Datasets:

rjac

/

clinicaltrials.gov-summary_and_eligibility

like 0

NCT06294782

Recruiting

PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia

This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized.

- EligibilityCriteria: Inclusion Criteria: Structural heart disease (SHD) defined as left ventricular dysfunction (LVEF < 55%), or right ventricular dysfunction (FAC <35%) or presence of ventricular scar, pathological hypertrophy, wall bulging or inflammatory conditions. Optimized medical treatment for the underlying SHD ICD or CRT-D recipient ≥ 1 episodes of sustained or treated (with either anti-tachycardia pacing or shock, internal or external) monomorphic VT (MMVT) resistant to at least one invasive VT ablation attempt, unless contraindicated or deemed at high risk. Reason for lack of ablation must be specified Exclusion Criteria: Age < 18 or > 85 years. Inability to provide informed consent. Acute myocardial infarction or recent primary coronary intervention or cardiac surgery (<3 months) Primary electrical disease (e.g. long QT syndrome, short QT syndrome, catecholaminergic polymorphic ventricular tachycardia, Brugada syndrome). Reversible and/or treatable cause of VT (e.g., drug-induced or intoxication) ICD electrode malfunction or ICD readings outside reference range Pregnancy or breast feeding Patients with polymorphic VT/VF - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06294769

Not yet recruiting

Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.

- EligibilityCriteria: Inclusion Criteria: adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type Exclusion Criteria: individuals diagnosed with dementia, cognitive impairment or chronic pain; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06294743

Recruiting

Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is: •Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea. Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles.

- EligibilityCriteria: Inclusion Criteria: women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain Exclusion Criteria: Malignant tumors requiring treatment. Pregnant Those who have other acute and chronic pain and are receiving relevant drug treatment. Those who are allergic to acetaminophen or have contraindications. Those who use hormonal contraceptives at the same time. Those with coagulation disorders or taking anticoagulant drugs. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: The patients who suffered with dysmenorrhea. - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06294730

Recruiting

COronary Microcirculation and Troponin Elevation in Septic Shock

Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition.

- EligibilityCriteria: Inclusion Criteria: Patients fulfilling the Sepsis-3 definition of and diagnostic criteria for sepsis or septic shock Age 40 - 85 years Life expectancy > 1 year hs-cTnT values >15 ng/L Exclusion Criteria: pregnancy previous medical history of coronary artery by-pass grafting heart transplant previously verified ejection fraction (EF) ≤39% prior to hospital admission Hypertrophic cardiomyopathy (Septum > 15 mm) severe aortic stenosis amyloidosis or sarcoidosis with myocardial engagement estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 prior to hospital admission asthma infectious endocarditis a medical history of abdominal, thoracic, or orthopaedic surgery within the last three months prior to hospital admission. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Sepsis- or septic shock-patients with a life expectancy of >1year and non-normal high-sensitive cardiac troponin T values (>15 ng/L) - SamplingMethod: Non-Probability Sample

NCT06294717

Not yet recruiting

The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section

Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section.

- EligibilityCriteria: Inclusion criteria; of postpartum women; Being between the ages of 20-35, Primiparous pregnancy Having a transverse cesarean section, It should be taken at the 8th hour postoperatively: since mobilization occurs at the 6th hour after the surgery, it should be taken from the 8th hour postoperatively to prevent fatigue in the woman's extremities and to avoid any health problems (nausea-vomiting, headache-waistache) that prevent her from doing the exercises. Primary school graduate, No mental disability or communication problems. Exclusion criteria; 1. Those who have an open wound on their body and/or a diagnosis of allergic disease on their skin, 2. Puerperal complications (bleeding, infection, fever), 3. Those with cardiac arrhythmia and a pacemaker, 4. At risk of experiencing convulsions; Those with diseases such as eclampsia and epilepsy, 5. Those with kidney or liver disease, 6. Those who have practiced progressive relaxation exercises before, 7. Morbidly obese (BKI over 40), 8. Women using chronic opioids, antidepressants, and psychoactive drugs were not included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06294704

Not yet recruiting

Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes

Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

- EligibilityCriteria: Inclusion Criteria: Major patient With type 1 diabetes for > 1 year Obese (BMI≥30) Having undergone bariatric surgery On a hybrid closed-loop insulin pump Not pregnant No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery Exclusion Criteria: - Patient informed and opposed to data use - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump. - SamplingMethod: Non-Probability Sample

NCT06294691

Not yet recruiting

Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases

To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

- EligibilityCriteria: Inclusion Criteria: Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited; Patients who are proposed to receive allo-PBSCT for the first time; Eastern Cooperative Oncology Group (ECOG) score 0-2; No serious organ failure and active infection; Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation; Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the patient's condition, if the patient's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative. Exclusion Criteria: Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas; Pregnant patients; Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation; Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction; Participants in other clinical studies that may affect aGVHD within 3 months; Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues). - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 60 Years - StdAgeList: Child, Adult

NCT06294678

Not yet recruiting

Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies

To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT)

- EligibilityCriteria: Inclusion Criteria: Definite diagnosis of malignant hematologic disease before transplantation, age 12-60 years old, gender is not limited, race is not limited; Patients who are proposed to receive allo-PBSCT for the first time; Eastern Cooperative Oncology Group (ECOG) score 0-2; No serious organ failure and active infection; Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation; Each subject must sign an informed consent form (ICF) indicating that he/she understands the purpose and procedures of the study and is willing to participate in the study; in view of the patient's condition, if the patient's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative. Exclusion Criteria: Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas; Pregnant patients; Patients and/or authorized family members who refuse to undergo an open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation; Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise patient safety and put the results of the study at unnecessary risk; drug-dependent individuals; patients with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction; Participants in other clinical studies that may affect aGVHD within 3 months; Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues). - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 60 Years - StdAgeList: Child, Adult

NCT06294665

Recruiting

Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block

The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries

- EligibilityCriteria: Inclusion Criteria: Age 18-65 years. Sex: Both sexes. American Society of Anaesthesiologists (ASA) Physical Status Class I and II. Scheduled for hip surgeries under spinal anaesthesia. Exclusion Criteria: Declining to give 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 disorder. American Society of Anesthesiologists (ASA) Physical Status Class III and IV. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06294652

Recruiting

AGMT Austrian Lymphoma Registry

Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL). There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted. Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups. Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities. Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis. Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus.

- EligibilityCriteria: Inclusion Criteria: The registry will include patients ≥ 18 years with lymphoma. Exclusion Criteria: There are no specific exclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Interested sites that treat patients in this indication will be invited to participate in this registry. - SamplingMethod: Probability Sample

NCT06294639

Not yet recruiting

ED50 of Esketamine for Laser Treatment in Children

There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.

- EligibilityCriteria: Inclusion Criteria: age between 3 years and 12 years old patients scheduled for laser treatment of facial lesion Exclusion Criteria: patients with airway infection during the last 1 month patients with cardiac or pulmonary disorder patients with hepatic or renal disfunction patients with neurologic or psychiatric disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06294613

Recruiting

A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases

Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 7 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker. Only one eye per subject can be enrolled.

- EligibilityCriteria: Inclusion Criteria: Given written Informed Consent by subject, Other, ... Exclusion Criteria: Uncontrolled systemic disease that could increase the operative risk or confound the outcome (autoimmune disease, uncontrolled hypertension, lung and heart disease impairing respiratory function, or any other medical condition as deemed by the Clinical Investigator), Other, ... - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06294600

Recruiting

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit.

- EligibilityCriteria: Inclusion Criteria: Age equal to or above 18 years Male or female gender In case of women of reproductive age, willingness to use dual contraceptive method during the study period Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation Community-acquired pneumonia (CAP) Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and/or iv) pleuritic chest pain PCT ≥0.25 ng/ml suPAR ≥6 ng/ml Exclusion Criteria: Age below 18 years Denial of written informed consent Any stage IV malignancy Any do not resuscitate decision Patients necessitating non-invasive ventilation or mechanical ventilation Hospitalization in Intensive Care Unit Infection by SARS-CoV-2 Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days Intake of any macrolide for the current episode of CAP under study Known infection by the human immunodeficiency virus Any chronic anti-cytokine treatment for more than two months QTc interval at rest in the ECG ≥500 msec or history of know long QT syndrome Medical history of allergy to macrolides Concomitant oral intake of astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids (e.g. ergotamine and dihydroergotamine), lomitapide and colchicine; patients may be enrolled in the trial if they stop these drugs during trial participation. Medical history of torsades de pointes arrhythmia Concomitant intake of lovostatin or simvastatin; patients may be enrolled in the trial if they stop these drugs during trial participation. Concomitant presence of end-stage liver failure and end-stage renal failure. Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored. Any contradictions for macrolide uptake Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study Participation in any other interventional trial within the last 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294587

Not yet recruiting

Evaluation of Free Gingival Graft Timing

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

- EligibilityCriteria: Inclusion Criteria: • At least 18 years old No uncontrolled medical conditions or medications that will affect their bone healing. Good oral hygiene is defined as a full-mouth plaque score ≤25%11. Must be able to read and understand the informed consent document. Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth. Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan. The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required. The patient is not pregnant or breastfeeding. Exclusion Criteria: Active infectious diseases. Liver or kidney dysfunction/failure. Uncontrolled diabetes (HbA1c ≥ 8.5). Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure. Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications). Metabolic bone diseases that affect bone healing such as osteoporosis. Pregnant or lactating women (self-reported). Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (&gt; 10 cigarettes) who quit &lt; 10 ago (self-reported). Poor oral hygiene. Vertical loss of bone at the edentulous ridge. History of periodontal disease. The patient is pregnant or breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294574

Not yet recruiting

Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction

The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.

- EligibilityCriteria: Inclusion Criteria: Patients with biopsy clips scheduled for surgery with SCOUT localization Exclusion Criteria: Patients who didn't have surgery, patients younger than 18 years old Patients older than 90 years old Inmates Non-English speakers - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06294561

Recruiting

TGRX-326 Pharmacokinetic Drug Interaction

This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer.

- EligibilityCriteria: Inclusion Criteria: healthy subject; male or female Age between 18 and 45 (inclusive) body mass index (BMI) between 19.0 and 26.0 (inclusive) agree to consent able to communicate with investigator well and complete the study according to study protocol Exclusion Criteria: abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.) any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody prolongation in QT interval use of substance that affects CYP3A4 enzyme activity with 30 days before screening use of any drug within 14 days of test article administration use of any investigational drug or participation of any clinical study within 3 months before screening vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period history of cardiovascular diseases history of mental conditions including depression, aggressive behaviours, epilepsy, etc. history of major surgery within 6 months before screen, or have unhealed surgical wounds. any clinically significant conditions that investigator believes could affect study outcomes history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of > 0.0 mg/dl at screening history of substance abuse, or positive drug results at screening history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice positive pregnancy test results, or pregnant/breast-feeding females history of unprotected sexual activities within 1 month before screening have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study any reasons that is deemed unsuitable for study participation as determined by investigator - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06294548

Not yet recruiting

Phase Ib/II Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC

This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.

- EligibilityCriteria: Inclusion Criteria: Subjects must meet all the following criteria to be eligible for enrollment into the study: Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures. Subjects ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed HCC diagnosis confirmed by histology/cytology or clinically by American Association for Study of Liver Diseases (AASLD) 36 criteria in cirrhotic patients. At least one measurable untreated lesion per RECIST v1.1 (see Section 12). Patients who received prior liver directed therapy (ie., Trans arterial chemoembolization [TACE], Y-90, liver directed radiation etc.) are eligible provided the target lesion(s) have not been previously treated with liver directed therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1 (See Section 12) Locally advanced, metastatic, or unresectable disease. No prior systemic therapy for advanced HCC. Child Pugh Class A. Barcelona Clinic Liver Cancer (BCLC) Stage B (not amenable to liver directed therapy) or Stage C. ECOG Performance Status (PS) 0 or 1. The following laboratory values obtained ≤ 28 days prior to registration. Local laboratory data must meet the following criteria at both Screening and prior to dosing on the planned Cycle 1 Day 1 visit to confirm relatively preserved organ function: Absolute neutrophil count (ANC) ≥1500/mm3 Platelet count 100,000/mm3 (platelet transfusion is not allowed within 14 days prior to screening assessment). Hemoglobin (Hgb) 9.0 g/dL (red blood cell transfusion is not allowed within 14 days prior to screening assessment). Total bilirubin (TBIL) ≤1.5 x ULN. ALT and AST ≤3 x ULN For patients not receiving therapeutic anticoagulation INR or aPTT ≤2 x ULN Creatinine clearance ≥40 mL/min (measured by the Cockcroft-Gault equation) If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, as detailed in Section 4.4, upon enrollment, during the Treatment Period, and for 6 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test >40 mIU/mL and estradiol <40 pg/mL (<140 pmol/L). If male with partner of childbearing potential, the subject must be surgically sterile or willing to use highly effective birth control (Section 4.4) upon enrollment, during the Treatment Period, and for 6 months following the last dose of study drug. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 6months after the final study drug administration. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and for at least 6 months after the final study drug administration. Provide informed written consent ≤28 days prior to registration. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study). Note: During the Active Monitoring Phase of a study (i.e., active treatment), participants must be willing to return to the consenting institution for follow-up. Willing to provide mandatory tissue specimens and blood specimens for correlative research purposes (see Section 10). Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 5.0, Grade ≤1 or Baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to enrollment and managed with standard of care treatment), which the Investigator deems related to previous anticancer therapy, composed of the following: Chemotherapy-induced neuropathy. Fatigue. Residual toxicities from prior immunotherapy treatment: Grade 1 or 2 endocrinopathies, which may include the following: Hypothyroidism/ hyperthyroidism. Type I diabetes. Hyperglycemia. Adrenal insufficiency. Adrenalitis. Skin hypopigmentation (vitiligo). Exclusion Criteria: Subjects who meet any of the following criteria will be disqualified from entering the study: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown: Pregnant persons Nursing persons Persons of childbearing potential who are unwilling to employ adequate contraception Liver directed therapy (Trans arterial chemoembolization [TACE], Y-90, liver directed radiation, etc.) ≤ 28 days prior to registration. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Uncontrolled or significant cardiovascular disease, including the following: Evidence of prolongation of QT/QTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method [QTcF] >470 ms) (average of triplicate determinations) Myocardial infarction within 6 months prior to Screening Uncontrolled angina pectoris within 6 months prior to Screening New York Heart Association (NYHA) Class 3 or 4 congestive heart failure Inadequately controlled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure >100 mmHg, based on average ≥3 blood pressure readings on ≥2 sessions. Anti-hypertensive therapy to achieve these parameters is allowed. Prior malignancy active within the previous 3 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer. History of treatment with other EZH inhibitors Current use of moderate or strong cytochrome P450 (CYP)3A inducers, and strong CYP3A and/or P-gp inhibitors in dose escalation phase (See Table 11). Immunocompromised patients and patients known to be Human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy or known acquired immunodeficiency syndrome. Regarding hepatitis B, patients must meet the following criteria to be eligible: Patients with Hepatitis B (positive HBs antigen test) have an HBV-DNA Viral Load <2000 IU/mL off treatment or on oral antiviral therapy for at least 4 weeks and during the participation in the study. For patients at high-risk of Hepatitis B reactivation: Patients with contact to the Hepatitis B virus (positive HBc antibody) that did not develop immunity (negative HBs antibody) must have an HBV-DNA Viral Load <100 IU/mL on oral antiviral therapy for at least 4 weeks and during the participation in the study. Patient has active Hepatitis C. Active Hepatitis C is defined by a positive Hep C Ab result and quantitative HCV RNA results greater than the lower limits of detection of the assay. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous antibiotics, antivirals, or antifungals. Note: Subjects with localized fungal infections of skin or nails are eligible. A medical history or complication considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study in the investigator's opinion. Psychological, social, familial, or geographical factors or substance abuse that would prevent regular follow-up to be compliant with the protocol. History of hemoptysis (≥2.5 mL of bright red blood per episode) within 1 month prior to initiation of study treatment Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) Current or recent (within 10 days of first dose of study treatment) use of aspirin (> 325 mg/day) or treatment with dipyramidole, ticlopidine, clopidogrel, and cilostazol. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR < 1.5 x ULN and aPTT is within normal limits within 14 days prior to initiation of study treatment. Prophylactic use of low molecular-weight heparin (i.e., enoxaparin 40 mg/day) is allowed. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 3 days prior to the first dose of bevacizumab. History of abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to initiation of study treatment History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding within 6 months prior to initiation of study treatment. Patients with signs/symptoms of sub-/occlusive syndrome/intestinal obstruction at time of initial diagnosis may be enrolled if they had received definitive (surgical) treatment for symptom resolution. Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure. Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (< 30 mm from the carina) of large volume Patients with vascular invasion of the portal or hepatic veins may be enrolled. History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to peptic ulcer disease, diverticulitis, or colitis Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to initiation of study treatment or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed. Known fibrolamellar carcinoma (FLC), sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma (cHCC-CC) Patients with untreated or incompletely treated varices with bleeding or high-risk for bleeding. Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure. History of allogenic organ transplantation. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion: Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the study physician Patients with celiac disease controlled by diet alone History of leptomeningeal carcinomatosis or intracranial metastases Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. Current or prior use of immunosuppressive medication ≤ 14 days prior to registration. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) Receipt of live attenuated vaccine ≤30 days prior to registration. Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294509

Not yet recruiting

taVNS Application Timing During Robotic Sensorimotor Task

The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task. Main Questions it Aims to Answer: How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation? Participants Will: Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings. Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions. Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session. Comparison Group: Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation.

- EligibilityCriteria: Inclusion Criteria: Healthy participants above 18 years of age and able to provide informed consent and understand the study requirements Exclusion Criteria: Individuals with major untreated depression, major cognitive and/or communication deficits, and major comprehension and/or memory deficits that may interfere with the informed consent process, task-specific practice, or communication of adverse events will be excluded from the study. Neurological conditions such as epilepsy, participation in any other research trial, pregnancy, use of implanted electrical devices, and use of medication or procedure that interferes with vagal functions. Pregnancy or trying to get pregnant. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294496

Recruiting

Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear. This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

- EligibilityCriteria: Inclusion Criteria: 1) Clinical diagnosis of carotid stenosis. Exclusion Criteria: Vascular stenosis with vascular malformations. Aneurysm. Severe heart, liver, or kidney disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adults aged between 18 and 80 years old - SamplingMethod: Non-Probability Sample

NCT06294457

Not yet recruiting

Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects

Objectives Main objective: Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain Secondary objectives: Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate

- EligibilityCriteria: Inclusion Criteria: Participants from 18 to 65 years old Sign informed consent Exclusion Criteria: Diagnosed diseases at the time of the study. Severe previous psychiatric conditions. Medical contraindications that prevent the use of non-invasive neuromodulation therapy. Having exercised in the hours prior to the NESA treatment. Having consumed coffee or tobacco in the hours prior to the treatment. Minors. Individuals who have previously received any type of neuromodulation treatment. Cancer. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06294444

Recruiting

Comparison of Constraint Induced Movement Therapy and Mirror Therapy

Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body. The aim of this study will be the to know the effect of mCIMT with and without mirror therapy on upper limb function in children with hemiplegic cerebral palsy. A randomized control trial will be conducted at Sheikh Zayed Hospital, RYK through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with mCIMT and Group B will be treated with mCIMT and mirror therapy. Outcome measure will be conducted through pain and disability questionnaire after 6 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. mCIMT with and without mirror therapy will be applied in patients with hemiplegic cerebral palsy to see the effect on upper limb function.

- EligibilityCriteria: Inclusion Criteria: Medically diagnosed with Hemiplegic CP Age ranges btween3-12 years Hemiplegic CP with motor disability No major contractures of upper limb muscle Both genders were included Able to follow command No orthopedic surgery during the previous six months(8) Exclusion Criteria: Functional limb Patients with contracture Patient with sensory,cognitive and perceptual disorders Patient with seizures Patient with orthopedic surgery - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06294431

Not yet recruiting

Radicle Clarity 24: A Study of Health and Wellness Products on Cognitive Function and Related Health Outcomes

A randomized, double-blind, placebo-controlled direct-to-consumer study of health and wellness products on cognitive function and related health outcomes

- EligibilityCriteria: Inclusion Criteria: Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed Resides in the United States Endorses better concentration or cognitive function (fewer feelings of brain fog) as a primary desire Has the opportunity for at least 20% improvement in their primary health outcome Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: Report being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid US shipping address and mobile phone number Reports current enrollment in another clinical trial Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety lak Reports a diagnosis or cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) Lack of reliable daily access to the internet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 105 Years - StdAgeList: Adult, Older Adult

NCT06294418

Recruiting

FCI in Post-operative Low Grade Gliomas

The aim of this pilot study is to explore the utility of a new imaging technique, called Field Cycling Imaging (FCI), in postoperative low grade gliomas. The main question it aims to answer is if FCI can differentiate subtypes of low grade gliomas. Participants will have one FCI scan.

- EligibilityCriteria: Inclusion Criteria: Patients with post operative low-grade glioma. Capacity to give informed consent. Capacity to co-operate with the scanning procedures and duration. Age 16 and above. Participants who can pass through a 50 cm-diameter circular hoop to ensure they will be able to fit inside the scanner. Participants who meet the safety criteria for undergoing an MRI scan. Participants must be mobile enough to be positioned onto the FCI scanner couch. Exclusion Criteria: MRI-incompatible conditions, as detected in the MRI safety screening form. Restrictions to mobility that would prevent the correct positioning in the scanner by trained research radiographer (e.g., severe kyphosis). Participants who are unable to give fully informed consent. Women who are pregnant. Participants who are unable to understand or communicate in English. Patients who suffer from claustrophobia. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult

NCT06294405

Recruiting

Intraocular Lens Implant Registry Study

The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.

- EligibilityCriteria: Inclusion Criteria: Treatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity Exclusion Criteria: Dementia Pregnancy Breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients who receive an intraocular lens are offered to participate in the study. - SamplingMethod: Non-Probability Sample

NCT06294392

Recruiting

KEEP Connecting Kin

The current study provides a unique opportunity to conduct a summative evaluation of the KEEP Connecting Kin (KEEP-CK) program by leveraging extant relationships with Oregon's Child Welfare System (CWS), Self-Sufficiency Program (SSP), and our community partners to address the needs of informal kinship families and the youth in their care. Specifically, a randomized "services-as-usual" (SAU) waitlist control design plus qualitative methods will be used to evaluate the immediate (post-intervention) and sustained (10 month) impacts of the KEEP-CK program on child, adult, and service utilization outcomes, and prevention of entry into the CWS.

- EligibilityCriteria: Inclusion Criteria: Informal kinship caregivers in Oregon are defined as relatives or fictive kin who are caring for children between the ages of 4 to 18 years outside of the child welfare system with no birth/step parent living in the home. Exclusion Criteria: Informal kinship caregivers in Oregon who have previously participated in a KEEP or KEEP-CK group, or have a partner living in their home who has previously participated in a KEEP or KEEP-CK group. Focal child is not between the ages of 4-18 years at the baseline assessment. Focal child has been adopted by the kinship parent at the baseline assessment. Focal child is not living with the kinship caregiver full time (e.g., babysitting/weekends/vacations) at the baseline assessment. Focal child is in child welfare at the baseline assessment. Focal child is living with the kinship caregiver in a certified foster home at the baseline assessment. Focal child has a developmental disability or delay that impairs their ability to be responsive to the parenting content of KEEP-CK. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06294379

Recruiting

Shared Decision Making in Melanoma Patients Receiving Adjuvant Therapy

This study aims to develop test and evaluate a Patient Decision Aid called "The Decision Helper" among melanoma patients eligible for adjuvant treatment. Is the Decision Helper an acceptable tool for patients and clinicians and is it feasible in clinical practice? Are there any differences in the levels of decisional regret in the patients who have not used the Decision Helper (pre-implementation) compared to the ones who have (post-implementation?

- EligibilityCriteria: Inclusion Criteria: Danish speaking Diagnosed with stage 3 malignant melanoma Eligible for adjuvant immunotherapy Exclusion Criteria: Metastatic disease Mental impairment - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients diagnosed with malignant melanoma who at about to receive adjuvant therapy with immunotherapy or targeted therapy - SamplingMethod: Non-Probability Sample

NCT06294366

Recruiting

Bipolar Transurethral Enucleation Versus Resection in the Treatment of Benign Prostatic Hyperplasia: a Comparative Study

Benign prostatic hyperplasia (BPH) is a common chronic progressive disease resulting in the enlargement of the prostate gland and bladder outlet obstruction in aging men . Because of the increasing aged population and advancements in diagnostic tools, the incidence and importance of BPH have increased . BPH can be treated either with watchful waiting, drug therapy, or surgery being the most effective treatment option for BPH . Transurethral resection of the prostate (TURP) has been recognized as the standard treatment for BPH with morbidity rate varies from 18% and 26% Until now, only open prostatectomy and transurethral Holmium laser enucleation of the prostate (HoLEP) have shown an equal efficacy and durability compared to TURP

- EligibilityCriteria: Inclusion Criteria: all patients with symptomatizing BPH who have a prostate volume > 60 gm and indicated for surgical treatment. Exclusion Criteria: patients with small fibrotic prostates, high PSA (not co-inciding with BPH), neurogenic bladder. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 50 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06294353

Recruiting

Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders. The main questions it aims to answer are: Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders? Is the WELT-ED safe for use in the target population without causing adverse effects? Participants will: Undergo assessments to determine their baseline health status and severity of eating disorder symptoms. Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks). Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.

- EligibilityCriteria: Inclusion Criteria: Adults aged between 19 and 65 years Diagnosed with an eating disorder according to ICD-10. F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified) Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening. Able to use a mobile application (app) on a smartphone without difficulty. After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent. Exclusion Criteria: Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder. Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass). Have a BMI less than 17 kg/m^2 or more than 40 kg/m^2 at the time of screening. Diagnosed with a major psychiatric disorder according to the MINI. Have a past or current diagnosis of schizophrenia or bipolar disorder. At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks. Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months. Pregnant or planning to become pregnant during the trial period. Participated in another clinical trial within 4 weeks prior to screening. Have a history of alcohol or substance abuse. Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06294340

Not yet recruiting

Noise, Oxidative Stress and Cardiovascular System

Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.

- EligibilityCriteria: Inclusion Criteria: age 18-65 both genders good self-reported health Exclusion Criteria: diabetes mellitus arterial hypertension or other cardiovascular diseases kidney diseases pregnancy malignant diseases mental diseases - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All persons who visit the Nutrition Counselling Unit of the Institute of Hygiene and Medical Ecology, located at the Faculty of Medicine, University of Belgrade will be eligible to participate in the study. The study population will include 75 participants with normal weight and 75 overweight/obese participants who meet the inclusion criteria for the survey. Participants will be informed of the protocol and sign an informed consent form. - SamplingMethod: Non-Probability Sample

NCT06294327

Recruiting

RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress

Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%). The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research & Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings. This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.

- EligibilityCriteria: Inclusion Criteria: Norton score < 14 Bed and/or chairfast no pressure ulcers or at least pressure ulcer category I Exclusion Criteria: Norton Score >/=14 Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer Expected length of hospital stay < 2 days Medical contraindication for use of reactive static air support surfaces End of life care (or Do Not Reanimate (DNR) code IV) Age < 18 years - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294314

Recruiting

Return to Play After ACL Reconstruction With Bone Marrow Aspirate, DBM, and an Internal Brace

The Investigators are studying the effect of an ACL reconstruction on return to play by capturing outcome measures and biomechanics information.

- EligibilityCriteria: Inclusion Criteria: INCLUSION CRITERIA: All patients must meet the following criteria: Patients must be age 14-26 years old. Skeletally mature patients, with an ACL deficient knee who desire to have ACL reconstructive surgery using autograft augmentation. Patients must be a tanner stage of 5 and a posteroanterior left hand film x-ray will be obtained to confirm bone age and skeletal maturity Patients with associated meniscal and chondral pathology (except patients falling into exclusion criteria below) will be included in the study; such pathology will be treated at the time of ACL reconstruction at the discretion of the surgeon, and such pathology and treatment will be recorded. An understanding of the purpose of the study and providing written informed consent. Exclusion Criteria: EXCLUSION CRITERIA: Patients with multi-ligament surgery (MCL, PCL, LCL, PMC, or PLC repair or reconstruction), Patients who have undergone previous ACL reconstructive surgery. Patients who are currently pregnant or nursing. Patients who have a current infection at the operative site. Any condition or personal issue that the surgeon deems ineffective to the outcome of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 14 Years - MaximumAge: 26 Years - StdAgeList: Child, Adult - StudyPopulation: patients 14-26 years old with ACL ruptures - SamplingMethod: Probability Sample

NCT06294301

Recruiting

A Study of Single and Multiple Doses of LP-005 in Healthy Adult Participants

The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-005 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-005 and Part 2, multiple ascending dose (MAD).

- EligibilityCriteria: Inclusion Criteria: Healthy males or females aged 18 through 50 years Male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and BMI between 19.0 and 26.0 kg/m² (inclusive). Vaccination: Meningococcal Conjugate Vaccine, Serogroups A, C, W, Y (MPV-ACYW) meningococcal conjugate vaccine and Streptococcus pneumoniae vaccine should be given 14 days or more before randomisation. Male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, Iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs. The subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent. The subjects were able to communicate well with the researchers and complete the study according to the protocol. Exclusion Criteria: Participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4). Any history of Neisseria gonorrhea, meningitis infection, and Guillain-Barré syndrome. Contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders). Presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening. History of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing. Malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years. Positive HIV test (HIV-Ab), positive hepatitis B virus (HBV) test (HBsAg), positive hepatitis C virus (HCV), positive anti-syphilis helix-specific antibodies. Participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period). Women who are pregnant, breastfeeding, or at risk of pregnancy. Any condition deemed unsuitable for study participation by the investigator. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06294262

Recruiting

Safety, Tolerability, Immunogenicity and Immunological Mechanisms of TETRALITE, a Novel Seasonal Influenza Vaccine

The effect of LiteVax Adjuvant supplemented to licensed seasonal influenza vaccine on safety and immunogenicity will be investigated in both younger and older healthy participants. Local and systemic adverse events, and humoral and cellular immune responses will be determined at different time intervals after a single administration. Mode of action of LiteVax Adjuvant will examined by detailed genetic analysis and omics approaches such as transcriptomics, proteomics and metabolomics.

- EligibilityCriteria: Inclusion Criteria: Written signed informed consent obtained before any study-related activities. Aged 18 to 50 years inclusive, at the time of signing the ICF in the younger age cohorts (Cohort 1, Cohort 2 and Cohort 3) and aged 60 years or older, at the time of signing the ICF in the older age cohorts (Cohort 4, Cohort 5 and Cohort 6). Participants who are considered to be in good general health as determined by medical evaluation including medical history, physical examination (PE) and laboratory tests within 21 days prior to enrollment. Participants with a BMI within the range 18.5 to 35 kg/m2 inclusive at screening. Women who are not pregnant or breastfeeding, and one of the following conditions applies Women of non-childbearing potential (WONCBP) as defined in Appendix 1. or WOCBP and using a highly effective contraceptive method (with a failure rate of less than 1 % per year) as defined and described in Appendix 1 from at least 1 month prior to study vaccination and for 3 months post-vaccination. The investigator should evaluate the potential for contraceptive method failure (e.g. noncompliance, recently initiated) in relationship to study vaccination. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant. The participant should commit her abstinence to at least 1 month prior to study vaccination and for 3 months post-vaccination. If the participant will not maintain abstinence and changes her status, the participant must first commit to another highly effective method of contraception, which should be discussed with the investigator prior to terminating sexual abstinence as contraceptive method (34). WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before vaccination at Day 1. Refer to Section 8.3.5 for Pregnancy Testing. The investigator is responsible for review of medical history and menstrual history to decrease the risk for inclusion of a woman with an early undetected pregnancy. Participants who are willing and able to comply with the study procedures and are in the view of the investigator capable of completing the study. Exclusion Criteria: Medical Conditions History of previous laboratory confirmed influenza infection in the past 6 months, excluding laboratory confirmed COVID-19 infections, prior to the day of study vaccination. Positive (in the past, suspected or ongoing) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody. Past or current history of immune-mediated and/or autoimmune diseases as indicated by the investigator, e.g. diabetes mellitus type I and thyroid disease. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator. Clinical conditions representing a contraindication for IM administration, as judged by the investigator, e.g. history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM administration or blood draws. History of confirmed hypersensitivity, allergy and/or anaphylaxis to eggs (ovalbumin or chicken proteins), squalene-based adjuvants, or other components of the study vaccine (neomycin, formaldehyde or octoxinol-9). Current history of uncontrolled medical illness (unstable for the past 3 months) as judged by investigator, e.g. hypertension, diabetes mellitus type 2. Past or current history of any neurological disorder, e.g. Guillain-Barré syndrome and seizure disorder other than: 1) childhood febrile seizures, or 2) seizures that have not required treatment within the last 3 years. History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. Active malignancy or malignancy within the past 5 years, except basocellular carcinoma (single lesion) that has been fully removed. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years or that is expected to require the use of oral or intravenous corticosteroids. History of hereditary angioedema, acquired angioedema or idiopathic forms of angioedema. History of idiopathic urticaria within the past year. Current or recent (< 2 years ago) heavy smoking (> 20 cigarettes per day). If candidate stopped smoking > 2 years ago, the investigator will make an individual judgement based on the total packs per year and the candidate's overall health status. Drug - or alcohol abuse/addiction (including alcohol dependence), or psychiatric condition (e.g. past or present psychoses; disorder requiring lithium; or within 5 years prior to administration of study vaccine, a history of suicide plan or attempt), which in the investigator's opinion could compromise the participant's safety and/or compliance with the protocol. A rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection local reaction rating. Prior/Concomitant Therapy Prior receipt of an investigational or licensed seasonal or pandemic influenza vaccine in the 9 months before administration of study vaccine or planning to receive the influenza vaccination during the study period. Prior receipt of a live attenuated vaccine in the 28 days prior to administration of study vaccine, or within 14 days for subunit or inactivated vaccines other than seasonal or pandemic influenza vaccination, excluding COVID-19 vaccine. Prior receipt of vaccination with TETRALITE + 0.5 mg LVA or TETRALITE + 2 mg LVA. Prior receipt of COVID-19 vaccine in the 7 days before administration of study vaccine, or planning to receive a COVID-19 vaccine during the first 14 days following study vaccination. Planning to receive a vaccine during the first 28 days following the administration of study vaccine, other than COVID-19 vaccine. Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug, vaccine or medical device in the 4 weeks prior to study vaccination (with the exception of influenza vaccine, refer to exclusion criterium 16). Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of study vaccine, or planning to receipt such product during the study period. Chronic administration (defined as 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to vaccination or planned administration during the study (excluding topical, inhaled and intranasal preparations and intra-articular injections). For corticosteroids, this is prednisone >= 20 mg/day, or equivalent. Current intake of more than 1 anticoagulant medication (coumarin derivatives, low molecular weight heparin, DOAC) or 1 anticoagulant medication in combination with antiaggregation medication. Current anti-tuberculosis prophylaxis or therapy. Elective surgery planned in the first 14 days following study vaccination. Other Exclusion Criteria WOCBP who are pregnant, breast-feeding or planning to become pregnant during the study. Participants with history of any medical conditions that, in opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants due to participation in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294236

Not yet recruiting

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 and ≤75 For LN cohort: Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Biopsy-proven LN class III or IV, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria Refractory disease to ≥ 2 prior treatment regimens For ERL cohort: Diagnosis of SLE based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE Severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies For AAV Cohort, diagnosed with Granulomatous Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) based on the 2022 ACR/EULAR classification criteria Exclusion Criteria: Prior CD19-directed cell therapy including CAR T treatment or other genetically modified cell therapy (e.g., Natural Killer (NK) cell) For LN and ERL Cohorts, central nervous system (CNS) lupus manifestations or history or presence of CNS disorder For LN and ERL Cohorts, diagnosis of anti-phospholipid antibody syndrome For AAV Cohort only, Diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) as defined by the 2022 ACR/EULAR classification criteria for EGPA - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06294223

Not yet recruiting

Upper Extremity and Muscle Oxygenation

The aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy.

- EligibilityCriteria: Inclusion Criteria: Volunteering to participate in the study Being over 18 years old Having a Body Mass Index (BMI) value between 23-30 kg/m2 Absence of comorbid disease of the orthopedic, neurological, cardiopulmonery system Exclusion Criteria: Smoking / alcohol use Presence of orthopedic disease effecting the upper extremity or previous surgery Presence of cardiopulmonery disease that prevents exercise Participants who performed resistance exercise regulary for more than 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06294210

Not yet recruiting

Supporting Secondary School Student Wellbeing Through a Mobile App and Wearable Biofeedback

This study aims to investigate the effects of an app and wearable device on the wellbeing of secondary school students. The app will offer support for stress management, sleep improvement, and time management. Additionally, it will provide access to educational resources, text-based coaching, and biofeedback monitoring through the wearable device. The device, worn around the wrist, will measure heart rate variability as an indicator of stress response. Throughout the study, students will complete bi-monthly surveys on sleep, stress, and overall wellbeing. To assess the specific impact of each feature, the app features will be released incrementally over the course of a year. The intervention group, comprising students in their last two years of secondary school, will have access to the app and wearable device, while a control group within the same class will not use the system but will complete the same wellness surveys. Coaches on this platform will come from the Centre for Positive Health Sciences MSc in Positive Health Coaching as part of their continued training in coaching. Coaching will be asynchronous so that students can post questions at any time during the day, but coaches will respond within 24 hours, during office hours. It will be made clear that this is not a therapeutic service and will be directed to other resources for these services. Coaches will file an incident report if a risk arises from a message with participants. Participants will be given guidelines for the type of questions they can ask such as asking for advice for setting goals related to their digital habits and sleeping better. The study&#39;s findings will provide valuable insights into the effectiveness of the app and wearable device in enhancing student wellbeing leading up to their leaving certification exams.

- EligibilityCriteria: Inclusion Criteria: entering their 5th year in secondary school attending one of the three secondary school programmes involved (St. Wolstans, Gorey CS, and the Rush Youth Reach) receive consent to participate from a parent/guardian in possession of a smart phone Exclusion Criteria: students did not return parental consent forms - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06294197

Recruiting

Examination of the Effects of Pelvic Floor Exercises on Vaginal and Sexual Health in Postmenopausal Women.

The purpose of this study; To investigate the effects of pelvic floor muscle exercises on vaginal and sexual health in postmenopausal women. Vaginal symptoms such as vaginal dryness, burning and dyspareunia occur in the postmenopausal period. Vaginal symptoms affect sexual function, leading to a decrease in quality of life. In our study, we plan to evaluate vaginal dryness, one of the vaginal symptoms, using Schirmer's Test. Also in our study; Severities of vaginal dryness, burning and dyspareunia will be evaluated with the visual analog scale (VAS), sexual function will be evaluated with the Post-Menopausal Sexuality Questionnaire and Female Sexual Function Scale, vaginal aging will be evaluated with the Daily Effect of Vaginal Aging Scale, and the presence/severity of pelvic floor symptoms will be evaluated with the Pelvic Floor Distress Inventory-20. The cases will be randomized into two groups and pelvic floor exercises will be given to one group. After the exercises are given, vaginal pH and moistness will be evaluated for acute effect. In the other group, vaginal PH and moisture will be measured after 5 minutes. The cases will be followed without any intervention to the control group. After 12 weeks, the same evaluations will be made to both groups and the results will be compared. The data will be compared using appropriate statistical methods (statistical significance value will be taken as p<0.05) and discussed with the literature.

- EligibilityCriteria: Inclusion Criteria: Having applied to Istanbul Training and Research Hospital, Gynecology and Obstetrics Polyclinic Being literate Volunteering to participate in the study Amenorrhea for 12 months Being sexually active BMI < 35 Mini Mental Test Score threshold value for individuals over 65 years of age is 24 Exclusion Criteria: Active vaginal infection Having a history of active malignancy and receiving radiotherapy and/or chemotherapy accordingly Having received Hormone Replacement Therapy within the last year, Use of local estrogen Coitus in the last two days Pelvic organ prolapse stage 2 or higher Having had mesh surgery Presence of a disease/medication that causes vaginal dryness (e.g. Sjögren's syndrome, Lichen planus, Lichen Sclerosis / use of antidepressants or antihistamines). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Postmenopausal women - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06294184

Recruiting

tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

- EligibilityCriteria: Inclusion Criteria: 1) Be between the ages of 12-25; 2) is right-handed on the Edinburgh Handedness Inventory; 3) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA); 4) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, &lt; 24 points; 5) Gender is not limited; 6) Subjects and their families voluntarily participate and sign the informed consent form. Exclusion Criteria: 1) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL); 2) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days; 3) Severe or unstable physical illness; 4) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale); 5) Received transcranial direct current stimulation in the past three months (continuous intervention time: &gt;2 weeks); 6) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy; 7) Magnetic resonance scanning is contraindicated, such as in vivo metal implants. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 25 Years - StdAgeList: Child, Adult

NCT06294158

Not yet recruiting

Light and Noise: Objectively Assessing Environmental Risk Factors for Delirium in the ICU

Recognition of delirium as a medical entity with relevance to both morbidity and mortality, especially in critically ill patients, is a relatively recent development. However, research into delirium prevention and treatment is now in focus of scientific efforts internationally. Knowledge of intensive care unit (ICU) environment as a potential modifiable risk factor for delirium is insufficient to this date. This study thus seeks to evaluate, whether potentially modifiable environmental factors, such as noise or dazzling, are associated with development of delirium. Knowledge derived from this investigation could change both the process of care provision in intensive care units as well as the design of ICUs in general in the future. This project is planned to be carried out as an observational pilot study at three perioperative ICUs at the University Medical Centre Graz. Adult patients shall be screened for inclusion, if not deeply sedated. Suitable patients shall be included into the study after written informed consent or deferred consent if they can be expected to remain in the ICU for at least another two days, if they are not already in delirium, if the ICU environment is not actively modified for therapeutic reasons and if no treatment limitations are in place. Over a study duration of one year, 250 to 300 patients are expected to be enrolled into the study. Of those, 60 to 120 patients are likely to develop delirium. Baseline data known to be of relevance for outcome prediction in critically ill patients and factors known to predispose for development of delirium during ICU and hospital stay will be collected. Study equipment will be deployed to measure noise levels and illumination repeatedly over the day. Daily assessments for delirium using the Confusion Assessment Method in Intensive Care Units (CAM-ICU) will be performed. Vital status, physiologic parameters and parameters of ongoing treatment will concomitantly be documented on a daily basis. Data on light and noise levels are then to be unified with parameters of physiology and treatment, vital status, and results of daily assessments for delirium. Statistical analysis using methods of descriptive and comparative statistics as well as both unadjusted and adjusted logistic regression analysis will be performed to identify factors significantly associated with the development of delirium (i.e., risk factors).

- EligibilityCriteria: Inclusion Criteria Adult patients (age ≥ 18 years) Admission to participating Intensive Care Unit Expected (further) stay in participating Intensive Care Unit ≥ 48 hours Not (currently) deeply sedated (RASS ≥ -3) Exclusion Criteria Patient already in delirium (CAM-ICU positive) Environmental modification due to treatment necessities (e.g., burns care) Advanced directives / Treatment limitation Current inclusion in other (interventional) trial Documented patient refusal in advance - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients shall be included into the study if they can be expected to remain in the ICU for at least another two days, if they are not yet in delirium, if the ICU environment is not actively modified for therapeutic reasons (e.g., in the treatment of burns patients), if no treatment limitations are in place and if the patient can provide written informed consent. In those patients, who cannot provide informed consent upon recruitment due to their current illness or injury, consent by patients or their representatives shall be sought if and once they regain capacity (deferred consent). - SamplingMethod: Probability Sample

NCT06294145

Recruiting

Effects of a Wellbeing Intervention on Inflammation Through Reward and Threat Processes

This study aims to evaluate how savoring influences reward and threat processes and downstream inflammation. Savoring is designed to enhance positive affect, which may blunt stress responses and reduce downstream inflammation. The investigators aim to examine changes in the brain following the savoring intervention. The investigators are particularly interested in changes in brain activity that are correlated with changes in inflammation-related markers in the blood. In this single-armed pilot trial, the investigators will assess how savoring alters reactivity to rewarding and threatening experiences, and then examine related changes in downstream inflammation. The investigators intend to recruit 20 undergraduate students to complete a 7-week standardized savoring intervention. Participants will complete brain scans, daily diaries, questionnaires, a behavioral task, and blood collection at pre- and post-intervention assessments.

- EligibilityCriteria: Inclusion Criteria: Moderate depression indicated by a PHQ-8 score between 9 and 15; low positive affect indicated by a PANAS score of less than 24; no anxiety to moderate anxiety indicated by a GAD-7 score of less than 15; 18 to 22 years old; English speaking; and willingness to refrain from starting other psychosocial/pharmacological treatments until study completion. Given the small sample size of this study and the lingual limitations of our study staff, we are recruiting only English speaking participants as the burden of translation exceeds the scope of this project. Exclusion Criteria: MRI contraindications (left-handedness, claustrophobia, colorblindness, pregnancy, metal implants, and BMI above 35); presence of disease that may influence inflammation (e.g. asthma requiring inhaler, autoimmune or inflammatory diseases, gum disease, sleep disorder, eating disorder); presence of serious medical conditions (e.g. anemia, cancer (current or history), diabetes, endocrine disorder, fibromyalgia, heart problems); presence of disease that may impact patterns of neural activity (e.g. Attention Deficit/Hyperactivity Disorder, bipolar disorder, schizophrenia, head trauma, epilepsy, problems with drugs or alcohol); use of medications that may influence inflammation in last 6 months; bupropion, dopaminergic or neuroleptic medications in last 6 months, consistent with other studies that investigate anhedonia (e.g., Hanuka et al., 2022), given their potential influence upon reward processing; current use of heterocyclics and SSRIs if not stabilized for at least 3 months; history of regular (5-7 times per week) drug use (marijuana, cocaine, stimulant use before age of 15); current nicotine use (more than 11 cigarettes a week or nicotine equivalent); prior or current behavioral activation psychotherapy; and concurrent psychotherapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 22 Years - StdAgeList: Adult

NCT06294132

Recruiting

Effect of Lumbar Manipulation on Intervertebral Motion, Pain, and Disability

Background / Purpose: There is an ongoing debate regarding the ability of physical therapists to manually sense intervertebral motion. Physical therapists use intervertebral hypomobility as a clinical indicator for spinal manipulation. Also in question is the mechanism of improvement observed after spinal manipulation. Some argue that the improvement is purely neurophysiologic and unrelated to changes in intervertebral motion. This study aimed to determine the diagnostic accuracy of a physical therapist's manual assessment of lumbar intervertebral motion compared to ultrasound imaging and the effect of lumbar manipulation on intervertebral motion, pain, and disability, Methods: Subjects will complete a Numeric Pain Rating Scale (NPR),Oswestry Disability Index (ODI), and a Central Sensitization Inventory before arriving for the study via Qualtrics survey tool. They will be screened for contraindications to manipulation and neurological signs and symptoms. Active forward bending will be quantified by measuring the distance of the subject's fingertips to the floor. Two experienced physical therapists will evaluate the subject's lumbar intervertebral mobility. They will identify the lumbar segment with the least motion or hypomobility. The subjects will be imaged from L1 to S1 with a 5 MHz curvilinear transducer (Edge II MSK ultrasound unit, SonoSite, Inc, Bothell, WA) in the sidlying position with their trunk and hips flexed to end-range. The examiner will save the sagittal image and then place a digital caliper to measure the distance between the spinous processes from the peak of the hyperechoic curvature of the caudal spinous process to the peak of the hyperechoic curvature of the cranial spinous process of each lumbar segment (L5-S1, L4-L5, L3-L2,L2-L1). Subjects will then be randomized to receive a high-velocity low amplitude thrust manipulation or a sham manipulation. The lumbar spine will be reimaged. The ultrasound examiner will be blinded to the manipulation and the caliper measurements. Finally, subjects will be asked for their Global Rating of Change (GROC) and to actively bend forward to remeasure the distance of their fingertips to the floor. One week later, patients will receive an e-mail containing links to repeat the NPR, GROC, and ODI.

- EligibilityCriteria: Inclusion Criteria: 18 years old to 60 years old Individuals with mechanical low back pain who have limited spine mobility without signs of nerve root involvement. Exclusion Criteria: Subjects cannot participate in this study if they: ever had any type of spinal surgery ever had a spinal infection ever had a fracture in your spine recently had an episode of acute physical trauma ie a motor vehicle accident or a fall and - were not evaluated by a medical practitioner. are apprehensive about their spine being manipulated have osteoporosis or have been on corticosteroids for an extended period of time have Rheumatoid Arthritis have Marfans Syndrome or Ehlers-Danlos Syndrome currently have cancer or any other illness have a bleeding disorder or are now on blood thinning medications have symptoms of tingling, numbness, or weakness below the knee are unable to remain in a sidelying position for at least 30 minutes are currently pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06294119

Recruiting

Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay

MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression. In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression. Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.

- EligibilityCriteria: Inclusion Criteria: age older than 18 years spontaneous sinus rhythm signed informed consent indication to heart surgery Exclusion Criteria: age lower than 18 years absence of sinus rhythm pregnancy impossibility of informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294106

Not yet recruiting

eTMS for Veterans and First Responders With PTSD

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

- EligibilityCriteria: Inclusion Criteria: Veteran or first responder diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above Exclusion Criteria: Claustrophobia Contraindications to MRI Pregnant Uncontrolled medical, psychological, or neurological conditions Unable to calculate EEG alpha frequency History of ECT or rTMS History of intracranial lesion or increased intracranial pressure History of stroke History of other neurologic conditions Family history of epilepsy Personal history of epilepsy certain medications - HealthyVolunteers: No - Gender: All - MinimumAge: 22 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06294093

Not yet recruiting

Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure

this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.

- EligibilityCriteria: Inclusion Criteria: run regularly at least twice a week for half an hour, over 80% of the training on a treadmill or road Exclusion Criteria: pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days. past Achilles tendon surgeries, sprained ankle in the last six months, lower limb and back pain while running participants who report running with minimalist shoes. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: healthy runners who run on a regular basis, without injuries or pain during the last 6 months - SamplingMethod: Non-Probability Sample

NCT06294080

Not yet recruiting

Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults

The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases

- EligibilityCriteria: Inclusion Criteria: healthy male and female adults of any ethnicity aged from 18 to 59 no chronic medical conditions and no physical injuries in the past 3 months that could potentially affect physical activities Exclusion Criteria: participants who are currently engaging in regular dance or Tai Chi classes currently has a chronic disease or acute illness - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult

NCT06294067

Not yet recruiting

A Dose Response Investigation of Docosahexaenoic Acid (DHA)

Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values. Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present. Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers. Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome. Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients.

- EligibilityCriteria: Inclusion Criteria: Healthy vegans or vegetarians who do not consume meat or fish. Exclusion Criteria: Has regularly consumed EPA and/or DHA supplements within the past six months Having 3% or higher of DHA in their total plasma lipids BMI <18 kg/m2 or >30 kg/m2 Menopausal or post-menopausal Pregnant or breastfeeding Currently taking contraceptives Has a chronic or communicable diseases (like multiple sclerosis, kidney and inflammatory bowel disease, Type 2 diabetes, cancer or heart disease) Suffers from acute or chronic infections, use of chronic anti-inflammatory medication, use of lipid-controlling medication, hypertriglyceridemia (>4 mmol/l) or hypercholesterolemia (LDL-C >5 mmol/l) Anticipates major changes in lifestyle Is a smoker Is a heavy alcohol user (>3 drinks/day) Has had a major surgery involving organs like open heart surgery or organ transplants in the last six months Is or has participated in an intervention trial in the last six months - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06294041

Not yet recruiting

INvestigating the Value of Early Sleep Therapy

Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia. Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment. This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.

- EligibilityCriteria: Inclusion Criteria: Participant is willing and able to give informed consent Aged 18 years and above Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or duration, accompanied by other night / daytime symptoms, present for between 2 weeks and 3 months Newly diagnosed with non-metastatic breast cancer Primary cancer treatment is surgery Exclusion Criteria: Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT. Pregnancy Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at study screening interview Dementia / Mild Cognitive Impairment Epilepsy Psychosis (schizophrenia, bipolar disorder) Current suicidal ideation with intent or attempted suicide within past 2 months Night, evening, early morning, or rotating shiftwork Current / previous psychological treatment for insomnia during the last 12 months Chemotherapy and / or radiotherapy commenced - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06294028

Not yet recruiting

International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction

Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias. On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies. Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.

- EligibilityCriteria: Inclusion Criteria: ischemic heart disease with history of infarction - LVEF> 35% (measured by MRI) sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest - having signed informed consent affiliated to a social security system Exclusion Criteria: transient regressive cause of ventricular tachycardia recent myocardial infarction (<2 months) ventricular tachycardia by reentry from branch to branch serious conduction disturbances (with indication of stimulation) contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy <1 year, relevant comorbidities) pregnancy age <18 years Patient under legal protection, guardianship or curatorship - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06294015

Not yet recruiting

Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.

Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops. Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment. The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates. The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.

- EligibilityCriteria: Inclusion Criteria: Patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops; Epitheliopathy refractory to conventional therapies (Artificial Tears, ointment, topical cyclosporine or punctal plug, etc.); National Eye Institute score of 3 or more for both eyes; Adults aged 18 to 90 years inclusively. Exclusion Criteria: Corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency); Glaucoma surgery within the last six (6) months; Previous corneal surgery; Active autoimmune disease; Frequent contact lense wear; Pregnant or actively breast-feeding; Known systemic infection with HIV, hepatitis B and C or syphilis; Known severe anemia (Hb < 100 g/L); Inability to give informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06293989

Not yet recruiting

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

- EligibilityCriteria: Inclusion Criteria: -patients between 18 and 70 years of age with a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature. Exclusion Criteria: *Patients aged > 70 years as central vertigo , *patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial, *history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid, *history of syncope or cardiac event, considerations of a central origin for vertigo *evidence of drug-induced vertigo or orthostatic hypotension *history of mental or neurological illness. - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06293976

Recruiting

Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study

Background: Reverse triggering (RT) is a frequent phenomenon observed in sedated patients under a mechanical ventilation mode called assist-control ventilation. RT is when the ventilator would trigger the patient's respiratory effort instead of the correct order of the patient's respiratory effort triggering the ventilator. Reverse triggering can have negative consequences (loss of protective lung ventilation, and causing double breaths - with the ventilator giving two consecutive breaths and not allowing the patient to exhale) but also offer some protective effects (avoid diaphragm disuse atrophy). The balance of its negative vs positive effects depends on its frequency and magnitude of its associated respiratory effort. Respiratory entrainment is the most often referred mechanism involving a change in patient's rate of breathing effort from that of patient's intrinsic rate to the rate of mechanical insufflation. The specific ventilatory settings associated with or responsible for RT remains unknown. Aims: To assess in mechanically ventilated critically ill patients the influence of the set respiratory rate (RR) and tidal volume (Vt) on the presence/development of RT and to describe the pattern of respiratory muscle activity during Reverse Triggering (RT). Methods. 30 adult patients (15 in each group), sedated and under assist-controlled ventilation will be included. Ventilator settings will be modified to modulate the frequency and magnitude of reverse triggering. Initially, with the ventilator on a mode called volume control, which means the ventilator controls the amount of air (tidal volume) and the number of breaths the patients gets every minute (respiratory rate [RR]). The tidal volume will be set at the current standard clinical practice setting (6 ml/kg of predicted body weight). The presence of an intrinsic respiratory rate will be assessed with an end-expiratory occlusion maneuver. Next, the number of breaths the ventilator gives per minute (RR) will be changed from 6 breaths less to 6 breaths more, in steps of 2 breaths every minute. The protocol will be repeated again changing the amount of air the patients gets (tidal volume) from 4, 5, 7 and 8 ml/kg. Continuous recordings of airway pressure, flow, esophageal pressure, electrical activity of the diaphragm, main accessory muscles and frontal electroencephalography will be obtained during the protocol and baseline clinical and physiological characteristics and outcomes will be recorded. A validated software will be used to detect RT and measure the intensity and timing of each muscle electrical activity and the magnitude of the inspiratory effort during RT.

- EligibilityCriteria: Inclusion criteria: Patients intubated for more than 12 hours On assist-control ventilation, not triggering the ventilator Exposed to sedation for at least 6 hours With a sedation-agitation score ≤ 4. Exclusion Criteria: primary severe neurological disorders previous lung transplant contraindications for esophageal catheter insertion current use of continuous neuromuscular blocking agents at the time of the study procedure severe metabolic acidosis (pH < 7.25) at the time of study procedure. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293963

Not yet recruiting

Front-of-package Label Effects in Latine and Limited English Proficiency Populations

The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are: What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products? What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products? Additionally, this experiment also aims to answer the following question: Do the benefits of front-of-package label designs differ by English proficiency and parental status? Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.

- EligibilityCriteria: Inclusion Criteria: Identifying as Latino or Hispanic Ages 18-55 years old Residing in US Exclusion Criteria: Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06293950

Recruiting

Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

- EligibilityCriteria: Inclusion Criteria: 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD Exclusion Criteria: Age > 14 years. Patient weighing < 10 kg. History of severe Allergy History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke. Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past. Evidence or history of severe, moderate, or uncontrolled systemic disease. Inability to follow the prescribed dosing and follow-up schedule. Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period. Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study. History of premature birth <35 weeks' gestation. Prior history of stroke in utero or other in utero insult. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 14 Years - StdAgeList: Child

NCT06293937

Not yet recruiting

Impact of Front-of-package Labels on Weight Bias Among Latines

The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are: Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers? Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers? Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs.

- EligibilityCriteria: Inclusion Criteria: Identifying as Latine or Hispanic Ages 18-55 years old Residing in the United States Exclusion Criteria: Not identifying as Latine or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06293924

Not yet recruiting

Pericardial Fluid Analysis in Recurrent Pericarditis

This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation. This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies.

- EligibilityCriteria: Inclusion Criteria: Patients with acute idiopathic or post-cardiac injury pericarditis who require diagnostic or therapeutic pericardiocentesis (Interventional arm) Subjects with non-inflammatory pericardial effusion who require diagnostic or therapeutic pericardiocentesis (First control arm) Patients who undergo cardiac surgery that involves a pericardiotomy (Second control arm) Exclusion Criteria: Pregnancy or breastfeeding Ongoing infections, including active viral hepatitis or Coronavirus Disease 19 (COVID-19) positivity in the previous 21 days Systemic inflammatory disorders not attributable to pericarditis, excluding inflammatory diseases in remission Solid or haematological malignancies, ongoing or less than 6 months disease-free interval or anti-blastic chemotherapy (excluding the hormone therapy) Immunosuppressive therapy for reasons other than pericarditis treatment. Moderate-severe kidney failure (GFR < 30 ml/min) Moderate-severe liver failure (Child-Pug B or C), active hepatitis Diabetes mellitus Severe hypoproteinemia/malnutrition - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: For the first two arms, patients from the primary care clinic (Emergency room department). For the third arm, patients who need to undergo cardiac surgery with pericardial sac involvement. - SamplingMethod: Non-Probability Sample

NCT06293911

Not yet recruiting

Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome

The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome. Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders. Then, they will be randomly divided into two groups according to the home treatment: in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study. Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.

- EligibilityCriteria: Inclusion Criteria: not bedridden patients with Down syndrome gingival inflammation and bleeding Exclusion Criteria: lack of compliance signalled by caregivers other systemic diseases - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06293898

Recruiting

Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

- EligibilityCriteria: Inclusion Criteria: Age: ≥18 years Has a life expectancy of ≥3 months Has documented locally advanced or metastatic HER2 expressing (IHC 1+ to 3+) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy Cohort 1: Subjects with HER2 expression in endometrial cancers (EC) Cohort 2: Subjects with HER2 expression in cervical cancers (CC) Cohort 3: Subjects with HER2 expression in ovarian cancers (OC) Cohort 4: Subjects with HER2 expression in urothelial cancers (UC) Cohort 5: Subjects with HER2 expression in biliary tract cancers (BTC) Agree to provide existing tumor samples Has at least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1 Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 Toxicity of previous antitumor therapy has returned to Grade ≤1 Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50% Has adequate organ function before registration Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN Urinary protein ≤2+ or ≤1000 mg/24 hours For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy test must be negative and subject must be nonlactating. Must agree to use adequate contraceptive measures during the treatment and for 6 months after the end of treatment for all subjects (regardless of gender) Exclusion Criteria: Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration Subjects with history of severe heart disease Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block Subjects who received treatment with topoisomerase 1 inhibitors as a free form or as other formulations Active autoimmune diseases and inflammatory diseases Other malignant tumors diagnosed within 5 years prior to the first administration considered to be in remission Subjects with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) Subjects who have Grade 3 lung disease or a history of interstitial lung disease Deep vein thrombosis or pulmonary embolism unless under adequate anticoagulant treatment Patients with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and/or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (<20 mg prednisone or equivalent/day) may participate. Subjects who have a history of allergies to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL M07D1 Subjects who have a history of autologous or allogeneic stem cell transplantation Has received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2 Known human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > the lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > the lower limit of detection) Subjects with active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc. Participated in another clinical trial within 4 weeks or two half-lives (whichever is longer) prior to first dose of study treatment Other conditions that the investigator believes are not suitable for participating in this clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293885

Not yet recruiting

Pleurodesis Using Hypertonic Glucose

Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.

- EligibilityCriteria: Inclusion Criteria: Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system Exclusion Criteria: - None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293846

Not yet recruiting

BeFit Toolbox Collaboration: Building Empowerment Through Fitness

This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.

- EligibilityCriteria: Inclusion Criteria: Eligibility criteria for participants are as follows: female, at least 18 years of age, mothers of school-aged children (K-12), tenants of HABD in good standing with a minimum of one year of stable living arrangements, and availability during program hours. Exclusion Criteria: Inability to understand study instructions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: This is a women&#39;s health study investigating barriers women heads of household face in engaging in physical activity. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293820

Not yet recruiting

A Study Of TL-925 For The Treatment of AC

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally. The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.

- EligibilityCriteria: Inclusion Criteria: Individuals aged 18 years or older Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study. Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months. Calculated best-corrected visual activity of 0.7 LogMAR or better Positive bilateral CAC reaction Exclusion Criteria: Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study. Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months Any ongoing ocular infection (bacterial, viral or fungal) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293794

Not yet recruiting

Decision Support for Heart Failure Prescribing

Clinical decision support (CDS) tools can 'nudge' clinicians to make the best decisions easy. Although required by "meaningful use" regulations, more than 40% of CDS lead to no change and the remaining lead to improvements that are modest at best. This is because CDS tools often ignore contextual factors and present irrelevant information. Although many tools have undergone patient-specific optimization, 'traditional CDS' are rarely clinician-specific. For example, a traditional CDS tool for beta blockers and heart failure with reduced ejection fraction (HFrEF) addresses common prescribing misconceptions by stating asthma is not a contraindication and providing a safe threshold for blood pressure. For clinicians without these misconceptions, these statements are irrelevant and distract from key information. A 'personalized CDS' would evaluate clinician past prescribing patterns to determine whether prescribing misconceptions might exist and then conditionally present information to address those misconceptions. The objective of this research is to create personalized clinician-specific CDS that overcome shortcomings of traditional CDS. The central hypothesis is a personalized CDS that minimizes irrelevant information will lead to a higher rate of prescribing guideline-directed management and therapy (GDMT) for HFrEF compared to a traditional CDS.

- EligibilityCriteria: Inclusion Criteria: The study subjects are potential users of the CDS, specifically clinicians with prescribing privileges who practice at one of the health system's (UCHealth) outpatient cardiology or primary care clinics. Because we are observing their prescribing behaviors, we are also evaluating patient characteristics which could influence their prescribing decisions. Exclusion Criteria: Clinicians who do not practice in cardiology or primary care clinics or do not practice within UCHealth system. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult

NCT06293781

Recruiting

Application of the Web-based Acceptance and Commitment Therapy for Depression

PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY

- EligibilityCriteria: Inclusion Criteria: Patients who diagnosed major depressive disorder Exclusion Criteria: Patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease Women who were pregnant or nursing Patients at high risk for suicide - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06293742

Recruiting

ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants.

- EligibilityCriteria: Inclusion Criteria: Male and female participants of non-childbearing potential (NCBP) between the ages of 18 to 65 years of age BMI of 18.0 to 32.0 kg/m2 Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence Male participants agree to use contraception, or agree to practice true abstinence No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history Able to understand and sign and date informed consent Exclusion Criteria: Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study Concomitant participation in any investigational study of any nature Blood loss of non-physiological reasons ≥ 200 ml (i.e., trauma, blood collection, blood donation) within 2 months prior to the first dose of study treatment, or plan to donate blood during this trial and within 1 month after the last dose of study treatment Serum calcitonin > 20 ng/L Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC History of pancreatitis Significant allergic reaction to active ingredients or excipients of the study drug Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study Used or plan to use any drugs or substances that can modulate the activity of CYP3A4 within at least 14 days prior to the first dose of study treatment until after their final follow up visit Use of drugs with enzyme-inducing properties such as St. John's Wort within 3 weeks prior to the first dose of study treatment until after their final follow up visit - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06293729

Not yet recruiting

Safety and Efficacy Study of NGGT006 in Refractory Hypercholesterolemia Patients

This is an early phase 1, open-label, single-center, dose-escalation pilot trial to evaluate the safety and efficacy of an intravenous infusion of NGGT006 in patients with refractory Hypercholesterolemia diagnosed by gene testing for familial hypercholesterolemia. NGGT006 uses adeno-associated virus (AAV) as a vector, carrying a liver specific promoter and codon optimized human LDLR gene, driving the expression of LDLR protein with normal function and promoting the clearance of low-density lipoprotein cholesterol (LDL-C).

- EligibilityCriteria: Inclusion Criteria: 18 ≤ age ≤ 55 years old; A patient with a clear diagnosis of refractory hypercholesterolemia and confirmed by genetic testing to be familial hypercholesterolemia; AAV binding antibody titer ≤1:80 and AAV neutralizing antibody ≤1:5; 18≤BMI (body mass index)≤35; During the screening period, the subjects have received stable maximum tolerated dose of lipid-lowering drug treatment, but LDL-C was still ≥70mg/dL with clinical atherosclerotic cardiovascular disease; or LDL-C level was ≥ 100 mg/dL without clinical atherosclerotic cardiovascular disease: the highest tolerated dose refers to (the following must be met at the same time): ① Moderate to high doses of statins for ≥4 weeks, whether used alone or in combination with other lipid-lowering drugs; exceptions: subjects cannot tolerate statins; or subjects cannot receive statin treatment due to other reasons, such as low BMI, etc.; ② Ezetimibe ≥ 4 weeks; ③ Alirocumab 150mg Q2W or 300mg Q4W; evolocumab 140mg Q2W or 420mg Q4W; ≥8 weeks; And during the clinical trial process, any adjustment involving the type and dosage of lipid-lowering drugs must be approved by the researcher; Stable healthy diet for ≥12 weeks, and can adhere to a healthy diet throughout the entire clinical trial; Voluntarily sign the informed consent form and be willing to comply with the trial visit plan; Willing to maintain a similar amount and intensity of exercise during the study period as during the baseline period; Maintain good living habits, have no history of alcoholism or alcohol dependence (ICD-10 diagnosis is F10) No new or recurring cardiovascular events (myocardial infarction, cerebral infarction, etc.) within half a year; No stent implantation plan within three months; Female subjects have not had sexual intercourse for 14 days before administration, and their blood tests indicate that they are not pregnant; Subjects of childbearing age agree to use highly effective contraceptive measures for at least 365 days from the time of NGGT006 administration. Exclusion Criteria: Secondary hyperlipidemia; Use of other drugs or nutritional products that may affect blood lipids (such as fibrates) within 6 weeks; Have received low-density lipoprotein apheresis (LDL apheresis) within the past 2 months; Large weight fluctuations (≥5kg) in the past 2 months; Positive for hepatitis B surface antigen, hepatitis C, human immunodeficiency virus (HIV)，syphilis test or other infections (such as Epstein-Barr virus, Mycoplasma pneumoniae, tuberculosis virus, HPV, Chlamydia pneumoniae, respiratory syncytial virus, Adenovirus and coxsackievirus group B, etc.); Clinically significant abnormalities in liver function test: alanine aminotransferase (ALT) >2 × upper limit of normal (ULN) and/or aspartate aminotransferase (AST) >2 × ULN; RR at the baseline >160/100mmHg (one repeated measurement is allowed); Uncontrollable myocardial infarction or heart failure, and those planning surgery within one year; or new acute coronary syndrome in the past six months; Diabetes diagnosed within 3 months or with poor control (HbA1c >9%); Abnormal thyroid function, or those using thyroid hormone replacement therapy but poorly controlled (TSH within the normal range for <12 weeks); Acute or chronic renal insufficiency; Hemoglobin (Hb) < 120g/L (male), Hb < 110 (female); Abnormal platelet counts or morphology; History or laboratory tests suggestive of thrombosis; Had contraindications to glucocorticoid (e.g., epilepsy, severe schizophrenia, active peptic ulcer)； Used systemic glucocorticoid treatment within 6 weeks before enrollment; Life expectancy less than 1 year; Suffering from malignant tumors such as liver cancer; liver fibrosis; Previous gene therapy treatment; Hypersensitivity to AAV preparations (for example trehalose) or cortisone or immunosuppressants (sirolimus, rituximab, tacrolimus); Suffering from immunodeficiency disease Participation in any other clinical trial within 3 months; Breastfeeding females; Any other condition that may not be appropriate for the study in the opinion of the Investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06293716

Not yet recruiting

CVL237 Tablets for APDS/PASLI

This study was designed to evaluate the efficacy and safety of CVL237 tablets in patients with APDS/PASLI (activated phosphoinositol 3-kinase δ syndrome /p110 delta-activated mutation leading to senescent T cells, lymphadenopathy, and immune deficiency).

- EligibilityCriteria: Inclusion Criteria: Male and female patients aged 18-75 years (including boundary values); Patients with a clinical phenotype consistent with APDS, including a history of recurrent ear, sinus, or lung infections (more frequently than expected in immunoactive individuals), and patients known to have type 1 APDS-related gene PI3K mutations (e.g., E1021K, N334K, E525K, and C416R) or type 2 APDS-related mutations; In Parts I and II, the patient must have lymph node and/or extranodal lymphocyte proliferation, as well as clinical findings and manifestations consistent with APDS/PASLI, such as a history of recurrent ear - sinus - lung infections and/or organ dysfunction (e.g., lung, liver). In addition, in Part II, patients must have at least one measurable lymph node lesion on a CT or MRI scan. During screening, vital signs (systolic blood pressure, diastolic blood pressure, and pulse rate) were assessed by sitting position after at least 3 minutes of rest. Seated vital signs should be within the following range: Systolic blood pressure, 90-139 mm Hg Diastolic blood pressure, 50-89 mm Hg pulse rate, 50-100 bpm; Up to 110 bpm in teenagers Expected survival ≥3 months; Pregnant or lactating women or fertile women with a negative pregnancy test at baseline; Men and women with 6) fertility must consent to the use of medically approved contraceptive methods during the study period and within 6 months after the last dosing; Did not participate in any clinical trials within 1 month before joining the study; Able to comply with the test protocol (as determined by the investigator); Volunteer to participate in this clinical trial, understand the study procedure and be able to sign the informed consent in person. Exclusion Criteria: Previous or concurrent use of immunosuppressive drugs, such as: Use of mTOR inhibitors (e.g., sirolimus, rapamycin, Everolimus) or PI3kδ inhibitors (selective or non-selective PI3K inhibitors) within 5 half-lives prior to initial medication, but allow short-term use, for a total of no more than 5 days, but only within 1 month prior to enrollment in the study. Use B cell depleting agents (e.g. Rituximab) within 5 half-lives prior to initial administration; If the patient has previously been treated with B cell depleting agents, the absolute B lymphocyte count in the blood must return to normal. had taken Belimumab or cyclophosphamide within 5 half-lives before first taking the study drug. Use of cyclosporin A, nystatin, 6-mercaptopurine, azathioprine, or methotrexate within 5 half-lives prior to first administration of the study drug. Use more than 25 mg of prednisone or an equivalent dose of glucocorticoids daily for 2 weeks prior to the first dose. Other immunosuppressive drugs whose effects are expected to remain at the start of the study. Being treated with known OATP1B1 and OATP1B3 substrate drugs, CYP3A4/5 substrate drugs, intermediate-acting and potent CYP3A4/5 inhibitors, CYP3A4/5 potent inducers, if treatment cannot be terminated or switched to another drug before initiating investigational therapy; Drugs currently used that are metabolized by the isoenzyme CYP1A2 and have a narrow therapeutic index (exposure responses indicate that drugs that accompany increasing their exposure levels with the use of powerful inhibitors may cause serious safety concerns (e.g., tip torsion ventricular tachycardia)) Current history of liver disease or chronic disease, unless liver enlargement is determined by their clinicianto be secondary to APDS, or known liver or biliary tract abnormalities (other than Gilbert syndrome or asymptomatic gallstones) The investigator determined that the patient had clinically significant abnormalities in laboratory results (blood routine, blood biochemical, or urine routine) Patients with liver disease or liver injury, clinically significant abnormal liver function tests (alanine aminotransferase and aspartate aminotransferase > 2.5 times the upper limit of normal), a history of kidney injury/kidney disease (e.g., kidney trauma, glomerulonephritis, or having only one kidney), or impaired kidney function, The serum creatinine level was >1.5 mg/dL (133 μmol/L). LVEF < 50%, Fridericia corrected QT Interval (QTcF) ≥450 ms for men and 470 ms for women; If a subject's clinical abnormality or laboratory parameters are not specifically listed in the inclusion or exclusion criteria and are outside the reference range of the studied population, they may be included in the study only if the investigator agrees and records that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedure. The history of regular alcohol consumption within 6 months of the study was defined as an average weekly intake of > 14 units. One unit is equivalent to 8 grams of alcohol: half a pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 glass (25 ml) of spirits. Screen positive for substance abuse. Testing for drugs used for legitimate medical purposes (e.g. benzodiazepines, opioid analgesics) does not necessarily exclude study participation and will be at the discretion of the principal investigator. A history of sensitivity to any investigational drug or its components (including lactose) or to a history of drug or other allergies (including milk protein allergies) that the investigator deemed unsuitable for participation in the study. Positive hepatitis B surface antigen (HBsAg) and hepatitis C antibody test results at the time of screening or within 3 months before first receiving the study drug. Patients infected with hepatitis B virus (HBV) or hepatitis C virus (HCV) (defined as Hepatitis B Surface antigen (HbsAg) and/or Hepatitis B core antibody (HbcAb) positive and HBV DNA > 500 IU/mL or > 2500 copies/mL; Positive anti-HCV antibody and HCV-RNA quantification > upper limit of normal test unit). Have uncontrolled pulmonary fibrosis, acute lung disease, interstitial pulmonary inflammation; People with active viral, bacterial, fungal or other infections requiring systematic treatment (e.g., active tuberculosis), excluding nail bed fungal infections; Blood donation/blood loss ≥400 ml or more within 8 weeks before the first dose; History of immunodeficiency (acquired and congenital), history of organ transplantation, allogeneic bone marrow or hematopoietic stem cell transplantation; Active autoimmune disease or history of autoimmune disease (such as autoimmune enteritis and systemic lupus erythematosus); There are many factors affecting drug administration and absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction (functional). Participants participated in a clinical trial and received the investigational drug during the following time period prior to administration of the first investigational drug in this study: 30 days, 5 half-lives, or twice the duration of the investigational drug's biological effect, whichever is older. Present with difficult or important cardiovascular disease: history of heart or aortic surgery; History of myocardial infarction; Had uncontrollable angina in the 6 months prior to the screening period, or is currently taking anti-angina medication; Grade III/IV congestive heart failure; Arrhythmias requiring clinical intervention; Any other cardiovascular disease that the investigator determines is not suitable for participation in the study; Live vaccines (including any attenuated live vaccines) were administered within 6 weeks before the first administration of the trial drug, during the study period and within 7 days after the last administration of CVL237 tablets. Patients who cannot stop taking medications that may cause QT prolongation, such as antiarrhythmic drugs, during the study period. The patient has a history of malignancy (other than lymphoma) or evidence of residual disease from a previously diagnosed malignancy within 3 years prior to initial dosing; Subjects deemed unsuitable for this trial for other reasons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06293703

Recruiting

Effect of Limb Length Ratio on Roux-en-Y Gastric Bypass Outcomes (CLIMB II Study)

The investigators propose a randomized controlled trial comparing BP and roux limb lengths measuring 30 and 15% respectively of patient's total small bowel length versus current standard practice using fixed lengths. The findings would provide further insight into feasibility of standardizing RYGB limb lengths and optimizing resultant weight loss and metabolic effects. The investigators hypothesize RYGB with ratio-adjusted limb lengths (aRYGB) will result in higher total weight loss and resolution of metabolic syndrome comorbidities, including diabetes, hyperlipidemia, and hypertension compared to standard fixed-length RYGB (sRYGB). The study will also utilize the Short Form Rand 36-Item Health Survey (SF36) to determine differences in postoperative quality of life metrics.

- EligibilityCriteria: Inclusion Criteria: morbidly obese patients (defined by BMI between 40 and 60). Patient who understands and accepts the need for a long-term follow-up. Patient who agrees to be included in the study Exclusion Criteria: individuals unable to understand and sign a written consent form patients with history of previous bariatric surgery procedures presence of a severe and evolutive life threatening pathology unrelated to obesity previous gastric or small bowel resection active cancer pregnancy or desired to be pregnant during the study mentally unbalanced patients under supervision or guardianship, patient unable to give consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06293690

Not yet recruiting

Toripalimab Combined With SBRT for NSCLC

This study aimed to evaluate the efficacy and safety of Toripalimab injection (js001) combined with SBRT radiotherapy and neoadjuvant therapy with or without chemotherapy for operable or potentially operable stage IIa to IIIb NSCLC

- EligibilityCriteria: Inclusion Criteria: Age range from 18 to 75 years old, regardless of gender; ECOG behavior status score 0-1 points; Non small cell lung cancer diagnosed pathologically and clinically classified as stage IIA-IIIB (8th AJCC staging standard); Sufficient tumor tissue can be provided for biomarker analysis; Patients with distant metastasis are excluded through CT or PET/CT, and their physical condition is evaluated as acceptable for radical lung cancer surgery; Primary lung lesions are suitable for SBRT treatment; Confirming the absence of EGFR/ALK/ROS-1 sensitive gene mutations through molecular pathological diagnosis of the organization; The main organ functions within 7 days before the first administration meet the following standards: a Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11 treatment received within 14 days prior to platelet count test);b Coagulation function: INR and PT&lt;1.5 × ULN, APTT ≤ 1.5 × ULN;c Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in subjects with Gilbert&#39;s syndrome or liver metastasis) × ULN);d Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);e Adequate lung function: According to the doctor&#39;s judgment, lung function can meet the requirements of thymectomy surgery. Exclusion Criteria: Pathological findings indicate complex small cell lung cancer, etc; History of previous lobectomy surgery and previous experience with radiotherapy and chemotherapy; Patients with concurrent secondary primary cancer and a history of malignant tumors less than 5 years (excluding completely cured cervical carcinoma in situ or basal or squamous cell skin cancer); The patient has any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, etc.); Have active infection or active tuberculosis history requiring systemic treatment; Those who have combined the following active infectious diseases, including those who are highly positive for hepatitis, known human immunodeficiency virus (HIV) infections, and sexually transmitted diseases such as active syphilis; Those who are known to have or combine with other uncontrollable diseases and are unable to receive surgical treatment; Physical examination or clinical trial findings that researchers believe may interfere with the results or increase the risk of treatment complications for patients; Previous history of interstitial lung disease, drug-induced interstitial disease, or any clinically proven active interstitial lung disease, baseline CT scan reveals the presence of idiopathic pulmonary fibrosis; Uncontrolled large amounts of pleural or pericardial effusion; Unstable systemic comorbidities (active infection period, moderate to severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina, congestive heart failure, myocardial infarction occurring within 6 months, severe mental disorders requiring drug control, metabolic diseases of the liver, kidney or other organs, neuropsychiatric disorders such as Alzheimer&#39;s disease); History of congenital or acquired immunodeficiency diseases or organ transplantation; Have received any of the following treatments:a Previously received chemotherapy, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs, or other drugs that synergistically inhibit T cell receptors such as CTLA-4, OX-40, and CD137; Received any investigational medication within 4 weeks prior to the first use of the investigational medication;b Simultaneously enroll in another clinical study, unless it is an observational (non-intervention) clinical study or an intervention clinical study follow-up;c Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the investigational drug;d Having undergone major surgery or severe trauma within 4 weeks before the first use of the investigational drug; - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06293677

Not yet recruiting

Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance

This clinical trial focuses on children with cancer who face infections after receiving chemotherapy. Chemotherapy affects the bone marrow, leading to a decrease in the production of certain white blood cells, particularly those that defend against bacterial infections (neutrophils). One significant concern is febrile neutropenia, where children experience a fever during a period of low white blood cell count. This condition often results from bacterial infections, necessitating prompt wide-spectrum antibiotic treatment. However, some children eliminate antibiotics in the urine too quickly during febrile neutropenia. Their kidneys function more than they normally do (renal hyperfiltration). This can lead to insufficient exposure to antibiotics to control the infection. The current standard antibiotic regimens do not account for this variable elimination rate. In this study we focus on two antibiotics used in this context: piperacillin-tazobactam and meropenem. The main questions this study aims to answer are, in these children: Would higher doses of antibiotics result in better blood levels of antibiotics? Would they have more sides effects with higher antibiotics dosages? Would they recover more quickly with higher antibiotic doses? All patients will undergo a blood test upon hospital arrival, including an assessment of renal function. If renal function is normal or diminished, the patient will receive the standard antibiotic dose. Children with increased renal function will be randomly assigned to two groups during each episode of febrile neutropenia. One group will receive standard antibiotic dosages, while the other will receive higher doses to compensate for renal hyperfiltration. Throughout the study, antibiotic levels in the blood will be monitored for all patients. This monitoring will determine if target concentrations can be achieved more quickly with experimental dosages and will allow doctors to readjust the doses if needed.

- EligibilityCriteria: Patients' inclusion criteria Oncologic patients aged 2 months to 17 years (older than 60 days and younger than 18 years), High probability of febrile neutropenia during the study period Written informed consent from parents and adolescents older than 14 years Patients' exclusion criteria Neutropenia not related to cancer and/or chemotherapy Refusal to participate Non-French speaking parents/patients older than 11 years old Absence of febrile neutropenia or agranulocytosis during the study period (secondary exclusion) Febrile neutropenia episodes inclusion criteria Febrile neutropenia or agranulocytosis defined as: Neutropenia: absolute neutrophils &lt;500 cells/µL or agranulocytosis: absolute neutrophils &lt;100 cells/µL or patients expected to be neutropenic in the next 24 hours due to ongoing chemotherapy body temperature (tympanic or axillary) ≥38°C during at least one hour or a single T ≥38.5°C At least 2 weeks after the end of the previous antibiotic treatment for another included episode of febrile neutropenia. Febrile neutropenia episodes exclusion criteria: Severe renal failure (GFR&lt;15 mL/min/1.73 m²) Pregnancy Inability to obtain the first therapeutic drug monitoring (TDM) result within 72 hours of sampling (e.g. admission before or during public holidays laboratory closure) - HealthyVolunteers: No - Gender: All - MinimumAge: 61 Days - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06293664

Recruiting

Protocol for Alpha MSH Infusion Study in Patients With Type 2 Diabetes

Alpha-melanocyte stimulatory hormone (α-MSH) is a melanocyte-stimulating hormone produced by the hypothalamus and released from the pituitary gland. It acts as an agonist to the melanocortin 5 receptor (MC5R) in human skeletal muscle, playing a role in glucose uptake and disposal. This study aims to investigate whether α-MSH can enhance glucose tolerance in patients with Type 2 Diabetes Mellitus (T2DM).

- EligibilityCriteria: Inclusion Criteria: People with T2DM treated with oral or injectable medications which have been stable for 3 months, but not insulin therapy for type 2 diabetes. Stable body weight and HbA1c for at least 3 months The participant is capable of giving written informed consent The participant is able to read, comprehend and record information written in English Exclusion Criteria: Previous or current psychiatric diagnosis listed in DSM-V Axis 1. Significant current or past medical or psychiatric history that, in the opinion of the investigators, contraindicates their participation. History of type 1 diabetes mellitus. History of endocrine disorder. History of ischaemic heart disease, hypertension (current BP > 160/95 mmHg), heart failure, cardiac arrhythmia, peripheral vascular or cerebrovascular disease. History or presence of significant respiratory, gastrointestinal, hepatic, oncological, neurological or renal disease or other condition that in the opinion of the Investigators may affect participant safety or outcome measures. Unwillingness or inability to follow the procedures outlined in the protocol. History of sensitivity to any of the peptides, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators, contraindicates their participation. Use of current regular prescription or over-the-counter medications that in the opinion of the Investigators may affect participant safety or outcome measures. Clinically significant abnormalities in screening electrocardiogram (ECG) or blood tests abnormalities which in the opinion of the study physician, is clinically significant and represents a safety risk. Current pregnancy or breast-feeding in female participants (the investigators would advise using contraception for the duration of the study). Pulse rate <40 or >100 beats per minute OR systolic blood pressure >160 and <100 and a diastolic blood pressure >95 and <50 in the semi-supine position. The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first experimental visit in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). Exposure to more than 3 new investigational medicinal products within 12 months prior to the screening. Participants who have donated, or intend to donate, blood within three months before the screening visit or following study visit completion. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06293651

Not yet recruiting

Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors

This study is an Open-Label, Phase 1/2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.

- EligibilityCriteria: Inclusion Criteria: Aged 18 and older. Capable of giving signed informed consent. Diagnosed with particular disease characteristics. Expected survival ≥ 3 months. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. A female patient is eligible to participate if she is not pregnant or breastfeeding. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy. Have measurable disease by revised RECIST v1.1 criteria. Exclusion Criteria: Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption. Current enrollment or past participation in another clinical trial. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy. Autologous transplantation within 60 days. Prior allogeneic transplantation. Major surgery within 30 days, or unresolved complications after a major or minor surgery. History of or currently active cardiovascular disease. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders. History of other malignancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293638

Recruiting

Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor

The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will be asked to remain seated with their head inside of a Magnetoencephalography (MEG) recording system as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.

- EligibilityCriteria: Inclusion Criteria: Between 40 and 80 years of age; Ability to provide informed consent; Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and being treated with a DBS; OR Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and not being treated with a DBS; OR No known neurological disease or disorder. Exclusion Criteria: Secondary Parkinsonism, stroke, or progressive central nervous system disease other than ET; Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation other than depression or anxiety. History of cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, as documented in chart; Lack of English-language fluency which would interfere with the ability to understand the study consenting process and potential study risks; Hearing or visual impairment precluding testing; Motor impairment impacting test responses (i.e., orthopedic injury or disease). Anyone currently taking medications with Antabuse-like effects will be excluded from any alcohol administration. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Participants will be selected from the known patient population from a large research medical center located in a medium-to-large American city. - SamplingMethod: Non-Probability Sample

NCT06293625

Not yet recruiting

Personalising and Refining Neo-adjuvant Chemotherapy in Locally Advanced But Resecable Colon Cancer in the Elderly of 70 Years Old or More

Colon cancer (CC) is the 5th most common cancer worldwide. Standard care for locally advanced disease is surgical resection followed by 3-6 months of adjuvant chemotherapy (AC) with oxaliplatin and 5-fluorouracil (OxFp). Almost all of these patients undergo surgery, but many do not receive AC due to frailty (following surgery). This particularly affects patients over 70, who represent the majority of patients diagnosed with CC. FOxTROT 2, a trial to test the role of NAC in older patients.

- EligibilityCriteria: Inclusion Criteria: Biopsy-confirmed adenocarcinoma of the colon (or upper rectum if too high for radiotherapy), high-grade dysplasia is not acceptable , Patients with synchronous tumors are eligible, if the most advanced tumor meets the criteria above Radiological stage T3/T4 and N0/N1/N2 and M0 Patient eligible for curative surgery (without the necessity of chemotherapy) No clinical, radiological and colonoscopy evidence of bowel obstruction Age ≥ 70 at the time of registration pMMR/MSS tumour status Colon cancer specialist or geriatric oncologist (if available on site) assessed fit to receive 6 weeks (3 courses) of NAC with FOLFOX (either full or 80% of FOLFOX dose) and surgery Uracilemia <16 ng/ml. (homozygous for DPYD germline mutations will be done but it's optional) Adequate full blood count: WBC >3.0 x109/l; platelets >100 x109/l and neutrophils ≥ 1.5 x x109/l Anaemia (Hb < 10.0 g/dl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given according to the decision of the surgical and oncology teams. Serum electrolytes: Ca2+ > 2.1 mmol/L, Mg2+ > 0.65 mmol/L, K+> 3.4 mmol/LAdequate renal biochemistry: GFR >50 ml/min as assessed by local standards Adequate hepatobiliary function: bilirubin < 1.5 ULN (Patients with Gilbert's syndrome who have raised bilirubin but otherwise normal liver function tests are eligible for the study if bilirubin < 3 ULN) AST/ALT < 2.5 x ULN Patient able to understand and willing to provide written informed consent for the study Patient affiliated to a social security scheme Exclusion Criteria: Any patient for whom radiotherapy is advised by the MDT Strong evidence of distant metastases or peritoneal nodules (cM1), However, cases with indeterminate abnormalities should be managed and investigated as per standard local MDT procedures and can be considered for trial entry if the MDT opinion is that these are considered most likely to be benign. Peritonitis (secondary to perforated tumour) T1-T2 Serious medical comorbidity, as assessed by leading clinician (such as uncontrolled angina) Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk <10% Known dMMR/ MSI-H tumour status Have a peripheral sensitive neuropathy with functional impairment (≥ grade 2 according to NCI-CTCAE v5.0) Recent (within four weeks prior to randomisation) or concomitant treatment with brivudine, sorivudine or their chemically related analogues Person under guardianship, curatorship, and safeguard of justice or person deprived of liberty Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons Known hypersensitivity to the active substance of the trial treatments or to any of the excipients Patient with poor nutritional status at appreciation by each clinician bone marrow hypoplasia Potentially severe infection 1 month before NAC Patients who have received live attenuated vaccines (yellow fever, varicella, shingles, measles, mumps, rubella, tuberculosis, rotavirus, influenza) 1 month before NAC Any case of clinically significant active heart disease or myocardial infarction within 6 months, Any chronic condition not balanced in the last 6 months: Liver failure, renal failure, respiratory failure, QT/QTc interval > 450 msec for men and > 470 msec for women Known Pernicious anaemia or other anaemias due to vitamin B12 deficiency - HealthyVolunteers: No - Gender: All - MinimumAge: 70 Years - StdAgeList: Older Adult

NCT06293599

Not yet recruiting

Effect of Scapular Stabilization Exercises Versus Virtual Reality Exercises in Basketball Players With Scapular Dyskinesia

this study will be conducted to compare virtual reality and scapular stabilizing exercise among basketball player with scapular dyskinesia on scapular muscle performance, rounded shoulder, pain intensity , disability and hand grip strength

- EligibilityCriteria: Inclusion Criteria: ninety basketball players of both genders. Subjects with age between 20 and 25 years old. Subjects with Body Mass Index (BMI) ranging from 18 to 25 kg/m². Exclusion Criteria: An injury within the four weeks before testing. Upper extremity fractures. Bilateral repetitive strain injuries Osteoarthritis on hand - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 25 Years - StdAgeList: Adult

NCT06293586

Recruiting

Comparison Between Peribulbar And Sub-tenon Blocks on Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery

The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique.

- EligibilityCriteria: Inclusion Criteria: Participants were children (6-13 years), ASA I-II patients, scheduled to undergo strabismus surgery. Exclusion Criteria: Children with tumors or infections of the orbit, raised intraocular pressure more than 20 mm Hg, axial length more than 28 mm, eye injury, airway abnormalities or who were blind in the eye other than that which was to be operated on were excluded. Other exclusion criteria included patients undergoing revision surgery, known allergy to local anesthetics or non-steroidal antiinflammatory drugs (NSAIDs), steroid therapy, parental refusal to participate and patients with INR more than 1.5 or with platelets less than 100. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 13 Years - StdAgeList: Child

NCT06293560

Recruiting

Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children

The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC

- EligibilityCriteria: Inclusion Criteria: All MAC cases Parents of the above children. Siblings of the above children. English or Spanish speaking. Exclusion Criteria: All subjects who do not meet the inclusion criteria listed above. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Children diagnosed with congenital microphthalmia, anophthalmia, or coloboma (without a recognized syndrome). - SamplingMethod: Non-Probability Sample

NCT06293534

Not yet recruiting

Thyroid Dysfunction in Patients With Major Psychiatric Disorders

Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital

- EligibilityCriteria: Inclusion Criteria: patients with major psychiatric disorders admitted to psychiatric unit of neuropsychiatry department of Assiut university hospital in Egypt. Exclusion Criteria: pregnant or lactating females Patients on estrogen therapy or contraceptive Patients on carbamazepine, oxcarbazepine, phenytoin - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with mental illness, diagnosed based on DSM 5-TR and whose condition is severe enough to require admission in the psychiatric ward. - SamplingMethod: Probability Sample

NCT06293521

Not yet recruiting

Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

- EligibilityCriteria: Inclusion Criteria: Aged 4 to 6 years , in good general health The parents provided written informed consent. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue. Restorable teeth. Exclusion Criteria: With systemic disease. Physical or mental disability. Unable to attend follow-up visits. Refusal of participation. Previously accessed teeth. Swelling, tenderness to percussion or palpation, or pathological mobility. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 4 Years - MaximumAge: 6 Years - StdAgeList: Child

NCT06293508

Not yet recruiting

mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public

Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study, Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group.

- EligibilityCriteria: Inclusion Criteria: Malaysian women aged 40 years and above Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed. Have not been diagnosed with cancer before. Exclusion Criteria: Underwent Clinical Breast Examination in the past 12 months. Mammogram screening in the past 2 years. Subjects who are deemed to have cognitive impairment and unable to provide consent to the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult

NCT06293495

Not yet recruiting

Incidence of Cut-out Using Intramedullary Nails With Double Cephalic Screw vs. Unique in Pertrochanteric Fractures

The goal of this clinical trial is to compare outcomes in the treatment of proximal femur fractures. The main question it aims to answer is whether the use of a double cephalic screw prevents nail failure (cut-out). Participants will be treated using open reduction and internal fixation with a proximal femoral nail. Researchers will compare intramedullary nailing with a single cephalic screw (Gamma nail) and with a double cephalic screw (Chimaera nail) to see the cut-out rate.

- EligibilityCriteria: Inclusion Criteria: Patients with proximal femur fracture (OTA/AO 31-A1, A2 and A3) requiring surgical treatment. Signing of written informed consent according to current legislation before collecting any information, either by the patient or by the legal representative or by people linked by family ties. Exclusion Criteria: Presence of other fractures in the ipsilateral femur that condition the surgical treatment of the pertrochanteric femur fracture. Subcapital fracture of the proximal femur. Subtrochanteric fracture of the proximal femur. Pathological fracture. - HealthyVolunteers: No - Gender: All - MinimumAge: 70 Years - StdAgeList: Older Adult

NCT06293482

Not yet recruiting

Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population

This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation. Following cochlear implantation, participants will complete speech perception assessments and questionnaires over the course of seven visits.

- EligibilityCriteria: Inclusion Criteria: Individuals 18 or older at the time of consent Meets the following audiometric criteria for the ear to be implanted: clinically established sensorineural hearing loss (SNHL) defined by a four frequency pure tone average (PTA) at 500, 1000, 2000, & 4000 Hz of: ≥60 dB HL and compromised functional hearing in the aided condition defined as <50% correct on a word recognition test Meets the following audiometric criteria for the non-implanted contralateral ear: clinically established SNHL defined by a four frequency PTA at 500, 1000, 2000, & 4000 Hz of >30 dB HL Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator. Willing and able to provide written informed consent. Exclusion Criteria: Meets current indications on audiometric thresholds for traditional adult CI candidates (i.e., bilateral moderate to profound hearing loss in the low frequencies and profound [≥ 90 dB HL] hearing loss in the mid to high speech frequencies) Absence of cochlea development or a cochlear nerve Presence of active middle ear infection in the ear to be implanted Tympanic membrane perforation in the presence of active middle ear disease in the ear to be implanted Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation. Existing contralateral cochlear implant or medical plan to implant a contralateral cochlear implant during the clinical investigation. Pregnant or breastfeeding women. Women who plan to become pregnant during the course of the clinical investigation. Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator. Additional disabilities that may affect the participant's participation of safety during the clinical investigation. Unable or unwilling to comply with all of the requirements of the clinical investigation as determined by the investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Employees of Cochlear. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293469

Not yet recruiting

Accelerated Flap Coverage in Severe Lower Extremity Trauma

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

- EligibilityCriteria: The inclusion criteria are: Patients 18 years of age or older. Severe lower extremity open fracture and/or dislocation below the knee requiring an acute flap for management of the musculoskeletal injury. Will have all planned musculoskeletal injury surgeries performed by a participating surgeon or delegate. Able to be randomized within 48 hours of injury. Site anticipates being able to implement the accelerated flap protocol due to temporary local logistics. The exclusion criteria are: Primary amputation anticipated prior to attempted flap for management of the injury. Critical limb ischemia that requires re-vascularization for limb perfusion. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery. Burns at the musculoskeletal injury site. Incarceration. Currently enrolled in a trial that does not permit co-enrollment. Declined to provide informed consent. Unable to obtain informed consent due to language barriers. Unable to obtain informed consent because a legally authorized representative was unavailable. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient. Prior enrollment in the trial. Other reason to exclude the patient, as approved by the Methods Centre. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293443

Recruiting

Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

- EligibilityCriteria: Inclusion Criteria: Unilateral lower extremity amputation, Being using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities, Exclusion Criteria: Bilateral lower extremity amputation Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease, - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06293430

Not yet recruiting

Registry on Luma Vision's VERAFEYE System (ENLIgHT)

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures. Results from this study will be used to guide development of the VERAFEYE System.

- EligibilityCriteria: Inclusion Criteria: Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as intracardiac echocardiography imaging system, per physician discretion; Subject is able to understand and willing to provide written informed consent Subject is able and willing to complete all study assessments at an approved clinical investigational center Exclusion Criteria: Subject is contraindicated for intracardiac echocardiography (ICE) catheter placement or placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion Any known contraindication to intracardiac echocardiography imaging, including those listed in the system instructions for use Subjects with an indication for intracardiac echocardiography imaging that is not according to the system instructions for use Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure) Subjects who are currently enrolled in another study that would directly interfere with this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects will be recruited from the investigator's general patient population. Subjects considered for participation in this study will be entitled to undergo a standard of care AF ablation and/or LAAC procedure. - SamplingMethod: Non-Probability Sample

NCT06293417

Not yet recruiting

To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

The goal of this observational study is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: major adverse cardiovascular events within 48 months of the trial duration microvascular events within 48 months of the trial duration

- EligibilityCriteria: Inclusion Criteria: Patients with type 2 diabetes diagnosed by American Diabetes Association criteria Age ≥ 19 years Non-HDL-C ≥100 mg/dL, TG ≥200, <500 mg/dL on moderate-intensity statins with cardiovascular risk factor Exclusion Criteria: Pregnant or breastfeeding women Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.) Patient with myopathy and rhabdomyolysis AST/ALT more than 3 ULN Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with type 2 diabetes, Dyslipidemias - SamplingMethod: Probability Sample

NCT06293404

Not yet recruiting

The Effect of Spinal Column Flexion on Unilaterality of Spinal Anesthesia

The effect of two different positions on spinal anesthesia in hip fracture surgery

- EligibilityCriteria: Inclusion Criteria: ASA 1-2-3 Hip fracture 18-85 Age BMI: 18-40 Exclusion Criteria: ASA score of 4 and above Left ventricular ejection fraction below 40% Severe aortic valve stenosis Obesity (BMI >40) Presence of cardiac arrhythmia Having peripheral vascular disease Failure of spinal block Bleeding diathesis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06293378

Recruiting

Safety and Effectiveness of Sulfasalazine in the Treatment of Liver Fibrosis/Cirrhosis.

This is a controlled, observational clinical study initiated by investigators to investigate the efficacy and safety of sulfasalazine in the treatment of cirrhosis in patients with cirrhosis. Four cohorts were planned: primary biliary cirrhosis, hepatitis B and C cirrhosis, and alcoholic cirrhosis. The four groups were divided into experimental group and control group, and the experimental group: each group of patients was orally treated sulfasalazine for 12 months, taken three times a day, each time taking 0.5g. The control group did not take sulfasalazine. After 12 months, changes in fecal flora and metabolites before and after the use of sulfasalazine were observed.

- EligibilityCriteria: Inclusion Criteria: Sign the informed consent form before the trial and be able to complete the study in accordance with the requirements of the trial protocol; The age is 18~70 years old (including boundary value), the weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) in the range of 18~32kg/m2 (including critical value); Enrolled patients also need to meet: A:Patients with PBC cirrhosis (1) according to the biochemical response criteria for 2021 PBC, enrolled patients need to meet the criteria of ALP ≥1.67 × ULN as a poor biochemical response for UDCA; (2) meeting the diagnostic criteria for primary cholangitis (PBC) , i.e. meeting at least two of the following criteria: 1 indicators of cholestasis such as elevated Alkaline phosphatase; 2 Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive 3 liver biopsy consistent with PBC; Patients with newly diagnosed primary cholangitis (PBC-RRB- met the diagnostic criteria of at least two of the following: 1 indicators of cholestasis such as elevated Alkaline phosphatase; 2 Anti-mitochondrial antibody AMA or AMA-m2 positive, or if AMA negative, PBC-specific antibodies (anti-GP210 Andor anti-SP100) positive 3 liver biopsy consistent with PBC; B:Diagnosis of hepatitis B (C) cirrhosis based on clinical history, histology or imaging. Alcoholic hepatitis cirrhosis C:Diagnosis of alcoholic cirrhosis based on clinical history, histology, or imaging. Exclusion Criteria: Those who have a history of allergies in the past, or the investigator suspects that they are allergic to the active ingredients of the drug or their excipients under study; Allergy to sulfasalazine and its metabolites, sulfonamides or salicylic acid; Patients with intestinal obstruction or urinary tract obstruction; Patients with porphyria, such as sulfonamides, have been reported to cause acute attacks. Acute and chronic liver disease with clinical significance caused by infections other than HBV, HCV, PBC, and alcoholic liver disease; Primary liver cancer; alpha-fetoprotein (AFP) greater than 50 ug/L or imaging suggests malignant liver mass; Those with other malignancies or a history of other malignancies in the 5 years prior to screening (except for complete remission of malignant tumors after treatment and no additional medical or surgical intervention within 3 years prior to screening); The investigator judged that there is impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs, such as severe gastric ulcer, erosive gastritis, partial gastrectomy, and persistent >Grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, or diarrhoea); Serious diseases of circulatory, respiratory, urinary, blood, metabolic, immune, psychiatric, neurological, renal and other systems; Those who have had major trauma or undergone major surgery within 3 months before screening; or those who plan to undergo surgery during the study; Donated blood or lost blood ≥ 400mL within 3 months before screening, or received blood transfusion; or ≥ blood donation or blood loss within 1 month prior to screening 200mL； Those who are positive for AIDS antigen/antibody, positive for Treponema pallidum antibody and positive RPR test; History of drug dependence or drug abuse within 1 year prior to screening; Participate in clinical trials of other investigational drugs or medical devices within 3 months before screening, and take experimental drugs or use them Those who have medical devices; Those who have a positive pregnancy test during lactation or screening, or who have fertility requirements in the past two years; Subjects who the investigator believes have other factors that are not suitable to participate in this trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06293365

Not yet recruiting

Two-period Crossover Study to Demonstrate the Comparability of Pharmacokinetics of Subcutaneous Ianalumab Between 2mL Auto-injector/2mL PFS with1mL Pre-filled Syringe in Adult Participants With Autoimmune Disease

The purpose of this study is to demonstrate the comparability of ianalumab exposure following the sub-cutaneous (s.c.) administration of one injection of 300 mg/2 mL auto-injector (AI) versus two injections of 150 mg/1 mL pre-filled syringe (PFS), and to evaluate the safety and tolerability of ianalumab following the s.c. administration of both devices in participants with rheumatoid arthritis (RA), Sjögren's disease (SjD), or systemic lupus erythematosus (SLE). A second optional cohort may be included with the objective of demonstrating the comparability of pharmacokinetics of ianalumab between 1 x 2 mL Pre-filled Syringe (PFS) and 2 x 1 mL PFS.

- EligibilityCriteria: Key Inclusion criteria: Signed informed consent must be obtained before any assessment is performed. Male and female patients aged 18 years to 70 years (inclusive). Body weight at least 35 kg and not more than 150 kg and must have a body mass index (BMI) within the range of 18 - 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2 at screening. Diagnosed with RA, SjD and/or SLE as determined by the investigator. Have active disease (RA, SjD or SLE) that may benefit from B-cell depletion therapy, as determined by the investigator. Participants currently receiving protocol-allowed SoC should be on stable doses of SoC medications for 4 weeks prior to first dosing of study treatment. Ability to communicate well with the investigator, understand and agree to comply with the requirements of the study. Key Exclusion criteria: Use of prohibited therapies. Active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection. Plans for administration of live vaccines during the study period. Uncontrolled co-existing serious disease. Pregnant or nursing (lactating) women. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug. US (and other countries, if locally required): sexually active males unless using barrier protection during intercourse with women of child-bearing potential while taking study treatment. Other protocol-defined inclusion/exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06293352

Not yet recruiting

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in. We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria Exclusion Criteria: Patients who are unable to consent Infection at site of revision TKA Soft tissue envelope compromise Allergies to study materials (cement, vancomycin, tobramycin) Incompetent extensor mechanism Extensive bone loss Randomization-specific exclusion criteria Extensive soft tissue defect Extensor mechanism compromise - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293339

Not yet recruiting

Durability of Protection After Single Immunisation With GA2 Sporozoites (CoGA-Rechallenge)

This study will assess the durability of protection of a single immunisation with the Genetically Attenuated Parasite 2 (GA2) against controlled human malaria infection by rechallenging previously immunised and protected participants from the CoGA study (NCT05468606)

- EligibilityCriteria: Inclusion Criteria: Participant is aged ≥18 and ≤35 years and in good health. Rechallenge group only: participation in CoGA study, having received immunisation with 1x 50 GA2-infected MB, and protected during subsequent CHMI. Participant has adequate understanding of the procedures of the study and agrees to abide strictly thereby. Participant is able to communicate well with the investigator. Participant is available to attend all essential study visits. Participant agrees that his/her general practitioner (GP) will be informed about participation in the study. Participant agrees to refrain from blood donation to Sanquin or for other purposes. throughout the study period and for a defined period thereafter according to Sanquin guidelines. Participants of child bearing potential (i.e., have an uterus and are neither surgically sterilized nor post-menopausal) agree to use adequate contraception and to not breastfeed for the duration of study. Participant agrees to refrain from intensive physical exercise (disproportionate to the participants' usual daily activity or exercise routine) for twenty-one days following the immunization and during the malaria challenge period. Participant signs informed consent. Exclusion Criteria: Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions which could compromise the health of the participant during the study or interfere with the interpretation of the study results. These include, but are not limited to, any of the following: a. Body Mass Index (BMI) >35.0 kg/m2 at screening. b. An elevated risk of cardiovascular disease, defined as: i. An estimated ten-year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation 2 (SCORE2) . See Appendix 1 for the SCORE2 risk classification; ii. History, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or iii. A positive family history of cardiac events in first- or second-degree relatives (according to the system used in medical genetics) <50 years old. b. Known functional asplenia, sickle cell trait/disease, thalassemia trait/disease or G6PD deficiency. c. History of epilepsy in the period of five years prior to study onset, even if no longer on medication. d. Positive HIV, HBV or HCV screening tests. e. Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other drugs that might have an influence on the immune system (excluding inhaled and topical corticosteroids and incidental use of oral anti-histamines), within three months prior to study onset or expected use of such during the study period. f. Skin disease affecting the site of administration in such a way that administration of mosquito bites is deemed impossible by investigator. g. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years. h. Any history of treatment for severe psychiatric disease by a psychiatrist in the past year. i. History of drug or alcohol abuse interfering with normal social functioning in the period of one year prior to study onset, positive urine toxicology test for cocaine or amphetamines at screening. For participants of child bearing potential: breastfeeding, or positive serum pregnancy test prior to CHMI. Infection controls only: any history of malaria or previous participation in any malaria (vaccine) study or CHMI. Known hypersensitivity to or contra-indications for both atovaquone/proguanil or artemether/lumefantrine. QT prolonging drugs are only considered an exclusion criterion when QT prolongation is observed at the ECG at screening. A history of severe (allergic) reactions to mosquito bites. Participation in any other clinical study assessing an investigational medical product in the 30 days prior to the start of the study or during the study period. Any condition or situation that could influence the independent consent of participant (e.g. being a direct colleague or family member of study personnel). Any other condition or situation that would, in the opinion of the investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol or would compromise the integrity of the data. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06293326

Not yet recruiting

A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants

Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time. Heartburn is the burning sensation or pain in the chest which occurs when stomach acid rises up in the food pipe (esophagus). Calcium carbonate tablets are used to treat heartburn, indigestion, and related digestive problems. Calcium carbonate works by neutralizing the excess acid in the stomach. The study treatment is a new bi-layer calcium carbonate tablet that has two layers. One layer quickly releases calcium carbonate aimed to provide quick relief (called immediate release) while the other layer releases calcium carbonate slowly to make the relief last longer (called sustained release). In this study, bi-layer calcium carbonate tablets will be given to healthy men for the first time. This study will provide information on how the new bi-layer tablet works inside the body. The main purpose of this study is to learn about how the new bi-layer calcium carbonate tablet changes the average acidity levels (measured using pH) compared to the standard calcium carbonate tablet during the night-time. For this, researchers will measure the acidity levels in the upper part of the stomach at regular intervals during the night-time. The participants will be randomly (by chance) assigned to one of two treatment groups: Participants in the first group will take the treatments at night. Participants in the second group will take the treatments during the day. All participants in both groups will take 2 bi-layer tablets and 2 standard tablets after a meal with a gap of 6 to 8 days between treatments. However, in each group, half the participants will receive the bi-layer tablets first while the other half will receive the standard tablets first. Each participant will be in the study for around 52 days with up to 4 visits to the study site. This includes: visit about 28 days before the treatment starts during which the doctors will confirm that the participant can take part in the study visits for treatment with a gap of 6-8 days between each treatment, and 1 visit 7 to 14 days after the treatment ends during which the doctors will monitor the participants' health. During the study, the doctors and their study team will: check participants' overall health by performing tests such as blood and urine tests, and check heart health using an electrocardiogram (ECG) take images of the stomach at different times after taking the treatment measure acidity level (pH) using a device called pH probe that is inserted into the upper part of the stomach ask the participants questions about how easy it is to take the study treatment ask the participants what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think it is related to the study treatment, or not. As this study is conducted in healthy men who will not gain any benefit from this treatment, access to the study treatment after the study is not planned.

- EligibilityCriteria: Inclusion Criteria: Male Participant must be 18 to ≤65 years of age inclusive, at the time of signing the informed consent. Participants must have a verified diagnosis of "healthy": the results of the standard clinical, laboratory, and instrumental examinations are within the normal range (limits of reference range). The Investigator can interpret individual findings based on the participant's age, physical state and level of fitness. Participants with readings marginally outside the normal range may be included in the study if, in the Investigator's opinion, these are not clinically significant (NCS); this decision will be documented in the Case Report Form (CRF). Results of safety laboratory tests are within normal range (limits of reference range). Non-smokers or passive smokers exposed to smoke in an enclosed room for less than 4 h per week. Body mass index (BMI) within the range 18.5 to ≤30 kg/m2 (inclusive). Unless participant has had bilateral orchidectomy or a vasectomy (with confirmed sterility), must be abstinent from penile-vaginal intercourse for the duration of the study and agree to remain abstinent for 90 days after the last dose of IMP, OR agree to use a condom during each episode of penile-vaginal intercourse, in addition to their partner (if a person who could become pregnant) using a highly effective form of contraception as described in protocol. Participant has given written informed consent to participate in the trial prior to admission to the trial as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the protocol. Exclusion Criteria: A history of physical or psychiatric diseases (e.g., diabetes, hypothyroidism and other metabolic diseases, renal disease). Recent unexplained significant weight loss (6-7 kg) in the last 6 months. A history or current symptoms of Zollinger-Ellison syndrome, gastric carcinoma, peptic ulcer disease, pernicious anaemia, Barrett's oesophagus or systemic sclerosis. Meal-induced heartburn of severe severity, historically and - Use of any H2-receptor antagonist and/or PPI within one week prior to Screening. History and currently prescribed medication for treatment of heartburn associated with increased acidity, reflux esophagitis, and peptic ulcers. Current or history of drug or alcohol abuse. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06293313

Recruiting

The Effect of Mindfulness Practice on Coping With Primary Dysmenorrhea on Pain and Anxiety Level

The aim of this project is to determine the effect of mindfulness practice to cope with dysmenorrhea on pain and anxiety levels. The project will be carried out in a semi-randomized controlled manner. It will be applied to 100 students with dysmenorrhea (100 students by increasing by 10%, taking into account the losses that may occur in the 90 students determined in the sample calculation). Students who meet the inclusion criteria and approve of participating in the project will be given a pre-test before the application. 'Introductory Information Form', 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the pre-test. After the pre-test, mindfulness practice will be applied for 8 weeks (1 day/120 minutes per week). At the end of 8 weeks, an intermediate test will be performed in the first 3 days of the first menstrual cycle. After the mid-term test, students will practice mindfulness on their own with the brochures provided. Motivational messages will be sent to students for mindfulness practice, starting 3 days before their cycle. The final test will be administered 3 months after the intermediate test. 'VAS Scale' and 'State and Trait Anxiety Scale' will be used in the mid-test and post-test.

- EligibilityCriteria: Inclusion Criteria: Being over 18 years old, Being literate, Having dysmenorrhea, Volunteering to participate in the study, Participating in mindfulness practice for 8 weeks, Not using any pharmacological or non-pharmacological methods, Studying at Bartin University Exclusion Criteria: Not being a university student Not experiencing dysmenorrhea Not attending at least two mindfulness practices - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Female students who are 18 years of age or older studying at the university will be included. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293300

Not yet recruiting

Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

- EligibilityCriteria: Inclusion Criteria: Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities. ≥18 years of age who are able to consent. Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (>1 year). Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition. Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions. English as primary language (by self-report). Exclusion Criteria: Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc. Patients who are participating in another study with an investigational drug within one month prior to screening. Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or >12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan. Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293287

Recruiting

Enoxaparin for Preventing the Radical Artery Occlusion After the Transradial Access Hepatic Arterial Infusion Chemotherapy

The present investigation is designed as a single-blind, randomized, controlled, bicentric trial. The objective is to ascertain whether the subcutaneous administration of enoxaparin sodium for prophylactic anticoagulation during transradial hepatic arterial infusion chemotherapy (HAIC) can diminish the incidence of radial artery occlusion (RAO) post-procedure

- EligibilityCriteria: Inclusion Criteria: Signed informed consent; Age: 18-69 years; Pathologically diagnosed with hepatocellular carcinoma or clinically in accordance with the American Association for the Study of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma; Clinical stage: BCLC stage B or C, liver function Child-Pugh class A or B$ (≤7 points)$, ECOG $score <2$; suitable for HAIC treatment; Adequate hematological and organ function, i.e., based on laboratory results obtained within 7 days before treatment, such as complete blood count, liver and kidney function, coagulation function, myocardial enzymes, etc., to assess whether the patient is suitable for HAIC treatment; Low-risk patients for VTE (Venous Thromboembolism) according to the Padua scoring system (≤3 points). Exclusion Criteria: Concomitant primary tumors of other organs or histologically diagnosed tumors inconsistent with hepatocellular carcinoma; Serious diseases of the heart, lungs, kidneys, or other organs; Patients who have received trans-radial interventional surgery within the past 3 months; Patients with thrombocytopenia $and/or $leukopenia due to cirrhosis-related coagulation disorders or splenic hyperfunction are excluded; Preoperative radial artery ultrasound suggests vascular anatomical abnormalities, malformations, etc., unsuitable for trans-radial interventional treatment; Patients with thrombotic diseases who are undergoing anticoagulation therapy; Any unstable conditions or situations that may jeopardize the patient's safety or their compliance with the study; Pregnant and lactating women. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult

NCT06293274

Recruiting

The Importance of Discharge Education for Mommy Blues

The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province. The sample size of the study was calculated using the G*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.

- EligibilityCriteria: Inclusion Criteria: 38-42. Those who gave birth between weeks of gestation, Those who have had vaginal birth or caesarean section, Able to speak and understand Turkish, Those over 18 years of age, Mothers with a single healthy baby Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening Exclusion Criteria: Preterm or postterm birth, Received psychiatric treatment or used psychotropic medications during pregnancy, Having a history of substance dependence and/or use in the past 6 months, Being in the high-risk category, Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver), Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography). Participants who wish to withdraw from the study at any time will not be included in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06293235

Not yet recruiting

Towards Optimal Fertility, Fathering and Fatherhood studY

This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics.

- EligibilityCriteria: Inclusion Criteria: Subfertile couples: men aged ≥21-49 years men with a female partner aged 21-39 years couples who are not able to conceive for at least 12 months couples who are Singapore citizen or permanent resident Fertile couples: men aged 21-49 years men with a female partner aged 21-39 years men with proven fertility defined as those female partners who are currently pregnant and with viable intrauterine pregnancy at gestational weeks of less or equal to 16 at the time of the study couples with attempted time to conceive within 12 months to achieve this pregnancy or with unplanned pregnancy couples who are Singapore citizen or permanent resident Exclusion Criteria: Subfertile couples: male infertility of a known aetiology including azoospermia, retrograde ejaculation, genetic disorders, cancer treatment, or testes trauma female infertility diagnosis as confirmed by diagnostic imaging or having severe endometriosis female partners with irregular menstrual cycle >35 days couples with known chromosomal abnormalities Fertile couples: couples who achieve pregnancy after oocyte or spermatozoa donation couples with known chromosomal abnormalities female partners with known uterine abnormalities - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: Based on biological sex identity for males and females - MinimumAge: 21 Years - MaximumAge: 49 Years - StdAgeList: Adult - StudyPopulation: The subfertile couples will be recruited from the infertility clinics, while the fertile couples will be recruited from the antenatal clinics. Both groups will also be recruited from on-going preconception and pregnancy programs in the hospital. - SamplingMethod: Non-Probability Sample

NCT06293196

Recruiting

Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes

This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye.

- EligibilityCriteria: Inclusion Criteria: healthy people of all ages Exclusion Criteria: presence of systemic diseases history of other eye diseases, surgeries, and/or medications, as well as eye trauma incomplete healing of the surgical site after eye surgery consumption of coffee, tea, or vasodilators within 6 hours before the commencement of the test exclusion of children, pregnant, and lactating women - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06293183

Not yet recruiting

The Effect of Artificial Intelligence Supported Mobile Learning on Nutrition/Hydration Control and Individual Management

The adherence to recommended nutrition and fluid restrictions is crucial for the success of hemodialysis treatment. However, approximately 80% of patients receiving HD treatment are non-compliant with fluid restriction, leading to various complications. Cardiovascular complications are among the most common complications associated with this issue. When reviewing national and international literature on the subject, it is observed that in order to improve treatment adherence in HD patients, written materials are often used in addition to individual or group education sessions, focusing mainly on assessing patients&#39; quality of life and self-efficacy. However, a mobile-supported learning method that enables patients to manage their nutrition and fluid control individually is not commonly utilized. This research aims to investigate the impact of an artificial intelligence-supported mobile application developed for HD patients on the control of nutrition/fluid intake and individual management.

- EligibilityCriteria: Inclusion Criteria: 18 years and over, Conscious and able to communicate, Having received hemodialysis treatment for the last 3 months, Able to use an Android-based phone (for those who do not have a personal mobile phone, an application will be installed on the primary caregiver&amp;#39;s phone), Having a digital literacy scale score over 17, Patients who agree to participate in the research will be included in the research. Exclusion Criteria: Patients diagnosed with acute renal failure Having vision problems - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293170

Not yet recruiting

Automated Screening for Clinically Ascertained Loss of Cerebral Functions

Rationale: The low organ donation rate in Germany is associated with the inadequate identification of patients at risk of developing irreversible loss of brain function (ILBF; i.e. brain death). An automated digital screening tool, DETECT (AutomateD ScrEening for Clinically AscerTainEd Loss of Cerebral FuncTions in Patients with Severe Brain Damage), has been developed to prospectively identify intensive care patients who are at risk of developing ILBF. Objective: The objective of the study is to evaluate the effectiveness of an automated digital screening tool in the identification of patients with severe brain damage who are at risk of impending ILBF compared to standard practice without digital support. Study design: Stepped-Wedge, multicenter, cluster-randomized, controlled trial Study population: The study includes patients aged 18 years or older with primary and/or secondary acute brain damage, requiring mechanical ventilation, and who are deceased upon hospital discharge. Intervention: DETECT periodically processes real-time data from the corresponding electronic medical record system to screen for a combination of coma, indicated by a Richmond Agitation Sedation Scale (RASS) score of - 4 or - 5 or Glasgow Coma Scale (GCS) score of 6-3, along with manually assessed absence of bilateral pupillary light reflexes. Both findings are considered early indicators of impending ILBF. In case of positive screening results, an automated notification will be sent via the hospital's email server to the corresponding transplant coordinators and intensivists. The email sent aims to prompt clinical assessment of the reported patient and, if necessary, initiate a guideline-based ILBF examination. Primary study endpoint: The primary endpoint is the identification of patients who eventually develop ILBF during hospitalization. Secondary study endpoints: Secondary outcomes encompass the missed identification of potential ILBF cases (as retrospectively classified) and the rate of deceased organ donations. Upon completion of the study, a survey will be conducted to investigate the stakeholders' experiences with DETECT.

- EligibilityCriteria: Inclusion Criteria: Primary and/or secondary acute brain damage At least 18 years or older Necessity of mechanical ventilation Deceased upon hospital discharge Exclusion Criteria: • none - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293157

Recruiting

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants. Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants. Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment. Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.

- EligibilityCriteria: Inclusion Criteria: Metastatic spinal disease, ECOG quality of life of 0-2, Eligibility for SBRT treatment, Expected survival time >3 months, Signed informed consent to participate in the study, Sufficient organ capacity allowing to survive the perioperative period. Exclusion Criteria: Primary tumor of the spine, Age <18 years old, Expected survival time <3 months, Eligibility for palliative radiotherapy, No informed consent to participate in the study, Pregnancy or breastfeeding, The advancement of the disease preventing the technical use of implants. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06293144

Recruiting

the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People

Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM)

- EligibilityCriteria: Inclusion Criteria: Age ≥ 65 years ASA grade I~III BMI 18~28 kg/m2 Exclusion Criteria: Contraindications to intrathecal anesthesia Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months Difficult airway or having respiratory diseases such as upper airway obstruction Severe cardiovascular system diseases Severe hepatic or renal dysfunction Allergy or contraindication to propofol and its drug-related components Patient Prefusal - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult