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NCT06302634

Recruiting

Cardio-Oncology Rehabilitation Care Process

The objective of this observational study is to assess the outcomes of a hospital-based Cardio-Oncology Rehabilitation (CORe) program focused on exercise in cancer patients undergoing cardiotoxic treatment. This evaluation will be conducted by analyzing disease-related health indicators, functional capacity, and quality of life. Patients at risk of cardiotoxicity attending the Cardio-Onco-Hematology Unit will be offered the exercise program, which includes two modalities: in-person (center-based) and remote (home-based) options. The assignment to either modality is non randomized, based on the functional assessment conducted in the Rehabilitation Unit and the agreement between healthcare professional and patient. All participants will perform a 3-month supervised exercise intervention. There are 3 time points for assessment: at baseline (T0), 3-month after the exercise program (T1) and follow-up at 9 months from baseline (T2).

- EligibilityCriteria: Inclusion Criteria: High risk of cancer treatment-related cardiotoxicity Possibility of completing a cardio-onco rehabilitation program (centre-based or home-based) and programmed visits. Providing written informed consent. Exclusion Criteria: Patients with physical or mental limitation to carry out an exercise program. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Women with breast cancer at high risk of developing cardiotoxicity - SamplingMethod: Non-Probability Sample

NCT06302621

Not yet recruiting

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

This study is researching whether the combination of Afatinib and Pemigatinib is safe and effective in FGFR altered unresectable or metastatic advanced solid tumors. The study is also trying to discover the highest doses of the study drugs that can be administered without causing any intolerable side effects. This research study involves the study drugs Afatinib and Pemigatinib.

- EligibilityCriteria: Inclusion Criteria: All Patients Unresectable or metastatic, histologically confirmed advanced solid tumor, where standard curative or palliative measures are no longer effective or are not considered appropriate or safe in the opinion of the investigator. FGFR1-3 fusion, rearrangement, activating mutation, or FGFR2 extracellular domain in-frame deletions on tumor profiling in tumor tissue as determined by testing routinely performed at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on circulating tumor DNA (ctDNA) analysis alone, the patient may be eligible with principal investigator approval. Additional mutations may be considered with principal investigator approval. Eastern Cooperative Oncology Group (ECOG) 0-1. At least 18 years of age. Ability to swallow tablets. Life expectancy >/=3 months Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation. Patients with cholangiocarcinoma must have adequate biliary drainage (per investigator's discretion), with no evidence of ongoing infection. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment. Measurable or non-measurable disease as determined by RECIST 1.1. Adequate organ function defined as: ALT or AST ≤ 3 × the ULN in the absence of liver metastases, OR ≤ 5 × ULN with documented liver metastases Total bilirubin ≤ 2.0 × ULN in the absence of Gilbert's Disease, OR ≤ 3 × ULN with Gilbert's Disease provided direct bilirubin is ≤ ULN Serum Creatinine ≤ 1.5 × ULN OR calculated creatinine clearance ≥ 60ml/min Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Absolute Neutrophil Count ≥ 1.5 x 109/L Platelets ≥ 75 x 109/L INR or PT, aPTT or PTT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy NOTE: Transfusions to increase a patient's hemoglobin level or initiation of erythropoietin or G-CSF therapy to meet enrollment criteria are not allowed in the 14 days preceding the first dose of study drug. If a patient receives transfusions, erythropoietin, or G-CSF therapy ≥ 14 days prior to the first dose, the hematologic criteria listed above must be met following the 14-day window and prior to the first dose of study therapy Dose expansion cohort 1: Patients should fulfill the eligibility criteria above for all patients in addition to the following: Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma No prior treatment with a selective FGFR inhibitor treatment FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion on tumor profiling in tumor tissue as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval. An archived tumor tissue sample is available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval. Dose expansion cohort 2: Patients should fulfill the eligibility criteria above for all patients in addition to the following: Histologically or cytologically confirmed diagnosis of advanced or metastatic cholangiocarcinoma Prior FGFR inhibitor treatment at any time prior to treatment start is required FGFR2 fusion, in-frame rearrangement, or extracellular domain in-frame deletion for which they derived clinical benefit (objective response of any duration or stable disease for at least 6 months) from prior FGFR inhibitor therapy, as determined by testing routinely performed on tumor biopsy at a CLIA or other similarly certified laboratory. If the FGFR alteration is present on ctDNA analysis alone, the patient may be eligible with principal investigator approval An archived tumor tissue sample after progression on or intolerance of prior FGFR inhibitor available in patients not undergoing fresh tumor biopsy. Patients who do not have adequate archival tumor tissue available are required to undergo a fresh tumor biopsy. If a fresh biopsy cannot be safely performed, the patient may be eligible with principal investigator approval. Exclusion Criteria: Known hypersensitivity to afatinib or pemigatinib or excipients of pemigatinib For patients treated with a prior FGFR inhibitor, those with known activating mutation(s) in the FGFR2 kinase domain on ctDNA or biopsy analysis within 8 weeks of start of study drugs; activating mutations in the FGFR2 kinase domain seen on ctDNA or biopsy analysis prior to the 8-week timepoint may be allowed after discussion with the study PI. Systemic or liver-directed anticancer therapy within 2 weeks; or anticancer monoclonal antibody within 4 weeks prior to planned start of pemigatinib and afatinib. Patient has adverse events from prior therapy that have not resolved to ≤ grade 1; exceptions for non-clinically meaningful AEs can be made with input from the principal investigator. Major surgery within 4 weeks prior to planned start of pemigatinib and afatinib (tumor biopsy, biliary stent or catheter placement, and feeding tube placement are not considered major surgical procedures). Received prior palliative non-CNS radiation within 2 weeks or extended-field radiation administered within 4 weeks of first dose of study drug. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Fibrotic pulmonary disease from prior radiotherapy is permissible with approval of the study PI. Known pre-existing interstitial lung disease Current hypovitaminosis D requiring supraphysiologic (eg 50,000 IU/weekly) to replenish the deficiency. Vitamin D supplements are allowed. History and/or current evidence of clinically significant ectopic mineralization/calcification or non-tumor related alteration of calcium-phosphorus homeostasis. History and/or current evidence of clinically significant corneal or retinal disorder confirmed by ophthalmological examination Child-Pugh B and C cirrhosis Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the investigator. This includes significant or recent gastrointestinal disorders with diarrhea as a major symptom Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug. Patients with a history of another primary malignancy that is currently clinically significant, and has potential for metastases or currently requires active intervention (except for gonadotropin-releasing hormone (GnRH) or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or hormonal therapy in breast cancer Have history of hepatic encephalopathy of any grade Patients with ascites requiring serial paracenteses Active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate provided that they are stable for ≥ 2 months. Patients with suspected or confirmed leptomeningeal disease are not eligible even if treated. Patients with glioblastoma multiforme (GBM) are not eligible. Clinically significant, active cardiovascular disease such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, or history of myocardial infarction within 6 months prior to planned start of pemigatinib and afatinib Fridericia's corrected QT interval (QTcF) > 480 ms on ECG conducted during Screening, or history of torsades de pointes or personal or family history of prolonged QT syndrome.Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation. Active uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and the sponsor-investigator makes it undesirable for the patient to participate in the trial. Screening for chronic conditions is not required. Active hepatitis B virus (HBV) -- Note: Controlled (treated) hepatitis will be allowed if they meet the following criteria: antiviral therapy for HBV must be given for at least 1 month prior to first dose of study drug, and HBV viral load must be less than 2000 IU/ml (104 copies/ml) prior to the first dose of study drug. Those on active HBV therapy with viral loads under 2000 IU/ml (104 copies/ml) should stay on antiviral therapy throughout the study treatment. Known human immunodeficiency virus (HIV) and on anti-retroviral therapy for HIV(excluded due to potential drug-drug interactions between anti-retroviral medications and study treatment but HIV itself is not an exclusion). Known or suspected active drug or alcohol use Concomitant treatment with known strong p-gp inhibitor. Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. -- Note: Moderate CYP3A4 inhibitors are not prohibited Pregnancy during the study or within 30 days of the last dose of study intervention. Also excluded are any persons of childbearing potential, including men who are able to father a child, who are unwilling to use a medically acceptable method of contraception during the trial (see below section 3.3). Lactation and breastfeeding during the study or within 30 days of the last dose of study intervention is also not allowed. Female patients must have a negative pregnancy test (B-HCG test in urine or serum) prior to commencing study treatment. Unable to swallow pills Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug. Patients unable or deemed by the investigator as unlikely to comply with the protocol are also excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302595

Recruiting

MRI Guided Prostate Biopsy

This study aims to assess the feasibility of magnetic resonance (MR) guided prostate biopsy using a needle holder frame. This frame is used to help position the needle used for the biopsy. The feasibility in this study is defined as whether the needle holder frame enables accurate tissue sampling from a suspicious region in the prostate found on an MR image. If it does, a biopsy can be carried out with the needle holder frame safely in a clinical routine. The study will be conducted during a routine MR-guided prostate biopsy procedure with an investigational needle holder frame instead of a conventional needle-guiding template.

- EligibilityCriteria: Inclusion Criteria: Either an abnormal serum prostate-specific antigen (PSA) level (> 4ng/Ml) or a palpable nodule in the prostate on digital rectal examination or prostate MRI suspicious lesion.. Diagnostic MRI of the prostate gland. Age > 30 years Signed informed consent. No contra-indications to MRI, i.e. no cardiac pacemaker. No recent or ongoing active ischemic heart disease. Exclusion Criteria: Inability to give informed consent. Contra-indications to MRI- cardiac pacemaker, inner ear implants, non-MR compatible intracranial aneurysm clips. Recent or ongoing active ischemic heart disease such as recent or ongoing angina. - HealthyVolunteers: No - Gender: Male - MinimumAge: 30 Years - StdAgeList: Adult, Older Adult

NCT06302582

Recruiting

Platelet Rich Plasma Combined With Human Umbilical Cord Mesenchymal Stem Cells for Stage 3 and 4 Stress Injury

This study is an open-label, single-center trial which aim to evaluate of efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) combined with platelet-rich plasma (PRP) in stage 3 and 4 stress injury.

- EligibilityCriteria: Inclusion Criteria: 18-80 years old, regardless of gender; Patients with stage 3 and stage 4 pressure injuries (According to National Pressure Ulcer Advisory Panel (NPUAP)/European Pressure Ulcer Advisory Panel (EPUAP) classification system for pressure ulcers); There were no complications affecting the wound healing; After through debridement for the first time, the wound volume meets the requirement of "10-100cm3"; Platelet count before treatment 100~300×109/L; The patient voluntarily participates and signs an informed consent form. Exclusion Criteria: Individuals with coagulation dysfunction or hemorrhagic diseases; People with skin diseases, diabetes and immune diseases; Individuals with mental or psychological disorders; Individuals with allergies to multiple drugs; Pregnant or lactating women; Those who need to take medication that affects platelet and coagulation function for a long time or in the near future, but have not stopped taking medication within the past week. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06302569

Not yet recruiting

Pembrolizumab Plus Enfortumab Vedotin in Collecting Duct and Renal Medullary Carcinoma

This is a single-arm, monocentric, phase II trial, enrolling patients with histological diagnosis of collecting duct carcinoma and renal medullary carcinoma with locally advanced or metastatic disease who will be treated with Pembrolizumab plus Enfortumab Vedotin. Approximately, 23 patients will be enrolled. At screening, pre-existing archival primary and metastatic FFPE tumor specimen will be collected and submitted for central pathology review and translational analysis. All participants will undergo baseline screening imaging for clinical staging. Patients will be treated with Pembrolizumab q21 plus Enfortumab Vedotin 1,8q21 for 3 cycles (3 infusion of Pembrolizumab and 6 infusion of Enfortumab Vedotin) then radiological imaging will be repeated and patients with SD, PR or CR will continue pembrolizumab until disease progression, unacceptable toxicities or completion of treatment (17 cycles). Patients with progressive disease after 3 cycles of study intervention will be treated as per clinical practice. Patients who will experience progressive disease during pembrolizumab monotherapy treatment could restart Enfortumab Vedotin. The study will also involve collection of a blood sample taken at the commencement of treatment, at the first cycle, after cycle 3 and at the end of treatment or progression of disease, to be used for research purposes.

- EligibilityCriteria: Inclusion Criteria: Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic or advanced Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma will be enrolled in this study. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Have confirmed histology diagnosis of Collecting Duct Carcinoma or Medullary Renal Cell Carcinoma by central pathology review. Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention. Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days prior to the start of study intervention. Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests are not required unless: Known history of HBV infection As mandated by local health authority Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization. Hepatitis C screening tests are not required unless: a) Known history of HCV infection b) As mandated by local health authority HIV-infected participants must have well-controlled HIV on ART, defined as: Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers) Exclusion Criteria: Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137). Has received prior systemic anti-cancer therapy, including investigational agents, within 2 weeks prior to treatment allocation. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS diseases permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid) Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. Has not adequately recovered from major surgery or has ongoing surgical complications. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Has had an allogenic tissue/solid organ transplant. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302556

Not yet recruiting

The Role of Immune Checkpoints in Lung Transplant (ILTRA)

The goal of this observational study is to learn about rejection in lung transplantation. The main question it aims to answer is: • what is the role of immune checkpoints in lung transplantation? Participants will describe pathways of rejection in lung transplantation analyzing the immune checkpoints on explanted lungs as well as trans-bronchial biopsies.

- EligibilityCriteria: Inclusion Criteria: Lung transplant patients Exclusion Criteria: Hyperimmunized patients History of auto-immune disorders - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Cohort 1: Participants who received lung re-transplantation for chronic lung allograft dysfunction. Cohort 2 and 3: Participants who received first lung transplantation for end stage respiratory insufficiency. - SamplingMethod: Non-Probability Sample

NCT06302543

Recruiting

Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone. Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.

- EligibilityCriteria: Inclusion Criteria: clinical diagnosis of premature Ovarian insufficiency. ineffective hormonal therapy. biochemical evidence of high gonadotropins. Exclusion criteria: solid or hematological malignancies. bleeding disorders. rejection of the procedure. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: mainly related to females - MinimumAge: 30 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06302530

Not yet recruiting

"Effectiveness of the Ultrasound - Guided Lengthening of the Gastrocsoleus Complex"

This research project compares the effectiveness of different surgical techniques for lengthening the gastrocnemius-soleus system in patients with equinus deformity. The study will compare 2 techniques: gastrocnemius tendon recession (Strayer) and plantaris resection. Increased ankle range of motion, complications, operative time, recovery time, pain scales and function will be measured. The results will help determine which technique is most effective and safe for correcting equinus deformity.

- EligibilityCriteria: Inclusion Criteria: Clinical and radiological diagnosis of clubfoot. Limitation of passive dorsiflexion of the ankle (<10°). Associated pain and functional limitation Absence of previous ankle/foot surgeries Exclusion criteria: Neurologic or congenital disease. Advanced ankle joint osteoarthritis Peripheral vascular insufficiency Uncontrolled diabetes mellitus Severe hepatic or renal disease Coagulopathies or anticoagulant therapy - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 90 Years - StdAgeList: Child, Adult, Older Adult

NCT06302504

Recruiting

Nature-based Mindfulness Intervention Program for Family Carers

The program integrates ordinary mindfulness exercise with nature environment. Participants will be able to practice mindfulness in a natural environment in some of the program sessions. The study will study the effects of nature-based mindfulness program in reducing caregiving stress. The program will last for 4 session, 8 hours in total.

- EligibilityCriteria: Inclusion Criteria: parents with children experiencing divorce or separation parents of children with special needs family caregivers who are the primary caregivers of an older adult with dementia Exclusion Criteria: parents or caregivers who cannot understand Cantonese version of Chinese parents or caregivers who have psychosis or developmental disabilities who are not able to comprehend the program - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06302491

Not yet recruiting

A Study of Safety and Efficiency of AND017 in Patients With Transfusion Dependent and Non-transfusion Dependent β-thalassemia

This is a phase II, randomized, double-blinded, placebo-controlled study to treat patients with transfusion-dependent and non-transfusion dependent β -thalassemia with AND017 and optimal supportive care, including blood transfusion and iron removal, based on the clinician's judgment and practice.

- EligibilityCriteria: Inclusion Criteria: Documented diagnosis of β-thalassemia or hemoglobin E/β-thalassemia, HbS/ β-thalassemia (β-thalassemia with α-bead mutation and/or multiplication is not allowed). TDT subjects: receive regular blood transfusions, defined as 6-20 RBC units (including threshold) in the 24 weeks prior to screening assessment, and no transfusion-free period of ≥ 5 weeks during this period. NTDT cohort: having transfused <6 RBC units in the 24 weeks prior to the screening assessment, no regular transfusion schedule, and no transfusion for 4 weeks prior to the screening assessment. Subject transfusion records should be obtained within 24 weeks prior to the screening assessment, containing the date of transfusion, transfused RBC units, and pre-transfusion hemoglobin values. ECOG score 0-1. NTDT subjects with Hb ≤ 10.0 g/dL at screening test and one follow-up test (two tests more than one week apart) and difference in values between the two tests ≤ 1.0 g/dL. Adequate liver function: Total bilirubin < 1.5 x upper limit of normal (ULN) (subjects with Gilbert syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin < 3 x ULN), aspartate aminotransferase Exclusion Criteria: Other causes of anemia (e.g., hemolytic anemia, history of pure red blood cell aplastic anemia, myelodysplastic syndrome, or multiple myeloma) Presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune diseases with inflammatory symptoms (e.g. generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, etc.) Complicated retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.) Inability to take oral medications, conditions with a history of gastrectomy/bowel resection that may have an effect on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy), or gastroparesis that remains symptomatic on current therapy Clinically significant bleeding (requiring emergency blood transfusion within 12 h or a decrease in hemoglobin ≥ 2 g/dL within one week) within 4 weeks prior to the first dose, or a tendency to bleed or risk of bleeding that has not been medically or surgically corrected Uncontrolled hypertension, defined as a diastolic blood pressure value >95 mmHg or a systolic blood pressure >160 mmHg on 2 or more of 3 repeated blood pressure tests (each at least 5 minutes apart) during the screening period Complicated congestive heart failure (New York Heart Association [NYHA] class III or higher). history of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or pulmonary infarction within 24 weeks prior to screening evaluation history of significant coagulation abnormalities, or platelet count >600 x 109/L or <80 x 109/L History of epilepsy or any past seizures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06302478

Not yet recruiting

5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are: Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care? Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care? Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different? Participants in the intervention group will receive the 5E program, including Education: health education regarding venous thromboembolism prevention Elevation: leg elevation of 10-20 degrees Exercise: ankle exercises Enough fluid: adequate fluid uptake Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

- EligibilityCriteria: Inclusion Criteria: Caprini scores of 5-8 and >8 Able to communicate in the Thai language Willing to participate in this study Exclusion Criteria: Alteration of consciousness Experiencing complications, including neurogenic shock and autonomic dysreflexia Being pregnant Having fluid restriction - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302465

Recruiting

Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells

Malignant tumor of bone is rare with poor prognosis. Surgery is the main treatment for non- metastatic bone tumor. Although neoadjuvant chemotherapy for non-metastatic bone tumor cannot improve survival rate based on adjuvant chemotherapy, it can reduce and clarify tumor boundary. Control of local recurrence rate is the core objective of oncotherapy. Surgery way and boundary have a significant effect on prognosis of non- metastatic bone tumor. Narlumosbartmab, a RANKL inhibitor, can make tumor boundary clear and reduce surgical difficulty by inhibiting osteoclast. This is a prospective, randomized, controlled, two-arm, open, single-center clinical trial to compare the efficacy and safety of narlumosbartmab combined with neoadjuvant chemotherapy and neoadjuvant chemotherapy alone in bone-derived malignancies with bone lytic lesions and multinucleated giant cells. Investigators mainly observe the local recurrence rate to evaluate the survival benefit for patients with poor prognosis.

- EligibilityCriteria: Inclusion Criteria: Age is more than 8 years old and no gender limitation. Histopathologically confirmed high-grade bone-origin malignancies of the limb with the following subtypes: high-grade osteosarcoma, Ewing sarcoma or Ewing sarcoma, malignant giant cell tumor, and undifferentiated pleomorphic sarcoma of bone (the pathological descriptions of the above disease types must include multinuclear giant cell components). Local tumors and isolated lung lesions must be confirmed by pathological diagnosis and multiple lung metastases must be determined by an experienced thoracic surgeon to be resectable. For newly treated tumors that have not been treated with standard therapy and surgery is performed at our center and the necrosis rate is measured. The ECOG physical status score is 0-1, and the expected survival period is more than 6 months. Hb≥ 120g/L，ANC≥1.5×109/L，PLT≥ 100×109/L Cr≤ 1.5×ULN，BUN≤ 2.5×ULN, TB≤ 1.5×ULN, AST and ALT≤ 2.5×ULN, ALB≥ 30 g/L INR）≤1.5，PT and APTT≤1.5×ULN Pregnancy test (urine beta-HCG) negative (for sexually active women of childbearing age). Sign an informed consent form (or legal representative sign) to demonstrate that patients understand the purpose of the study and the procedures required by the study and are willing to participate in the study. Exclusion Criteria: Past or current jaw osteomyelitis or jaw necrosis; Failure to recover from dental or oral surgery; Acute dental or jaw diseases requiring oral surgery; Those who planned to undergo invasive dental surgery during the study period. Any planned intravenous or oral bisphosphonate therapy during the study period. Past or current use of anti-nuclear factor κB activator ligand (RANKL) antibodies, such as disumab. Metastatic lesions determined by doctors to be unresectable. Have had other malignancies in the past 3 years, are currently being treated with other anti-tumor drugs, or are currently receiving other specific treatments for giant cell tumors of bone (such as radiation, chemotherapy, or embolization). Central nervous system metastases with obvious symptoms, such as headache, brain edema, blurred vision, etc. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite best medical treatment). Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and ≥470 ms for women). Patients with grade Ⅲ to Ⅳ cardiac insufficiency according to NYHA criteria, or with left ventricular ejection fraction (LVEF) < 50% indicated by heart color ultrasound, or had myocardial infarction within 6 months before enrollment, or with grade II or above heart failure according to NYHA criteria, uncontrolled angina, uncontrolled severe ventricular arrhythmia, and clinically significant pericardial disease, or electrocardiogram indicates acute ischemia or abnormal active conduction system. Uncontrolled co-morbidities include, but are not limited to poorly controlled diabetes, persistent active infections, or mental illness or social conditions that may affect participants' compliance with the study. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy. Patients with a history of psychotropic drug abuse and are unable to quit or have mental disorders. With significant factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction. Patients with active viral hepatitis B or hepatitis C, or those with active infections requiring antimicrobial treatment (e.g. antibiotics, antiviral drugs, antifungal drugs). Have participated in clinical trials of other antitumor drugs within 4 weeks. Known allergic reactions, hypersensitivities, or intolerances to chemotherapy agents or their excipients. During lactation. Patients received vaccination during the course of treatment, or within 4 weeks of vaccination. Any condition which, in the opinion of the investigator, is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements. - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - StdAgeList: Child, Adult, Older Adult

NCT06302452

Not yet recruiting

Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST) Prevention

The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are: (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states; (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.

- EligibilityCriteria: Electronic Medical Record (EMR) Participants: Inclusion Criteria: trauma patients admitted to adult trauma inpatient services at participating institutions Exclusion Criteria: none Patient participants Inclusion Criteria: at least 18 years of age; admitted to a participating trauma service for an injury; fluent in English or Spanish; able to provide written consent. Exclusion Criteria: prisoner or in police custody; admitted due to suicide attempt any acute conditions that would preclude provision of informed consent or assent (i.e., acute psychosis, altered mental status, cognitive impairment). Staff participants Inclusion Criteria: trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center Exclusion Criteria: none - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302439

Not yet recruiting

PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency

The purpose of this prospective registry is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase1(ENPP1) Deficiency and the infantile-onset form of adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) Deficiency longitudinally. The registry will prospectively gather information about the genetic, biochemical, physiological, anatomic, radiographic, and functional manifestations (including patient reported outcomes [PROs]) of each disease during routine, standard-of-care visits, with the aim of developing a comprehensive understanding of the burden of illness and progressive nature of the disease.

- EligibilityCriteria: Inclusion Criteria: Individuals eligible to participate must meet all the following inclusion criteria: Must provide written or electronic consent after the nature of the registry has been explained, and prior to any research-related procedures, per International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Agree to provide access to relevant medical records One of the following genetic or clinical criteria A confirmed prenatal or postnatal molecular genetic diagnosis of ENPP1 Deficiency with biallelic mutations (ie, homozygous or compound heterozygous) performed by a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA) certified laboratory or regional equivalent OR Monoallelic ENPP1 mutation confirmed by a certified CAP/CLIA laboratory or regional equivalent and any of the following clinical symptoms: i. ≥ 1 traumatic vertebral fracture ii. ≥ 2 fractures as an adult (eg, long-bones, digits, vertebrae) iii. Low bone mineral density (dual-energy X-ray absorptiometry [DXA] Z-score <1.5) and <55 years of age iv. Bone or joint pain interfering with movement or daily activities v. History of myocardial infarction (MI), unstable angina, transient ischemic attack (TIA) or low cardiac output before the age of 40 yrs. vi. History of rickets or bone deformity vii. Diagnosis of ossification of the posterior longitudinal ligament (OPLL) viii. Other clinical symptoms, with approval by Inozyme OR c. A confirmed prenatal or postnatal molecular genetic diagnosis of ABCC6 Deficiency with biallelic mutations confirmed by a certified CAP/CLIA laboratory or regional equivalent, and <18 years of age Exclusion Criteria: Individuals who meet the following exclusion criteria will not be eligible to participate: Participant or their legally designated representative does not have the cognitive capacity to provide informed consent Patients who are currently participating in an INZ-701 interventional clinical study, with the exception of expanded access programs and long-term safety follow-up studies Participants in interventional studies may be approached for inclusion in the registry once their involvement in the treatment period of the clinical study has been completed - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Evidence of biallelic ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) variants in ENPP1 Deficiency or Evidence of monoallelic ENPP1 variants and disease-related symptoms or Infantile onset with biallelic adenosine triphosphate (ATP) binding cassette transporter protein subfamily C member 6 (ABCC6) variants in participants aged <18 years. - SamplingMethod: Non-Probability Sample

NCT06302426

Not yet recruiting

Trial of INI-4001 in Patients With Advanced Solid Tumours

Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.

- EligibilityCriteria: Inclusion Criteria: Patient has locally advanced or metastatic cancer (all solid tumours allowed except primary brain/CNS tumour or untreated spinal cord compression) Patient has at least one extracranial measurable disease lesion per RECIST 1.1/ iRECIST criteria. Patients with known brain metastases are eligible if they meet all the following criteria: Patient has received definitive treatment of brain metastases with stereotactic body radiation therapy (SBRT) or surgery provided that the brain lesions are stable (without evidence of progression by imaging for at least 4 weeks before the first dose of study treatment) Patient is neurologically stable and has had no persistent side effects / complications from prior treatment. Patient has no evidence of new or enlarging brain metastases (confirmed by repeat imaging) and has not required steroids for at least 14 days prior to first dose administration on Day 1. Female patients must be of non-child-bearing potential i.e., surgically sterilised at least 6 weeks before the screening visit or postmenopausal Exclusion Criteria: Prior therapy with a TLR7 and/or TLR8 agonist, unless first approved by the medical monitor. Has primary brain/CNS tumour or untreated spinal cord compression. Has known active, uncontrolled brain or CNS metastases and/or carcinomatous meningitis. Evidence of abnormal cardiac function Clinically significant active infection within 2 weeks prior to commencement of treatment, or unexplained fever (temperature > 38.1°C) within 7 days prior to first dose administration on Cycle 1 Day 1. Known active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit. History of other malignancy not meeting inclusion criterion #1 within the past 2 years Major surgery within 28 days of Cycle 1, Day 1, or minor surgical procedures within 7 days of Cycle 1, Day 1. Received cancer-directed therapy A history of autoimmune diseases that has caused terminal organ damage or required systemic immunosuppression / systemic disease modulating drugs within the past 2 years. Chronic use of immune-suppressive drugs (i.e., systemic corticosteroids used in the management of cancer or non-cancer related illnesses, (e.g., COPD) in dosing exceeding 10 mg daily of prednisone equivalent). Inhaled steroids are allowed. History of prior organ allograft. Known hypersensitivity to the study drug or its inactive ingredients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302413

Recruiting

Enhancing Prospective Thinking in Early Recovery

The goal of this clinical trial is to use a novel virtual reality intervention to test for efficacy in reducing alcohol use and increasing abstinence, with concomitant increases in future self-identification, future time perspective, and delay-of-reward, in early recovering alcohol use disorder (AUD) persons. The main question[s] this trial aims to answer are: Will the Virtual Reality (VR) intervention decrease the number of stimulant use days? Will the VR intervention produce longer abstinence periods during follow-up visits? Will the VR intervention increase alcohol abstinence rates? Will the VR intervention increase future self-identification? Will the VR intervention increase self-reported future time perspective? Will the VR intervention increase preference for delayed rewards in a laboratory delay discounting task on the study day? Will the VR intervention produce gains in the behavioral effects of future self-identification, future time perspective, and delayed rewards at the 30-day and 6-month follow-ups? Researchers will compare the experimental and control groups to see if there are differences in the results for the questions outlined above.

- EligibilityCriteria: Inclusion Criteria: Abstinence between ≥14 days and ≤1 year Verbal endorsement of commitment to recovery Outpatient Psychotropic drugs for SUD-comorbidity Drug/alcohol abstinence ≥ 24 hours at the time of the study day visit English comprehension Exclusion Criteria: Unstable medical disorders Habitual drug use Mu-opioid drugs Smell/taste disorders Unstable psychiatric conditions Extravagant/elaborate face tattoos - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06302400

Recruiting

Individualized Dosimetry for Holmium-166 Radioembolization in Patients With Unresectable Hepatocellular Carcinoma

The goal of this clinical trial is to test the safety and effectiveness of a medical device called 166-Holmium microspheres (QuiremSpheres®) in patients with hepatocellular carcinoma (HCC) . The main questions it aims to answer are: What is the safety and toxicity profile of the 166-Holmium microspheres? Is the device effective in treating HCC? Participants will undergo a range of screening procedures to confirm they are eligible and to record their baseline results, including: A Computed Tomography (CT) scan A Magnetic Resonance Imaging (MRI) scan Blood tests Quality of life questionnaires Before receiving treatment with QuiremSpheres® the participant will receive a 'scout' dose of the microspheres, to check whether there is distribution of the radioactivity to other non-target areas of the body. This is measured using Single-Photon Emission Computed Tomography-CT imaging. If the distribution to non-target areas is deemed to not be too high, the participant will go on to receive the individualised therapeutic dose of QuiremSpheres®. Follow-up visits will occur 3 and 6 weeks post-treatment dose, and then at 3 and 6 months.

- EligibilityCriteria: Inclusion Criteria: Provided written informed consent. Female or male aged 18 years and over. Diagnosis of HCC established according to AASLD criteria: nodule >1 cm in a patient at risk for HCC, with combination of arterial hypervascularity and venous or delayed phase wash-out on multiphase CT-scan or MRI-scan. LR-5 and LR- 4 based on Liver Imaging Reporting and Data System can be included. No curative treatment options (resection, transplant, or in case of solitary tumour, RFA). Life expectancy of at least 6 months. ECOG Performance status 0-1. Liver-dominant disease (maximum 5 lung nodules all ≤1.0 cm, solitary clinically stable adrenal metastasis, and mesenteric or portal lymph nodes all ≤2.0 cm are accepted). Child-Pugh class A5-6 or B7. At least one measurable liver lesion according to the modified RECIST criteria. Negative pregnancy test for women of childbearing potential. Female patients of childbearing potential should use a highly effective acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) or should be more than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form), to prevent pregnancy. Exclusion Criteria: Evidence of significant extrahepatic disease (MRI-scan liver and multiphase abdominal CT as well as a thoracic CT are routinely performed at screening). Hepatic radiation therapy within the last 4 weeks before the start of study therapy. Previous or current treatment with RE. Previous treatment with TACE, surgery, RFA, and previous or current treatment with systemic treatment are allowed. Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy. Serum bilirubin > 34 umol/L in the absence of a reversible cause Glomerular filtration rate <35 ml/min. Non-correctable INR >1.5 in case of femoral approach (as opposed to radial). Platelet count <50 109/l. Significant cardiac event (e.g., myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2) within 3 months before entry, or presence of cardiac disease that in the opinion of the investigator increases the risk of ventricular arrhythmia. Pregnancy or breastfeeding. Patients suffering from psychic disorders that make a comprehensive judgment impossible, such as psychosis, hallucinations and/or depression. Patients who are declared incapacitated. Previous enrolment in the present study. Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form), to prevent pregnancy in a partner. Evidence of untreated, clinically significant grade 3 portal hypertension (i.e. large varices at oesophagi-gastro-duodenoscopy). In these cases, therapy with non-selective beta-blocker (propranolol) or rubber band ligation should be instituted according to accepted guidelines. In case of small varices, prophylactic propranolol is advised. Portal vein thrombosis (tumour and/or bland) of the main branch (diagnosed on contrast enhanced transaxial images). Involvement of the right or left portal vein branches and more distal is accepted. Untreated active hepatitis. In case of detectable viral HBV load, appropriate treatment should be instituted. Transjugular intrahepatic portosystemic shunt (TIPS). Body weight over 150 kg (because of maximum table load). Severe allergy for intravenous contrast used (Visipaque®) Lung shunt >30 Gy, as calculated using scout dose SPECT/CT. Extrahepatic deposition of scout dose activity. Activity in the falciform ligament, portal lymph nodes and gallbladder is accepted. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302361

Recruiting

Lymphovenous Anastomosis for Breast Cancer Lymphedema

This multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment. Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires. Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months. The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated. The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.

- EligibilityCriteria: Inclusion Criteria: Age >18 Female Unilateral arm lymphedema secondary to breast-cancer treatment Active pitting lymphedema Presence of dermal backflow in indocyanine green lymphography Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green Able to provide informed consent Able to read, understand and complete Danish questionnaires Exclusion Criteria: Allergy to iodine Pregnant, breast-feeding, or aiming to conceive withing the next year History of bilateral breast cancer - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302348

Not yet recruiting

A Study of Sepiapterin in Participants With Phenylketonuria (PKU)

The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.

- EligibilityCriteria: Key Inclusion Criteria: Women of childbearing potential must have a negative pregnancy test at screening and agree to abstinence or the use of at least one highly effective form of contraception for the duration of the study, and for up to 90 days after the last dose of the study drug. Established diagnosis of PKU with hyperphenylalaninemia (HPA) evidenced by at least 1 blood Phe measurement >600 μmol/L as documented in the medical history. For participants ≥1 month of age, a minimum of 1 documented blood Phe measurement <480 μmol/L within 1 month prior to Screening. For participants ≥1 month of age, 2 screening blood Phe concentration values must be in the range ≥120 to ≤480 μmol/L. Willing to continue prescribed diet during Screening and Part 1. For participants ≥30 months to <12 years of age, baseline FSIQ score ≥80. Key Exclusion Criteria: History of allergies or adverse reactions to synthetic tetrahydrobiopterin (BH4) or sepiapterin. Serious neuropsychiatric illness (for example, major depression) not currently under medical control or other concurrent disease or condition that, in the opinion of the investigator or sponsor, would interfere with the participant's ability to participate in the study or increase the risk of participation for that participant. Treatment with BH4 supplementation (sapropterin dihydrochloride, KUVAN) within 3 months prior to Screening. Current participation in another investigational drug study or use of any investigational agent within 30 days prior to Screening. Confirmed diagnosis of a primary BH4 deficiency as evidenced by biallelic pathogenic mutations in 6-pyruvoyltetrahydropterin synthase, recessive Guanosine-5'-triphosphate (GTP) cyclohydrolase I, sepiapterin reductase, quinoid dihydropteridine reductase, or pterin 4-alphacarbinolamine dehydratase genes. Any clinically significant laboratory abnormality as determined by the investigator. Any past medical history of an abnormal physical examination and/or laboratory findings indicative of signs or symptoms of renal disease, including calculated (Bedside Schwartz Equation) glomerular filtration rate (GFR) <60 milliliters (mL)/minute (min)/1.73 square meter (m^2). Major surgery within the prior 90 days of Screening. Note: Other protocol-defined inclusion and exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MaximumAge: 12 Years - StdAgeList: Child

NCT06302335

Recruiting

Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection

Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.

- EligibilityCriteria: Inclusion Criteria: Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology. Exclusion Criteria: age under 18; surgery classified as dirty; urgent/emergency surgery; patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ); known allergy to iodine. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302309

Not yet recruiting

Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease

The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.

- EligibilityCriteria: Inclusion Criteria: Men/women of age > 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria; Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?); Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary. Written informed consent. Exclusion Criteria: Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait. Severe cognitive impairment hampering the ability to comply to the study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302296

Recruiting

Evaluating the Effect of Injectable Platelet-rich Fibrin on Accelerating Orthodontic Tooth Movement

One of the main goals of orthodontic treatment is the reduction of treatment time through faster tooth movement. The previous studies evaluating platelet-rich fibrin (PRF) and orthodontic tooth movement (OTM) are limited, which makes the results difficult to generalize.

- EligibilityCriteria: Inclusion Criteria: The patient's age (18-26). Severe or very severe irregularity of the upper incisors greater than (7 mm) according to Little's index, so it is recommended to extract the upper first premolar. Class I or Class II malocclusion, first model according to Angle, with skeletal class I or II and a normal or mild vertical growth pattern. All permanent upper teeth, up to the first molar, are present, with the possibility of attaching brackets to all teeth in a correct position. The patient has good oral health. Exclusion Criteria: • The presence of any systemic disease that affects orthodontic dental movement. Severe malalignment of one of the teeth (palatal quadrant, ectopic canine, ectopic premolar). The patient has undergone previous orthodontic treatment. The patient is subject to any drug treatment that may affect orthodontic dental movement (cortisone, non-steroidal anti-inflammatory drugs). The patient has poor oral health. Commitment to periodic follow-up appointments. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 26 Years - StdAgeList: Adult

NCT06302270

Recruiting

CFTR Modulators in Pregnancy and Postpartum

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

- EligibilityCriteria: Inclusion Criteria: Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman Exclusion Criteria: none - HealthyVolunteers: No - Gender: All - MaximumAge: 50 Years - StdAgeList: Child, Adult - StudyPopulation: Woman with cystic fibrosis who is pregnant and treated with Kaftrio and her newborn infant - SamplingMethod: Probability Sample

NCT06302257

Not yet recruiting

Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine in Labor Epidural Analgesia.

Abstract: Background: The current "gold standard" epidural analgesia involves some undesirable side effects such as motor and sympathetic blockade. Here, the investigators suggest a new approach for inducing prolonged differential pain blockade during labor by selectively targeting local anesthetic chloroprocaine to the pain-related peripheral (nociceptive) fibers. The investigators approach involves nociceptor-selective anesthesia by selective targeting of ionized local anesthetics into nociceptive fibers via activation of nociceptor-specific TRPV1 channels. The authors demonstrated that activation of these channels by specific TRPV1-agonists (capsaicin or the local anesthetic lidocaine), allows entry of a polarized, membrane-impermeable lidocaine derivative (QX-314) specifically into nociceptive neurons, inhibiting their activity and pain blockade, without causing other neural effects. Capsaicin and QX-314 are not suitable for clinical use, as capsaicin causes severe injection pain and QX-314 is neurotoxic. Here, the investigators use lidocaine as the TRPV1 agonist, and use the high pKa chloroprocaine as the ionized local anesthetic instead of the toxic QX-314. Both drugs are in routine clinical use, but have not been described in co-administration before. The investigators preclinical results show that co-administration of chloroprocaine with TRPV1 agonists, leads to prolonged nociceptor-specific analgesia. KKK Hypothesis: The investigators hypothesize that co-administration of epidural lidocaine (to activate TRPV1 channels) and chloroprocaine (as a polarized local anesthetic which can gain preferential access to nociceptors via opened TRPV1 pores) will elicit selective nociceptive-anesthesia. Methodology: This study assess epidural local analgesia in nulliparous labor. There are 2 stages: Stage 1: Prior to direct comparison of lidocaine (Group L), chloroprocaine (Group C), and a lidocaine-chloroprocaine combination (Group L-C), the investigators first determine equipotential doses of epidural chloroprocaine and lidocaine using double-blinded up-down sequential analysis using the well-established minimum local anesthetic concentration (MLAC or ED50) design. ED50 is estimated using Dixon-Massey analysis and Wilcoxon and Litchfield probit regression. Stage 2: The main phase of the study involves a randomized double-blinded comparison between Groups L, C and L-C where all drug concentrations are based on the ED50/MLAC from the Stage 1. The primary endpoint is a composite measure of selective nociceptive analgesia (VAS pain score / modified Bromage motor score). Secondary outcomes are: 1. pain (VAS 0-100), 2. modified Bromage motor score, 3. thermal imaging of feet and hands, 4. sensory assessment to cold sensation using ice, 5. anesthesia requirement from the PCEA pump, 6. maternal blood pressure. 7. ambulation, and pushing ability in labor. Primary endpoint is assessed using repeated measures ANOVA (first 30-min) and mixed models ANOVA until first analgesic request. Implications: Positive findings will be the first evidence in humans of nociceptor-specific local anesthesia; will provide a more effective neuraxial analgesia protocol for labor, and will lead to future studies of systemic nociceptor-specific local anesthesia.

- EligibilityCriteria: Inclusion Criteria: Nulliparity Early active labor, cervical dilatation less than 5 cm, Age between 18 to 40, American Society of Anesthesiologists physical status class II Body weight less than 110 kg, Gestational age greater than 36 completed weeks, Singleton pregnancy Vertex presentation. Exclusion Criteria: Narcotic administration in the previous 3 hours Previous uterine surgery Pre-eclampsia Inability to adequately understand the consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06302231

Not yet recruiting

Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity

Time-restricted eating (TRE) is a dietary approach that aims to increase fasting time and decrease the eating window. Promising TRE effects on weight loss and improvements in some cardiometabolic risk factors have been reported in studies in animals and humans. However, the impacts of TRE combined with aerobic exercise training in individuals with overweight and obesity have been insufficiently investigated. Additionally, aerobic training performed in a fasted state appears to promote physiological adaptations that may improve the metabolic health in individuals with overweight and obesity. The present study investigates the effects of 8 weeks of TRE associated with aerobic training in a fasted state versus a fed state on body composition and cardiometabolic parameters in women with overweight and grade 1 obesity.

- EligibilityCriteria: Inclusion Criteria: Female; Body mass index (BMI) between 25 and 34.9 kg/m²; Age between 20 and 40 years; Not engaged in any structured exercise program; Weight stable for ~3 months before the beginning of the study; Able to give written informed consent. Exclusion Criteria: Current smoker; Habitual drinkers (>1 serving/day) of alcoholic beverages; Cardiometabolic diseases (dyslipidemia, diabetes, hypertension, etc); Current treatment with medication or supplements which significantly affect the main studied variables; Bariatric surgery; Night-shift workers; Strict vegetarian/vegan; Pregnancy, planned pregnancy (within the study period), lactating; Postmenopausal women; Self-reported menstrual cycle irregularities; Habitual fasting window >16 hours; Concomitant participation in other studies. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06302218

Not yet recruiting

ESPB vs iPACK+ACB in Total Knee Arthroplasty

Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following knee arthroplasty

- EligibilityCriteria: Inclusion Criteria: Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia. Exclusion Criteria: patients who have a history of bleeding diathesis, take anticoagulant therapy, have a History of chronic pain before surgery, have Multiple trauma, cannot assess their pain (dementia), have been operated on under general anaesthesia, have an infection in the area and do not accept the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult

NCT06302205

Recruiting

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

Research demonstrated that surgical patients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study the researchers aim to investigate the optimal rehabilitation intensity after liver transplantation. Patients will be randomized in one of the three PHOENIX-Liver training groups which all three rehabilitate at a different intensity (low, moderate, moderate to high). The six months rehabilitation training is conducted from the patient's home but supervised by a PHOENIX-investigator via electronical synchronization of extensive trainingsdata. At baseline, after three months of training and after six months of training, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. In the interim, questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness. To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at Gasthuisberg is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.

- EligibilityCriteria: Inclusion Criteria: de novo adult liver transplant recipients with a transplant vintage of two to three months access to a home freezer (± -18°C) Exclusion Criteria: Aberrant CPET (abnormal low cardiorespiratory fitness is not considered an exclusion criteria), unstable angina, life-threatening arrhythmias, uncontrolled hypertension/diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 < 50%), musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise multi-organ transplantation (exception: combined liver-kidney transplant is considered eligible for participation) ongoing treatment for malignancies unable to understand Dutch no access to smartphone and/or computer with internet access does not willing to except the general conditions of Coachbox. Preparticipation medical screening (cardiopulmonary exercise testing with 12-lead ECG + stratification of cardiovascular risk factors) will be performed by a cardiologist (Dr. Kaatje Goetschalckx at UZ Leuven). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302192

Not yet recruiting

Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are: PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation

- EligibilityCriteria: Inclusion Criteria: Age > 18 years Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria Beginning of IMV less than 48 hours or Clinical decision to begin IMV. Life expectancy > 24 hours Informed consent signed Exclusion Criteria: No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference. AKI prior to the onset of ARDS Chronic respiratory failure due to chronic respiratory diseases Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO Chronic Heart Failure Chronic liver disease Major trauma in the past 3 months Major surgery in the past 3 months Smoking and Alcohol drinking BMI ≥ 35 Patients needing of VV-ECMO and VA-ECMO Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive) Life expectancy <24 hours Cardio Circulatory Arrest Neoplasm in chemotherapy/radiotherapy Do Not Resuscitate or Comfort Measures Pregnancy at ICU admission Refused Informed Consent by the patient or surrogate decision-maker - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV). - SamplingMethod: Probability Sample

NCT06302166

Not yet recruiting

Effects of HICT and Intermittent Fasting on PCOS

The goal of this randomized controlled trial is to compare the effects of High intensity circuit training, Intermittent Fasting, and their combination on PCOS morphology, Anthropometrics, clinical hyperandrogenism and body image concerns in females with PCOS. Participants will be divided into three groups who will receive High intensity circuit training, Intermittent fasting and their combination. The outcomes will be PCOS morphology, anthropometrics', clinical hyperandrogenism and body image concerns.

- EligibilityCriteria: Inclusion Criteria: Unmarried females Diagnosed with PCOS Phenotype A based on Rotterdam Criteria: PCOM on US Ovulatory dysfunction Clinical Hyperandrogenism (Hirsutism modified Ferriman Gallway score ≥ 8) Not engaged in any regular lifestyle intervention for &lt;3 Months prior to inclusion Exclusion Criteria: Use of Estrogen, Progestin or combination. Taking medications or supplements for Insulin resistance &lt; 3 months prior to the inclusion Type I or II DM Hypo/hyperthyroidism BMI ≥27 (Obese according to BMI Asia) - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06302140

Not yet recruiting

A Mass Balance Study of [14C]-Nanatinostat and Relative Bioavailability Study of Nanatinostat in Patients With Advanced Cancers

This study will determine how nanatinostat is absorbed, modified, and removed from the body (Part A), the amount of nanatinostat that becomes available to the body (Part B), and will evaluate the safety and tolerability of nanatinostat (Part C) in patients with advanced cancers.

- EligibilityCriteria: Key Inclusion Criteria: Have histologically confirmed advanced stage cancers (excluding gastrointestinal tumors), have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment, and have no available treatment with curative intent. Eastern Cooperative Oncology Group Performance Status of ≤2 at Screening. Body mass index ≥18.5 but ≤30.0 kg/m2 at Screening. Adequate bone marrow, liver, and kidney function. Key Exclusion Criteria: Presence of active central nervous system and/or leptomeningeal disease. Anticancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy, or use of other investigational agents within 4 weeks before study entry. Inability to take or tolerate oral medication. Any gastrointestinal, liver, or kidney condition that may affect drug absorption and metabolism. Active infection requiring systemic therapy. Has received radiolabeled material <12 months (excluding that required for imaging) prior to study entry. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302127

Not yet recruiting

County Medical Community-based, Cardiovascular Risk Stratified Integrated Care Model: a Pragmatic Cluster Randomised Control Trial

The goal of this cluster randomized trial is to evaluate the effectiveness of the RISIMA model based on an integrated county healthcare consortium implemented by multi-level family health teams (FHTs)on patients with diabetes and/or hypertension, including CVD risk assessment, treatment, and management.

- EligibilityCriteria: Inclusion Criteria: Aged between 40 and 70 years old; Patients with hypertension or diabetes; Permanent residents of the county where the research is conducted; Already signed up with the family doctor team in the township where the research is located. Exclusion Criteria: Unable to independently carry out the interventions required for the study; Residing far from the village or township health center where the research is located, making it difficult to cooperate with visits; Patients who refuse to participate; Patients with comorbidities such as cancer that may interfere with the study visits or intervention effects; Pregnant or lactating women - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06302114

Recruiting

Upper Extremity Asymmetries in Overhead Athletes

Although overhead sports have different characteristics, the movements in the shoulder and upper extremity are similar. These sports may involve a combination of symmetrical, asymmetrical, bilateral and unilateral movements. In sports involving asymmetric movements, biomechanical changes are observed in that area due to the use of the dominant extremity. One of the reliable methods to reveal the stress effects caused by biomechanical stresses is to determine limb asymmetries. Considering the literature, limb asymmetries may be related to injury and performance.

- EligibilityCriteria: Inclusion Criteria: 15 years and older Attending regular sports training and competitions Exclusion Criteria: Acute injury during tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult

NCT06302101

Recruiting

Telerehabilitation Exercise in Older Adults

The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults. Older adults will be divided into two groups (intervention group n=16; control group n=16) .

- EligibilityCriteria: Inclusion Criteria: Getting a score of 6 or above on the Hodkinson Mental Test Exclusion Criteria: -Having another chronic disease that can cause pain Having a neurological disease Being blind Having an orthopedic, neurological or mental disability - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06302088

Not yet recruiting

The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals

The safety integration stakeholders (saints) program to integrate worker and patient safety in Oregon rural hospitals. The rationale is that the saints program will positively impact outcomes by identifying and training peer leaders on strategies to optimize environmental, administrative, and educational components to become a saint and regularly collaborate with safety stakeholders/administrative leaders at each site through continuous improvement cycles (e.g. plan-do-study-act).

- EligibilityCriteria: Inclusion Criteria: Employed at participating sites (critical-access hospitals in rural Oregon) Patient-care workers (e.g. RNs, CNAs) Exclusion Criteria: Non-clinical staff (e.g. clerical, janitorial) Non-unit staff (e.g. physical therapy) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302075

Recruiting

Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol

The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).

- EligibilityCriteria: Inclusion Criteria: Age 40<x<85 included Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence Primary medial gonarthrosis Signing of the Informed Consent and consent to collaborate in all study procedures. Exclusion Criteria: Cognitive decline Psychiatric disorders Neuromuscular disorders Age > 85 years or <40 Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence Patella symptoms Secondary medial gonarthrosis Minor age Pregnant women (self-declaration) - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06302062

Recruiting

Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection. To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.

- EligibilityCriteria: Before conducting tumor-associated lymph node sampling, it is necessary to verify that subjects meet the inclusion criteria marked with an asterisk (*). These criteria include: * being between the ages of 18 and 75; having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment; having at least one measurable target lesion; * voluntarily participating and signing an informed consent form; * having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated; * having an ECOG score of 0-1; * having an expected survival of more than 6 months; * female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication; * being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period. Before sampling tumor-associated lymph nodes, it is important to confirm that the subject does not meet any of the exclusion criteria marked with an asterisk (*). These criteria include： * Experiencing moderate to severe infection or at risk of opportunistic infection; * Present with active autoimmune disease (other than vitiligo or childhood asthma/allergies that have healed); * Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis. * Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases; Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks; * A history of severe hypersensitivity to any of the drugs used in this study; Known uncontrolled central nervous system (CNS) metastases and/or cancerous meningitis; * Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period; Previous anti-tumor therapy: within four weeks of radiotherapy, chemotherapy, one week after TKI inhibitor treatment, four weeks of investigational therapy or four half-lives, whichever is shorter; * Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study; * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; * Known history of interstitial lung disease. Exclude subjects with high suspicion of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; Or other moderate to severe lung diseases that seriously affect lung function; * Known history of primary immunodeficiency virus infection or positive HIV test; * Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded; * Any of the following cardiovascular diseases have evidence of acute or persistent episodes of myocardial ischemia; symptomatic pulmonary embolism is present; acute myocardial infarction occurred within 6 months prior to the initial study treatment; symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association Functional Scale) occurred within 6 months prior to the first study treatment; Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to the first study treatment; cerebrovascular accident or transient ischemic stroke occurred within 6 months prior to the first study treatment * Subjects with pleural effusion, pericardial effusion, or ascites that, in the investigator&amp;#39;s judgment, cannot be stably controlled by repeated drainage or other methods; Have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period; * Disease known to produce severe hypersensitivity to other monoclonal antibodies; Any condition that the investigator believes may result in a risk of acceptance of the study drug treatment or interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results; * With a second primary tumor (within 5 years). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06302049

Not yet recruiting

Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis

The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.

- EligibilityCriteria: Inclusion Criteria: Both males and females. Diabetic and non-diabetic patients. Age >18 years old. Overweight and obese patient: Body mass index (BMI) ≥ 25 kg/ m2 but <40 kg/ m2. Patients with heartburn, peptic ulcer, gastrointestinal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome and helicobacter pylori infection. Patients with established diagnosis of NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (>2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, HAIR score of 2 or 3. Exclusion Criteria: Patients with a history of hypersensitivity to esomeprazole. Patients with BMI ≥ 40 kg/ m2. Patients taking warfarin, clopidogrel, digoxin, diazepam and phenytoin to avoid drug-drug interactions as these drugs are CYP2C19 substrates. Patients infected with human immune deficiency virus taking antiretroviral medicines or dosage forms containing rilpivirine. Patients with a history of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease and alpha-1 antitrypsin deficiency. Patients on medications associated with steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, and methotrexate. Patients with cancer or with a history of cancer. Patients with cardiovascular diseases. Pregnant and lactating females - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06302036

Not yet recruiting

Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes

After two earthquakes in Kahramanmaraş Pazarcık in our country, the continuation of long-term aftershocks caused repetition of psychological problems and difficulties in recovery. Social and spiritual support plays a key role in the post-traumatic recovery period. It is necessary to use psychological support methods that can be applied in a short time and whose effect can be observed in a short time in the spiritual healing and healing of traumas. The emotional freedom technique (EFT) is One of the short-term psychotherapeutic techniques and ıt can also be applied online. EFT, which can be easily applied by individuals or professionals after receiving the necessary training; Cognitive therapy, acceptance and commitment therapy combine elements of acupuncture point stimulation, relying on manual stimulation of acupuncture points rather than using acupuncture needles. When we look at the literature, many scientific studies have been found in which the effectiveness of EFT on anxiety, stress and depression has been evaluated, but there has been no randomized controlled study evaluating the effectiveness of EFT online on individuals who have experienced earthquakes. With this project, it is aimed to determine the effect of online Emotional Freedom Techniques (EFT) on stress, anxiety and depression in university students who experienced earthquakes. This study, which will be carried out as a randomized controlled experimental study, will be carried out between 16.12.2023 and 20.12.2023 by online with university students who score 17 or higher on the Beck Depression Scale. Total of 60 students with depressive symptoms will be recruited to the intervention and control groups, EFT sessions will be applied to the intervention group, and the control group will only be followed. At the beginning of the application, pre-tests (Information Form, Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Inventory) and at the end of the last session, post-tests will be applied for both groups. With this study, a randomized controlled study will be brought to the literature on the effectiveness of a therapeutic method such as EFT, which is a method that can be used after an earthquake, which is easy to apply, has no cost, and can be accessed online in hard-to-reach areas. Our project will both contribute to the literature and provide short and long-term benefits in practice, in terms of raising awareness of students about important mental problems such as anxiety and depression, which are likely to be experienced after the earthquake, and enabling them to continue their education in a healthy way. It is aimed to present the work planned within the project as a paper in at least one national / international congress. It is aimed to publish in journals within the scope of SCI, SCI-Expanded related to the research area. The results and outputs of the research will be shared in various media (Kırklareli University and Osmaniye Korkut Ata University website and social media accounts). By determining the stress, anxiety and depression status of university students who have experienced an earthquake, it will be possible to reduce their stress, anxiety and depression with EFT application. The fact that the application used is a short-term, effective and easy psychotherapy method will prevent the disruption of the normal education processes of the students. It will make an economic contribution by reducing the need for psychological drugs that may be needed to reduce the effects of the earthquake.

- EligibilityCriteria: Inclusion Criteria: Being 18 years of age or older, being a university student, being in the earthquake zone during the earthquake and having experienced the earthquake, not having any infections, wounds or scars in the tapping areas, having a score of 17 or above on the back depression inventory. Exclusion Criteria: Having any problem that prevents communication (such as not knowing Turkish, having impaired hearing, speaking and understanding abilities), being receiving psychiatric treatment (Pharmacotherapy or psychotherapy), not being able to participate online. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06302023

Not yet recruiting

Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor The main questions it aims to answer are: Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor? How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day Group 2 (control) Participant will not need to take a DHA

- EligibilityCriteria: Inclusion Criteria: Singleton pregnancy Between 24 wk to 34 wk of gestational age Pregnant women diagnosed threatened preterm labor (with no cervical change) Exclusion Criteria: Fetal anomalies Multiple pregnancy Premature rupture of membrane Placental disorders: placenta previa, placental abruption Fetal growth restriction Pregnancy complication: gestational diabetes mellitus, Chronic hypertension Allergic reaction to DHA - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302010

Not yet recruiting

The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy

This research will be conducted to determine the effect of stress ball intervention during NST on anxiety and fetal well-being in high-risk pregnant women. Women with high-risk pregnancies randomly assigned to intervention (n=43) and control (n=43) groups at a state and a faculty hospital in Turkey will be included in the study. Pregnant women in the intervention group will be told to squeeze and release the ball once after counting to three, to inhale each time they press the ball, to exhale when they relax their grip and to focus only on the ball. Pregnant women will be instructed to continue this practice throughout the NST procedure (approximately 20 minutes). Pregnant women in the control group will not receive any intervention other than routine hospital care during the NST procedure. Data on anxiety and fetal well-being outcomes will be collected before and after NST.

- EligibilityCriteria: Inclusion Criteria: Volunteering to participate in the research, Being over 18 years of age, Having a medically diagnosed risky condition during pregnancy (diabetes, hypertension, the threat of premature birth, eclampsia, etc.) Compliance with at least one of the criteria in the "Ministry of Health Pregnancy Risk Assessment Form" in the evaluation of "Current Pregnancy" (Table 1) Being at or above the 32nd week of pregnancy, Having a single living fetus, Having eaten at least two hours before the NST procedure, Not having smoked or consumed alcohol at least two hours before the NST procedure, Knowing how to read and write Turkish. Exclusion Criteria: Deceleration or uterine contraction during NST, Presence of cardiovascular disease in the fetus, Presence of fetal distress, Presence of fetal anomaly, According to the physician, urgent intervention is needed, Having a diagnosed psychiatric disease, Having a visual, hearing, speaking, physical or mental disability. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06301984

Not yet recruiting

Safety and Efficacy Evaluation of Insight GS Growing System

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE). Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study. Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.

- EligibilityCriteria: Inclusion Criteria: TCLE signed by parents Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4 Cobb angle bigger than 30° Thoracic spine height T1-T12 less than 22 centimeters Risk of thoracic insufficiency syndrome (TIS). Exclusion Criteria: Need for fixation at occipital or cervical levels Risser sign greater than or equal to 1 Sanders bigger than 4 Previous spine surgery Medullary abnormalities Existence of malignant processes Local or systemic inflammations and infections, acute or chronic Allergy or intolerance to materials Non-reducible scoliosis Morbid obesity Insufficiency or absence of skin coverage - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 10 Years - StdAgeList: Child

NCT06301971

Recruiting

A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of [14C]-emraclidine in healthy adult male participants.

- EligibilityCriteria: Inclusion Criteria: Body mass index (BMI) of 18.5 to 35.0 kilograms per square meters (kg/m^2), inclusive, and a total body weight ≥50 kg [110 Pounds (lbs)]. A male participant who is sexually active with a pregnant or a nonpregnant woman of childbearing potential must agree to use a condom during the trial and for 90 days after the dose of investigational medicinal product (IMP). In addition, male participants should not donate sperm for a minimum of 90 days following the dose of IMP. Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures. Capable of consuming the standard diet. History of a minimum of 1 bowel movement per day. Exclusion Criteria: Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime): Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods [Not Plan] without Intent to Act) Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months): Suicidal Ideation Item 1 (Wish to be Dead) Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary. Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy. Use of any prescription and over-the-counter medications from 28 days prior to first dose of IMP or likely to require concomitant therapy. Vaccinations or boosters within 28 days of planned dosing or while on trial. Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening. Positive drug screen (including cotinine and tetrahydrocannabinol [THC]) or a positive test for alcohol. Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2× upper limit of normal (ULN). Total bilirubin ≥1.5×ULN. If Gilbert's syndrome is suspected, total bilirubin ≥1.5×ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin. Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients. NOTE: Other protocol-defined inclusion/exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: U.S. Food and Drug Administration (FDA) recommends that radiation exposure to participants should be kept as low as is reasonably achievable; and since there is no available data to suggest metabolism of the emraclidine is different in women versus men. Hence, female participants are excluded from this study. - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06301958

Recruiting

Dextrose Prolotherapy on Articular Cartilage

Dextrose prolotherapy is a controversial injection therapy in sports medicine. Currently, 25% hypertonic glucose solution is commonly used in clinical practice. Although this method has a certain therapeutic effect, there is still some controversy about the molecular mechanism of dextrose prolotherapy. In the past, it was thought that local stimulation would increase inflammatory reactions such as local leukocyte and macrophage infiltration and restart the "self-healing mechanism." However, some studies have pointed out that this treatment can cause cell apoptosis. In my clinical work, I often perform dextrose prolotherapy. I deeply feel the importance of exploring the detailed mechanism of action of this therapy in order to apply this therapy more appropriately to patients. We believe that the concentration of 25% hypertonic glucose solution should show a stepwise decrease in the joint cavity. Our preliminary cell experiment results using 2-fold serial dilutions of 25% glucose solution showed that 25%, 12% and 6% glucose solution will trigger the apoptosis of chondrocytes, vascular endothelial cells and immune cells, and will also inhibit the expression of the pro-inflammatory factor IL-6. Glucose solution below 3% will not have the effect of inducing apoptosis on cells. We believe that the therapeutic effect of 25% hypertonic glucose solution in the joint cavity may have cell-specific effects as the concentration changes dynamically. Therefore, in this study, we will clarify the therapeutic mechanism of dextrose prolotherapy for arthritis through basic research and clinical specimen analysis. The clinical research part will use clinical synovial fluid specimens to verify the therapeutic mechanism of hypertonic glucose dissolution. The joint pain level assessment of different types of patients (OA and RA) before dextrose prolotherapy (preliminary period), 1 month after treatment (midterm period) and 3 months after treatment (late period) will be collected, and joint effusion will be measured. Further analyze the cell apoptosis and concentration changes of inflammatory response factors in the liquid. We hope that through this study, we will have a clear understanding of the molecular mechanism of dextrose prolotherapy on joint component cells. This result will have reference value for the more appropriate application of dextrose prolotherapy in the treatment of human cartilage-related lesions.

- EligibilityCriteria: Inclusion Criteria: Willing to sign a written consent form Adult men and women with arthritis Exclusion Criteria: Pregnant or lactating women Septic arthritis Those who have undergone joint surgery within 30 days - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult

NCT06301945

Recruiting

Artificial Intelligence Prediction Tool in Thymic Epithelial Tumors

This multicentric observational study aims to enhance thymic epithelial tumor classification and predict recurrence risks using AI models. By analyzing digital pathology and clinical variables, the project addresses discrepancies in the current WHO classification system. Main Questions: Can AI models improve the accuracy of thymic epithelial tumor classification? Do AI models better predict recurrence risks compared to the WHO classification system? Participant Tasks: Digital pathology analysis. Develop AI models for precise classification and recurrence risk prediction. Comparison Group: Researchers will compare AI-enhanced classification with the WHO system to determine if AI models provide more precise subtyping and better predict recurrence risks. Study Design: This international project utilizes three databases from Rotterdam, Maastricht, and Lyon, with one database for AI model building and the other two for external validation. Ultimate Goal: Develop AI models supporting pathologists in accurately subtyping thymic epithelial tumors, preventing under- or overtreatment with adjuvant radiotherapy for more personalized and effective treatment.

- EligibilityCriteria: Inclusion Criteria: Participants with specific diagnoses are eligible for inclusion in the study. The eligible diagnoses include various subtypes of thymoma and thymic carcinoma, specifically: Thymoma A Thymoma AB Thymoma B1 Thymoma B2 Thymoma B3 Thymic Carcinoma Inclusion is based on a consensus diagnosis with a level of agreement less than 70%. This criterion is applied during the training phase of the model. Recurrence Criteria: Participants with a documented recurrence outcome within a 5-year period are considered eligible for this aspect of the study. This criterion is primarily applied during the validation phase. - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Study Population: This study focuses on individuals diagnosed with thymic epithelial tumors. The study includes patients from three datasets: Erasmus MC (710 patients), Maastro (137 patients), and University Hospital Lyon (181 patients). Additional Information: Erasmus MC (710 patients): Includes age, gender, and diagnosis information; each patient may have multiple whole slide images. Maastro (137 patients): Each patient may have multiple whole slide images. University Hospital Lyon (181 patients): Each patient may have multiple whole slide images. - SamplingMethod: Non-Probability Sample

NCT06301919

Recruiting

Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization

NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties. Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization. The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.

- EligibilityCriteria: Inclusion Criteria: All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan. Exclusion Criteria: Patients lost for follow-up, patients without preoperative CT. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan. - SamplingMethod: Non-Probability Sample

NCT06301906

Recruiting

Red Yeast Rice for Primary Prevention of Hypercholesterolemia

This two-year observational study will be conducted at the outpatient clinic of the Department of Traditional Chinese Medicine of Taoyuan Chang Gung Hospital from February 26, 2024 to December 31, 2025. This study will enroll 35~55 year-old male patients who are expected to take LipoCol Forte Capsules for primary prevention of hypercholesterolemia. The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. This study will evaluate the efficacy, durability and safety of LipoCol Forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.

- EligibilityCriteria: Inclusion Criteria: Aged 35~55 years old, LDL-C≥130mg/dl or patients with diabetes or chronic kidney disease with LDL-C ≥ 100mg/dl, expected to receive LipoCol Forte Capsule 600mg bid Exclusion Criteria: Have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month; Female; Have experienced rhabdomyolysis or abnormal liver function ALT >72 U/L due to taking red yeast rice; Bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month Liver insufficiency ALT >72 U/L or renal insufficiency eGFR < 30 mL/min/1.73 m2; Have ever had coronary heart disease, myocardial infarction or cerebrovascular disease; Stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated; Uncontrolled hypertension (blood pressure ≥160/100 mmHg); Use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study; Drug abuse or poor compliance; Use of traditional Chinese medicine in the past month - HealthyVolunteers: No - Gender: Male - MinimumAge: 35 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: The investigators will collect the TCM constitution questionnaires from patients before taking LipoCol Forte Capsules and every three months after taking the medicine. At the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. Fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. - SamplingMethod: Non-Probability Sample

NCT06301893

Recruiting

Uganda Sickle Surveillance Study (US-3)

It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda.

- EligibilityCriteria: Inclusion Criteria: Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings. Exclusion Criteria: Repeat samples on the same individuals during the study period will be excluded. - HealthyVolunteers: No - Gender: All - MaximumAge: 12 Months - StdAgeList: Child - StudyPopulation: All Dried Blood Spot (DBS) samples collected from HIV exposed infants from all districts of Uganda from approximately February 2014 to March 2015 will be included in the primary analysis. Up to 1,000,000 additional samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings. - SamplingMethod: Probability Sample

NCT06301867

Not yet recruiting

Preventing Failed Extubations

More than 300,00 people in the United States experience acute respiratory failure and require mechanical ventilation every year. Of those that recover and are extubated, the most common reason for reintubation is recurrent respiratory failure. Our study proposes a novel methodology for identifying those patients most at risk for recurrent respiratory failure.

- EligibilityCriteria: Inclusion Criteria: Extubated in participating ICU during study period Exclusion Criteria: Previously extubated during hospitaliztion Extubation as part of transitioning to comfort measures - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All mechanically ventilated patients in participating intensive care units. - SamplingMethod: Non-Probability Sample

NCT06301854

Not yet recruiting

Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

This is a multicenter, open study to evaluate the long-term safety and efficacy of TPN171H in men with erectile dysfunction.

- EligibilityCriteria: Inclusion Criteria: 18 years to 75 years (inclusive); Males with ED at least 3 months; IIEF-5 ≤ 21 at visit 1; Patients in a stable, heterosexual relationship during the study; At the end of the untreated baseline period, the following conditions are met：（1）The subject must make at least four attempts at sexual intercourse during the untreated baseline period.（2）5≤IIEF-EF≤25; Patients who are willing to have 4 or more attempts of sexual intercourse per month, demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial; Patients who are willing to take proper contraceptive during the study and within 3 months after the last dose; Patients who have voluntarily decided to participate in this study, and signed the informed consent form. Exclusion Criteria: Patients who have a history of hypersensitivity to other PDE5 inhibitors or TPN171H; Patients with anatomical malformations of the penis; Patients with primary hypoactive sexual desire; Patients with ED, which is caused by any other primary sexual disorder; Patients with ED, which is caused by spinal injury or have had a radical prostatectomy or other surgery; Patients who have a penile implant; Patients who do not respond to marketed PDE5 inhibitors or have adverse reactions that lead to drug discontinuation; CYP3A4 potent inhibitors, moderate inhibitors, and potent inducers need to be used during the trial or discontinued for less than 7 drug half-times before enrollment; Subjects who are taking nitrate or NO donor drugs, guanylate cyclase agonists and cannot be discontinued during the trial; Patients with the following cardiovascular disease: Myocardial infarction or stroke within the last 6 months; Unstable angina or angina occurring during sexual intercourse; New York Heart Association Class 2 or greater heart failure in the last 6 months; Uncontrolled hypotension (<90/60mmHg) or uncontrolled hypertension (≥180/110mmHg); Patients with diabetic complications (diabetic nephropathy, peripheral neuropathy); Patients with hepatic or renal dysfunction as per the following: AST, ALT>3*ULN, serum creatinine exceeds 50% of the upper limit of normal value; Patients with active gastrointestinal ulcers and bleeding disorders; Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa; Patients who have a history of sudden decrease or loss of hearing; Patients with a history of severe central nervous system injury or peripheral muscular neurological disease in the past 6 months; Patient with a history of malignancy; Patients with significant neurological abnormalities who are unable or unwilling to cooperate; Patients whose partner is breastfeeding/pregnant/trying to become pregnant, has a gynecological disease or is restricted in their activities during treatment; Patients who have used other drugs in clinical trials within the last 1 month; For other reasons besides the aforementioned cases, patient whose participation is deemed inappropriate. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06301841

Not yet recruiting

An Antibiotic Protocol Guided by a Multimodal Approach in AECOPD With Pneumonia in Intensive Care

Investigators propose to conduct a multicenter, prospective, randomized, controlled, assessing the interests of an antibiotic protocol guided by the combined use of serum procalcitonin (PCT) and a broad-panel respiratory multiplex PCR (mPCR) to reduce duration of antibiotics exposure in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) with pneumonia. The primary endpoint is the number of antibiotic-days for the treatment of pneumonia.

- EligibilityCriteria: Inclusion Criteria: Patients over 18 years Documented or suspected clinically COPD according to the criteria of GOLD Community-acquired pneumonia defined as the presence of a radiological (i.e., chest X-ray or CTscan) infiltrates consistent with an infectious site and associated with one or more of the following items: dyspnea, cough, sputum, fever above 38 ° C, chest pain, localized crackles with or without signs of pleural effusion, higher leukocytosis at 10,000 / mm³ or leukopenia below 4000 / mm³ Admitted to the hospital for less than 48 hours ICU Admission Informed Consent signed by the patient or his representative Exclusion Criteria: Patient immunocompromised including congenital immunodeficiency, haematologic malignancy, immunosuppressive drugs (including anticancer chemotherapy and post-transplantation therapies), neutropenia neutrophil count below 500 / mm³ secondary to chemotherapy, corticosteroids greater than 0.5 mg / kg / day for more than 10 days, HIV infection Therapeutic limitation Existence Minor patient or under guardianship or custody Pregnant woman Refusal to participate in the study The inclusion of the subject in another biomedical research protocol in progress or for less than 30 day Patients treated with antibiotics before ICU referral are no excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301828

Recruiting

Endostar Combined With SBRT and Envafolimab in the Treatment of Advanced Gastrointestinal Tumors

This is a single-arm, prospective, exploratory clinical study to evaluate the efficacy and safety of endostar combined with stereotactic body radiation therapy (SBRT) and Envafolimab in patients with advanced gastrointestinal cancer after multi-line treatment.

- EligibilityCriteria: Inclusion Criteria: 18 to 75 years old, regardless of gender advanced gastrointestinal tumors confirmed by histopathology or cytology; patients with gastrointestinal tumors who did not or refused standard treatment at enrollment；Each line of treatment for advanced disease includes one or more drugs for one or more cycles； The pre-permissible treatment was combined with molecular targeted drugs (except endostar)； Patients with previous PD-1 treatment were eligible ECOG-PS score of 0-2 The main organ function was normal and met the following requirements: Blood routine examination (no blood transfusion within 14 days) : a. HB≥80g/L; b. ANC ≥1.5×109/L; c. PLT ≥60×109/L; ② Biochemical examination should meet the following criteria: a. BIL<1.5 times the upper limit of normal (ULN); b. ALT and AST<2.5×ULN; ALT and AST< 5×ULN，if liver metastasis was present; c. Serum Cr≤1×ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula) predicted survival time ≥3 months Patients voluntarily participated in this study and signed the informed consent form (ICF) Exclusion Criteria: hypertensive patients whose blood pressure could not be reduced to normal range by antihypertensive drugs (systolic blood pressure>140 mmHg/diastolic blood pressure >90 mmHg); Patients with ≥ grade Ⅱ coronary artery disease, arrhythmia (including QTc prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency patients with active immune diseases abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN) with bleeding tendency symptomatic central nervous system metastasis pregnant or lactating women Other patients deemed ineligible for enrollment by the treating physician - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06301815

Not yet recruiting

Feasibility of Measuring Vertical Perception in Acute Stroke

The goal of this observational study is to establish if it is feasible to identify vertical perception deficits in people with acute stroke. The primary purpose to the study is: • To establish the feasibility of completing the Catherine Bergego Scale, Scale for Contraversive Pushing (SCP) and bucket test in a clinical environment with acute stroke patients to assist with identification of vertical perception loss. Participants will be asked to complete the assessments with a therapist 48 hours after admission. If they are not completed for any reason attempts will be made to complete them at one, two and four weeks after admission. Some participants will have them completed again on discharge. The Catherine Bergego Scale and SCP are observational and will involve a therapist watching the participant undertake daily activities. The bucket test involves a therapist placing a bucket in front of the face of the participant and asking them to identify when a line on the bottom of the bucket is vertical. Acceptabiliy and feasibility will be further investigated using a survey of participants who complete the assessments and through focus groups with the rehabilitation professionals admininstering the assessments. If it is feasible and acceptable to complete these assessments then further research can use them as an acceptable measure of vertical alignment in the clinical setting.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of first stroke by stroke consultant based on clinical or radiographical findings Admitted to stroke unit with a length of stay of over 72 hours Ability to consent or an advocate to consent on their behalf Pre-morbid Modified Rankin Scale of less than 4 Exclusion Criteria: Under the age of 18 Diagnosis of Transient Ischaemic Attack (TIA) Previous diagnosis of stroke or other neurological diagnosis affecting the brain with residual impairment Patients on an end of life pathway Patients with pre-morbid visual impairment that will not allow them to see the bucket test. Glasses can be worn. Inability to speak the English language and no interpreter can be found - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Acute stroke patients in inpatient care - SamplingMethod: Non-Probability Sample

NCT06301802

Recruiting

Outcomes of Proactive Management of Children With Myelomeningocele

Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence.

- EligibilityCriteria: Inclusion Criteria: all patients with myelomeningocele attending Assiut university urology hospital. Exclusion Criteria: Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: all patients with myelomeningocele attending Assiut university urology hospital. - SamplingMethod: Non-Probability Sample

NCT06301789

Not yet recruiting

Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries

The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.

- EligibilityCriteria: Inclusion Criteria: Age from 18 to 80 years old Both gender Weight from 55 to 85 kg ASA groups 2 and 3 Lower abdominal cancer surgeries Exclusion Criteria: 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06301776

Recruiting

A Prospective, Experimental, Multicenter, Open-label, Randomized, Controlled Trial of 3-month Dual Antiplatelet Therapy Followed by Ticagrelor Versus 6-month Dual Antiplatelet Therapy Followed by Ticagrelor After Implanting Bridge

To compare the incidence of the composite endpoints of non-fatal ischaemic stroke, transient ischaemia (TIA) and all-cause mortality at 12-month follow-up after implantation of Bridge for the treatment of symptomatic vertebral artery stenosis in subjects who had been taking different durations of dual-antiplatelet therapy (3 vs 6 months) and ticagrelor monotherapy.

- EligibilityCriteria: Inclusion Criteria: Patients who are suitable for Bridge implantation Symptomatic vertebral artery stenosis with a history of posterior circulation-related ischaemic stroke or TIA despite the use of at least one antithrombotic medications and intervention for risk factors Responsible vertebral artery stenosis (≥70% stenosis, measured by the NASCET method ) confirmed by DSA imaging The patient and/or his/her authorised person understands the purpose of the study, agrees to participate in the study and signs the informed consent form Exclusion Criteria: mRS≥3 Presence of tandem stenotic lesions in the target lesion areaor combined basilar artery stenosis Presence of ≥2 stenotic cerebrovascular lesions requiring concurrent intervention The presence of severe tortuosity or calcification of the target vessel, or the presence of extensive abnormal vascular structural variants that are difficult for catheters or stents to pass or cannot be implanted Lesions or stenosis that is too large and beyond the specification of the stent Non-atherosclerotic stenosis such as atrial fibrillation, vasculitis stenosis, arterial entrapment, smoky disease, active phase of arteritis, or unknown cause Contraindication to heparin, aspirin, tegretol, clopidogrel, or other antiplatelet drugs, and those who cannot tolerate anticoagulant and antiplatelet drug therapy Have had intracranial haemorrhage within 3 months Had a myocardial infarction or large cerebral infarction within 2 weeks Accompanied by other intracranial disease such as aneurysm, arteriovenous malformation, intracranial tumour, intracranial infection, etc Presence of active bleeding or extremely dangerous risk of haemorrhage (e.g. active peptic ulcer disease, gastrointestinal lesions with bleeding risk, malignant tumours with bleeding risk, etc.) Severe cardiac, hepatic, splenic, pulmonary, or renal impairment, or allergy or intolerance to contrast media, rapamycin (Rapamycin) and its derivatives, cobalt-based alloys, or polylactic acid - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06301750

Not yet recruiting

Oral Enteral Nutrition Feeding in Alzheimer's Patients

This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

- EligibilityCriteria: Inclusion Criteria: age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease. presence of no contraindication for enteral nutrition. with dysphagia verified by Imaging materials. with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications Minimum Mental State Examination ranging from 10-26 Exclusion Criteria: unable to cooperate in completing treatment and assessment due to personal reasons or other disorders. complicated with other intracranial lesions, such as stroke. abnormal structure of swallowing-related organ and tissue. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06301724

Not yet recruiting

Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease. Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

- EligibilityCriteria: Inclusion Criteria: Age >18 years. Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the - - Chinese Medical Association in 2006. Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. Stable vital signs, conscious, able to cooperate with assessment and treatment. Exclusion Criteria: Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. History of mental diseases or use of antipsychotics. Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301711

Not yet recruiting

Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

- EligibilityCriteria: Inclusion Criteria: Age>18 years. Meeting the diagnostic criteria for cerebral small vessel disease. Dysphagia confirmed by Videofluoroscopic Swallowing Study Mini-Mental State Examination (MMSE)<27, indicating the existence of cognitive impairment. No history of prior stroke. Exclusion Criteria: Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease. Neurological blockade contraindications such as bleeding tendency, blocked site infection. Unable to successfully finish the assessment of this study. Complicated with severe liver and kidney failure, tumors, or hematological disorders. Simultaneously in need to undergo other therapy that might affect the outcomes of this study. Pregnant or nursing females - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301698

Not yet recruiting

The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction

This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy. Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study. Age >18 years. First-time stroke. Steady vital signs, Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset. Exclusion Criteria: The bulbar palsy caused by other diseases, such as neurodegenerative diseases. Pseudobulbar palsy. Complicated with other neurological diseases. Tracheostomy tube inserted. Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. Dysphagia caused by other possible diseases. Pregnant females. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301685

Not yet recruiting

Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder

The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is: Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

- EligibilityCriteria: Inclusion Criteria: Diagnosed as Autistic Disorder. Aged between 3 years old and 6 years old. No contraindications to stellate ganglion block. Exclusion Criteria: Other significant physical or neurodevelopmental disorders. Other significant medical conditions - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 6 Years - StdAgeList: Child

NCT06301672

Not yet recruiting

Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

- EligibilityCriteria: Inclusion Criteria: Age between 30 and 65 years. With the history of Nasopharyngeal Carcinoma and radiation therapy. With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support. Conscious and with stable vital signs; Willing to participate and sign the written informed consent form either personally or by a family member. Exclusion Criteria: Presence of other diseases that might cause dysphagia. With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies. Concurrent participation in other treatments that could interfere with the trial. Inability to cooperate with treatment due to aphasia, mental health issues, etc. Received tube feeding for enteral nutrition support within the past three years. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301646

Not yet recruiting

Oral Enteral Nutrition Tube Feeding on Stroke Survivors

The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are: Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom.

- EligibilityCriteria: Inclusion Criteria: age ≥ 18 years; meeting the diagnostic criteria of stroke; any degree of dysphagia at admission; steady vital signs, without severe cognitive impairment or sensory aphasia. transferred out within three weeks of hospitalization in the neurology department. Exclusion Criteria: complicated with other neurological diseases; damaged mucosa or incomplete structure in nasopharynx; tracheostomy tube plugged; unfeasible to the support of parenteral nutrition; simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301633

Not yet recruiting

Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia

This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

- EligibilityCriteria: Inclusion Criteria: age ≥ 18 years; meeting the diagnostic criteria of stroke; any degree of dysphagia at admission; steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. transferred out within three weeks of hospitalization in the neurology department. Exclusion Criteria: complicated with other neurological diseases; damaged mucosa or incomplete structure in nasopharynx; tracheostomy tube plugged; unfeasible to the support of parenteral nutrition; simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301620

Not yet recruiting

Intra-articular Injection: A Innovational Approach for Joint Disorder

The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction The main question it aims to answer is: • Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction

- EligibilityCriteria: Inclusion Criteria: Presence of significant temporomandibular disorder clinical symptoms. Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination. Patients voluntarily participate in this study and provide signed informed consent. Normal cognitive function Exclusion Criteria: Rheumatic, rheumatoid, or other severe systemic diseases. Infectious temporomandibular joint arthritis or joint tumors. Individuals who have recently received joint injection treatment or photodynamic therapy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301607

Not yet recruiting

The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients

The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

- EligibilityCriteria: Inclusion Criteria: Age>18 years. Meeting the diagnostic criteria for ischemic stroke . Dysphagia confirmed by Videofluoroscopic Swallowing Study. Clear consciousness. No history of prior stroke. Stable vital signs. Exclusion Criteria: Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. Complicated with severe liver and kidney failure, tumors, or hematological disorders. Simultaneously in need to undergo other therapy that might affect the outcomes of this study. Pregnant or nursing females. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301594

Not yet recruiting

Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals

The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

- EligibilityCriteria: Inclusion Criteria: Age over 60 years old. No hospitalization within the past six months. With clear consciousness and able to cooperate with questionnaires and training. The elderly people who voluntarily participate and agree to adhere until the end of the study. Exclusion Criteria: Complicated with severe liver and kidney failure, tumors, or hematological disorders. Physical disability. Difficulty in mobility. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06301581

Recruiting

Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant

This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.

- EligibilityCriteria: Inclusion Criteria: Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including Ultra Version V2 newly implanted on this side (Group 1) Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2) Informed consent signed Exclusion Criteria: no exclusion criteria - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The studied population consists of all CI users implanted with a HiRes Ultra Version V2 or HiRes Ultra 3D Version V2 CI at the Medical University of Hannover in Germany (MHH). - SamplingMethod: Non-Probability Sample

NCT06301568

Recruiting

Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks.

- EligibilityCriteria: Inclusion Criteria: Being implanted with HiRes Ultra or HiRes Ultra 3D SlimJ Being a user of the "acoustic earhook" system Having provided informed consent regarding use of his/her data for research. Exclusion Criteria: no exclusion criteria - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The studied population consists of all CI users implanted with a HiRes Ultra or HiRes Ultra 3D SlimJ between January 2017 and August 2022 and using an acoustic earhook at the Medical University of Hannover in Germany (MHH) - SamplingMethod: Non-Probability Sample

NCT06301542

Recruiting

Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation

The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home.

- EligibilityCriteria: Inclusion Criteria: Age >= 18 years Capacity to consent Post-stroke community-dwelling adults Ability to follow 3-step commands Exclusion Criteria: Undomiciled Active substance use disorder Active psychosis Domestic violence or neglect Inability to communicate with investigators Other comorbidities that prevent full participation in the research - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Twenty post-stroke community-dwelling adults will participate in a single in-laboratory and in-home visit, performing 5x sit-to-stand (5XSST), 5x Comfortable and 3x Fast walking speed at a 5M distance, and 5x modified Timed Up and Go (TUG). The tests will be performed twice: once with and without the task aware-neuroprosthesis. - SamplingMethod: Non-Probability Sample

NCT06301516

Recruiting

Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD

Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.

- EligibilityCriteria: Inclusion Criteria: Aged 10-17 years old Identified through the TriNetX database as having a conduct disorder diagnosis English speaking Exclusion Criteria: Youth aged <10 years and >18 years old Non-English speaking Youth of caregivers younger than 18 years old. - HealthyVolunteers: No - Gender: All - MinimumAge: 10 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06301503

Not yet recruiting

Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB)

The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia. The main questions it aims to answer are: Will there be a significant difference in QoR-40 scores between both groups? Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours? Will the combined LPB-SNB significantly increases postoperative duration of analgesia? Participants will: Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants. Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire. Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries.

- EligibilityCriteria: Inclusion Criteria: Patients undergoing lower extremity orthopaedic surgery with spinal anaesthesia Patients aged between 18-65 years Patients with American Society of Anesthesiologists (ASA) physical status classification of I-III Patients with a body mass index (BMI) between 18-30 kg/m2 Exclusion Criteria: Patients with a history of allergy towards the local anaesthetic agents used Patients with contraindication to regional anaesthesia based on the American Society for Regional Anesthesia guidelines Patients with pre-existing mental or psychological disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301477

Not yet recruiting

PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.

- EligibilityCriteria: Inclusion Criteria: Age between 8.0 to 16.9 years of age. Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf. Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon. CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5). Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD. No changes in medical treatment for the previous month and without anticipated changes for the next month. Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study. Exclusion Criteria: Allergy to RS or excipients. Co-existing diagnosis with diabetes mellitus type 1. Treatment with another investigational drug or intervention throughout the study. Current illicit drug or alcohol dependence. Inability or unwillingness of an individual or legal guardian to give written informed consent. Other conditions requiring immunomodulating or biological medications. Pregnancy. Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay. - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 16 Years - StdAgeList: Child

NCT06301451

Recruiting

Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia

In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells. Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer. In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out.

- EligibilityCriteria: Inclusion Criteria: Age 18-65 (inclusive), gender is not limited; Subjects with clinical diagnosis of hyperlipidemia; The subjects' fasting LDL-C and carotid artery color Doppler ultrasound meet one of the following requirements: 1. Bilateral carotid artery color Doppler shows no plaque formation, and 2.6 ≤ LDL-C < 4.92mmol/L; 2. Bilateral or unilateral neck Arterial plaque formation, and 2.6≤LDL-C<3.4mmol/L; 18.5 kg/m2≤BMI≤35 kg/m2, Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2); Subjects who are willing to participate in the trial and sign informed consent. Exclusion Criteria: Secondary hyperlipidemia caused by systemic diseases (such as nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, liver disease or renal failure, etc.); Fasting triglycerides > 5.6 mmol/L; Diabetic patients; Those who plan to undergo bariatric surgery (gastric retraction, gastric bypass, gastric banding, etc.) during the study period; Have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) ) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.) who intervene; Those who have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.); Subjects who have used heparin, thyroxine treatment drugs, diuretics, phenothiazines, beta-blockers, adrenal corticosteroids and certain contraceptives in the past 8 weeks, which may affect blood lipid metabolism; Combined with malignant tumor or mental disorder; Accompanied by severe cardiovascular and cerebrovascular diseases, liver and kidney function damage (NYHA grade greater than or equal to 3, ALT or AST > 3 times the upper limit of normal, Cr > 1.5 times the upper limit of normal); Those who have participated in clinical trials of other drugs or medical devices within 3 months; Those who plan to become pregnant, are pregnant or are breastfeeding during the study period and those who cannot take contraceptive measures; Patients deemed unsuitable for participation in this study by the investigator. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301438

Not yet recruiting

Dalpiciclib in HR+/HER2- ABC

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

- EligibilityCriteria: Inclusion Criteria: Histologically confirmed advanced breast cancer Hormone receptor-positive and human epidermal growth factor receptor 2-negative ECOG 0-1 Exclusion Criteria: Pregnant or breastfeeding History of immunodeficiency - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer - SamplingMethod: Non-Probability Sample

NCT06301425

Not yet recruiting

MRD Response-adapted Allo-HSCT for Adverse-risk AML

This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial.

- EligibilityCriteria: Inclusion Criteria: Newly diagnosed AML; Categorized into adverse-risk group according to ELN 2022 criteria; 16-65 years of age at the time of diagnosis; achieving CR after 1 or 2 courses of induction chemotherapies; 4) ECOG PS score of 0 to 1 5) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent. Exclusion Criteria: Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria; < 16 years, or older than 65 years at the time of diagnosis; Achieving CR after 3 or more courses of induction chemotherapies, or could not achieve CR after induction chemotherapies; ECOG PS score of 2 or more; Patients with other comorbidities or mental diseases that influence the life safety and compliance of patients as well as affect informed consent, enrollment in the research, follow-up visit or result interpretation. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult

NCT06301412

Not yet recruiting

Combination of Hypothermia and Thrombectomy in Acute Stroke

The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion. The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed. Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications.

- EligibilityCriteria: Inclusion Criteria: Pre-stroke modified Rankin Scale (mRS) 0-2 [7-point scale rating from 0 (no symptoms) to 6 (dead)] Acute ischemic stroke with NIHSS >5 Intracranial occlusion of the M1 or M2 segment of the middle cerebral artery (MCA) or internal carotid artery (ICA) or tandem occlusion on CT-angiography or MR-angiography with indication for endovascular treatment: Time window 0-24h: Last seen normal to groin puncture < 6h: native CT or MRI-DWI with ASPECTS >5 Last seen normal to groin puncture 6-24h or unknown time window: significant mismatch imaging according to the eligibility criteria of the DEFUSE-3 trial Infarct core <70ml (DWI oder CBF<30%) Penumbra > 15ml (Tmax >6sec) Ratio penumbra/core >1.8 with or without iv thrombolysis with rtPA Exclusion Criteria: Patients with an intranasal obstruction that prevents complete insertion of the nasal cannula should not be treated with the RhinoChill system. Known severe hemorrhagic diathesis (International Normalized Ratio (INR) >3.0, partial thromboplastin time (PTT) > 70s, platelet count < 50.000/μl) Brain trauma or neurovascular surgery/intervention <3 months Severe infection Pregnant women or women of childbearing potential (women of childbearing potential with negative pregnancy test may be included) Known cerebral vasculitis Proof of bleeding in cerebral CT or MRI (cerebral microbleeds in MRI [hypertensive or in the context of cerebral amyloid angiopathy] is permitted). Known life expectancy < 6 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301399

Not yet recruiting

Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study

Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma

- EligibilityCriteria: Inclusion Criteria: 1)written informed consent signed prior to enrolment. 2) Age 17-79 years old (including boundary), male or female; 3) Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or clinical diagnosis that meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma 4) Previous progression or intolerance after failure to target, immunization, or conventional therapy (including TKI, ICI, chemotherapy, VEGF monoclonal antibody, or ICI combined with TKI/VEGF monoclonal antibody/chemotherapy) 5) 2 weeks after the end of previous systemic therapy ≥ the first dose of this study, and the treatment-related AEs recovered to NCI-CTCAE ≤ Grade 1 (except for alopecia) 6) Child-Pugh liver function rating within 7 days prior to the first dose of the study drug: A grade and good B grade (≤ 7 points) 7) Phase B or C as assessed by BCLC or Phase III as assessed by CNLC 8) At least one measurable target lesion as assessed by the investigator according to the requirements of mRECIST v1.1 within 4 weeks prior to the first dose 9) Have adequate organ function (without receiving blood transfusion, erythropoietin, granulocyte colony-stimulating factor, albumin, or other medical support within 14 days prior to initiation of study drug therapy) 10) If the patient has HBsAg(+) or HBcAb(+), HBV-DNA must be < 2500 copies/mL or < 500 IU/mL or < upper limit of normal (ULN) to be enrolled, and those with elevated HBV-DNA must agree to receive nucleoside anti-hepatitis B virus therapy. Subjects who are negative for HCV antibody (-) or HCV-RNA are allowed to enroll, if HCV-RNA is positive, they need to agree to receive local standard standard antiviral therapy, and subjects must have ALT, AST, ≤ 3×ULN to enroll, and subjects with hepatitis B and C co-infection need to be excluded (HBV-DNA and HCV-RNA are positive) 11) Patients with cured hepatitis C are acceptable, and the lower limit of detection of HCV RNA < test center before starting study drug treatment 12) ECOG PS score: 0-1 13) Expected survival ≥ 12 weeks 14) Male or female of childbearing potential who are willing to use contraception in the trial, and females of childbearing potential must have a pregnancy test within 7 days prior to the first dose with a negative result Exclusion Criteria: 1) Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma 2) History of hepatic encephalopathy within 6 months prior to the first dose of this study 3) Portal hypertension with endoscopic red signs, or those who are considered by the investigator to have a high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months before the first dose 4) Symptomatic brain or meningeal metastases (unless the patient has been >treated for 3 months, there is no evidence of progression in imaging results within 4 weeks before the first dose, and tumor-related clinical symptoms are stable) 5) The patient has human immunodeficiency virus (HIV) or active tuberculosis, or other uncontrolled active infection 6) Those who have undergone major surgery within 4 weeks before enrollment, and those who have had bone marrow biopsy, open biopsy, and intracranial biopsy within 7 days before screening 7) Those who have other malignant tumors in the past 5 years and have not been effectively controlled, except for carcinoma in situ of the cervix, squamous cell carcinoma of the skin or localized basal cell skin cancer 8) Known history of severe allergy to any monoclonal antibody or study drug excipient 9) Pregnant or lactating women 10) Other reasons judged by the investigator to be unsuitable for participating in this study - HealthyVolunteers: No - Gender: All - MinimumAge: 17 Years - MaximumAge: 79 Years - StdAgeList: Child, Adult, Older Adult

NCT06301386

Not yet recruiting

Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients

The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years old, both sexes; Patients with histologically or cytologically confirmed locally advanced and advanced colorectal cancer that cannot be R0 resected; Recist1.1-defined disease progression or intolerance to prior standard therapy during or after standard therapy. Standard therapy was required to include all the following agents: fluorouracilines, chemotherapy agents such as irinotecan, and oxaliplatin, with or without an anti-VEGF monoclonal antibody (e.g., bevacizumab). Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab). Before enrollment, the tumor tissue was PTEN mutations; Patients with ECOG score of 0-1 and expected survival time ≥3 months, patients who can cooperate to observe adverse reactions and efficacy; At least one measurable tumor lesion according to RECIST 1.1 criteria; Good organ function: neutrophil ≥1.5*109/L; Platelet ≥100*109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl; Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3 and T4 in the normal range; bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal; Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy; Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal; There were no serious concomitant diseases that could make the survival time less than 5 years; Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients; Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol; Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study; Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures; Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices. Exclusion Criteria: Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor; Prior treatment with PD-1 antibody; Prior treatment with mTOR inhibitor; Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma/allergy without any intervention in adulthood; A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation; Contraindications to antiangiogenic drugs (such as active bleeding, gastrointestinal bleeding, hemoptysis, etc.); History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia; Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment; The subject has active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay) Severe cardiopulmonary and renal dysfunction; Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); A history of psychotropic substance abuse, alcohol or drug abuse; Other factors that may affect subject safety or trial compliance as judged by the investigator. Severe medical conditions requiring concomitant treatment (including mental illness), serious laboratory abnormalities, or other family or social factors. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301373

Not yet recruiting

Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy. This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48. This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines.

- EligibilityCriteria: Inclusion Criteria: Patients were diagnosed according to the 1987 American College of Rheumatology or 2010 American College of Rheumatology/European League Against Rheumatism criteria Patients had moderate or high disease activity Patients had a synovial biopsy and with a myeloid-stromal pathotype Patients with good compliance, willing to participate in this study and sign an informed consent form Exclusion Criteria: Patient received conventional synthetic disease modifying anti-rheumatic drugs treatment in the first 12 weeks of randomization Patient received biologic agents treatment in the first 6 months of randomization Patient received Janus kinase inhibitor treatment before randomization Patient with serious diseases under control (such as diabetes), serious respiratory diseases, serious chronic gastrointestinal diseases (such as active or recurrent gastrointestinal ulcers), serious blood system diseases (such as aplastic anemia, myelodysplastic syndrome) or any disease that can cause hemolysis or erythrocyte instability (such as malaria, hemolytic anemia) Patients with moderate to severe congestive heart failure (New York Heart Association grade III or IV), or recent (within 6 months prior to screening) cerebrovascular accident, myocardial infarction, coronary stent implantation, or uncontrolled hypertension Patients with blood routine WBC<4.0 × 109/L, and/or Hb<90g/L, and/or Plt<100 × 109/L during the screening period Patients with active chronic liver disease or abnormal liver function, AST, ALT, GGT, and TBIL are more than twice the upper limit of normal during the screening period Patients with estimated glomerular filtration rate <30ml/min during screening period Patients with history of symptomatic herpes zoster infection (within the first 12 weeks of randomization), recurrent or disseminated (even if only once) herpes zoster or disseminated (even if only once) herpes simplex infection Chest X-ray or CT examination indicates active tuberculosis, or latent tuberculosis (T-SPOT or TB-IGRA positive) without prophylactic tuberculosis treatment for at least 4 weeks Patients woth hepatitis C virus ribonucleic acid (HCV-RNA) testing are higher than the lower limit of detection; Or positive for Treponema pallidum antibody (TP Ab); Or human immunodeficiency virus antibody (HIV Ab) positive during the selected period Patients with hepatitis B surface antigen positive without prophylactic antiviral treatment Patients with history of lymphoproliferative diseases, or possibly various signs or symptoms of lymphoproliferative diseases Patients with any active malignant tumors or history of malignant tumors within the first 5 years, except for skin squamous or basal cell carcinoma, cervical carcinoma in situ, or breast ductal carcinoma in situ that has been treated and considered cured Patients with history of thromboembolism, including deep vein thrombosis, pulmonary embolism, arterial thrombosis, etc., or high risk factors prone to thromboembolism (such as obesity, smoking, abnormal coagulation function, diabetes, long-term use of estrogen or use of compound hormonal contraceptives or hormone replacement therapy, long-term braking, etc., which are comprehensively judged by the investigator according to clinical evaluation) Patients with undergone major surgery within the first 4 weeks of randomization, or is expected to undergo major surgery after enrollment; Or a history of chronic pain that may affect the evaluation of the study; Or have received organ transplantation before Patients with history of mental illness, alcoholism, drug or other substance abuse Pregnant women, lactating women, and men or women who plan to conceive in the near future The researchers believe that there are any other factors that may affect the progress or evaluation of the results of this study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301360

Recruiting

Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned. Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT). The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created. The research question for this specific study is: Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?

- EligibilityCriteria: Inclusion Criteria: The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms. The subject rates either moderate distress from bodily symptoms in the PHQ-15 (over 10 points) or severe distress from a single bodily symptom (at least 2 points for this symptom). The research participants expresses interest in investigating whether emotional factors such as stress may contribute to symptoms. Research subjects either affirm the presence of emotionally difficult life events (affirm at least 1 such event in the Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p in the PCL-5). Drugs used should have been stable for at least 1 month. Exclusion Criteria: Research subjects suffer from ongoing substance abuse (alcohol or drugs) or are deemed to have serious mental illness (psychotic illness, suicidal ideation, antisocial personality disorder etc). The research subjects have ongoing medication of a clearly addictive and sedative nature (e.g. benzodiazepines). The research subject participates in other psychological treatment focusing on physical symptoms. However, other psychological treatment is allowed where the support therapy does not take place more often than once a month. The research subject does not master the Swedish language sufficiently to be able to assimilate written material in Swedish. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301347

Not yet recruiting

Learning Through Play Plus for Psychosis

Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia.

- EligibilityCriteria: Inclusion Criteria: Diagnostic and Statistical Manual-V (DSM-V) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder. Parents (Mother or Father), age 18 year and above Parents (Mother or Father) having a child from birth to 36 months Parents (Mother or Father) living within the catchment area of recruitment site. Competent and willing to give informed consent Parents (Mother or Father) are stable on medication for at least 3 months prior to the intervention. Exclusion Criteria: Violation of any inclusion criteria Failure to perform screening or baseline examinations. Patients who will meet the criteria for a DSM-V diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-V alcohol or substance dependence (other than for nicotine) within the last 6 months Temporary resident unlikely to be available for follow up. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301334

Not yet recruiting

Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy

A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy

- EligibilityCriteria: Inclusion Criteria: • Age from 18 to 75 years old. Both sexes. American Society of Anesthesiologists (ASA) physical status I-II-III. Patient undergoing unilateral thoracotomy surgery. Exclusion Criteria: • BMI more than 30 kg/m2. Patients who are taking analgesics for chronic illness or have a history of substance abuse. Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder). Patients with a history of coagulopathy. Severe heart diseases. Hepatic or renal insufficiency. Infection at the site of infiltration - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06301321

Recruiting

The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients

Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves.

- EligibilityCriteria: Inclusion Criteria: Leftover RNA samples from CML patients were recruited from the Hematology Laboratory Division of Hematology Department of Medicine Faculty of Medicine, Siriraj Hospital Mahidol University, after TKI treatment and regular follow-ups or newly diagnosed. All samples were successively tested by QXDx BCR-ABL %IS Kit (Bio-Rad) which used Droplet Digital PCR (ddPCR) technique. Exclusion Criteria: In adequate or poor-quality specimen - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients 18 years and older who were newly diagnosis and known to have CML - SamplingMethod: Probability Sample

NCT06301308

Recruiting

A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial

The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C.

- EligibilityCriteria: Inclusion Criteria: Male patients under the age of 50 referred for postoperative cystoscopy for bladder cancer Exclusion Criteria: - 1. Other evident causes contributing to lower urinary tract symptoms, such as obvious glandular cystitis and severe urinary tract infections. 2. Excessive prostatic hyperplasia. 3. Urethral stricture. 4. A history of prior urethral surgeries. 5. Uncontrolled hypertension, cardiac conditions, and chronic obstructive pulmonary disease. - HealthyVolunteers: No - Gender: Male - MaximumAge: 50 Years - StdAgeList: Child, Adult

NCT06301295

Not yet recruiting

Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer

This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 20 years Obtained written informed consent Subjects suspected with resectable lung cancer and planning to undergo bronchoscopy Subjects with no contraindication to brochoscopy Subjects planning to undergo surgery for suspected lung cancer and opting for tissue or liquid biopsy for genetic alteration using Next Generation Sequencing Exclusion Criteria: Patients who withdraw informed consent Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for genetic alteration with Next Generation Sequencing based on the investigator's judgement - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult

NCT06301282

Recruiting

Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease

Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood. The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation. For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration. This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of Parkinson's disease (PD) based on United Kingdom PD Society Brain Bank Criteria Patients in the PD phase called "fluctuation stage". PD can be defined according to the four following disease stages: de novo stage (i.e. at the time of diagnosis, dopamine replacement therapy not yet introduced), honeymoon stage (i.e. dopamine replacement therapy compensates PD symptoms), motor and non-motor fluctuations stage (fluctuations in the clinical effect of the dopamine replacement therapy) and the decline phase (i.e. onset of cognitive impairment and falls). Presence of motor and non-motor fluctuations are based on: For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale IV For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessment of PD To be on dopaminergic replacement therapy. The daily dose of dopaminergic replacement therapy will be converted into a common unit (levodopa equivalent daily dose) to get an idea of the dopaminergic replacement therapy dose needed per day for each patient The course of PD, and in particular the time of each PD phase, is very variable from one patient to another. A precise duration of illness can therefore not be included in the inclusion criteria. The dose of dopaminergic replacement therapy required for each patient is also extremely variable from one patient to another and cannot be included in the inclusion criteria. Healthy controls will be subjects: • Without any known central nervous system (CNS) lesion or CNS clinical signs on examination Exclusion Criteria: Age greater than 80 years Dementia or mild cognitive impairment based on a score <24 on the MOntreal Cognitive Assessment, Ongoing depression with suicidal ideation, Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory, cerebrovascular disease or other serious progressive physical diseases, Participating in a pharmacological study, Intolerable "OFF-levodopa" states when the effects of the PD medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning upon waking), Inability to provide informed consent (legal guardianship), Inability to speak or read French. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Parkinson's Disease (PD) patients will be recruited from the outpatient movement disorder clinic of the Neurology Department at the Geneva University Hospital (HUG). Patients, who participated in previous studies and who are now followed-up by private physicians, could also be contacted by trained members of the clinic/research staff to propose the study. Flyers with a brief explanation of the project could also be distributed to the physicians for inviting patients to consider participating and reach out to a staff member for further information. Healthy controls will be recruited among the spouse of patients and through advertisement placed in the HUG and the University Medical Centre. - SamplingMethod: Non-Probability Sample

NCT06301269

Recruiting

A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia

The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia. The main questions it aims to answer are: What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia? Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables? What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia? Participants will fill out the questionnaire to complete the study.

- EligibilityCriteria: Inclusion Criteria: primary caregivers of dementia patients diagnosed by specialists aged 18 and above who spend 8 hours or more daily (including overnight caregivers) providing care Exclusion Criteria: Those who do not agree to participate in the research Caregivers in a paid relationship with dementia patients, such as foreign domestic helpers and government-provided resident care attendant - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will include primary caregivers of people with dementia. Participants will be adults aged 18 years and older who are currently providing care for a family member , Participants will be recruited from NTUH Neurology ward and Out-Patient Departments (OPD). - SamplingMethod: Probability Sample

NCT06301256

Not yet recruiting

Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa

The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks .

- EligibilityCriteria: Inclusion Criteria: Written informed consent provided by the patient. Male or female, age 18 years. BMI of 27 or greater Subject must be in general good health (except for hidradenitis suppurativa) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. NOTE: the definition of good health means a subject that does not have uncontrolled significant co-morbid conditions. Must have a diagnosis of HS for at least 6 months prior to Baseline/Screening visit Subjects with moderate to severe HS with a PGA score of 3 or more. 3 is defined as having: 0 abscesses, 0 draining fistula, and 5 inflammatory nodules; or 1 abscess or draining fistula and 1 inflammatory nodule; or 2-5 abscesses or draining fistulas and 10 inflammatory nodules. Patients with more than 5 abscesses or 5 draining fistulas, and/or excessive scarring, will be excluded. HS lesions must be present in at least two distinct anatomic areas, one of which must be at least Hurley Stage II (see definition of terms) Subject must have stable HS for at least 2 months (60 days) prior to Screening/Baseline visit as determined by the investigator through subject interview and review of medical history. Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the- counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater. Premenopausal women must have a negative serum pregnancy test on entry in the study. Women who are post-menopausal will have their FSH checked to confirm their status. Females of childbearing potential (FCBP)† must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS, one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide d) oral hormonal contraception. Use of Tirzepatide may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose Escalation with tirzepatide. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made from natural [animal] membrane [for example, polyurethane]) while on investigational product and for at least 28 days after the last dose of investigational product. A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) and 2) has not been postmenopausal for at least 24 consecutive months (that is, has had menses at any time during the preceding 24 consecutive months). The female subject's chosen form of contraception must be effective by the time the female subject is screened into the study (for example, hormonal contraception should be initiated at least 28 days before screening). The screening/baseline laboratory test results must meet the following criteria (WNL means within normal limits for patients with HS [e.g., may have slightly higher WBC and platelet counts]): WBC (white blood cell count): WNL ANC (absolute neutrophil count): WNL Hemoglobin: >10 mg/dl Platelets: WNL Serum Creatinine: WNL SGOT (AST - aspartate aminotransferase): <3 times upper normal limit SGPT (ALT - alanine aminotransferase): <3 times upper normal limit Alkaline phosphatase:<3 times upper normal limit FSH for postmenopausal women (to confirm menopause has occurred and exclude the need for contraception) Exclusion Criteria: Subjects with 20 nodular lesions and/or significant scarring (defined as any linear, indurated area, extended across more than 50% of the circumference of the affected area), more than 5 abscesses, more than 5 fistulas or sinus tracts. Patient with PGA 0-2 (no disease or minimal disease i.e.: Hurley Stage 1) will be excluded. Patients with BMI lower than 27 Patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients with Type 1 Diabetes Mellitus History of pancreatitis Other than hidradenitis suppurativa, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled. Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study. Prior history of suicide attempt at any time in the subject's lifetime prior to or major psychiatric illness requiring hospitalization within the last 3 years. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last study drug dose (this includes fathers who plan on fathering a child within 6 months after their last study drug dose. Known serious hypersensitivity to tirzepatide or any of the excipients in it. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. Active substance abuse or a history of substance abuse within 6 months prior to Screening Malignancy or history of malignancy, except for treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas; treated [i.e., cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years. Active substance abuse or a history of substance abuse within 6 months prior to screening Patient with diagnosis or suspected Crohn's disease or ulcerative colitis. Patient who is on a stable dose of analgesics, will be allowed to remain on them. No new opiates will be permitted during the trial. Use of any investigational drug within 5 weeks prior to screening, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer). Known allergy to tirzepatide, semaglutide, exenatide, liraglutide or other incretins (GLP1 receptor agonists) Have a known history of serious infections (i.e, hepatitis, pneumonia or pyelonephritis) in the previous 3 months Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (eg, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access. Patient with significant scarring, fistulas, or sinus tract involvement will be excluded. Only subjects with inflammatory abscesses and nodules will be allowed to enter the study. Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to Baseline. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS; History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV); Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study; Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBsAb positive subjects; Or Hepatitis C Have evidence of active or Latent TB Pregnant (or considering becoming pregnant) or lactating females. Subjects currently undergoing any of the following treatments for HS will require a 4 week wash- out period: minocycline; tetracycline; clindamycin; rifampin and steroids. Patients treated with any biologic therapy including adalimumab, will require a washout period of 5 half lives. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301243

Recruiting

Molecular Signature of Inactivity Induced Exercise Responsiveness

Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases.

- EligibilityCriteria: Inclusion Criteria: free from acute or chronic illness (cardiac, pulmonary, liver, or kidney abnormalities, cancer, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other known metabolic disorders) free from orthopedic limitations (including any artificial joints) no known lidocaine allergy do not currently smoke or participate in other forms of tobacco use. not currently in a structured exercise program - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06301191

Recruiting

The Effect of Semaglutide on Cardiovascular Markers and Liver Function

Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study. 25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors. At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function.

- EligibilityCriteria: Inclusion Criteria: Diabetes Mellitus type 2 NAFLD Exclusion Criteria: malignancies chronic inflammatory disease chronic kidney disease (estimated glomerular filtration rate <60 ml/min/m2 for a period of at least 90 days) peripheral vascular disease retinopathy previous therapy with a Glucagon-like peptide-1 agonist. None of the female patients was on hormone replacement treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 50 subjects with T2DM and NAFLD, who attended the Diabetes Outpatients Clinic were enrolled in the study. 25 patients will reciece semaglutide 1 mg (treatment group) and 25 patients will receive DPP-4 inhibitors (either linagliptin or alogliptin or vildagliptin or sitagliptin - control group). Exclusion criteria were malignancies, chronic inflammatory disease, chronic kidney disease (estimated glomerular filtration rate <60 ml/min/m2 for a period of at least 90 days) peripheral vascular disease, retinopathy, and previous therapy with a Glucagon-like peptide-1 agonist. None of the female patients was on hormone replacement treatment. - SamplingMethod: Probability Sample

NCT06301178

Not yet recruiting

Effect of Vitamin D Injection on Hypertrophic Scars and Keloids

Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand. The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes

- EligibilityCriteria: Inclusion Criteria: - Age from 12 years to 50 years. Patients with hypertrophic scars and keloids Exclusion Criteria: Age below 12 years and above 50 years. Patients received other treatment modalities for hypertrophic scars and keloids. Systemic and other skin diseases. Patients were already receiving supplemental vitamin D. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06301165

Not yet recruiting

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.

- EligibilityCriteria: Inclusion Criteria: Age between 18 and 65 years; Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma (WHO type II or III); Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition); Easte Cooperative Oncology Group performance status of 0 or 1; Adequate bone marrow: leucocyte count ≥ 4×109/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×109/L; Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN; Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment; Patients must be appraised of the investigational nature of the study and provide written informed consent. Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma; Treatment with palliative intent; Prior malignancy (except for adequately treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin); History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume); Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period); Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance; Prior allergic reaction to the study drug(s) involved in this protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301126

Recruiting

Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries

After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

- EligibilityCriteria: Inclusion Criteria: Patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy) no prior surgical intervention for esophageal, gastric, or biliary tract resection age 18-60 years acceptable physical condition (permitting pulmonary function and functional capacity test). Exclusion Criteria: Cerebrovascular disease use of immunosuppressants within 30 days of surgery cardiovascular instability chest physical therapy within the 8 weeks preceding study enrollment visual impairment or hearing impairment; bed-ridden patients; any lung disorders insulin-dependent diabetes mellitus less than 6-months post thoracic or cardiac surgery musculoskeletal impairment cognitive disorders Patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does heavy smokers or alcoholism - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06301100

Recruiting

Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT

This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT.

- EligibilityCriteria: Inclusion Criteria: Voluntarily participate in and sign the informed consent in person. 2. Over 18 years old, gender unlimited; 3. After imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, MDT decided to treat SBRT 4. Clinical stage IA-IV (cT1-4N1-3M0-1); 5. No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency; 6. Coagulation function: activated partial thromboplastin time (APTT) < the upper limit of normal 10 seconds, prothrombin time (PT) < the upper limit of normal 3 seconds, plasma fibrinogen 2-4g/L; 7. Hemoglobin ≥100g/L, WBC≥4×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L 8. Bilirubin < 1.5 times the upper limit of normal value; Glutamic oxalic aminotransferase (ALT) & Glutamic pyruvic aminotransferase (AST) ≤1.5 times the upper limit of normal value; 9. Serum creatinine ≤1.5 times the upper limit of normal value; 10. The willingness of men or women of childbearing age to use contraception in the trial; 11. Physical condition score ECOG level 0 ~ 2; 12. Expected survival >3 months;13, Can acquire MRI scanning Exclusion Criteria: Patients could not tolerate or were unwilling to undergo CT examination; 2. The primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy; 3. Subjects who have received other drug trials within the last 1 month; 4. People with severe allergic history or idiosyncrasies; 5. Patients with a history of severe lung or heart disease; 6. Severe comorbidities, such as uncontrolled hypertension, heart failure, etc.; 7. Pregnant or lactating women; 8. Previous history of malignant tumor; 9. Refusal or inability to sign informed consent to participate in the trial; 10. Currently or planning to participate in other clinical trials; 11,Can not acquire MRI scanning - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients with primary or metastatic tumors in the lungs and brains, in good general condition and are proposed to undergo SBRT - SamplingMethod: Non-Probability Sample

NCT06301074

Not yet recruiting

The Phase I Study of HS-10509 in Chinese Adult Subjects

The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia. Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part.

- EligibilityCriteria: Inclusion Criteria: Part 1(SAD) for healthy adults When signing the ICF, the subject should be between 18 and 45 years old (inclusive); Have a full understanding of the trial content, process and possible adverse reactions, be willing and able to abide by the contraindications or restrictions stipulated in this program, and voluntarily sign the ICF; Male weight ≥50kg, female weight ≥45kg, body mass index (BMI= weight/height 2[kg/m2]) in the range of 18-28 (inclusive); Agree to use (or have their partner use) an effective contraceptive method from the date of signing the ICF until 90 days after the last dose, and there are no plans to donate eggs/sperm. Part 2 (MAD) for Schizophrenia patients When signing the ICF, the subject is between 18 and 65 years old (inclusive); BMI at screening and baseline was between 18.5 and 30.0 kg/m2 (inclusive), and male subjects were ≥50 kg and female subjects were ≥45 kg; Meet the diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5) diagnostic criteria for schizophrenia; The total score of PANSS during screening and baseline was ≤90 points; Clinical overall impression - severity of disease (CGI-S) score ≤4 points; Currently not using antipsychotic drugs; Female subjects of reproductive age, screening and baseline urine pregnancy test results were negative; Female and male subjects of reproductive age and their spouses agree to use a highly effective contraceptive method during the study medication period and within 3 months after the termination of medication, and no sperm or egg donation is planned; After fully understanding the purpose, content, process and possible risks of this study, subjects and guardians shall voluntarily participate in this clinical study and sign a written informed consent, and are willing to complete the entire study process according to the requirements of the trial. Exclusion Criteria: Part 1 (SAD) for healthy adults Other clinically significant diseases; After C-SSRS assessment, answer "yes" to question 4 or question 5 of the suicidal ideation questionnaire within 1 year, or have a history of suicidal behavior; allergies to multiple food or drug allergies, or known allergies to test drug ingredients; Within 2 weeks before the trial (or 5 half-lives of the drug, whichever is longer) or plan to take any medication during the trial, including prescription and over-the-counter drugs, Chinese herbal medicines, but not including vitamins, dietary supplements; Drug abusers or those who have used soft drugs (e.g., marijuana) within 3 months prior to the trial, or hard drugs (e.g., cocaine, PCP, etc.) within 1 year prior to the trial; Have a history of alcoholism or consume more than 14 units of alcohol per week in the last 2 weeks (1 unit = 285 mL for beer, 25 mL for spirits, 150 mL for wine); Smokers who smoked more than 5 cigarettes per day in the 3 months before the test, or could not stop using any tobacco products during the test; Blood donation or significant blood loss within 3 months before the first dose of the trial drug (≥450mL within 30 days, excluding blood collection at the screening stage), or a blood donation plan during the study period or within 3 months after the last visit; Those who had undergone surgery within 3 months prior to screening, or planned to undergo surgery during the study period; Or have undergone medical or surgical treatments that permanently alter the absorption, distribution, metabolism, and excretion of oral drugs (such as gastric or intestinal surgery); Participating in any clinical trial and taking any clinical trial drug within 3 months before the trial; Difficulty swallowing capsules and other solid preparations; The female subject is pregnant or breastfeeding, or the serum pregnancy test is positive; Difficulty in blood collection, unable to tolerate multiple intravenous blood collection and any blood contraindications; Positive baseline urine drug test, or positive alcohol breath test; Measured the blood pressure in the recumbent position, and within 3 minutes of changing the position to the upright position compared with the recumbent position, the systolic blood pressure decreased by ≥20mmHg or the diastolic blood pressure decreased by ≥10mmHg; During screening or baseline, physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, thyroid function, coagulation function, urine routine, serum prolactin, etc.), infectious disease screening, 12-lead electrocardiogram, abdominal B-ultrasound, chest X-ray and other abnormalities, which were judged by the investigator and were clinically significant, should not be included in the trial; Positive for viral hepatitis (hepatitis B or hepatitis C), AIDS antibody and treponema pallidum antibody during screening; Any physical or mental illness or condition that, as determined by the study physician, is likely to increase the risk of the trial, interfere with the subject's adherence to the protocol, or interfere with the subject's completion of the trial. Part 2 (MAD) for Schizophrenia patients Meet the DSM-5 diagnostic criteria for other mental disorders, and the researchers judge that it may have an impact on clinical research; Other diseases or disorders, as determined by the investigator, that are associated with the clinical trial; After C-SSRS scale assessment, the answer to question 4 or question 5 in the first 6 months of screening was "yes"; Suicide or self-injury within 1 year prior to screening; According to the judgment of the researchers, the clinical symptoms related to schizophrenia in this episode (such as severe impulsivity, agitation, etc.) may make it difficult for the patients to persist in completing the entire study process, and they are not suitable to participate in this study; Received electroconvulsive therapy within 3 months before screening; Use of long-acting antipsychotics within 6 months prior to screening; A history of epilepsy; Previous history of malignant syndrome; The presence of any surgical condition or condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a hazard to participants in the trial; Have a history of severe allergies; Female subjects were pregnant, puerperal, or lactating at the time of screening or baseline; Those who have a history of drug abuse within 1 year before screening; A history of alcohol abuse in the six months prior to screening (i.e. drinking more than 14 standard units per week, 1 standard unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or fail to stop alcohol during the study period; Smoking more than 5 cigarettes per day (including e-cigarettes) in the 3 months prior to screening, or cannot stop smoking during the study period; Abnormal physical examination, vital signs, 12-ECG, or lab tests at screening or baseline, which may affect clinical research, as assessed by the study investigator; Non-negative hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab) and syphilis serological test during screening; Blood donation or blood loss ≥200ml within 1 month before screening; Participate in any interventional clinical trial within 3 months prior to screening; Other situations in which the investigator deems it inappropriate to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06301061

Not yet recruiting

Focal Microvibration and Chronic Lumbosacral Radicular Pain

The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question[s] it aims to answer are: Can focal microvibration improve pain in this patient population? Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday. Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy.

- EligibilityCriteria: Inclusion Criteria: Pain duration≥6 months Magnetic resonance imaging (MRI) showing compression of lumbosacral nerve roots Neuropathic symptoms in the innervation territory of the compressed spinal nerve roots Monolateral pain Pain intensity: moderate-severe i.e. numeric rating scale (NRS)≥4. Exclusion Criteria: Psychiatric patients Cancer patients Patients affected by disease characterized by spasticity or muscular stiffness: Parkinson's disease, multiple sclerosis, stroke, spine injuries. Patients with spinal or dorsal root ganglion stimulators Patients undergone central of peripheral stimulation in the past 3 months Patients affected by fibromyalgia. Patients undergone central nervous system surgery Patients with reduced renal function eGFR≤60ml/min/1,73m2 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06301035

Not yet recruiting

Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group

Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field. Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure. Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure. Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure.

- EligibilityCriteria: Inclusion Criteria: 19 years of age or older Patients who applied mechanical ventilation treatment for more than 24 hours before the excision Patients who underwent endotracheal intubation rather than tracheal incision Planned extubation after successful spontaneous breathing trial (SBT) Reintubation High Risk Patients: If any of the following conditions are met Age > 65 Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation > 12 Body mass index (BMI) > 30 kg/m2 Inability to deal with respiratory secretions improper cough reflex If at least three aspirations are required in the 8 hours prior to the discharge Difficult or long delay in mechanical ventilation The first attempt to leave the mechanical ventilation failed Charlson Commercial Index (CCI) at least 2 categories of comorbidities Heart failure is the main indication of mechanical ventilation application Moderate to severe chronic obstructive pulmonary disease If there is a problem with airway openness (high risk of developing laryngeal edema) a woman Oral endotracheal intubation maintenance period of at least 3 days Difficult to intubate endotracheally (difficult airway) Long-term mechanical ventilation application: When applied for more than 7 days Exclusion Criteria: a patient with a tracheostomy tube Contraindicated application of nasal interfaces a nasal disorder Continuous positive pressure (CPAP) application contraindications pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc EIT application contraindications Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators) a patient with hyperhidrosis a patient whose physical movements are not controlled a pregnant woman BMI 50 or higher - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06301022

Recruiting

Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus

Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited. Methods: Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer.

- EligibilityCriteria: Inclusion Criteria: CKD without diabetes Exclusion Criteria: CKD with diabetes - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: the medical histories of 43 individuals who received outpatient services at the Department of Nephrology in The First Affiliated Hospital of Harbin Medical University, located in Harbin, China. - SamplingMethod: Non-Probability Sample

NCT06301009

Not yet recruiting

The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray

The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing.

- EligibilityCriteria: Inclusion Criteria: Consent to participate in the study Age between 40 and 75 years Clinical indication from the treating physician to undergo chest CT for CAC score evaluation Exclusion Criteria: Prior cardiovascular events (myocardial infarction, coronary revascularization, transient ischemic attack, stroke, symptomatic peripheral vascular disease, arterial revascularization of peripheral districts) Cancer or other chronic diseases with an estimated prognosis of less than five years Technical contraindications to the execution of chest CT with electrocardiographic gating (highly penetrant atrial fibrillation, frequent ventricular extrasystoles) - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06300996

Not yet recruiting

Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb

Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted.

- EligibilityCriteria: SMA Participant Inclusion Criteria: Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by determination of a genetic deletion in the SMN1 gene (5q12.2-q13.3). Subject is diagnosed as being non-ambulatory SMA based on the following criteria: a. Can't stand independently. Subject is ≥16 years of age and < 65 years of age. Subject is able to sit independently. A minimum score of 4 for Entry Item "A" of the Revised Upper Limb Module (RULM) scale for SMA: "can raise both arms simultaneously to shoulder height with or without compensation. Elbows bent or in extension". Subject (and subject's parent or legal guardian if subject is a minor) is willing and able to comply with scheduled visits and study procedures Participants must have started SMN inducing therapies (Spinraza or risdisplam) at least 6 months prior to enrollment. (They must have either gotten their first injection at at least 6 months prior, or they started daily intake of risdisplam at least 6 months prior to the study) Healthy Control Participant Inclusion Criteria: Subject is ≥18 years of age and < 65 years of age. Subject is able to stand independently for ≥3 seconds. Subject is willing and able to comply with scheduled visits and study procedures. SMA Participant Exclusion Criteria: Subject has deformation of the spinal canal preventing lead implantation as judged by the study neurosurgeon Subject has size of spinal canal that is insufficient for lead implantation as judged by the study neurosurgeon Subject has moderate or severe joint contractures that would affect ability to perform study measures Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety of anesthesia or the procedures, make it unlikely that intervention or follow-up will be correctly completed or impair the assessment of study results, in the opinion of the investigator Female subjects are pregnant or breastfeeding, as established by self-report. Subject has severe claustrophobia Subject is on anticoagulant, anti-spasticity or anti-seizure medication within 4 weeks of lead implantation or requires these medications during the treatment phase of the study Subject has medical implant that precludes magnetic resonance imaging Subject has a deconditioned respiratory system, per the discretion of the physician investigator. Subjects with renal insufficiency at the discretion of the physician investigator. Subjects requiring any form of sedation for MRI will be excluded. Healthy Control Participant Exclusion Criteria: Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study. Participants who have any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than stroke, etc.) or cognitive impairments that could affect their ability to participate in this study. Female subjects are pregnant or breastfeeding, as established by self-report. Subjects requiring sedation for MRI will be excluded. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 16 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult