The first group will receive photodynamic therapy, the second tricalcium phosphate varnish with 5% NaF (sodium fluoride), the third 1% chlorhexidine varnish, while the fourth group will be the negative control. Before and after the mentioned interventions, the participants will have the amount of plaque measured using the plaque index and the bacteriological composition of the plaque assessed using the mass spectrometry and PCR. The gingival condition will be assessed using the gingival index. Also, the occurrence of white spot lesions will be evaluated on intraoral photographs. ### Conditions - Plaque, Dental - Dental Plaque Induced Gingivitis - White Spot Lesion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Photodynamic therapy - Tricalcium phosphate (TCP) varnish with 5% NaF - Chlorhexidine varnish ### Outcomes Primary Outcomes - Assessment of dental plaque accumulation using plaque index - Assessment of the bacteriological composition of supragingival plaque using mass spectrometry Secondary Outcomes - Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction - Assessment of gingival condition using gingival index - Diagnosis of white spot lesions on intraoral photographs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus. - NCT ID: NCT06331429 - Study ID: EmoTiCare - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2025-02 - Lead Sponsor: University of Valencia ### Study Description The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness. ### Conditions - Type 1 Diabetes - Adolescent Development ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - EmoTiCare ### Outcomes Primary Outcomes - Change Quality of Life (Baseline-Pre-Post) - Change Emotional and Behavioral Problems (Baseline-Pre-Post) - Change Emotional Competences (Baseline-Pre-Post) - Change Self-concept (Baseline-Pre-Post) - Change Coping (Baseline-Pre-Post) - Change Social Skills (Baseline-Pre-Post) Secondary Outcomes - Change Threat of disease(Baseline-Pre-Post) - Change Psychoeducation Diabetes - Change Resilience (Baseline-Pre-Post) ### Location - Facility: Universitat de València, Valencia, N/A, N/A, Spain @@
## One-device Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation - NCT ID: NCT06331416 - Study ID: 208_2022H - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-09-30 - Lead Sponsor: University of Trieste ### Study Description Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD. ### Conditions - COPD - COPD Exacerbation Acute ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Telemonitoring ### Outcomes Primary Outcomes - Re-hospitalization at 90 days Secondary Outcomes - Re-hospitalization at 30 days - Functional decline - Unplanned medical evaluations - Need for mechanical ventilation at 30 days - Need for mechanical ventilation at 90 days - Satisfaction score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors - NCT ID: NCT06331403 - Study ID: 24-009 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Massachusetts General Hospital ### Study Description The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit.To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability.As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial.In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being. ### Conditions - Colorectal Cancer - Anal Cancer - Sexual Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mind-Body Group Intervention ### Outcomes Primary Outcomes - Feasibility of Intervention - Acceptability of Intervention Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis - NCT ID: NCT06331390 - Study ID: 2181-198-03-04-24-0008 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-07 - Lead Sponsor: University of Split, School of Medicine ### Study Description Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days ### Conditions - Contact Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - niacinamide cosmetic product - placebo ### Outcomes Primary Outcomes - tewameter Secondary Outcomes ### Location - Facility: University of Split School of Medicine, Split, N/A, N/A, Croatia @@
## Clinical and Molecular Characteristics of Histiocytic Disorders - NCT ID: NCT06331377 - Study ID: 17-004541 - Status: RECRUITING - Start Date: 2017-07-27 - Completion Date: 2027-07-31 - Lead Sponsor: Mayo Clinic ### Study Description This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders. ### Conditions - Histiocytic Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-Interventional Study ### Outcomes Primary Outcomes - Identify molecular markers - Change in PD-L1 and T-cell Bim expression Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## TREATment of Lower Respiratory Tract Infection in Sri Lanka (TREAT-SL) - NCT ID: NCT06331364 - Study ID: Pro00114347 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: Duke University ### Study Description This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka.The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed. ### Conditions - Lower Resp Tract Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - electronic clinical decision support tool (eCDST) diagnostic plan ### Outcomes Primary Outcomes - Total duration of antibacterial prescription for the index visit - Composite of adverse outcomes that could be attributed to withholding antibacterials Secondary Outcomes - Proportion of participants using non-invasive ventilation - Proportion of participants using mechanical ventilation - Proportion of participants readmitted to the hospital - Proportion of deaths - Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription - Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization - Duration of admission to the intensive care unit (ICU) during index hospitalization - Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization - Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization - Duration of non-invasive ventilation during index hospitalization - Duration of mechanical ventilation during index hospitalization - Duration of index hospitalization - Proportion prescribed antibacterials- cumulative - Proportion prescribed antibacterials- at time of assessment - Total antibacterial exposure per patient during hospitalization - Proportion prescribed oseltamivir- cumulative - Proportion prescribed oseltamivir- at time of assessment - Total oseltamivir exposure per patient during hospitalization - Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative - Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment - Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed - Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed - Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed - Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed - Physician adherence, as measured by the proportion in whom all treatment recommendations were followed ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis - NCT ID: NCT06331351 - Study ID: A11203001 - Status: RECRUITING - Start Date: 2024-02-22 - Completion Date: 2025-12-31 - Lead Sponsor: Dalin Tzu Chi General Hospital ### Study Description Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis. ### Conditions - Chronic Pharyngitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - control group - Jing Si herbal tea liquid packets ### Outcomes Primary Outcomes - Health questionnaire - Reflux Symptom Index (RSI) Secondary Outcomes ### Location - Facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi City, N/A, 66247, Taiwan @@
## Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes - NCT ID: NCT06331338 - Study ID: 202310085RIND - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-12-31 - Lead Sponsor: National Taiwan University Hospital ### Study Description Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Decision Cycle for Person-Centered Glycemic Management - Traditional diabetes self-management education ### Outcomes Primary Outcomes - glycemic control (HbA1c) Secondary Outcomes - Diabetes Self-Care Behavior Scale ### Location - Facility: National Taiwan University Hospital, Hsinchu, N/A, 302, Taiwan @@
## Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults - NCT ID: NCT06331325 - Study ID: 724 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-09-30 - Lead Sponsor: October University for Modern Sciences and Arts ### Study Description The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:* Does Frenotomy procedure have a lower relapse rate compared to frenectomy?* Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week. ### Conditions - High Frenum Attachment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Frenotomy - Frenectomy ### Outcomes Primary Outcomes - Rebound / Relapse. Secondary Outcomes - Postoperative pain ### Location - Facility: MSA University, Giza, N/A, 12566, Egypt @@
## Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR) - NCT ID: NCT06331312 - Study ID: CAIN457C22301E1 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2028-05-08 - Lead Sponsor: Novartis Pharmaceuticals ### Study Description The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica. ### Conditions - Polymyalgia Rheumatica ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Secukinumab ### Outcomes Primary Outcomes - Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs) Secondary Outcomes ### Location - Facility: Novartis Investigative Site, Parramatta, N/A, 2150, Australia @@
## A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer - NCT ID: NCT06331299 - Study ID: BL013 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-03 - Lead Sponsor: UroGen Pharma Ltd. ### Study Description This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC). ### Conditions - Bladder Cancer - Urothelial Carcinoma - Urothelial Carcinoma Bladder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - UGN-103 ### Outcomes Primary Outcomes - Complete response rate (CRR) Secondary Outcomes - Duration of response (DOR) - Durable complete response (DCR) rate - Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry) - Mitomycin plasma concentrations - Mitomycin maximum plasma concentration (Cmax) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity - NCT ID: NCT06331286 - Study ID: IIT20230091C-R1 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-12-31 - Lead Sponsor: First Affiliated Hospital of Zhejiang University ### Study Description The primary objective of this study is to investigate the effect of dulaglutide adjuvant treatment in patients with bipolar disorder with obesity, in addition to exploring the effect of GLP-1RA on cognition of bipolar disorder. ### Conditions - Bipolar Disorder - Obesity - Cognition ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - dulaglutide injection ### Outcomes Primary Outcomes - weight - Concentration of blood glucose in blood - Concentration of total cholesterol in blood - Concentration of high density lipoprotein in blood - Concentration of low density lipoprotein in blood - Concentration of triglyceride in blood - CBCT test results Secondary Outcomes - 17-item Hamilton Depression Rating Scale (HAM-D17) Score - Treatment Emergent Symptom Scale (TESS) Score ### Location - Facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, 310000, China @@
## Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma - NCT ID: NCT06331273 - Study ID: CT2024-ZJU-OBS3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Zhejiang University ### Study Description The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients. ### Conditions - Liver Transplantation - No-touch Technique - Hepatocellular Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Liver transplantation with "No-touch" technique ### Outcomes Primary Outcomes - Recurrence free surviavl rate - Overall survival rate - Tumor recurrence rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma - NCT ID: NCT06331260 - Study ID: CT2024-ZJU-OBS2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Zhejiang University ### Study Description As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC. ### Conditions - Liver Transplantation - Hepatocellular Carcinoma - Alpha-Fetoprotein - Protein Induced by Vitamin K Absence or Antagonist-II ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Recurrence free survival rate - Overall survival rate - Tumor recurrence rate Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II - NCT ID: NCT06331247 - Study ID: 20230520-2 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2025-12-31 - Lead Sponsor: Zhejiang University ### Study Description A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia. ### Conditions - Dementia - Stroke - Cognitive Change - Cerebrovascular; Disorder, Thrombotic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - General dietary advice - Localized MIND diet intervention - Routine medical care ### Outcomes Primary Outcomes - Change in global cognitive function - Change in MIND diet score Secondary Outcomes - Change in Montreal Cognitive Assessment (MoCA) score - Change in Mini-Mental State Examination (MMSE) score - Change in brain MRI markers - Change in memory function - Change in language function - Change in executive function - Change in visuospatial function ### Location - Facility: Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310058, China @@
## Effects of Vena Cava Inferior Measurements on AKI and Mortality. - NCT ID: NCT06331234 - Study ID: VCI - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-01 - Lead Sponsor: Inonu University ### Study Description Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is \< 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality. ### Conditions - Intensive Care Unit - Acute Kidney Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Vena cava inferior diameter ### Outcomes Primary Outcomes - acute kidney injury - mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense - NCT ID: NCT06331221 - Study ID: JSA_Fatigue_FADEUP - Status: RECRUITING - Start Date: 2023-11-02 - Completion Date: 2024-06-01 - Lead Sponsor: Universidade do Porto ### Study Description The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Muscle fatigue Protocol ### Outcomes Primary Outcomes - Absolute angular error - Relative angular error - Variable angular error Secondary Outcomes ### Location - Facility: Faculdade de Desporto, Universidade do Porto, Porto, N/A, 4200, Portugal @@
## Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure - NCT ID: NCT06331208 - Study ID: LUNG-HF:16181/21; G-21-57 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-30 - Lead Sponsor: Institute for Clinical and Experimental Medicine ### Study Description Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling.Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data. ### Conditions - Heart Failure - Pulmonary Hypertension - Pulmonary Vascular Resistance Abnormality ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - non-contrast chest CT - spirometry with diffusing lung capacity for carbon monoxide (DLCO) analysis - Omics analysis of blood plasma obtained from pulmonary artery or peripheral blood - supine bike exercise during right heart catheterisation - Lung ventilation/perfusion SPECT ### Outcomes Primary Outcomes - biomarker of pulmonary vasculopathy in HF - CT characteristics of pulmonary vasculopathy in HF - CT characteristics of presence of heart failure Secondary Outcomes ### Location - Facility: Institute for Clinical and Experimental Medicine - IKEM, Prague, N/A, 140 21, Czechia @@
## An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH) - NCT ID: NCT06331195 - Study ID: DICA-HF_MAIN - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Hospital do Coracao ### Study Description The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up. ### Conditions - Familial Hypercholesterolemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Placebo phytosterol - Placebo krill oil - Phytosterol - Krill oil ### Outcomes Primary Outcomes - LDL-c - Lp(a) Secondary Outcomes - TC - HDL-c - TG - VLDL - NHDL - CI I - CI II - TG/HDL-c - AI - ox-LDL - APOAI - APOB100 - AE - Adherence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain - NCT ID: NCT06331182 - Study ID: 36264PR552/2/24 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2024-08-01 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain. ### Conditions - Dexmedetomidine - Ketamine - External Oblique Intercostal Plane Block - Post Thoracotomy Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ketamine - Dexmedetomidine - Bupivacaine ### Outcomes Primary Outcomes - Time to the 1st rescue analgesia Secondary Outcomes - Intraoperative fentanyl consumption - Total morphine consumption in the 1st 24hr and 48 hr - Degree of pain - Heart rate - Mean arterial blood - The incidence of adverse events ### Location - Facility: Tanta University, Tanta, ElGharbia, 31527, Egypt @@
## Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer - NCT ID: NCT06331169 - Study ID: ALTER-BC-Ib-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-06-30 - Lead Sponsor: Fudan University ### Study Description A Prospective Phase Ib Study of Anlotinib with Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Anlotinib - Trastuzumab deruxtecan ### Outcomes Primary Outcomes - Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan - Objective Response Rate (ORR) Secondary Outcomes - Duration of Response (DCR) - Duration of Response (DOR) - Progression-free Survival (PFS) - Overall Survival (OS) - Number of Participants With Adverse Events (AEs) ### Location - Facility: Jian Zhang, Shanghai, Shanghai, 200433, China @@
## A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants - NCT ID: NCT06331156 - Study ID: 218485 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2024-11-19 - Lead Sponsor: GlaxoSmithKline ### Study Description The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment. ### Conditions - Gastroenteritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - HRV PCV-free - IPV ### Outcomes Primary Outcomes - Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab) Secondary Outcomes - Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs) - Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64 - Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab - Anti-RV IgA Ab geometric mean concentrations (GMCs) - Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL - Percentage of participants reporting solicited systemic events - Percentage of participants reporting unsolicited adverse events (AEs) - Percentage of participants reporting serious adverse events (SAEs) ### Location - Facility: GSK Investigational Site, Chengdu, Sichuan, 610041, China @@
## Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion - NCT ID: NCT06331143 - Study ID: 36264PR551/2/24 - Status: RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-09-01 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery. ### Conditions - Mid-Transverse Process Block - Intrathecal Morphine - Idiopathic Scoliosis - Posterior Spinal Fusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block - Morphine ### Outcomes Primary Outcomes - Degree of pain Secondary Outcomes - Heart rate - Mean arterial pressure - Patient satisfaction - Complications ### Location - Facility: Tanta University, Tanta, ElGharbia, 31527, Egypt @@
## Mesenteric Infiltration in Ovarian Cancer - NCT ID: NCT06331130 - Study ID: 6363 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents. ### Conditions - Ovary Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Computed Tomography ### Outcomes Primary Outcomes - Preoperative Artificial Intelligence assisted CT-based evaluation Secondary Outcomes - Evaluation of the Radiologist Assessment of the CT - Prediction of Platinum Resistance - Prediction of Progression Free Survival (PFS) and Overall Survival (OS) ### Location - Facility: Advanced Radiology Center, Roma, N/A, 00168, Italy @@
## Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies - NCT ID: NCT06331117 - Study ID: 3776 - Status: RECRUITING - Start Date: 2021-04-22 - Completion Date: 2026-04-22 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments. ### Conditions - RASopathy - Costello Syndrome - Noonan Syndrome - Cardio-Facio-Cutaneous Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Diagnostic test ### Outcomes Primary Outcomes - Metabolomic profile of the RASopathies Secondary Outcomes ### Location - Facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS, Roma, N/A, 00168, Italy @@
## Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone - NCT ID: NCT06331104 - Study ID: ChangyeZou - Status: COMPLETED - Start Date: 2012-06-14 - Completion Date: 2023-08-31 - Lead Sponsor: Changye Zou ### Study Description Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes. ### Conditions - Giant Cell Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - gene expression levels ### Outcomes Primary Outcomes - P27 expression levels - ESR1 expression levels Secondary Outcomes ### Location - Facility: Churong Yan, Guangzhou, Guangdong, 518010, China @@
## Physiotherapy and Reaction Time in Hemophilia - NCT ID: NCT06331091 - Study ID: YuzuncuYıl2022/2 - Status: COMPLETED - Start Date: 2022-12-10 - Completion Date: 2024-01-19 - Lead Sponsor: Yuzuncu Yıl University ### Study Description This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions. ### Conditions - Hemophilia Arthropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Home exercise - Manual therapy - Neuromuscular electrical stimulation - Supervised exercise ### Outcomes Primary Outcomes - Hemophilia Joint Health Score - Reaction time Secondary Outcomes ### Location - Facility: Van Yüzüncü Yıl University, Van, N/A, 65080, Turkey @@
## Square Step Exercises in Healthy Young Adults - NCT ID: NCT06331078 - Study ID: 29.02.2024/45 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2025-08-01 - Lead Sponsor: Fenerbahce University ### Study Description This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults. ### Conditions - Exercise - Square Step Exercises - Aerobic Exercise - Cognitive Function - Physical Fitness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Square Stepping Exercise training - Aerobic Exercise Training ### Outcomes Primary Outcomes - Schulte Grid Test - Stroop Test - Verbal Fluency Test - Digit Span Test - Vertical jump test - Horizontal jump test - Y Balance Test Secondary Outcomes ### Location - Facility: Marmara University, Maltepe, N/A, N/A, Turkey @@
## Promoting Mental Health at Work Among Hospital Professionals - NCT ID: NCT06331065 - Study ID: 69HCL21_1180 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Hospices Civils de Lyon ### Study Description Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders.Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders.According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management.Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence.Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others.Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work.The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit.The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group.The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond. ### Conditions - Mental Health Issue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Information session on mindfulness meditation and questionnaires - Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group ### Outcomes Primary Outcomes - Psychological fulfilment at work Secondary Outcomes - Psychological fulfilment at work - Mindful state - Aggressiveness - Impulsivity, experience of being disturbed by conflict, and psychological safety. - Occupational stress - Collective activity - Organizational leeway - Evolution of participants' representation of mindfulness meditation - The representation of mindfulness meditation among professionals - The representation of mindfulness meditation among professionals - The representation of mindfulness meditation among professionals - Fidelity and adherence to the mindfulness meditation intervention - Fidelity and adherence to the mindfulness meditation intervention - Barriers and facilitators to the implementation - Barriers and facilitators to the implementation - Mechanisms of the intervention effects - Mechanisms of the intervention effects - Mechanisms of the intervention effects ### Location - Facility: Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon), Bron, N/A, 69677, France @@
## 3-D Tractography FUS Ablation for Essential Tremor - NCT ID: NCT06331052 - Study ID: 23-2431 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2028-02-28 - Lead Sponsor: University of North Carolina, Chapel Hill ### Study Description The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes. ### Conditions - Essential Tremor ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - MR-guided Focused Ultrasound Ablation ### Outcomes Primary Outcomes - Number of Participants without Side Effects - Absolute Change in Tremor - Relative Change in Tremor Secondary Outcomes - Number of Participants with Procedure-Related Side Effects - Relative Change in Tremor-Related Quality of Life - Number of Participants Who Are Satisfied with Treatment ### Location - Facility: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27999, United States @@
## The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence - NCT ID: NCT06331039 - Study ID: CelalBayarU-5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-07-30 - Lead Sponsor: Celal Bayar University ### Study Description Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence. ### Conditions - Urinary Incontinence - Pelvic Floor Muscle Weakness - Muscle Weakness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PFMT - PFMT+Balance ### Outcomes Primary Outcomes - ankle muscle function - ankle range of motion - muscle strength - incontinence symptoms and severity - incontinence symptoms and severity - balance - bladdery diary - functional performance Secondary Outcomes ### Location - Facility: Melda BAŞER SEÇER, Mani̇sa, Yunusemre, 45000, Turkey @@
## A Bioequivalence Study of Two Different PEG-rhGH Preparations. - NCT ID: NCT06331026 - Study ID: GenSci004-106 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-07 - Completion Date: 2024-11-30 - Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. ### Study Description The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation. ### Conditions - Pediatric Growth Hormone Deficiency (PGHD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - PEG-rhGH with new preparation (T) - PEG-rhGH with present preparation (R) ### Outcomes Primary Outcomes - Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation - Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation - Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation Secondary Outcomes - Safety and tolerability（Number of participants with treatment-related adverse events） ### Location - Facility: Chengdu Xinhua Hospital, Chengdu, Sichuan, 610000, China @@
## CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr - NCT ID: NCT06331013 - Study ID: IEO 1872 - Status: RECRUITING - Start Date: 2023-02-20 - Completion Date: 2029-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CyberKnife ultra-hypofractionated SBRT ### Outcomes Primary Outcomes - Number of Participants with Acute GU and GI toxicities (RTOG) - Number of Participants with Late GU and GI toxicities (RTOG) - Evaluation of patient-reported toxicity - Evaluation of patient-reported quality of life Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, N/A, N/A, Italy @@
## Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment - NCT ID: NCT06331000 - Study ID: 9248 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: University Hospital, Strasbourg, France ### Study Description The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - elexacaftor-tezacaftor-ivacaftor treatment ### Outcomes Primary Outcomes - Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor Secondary Outcomes - Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl - Marker of metabolic status: HbA1c (mmol/l) - Marker of metabolic status: HbA1c (%) - Marker of metabolic status: C-Peptid (µg/L) - Marker of metabolic status: C-Peptid (nmol/L) - Markers of nutritional status: Evaluation of weight monitoring (kg) - Markers of nutritional status: Body Mass Index (BMI) - Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl) - Assessment of respiratory function parameters : number of IV antibiotics - Number patients with severe hypoglycaemia and serious adverse events ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Fetal Autonomic Nervous sysTem Evaluation - NCT ID: NCT06330987 - Study ID: 15110_MANNELLA - Status: RECRUITING - Start Date: 2019-08-13 - Completion Date: 2025-12-28 - Lead Sponsor: University of Pisa ### Study Description The autonomic nervous system (ANS) is involved in cardiovascular, metabolic and cognitive processes, so its study in the fetus can provide relevant functional diagnostic and prognostic information. In particular, the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus.The goal of this open-label, non-randomized, prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation.The objetives are:* To Evaluate Fetal Autonomic Nervous System (FANTE) through the analysis of maternal electrocardiogram (ECG) and others clinical parameters usually used in pregnancy monitoring.* To identify any variations in the fetal ECG in the event of developmental or pathological maternal and/or fetal pregnancy.Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent. ### Conditions - Pregnancy Related - Pregnancy Disease - Pregnancy Complications - Pre-Eclampsia - Gestational Diabetes - ECG Electrode Site Reaction - Fetal Growth Retardation - Fetal Complications ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - electrocardiograph ### Outcomes Primary Outcomes - Fetal Autonomic Nervous sysTem Evaluation (FANTE) Secondary Outcomes - Maternal Assesment - Obstetric Complications and mode of Delivery ### Location - Facility: Azienda Ospedaliera Universitaria Pisana, Pisa, N/A, 56126, Italy @@
## Allergy, Asthma, and Atopic Eczema in Finland - NCT ID: NCT06330974 - Study ID: FinnATOPY - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2034-12 - Lead Sponsor: Tampere University ### Study Description The summary is available at --\> https://www.finnatopy.fi/summary ### Conditions - Asthma - Asthma in Children - Allergy - Rhinitis, Allergic - Atopic Dermatitis - Allergen Immunotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Epidemiology of atopic diseases and allergic sensitization profiles in Finland - Burden of atopic diseases (allergies, asthma, and atopic eczema) as well as comorbidities in Finland - Evaluate and improve the current use of diagnostic tests for atopic diseases - Use and effectiveness of allergen immunotherapy in real world setting - Direct and indirect costs related to atopic diseases and comorbidities Secondary Outcomes ### Location - Facility: Tampere University, Tampere, N/A, N/A, Finland @@
## Effects of Different Kinds of Exercise in Low Back Pain - NCT ID: NCT06330961 - Study ID: 2023-MED-2756299 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2025-02 - Lead Sponsor: University of Valencia ### Study Description Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:* Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?* Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?* Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?* Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Isometric exercise - Aerobic exercise - Placebo intervention ### Outcomes Primary Outcomes - Pain intensity - Pain-pressure thresholds - Trunk flexion-extension electromyography (EMG) - Flexion-extension ratio (EMG) - Maximum ranges of lumbar and pelvic flexion - Trunk flexion-extension percentages of motion - Time of maximum flexion - Fear-avoidance beliefs - Pain distribution and supra-threshold stimulation Secondary Outcomes - Anthropometric data: height - Anthropometric data: weight - Date of birth/ age - Sex/ gender - Basic clinical history and occupational data ### Location - Facility: Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València, Valencia, N/A, 46010, Spain @@
## Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation - NCT ID: NCT06330948 - Study ID: NYCU112183AEF - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-01 - Lead Sponsor: National Yang Ming University ### Study Description Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement. ### Conditions - PreDiabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - SugarCut® Unripe Guava Fruit Extract - Placebo group ### Outcomes Primary Outcomes - GLUT4 gene expression - Hematology Test Secondary Outcomes ### Location - Facility: National Yang Ming Chiao Tung University, Taipei, Beitou Dist., 112, Taiwan @@
## Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury - NCT ID: NCT06330935 - Study ID: 192-2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Mansoura University ### Study Description Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population. ### Conditions - Traumatic Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tranexamic Acid (TXA) - Normal saline ### Outcomes Primary Outcomes - The early traumatic brain injury-related death in the hospital - The difference between treatment group in the Intracranial haemorrhage growth - The difference between the treatment groups in the incidence of mortality Secondary Outcomes - Need for neurosurgical management - Days in the intensive care unit - Need for blood transfusion - Adverse events - Pediatric Quality of Life (PedsQL) - Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Muscle-tendon Pathology and Metabolic Dysregulation in CP - NCT ID: NCT06330922 - Study ID: 10.55776/V992 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-12-31 - Lead Sponsor: University of Graz ### Study Description The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated.The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners).To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners. ### Conditions - Cerebral Palsy, Spastic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cardiorespiratory fitness training ### Outcomes Primary Outcomes - Muscle fascicle length and muscle thickness - Muscle fascicle pennation angle - Passive muscle stiffness - Isometric muscle strength - Muscle tissue oxygenation - Exosome size - Exosome content - Micro ribonucleic acid (RNA) cargo Secondary Outcomes - Metabolic parameters - Pro-inflammatory cytokines - Resting, mean, and peak heart rate - Resting blood pressure - Distance covered - Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak) - Peak respiratory frequency - Respiratory exchange ratio - VEpeak/VO2peak - VEpeak/VCO2peak - Perceived exertion - Well-being and quality of life - Total physical activity, time spent in different intensities - Passive range of motion (sagittal plane) of hip, knees, ankles - Step count ### Location - Facility: Institute of Human Movement Science, Sport and Health, University of Graz, Graz, N/A, 8010, Austria @@
## Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt - NCT ID: NCT06330909 - Study ID: P003103 - Status: RECRUITING - Start Date: 2022-08-18 - Completion Date: 2030-02 - Lead Sponsor: University Hospital Freiburg ### Study Description Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT - Radiotherapy (RT) Arm B - IMRT/IGRT ### Outcomes Primary Outcomes - Relapse free survival Secondary Outcomes - Time to local failure after randomization - Metastatic free survival after randomization - Overall (OS) and prostate cancer specific (PCSS) survival after randomization - Time to biochemical failure (phoenix definition) after randomization - Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26) - Patient reported late quality of life (QOL) - Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria - Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria - Dose constraints and prescription doses / recruited patients - Characterization of safety: adverse events ### Location - Facility: Medical Center - University of Freiburg, Freiburg, Baden-Württemberg, 79106, Germany @@
## Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing - NCT ID: NCT06330896 - Study ID: 346/2566(IRB3) - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Siriraj Hospital ### Study Description The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing* genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.* disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.* correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing. ### Conditions - Plasma Cell Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - genetic landscape of PCD Secondary Outcomes - genetic correlation - genetic landscape of relapse MM patients - overall survival - progression free survival - factor of genetic landscape differentiation - gender - age ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality. - NCT ID: NCT06330883 - Study ID: 2021/507 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-01-01 - Lead Sponsor: Selcuk University ### Study Description Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded. ### Conditions - Frailty - Mortality - COVID-19 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Prognosis ### Outcomes Primary Outcomes - Mortality Secondary Outcomes - The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score - Thorax computed tomography (CT) imaging - Laboratory values - Respiratory support - Vasoactive drugs administered - Renal replacement therapy - Patient positions - Length of stay in the intensive care unit ### Location - Facility: Selcuk University Hospital, Konya, Selçuklu, N/A, Turkey @@
## Brain Metastasis Development Mechanism in BCBM Patients - NCT ID: NCT06330870 - Study ID: BCBM_Breast - Status: RECRUITING - Start Date: 2023-04-06 - Completion Date: 2027-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis ### Conditions - Breast Cancer - Brain Metastasis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - WGS/TME evaluation ### Outcomes Primary Outcomes - Intracranial disease free survival Secondary Outcomes ### Location - Facility: Ji-Yeon Kim, Seoul, N/A, 06351, Korea, Republic of @@
## Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy - NCT ID: NCT06330857 - Study ID: Dnr2021-06921-02 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2002-05-28 - Completion Date: 2025-04-01 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years). ### Conditions - Rectal Prolapse - Fecal Incontinence - Defecation Disorder - Enterocele - Rectocele ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Laparoscopic vaginorectopexy ### Outcomes Primary Outcomes - Recurrence - Bowel function - Bowel related quality of life Secondary Outcomes - Postoperative complications - Peroperative complications - Operative time - Conversions to open surgery - Hospital days ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Race-Based Stress and Cognitive Training for MCI - NCT ID: NCT06330844 - Study ID: RBSEF-MCI-CCT - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2027-03-15 - Lead Sponsor: Rosalind Franklin University of Medicine and Science ### Study Description This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI) - Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT) ### Outcomes Primary Outcomes - Verbal learning and memory - Basic auditory attention and working memory - Psychomotor processing speed - Psychomotor processing speed; executive functioning - Self-report of prospective and retrospective memory - Self-report of cognitive concerns - The Patient Health Questionnaire-9 - Self-report symptoms of anxiety - Self-reported daily functioning - The Racial Microaggressions Scale - The Trauma Symptoms of Discrimination Scale Secondary Outcomes ### Location - Facility: Rosalind Franklin University of Medicine and Science, Chicago, Illinois, 60064, United States @@
## Intensive Group Based CIMT for Young Children - NCT ID: NCT06330831 - Study ID: x2ghr8pc - Status: COMPLETED - Start Date: 2016-05-09 - Completion Date: 2023-07-01 - Lead Sponsor: Rockhurst University ### Study Description This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer. ### Conditions - Hemiplegic Cerebral Palsy - Non-Accidental Traumatic Head Injury to Child ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Intensive, Group Based Constraint Induced Therapy (CIMT) ### Outcomes Primary Outcomes - Quality Upper Extremity Skills Evaluation Test (QUEST) - Assisting Hand Assessment (AHA) - Canadian Occupational Performance Measure (COPM) - Pediatric Evaluation Disability Inventory (PEDI) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients - NCT ID: NCT06330818 - Study ID: IMAGINE Moyamoya - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-30 - Lead Sponsor: University Hospital Tuebingen ### Study Description Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.Main tasks are:* Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT* Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling* Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients ### Conditions - Moyamoya Disease - Moyamoya ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - MRI - H2 15O PET/CT - Biosampling ### Outcomes Primary Outcomes - Value of CO2-triggered BOLD MRI compared to PET/CT Secondary Outcomes - Vessel-Wall contrast enhancement - Circulating endothelial cells - PCR-based virus sampling ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer - NCT ID: NCT06330805 - Study ID: OSU-23069 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-31 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:1. Comprehensive cardiac and exercise testing before and after starting ADT2. Completion of quality-of-life questionnaires at specific intervals during the study period3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers ### Conditions - Prostate Adenocarcinoma - Stage IIB Prostate Cancer AJCC v8 - Stage IIC Prostate Cancer AJCC v8 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Contrast Agent - Leuprolide - Magnetic Resonance Imaging - Physical Performance Testing - Relugolix ### Outcomes Primary Outcomes - Physiologic alterations in cardiopulmonary function - Myocardial perfusion - Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption Secondary Outcomes - Quality of life using EPIC-26 - Quality of life using EORTC QLQ-C30 - Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L) - Quality of life using PROMIS - Functional tests of strength and balance using Timed Up-and-Go - Functional tests of strength and balance using 10-meter walk time - Functional tests of strength and balance using Grip strength - Changes in body composition ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain - NCT ID: NCT06330792 - Study ID: mechanical low back pain - Status: NOT_YET_RECRUITING - Start Date: 2024-05-04 - Completion Date: 2024-12-01 - Lead Sponsor: Cairo University ### Study Description investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists ### Conditions - Mechanical Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - bio-mechanical awareness - core stability exercises ### Outcomes Primary Outcomes - intensity of low back pain Secondary Outcomes - back muscle endurance - level of function (disability) associated with mechanical Low Back Pain - Fatigue Severity - psycho-social factors at work ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trauma-adapted Yoga in Child & Adolescent Psychiatry. - NCT ID: NCT06330779 - Study ID: UWest - Status: NOT_YET_RECRUITING - Start Date: 2025-01-01 - Completion Date: 2028-12-31 - Lead Sponsor: University West, Sweden ### Study Description The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.Within and between group (yoga group vs waiting list) analyses will be performed. ### Conditions - ADHD - PTSD - Quality of Life - Self-Control - Pain - Affect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Trauma-adapted yoga ### Outcomes Primary Outcomes - Negative experience score CPSS-5-S - Inattention, impulsivity score - Resilience score Secondary Outcomes - Pain frequency and intensity - affect - Self-directednes - Quality of life score ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients - NCT ID: NCT06330766 - Study ID: PET24 - Status: RECRUITING - Start Date: 2020-01-01 - Completion Date: 2026-01-01 - Lead Sponsor: Odense University Hospital ### Study Description In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023. ### Conditions - Transcatheter Aortic Valve Implantation - Dental - Endocarditis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No preoperative dental screening ### Outcomes Primary Outcomes - Number of Participants with Infectious Endocarditis Secondary Outcomes - Number of Participants undergoing Oral surgical procedure at dental screening - Number of Participants undergoing Tooth extraction at dental screening - The different Bacteria types causing the infectious endocarditis assessed by blood culture - Number patients with Bacteremia assessed by positive blood culture - Number of Participants with IE caused by bacteria from oral foci - Number of Participants with Cardiac implantable electronic device risk of IE ### Location - Facility: Odense University Hospital, Cardiology Department, Odense, N/A, 5000, Denmark @@
## Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan - NCT ID: NCT06330753 - Study ID: 2024P000682 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-11-30 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are:Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient.Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters. ### Conditions - Trauma and Stressor Related Disorders - Violence, Structural - Violence, Domestic - Violence, Sexual ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Trauma-informed Care Plan- ### Outcomes Primary Outcomes - Acceptability of Trauma Informed Care Plans Secondary Outcomes - Intervention Appropriateness of Trauma-Informed Care plans - Feasibility of the trauma-informed care plans ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluations of CDS Systems - NCT ID: NCT06330740 - Study ID: AAAU3416 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12 - Lead Sponsor: New York Presbyterian Hospital ### Study Description Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors. ### Conditions - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Clinical Decision Support ### Outcomes Primary Outcomes - The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity - NCT ID: NCT06330727 - Study ID: KY20231109-09 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2024-10 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association. ### Conditions - Prediabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Coffee capsule - Corn starch capsule ### Outcomes Primary Outcomes - Continuous glucose monitoring parameters - glucose from a 75 g-oral glucose tolerance test （mmol/L） - insulin from a 75 g-oral glucose tolerance test （pmol/L） - C-peptide from a 75 g-oral glucose tolerance test (ng/ml) - glucagon from a 75 g-oral glucose tolerance test（pmol/L） - Glycated hemoglobin (HbA1c) ( % ) - Fasting total cholesterol (mmol/L) - Fasting high-density lipoprotein-cholesterol (mmol/L) - Fasting low-density lipoprotein-cholesterol (mmol/L) - Fasting triglycerides (mmol/L) Secondary Outcomes - C-reactive protein - Interleukin-6 - Body mass index ( kg/m^2) - Fat mass (FM) - body fat percentage (BF) - visceral fat - skeletal muscle mass (SMM) - fat-free mass (FFM) - Adiponectin - Systolic blood pressure（mmHg） - Diastolic blood pressure（mmHg） - Heart rate （bpm） - Controlled attenuation parameter (CAP) - Standard deviation of heart rate variability (SDNN) ### Location - Facility: Nanjing First Hospital, Nanjing, Jiangsu, 210006, China @@
## Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements - NCT ID: NCT06330714 - Study ID: AV.RMH.v01-01 - Status: COMPLETED - Start Date: 2018-07-01 - Completion Date: 2018-12-30 - Lead Sponsor: Aventyn, Inc. ### Study Description This is planned as a feasibility study.The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device ### Conditions - Chronic Disease of Cardiovascular System ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Symptoms of chronic illness. ### Outcomes Primary Outcomes - Mobile Home Device Hub Data Resiliency Secondary Outcomes - Patient Self Monitoring ### Location - Facility: Institute for Liver Health, Chandler, Arizona, 85248, United States @@
## Stone Access and Removal (STAR) Study - NCT ID: NCT06330701 - Study ID: 2023URO0001 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2025-03-31 - Lead Sponsor: Auris Health, Inc. ### Study Description The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology. ### Conditions - Kidney Calculi ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Robotic-assisted mini-PCNL ### Outcomes Primary Outcomes - Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed Secondary Outcomes - Stone Free Rate (%) - Number of Adverse Events - Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event ### Location - Facility: Indiana University, Bloomington, Indiana, 47401, United States @@
## Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique - NCT ID: NCT06330688 - Study ID: ΕΒΔ 53/25.01.2024 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2026-06 - Lead Sponsor: Attikon Hospital ### Study Description The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside. ### Conditions - Cholecystitis, Acute - Cholecystitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - percutaneous cholecystostomy ### Outcomes Primary Outcomes - Technical success - Procedure-related complications Secondary Outcomes - duration of the procedure - intraprocedural and post-procedural pain - clinical success ### Location - Facility: Attikon University Hospital, Chaïdári, Athens, 12461, Greece @@
## Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT - NCT ID: NCT06330675 - Study ID: 2022-01820 - Status: RECRUITING - Start Date: 2023-02-01 - Completion Date: 2027-06-01 - Lead Sponsor: Caporali Elena ### Study Description Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure. ### Conditions - Pacemaker - Defibrillators, Implantable ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Early mobilization - Standard of care ### Outcomes Primary Outcomes - Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion Secondary Outcomes - Post-operative pain - Sleep disturbance - Postoperative urinary retention - Delirium - Orthostatic intolerance - Quality of recovery - Pressure ulcer ### Location - Facility: Cardiocentro Ticino Institute - EOC, Lugano, N/A, 6900, Switzerland @@
## Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap - NCT ID: NCT06330662 - Study ID: 05-PA-30-19-6/2023. - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-01 - Completion Date: 2025-06-01 - Lead Sponsor: Andelina Sekelja ### Study Description The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA). ### Conditions - Gingival Recession ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only ### Outcomes Primary Outcomes - The effect of hyaluronic acid on recession reduction Secondary Outcomes - To examine the effect of tissue thickness on recession coverage (KTt) - To examine keratinized gingiva width (KTw) - To examine changes in periodontal clinical parameters: PPD - To examine changes in periodontal clinical parameters: CAL - To examine changes in periodontal clinical parameters: REC - To examine changes in periodontal clinical parameters: FMPS (full mouth plaque score) - To examine changes in periodontal clinical parameters: FMBS (full mouth bleeding score) - Assess the healing quality of the operated area by using a RES scale - Schiff test tooth examination - To examine the impact of oral health on quality of life - To evaluate the level of pain postoperatively during the healing of the surgical wound ### Location - Facility: University of Zagreb - School of dental medicine, Zagreb, Hrvatska, 10 000, Croatia @@
## The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism - NCT ID: NCT06330649 - Study ID: 2024-0095 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-08-31 - Lead Sponsor: The University of Texas at Arlington ### Study Description The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism ### Conditions - Cardiovascular Diseases - Hypertension - Diet ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Energy Drink - Water Control ### Outcomes Primary Outcomes - Peripheral blood pressure in millimeters of mercury - Oxygen consumption milliliters per kilogram of body weight per minute - Heart rate in beats per minute Secondary Outcomes ### Location - Facility: UT Arlington - Science and Engineering Innovation and Research Building, Arlington, Texas, 76019, United States @@
## The Acute Effect of D-allulose Consumption on Postprandial Glycaemia - NCT ID: NCT06330636 - Study ID: 336-0723 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-11 - Completion Date: 2024-07-31 - Lead Sponsor: University of Nottingham ### Study Description The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose. ### Conditions - Sugar; Blood, High ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - D-Allulose - Sodium Saccharin ### Outcomes Primary Outcomes - Incremental area under the curve (iAUC) 180 Glucose Test - iAUC 180 Glucose Placebo Secondary Outcomes - Glycaemia Test - Glycaemia Placebo - Insulinemia Test - Insulinemia Placebo - iAUC 180 Insulin Test - iAUC 180 Insulin Placebo - iCAS Test - iCAS Placebo - abdominal discomfort test - abdominal discomfort placebo - Dietary Fibre - Carbohydrate % - Fat % - Protein % - Sugars % ### Location - Facility: David Greenfield Human Physiology Laboratories, Nottingham, Notts, NG72UH, United Kingdom @@
## Developing Personalised Relative Physical Activity Thresholds in COPD. - NCT ID: NCT06330623 - Study ID: 0929 - Status: RECRUITING - Start Date: 2023-11-22 - Completion Date: 2025-09-01 - Lead Sponsor: University of Leicester ### Study Description The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.The main questions this study aims to answer are:* Phase 1: What does physical activity (intensity) mean to people with COPD?* Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.Phase 2:Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.Sub-study:Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity. ### Conditions - Chronic Obstructive Pulmonary Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Phase 1 - Semi-structured Interviews - Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity. Secondary Outcomes - Phase 1 - Medical Research Council (MRC) Dyspnoea Scale - Phase 1 - COPD Assessment Test (CAT) - Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR) - Phase 1 - Photovoice and photo-elicitation - Phase 2 - Medical Research Council (MRC) Dyspnoea Scale - Phase 2 - COPD Assessment Test (CAT) - Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR) - Phase 2 - Gait Analysis - Phase 2 - Exercise Capacity (ISWT) - Phase 2 - Exercise Capacity (ESWT) - Daily PROactive Physical Activity instrument in COPD (D-PPAC) - Phase 2 - Photovoice and photo-elicitation ### Location - Facility: NIHR Leicester Biomedical Research Centre - Respiratory, Leicester, Leicestershire, LE67 2DU, United Kingdom @@
## Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit - NCT ID: NCT06330610 - Study ID: 2021/0378/HP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-08-01 - Lead Sponsor: University Hospital, Rouen ### Study Description This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU. ### Conditions - Intermittent Fasting - Septic Shock - Organ Failure, Multiple ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intermittent enteral nutrition ### Outcomes Primary Outcomes - Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score. Secondary Outcomes - evaluation of caloric intake - evaluation of protein intake - Measurement of nutritionnal status - Evaluation of the digestive symptoms - Evaluation of the nosocomial infections - Evaluation of the metabolic response - Evaluation of the duration of hospitalisation - Evaluation of the intensive care neuromuscular weakness - Evaluation of death - Evaluation of quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## NIVIA-Hemodynamics - NCT ID: NCT06330597 - Study ID: 21-5196 - Status: RECRUITING - Start Date: 2021-07-17 - Completion Date: 2024-12-31 - Lead Sponsor: University Health Network, Toronto ### Study Description This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments. ### Conditions - Cardiogenic Shock - Heart Failure - Shock - Hemodynamic Instability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography and lung ultrasound ### Outcomes Primary Outcomes - Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP. Secondary Outcomes - Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution) - Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC - Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC - Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC - Correlation between PVR assessed by echocardiography (using PAT) and by PAC - Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI) - Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP. ### Location - Facility: University Health Network, Toronto, Ontario, M5G 2N2, Canada @@
## Administration of Intranasal Midazolam for Anxiety in Palliative Care - NCT ID: NCT06330584 - Study ID: AIM Care Study - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-10-31 - Lead Sponsor: Insel Gruppe AG, University Hospital Bern ### Study Description The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data. ### Conditions - Anxiety - Acute Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Placebo Nasal Spray 0 mg/spray - Midazolam Nasal Spray 0.45 mg/spray - Midazolam Nasal Spray 0.9 mg/spray ### Outcomes Primary Outcomes - Change from baseline in anxiety levels, measured by Visual Analogue Scale (VAS) - Change from baseline in anxiety levels, measured by Numerical Rating Scale (NRS) Secondary Outcomes - Sedation - Oxygen saturation SaO2 (percent %) - Heart rate (bpm) - Cortisol levels in oral fluid - Time to first requested additional dose - Cumulative number of doses over 24 hours - Number of patients with adverse drug events (ADEs) - Peak plasma concentration (Cmax) - Time to reach the peak plasma concentration (Tmax) - Elimination half-life (t1/2) - Area under the curve (AUC0-Τ, AUC0-∞) ### Location - Facility: Inselspital, Universitätsspital Bern, Bern, N/A, 3010, Switzerland @@
## The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial. - NCT ID: NCT06330571 - Study ID: Aligners in distalization - Status: RECRUITING - Start Date: 2024-04-27 - Completion Date: 2025-07-15 - Lead Sponsor: Ain Shams University ### Study Description The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization. ### Conditions - Orthodontic Aligners ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Molar distalization by aligners with attachment ### Outcomes Primary Outcomes - Efficiency of aligners in molar distalization Secondary Outcomes - Amount of anchorage loss - Amount of molar tipping ### Location - Facility: Ainshams university, Cairo, N/A, N/A, Egypt @@
## Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma. - NCT ID: NCT06330558 - Study ID: pheos - Status: COMPLETED - Start Date: 2016-09-01 - Completion Date: 2023-09-01 - Lead Sponsor: Zagazig University ### Study Description Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023. ### Conditions - Adrenal Tumor ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - laparoscopic right adrenalectomy ### Outcomes Primary Outcomes - conversion Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release - NCT ID: NCT06330545 - Study ID: STUDY02002161 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2032-04 - Lead Sponsor: Dartmouth-Hitchcock Medical Center ### Study Description The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?Participants will undergo:* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection* Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy ### Conditions - Dupuytren Contracture ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Radiation therapy ### Outcomes Primary Outcomes - Recurrence of Dupuytren's Contracture Secondary Outcomes - Radiation Toxicity - Patient Reported Outcomes after Radiation Treatment (RT) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients - NCT ID: NCT06330532 - Study ID: 4-2023-1526 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-28 - Lead Sponsor: Yonsei University ### Study Description This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery. ### Conditions - Cardiovascular Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - postoperative all cause mortality - major composite morbidity Secondary Outcomes - the number of days not in hospital - The number of participants who die ### Location - Facility: Yonsei University Health system, Severance Hospital, Seoul, N/A, 03722, Korea, Republic of @@
## Impact of Different Techniques on The Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis - NCT ID: NCT06330519 - Study ID: Ainshams University Dentistry - Status: COMPLETED - Start Date: 2023-09-25 - Completion Date: 2024-02-21 - Lead Sponsor: Ain Shams University ### Study Description The goal of this clinical trial is to assess the effect of* Preoperative intraligamentary corticosteroids injection* Cryotherapy which is cold application on : * Hard tooth structure ( crown of the tooth ) * Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block. ### Conditions - Pulpitis - Irreversible ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dexamethasone sodium phosphate injection - 1,1,1,2 tetrafluoroethane - intraoral soft tissue cryotherapy ### Outcomes Primary Outcomes - The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block Secondary Outcomes ### Location - Facility: Ain Shams University, Cairo, N/A, N/A, Egypt @@
## The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development - NCT ID: NCT06330506 - Study ID: 123456123456 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-09-10 - Lead Sponsor: Cukurova University ### Study Description This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program. ### Conditions - Pressure Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Pressure ulcer prevention pack ### Outcomes Primary Outcomes - Evaluation of pressure ulcer formation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## AcoArt Litos PCB Below-the-knee Global Trial - NCT ID: NCT06330493 - Study ID: AcoArt BTK Global Trial - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-12 - Lead Sponsor: Acotec Scientific Co., Ltd ### Study Description The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5) ### Conditions - Chronic Limb-Threatening Ischemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - PCB - PTA ### Outcomes Primary Outcomes - Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency - Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death) Secondary Outcomes - Composite of Limb Salvage and Primary Patency - Patency rate - Freedom from CD-TLR - Re-occlusion rate of target lesion - Rate of Major adverse events(MAE) - Rate of target limb major amputation - Rate of all-cause death - Amputation free survival rate - Change in ankle-brachial index(ABI) - Change in toe-brachial index(TBI) - Change in Rutherford category - Change in EQ-5D - Change in VascuQol - Primary sustained clinical improvement - Secondary sustained clinical improvement - Wound healing - Rate of Device Success - Rate of Technical Success - Rate of Procedure Success ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease - NCT ID: NCT06330480 - Study ID: Check@Home - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2028-11-01 - Lead Sponsor: Prof. Dr. Folkert W. Asselbergs ### Study Description The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:* Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.* Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.* Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.The primary study outcomes are:Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:* Participation rate of different screening strategies and phases;* Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);* Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);* Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE). ### Conditions - Atrial Fibrillation - Chronic Kidney Diseases - Diabetes Mellitus, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Intervention group ### Outcomes Primary Outcomes - Participation rate of the atrial fibrillation and albuminuria screening - Yield of the atrial fibrillation and albuminuria screening - Effectiveness of the atrial fibrillation screening - Effectiveness of the albuminuria screening Secondary Outcomes - Effectiveness of the atrial fibrillation screening based on incidence of MACE events - Effectiveness of the albuminuria screening based on incidence each individual MACE component - Safety of the atrial fibrillation screening - Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature. - Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Prevalence of Dissociative Identity Disorder in At-risk Outpatient Groups Reporting Childhood Trauma. - NCT ID: NCT06330467 - Study ID: 2023-A02442-43 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-06-30 - Lead Sponsor: Centre Psychothérapique de Nancy ### Study Description The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis.The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder.The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders.The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients.Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview. ### Conditions - Dissociative Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - psychometric assessment - semi-structured clinical interview ### Outcomes Primary Outcomes - SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders / DSM = Diagnostic and Statistical Manual of Mental Disorders / ICD = International Classification of Diseases Secondary Outcomes - SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders - CTQ-28 : Childhood Trauma Questionnaire - life events inventory DSM-5 - PCL-5 : Posttraumatic stress disorder CheckList-5 - ITQ : International Trauma Questionnaire - SDQ-20 : Somatoform Dissociative questionnaire - DIS-Q : Dissociation Questionnaire - DES : Dissociative Experience Scale ### Location - Facility: Centre Psychothérapique de Nancy - CLIP, Nancy, N/A, N/A, France @@
## Painful Total Knee Replacement (TKA) and I-one Therapy - NCT ID: NCT06330454 - Study ID: 483/2020/Disp/AOUFe - Status: RECRUITING - Start Date: 2020-10-22 - Completion Date: 2025-10-21 - Lead Sponsor: University Hospital of Ferrara ### Study Description Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later. ### Conditions - Knee Pain Swelling ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - I-ONE ### Outcomes Primary Outcomes - Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery. Secondary Outcomes - reduced NSAID intake - improved recovery of joint function ### Location - Facility: IRCCS Istituto Ortopedico Rizzoli, Bologna, BO, N/A, Italy @@
## Pancreatic Cancer Screening in a Population at High Risk - NCT ID: NCT06330441 - Study ID: MOU-2021-01 - Status: RECRUITING - Start Date: 2022-01-07 - Completion Date: 2028-01-06 - Lead Sponsor: Masaryk Memorial Cancer Institute ### Study Description Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons". ### Conditions - Pancreatic Ductal Adenocarcinoma - Hereditary Diseases - Pancreatitis, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - endoscopic ultrasonography - magnetic resonance - laboratory examination ### Outcomes Primary Outcomes - Number of participants with newly diagnosed pancreatic ductal adenocarcinoma Secondary Outcomes - Methods yield comparison - Screening methods cost-effectiveness - KRAS mutation status evaluation ### Location - Facility: Masaryk Memorial Cancer Institute, Brno, N/A, 65653, Czechia @@
## Investigation of the Effect of Sexuality-Based Family Planning Education Given to Women Via Podcast on Contraceptive Method Selection and Sexual Life Quality - NCT ID: NCT06330428 - Study ID: MU-Ebe-ZDKY-02 - Status: RECRUITING - Start Date: 2024-02-09 - Completion Date: 2024-08-10 - Lead Sponsor: Marmara University ### Study Description In this study, it was aimed to examine the effect of Sexuality-Based Family Planning Education given to women of childbearing age via Podcast on contraceptive method selection and sexual life quality.Accordingly, the hypotheses of the study are as follows:Hypotheses of the Project H1: Sexuality-based family planning education via podcast has an effect on women's conscious and appropriate contraceptive method selection.H2: Sexuality-based family planning education via podcast has a positive effect on women's sexual life quality.H3: Sexuality-based family planning education via podcast has a positive effect on the quality of sexual life of women by increasing their level of contraceptive knowledge.H4: Sexuality-based family planning education via podcast has a positive effect on women's attitudes towards family planning. ### Conditions - Contraception ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Sexuality-Based Family Planning Education via Podcast ### Outcomes Primary Outcomes - Contraceptive Knowledge Assessment Scale-Turkish Form Secondary Outcomes - Sexual Quality of Life Scale-Female ### Location - Facility: Marmara University, Istanbul, N/A, N/A, Turkey @@
## Effect and Process Evaluation of the SME Tool - NCT ID: NCT06330415 - Study ID: 25603 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-01 - Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) ### Study Description A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support. ### Conditions - Sick-listed Employees ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - The SME tool ### Outcomes Primary Outcomes - Satisfaction with the RTW support of employer assessed by the employee Secondary Outcomes - Social support - Total number of sick-leave days - Work performance - Quality of working Life - Self-efficacy - Satisfaction with the resumption of work of the respective employee ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Exploration of Gait Biomechanics and Pain - NCT ID: NCT06330402 - Study ID: N-20220063 - Status: RECRUITING - Start Date: 2023-09-26 - Completion Date: 2026-12-31 - Lead Sponsor: Kristian Kjær Petersen ### Study Description This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:* How do gait patterns change during painful walking?* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition). ### Conditions - Pain - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Hypertonic saline injection - Isotonic saline injection ### Outcomes Primary Outcomes - Infrared marker XYZ coordinates - Pain sensitivity. Secondary Outcomes - The Pittsburgh Sleep Quality Index score - The Pain catastrophizing Scale score - The Hospital Anxiety and Depression Scale - Knee symptoms - Ground reaction forces - Ground reaction moments - Ground contact XZ location - Muscle activation ### Location - Facility: Aalborg University, Aalborg, Nordjylland, 9000, Denmark @@
## Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay - NCT ID: NCT06330389 - Study ID: MRC-01-20-1074 - Status: COMPLETED - Start Date: 2020-04-01 - Completion Date: 2021-06-25 - Lead Sponsor: Hamad Medical Corporation ### Study Description Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. ### Conditions - SARS-CoV-2 Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Burn Injuries Graft Surgery ### Outcomes Primary Outcomes - Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic. Secondary Outcomes - Clinical diffreneces between burn injuries with positive vs negative COVID-19 status ### Location - Facility: HAMAD Medical Corporation- Al Wakra Hospital, Doha, N/A, 82228, Qatar @@
## Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD) - NCT ID: NCT06330376 - Study ID: PT-2022-30735 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-09-01 - Lead Sponsor: University of Minnesota ### Study Description Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients.The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL). ### Conditions - Post-Acute Sequelae of COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Usual care of traditional treatment - Specific DB program/Diaphragmatic manipulation program ### Outcomes Primary Outcomes - 6-minute walk test (6MWT) Secondary Outcomes - PHQ9: Patient health questionnaire 9 - GAD7: Generalized anxiety disorder 7-item - PROMIS score: Patient-Reported Outcomes Measurement Information System - QoL scale: Quality of life scale - FACIT fatigue scale 's Fatigue score - Modified Borg dyspnea scale - RR; respiratory rate with 6 min walk test - PR: pulse rate with 6 min walk test ### Location - Facility: University of Minnesota, Minneapolis, Minnesota, 55414, United States @@
## The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue - NCT ID: NCT06330363 - Study ID: METC 23-049 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Maastricht University Medical Center ### Study Description Rationale: Low level laser therapy, or photobiomodulation, is getting more attention as a non-invasive treatment strategy for numerous conditions. Phototherapy has been applied for more than 40 years for the treatment of musculoskeletal and neurological conditions. Low level laser therapy generally applies red or near-infrared lasers with a wavelength between 600 and 1000 nm and low power wattage from 5 to 500 mW and a power density between 1 and 5 W/cm2. The laser light is absorbed by the skin without thermal damage and penetrates deeply into tissues where it is supposed to induce its physiological effects at the cellular level. Laser therapy has been hypothesized to stimulate mitochondrial respiration, increase tissue oxygenation, and support tissue regeneration. Despite supportive research data on in vitro cell and in vivo animal data, there are surprisingly few data on the proposed impact of low level laser treatment (LLLT) on tissue metabolism in vivo in humans.Objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults. Secondary objectives include the in vivo assessment of cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity within muscle and skin.Study design: Within-subject study.Study population: 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) adults (6 men and 6 women).Intervention: One leg of the subjects will receive LLLT, while the other leg will receive no treatment. After the treatment muscle and skin biopsy samples will be taken from both legs.Main study parameters/endpoints: The primary outcome will be mitochondrial respiration of the LLLT treated and non-treated leg based on muscle samples. Secondary study parameters are muscle and skin gene expression, protein signalling and enzyme activity. ### Conditions - Muscles Metabolism - Skin Metabolism ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Laser therapy - Sham ### Outcomes Primary Outcomes - Muscle mitochondrial respiration Secondary Outcomes - Gene expression (mRNA) via real-time PCR - Protein expression via western blotting - Skin mitochondrial respiration ### Location - Facility: Maastricht University Medical Centre, Maastricht, N/A, N/A, Netherlands @@
## Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling - NCT ID: NCT06330350 - Study ID: METC 2023-0193 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Maastricht University Medical Center ### Study Description The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals. ### Conditions - Quality of Life - Ichthyosis - Palmoplantar Keratoses - Epidermolysis Bullosa - Ectodermal Dysplasia - Basal Cell Nevus Syndrome - Birt-Hogg-Dube Syndrome - Tuberous Sclerosis - Cutis Laxa - Albinism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Qualitative interview ### Outcomes Primary Outcomes - Assessment of perspectives of affected patients + partners and of healthcare professionals concerning reproductive decision-making Secondary Outcomes ### Location - Facility: Maastricht University Medical Center, Maastricht, Limburg, 6202 AZ, Netherlands @@
## Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma - NCT ID: NCT06330337 - Study ID: ZSLL-KY-2024-010-01 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-31 - Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University ### Study Description Gliomas are the most common type of primary brain tumors, with surgery followed by radiotherapy and chemotherapy as the main treatment modalities. However, they are highly prone to recurrence, presenting significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel, a common chemotherapeutic agent, exhibits antitumor effects in vitro that are 1400 times stronger than those of temozolomide (the first-line chemotherapy drug for gliomas). However, due to its large molecular weight (approximately 893 Da), it cannot cross the blood-brain barrier, precluding its use as a first-line treatment for gliomas. Preliminary research by our team has demonstrated that Specific Mode Electroacupuncture Stimulation (SMES) can open the blood-brain barrier, enhancing the concentration of albumin-bound paclitaxel (ABX) in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Consequently, this study aims to observe the safety and efficacy of SMES combined with ABX in treating patients with recurrent high-grade gliomas postoperatively, to explore its mechanisms of action, extend survival, improve quality of life, and forge new theories and methods for the integrative treatment of brain tumors combining traditional Chinese and Western medicine. ### Conditions - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Temozolomide（TMZ） injection or oral administration - Albumin-Bound Paclitaxel(ABX) intravenous drip - Specific mode electroacupuncture stimulation(SMES) intervention ### Outcomes Primary Outcomes - Overall survival（OS） Secondary Outcomes - Progression-Free Survival (PFS) - Head MRI (plain and enhanced) - he Karnofsky Performance Score (KPS) - The Eastern Cooperative Oncology Group (ECOG) - The Quality of Life (QOL) - The Neurological Assessment for Neuro-Oncology (NANO) ### Location - Facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang, N/A, N/A, China @@
## Reproductive Options in Inherited Skin Diseases - NCT ID: NCT06330324 - Study ID: METC 2023-0182 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2026-09-01 - Lead Sponsor: Maastricht University Medical Center ### Study Description The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children.To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe. ### Conditions - Ichthyosis - Palmoplantar Keratoses - Epidermolysis Bullosa - Ectodermal Dysplasia - Basal Cell Nevus Syndrome - Birt-Hogg-Dube Syndrome - Tuberous Sclerosis - Xeroderma Pigmentosum - Cutis Laxa - Albinism ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Assessment of clinical outcomes of reproductive options Secondary Outcomes ### Location - Facility: Maastricht University Medical Center, Maastricht, Limburg, 6202AZ, Netherlands @@
## Effectiveness of Whole-Body Vibration - NCT ID: NCT06330311 - Study ID: 20/551-EC - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-29 - Completion Date: 2024-09-29 - Lead Sponsor: Universidad Complutense de Madrid ### Study Description Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP. ### Conditions - Spastic Cerebral Palsy - Physical Therapy Modalities - Vibration; Exposure - Lower Extremity Weakness, Spastic - Muscle Spasticity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiotherapy ### Outcomes Primary Outcomes - GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) - GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) - GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) - GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions) - Modified Ashworth Scale (MAS) - Modified Ashworth Scale (MAS) - Modified Ashworth Scale (MAS) - Modified Ashworth Scale (MAS) Secondary Outcomes - 6 Minute Walking Test (6MWT) - 6 Minute Walking Test (6MWT) - 6 Minute Walking Test (6MWT) - 6 Minute Walking Test (6MWT) - Dynamometry - Dynamometry - Dynamometry - Dynamometry - Mini-Balance Evaluation System Test - Mini-Balance Evaluation System Test - Mini-Balance Evaluation System Test - Mini-Balance Evaluation System Test - Cerebral Palsy Quality of Life questionnaire (CP-QOL) - Cerebral Palsy Quality of Life questionnaire (CP-QOL) - Cerebral Palsy Quality of Life questionnaire (CP-QOL) ### Location - Facility: María José Díaz Arribas, Madrid, N/A, 28040, Spain @@
## Improving Social Cognition and Social Behaviour in Various Brain Disorders - NCT ID: NCT06330298 - Study ID: 202000479 - Status: RECRUITING - Start Date: 2021-05-31 - Completion Date: 2025-01-31 - Lead Sponsor: University Medical Center Groningen ### Study Description Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time. ### Conditions - Stroke - Multiple Sclerosis - Brain Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Treatment social cognition and emotion regulation (T-ScEmo) ### Outcomes Primary Outcomes - Change in social behaviour examined by proxy Secondary Outcomes - Social cognition: Emotion recognition as assessed using the Eckman-60 faces test - Social cognition: Theory of Mind as assessed using the Happé cartoons test - Social cognition: Theory of Mind as assessed using the Faux Pas test - Social cognition: assessed using the Hailing Sentence Completion Test - Demographic information - Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales. - Self-rated social behaviour as assessed using the Interpersonal Reactivity Index - Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales - Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index - Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale - Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales - Alexithymia - Life satisfaction - (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation - (Social) participation as assessed using the Impact on Participation and Autonomy scale - Mood and anxiety - Caregiving burden - Goal attainment ### Location - Facility: Deventer Hospital, Deventer, Overijssel, 7416SE, Netherlands @@
## Comparison of E-Learning and Face-to-Face Learning in Cardiopulmonary Exercise Test Training - NCT ID: NCT06330285 - Study ID: e learning pgme/cpet - Status: NOT_YET_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2024-08-15 - Lead Sponsor: Kayseri City Hospital ### Study Description The main purpose of this study is to compare the effect of teaching Cardiopulmonary Exercise Test (CPET) via e-learning and face-to-face to doctors receiving postgraduate medical education (PGME). ### Conditions - Exercise Test - Learning ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - e-learning - face to face learning ### Outcomes Primary Outcomes - Open-Ended Achievement Test - Adult Motivation Scale - Distance Education Attitude Scale in Lifelong Learning - Cognitive Flexibility Scale - State and Trait Anxiety Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study - NCT ID: NCT06330272 - Study ID: UCeuma - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-03 - Lead Sponsor: Meire Coelho Ferreira ### Study Description MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse. ### Conditions - Molar Incisor Hypomineralization ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Application of dental mousse based on CPP-ACPF ### Outcomes Primary Outcomes - To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse Secondary Outcomes ### Location - Facility: Josue Montello, Universidade Ceuma, São Luis, Maranhão, 65075-120, Brazil @@

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