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NCT06261086

Not yet recruiting

Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study

Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally. It can affect ethnic groups and people of all skin types with no predilection (4). Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β & IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo.

- EligibilityCriteria: Inclusion Criteria: Patients with vitiligo ≥ 18 years old, both male and female patients will be included. Exclusion Criteria: Patients with the following criteria will be excluded from our study: Pregnancy and breast-feeding women patients on antioxidants or anti-inflammatory drugs Patients on topical/systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study Patients with other dermatological diseases as psoriasis, lichen planus, viral infection, etc. Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06261073

Not yet recruiting

Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients

Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012). Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018). The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017). The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling.

- EligibilityCriteria: Inclusion Criteria: Patients with non-segmental vitiligo attending the dermatology outpatient clinics of Sohag University hospital. A group of age and sex- matched healthy participants will be included as a control group. Exclusion Criteria: (A) Pregnancy and lactation. (B) Patients on topical and systemic treatment for vitiligo in the last 4weeks prior to enrollment in the study. (C) Malignacies. (D) Patients with systemic diseases, diabetes, hypertension and bleeding disorders. (E) Patients who are receiving chemotherapy or radio therapy. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06261060

Not yet recruiting

Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder

To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD.

- EligibilityCriteria: Inclusion Criteria: Participants has provided signed, informed consent before initiation of any study specific procedures Aged ≥18 years at the time of signing the informed consent Confirmed P/LP germline RUNX1 variant per ClinGen Myeloid Malignancy Variant Curation Expert Panel (MM-VCEP) RUNX1-specific variant curation rules80 Participants must be willing to provide bone marrow sample at time of screening and at the end of treatment with sirolimus Platelet count of ≥50,000/µL Adequate renal function: estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation, >30 mL/min/1.73m2 Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × upper limit of normal (ULN) and total bilirubin <1.5 × ULN Adequate cardiac function: left ventricular ejection fraction >50% Exclusion Criteria: Known allergy to sirolimus History of lymphoma or other hematologic malignancies Uncontrolled bleeding Any prior diagnosis of myelodysplastic syndrome or other hematologic malignancy using International Working Group criteria Prior treatment with sirolimus or a rapalog, mTOR inhibitor, or B-cell-depleting therapy within 28 days before study day 1 Treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4; eg, ketoconazole, voriconazole, itraconazole, erythromycin, telithromycin, and clarithromycin), strong inducers of CYP3A4 (eg, rifampin and rifabutin), other drugs that could increase sirolimus blood concentrations (eg, bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem, fluconazole, letermovir, protease inhibitors [eg, ritonavir, indinavir, boceprevir, and telaprevir], metoclopramide, nicardipine, troleandomycin, and verapamil), other drugs that could decrease sirolimus blood concentrations (eg, carbamazepine, phenobarbital, phenytoin, rifapentine, St. John's Wort [Hypericum perforatum]), or drugs with blood concentrations that could increase (eg, verapamil) within 7 days before study day 1 Use of cannabidiol, which can increase blood levels of sirolimus, within 7 days before study day 1 Myocardial infarction within 6 months before study day 1, congestive heart failure (New York Heart Association > class II) Total cholesterol >300 mg/dL or triglyceride >400 mg/dL Arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before study day 1 Infection requiring intravenous anti-infective treatment within 1 week of study day 1 Live vaccines (eg, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid) within 28 days before study day 1 Known diagnosis of chronic viral infection (eg, hepatitis B or C or HIV, and Epstein-Barr) or tuberculosis Women who are pregnant, may become pregnant, or who are breastfeeding - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06261047

Recruiting

Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer

Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches.

- EligibilityCriteria: Inclusion Criteria: Obtain written informed consent before implementing any trial-related procedures. Male or female, aged 18 years or older, and 75 years or younger. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1. Histological or cytological confirmation of primary hepatocellular carcinoma (HCC), or diagnosed according to the Clinical Diagnosis and Treatment Guidelines for Primary - Liver Cancer (2019 edition) issued by the National Health Commission of the People's Republic of China. Tumor staged as BCLC stage C; patients have ≤5 lesions (≤3 affected organs) with oligometastasis or oligoprogression. Liver function assessed by Child-Pugh score ≤7 points. Availability of tumor samples for biomarker assessment. Stable disease with systemic therapy for ≥3 months and an anticipated survival period of ≥6 months. Exclusion Criteria: Diagnosis of malignancy other than liver cancer within 3 years before enrollment (excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma). Currently participating in interventional clinical research treatment, or received other investigational drugs or investigational device therapy within the past 4 weeks before enrollment. Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before enrollment (including thymosin, interferon, interleukin, except for local use to control pleural effusion). Experienced active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years before enrollment. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatment. Received radiotherapy within 2 weeks before enrollment. HIV + Active untreated hepatitis B (defined as HBsAg positive with HBV-DNA copy number exceeding the upper limit of normal value in the laboratory of the participating center). Pregnant or lactating women. - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Hepatocellular carcinoma, stage IIIB, oligo progress - SamplingMethod: Probability Sample

NCT06261034

Not yet recruiting

A Study of Sex Differences in Neurocirculatory Control

The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA).

- EligibilityCriteria: Inclusion Criteria: 20-70 years of age Exclusion Criteria: Coronary artery disease Heart failure Pregnancy COPD Diabetes CKD Sleep disorders other than OSA Shift workers Individuals who typically go to sleep after midnight Individuals who traveled across ≥2 time zones within one week of study visits BMI ≥40.0kg/m2 Use of nicotine-containing products within the two years preceding study visits Use of allopurinol, proton pump inhibitors, or other medications/supplements which interfere with outcome measures - Gender: All - MinimumAge: 20 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects with or without untreated obstructive sleep apnea will be recruited from Mayo Clinic in Rochester, MN. - SamplingMethod: Non-Probability Sample

NCT06261021

Not yet recruiting

Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

- EligibilityCriteria: Inclusion Criteria: Male or female subject 18 years of age or older at the time of consent. Confirmed DLE diagnosis. Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1. Female subject of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures. Subjects must be willing to comply with all study procedures and must be available for the duration of the study. Exclusion Criteria: Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study. Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments. Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening. Subject is known to have immune deficiency or is immunocompromised. Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots. Subject is known to have hepatitis B or hepatitis C viral infection. Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices. Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab. Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1. Subject has a known or suspected allergy to ruxolitinib. Subject has used ruxolitinib cream (OpzeluraTM). Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06261008

Not yet recruiting

Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening

In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour.

- EligibilityCriteria: Inclusion Criteria: 50-75 years old already enrolled in the Program with negative FIT results in 2022 eligible for the Program inclusion and due for repeat FIT screening in 2024 either the participants themselves or their family members / caregivers have access to and agree to be contacted via WhatsApp ability to understand Chinese Exclusion Criteria: who have incomplete conversations with the chatbot, lack of access to WhatsApp, or are unable to provide informed consent will be excluded - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06260995

Recruiting

The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol

Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time. This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future.

- EligibilityCriteria: Inclusion criteria Aged ≥18 years Referred to intermediary service for any reason OR self-referred to intermediary service for any reason Meets the eligibility criteria of the intermediary service Intermediary facilitates a connection to local physical activity Exclusion criteria Non-community dwelling e.g., hospital in-patients, living in residential care facilities Diagnosis of dementia Inappropriate for health or social reasons (such as terminal illness, family or other social crisis) Refused to engage with the intermediary service Unable to give explicit informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants are adults aged >18 years old, able to give explicit informed consent, referred to an intermediary and that the intermediary plans to connect to local physical activities. - SamplingMethod: Non-Probability Sample

NCT06260982

Recruiting

Cognitive Disorders in Hereditary Spastic Paraplegia Type 4

Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized.

- EligibilityCriteria: Inclusion Criteria: Patient over 18 years of age, living in the Grand Est region (France) Patient with a pathogenic or probably pathogenic variant (class 4 or 5) in the SPAST gene. Exclusion Criteria: dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Patients followed in the Grand Est region for type 4 spastic paraplegia with identification of a pathogenic or probably pathogenic variant in the SPAST gene. - SamplingMethod: Non-Probability Sample

NCT06260969

Recruiting

Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis

The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.

- EligibilityCriteria: Inclusion Criteria: CT scan to exclude intracranial haemorrhage；CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography showing occlusion of the distal intracranial carotid artery or the first segment of the middle cerebral artery；ELVO with a base ICAS of > 70%；Mechanical thrombectomy within 6h after symptom onset in ischemic stroke；NIHSS≥6；receiving endovascular treatments；informed consent form signed by the patient or their legal representatives. Exclusion Criteria: Hemorrhagic body, coagulation factor deficiency or oral anticoagulant therapy(INR > 3.0)；Baseline platelet count <50,000/µL；Baseline blood glucose <50mg/dL or >400mg/dL；Intractable hypertension(systolic blood pressure >220 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by medication；Patients intubated without a NIHSS score assessed by a neurologist or emergency physician prior to intubation；Stroke attack with epilepsy affecting baseline NIHSS score；End-stage diseases leading to less than one year of expected survival for patients；Severe allergy to contrast media；Patients with renal insufficiency (blood creatinine ≥ 3 mg/dL)；Female patients who are pregnant or breastfeeding；The patient is participating in other drugs or device studies that may affect this study；Patient with cerebral vasculitis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with acute cerebral infarction with underlying intracranial artery stenosis receiving endovascular treatment - SamplingMethod: Non-Probability Sample

NCT06260956

Not yet recruiting

Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg

Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding.

- EligibilityCriteria: Inclusion Criteria: Participant must be able to understand and provide informed consent Parental permission must be provided for infants Adults, 18 years and older and their child Pregnant women in first or second trimester, carrying a fetus with a first-degree relative with any self- reported or physician-diagnosed allergic disease (asthma, allergic rhinitis, atopic eczema or food allergy) Intention to breastfeed more than 3 months Must have history of eating peanut and egg and have tolerated consumption with no food allergy reactions Willing to be randomized to consumption or avoidance diet Exclusion Criteria: Inability or unwillingness of a participant to give written informed consent or comply with study protocol. Chronic infection or inflammatory disease such as cystic fibrosis or inflammatory arthritis. Renal/liver/cardiac insufficiency. Mothers with peanut or egg allergy. Mothers who refuse to eat peanut (or peanut products) and/or eggs (or products containing eggs) . Known immunodeficiency. Current, diagnosed, mental illness or current, diagnosed, or self-reported, drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks to the mother or infant from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: To understand the mechanisms whereby maternal diet either positively or negatively affects the development of their infant from the womb through the first few months of life, it is necessary to recruit healthy pregnant women. - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06260943

Not yet recruiting

Targeted Navigation in Hepatocellular Carcinoma (HCC)

The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.

- EligibilityCriteria: Inclusion Criteria: HCC Patients: Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma. Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0. Adults, age 18 or older Able to provide informed consent All other interviewees: Advocates who will self-identify as having had HCC. Others who self-identify as either a caregiver or support person of an HCC patient. Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients. Exclusion Criteria: Unable to speak Spanish or English West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment. Adults unable or unwilling to consent Individuals who are not yet adults (infants, children, teenagers) Prisoners Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260904

Not yet recruiting

Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus

Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc. Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus. Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients.

- EligibilityCriteria: Inclusion Criteria: Patients aged ≥18 of either sex with the clinical diagnosis of oral lichen planus. Patients with a PGA score of ≥3 (moderate and severe oral LP). Patient not responding to topical or intralesional corticosteroid. Patients who are willing to give informed written consent. Exclusion Criteria: Treatment with a systemic corticosteroid within the last 4 weeks. Patients on any immunosuppressive agents such as azathioprine, cyclosporine and others within one month of recruitment. Patients with clinical history and any lesion distribution suspicious of a lichenoid drug eruption and patients with other skin diseases. Past or current history of any malignancy including moderate to severe dysplasia of the oral mucosa on oral biopsy. Severe active infection, including active tuberculosis, hepatitis B or C infection Patients with cytopenia (Hb <9g/dl, leukocyte count <4000/mm3, platelet count <100,000/mm3) Patient with history of alcohol abuse. Decreased liver or renal function (creatinine > 2.0mg/dl, total bilirubin > 2.5 mg/dl). Severe acute infection, uncontrolled diabetes mellitus, untreated glaucoma, congenital or acquired immunodeficiency, active gastroduodenal ulcer, severe osteoporosis, severe cardiac disease (NYHA grade IV), MI in the last four weeks, severe schizophrenia or depression. Patient with a history of hypersensitivity to Methotrexate or Apremilast. Pregnancy and lactation, women of childbearing age without effective contraception. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260891

Not yet recruiting

Zinc Supplementation in Sickle Cell Disease

The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS.

- EligibilityCriteria: Inclusion Criteria: Age: ≥ 15.0 to ≤ 35.0 years Diagnosis: SCD-SS, in steady state (defined as a minimum of 10 days following pain crisis) Male or Female (n=17 of each) stratified by age group (15-25 ; 25-35 years) Exclusion Criteria: Taking zinc supplements and unable/willing to stop for 3 months prior to study start On chronic transfusion therapy (defined as >8 Transfusions/year) Unable swallow pills or take daily supplement as instructed Renal dysfunction (defined as creatinine > 1.5 mg/dL or estimated glomerular filtration rate < 60) - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult

NCT06260878

Not yet recruiting

Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.

- EligibilityCriteria: Inclusion Criteria: age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age) ability to give informed consent native major papillary anatomy ability and willingness to obtain bloodwork the day after ERCP Exclusion Criteria: prior ERCP with sphincterotomy and/or sphincteroplasty confirmed or suspected cholangitis or sepsis confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days NYHA Class II or greater heart failure active pulmonary edema myocardial infarction or ischemia within the preceding 3 months renal insufficiency with CrCl < 40 mL/minute CPT Class B or C cirrhosis and/or end-stage liver disease room air oxygen saturation <90% or requirement of home O2 hypernatremia with Na+ ≥ 150 mEq/L or Na+ <130 mEq/L uncontrolled hypertension or hypotension pregnant status - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06260865

Not yet recruiting

A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome

This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome.

- EligibilityCriteria: Inclusion Criteria: Patients with peripatellar or posterior patellar pain in one or more knee joints for 3 months or longer Patients with peripatellar or posterior patellar pain provoked by squatting Patients who have pain provoked by 2 or more following activities: prolonged sitting, cycling, running, going up or down stairs, kneeling, compression of the patella, palpation of the patellar facets Patients who signed a written informed consent form Exclusion Criteria: Patients with osteoarthritis which scored 3 or higher grade of the Kellgren-Lawrence scale Patients diagnosed with a fracture or dislocation around the knee within the last 3 months Patients who had knee surgery within the last 3 months Patients diagnosed with patellar tendinitis based on imaging within 3 months Patients taking narcotic pain medications for pain control Patients taking or planning to take any medication that is a contraindication within the next 16 weeks at the time of screening Patients who are pregnant Patients currently participating in another clinical trial or have participated in another clinical trial within the past 3 months at the time of screening Patients deemed unsuitable for this study by the investigator - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06260852

Recruiting

Identification of Minimum Focal Points in Vision Curve Formation

The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.

- EligibilityCriteria: Inclusion Criteria: age over 40, previous bilateral premium cataract surgery, best corrected visual acuity (BCVA) < 0,2 logMAR Exclusion Criteria: taking topical medication to reduce intraocular pressure (IOP), macular diseases, corneal diseases, inability to understand the procedure, postoperative astigmatism >1.50 diopters, postoperative clouding of the posterior capsule - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: participants that underwent uncomplicated pseudophakic presbyopia correction with bilateral premium intraocular lenses (IOL) implantation - SamplingMethod: Non-Probability Sample

NCT06260839

Recruiting

the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography

The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). The main question it aims to answer are: magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture. Participants will underwent preoperative magnetic resonance examination according to different groups, and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings. In the control group, preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture, and the magnetic resonance results were not used to assist in the design of surgical approach. In the control group, non-MRN-assisted minimally invasive release was performed. The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect.

- EligibilityCriteria: Inclusion Criteria： （1). Meet the clinical and imaging diagnostic criteria of GMC ; (2).According to Zhao &#39;s classification system, patients with moderate to severe GMC diagnosed by medical history, symptoms and physical examination ; (3).Conservative treatment is ineffective for at least 6 months, and daily life is significantly affected ; (4).willing to be hospitalized and receive minimally invasive surgery ; (5). Can cooperate to complete the follow-up ; (6).Patients or immediate family members signed informed consent ; (7). Age 18-65 years old Exclusion Criteria: . There is clinical or imaging evidence that there is or may be spinal or lower extremity neurological disease ; . There is evidence of hip dysplasia or subluxation ; .after evaluation of intolerance to surgical anesthesia ; .coagulant dysfunction ; . unable to complete the follow-up for various reasons ; . Patients can not complete the scale assessment for other reasons - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06260813

Recruiting

Biomechanical and Morphological Characterization of PTTD

Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity. Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint). Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients. The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients.

- EligibilityCriteria: Inclusion criteria: Patient groups: Posterior tibial tendon dysfunction (all clinical stages) Age 18-675 year ICF obtained Control group: No pain complaints No pes plano valgus, PTTD or pes cavo varus or other foot and ankle pathology Age 18-75 year ICF obtained Exclusion criteria patient and control groups: Being younger than 18 years Inability to walk without mobility aids Inability to walk < 100 meter Difference in leg length > 3cm Subjects with BMI>30 kg/m², due to less accurate gait analysis by absence of anatomical landmarks Subjects unable to perform a gait analysis Any medical condition possibly affecting normal gait. Pregnancy: at the start or during the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06260800

Recruiting

Spanish Version of Credibility and Expectancy Questionnaire in Patients With Musculoskeletal Injuries

Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire.

- EligibilityCriteria: Inclusion Criteria: Volunteer patients who are going to start physiotherapy treatment due to musculoskeletal injuries. Age above 18 years old. Understanding of the study purpose and signing the informed consent. Exclusion Criteria: Patients with cognitive deprivation. Not able to fill in the questionnaires autonomously. Mother tongue different from Spanish. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who are going to start physiotherapy treatment due to musculoskeletal injuries. - SamplingMethod: Probability Sample

NCT06260774

Not yet recruiting

Study of TTX-MC138 in Subjects With Advanced Solid Tumors

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors

- EligibilityCriteria: Inclusion Criteria: Have histologically or cytologically confirmed diagnosis of relapsed/refractory metastatic or locally advanced solid tumor where no standard therapy exists, standard therapy has failed and have no available therapies with known clinical benefit. Must have measurable or evaluable disease per RECIST version 1.1. ≥18 years at the time of informed consent. Life expectancy of ≥3 months Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. Have adequate organ function defined as: Platelet count ≥75×109/L with no platelet transfusions in the past 7 days Absolute neutrophil count ≥1.0×109/L Hemoglobin ≥8 g/dL (red blood cell transfusion may be used to reach 8 g/dL but must have been administered at least 1 week prior to the administration of the study drug) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5× the upper limit of normal (ULN) if no hepatic metastases are present; <5× ULN if hepatic metastases are present Total bilirubin <1.5× ULN; <3 X ULN in the presence of Gilbert's disease Estimated (Cockcroft-Gault formula) or measured creatinine clearance ≥60 mL/min International normalized ratio (INR) ≤1.5× ULN unless participant is receiving anticoagulant therapy as long as the prothrombin time (PT) or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants If female of childbearing potential, either abstain from sexual intercourse or employ highly effective contraception measures during the study and for ≥30 days after the administration of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for women <50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 30 days after the administration of the study drug. For male subjects not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 30 days after the administration of the study drug. Male subjects should also avoid semen donation or providing semen for in vitro fertilization during the above-mentioned duration. Able to understand and willing to provide informed consent and able to comply with the study procedures, including biopsy, and restrictions. Exclusion Criteria: Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions. Have received anticancer therapy (including both systemic therapy and radiotherapy, but not including immunotherapy or other antibody therapies) within 14 days or 5 half-lives (whichever is shorter) of study drug administration or; a. received antibody therapy within 30 days before the start of study drug administration. Have a history of a second primary malignancy that has been diagnosed or required active therapy within the past year. a. Note: The following prior malignancies are not exclusionary: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate or breast cancer, curatively treated localized thyroid cancer, and completely resected carcinoma in situ of any site. Have central nervous system (CNS) metastases or primary CNS tumor that is associated with progressive neurologic symptoms or requires ongoing corticosteroids to control the CNS disease. Subjects must have a stable neurologic status without steroid support for ≥2 weeks before the start of study drug administration. Subjects with stable or asymptomatic CNS metastases or primary CNS are eligible. Require treatment with traditional/herbal medicines or their preparations indicated for tumors or with adjuvant anti-tumor effects that cannot be discontinued during the study. Have clinically significant, uncontrolled cardiovascular disease including congestive heart failure Class III or Class IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; uncontrolled hypertension (Grade ≥3); or clinically significant, uncontrolled arrhythmia, including bradyarrhythmia that may cause QT prolongation (eg, Type II second-degree heart block or third-degree heart block). Have QT interval corrected using Fridericia's formula >480 msec. Unless the subject has a history of prolonged QT syndrome or torsade de pointes or a familial history of prolonged QT syndrome. Have a history of acute ischemic stroke, diagnosed by imaging (CT or MRI) or clinical diagnosis within 6 months prior to screening. Have any severe or uncontrolled systemic disease or condition per clinical judgement, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary, or renal conditions; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal, or other infection that would pose a significant risk to the subject in the opinion of the Investigator; (v) cerebrovascular accident within the last 6 months before administration of study drug. Have received a major surgical procedure within 28 days before the start of study drug administration (procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures). The study center should discuss other minor surgeries with the sponsor. Clinical diagnosis of hemochromatosis or secondary iron overload, Have known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection that is not well-controlled and meets any of the following exclusion criteria: Documented detectable HIV RNA within 4 weeks of study drug administration, Acquired immunodeficiency syndrome defining opportunistic infections within the past 12 months prior to study enrollment, and Is not on antiretroviral therapy for at least 4 weeks prior to study enrollment. Have clinical signs or symptoms consistent with COVID-19 infection or confirmed infection by appropriate laboratory test (done at the discretion of Investigator or per local regulation) within the last 2 weeks before the administration of the study drug. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required. Have received or are planning to receive a COVID-19 vaccination within 2 weeks before or after the administration of the study drug. However, COVID-19 vaccinations received >2 weeks before or after the administration of the study drug are permitted. Have received a live or live attenuated vaccines within 30 days before the administration of the study drug. Have any unresolved clinically relevant toxicities from prior therapy, greater than NCI CTCAE Grade 1 at the time of starting study treatment, except for alopecia. Have a history of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug, including ferumoxytol (Feraheme®). Have an active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy, including >10 mg prednisone per day or equivalent. Pregnant or breastfeeding at the time of screening or on Day 1 before TTX-MC138 as documented by a serum beta human chorionic gonadotropin pregnancy test consistent with pregnancy. Known current drug or alcohol abuse. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06260748

Not yet recruiting

A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX)

This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA.

- EligibilityCriteria: Inclusion Criteria: Signed informed consent form (or assent form as appliable) Aged from 2 to 75 years old Has a new or suspected diagnosis of CTX as defined by an elevated plasma cholestanol concentration (>10 mg/L/>25.7 μmol/L) in conjunction with a clinical presentation consistent with the diseased as assessed by the investigator Has never received treatment with CDCA Has never received treatment with other bile acid products Exclusion Criteria: Any medical condition that, in the opinion of the investigator, precludes the participant's participation in the study Presence of known hepatocyte dysfunction or bile ductal abnormalities such as intrahepatic cholestasis, primary biliary cirrhosis or sclerosing cholangitis Inability to adhere to treatment and visit schedule Female participants who are pregnant Female participants who are breast feeding Female participants who are using estrogen-containing compounds and cannot/will not discontinue them for the duration of the study Female participants of childbearing potential who are not using locally approved birth control method(s) or double barrier contraception (ie, condom and diaphragm, condom or diaphragm and spermicidal gel or foam) Taking any of the following medications: bile acid products; inhibitors of bile acid transporters; bile acid binding resins; aluminum-based antacids; coumarin and its derivatives; cholestyramine; ciclosporin; sirolimus; or phenobarbital - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 75 Years - StdAgeList: Child, Adult, Older Adult

NCT06260735

Recruiting

Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols. This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.

- EligibilityCriteria: Inclusion Criteria: Has spinal cord injury, 6 mo or longer since injury Is between 20 and 65 years of age Has difficulty with trunk and/or lower limb function Stable medical condition Non-progressive etiology of spinal injury No ventilatory support Exclusion Criteria: Genetic or degenerative etiology of spinal injury Need for ventilatory or other life-sustaining medical support History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06260722

Recruiting

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

- EligibilityCriteria: Inclusion Criteria: Have Type 2 Diabetes (T2D) Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening Are of stable weight for at least 90 days prior to screening Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m^2) Exclusion Criteria: Have Type 1 Diabetes (T1D) Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory Have a prior or planned surgical treatment for obesity Have New York Heart Association Functional Classification IV congestive heart failure Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening Have a known clinically significant gastric emptying abnormality Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years Have any lifetime history of a suicide attempt Had chronic or acute pancreatitis Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260709

Recruiting

A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis

This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years).

- EligibilityCriteria: Inclusion Criteria: Completed study intervention in NN6019-4940 and attended the last study visit (week 64; visit 16), and no later than 12 weeks after visit 16. Expected to be on stable doses of cardiovascular medical therapy 6 weeks prior to the enrolment visit. Exclusion Criteria: A prior solid organ transplant. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening. Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response. Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06260683

Not yet recruiting

A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health.

- EligibilityCriteria: Inclusion Criteria: >= 21 years old Smoke >= 5 cigarettes per day for the past year Willing to use either an EC or NRT Read and speak English Have a smartphone Exclusion Criteria: Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation Current use of an EC > 4 days a month Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD) Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia History of cardiac event or distress within the past 3 months Currently pregnant, planning to become pregnant within 6 months, or breastfeeding High blood pressure not controlled by medications Serious angina pectoris or chest pain Stroke within the past three months Known allergy to propylene glycol or vegetable glycerin - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult

NCT06260657

Not yet recruiting

Search for Olfactory Cells Within the Fetal Ethmoid Epithelium

The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis. In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base. The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population. This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa.

- EligibilityCriteria: Inclusion Criteria: Fetus aged at least 7 weeks of gestation up to 14 weeks + 6 days. Fetus resulting from an in-hospital procedure of voluntary termination of pregnancy, either medicinal or surgical. Fetus whose mother is of legal age and legally responsible. Fetus whose mother has been provided with fair and complete information about the research conducted and has given informed, voluntary, and written consent for the use of fetal products from the voluntary termination of pregnancy procedure she is undergoing. Fetus whose mother has not objected to the utilization of data derived from the research. Exclusion Criteria: Fetus macroscopically exhibiting a craniofacial malformation - Gender: All - MinimumAge: 7 Weeks - MaximumAge: 15 Weeks - StdAgeList: Child - StudyPopulation: Fetus aged 7 to 14+6 weeks of gestational age resulting from an in-hospital voluntary termination of pregnancy procedure - SamplingMethod: Non-Probability Sample

NCT06260631

Not yet recruiting

Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP).

- EligibilityCriteria: Inclusion Criteria: The patients had CNSLBP with age from 20 to 40 years from both genders. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm. Patients with normal BMI ranges between 18.5:24.9 kg/m2. The study populations must be willing to participate in the study Exclusion Criteria: Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II. Psychiatric/mental deficit. Patients who had a previous surgical history (within 6 months) will also excluded. participation in other treatment within the previous 3 month. Pregnancy. History of spinal fracture, tumor, osteoporosis use of medication, such as corticosteroids, anticonvulsants, and anti-inflammatory drugs that may affect the outcome of the study. prior history of adverse effects to physical stimulation therapy. significant physical or mental deficiencies preventing a clear understanding of the study procedure. spinal stenosis, thyroid dysfunctions, obesity, pace-maker. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06260618

Recruiting

Effect of Chitodex Gel in Tympanoplasty Surgery

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP).

- EligibilityCriteria: Inclusion Criteria: Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND Are indicated to undergo closure of the perforation via tympanoplasty surgery AND Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND Are 18 years of age or over AND Are able to give written informed consent AND Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op Exclusion Criteria: Operative ear is the better or only hearing ear The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination dysfunction during otoscopic and tympanometric examination Known allergy to shellfish or ciprofloxacin antibiotics Pregnant or breastfeeding Hepatitis, HIV or any blood disorders COVID-19 positive patients - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260592

Recruiting

Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses

Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient&#39;s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures.

- EligibilityCriteria: Inclusion Criteria: Becoming an intensive care nurse Volunteering to participate in the study Exclusion Criteria: Not being an intensive care nurse Not volunteering to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Nurses actively involved in the intensive care unit. - SamplingMethod: Non-Probability Sample

NCT06260579

Recruiting

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

- EligibilityCriteria: Inclusion Criteria: De novo adult KTRs Exclusion Criteria: Underlying heart disease, defined as aberrant CPET, unstable angina, non-revascularized lesions or life-threatening arrhythmias Uncontrolled hypertension Uncontrolled diabetes, defined as HbA1c ≥ 9% Musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise Multi-organ transplantation Ongoing treatment for malignancies Unable to understand Dutch No access to smartphone and/or computer with internet access Severe pulmonary disease defined as either forced vital capacity (FVC) <50%, one-second value (FEV1) <50%, or a diffusing capacity for carbon monoxide (DLCO) <40% that excludes all serious underlying respiratory disease (pulmonary fibrosis, COPD GOLD II-IV, PAH). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260566

Not yet recruiting

Tolerability of Enteral NAC in Infants

Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology. This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants.

- EligibilityCriteria: Inclusion Criteria: 122-273 days of life at time of enrollment Confirmed diagnosis of biliary atresia based on intraoperative cholangiogram Able to tolerate oral nutrition and medications and not on continuous tube feeds Anticipated inpatient admission of at least 4 days Legal guardian(s) consent to study enrollment after understanding the risks and investigational nature of the study Exclusion Criteria: Gestational age of <32 weeks at birth Inability or contraindication to taking oral nutrition Neonatal intensive care unit admission Short bowel, or other malabsorptive, syndrome Decompensated liver disease (INR > 1.3 despite vitamin K administration) Active respiratory infection Severe concurrent illnesses that would interfere with the conduct and/or results of the study Concurrent participation in another drug trial - HealthyVolunteers: No - Gender: All - MinimumAge: 122 Days - MaximumAge: 273 Days - StdAgeList: Child

NCT06260540

Recruiting

Core Endurance in Healthy Young Adults

This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance. The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time.

- EligibilityCriteria: Inclusion Criteria: Individuals between the ages of 18-25. Individuals who volunteer to participate in the research. Individuals with normal joint movement. Exclusion Criteria: Individuals with orthopedic or neurological diseases. Individuals who have suffered fractures, dislocations, surgeries, etc. in the upper extremities. Individuals with diseases that may affect upper extremity performance Individuals who exercise regularly Individuals who play any musical instrument - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult - StudyPopulation: 104 Healthy young adults - SamplingMethod: Non-Probability Sample

NCT06260527

Recruiting

Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers

This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers.

- EligibilityCriteria: Inclusion Criteria: Healthy female and male subjects between the ages of 18 and 55 years. Body Mass Index (BMI) of 19.0 to 28.0 kg/m2; and a total body weight male ≥50.0 kg, female ≥45.0 kg. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. No evidence or history of clinically significant abnormalities of , vital signs (body temperature, pulse and blood pressure), laboratory tests (blood hematology and biochemistry, urine and coagulation function), 12-lead ECG and other examinations. Subjects has no fertility and sperm donation, egg donation plan and takes highly effective contraception during correctly for the duration of the active treatment period and for at least 90 days after the last dose of investigational drugs. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 150 mL) of wine or 360 mL of beer or 45 mL of hard liquor within 3 months of screening. History of tobacco/nicotine containing products in excess of >5 cigarettes/day within 3 months of screening. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer. 12-lead ECG demonstrating QTc >450, or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc (or QRS) values should be used to determine the subject's eligibility. Screening laboratory abnormalities as defined by the protocol. Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol. Subjected is not appropriate to be enrolled in the study per investigator's assessment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06260514

Not yet recruiting

Study of APR-1051 in Patients With Advanced Solid Tumors

The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years Diagnosis of advanced/metastatic solid tumor Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70% Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation Adequate bone marrow and organ function Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry Exclusion Criteria: Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1 Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051 Major surgery within 21 days prior to Day 1 Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab) Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260488

Not yet recruiting

Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence

The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules. There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue. This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications.

- EligibilityCriteria: Inclusion criteria: Male or female of legal age Subject with a planned transfemoral amputation in the vascular surgery department of the Hôpitaux Universitaires de Strasbourg as standard care Subject with a CT as part of standard care Subject who has given his/her non-opposition to participate in the study Exclusion criteria: - Impossible to give the subject informed information (subject in emergency situation, difficulties in understanding) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260475

Not yet recruiting

IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions

This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II

- EligibilityCriteria: Inclusion Criteria: Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12). Age >18 years old Exclusion Criteria: Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing revascularization of the aorto-iliac sector for peripheral arterial disease at any of the center in study starting in January 2016 until December 2023.A consecutive sample will be prepared, containing all patients at the recruiting centers, fulfilling the following criteria - SamplingMethod: Non-Probability Sample

NCT06260436

Recruiting

Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse

. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.

- EligibilityCriteria: Inclusion Criteria: Age; greater than or equal to 18 years women with urogenital prolapse grade 3 or more indicated for surgical repair for pelvic organ prolapse Willing and able to sign an informed consent Willing to comply with the study protocol Exclusion Criteria: Anti-incontinence surgery Lower urinary tract anomaly Active urinary tract infections Bladder tumor. Bladder stones - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: only female cases will be eligible to participate - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: female cases at women health hospital at assuit university - SamplingMethod: Probability Sample

NCT06260423

Recruiting

The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer

Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically.

- EligibilityCriteria: Inclusion Criteria: patients with symptoms of irreversible pulpitis without apical periodontitis related to the maxillary first premolar ranging from 20 to 40 years old and with separate roots were selected from patients referred to the diagnosis clinic, Faculty of dental medicine Al-Azhar University, Cairo, Boys branch. Exclusion Criteria: Patients with any systemic disorders. Pregnancy. teeth with positive response to palpation test Non vital teeth. Teeth with positive response to percussion test. Teeth with mobility of grade II or III. teeth with probing depth more than 3 mm. Teeth with abnormal morphology. Teeth with root curvatures more than 20 degree (according to Schneider's method). Teeth with internal or external root resorption. Teeth with vertical root fracture. Teeth with open apices. Teeth with any root canal type other than type I. Patients with (VDS) test with score 4 or less. 15- teeth with fused roots or single root. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06260410

Not yet recruiting

Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics

This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.

- EligibilityCriteria: Inclusion Criteria: Participants should be at least 18 years old. Participants should be able to understand the written information and be able to provide informed consent. Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care. Exclusion Criteria: None applicable - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care. - SamplingMethod: Non-Probability Sample

NCT06260397

Not yet recruiting

Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

- EligibilityCriteria: Inclusion Criteria: American Society of Anaesthesiologists (ASA) Physical Status Class I, II. Scheduled for modified radical mastectomy (MRM). Body weight ranging from 60 to 100 kilograms. Exclusion Criteria: Declining to give a written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection). Psychiatric disorders. Significant cognitive dysfunction. American Society of Anesthesiologists (ASA) Physical Status Class III and IV. Daily use of opioids. Obesity (BMI > 35 kg/m2). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06260384

Recruiting

Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry)

The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study. The exclusion criteria will be any participant who does not consent to the study. A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded. A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center. Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center.

- EligibilityCriteria: Inclusion Criteria: Patients who have a preexcitation (WPW) pattern on an ECG. Exclusion Criteria: any participant who does not consent to the study. Any participants who have structural heart disease History of other arrhythmogenic diseases like Brugada syndrome, Arrhythmogenic AR dysplasia, long QT syndrome..etc Any implantable cardiac rhythm devices - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants are recruited from outpatient cardiology clinics and inpatient cardiology wards at twenty cardiac centers in 17 countries spread across all African regions. They all belong to the Africa Heart Rhythm Association (AFHRA) network, and participants were included if they have preexcitation (WPW) pattern on an ECG either they have symptoms, documented tachyarrhythmias or asymptomatic and accidently discovered - SamplingMethod: Non-Probability Sample

NCT06260371

Recruiting

National Observatory of Mycoplasma Infections in Children Under 18 Ages in France

This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023. Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management.

- EligibilityCriteria: Inclusion Criteria: Age <18 years (only hospitalized children) Documented mycoplasma infection (positive multiplex PCR and/or positive serology) Exclusion Criteria: Refusal by one of the parents or by Child in understanding age - Gender: All - MinimumAge: 1 Day - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: hospitalised children under 18 age, with Mycoplasma infection - SamplingMethod: Non-Probability Sample

NCT06260358

Recruiting

Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes. Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years old; Overt biopsy-proven diagnosis of cervical cancer, at any stage; Signed written informed consent to personal data treatment for research purposes Exclusion Criteria: Age <18 years old; Uncertain diagnosis of cervical cancer; MRI scan not according the standard acquisition protocol (ESUR guidelines); Patients candidate to non-standard treatments; Refusal to sign the written informed consent to personal data treatment for research purposes - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with biopsy-proven cervical cancer (any FIGO stage) undergoing staging MRI afferent to the participating centers satisfying the following inclusion/exclusion criteria. - SamplingMethod: Probability Sample

NCT06260345

Recruiting

CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit

Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections.

- EligibilityCriteria: Inclusion Criteria: Age <18 years (only hospitalized children) Severe communautary bacterial infection defined by hospitalization in a pediatric intensive care unit (documentation of infection by identification of the bacteria in a sterile environment). Exclusion Criteria: Refusal by one of the parents or by Child in understanding age Nosocomial infection - HealthyVolunteers: No - Gender: All - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Children under 18 ages, with severe communautary invasive bacterial infections, hospitalized in pediatric intensive care unit. - SamplingMethod: Non-Probability Sample

NCT06260332

Recruiting

Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors

This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors.

- EligibilityCriteria: Inclusion Criteria: Women who have completed surgery for invasive breast cancer >= 6 months prior to enrollment Any breast surgery (lumpectomy or mastectomy) Baseline low to moderate activity level (exercise less than 120 minutes a week) PBSPS defined as pain in the area of breast surgery of at least moderate intensity (>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time Self-identified as Hispanic/Latinx Age, >= 18 and =< 60 years Endocrine therapy and ovarian suppression is allowed Exclusion Criteria: Metastatic or locally recurrent disease with no option for curative intent treatment Meeting or exceeding physical activity guidelines (> 150 minutes per week of moderate-intensity exercise) Unable to speak, read, and understand English or Spanish Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors Adults not able to consent are excluded from participation Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above Pregnant women Prisoners may not participate in this study as this is a study of free-living individuals - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06260306

Recruiting

Hip Activation vs. Hip Activation + Core Stabilization

The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals. Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP. Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP. Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP. Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG.

- EligibilityCriteria: Inclusion Criteria: Participants will be current first- or second-year Doctor of Physical Therapy (DPT) students in the School of Allied Health Professions (SAHP) at Louisiana State University Health Shreveport over the age of 21. Exclusion Criteria: Current pain or pathology in either LE which currently limits their ability to perform the FSDT or drop landing task, a history of low back pain in the last three months, known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA) which may be exacerbated by participation in the intervention and could be a confounding variable, and current participation in other clinical trials. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 22 Years - StdAgeList: Adult, Older Adult

NCT06260280

Not yet recruiting

Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume

Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training.

- EligibilityCriteria: Inclusion Criteria: New resident physicians assigned to the High Specialty Medical Unit, Hospital de Especialidades No. 1 Centro Médico Nacional Del Bajío. Exclusion Criteria: - Patients who have ingested caffeine, nicotine or alcohol in the last 24 hours. Patients with sleep disorders who present a score greater than 5 in the initial assessment of the Pittsburgh Sleep Quality Index. Patients with psychiatric treatment. Patients ingesting medications that intervene in the awake state. Patients with drug abuse (marijuana, cocaine, etc.). Patients with claustrophobia. Patients with metallic implants. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 24 Years - MaximumAge: 30 Years - StdAgeList: Adult - StudyPopulation: All first-year medical residents admitted to our hospital unit who meet the inclusion criteria will be informed of the purpose of the study and, after signing the informed consent, will undergo cranial magnetic resonance imaging. - SamplingMethod: Non-Probability Sample

NCT06260267

Not yet recruiting

A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).

- EligibilityCriteria: Inclusion Criteria: Subject aged ≥18 at screening Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening Exclusion Criteria: Active disease or history of Crohn's disease Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC Active gastrointestinal infection. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260254

Recruiting

Effects of Railway Vibration on Sleep and Disease

This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes.

- EligibilityCriteria: Inclusion Criteria: 1) live in or around the city of Gothenburg area (Sweden) Exclusion Criteria: aged <18 or >30 years; habitual sleep and wake timings more than ±1 hour different from the study sleep times (i.e. habitual sleep time should be 22:00-00:00 and habitual wake time should be 06:00-08:00); BMI>25 kg/m2; regular sleep medication use (prescribed or "over-the-counter"); poor hearing acuity (measured during screening via pure tone audiometry); diagnosed with sleep disorders; diagnosed with diabetes indications of sleep apnea on the STOP-BANG questionnaire; shift work; smoking, vaping, snus, or other nicotine use; pregnant or breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06260241

Recruiting

Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children.

The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with & without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis. The main question[s] it aims to answer is: • Gain in stretched penile length after phalloplasty with and without penile traction in children.

- EligibilityCriteria: Inclusion Criteria: Infants and children aged 4 years to 13 years of age. Presenting with concealed penis for circumcision. Exclusion Criteria: Congenital Buried Penis Webbed penis Structural abnormalities of the penis such as hypospadias, Epispadias etc. Existing co-morbid syndromes or conditions Unfit for general anesthesia Known bleeding diathesis Incomplete foreskin Any previous penile surgery - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: Male - MinimumAge: 4 Years - MaximumAge: 13 Years - StdAgeList: Child

NCT06260228

Recruiting

HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's)

The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD) The main questions it aims to answer are: Can the current HOBSCOTCH program be adapted for people with PD? Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program? Participants will be asked to: attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach complete a brief clinical questionnaire about their diagnosis of PD complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program

- EligibilityCriteria: Inclusion Criteria: Age 30 - 75 years Diagnosis of Parkinson's Disease per participant's provider Literate, English-speaking with grade 12 or equivalent in education Self-reported cognitive/memory difficulties Telephone and internet access Exclusion Criteria: Cognitive dysfunction that precludes participation in giving informed consent Significant visual impairment precluding reading or writing No reliable telephone or internet access - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06260215

Recruiting

Recovery Kinetics Following a Soccer Training in Middle-aged Males

This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session [A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training.

- EligibilityCriteria: Inclusion Criteria: Free of musculoskeletal injuries No use of ergogenic supplements or medication Free of chronic diseases age of 40-60 years Exclusion Criteria: Musculoskeletal injury Use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 40 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06260202

Not yet recruiting

Nutrition Under Noninvasive Ventilation

Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes.

- EligibilityCriteria: Inclusion Criteria: Adult patients; Admission to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023; Noninvasive ventilation treatment for acute respiratory failure of any cause; Duration of noninvasive ventilation treatment of more than two days; Informed consent signed. Exclusion Criteria: Patients under 18 years of age; Duration of noninvasive ventilation treatment of less than two days. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients admitted to the Intensive Care Unit of Maggiore della Carità University Hospital from March 1st 2020 to February 28th 2023, undergoing noninvasive ventilation for any diagnosis of acute respiratory failure and for any cause (to avoid endotracheal intubation, as alternative to invasive ventilation, as weaning from invasive ventilation) will be considered. - SamplingMethod: Non-Probability Sample

NCT06260189

Recruiting

Assessment Of Serum And Tissue Levels Of Cold-Inducible RNA-Binding Protein In Patients With Lichen Planus

Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology. Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls.

- EligibilityCriteria: Inclusion Criteria: Patients from both sexes aged 18 - 60 years, having clinical and dermoscopic confirmed LP and did not receive any topical or systemic treatment in the last 3 months for LP. Exclusion Criteria: 1 . Pregnancy and lactation. 2. Patients with any infections or sepsis. 3. Patients with any other dermatological diseases associated with increased CIRP levels (eg. psoriasis, vitiligo or alopecia areata). 4. Patients with systemic illness (cardiac, renal, hepatic or respiratory), malignancy, with history of connective tissue diseases or on immunosuppressive treatment. 5. Patients who received any topical or systemic treatment for LP 3 months before the study. 6. Patients with oral, nail or scalp LP. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: 40 patients with LP and 40 age and gender matched healthy controls who will attend the Dermatology Outpatient Clinics, Sohag University Hospitals. Diagnosis of LP will be clinically and will be confirmed by dermoscopy. - SamplingMethod: Probability Sample

NCT06260163

Recruiting

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

- EligibilityCriteria: Inclusion Criteria: Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC. Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy, and a baseline Mayo rectal bleeding subscore >=1 Medically stable on the basis of physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids Exclusion Criteria: Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon Presence of a stoma Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline Have severe colitis or have evidence of Crohn's Disease (CD) - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06260124

Not yet recruiting

Acute Physiological Effects of Greek Traditional Dancing

In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order.

- EligibilityCriteria: Inclusion Criteria: Premenopausal and postmenopausal women. Abstain from vigorous physical activity and/or exercise during the last (at least) 6 months prior to the study. Free of musculoskeletal diseases and injuries. Free of cardiometabolic diseases. Free of mental health disorders No body weight loss >10% over the last 6 months prior to the study Non-smokers Exclusion Criteria: Perimenopause and menopause women Participation vigorous physical activity and/or exercise during the last (at least) 6 months prior to the study Presence of musculoskeletal diseases and injuries. Presence of cardiometabolic diseases. Presence of mental health disorders Body weight loss >10% over the last 6 months prior to the study Smokers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Healthy pre-menopausal and post-menopausal women - MinimumAge: 20 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06260111

Not yet recruiting

Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation

The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment.

- EligibilityCriteria: Inclusion Criteria: Adults over 18 years of age with hematological neoplasms who require medical indication of an HSCT according to the Transplant Committee at Clinica Dávila With sufficient understanding of Spanish. Exclusion Criteria: Observed cognitive deficit Patients who do not meet the criteria of clinical stability, progression of the disease, and that do not fulfill requirement of the National Hematopoietic Stem Cell Transplantation Program. Participants with an oral infection from any type of Candida prior to HSCT. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06260098

Recruiting

StressLess Yoga Study

The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions.

- EligibilityCriteria: Inclusion Criteria: Aged 18 years or older Self-identification as "stressed" Scoring 8 or higher on the Perceived Stress Scale (PSS) indicating moderate-to-high stress Willingness to complete the 8-week yoga intervention Willingness to attend baseline and follow-up visits Ability to read and write in English Having practiced yoga ≤ 2x in the last 6 months Exclusion Criteria: Serious or unstable psychiatric illness (e.g., psychosis, mania) Major coexisting medical illness (e.g., cancer, COPD, obesity) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260072

Recruiting

Magnesium and Riboflavin Treatment for Post-Concussion Headache

This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.

- EligibilityCriteria: Inclusion Criteria: Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion; Less than 3 days have elapsed since their injury; Able to swallow capsules Exclusion Criteria: Concussion complicated by cranial bleed, skull fracture, additional severe injury; Kidney disfunction or failure; Significant gastro-intestinal dysfunction; Varsity Athlete; Two or more previous concussions; Women who are pregnant or breast feeding; Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06260059

Not yet recruiting

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).

- EligibilityCriteria: Inclusion Criteria: Diagnoses of Congenital Heart Disease Age 18+ ACHD level of structural complexity II or III Recent (<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF < 60% Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by > 5% in the last 6 months or less. Must be able to complete neurocognitive assessments on a handheld computer. Exclusion Criteria: Diagnosed with Diabetes Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022). Previous therapy with Jardiance at <4 weeks Glomerular Filtration Rate <20 Pregnancy, breastfeeding, or planning to become pregnant in the coming year History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1) Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease, Gaucher disease, Tay-Sachs disease, Mucolipidosis IV, Niemann-Pick disease, Type A mitochondrial disease, Metabolic disorders related to glucose metabolism - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260046

Not yet recruiting

Effect of Sufentanil on the Postoperative Pain

This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery.

- EligibilityCriteria: Inclusion Criteria: Patients who undergo elective robot-assisted nephrectomy surgery American Society of Anesthesiologists grade 1,2,3 Age > 18 years old Exclusion Criteria: Refuse to participate to the study Allergic history of opioid chronic pain opioid user before surgery MAO inhibitor user Severe respiratory insufficiency - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06260033

Not yet recruiting

Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer

This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment. This trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.

- EligibilityCriteria: Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative Age: ≥ 18 years Female or male Eastern Cooperative Oncology Group (ECOG) ≤ 2 Ability to read and understand English or Spanish for questionnaires Histologically confirmed ER+ (any progesterone receptor [PR] and human epidermal growth factor receptor 2 [HER2] status is allowed) metastatic breast cancer The presence of metastatic breast cancer at the time of study entry with progression in 1-4 lesions (including new lesions). Patients that have disease progression in the breast and/or ipsilateral axilla will be considered to have only 1 site of progression even if multiple nodules/lymph nodes are present. Patients with progression in > 4 lesions are not allowed. Patients with current progression of malignant pleural effusions, malignant ascites, abdominal carcinomatosis, and/or lymphangitic pulmonary involvement are considered to have > 4 metastases (Note that patients with a history of these conditions earlier in the disease course with no evidence of progression of these conditions are eligible.) Evidence of extracranial disease progression in 1-4 discrete lesions will be defined by either of the following: Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0 criteria OR Progression of disease in at least 1 but up to 4 lesions as determined by the patient's treating oncologists such that the treating oncologist recommends changing to the next line systemic therapy. Note that a patient may not technically meet RECIST v 1.1 criteria for disease progression in this setting SBRT must be feasible for all progressing lesions. Feasibility includes but is not limited to: All progressing lesions must have distinct borders AND Progressing lesions may not be located within 3 cm of previously irradiated critical structures such as the spinal cord, brachial plexus, brainstem, stomach, and/or small/large bowel that would render the metastasis unsafe to target with SBRT per the treating radiation oncologist Patients with prior treated brain metastases that are stable are allowed. Patients must not have intracranial disease progression. Patients with prior or current leptomeningeal disease are not allowed All progressing lesions must be amenable to stereotactic body radiation therapy to a dose of 30 Gy to 40 Gy in 3 to 5 fractions per the treating radiation oncologist Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy. Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only) Exclusion Criteria: Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease Patients may not have received chemotherapy, radiation therapy, biological therapy, immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held during study therapy and can resume 7-14 days after completion of all study therapy (SBRT) at the discretion of treating physician. (Patients may continue anti-endocrine/hormone therapy before, during and after study therapy at the discretion of the treating medical oncologist.) Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer. Prior malignancies not listed require principal investigator (PI) approval Patients that have only liver metastases will not be allowed Females only: Pregnant or breastfeeding Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06260020

Not yet recruiting

Development and Validation of a Comprehensive Module for Management of Sleep Disorders in ASD Children

Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.

- EligibilityCriteria: Inclusion Criteria: Children aged 4-10 years with diagnosis of ASD and ICSD based sleep disorder At-least 6 months of behavioral therapy and follow-up at AIIMS Exclusion Criteria: Refractory epilepsy Secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis ASD with metabolic disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 10 Years - StdAgeList: Child

NCT06260007

Not yet recruiting

Efficacy and Safety Study of Products Based on Tribulus Terrestris, L. in Men With Oligospermia

Efficacy and Safety of Products Based on Tribulus terrestris, L. in Men with Oligospermia. It is expected that the benefits of investigational products outweigh the risks that will be mitigated or carefully managed by the study team.

- EligibilityCriteria: Inclusion Criteria: - Male; - Ages 25 and 60; - Diagnosis of oligospermia; - With sexual partner; - Indication of drug treatment with steroid hormones, precursors or analogues. Exclusion Criteria: - Severe oligospermia - Anatomical change - Previous treatment for oligospermia or concomitant treatment with steroid, anabolic, hormonal precursors such as testosterone or analogues; - BMI 35; - Participant who presents liver enzyme and creatinine values above the upper limit of normality; - History of testicular cancer, or prostate cancer or any other condition that carries risks in this case increased testosterone; - Hypersensitivity to any ingredient present in the formulation; - Any criteria or clinical history that, in the investigator's opinion, could compromise the well-being and participant safety; - Proven infertility of the partner; - History of genetic disorder; - History of psychiatric disorder, serious or decompensated illness or any situation that, Investigator's discretion, puts the participant's safety at risk; - Active cancer at the discretion of the Investigator; - Participants with pregnant and breastfeeding partners; - Cycling and horse riding more than 3 hours per week; - Alcoholism characterized by the inability to control alcohol consumption according to WHO "drinker excessive, whose dependence on alcohol is accompanied by mental, health and physics, relationships with others and social and economic behavior". Source: https://www.cancer.gov/publications/dictionaries/cancerterms/def/alcoholism; - Smoking greater than half a pack per day or equivalent. - HealthyVolunteers: No - Gender: Male - MinimumAge: 25 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06259994

Not yet recruiting

Dexamethasone and Pregnancy: Maternal Effects

This study will analyze obstetric, endocrine and metabolic follow-up data in women treated with DEX. It will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities. A few studies suggest problems in women treated with DEX during pregnancy. However, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. Moreover, it would appear that a third of women treated with DEX no longer wish to resume the treatment (8). Compliance with treatment is strongly linked to its efficacy. It is therefore important to start investigating the pregnancy outcomes of women treated with DEX. This project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. The results of this study will guide us in the management of women presenting an indication for prenatal DEX treatment, and will help to inform the Order of November 15, 2022.

- EligibilityCriteria: Inclusion Criteria: Femme majeure (âge ≥ 18 ans) Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS : Mutation sévère du gène CYP21A2 chez chacun des parents Fœtus féminin Grossesse unique Ayant commencé un traitement anténatal par DEX depuis au moins 24h Exclusion Criteria: Contraindication to dexamethasone treatment Objection to use of data Persons under legal protection (curatorship, guardianship), court-appointed guardians - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All women treated with dexamethasone during pregnancy at risk of Congenital Adrenal Hyperplasia - SamplingMethod: Non-Probability Sample

NCT06259981

Not yet recruiting

A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity

This study will evaluate the efficacy, safety, and tolerability of GLY-200 in participants with obesity.

- EligibilityCriteria: Inclusion Criteria: Male or female, ≥ 18 and ≤ 70 years old at the time of screening BMI ≥ 32 and ≤ 40 kg/m² at screening Exclusion Criteria: Known history of any form of diabetes mellitus, or HbA1c ≥6.5% (48 mmol/mol) Participants who have had an increase or decrease in body weight more than 5% within the last 3 months Treated with any prescription medication or procedure that promotes weight loss or weight gain in the last 6 months Use of any drug treatment that affects gastric pH Use of any drug treatment that affects gastrointestinal motility Diagnosis or treatment of any symptomatic or structural abnormality of the GI tract or active disease within 12 months Clinically significant symptoms (as determined by the Investigator) of nausea, vomiting, bloating, diarrhea, flatulence, constipation, or abdominal pain in the last 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06259968

Not yet recruiting

Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial

This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function. All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.

- EligibilityCriteria: Inclusion Criteria: - Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period. Exclusion Criteria: Failure to attend the pre-surgery assessment session; Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study; Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06259929

Not yet recruiting

NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: To evaluate the mechanisms of response and resistance to therapy; To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

- EligibilityCriteria: Inclusion Criteria: Female patients willing and able to give written informed consent; Women≥18 years of age; Postmenopausal women, as defined by at least one of the following criteria: ≥12 months of amenorrhea without an alternate medical cause plus follicle-stimulating hormone (FSH) and plasma estradiol levels within postmenopausal range by local laboratory assessment, in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone agonist or antagonist. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; Documented bilateral oophorectomy (≥ 14 days prior to first treatment on Day 1 of Cycle 1 and recovery from surgery to baseline); Patients with cT1c (≥1.0 cm)-cT4a-c BC at presentation; a-c primary tumor must be ≥ 1.0 cm in longest diameter by ultrasound; Confirmed ER+ disease by local testing on primary disease specimen: tumor must be ER ≥ 10% defined by immunohistochemistry (IHC) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing; Confirmed HER2- disease by local testing on primary disease specimen: tumor must be HER2- according to ASCO/CAP 2023 guidelines for HER2 testing; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathologic criteria for ER positivity and HER2 negativity. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy; Patients considered appropriate for endocrine therapy according to physician judgment; Ki67 score ≥10% analyzed locally and centrally confirmed. Ki67 will be analyzed locally at the time of inclusion. Patients with basal Ki67≥20% will be assessed locally and centrally confirmed retrospectively and patients with 10-19% will be assessed centrally before inclusion. Patients with breast cancer eligible for primary surgery; Eastern Cooperative Oncology Group (ECOG) performance status≤1; Adequate bone marrow and coagulation and adequate organ function defined as follows: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets count ≥100x 109/L; Haemoglobin ≥9 g/dL (90 g/L); Serum creatinine≤1.5 x upper limit of normal (ULN) or estimated creatinine clearance≥60 ml/min as calculated using the standard method for the institution; Total serum bilirubin ≤1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits could be included); AST and/or ALT ≤3 x ULN; Alkaline phosphatase ≤2.5 x ULN; Patients able to swallow oral medications. Exclusion Criteria: Patients with bilateral invasive BC; Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1_cN2a); Patients with inflammatory BC; Non post-menopausal patients; Patients having received previous systemic or local treatment for BC, in particular history of any prior treatment with aromatase inhibitors (AIs), tamoxifen, selective estrogen receptor down regulator, or cyclin-dependent kinase 4 and 6 inhibitors; Participants who have active cardiac disease or history of cardiac dysfunction, including any of the following: History (within 2 years of screening) or presence of idiopathic bradycardia or resting heart rate < 50 beats per minute at screening History of angina pectoris or symptomatic coronary heart disease within 12 months prior to randomization History of documented congestive heart failure (New York Heart Association Class III or IV) or cardiomyopathy QT interval corrected through use of Fridericia's formula >470 ms for women > 450 ms for men based on mean value of triplicate ECGs, history of long or short QT syndrome, Brugada syndrome or known history of corrected QT interval prolongation, or torsades de pointes Presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or sick sinus syndrome o Participants with first-degree heart block may be considered for inclusion following consultation with a cardiologist and determination that no additional cardiac risks are present. Participants with pacemakers to treat more severe heart blocks and other arrhythmias are permitted. Patients with history of well-controlled atrial fibrillation are eligible. History (within 12 months) or presence of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as significant structural heart disease (e.g., severe left ventricular systolic dysfunction, restrictive cardiomyopathy, hypertrophic cardiomyopathy, infiltrative cardiomyopathy, moderate-to-severe valve disease), or family history of long QT syndrome) o Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia) should be corrected prior to enrollment. Patients with known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis; Patients with history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ and other malignancy within 5 years prior to screening; Patients with documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism; Patients on concurrent treatment with exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate); Patients with active systemic bacterial infection (requiring intravenous antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C [for example, hepatitis B surface antigen positive]; Patients with serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study, e.g. interstitial lung disease (ILD), severe dyspnoea at rest requiring oxygen therapy, severe renal impairment (i.e. estimated creatinine clearance <30 ml/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea); Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients; Patients with history of non-compliance to medical regimens; Patients refusing to perform liquid and tissue biopsy; Patients unwilling to or unable to comply with the protocol; Patients having had major surgery within 14 days prior to screening; Pregnant or lactating females prior to treatment; Patients having received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to initiation of study treatment, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study; Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259916

Recruiting

Distinguishing Alcohol Intoxication, Cannabis Intoxication and Co-intoxication Using Electroencephalography (EEG)

This is a randomized, parallel-group study designed to explore the differences between cannabis intoxication, alcohol intoxication and co-intoxication involving both alcohol and cannabis, utilizing electroencephalography (EEG) as well as more traditional intoxication measures such as breath alcohol concentration and balance metrics. If eligible for the study, participants will be randomized to complete one study session in our mobile laboratory, during which they will use either alcohol, cannabis (which will be self-administered, ad libitum) or both alcohol and cannabis.

- EligibilityCriteria: Inclusion Criteria: 21-50 years old Heavy drinkers (consuming more than 4 drinks/day or more than 14 drinks/week for men, or more than 3 drinks/day or more than 7 drinks/week for women) Regular users of legal-market flower cannabis (at least 2x/week in past 3 months) report simultaneously using alcohol and legal-market flower cannabis at least once per month in the past 3 months English speakers. Exclusion Criteria: Daily tobacco users Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD) Females cannot be pregnant, breastfeeding or trying to become pregnant Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders, 5) Current use of psychotropic (except anti-depressants) Report illicit drug use in past 60-days or fail drug screen on the day of the study appointment Major medical condition contraindicating alcohol and/or cannabis consumption. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06259903

Not yet recruiting

Subcutaneous Administration of MD-18 in Healthy Subjects

A Single Center, Single Dose, Double-blind, Randomized, Placebo-controlled Dose-Escalating Study to Evaluate Safety, Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects.

- EligibilityCriteria: Inclusion Criteria: Subjects aged 18-70 years, both genders. Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following: Absence of clinically significant illness or surgery within the preceding 12 weeks. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease. Male subjects with female partners of childbearing potential must agree to utilize an approved contraceptive during the study. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use contraception during the study. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal). Body mass index (BMI) of 18.5-39.9 kg/m2 Exclusion Criteria: History of excessive alcohol use (defined as >21 drinks per week for males and >14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. Note: use of Cannabinoids for medical purposes is allowed. Pregnant or breastfeeding within six months of screening assessment. Substantial changes in eating habits or exercise routine within the preceding three months. Evidence of eating disorders. >5% weight change in the past three months. Bariatric surgery within the past five years. Significant renal impairment glomerular filtration rate (GFR) <60 milligram/milliliter/1.73m2). Liver function tests (i.e., alanine aminotransferase, Aspartate Amino Transferase, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression). Use of drugs approved for the treatment of obesity. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. A baseline prolongation of ventricular activation and recovery interval after repeated measurements of >450 millisecond; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS). Participation in an investigational drug trial within three months prior to dosing in the present study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06259890

Recruiting

Influence of Sodium Intake in spondyLoarthriTes

The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.

- EligibilityCriteria: Inclusion Criteria: patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) Exclusion Criteria: catient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists. current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old. patients on systemic corticosteroids with corticosteroid therapy > 10 mg prednisone equivalent pregnant woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06259877

Recruiting

Relationship Between Respiratory Muscle Strength, Balance, Trunk Control, Functional Capacity in Stroke Patients

The purpose of this study; To determine the relationship between respiratory muscle strength, balance, trunk control, functional capacity and motor functions in stroke patients and compare them with healthy individuals.

- EligibilityCriteria: Inclusion Criteria: Stroke individuals over the age of 18 Exclusion Criteria: Patients with another neurological problem (Parkinson, Multiple sclerosis, etc.) that will affect functionality and balance other than stroke Patients with orthopedic problems (short limbs, spine and lower extremity surgery) with pulmonary disease Patients with cooperation and communication problems - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Stroke individuals over the age of 18 and healthy individuals who are followed up with a diagnosis of ischemic or hemorrhagic stroke and who apply to Kırıkkale University Faculty of Medicine Physical Medicine and Rehabilitation clinic will be included in our study. Socio-demographic characteristics of all individuals (age, height, body weight, body mass index, exercise and smoking habits, dominant side, lesion side, stroke type and onset, comorbid conditions, fall history, etc.) will be recorded. - SamplingMethod: Probability Sample

NCT06259864

Recruiting

Effects of Mollii Suit in Children With Non-Ambule Cerebral Palsy

The aim of our study is to examine the effectiveness of the Mollii Suit application on gross motor function, spasticity, postural control, upper extremity skills, selective motor control, daily living activities, quality of life, pain, sleep, constipation and drooling problems in non-ambulatory individuals with cerebral palsy (CP).

- EligibilityCriteria: Inclusion Criteria: GMFCS 4 or 5 with spastic cerebral palsy children Volunteering to participate in the study Exclusion Criteria: Botulinum toxinA injection in the last 3 months Surgical intervention involving the musculoskeletal system in the last 6 months Having an invasive medical pump (baclofen, insulin, etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06259851

Recruiting

rTMS-enhanced Psychotherapy for Borderline Personality Disorder

This project assesses the effectiveness and lasting impact of combining Dialectical Behavioral Therapy (DBT) with prefrontal repetitive transcranial magnetic stimulation (rTMS) in patients with borderline personality disorder.

- EligibilityCriteria: Inclusion Criteria: diagnosis of borderline personality disorder according to Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria (rated by Structured Clinical Interview for DSM-5 for Personality Disorders, BPD section) minimum age 16, informed consent of the patient informed consent of patient's legal representative in case of patients under age 18 Exclusion Criteria: neurological disorder comorbid affective disorder or schizophrenia-related disorder intelligence quotient<70 contraindications for MRI measurement contraindication for rTMS treatment pregnancy - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: cisgender female - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult

NCT06259825

Not yet recruiting

Omega-3-Index Response to Eating Poultry Foods Naturally Enriched With Omega-3 Polyunsaturated Fatty Acids

Diets low in seafood omega-3 polyunsaturated fatty acids (PUFAs) are very prevalent. Such diets have recently been ranked as the sixth most important dietary risk factor-1.5 million deaths and 33 million disability-adjusted life-years worldwide are attributable to this deficiency. Wild oily fish stocks are insufficient to feed the world's population, and levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in farmed fish have more than halved in the last 20 years. The primary objective of this randomised, double-blinded, controlled nutritional trial will be to test if consumption of at least 4 servings of omega-3 PUFA-enriched chicken-meat and 4 enriched eggs per week, over a 4-month period, results in measurably higher blood levels of EPA and DHA in healthy Saudi adults. This will be a randomised double-blind interventional study. Eighty adult male and female participants (age ≥ 18 years of age) will be asked to eat at least 4 portions of omega-3-PUFA enriched (or control) chicken-meat per week, and at least 4 omega-3-PUFA enriched (or control) eggs per week, for 4 months. Participants will be assessed at baseline and at monthly intervals for 4 months. Assessments at these visits will include; comprehensive lifestyle and medical history; food frequency questionnaire; 3 days food record; height, weight, waist and hip circumferences; blood sampling; participant well-being and adverse events. Measurement of plasma and red blood cell levels of EPA, DHA and Docosapentaenoic acid (DPA) will be performed at baseline and at study end using gas chromatography-mass spectroscopy. The primary end point will be the change in red blood cell omega-3-index (sum of EPA and DHA expressed as percentage of total fatty acids in erythrocyte membranes) at 4 months. The nutritional trial will be analyzed on an intension to treat basis. Repeated measures ANOVA will be used to compare the two study groups. The study will be reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 statement.

- EligibilityCriteria: Inclusion Criteria: Adults (≥ 18 years and < 70 years) Regular consumers (≥ 4 portions weekly) or willing to be regular consumers of chicken-meat. Regular consumers (≥ 4 eggs weekly) or willing to be regular consumers of eggs. Able to give informed consent. Exclusion Criteria: Concurrent or recent (within last 3 months) regular intake of long-chain omega-3-PUFA supplements (containing EPA, DPA and/or DHA). Previous diagnosis of; significant cardiovascular disease (e.g. myocardial infarction, coronary intervention, or stroke), significant mental ill-health (e.g. major depression, psychosis or dementia) or a haemoglobinopathy such as sickle cell anaemia or thalassemia . Any other serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06259812

Not yet recruiting

Machine Learning Prediction of Parameters of Early Warning Scores in Intensive Care Units

A large number of different organ functions are recorded in real time for patients being monitored in an intensive care unit. On the one hand, the measured values collected are used for continuous monitoring of vital parameters, e.g. blood pressure, heart rate and respiratory rate, but are also evaluated several times a day in conjunction with other data as part of ward rounds. In both cases, continuous monitoring from a limited number of parameters, but also in the distinct evaluation with a more extensive set of analyzable parameters, there are limitations in the evaluability even with all the care and expertise available: In continuous analysis, interpretation is limited by the restricted number of continuously recorded parameters described above. Although a large number of such measurements are possible, and at least theoretically a larger number of parameters could be measured, patient-specific limits such as patient cooperation, medical limits such as the significance of the measured values in specific situations, but also economic limits are often decisive in this context. Although accurate conclusions can be drawn from the continuous and therefore complete representation of aspects of human physiology, the limitation of the available parameters reduces the interpretability of the synthesis of different statuses. In the broader, more comprehensive assessments during visits at specific points in time, on the other hand, there are limitations due to, among other things, point recordings of individual measured values and the predefined visit times. Even if limit values are (or can be) defined for the measured data, and a consequence, e.g. a therapy step, is initiated if these values are exceeded or not reached, this alert can only be initiated retrospectively if these values are exceeded and a consequence can only be initiated retrospectively. In this situation, a pathophysiological change is already so far advanced that in many cases a compensation mechanism no longer functions adequately and turns into a decompensation situation. In this situation, the patients affected in an intensive care unit are in many cases in mortal danger. Both situations, continuous recording of a limited number of parameters and the evaluation of extensive data in the form of a snapshot could be optimized despite the limitations mentioned. Without changing the collection of data (time, scope, etc.), the possibilities for optimizing their interpretation and the consequences that can be derived from the interpretation remain. The interpretation of the data is primarily determined by the interpreters as the method of interpretation. Current approaches attempt to use machine learning (ML) methods to predict individual situations that recognize adverse events in the given data and at the same time allow alarms to be triggered pre-emptively, i.e. before a life-threatening situation occurs. Furthermore, there are already studies on the change of early warning scores in time series, which are, however, limited in their informative value for longer prediction periods.

- EligibilityCriteria: Inclusion Criteria: Treated in intensive care between 2010-01-01 and 2023-12-31 at the study center. Exclusion Criteria: None. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated in intensive care. - SamplingMethod: Non-Probability Sample

NCT06259799

Not yet recruiting

Efficacy of a Smart Water Bottle Intervention to Increase Fluid Consumption in College Students

Approximately 60% of males and 40% of females do not meet current fluid intake recommendations, which is associated with adverse health consequences such as obesity, diabetes, and chronic kidney disease. Newer technologies have been designed to promote fluid intake. "Smart Water Bottles" use mHealth technology to capture fluid intake behaviors automatically and provide cues to encourage fluid consumption. Studies using Smart Water Bottles have helped some individuals increase fluid intake to help reduce kidney stone formation. However, limited research has assessed the efficacy of this technology on improving fluid intake in college students. College is a time with the potential to form healthy habits that carry into adulthood. Previous work has also identified daily changes in morning urine color, thirst perception, and body mass, as simple, inexpensive indicators of daily fluctuations in water balance. Tracking changes in these metrics has the potential to provide participants with evidence of adequate or inadequate fluid consumption. Thus, the combination of prompting from a smart water bottle, as well as daily self-monitoring changes in hydration status, may encourage college students to increase daily fluid consumption.

- EligibilityCriteria: Inclusion Criteria: Participants must report currently drinking less than the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (<2.5 L per day for males; <2.0 L per day for females). Has access to a cell phone which can download the app associated with the Smart Water Bottle. Exclusion Criteria: Currently trying to gain or lose weight Have had surgery of the digestive tract Currently taking diuretics (e.g., Thiazide, Loop diuretics or potassium-sparing diuretics) Currently taking centrally-acting medications (e.g., anesthetics, anticonvulsants, central nervous system stimulants/amphetamines, muscle relaxants) Report currently consuming at least the European Food Safety Authority Recommendations for fluid, as determined by an online pre-screening survey (>= 2.5 L per day for males, >=2.0 L per day for females). Currently pregnant (females) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06259786

Recruiting

Investigation of Adolescents With Nocturnal Bruxism

The aim of this study is to examine the effects of bruxism on mandibular movement capacity, cervical proprioception, posture and quality of life in adolescents diagnosed with nocturnal bruxism (clenching and grinding teeth while sleeping) between the ages of 13-18 and to compare them with healthy adolescents. Method: A total of 40 adolescents, 20 with nocturnal bruxism and 20 healthy, will be included in the study. Mandibular movement capacity will be evaluated with a caliper and ruler, cervical proprioception with a CROM device, posture with the New York Posture Scale, and quality of life with the PedsQL 13-18 age scale. Hypotheses: H1: Nocturnal bruxism reduces the movement capacity of the mandible in adolescents. H2: Nocturnal bruxism reduces cervical proprioception in adolescents. H3: Posture disorder increases in adolescents with nocturnal bruxism. H4: Nocturnal bruxism affects the level of daily life quality in adolescents.

- EligibilityCriteria: Inclusion Criteria: Being diagnosed with nocturnal bruxism, Having received parental consent to participate in the study, Being between the ages of 13 and 18 (including 13,18 years old) Being in good mental state, Being able to understand and follow the locations in the work, Having a Class 1 occlusion. Exclusion Criteria: Not consenting to participate in the study and withdrawing from the study, Not being able to cooperate well, Having a history of surgery, Having any physical disability or chronic disease, Having received dental treatment in the last six months, - HealthyVolunteers: No - Gender: All - MinimumAge: 13 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: 20 patients with Nocturnal Bruxism and 20 non-Nocturnal Bruxism Adolescence will be included. - SamplingMethod: Non-Probability Sample

NCT06259773

Recruiting

The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury

Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements. Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee. Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.

- EligibilityCriteria: Inclusion Criteria: Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital. Exclusion Criteria: Unable receing MRI exam, any op history of knee or fracture history on the impaired knee. - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Over 20 years old, suspected ligament damage caused by knee contusion - SamplingMethod: Non-Probability Sample

NCT06259760

Recruiting

AKI Risk Factors Analysis After Intentional Hypotensive Anesthesia

This project investigates intentionally hypotensive management such as NTG (nitroglycerin) or NTG+Trandate during general anesthesia in patients undergoing orthognathic surgery. Throughout the entire surgical procedure, blood biochemical and urine monitoring will be conducted. Serum creatinine (Cr) levels, urine analysis, and perioperative monitoring will be utilized as indicators for assessing renal function during the surgery. The objective is to assess its potential renal injury and identify early risk factors for acute kidney injury (AKI). Timely recognition of these factors will allow for the implementation of appropriate intervention strategies, aiding in the prevention of postoperative acute kidney injury. This approach contributes to achieving the goals of Enhanced Recovery After Surgery (ERAS) for surgical patients, promoting faster postoperative recovery.

- EligibilityCriteria: Inclusion Criteria: America society anesthesiologist classification class I to II patients undergoing oro-maxillo-facial surgery unlimited mouth opening Exclusion Criteria: patients with arthritis with limited mouth opening persistent liver dysfunction chronic renal insufficiency body mass index ≧35 kg/m2. past history of malignant hyperthermia or personal or family history diabetes with insulin treatment essential hypertension without controlled - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected. - SamplingMethod: Non-Probability Sample

NCT06259734

Not yet recruiting

Transfusion Camp for Medical Students in Rwanda

Transfusion medicine is closely linked with safe surgery. Transfusion Camp is a multidisciplinary educational project aimed at improving transfusion medicine knowledge in physicians. The course has been piloted in Rwanda, showing improvement in participant knowledge and confidence, resulting in its recommended implementation into the medical school curriculum. This project aims to evaluate a multi-day Transfusion Camp course mandatory for graduating medical students and first-year interns practicing in district hospitals in Rwanda. Its implementation is evaluated through pre- and post-course testing, collecting participants' blood ordering practices following the course, and conducting participant interviews about barriers to safe transfusion medicine in their hospital.

- EligibilityCriteria: Inclusion Criteria: Final year graduating University of Rwanda medical students about to enter their internship year at district hospitals in Rwanda and new interns currently in their first year of their internship at district hospitals in Rwanda. Exclusion Criteria: N/A - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06259721

Recruiting

Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.

- EligibilityCriteria: Inclusion Criteria: Histologically or cytologically confirmed with recurrent or metastatic nasopharyngeal carcinoma which is not amenable to curative treatment with surgery and/or radiation therapy. If the patient refuses biopsy of metastatic lesions, those diagnosed with metastasis based on imaging evidence and clinical evidence can be enrolled. Have failed for first-line platinum-based chemotherapy. Previously received first-line platinum-based chemotherapy for recurrent or metastatic disease and had disease progression during or after treatment; or recurrence and metastases within 6 months after treatment of platinum-based chemoradiation. Age ≥ 18 years and ≤ 75 years, both genders. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 The life expectancy of at least 3 months. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria. Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment) as determined by: Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L; Hemoglobin ≥ 9 g/dL; serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN), (for subjects with liver metastases, TBIL ≤3×ULN; ALT and AST≤5×ULN); Creatinine ≤1.5×ULN or creatinine clearance rate≥50 ml/min (Cockcroft-Gault formula); serum albumin ≥28 g/L; Thyroid-stimulating hormone (TSH) levels ≤1×ULN (however, patients with free Triiodothyronine [FT3] or free Thyroxine [FT4] levels ≤1× ULN may be enrolled); INR, APTT≤1.5 x ULN. All women with fertility potential must undergo a urine or serum pregnancy test during screening and the results are negative. Written informed consent. Exclusion Criteria: 1. Those with a history of severe immediate allergy to any drugs used in this study; 2. Patients who have previously received anti-EGFR monoclonal antibodies (nitolizumab, cetuximab) and anti-PD-1 monoclonal antibodies. 3. Combined with other malignant tumors; 4. Any of the following conditions exist within 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Paroxysmal or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50% must be treated with an optimized and stable medical regimen as determined by the treating physician, who may consult a cardiologist if appropriate; 5. Patients who have received any of the following treatments: (1) Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time; (2) Use of large amounts of glucocorticoids or other immunosuppressants (including but not limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide and anti-tumor necrosis factor within 4 weeks before treatment (drugs against TNF), or subjects who require hormonal therapy during clinical trials. Other special circumstances need to be communicated with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses >10 mg/day prednisone therapeutic dose are allowed; (4) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of the study drug; (5) Have undergone major surgery or serious trauma within 4 weeks before using the study drug for the first time; (6) Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 6. Patients with active autoimmune diseases or a history of autoimmune diseases that may relapse Note: Patients with the following diseases are not excluded and can enter further screening: Controlled type 1 diabetes Hypothyroidism (if it can be controlled with hormone replacement therapy alone) Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, alopecia) Any other disease that is not expected to recur in the absence of external triggers 7. Active infections, including tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA <1000 copies/mL are eligible to participate in this study; patients with positive HCV antibody test results can only participate if the HCV RNA polymerase chain reaction test result is negative. Selected for this study; 8. History of idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (bronchiolitis obliterans), idiopathic pneumonia or evidence of active pneumonia on chest CT scan during screening; 9. No capacity for civil conduct or limited capacity for civil conduct; 10. Drug abuse or alcohol addiction, the patient has physical or mental illness, and the researcher believes that the patient cannot fully or fully understand the possible complications of this study; 11. Other serious acute or chronic medical conditions that may increase the risks related to the treatment of the research protocol, or may interfere with the interpretation of the research results and (according to the investigator's judgment) may make the patient unfit to participate in this study (including immune colitis, inflammatory colitis, Enteropathy, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including dementia and epilepsy, suicidal ideation or behavior recently, within the past year, or active) or abnormal laboratory tests; 12. Previously diagnosed with immunodeficiency or known diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 13. Pregnant or lactating female patients, male or female patients with childbearing potential but unwilling or unable to use contraception during the entire study period and for at least 1 year after the end of the treatment plan; 14. Those with recurrent nasopharyngeal carcinoma are suitable for surgical treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06259708

Not yet recruiting

Using Low Intensity Focused Ultrasound to Modulate Deep Brain Areas for Tremor Control in Parkinson's Disease Patients.

Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). They noticed that ET patients initially responded better to the treatment than PD patients, but by the end of the treatment, both groups showed similar improvement. The study also suggested that targeting a specific area of the brain called the Zona Incerta (ZI) may be more beneficial for PD patients. Based on these findings, the investigators plan to use low-intensity focused ultrasound to directly modulate the ZI area and investigate the mechanisms of reduced tremors in PD patients. The investigators will also compare the effectiveness of this approach with the current target, the ventral intermediate nucleus (Vim) of the thalamus. The investigators will use a simulation model to determine the best ultrasound parameters for this new approach and will also examine the impact of the treatment on the brain's network activity using functional Magnetic Resonance Imaging. Success of this project may lay the foundation for finding a more effective target for MRgFUS treatment of PD tremor.

- EligibilityCriteria: Inclusion Criteria: Confirmed diagnosis of Parkinson's disease Resting tremor score (MDS-UPDRS III 3.17 Rest Tremore Amplitude (RUE or LUE)) ≥ 2 Between the ages of 40-80 years Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state Patients who are willing to have a partial (~8 cm diameter circular area above the ear) hair shaving. Exclusion Criteria: Atypical Parkinsonism History of essential tremor Dementia preventing informed consent Change in Parkinson's medication with the last 2 weeks Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes) Concurrent treatment for PD with Duodopa Concurrent treatment for PD with deep brain stimulation (DBS) Thickness of the temporal bone < 7 mm Individuals should also not participate if they have any of the following contraindications for undergoing fMRI scanning: Cardiac pacemaker, wires, or defibrillator Metal in eye or orbit, including the history of any eye injury involving metal fragments and increased risk due to (history of) working as a metal worker (grinding, machining, or welding) Ferromagnetic aneurysm clip Possibility of pregnancy Artificial heart valve Ear or eye implant, including cochlear implant Brain aneurysm clip Implanted drug infusion pump Electrical stimulator to nerves or bones Coil, catheter, or filter in any blood vessel Orthopedic hardware (artificial joint, plate, screw, rod) Other metallic prostheses Shrapnel, bullets, or other metal fragments Surgery, piercings or tattoos (including tattooed eyeliner) in the last six weeks Medication releasing skin patches (i.e. nicotine, birth control, nitroglycerine) History of claustrophobia - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06259682

Not yet recruiting

A Mixed-method Pilot Investigation of Paradoxical Intention for Insomnia.

The investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. Previous research has tested this technique for insomnia and found overall positive results. However, during the last decades very few studies have examined paradoxical intention. Therefore the investigators wish to conduct a pilot study examining the effects in a modern context.

- EligibilityCriteria: Inclusion Criteria: Undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion. Screening resulting in diagnosis of insomnia, including co-morbid insomnia. Participant should fulfill the following DSM-5 criteria. (1)Difficulty in sleep Initiation, maintenance, or early morning awakening. (2)Frequency and duration of at least three nights per week and has been present for at least three months.(3) Problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) The sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. Age above 18 and Swedish resident and language proficient. Exclusion Criteria: Excludes candidates with bipolar or psychotic disorders. Suicidal intentions or actions is an exclusion criteria and the applicant will be referred to appropriate services.. Reports of current substance abuse Recent changes in psychopharmacotherapy within the last three months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06259669

Recruiting

Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

- EligibilityCriteria: Inclusion Criteria: Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD. Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent. Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome). Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort. Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period. Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up. Permission to contact the participant's and her infant's HCPs. Exclusion Criteria: If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study. Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 15 Years - MaximumAge: 50 Years - StdAgeList: Child, Adult - StudyPopulation: Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period. - SamplingMethod: Non-Probability Sample

NCT06259656

Recruiting

Correlation of Antibody Response to COVID-19 Vaccination in Pregnant Woman and Transplacental Passage Into Cord Blood.

The goal of this study is to study the correlation of maternal and cord blood level of Anti SAR-CoV.

- EligibilityCriteria: Inclusion Criteria: Thai term pregnant women 18-45 year old At least 1 covid vaccination received admission at Vachira Phuket Hospital Labor Room Exclusion Criteria: Do not want to participate Unstable or Emergency condition - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06259643

Recruiting

Effects of Power Wheelchair Soccer for Individuals Presenting With Physical Impairments

This study is a prospective interventional study. It will be conducted at a single center with participants who have neuromotor impairments. The primary objective is to assess and measure the clinical and psychosocial effects of a season of power wheelchair soccer among its participants presenting with severe motor impairments due to neuromuscular lesion. A maximum of twenty participants will be recruited and included in the same group. Data collection will be performed before, during, and after the wheelchair soccer season. The study will span the entire season, starting in November 2023 and ending in June 2024. Clinical and psychosocial assessments will be conducted every 3 months. Each assessment session will last 2 hours per participant. Before and after the wheelchair soccer season matches, we will evaluate parameters related to the physical load of the sport. These evaluations will last 10 minutes per participant.

- EligibilityCriteria: Inclusion Criteria: Being a male or female between the ages of 12 and 50. Presenting with severe motor impairments due to neuromotor and/or musculoskeletal impairment. Using a power wheelchair in everyday life. Being part of a power wheelchair soccer team. Committing to participating in the 2023-2024 season of their sport within the team. Exclusion Criteria: Practicing another adaptive sport outside of power wheelchair soccer in a regular way (once a week or more). Occasionally practicing power wheelchair soccer (twice a month or less). Presenting with severe cognitive impairments affecting understanding of instructions on how to answer questionnaires and undertake tests. Presenting with contraindications towards the practice of an adaptive sport such as power wheelchair soccer. Participating in another study at baseline. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 50 Years - StdAgeList: Child, Adult

NCT06259617

Recruiting

The Munich Cardiovascular Adaptation in Young Athletes Plus Study

The aim of the 3-year longitudinal study is to investigate the cardiovascular system's response to training loads in young athletes. For the first time, these parameters will be examined alongside biochemical and metabolic laboratory measures, as well as body composition. The study focuses on the impact of training frequency and intensity, as well as performance, on cardiovascular structure and function. The following research questions are being investigated: What structural and functional cardiovascular changes can be observed in young athletes compared to the norm? What is the relationship between cardiac and vascular parameters depending on the athletic load (training frequency and intensity) as well as athletic performance? Do cardiac/vascular parameters change over the course of the study, and what role do athletic load (training frequency and intensity) as well as athletic performance play? What laboratory chemical changes can be observed in young athletes depending on the athletic load (training frequency and intensity) as well as athletic performance? What connections exist between laboratory chemical parameters and cardiac and vascular parameters in young athletes? Is there a correlation between structural and functional cardiovascular changes and body composition as well as eating behavior?

- EligibilityCriteria: Inclusion Criteria: Participants aged ≥7 and <18 years, presenting for sports medical examination and meeting the criteria mentioned for a period of 3 years Athletes participating in competitions, engaging in regular training in a primary sport, being members of a club or association, and training ≥3 hours per week The last intensive training must have occurred 12 hours ago to ensure sufficient recovery No acute infection, confirmed by a medical examination on the day of testing No orthopedic injury, confirmed by a medical examination on the day of testing No chronic disease, confirmed by a medical examination on the day of testing Clearance for cardiopulmonary stress testing after a medical examination on the day of testing Annual participation (1 time per year) in the sports medical examination for 3 years Maintaining regular training, training duration ≥3 hours per week, and participation in competitions Exclusion Criteria: Presence of an acute infection, acute orthopedic injury, or chronic disease Missing consent from the participant and/or legal guardian - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Participants aged ≥7 and <18 years, which are participating in athletic competitions, engage in regular training in a primary sport and are members of a club and/or association, with a training load of ≥3 hours per week The participants are recruited at the Pediatric Sports Medicine Outpatient Clinic at the Chair of Preventive Pediatrics. Children and adolescents voluntarily present themselves for sports fitness examinations, either for their competitive activities or as a requirement. These include young athletes who have been examined in previous years or those undergoing a sports fitness examination for the first time. - SamplingMethod: Non-Probability Sample

NCT06259604

Not yet recruiting

Preterm Infant Oral Motor Intervention (PIOMI)

The purpose of this research; The aim of this study is to examine the effects of oral motor intervention (PIOMI) and combined kangaroo care applied to preterm babies on weight gain, oral feeding skills, transition to full oral feeding and discharge time.

- EligibilityCriteria: Inclusion Criteria: Gestational age at birth is 28-32 weeks, depending on the mother's last menstrual period, 29-32. can be administered PIOMI per week and can tolerate the transition to oral feeding, Able to tolerate the transition to oral feeding according to the cue-based feeding model, Maintains physiological stabilization (heart rate, oxygen saturation, respiratory rate) during the procedure when oxygen support is provided with room air or nasal cannula or hood. Apgar score of 4 or higher at the 5th minute after birth Not receiving mechanical ventilator support or 48 hours after weaning from mechanical ventilator support Babies with written and verbal permission from their parents will be included in the research. Exclusion Criteria: Those with congenital anomalies (cleft lip, cleft palate, gastroschisis, omphalocele, short bowel syndrome and other anomalies) According to the criteria of Jobe and Bancalari (2001), patients with severe bronchopulmonary dysplasia and patent ductus arteriosus (PDA) requiring surgical treatment Babies with gastrointestinal, neurological and genetic diseases (necrotizing enterocolitis, level 3 and 4 intracranial hemorrhage, periventricular 25 leukomalacia, hydrocephalus, down syndrome) will not be included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 29 Weeks - MaximumAge: 32 Weeks - StdAgeList: Child

NCT06259591

Recruiting

Pedometer Coaching to Promote Postoperative Ambulation

The goal of this randomized controlled trial is to evaluate whether remote pedometer follow-up and virtual coaching can improve ambulation after major abdominopelvic surgery, and how this affects key postoperative outcomes. The main questions it aims to answer are: Does pedometer-guided ambulation coaching increases ambulation after surgery? Does pedometer-guided coaching improve satisfaction, quality of recovery, while reducing postoperative complications? Participants will be asked to install a pedometer app for the purpose of data sharing. Study personnel will compare pedometer follow-up plus text message coaching (intervention) with pedometer follow-up only (control) to investigate whether coaching improves adherence to the postoperative ambulation recommendation, and whether this leads to improvement of the secondary outcomes.

- EligibilityCriteria: Inclusion Criteria: Adult subjects ≥18 years at screening Subjects undergoing major abdominopelvic surgery under general anesthesia, expected to last more than 3 hours from induction of anesthesia to anesthesia stop time. Able to understand the study procedures and voluntarily provide study informed consent Agree to be followed up for the duration of the study period Has access to a smart phone with app compatibility Planned inpatient stay for 1 night or more Exclusion Criteria: Subjects undergoing liver surgery or upper gastrointestinal surgery Refusal to install the app/ deleted app before end of the monitor period Subjects who are unable to walk at baseline Medical contraindications for unrestricted ambulation Patients with spinal or lower limb pathology, chronic or poorly controlled pain potentially preventing full postoperative ambulation Neurological impairment precluding unrestricted ambulation Cognitive impairment precluding consent or follow up study activities BMI >40 Patients who require any mobility aid at baseline Subjects discharged to a rehab facility or never discharged from the hospital alive Hospital length of stay > 1 week Patient not cleared by physical therapy for unrestricted ambulation on discharge - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259578

Recruiting

UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study)

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

- EligibilityCriteria: Inclusion Criteria: Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. Subjects already received 2 (two) doses of INAVAC vaccines (5 ug), mostly during the phase I/II/III clinical trial of this vaccine. The interval between the second primary injection and the booster is 12-18 months. Subjects have been informed properly regarding the study and signed the informed consent form Subjects will commit to comply with the instructions of the investigator and the schedule of the trial Female subjects of childbearing potential must agree to postpone pregnancy from at least 21 days before enrollment and through 6 months after the vaccination. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine. Participants must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study. Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrently or within 7 days before study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Any autoimmune or immunodeficiency disease/condition Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products, long-term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroids will be permitted. Inhaled glucocorticoids are prohibited. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, and diabetes requiring the use of medicine. The final decision regarding this condition will be made by the attending field clinicians or investigators. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives Individuals who previously received any vaccines against Covid-19, other than INAVAC. Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the booster dose Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of this study, or in close contact in the last 14 days with a confirmed case of Covid-19. Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination. Testing may be repeated during the screening period if exposure to a positive confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator. History of alcohol or substance abuse HIV patients. Malignancy patients within 3 years before study vaccination. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision. Women who are pregnant or who plan to become pregnant during the study. Participant has a major psychiatric problem or illness Participant cannot communicate reliably with the investigator Participant has contraindications to intramuscular injection and blood draws, such as bleeding disorders or phobia. The participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time the participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results Study team members. Subject planning to move from the study area before the end of the study period. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259565

Not yet recruiting

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years Patient receiving any NIV modality for acute respiratory failure of any etiology Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department Presence of one or more of the following after optimized NIV treatment (Appendix 1 Table 1): Agitation (Defined as a Richmond Agitation and Sedation Scale [RASS] score of ≥+2 or a Riker Sedation-Agitation Scale [SAS] score of ≥5) (Appendix 1 Table 2 and Table 3) Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded) Exclusion Criteria: Bradycardia defined as: a-Persistent bradycardia defined as a heart rate (HR) ≤60bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome Persistent hypotension, defined as a mean arterial pressure (MAP) ≤65mmHg despite volume resuscitation and vasopressors Acute hepatic failure Imminent need for endotracheal intubation Death is deemed imminent and inevitable Patients already on dexmedetomidine at time of enrolment Known allergy to dexmedetomidine Current pregnancy (should not breastfeed until 24 hours from discontinuation of medication) Treating physician refuses enrolment (reasons for refusal will be captured) Previously enrolled in the inDEX trial - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259552

Not yet recruiting

A Study of SPX-303, a Bispecific Antibody Targeting LILRB2 and PD-L1 in Patients With Solid Tumors

Part 1 of this study is an open-label, dose-escalation, and safety expansion study of an anti-LILRB2 / anti-PD-L1 bispecific antibody SPX- 303 in patients with solid tumors. Part 2 of this study is an indication-specific dose expansion study of SPX-303.

- EligibilityCriteria: Inclusion Criteria: Males and females ≥18 years of age who comprehend, are not incarcerated, are willing and able to provide consent by signing an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including other requirements for the study Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy Patients who have progressed on or after prior therapy and who are not eligible for available treatment options Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Has at least 1 measurable lesion per RECIST 1.1 criteria Recovery from previous treatment related adverse events (TRAEs) to allow safety evaluations of SPX-303. Previous TRAEs include adverse drug reactions, and consequences of radiation, surgery, and other therapeutic modalities Adequate hepatic function; bilirubin ≤1.5x upper limit of normal (ULN) (except for patients with Gilbert syndrome: ≤ 3xULN), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN (≤5 x ULN if liver metastases present). Adequate renal function as calculated (e.g. Cockroft Gault) creatine clearance (CrCl) ≥ 30 mL/min or 24-hour urine CrCl ≥ 30 mL/min. Adequate hematological function: absolute neutrophil count (ANC) ≥1 x 10^9/L; platelets ≥75 x 10^9/L, hemoglobin ≥9 g/dL. Patients with well controlled HIV infection (ie CD4+ count >350 cells/uL and viral copies less than 400/mL after at least 4 weeks of ART) are eligible for the trial. Adequate coagulation function: INR, PT and aPPT ≤ 1.5x ULN except for patients on anti-coagulation as long as PT, aPPT, or INR are within intended range. Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 45% by multi-gated acquisition (MUGA) or echocardiography (ECHO) scan. Fridericia-corrected QT interval (QTcF) ≤480 msec. Women of childbearing potential must have a negative pregnancy test and must agree to use of 2 different methods of acceptable contraception from screening until 4 months after the last dose of study drug. Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, hormonal contraception in combination with a barrier method or abstinence). Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy >6 months before signing the ICF. Exclusion Criteria: History of prior malignancy, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease free for at least 3 years. Prostate cancer patients on active surveillance are eligible. Active brain or leptomeningeal metastasis. Except patients with known brain metastases if they have been treated and MRI shows no evidence of progression for at least 8 weeks and require less than 10 mg/day prednisone/prednisolone or equivalent. Treatment with anti neoplastic therapy ≤ 28 days or ≤ 5× elimination half life, whichever is shorter, before the first dose of study drug. Major surgery requiring general anesthesia ≤ 28 days prior to dosing. History of permanent discontinuation of prior IO therapy due to irAE. Prior treatment targeting ILT2 and/or ILT4 or targeting HLA G. Live or live attenuated vaccine ≤ 28days prior to dosing. Immunosuppressive systemic medication, except topical corticosteroids or systemic corticosteroids at a dose level of ≤ 10 mg/d of prednisone/prednisolone or equivalent. Note: patients with adrenal insufficiency requiring hormonal replacement may receive higher dose of steroids. Prior solid organ or bone marrow transplantation (except cornea transplantation). History of clinically significant cardiovascular events (e.g. DVT ≤ 6 months, PE ≤ 12 months, MI or hospitalization for CHF ≤ 12 months, bleeding disorder or bleeding event ≤ 6 months, current clinically significant arrhythmia or unstable angina pectoris, current uncontrolled history of cerebrovascular accident in the past 6 months, current uncontrolled hypertension). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259526

Recruiting

A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression

The purpose of this study is to evaluate the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression

- EligibilityCriteria: Inclusion Criteria: All of the following standards must be met: Age range from 18 to 65 years old (including boundary values), both male and female; Single or recurrent episodes (296.2/296.3) that meet the diagnostic criteria for depression in DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition); During the screening and baseline periods, the total score of the Montgomery Asperger Depression Rating Scale (MADRS) was ≥ 26 points; Screening and baseline periods, with a Clinical Global Impression Scale Disease Severity (CGI-S) score of ≥ 4 points; Voluntary participation in clinical trials, able to sign informed consent forms, and able to understand and comply with research procedures. Exclusion Criteria: Those who meet any of the following criteria cannot be included in this experiment: Individuals with a history of severe drug allergies or allergies to Piper Piper (pepper plant) or Duloxetine; Those who have used at least two antidepressants in sufficient dosage and duration (treated according to the maximum dosage in the instructions for at least 4 weeks) in a single or current episode in the past but still have no effect; Those who have been ineffective in using Duloxetine in sufficient amounts during the previous treatment course; The patients of depression secondary to other mental or physical illnesses; Patients of depression with accompanying psychiatric symptoms; Significant suicidal attempt or behavior within the past year, with a score of ≥ 3 on the 10th item (suicidal ideation) of the MADRS scale; During the baseline period, those with a reduction rate of ≥ 25% in the MADRS scale score compared to the screening period; Individuals with a history of epileptic seizures (excluding convulsions caused by febrile seizures in children); Individuals who have received depression related systemic physical therapy within 3 months prior to their first administration: modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), phototherapy, or systemic psychotherapy; Systematically receiving antidepressant treatment within the first 2 weeks of randomization, or discontinuing antidepressant medication for less than 5 half-lives before randomization; Individuals with severe unstable cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, and other physical diseases or medical history; Accompanied by a history of malignant tumors (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); Screening or baseline electrocardiogram abnormalities that have clinical significance and are deemed unsuitable for inclusion by investigators, such as male QTcF ≥ 450 ms, female QTcF ≥ 470 ms, or having a history of long QT syndrome; A history of symptomatic orthostatic hypotension (i.e. orthostatic syncope) with clinical significance; During the screening or baseline period, TBIL is above 2 times the upper limit of normal value, and ALT or AST is above 2 times the upper limit of normal value; Cr is higher than 1.2 times the upper limit of normal value; Thyroid dysfunction (TSH above 1.2 times the upper limit of normal value or below 0.8 times the lower limit of normal value) or the presence of hyperthyroidism or hypothyroidism determined by the investigators; Individuals with a history of elevated intraocular pressure or narrow angle glaucoma; Screening period, drug abuse screening positive individuals; A history of alcohol dependence within one year prior to screening; Pregnant and lactating women, male or female subjects who have a family planning or are unable to take effective contraceptive measures within 30 days after signing the informed consent form and ending the trial; Screening for individuals who have participated in clinical trials and taken investigational drugs within the first 30 days; The investigators believe that the subjects have poor compliance or there are other clinical, social, or family factors that are not suitable for enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06259513

Recruiting

Omission of Axillary Surgery in Breast Cancer Patients

The treatment and prognosis of breast cancer (BC) are dependent on its molecular subtype and nodal burden. In early BCs with favourable molecular subtype, the incidence of axillary node involvement is low. However, these patients are still subjected to an axillary operation, which can result in additional cost, operating time and morbidities. Similarly, in patients with limited nodal burden of 1-2 metastatic nodes, there is emerging evidence that these patients may need sentinel lymph node biopsy (SLNB) only, instead of an axillary clearance (AC), which has more surgical morbidities. We aimed to determine if axillary surgery could be safely tailored in BC patients based on their molecular subtype and nodal burden, without compromising their oncological outcomes. This could in turn reduce the morbidities associated with the axillary surgery, Total 350 patients will be enrolled. 50 patients with early BC and favourable molecular subtype will be enrolled in a pilot study A (SentiOMIT), whereby SLNB is omitted. For eligible patients who declined study A and other stage I-II patients, with preoperative N0 status, undergoing upfront surgery but did not meet the inclusion criteria of Study A, these patients will be enrolled into study B (SentiMACRO) to undergo SLNB. In study B, the patients will be categorized based on SLNB into 3 groups with 100 patients in each arm: B1 with pN0, B2- 1-2 metastatic nodes and B3- >/=3 metastatic nodes. In Study B, we aim to investigate if the B2 group (100 patients) can be treated with a less invasive procedure of SLNB alone instead of AC, without affecting oncological outcomes. B1 and B3 are controls. The outcomes for study A and B include short term outcomes such as morbidity rates, cost and operating time savings. Long term outcomes include recurrence and survival rates. This study will allow individualisation of axillary surgery based on the patient's molecular subtype and nodal burden, to benefit patients' care.

- EligibilityCriteria: Inclusion Criteria: female patients aged >/=55 years old unifocal cancer on imaging breast tumour size based on imaging of </=3cm no evidence of axillary adenopathy on imaging patients with strongly positive ER and PR and negative HER2 on biopsy grade 1-2 tumour on core biopsy patient who opt for mastectomy Exclusion Criteria: patients with T3/T4 or stage IV disease, patients with preoperative known N+ disease, bilateral breast cancers, patients planned for neoadjuvant chemotherapy, patients with other malignancies. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Female breast cancer - MinimumAge: 21 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06259487

Recruiting

Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.

This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure. The main question it aims to answer is: • Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?

- EligibilityCriteria: Inclusion Criteria: Age above 18 years Willingness to provide informed consent for participation in the study Diagnosis of heart failure No previous vaccination against RSV or influenza Exclusion Criteria: History of an anaphylactic reaction to vaccination Hypersensitivity to any component of the vaccine Receipt of vaccination against RSV or influenza in the current infectious Active infection Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06259474

Not yet recruiting

Effect of Hypopressive Exercises on Postpartum Backache and Functional Disability

The purpose of this study was to evaluate the effectiveness of hypopressive exercise in postpartum females with abnormal hyperlordosis and back pain.

- EligibilityCriteria: Inclusion Criteria: Participants must have a healthy pregnancy Normal vaginal birth LBP that existed 24 weeks after giving birth Functional limitations in daily activities. Participants' age from 20 to 35 years Exclusion Criteria: No more than two prior pregnancies BMI of less than 25 kg/m2 to participate. Women who were under pharmacological or psychological treatment, had pelvic tumors, lumbar disk herniation, heart disease, hypertension, lumbar spine tumors, chronic uterine prolapse, chronic pelvic pain, lumbar spondylosis, or lumbar spondylolisthesis. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06259448

Recruiting

Feasibility of Optimizing Organized Cervical Cancer Screening by Urine Self-sampling

This project addresses the issue of promoting organized cervical cancer screening (CCS) from the perspective of the use of urine self-sampling (USS). Via a prospective and monocentric study, the present study aims to evaluate the acceptability of women to collect a urine self-sample and to respond to a questionnaire on their feelings about this screening method.

- EligibilityCriteria: Inclusion Criteria: Women aged 31 to 49 Coming to the Bordeaux University Hospital for a gynecological consultation in order to have a cervical swab (PCC) for screening or follow-up. Patient affiliated to or benefiting from a social security system Non-objection to study participation Exclusion Criteria: Patient unable to speak French and/or illiterate Patient under legal protection - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 49 Years - StdAgeList: Adult

NCT06259435

Not yet recruiting

Modulating Energy Density in Time-Restricted Eating

The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces: Insulin resistance and Body weight. Researchers will compare the groups: Following time-restricted eating and given a diet reduced in energy density or Following time-restricted eating and given a diet typically consumed in this population

- EligibilityCriteria: Inclusion Criteria: Body mass index (BMI) ≥ 30kg/m2. Mini-Mental State Examination (MMSE) > 25 Geriatric Depression Scale-15 (GDS-15) < 9 Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3. Exclusion Criteria: Diagnosis of Type 2 diabetes received more than five years ago Diagnosis of type 1 diabetes Evidence of clinically significant renal dysfunction or disease History of malignancy during the past five years Being treated with systemic steroids, olanzapine, or clozapine Being treated with prescription medications for obesity Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin Weight change > 3 kg in the preceding three months Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team) - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult