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NCT06305819

Recruiting

Effectiveness of a Self-management Program After Traumatic Injury

Traumatic injuries, defined as a physical injury with sudden onset, are a leading cause to disability and impaired health. Persons who sustain a traumatic injury often report problems in daily life activities and reduced quality of life, which may limit participation in work/studies, leisure activities and family life. Consequently, complex rehabilitation and support is recommended in National Trauma guidelines due to the often long-lasting physical and psychological sequela of the injury. The main goal of this study is to determine the effectiveness of a self-management support program delivered to persons with a moderate or severe traumatic injury in the sub-acute phase of recovery (i.e. 3-4 months after injury). The self-management program aims to enhance patients' self-efficacy by building skills and self-management strategies to cope with injury-related consequences. The program has a group-based format and consists of eight sessions comprising psychoeducation, skill mastery and sharing of experiences. The participants who will be included in the study must be between 18 and 70 years, be residing in the southeast region of Norway, be admitted to Oslo University hospital or transferred from local hospital within 72 hours after injury, have at least a two-day hospital stay, and be able to read and understand Norwegian language. Participants will be randomly assigned to either intervention or control group. A group of patients will also be able to self-select if they want to receive the self-management support program or be in the control group. The latter is an explorative part of the study to evaluate the influence of patients' treatment-preferences on the study outcomes. Participants in the control group will receive treatment as usual.

- EligibilityCriteria: Inclusion Criteria: Adults residing in the southeast region of Norway who are aged between 18 and 72 years. Admitted to OUH directly or after transfer from local hospitals within 72 hours of injury. At least a two-day hospital stay. Traumatic injury corresponding to a New Injury Severity Scale score (NISS) >9. Patients reporting injury-related symptoms, functional impairments, and/or difficulties with daily activities at the discharge from OUH. Exclusion Criteria: Cognitive function corresponding to a Mini Mental Status score (MMS) < 20 points. Psychiatric diseases that require treatment. Drug/alcohol dependence that require treatment. Complete spinal cord injury and isolated thoracic or abdominal injury Insufficient command of Norwegian - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 72 Years - StdAgeList: Adult, Older Adult

NCT06305806

Not yet recruiting

RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

- EligibilityCriteria: Inclusion Criteria: See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study) Additional Appendix B (Ivabradine Sub-study) Level Inclusion Criteria: Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms COMPASS-31 Score > 25 and not enrolled in the IVIG appendix Exclusions Criteria: See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study) Additional Appendix B (Ivabradine Sub-study) Level Exclusion Criteria: A person of child-bearing potential who is not taking effective contraception Use of the following medications: clonidine, tizanidine, amphetamines, and serotonin and norepinephrine reuptake inhibitors (SNRIs) with the exception of modafinil Use of beta-blockers (any formulation), calcium channel blockers, midodrine, pyridostigmine, fludrocortisone, and guanfacine will be excluded unless participant is on a stable dose (>4 weeks). Participants on stable doses will be allowed to continue the medication throughout the study. Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties Lactating and breast-feeding women Severe hepatic impairment Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine Concomitant use of digoxin Participants who are pacemaker dependent Patients with hypokalemia (serum K+<3.5 mEq/L) Patients taking potassium-depleting diuretics A history of congenital or acquired long QT syndrome, with or without torsade de pointes Patients with high degree AV block such as Mobitz II - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305793

Not yet recruiting

RECOVER-AUTONOMIC: Platform Protocol, Appendix A (IVIG)

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in Post-Acute Sequelae of SARS-CoV-2 infection (PASC) participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

- EligibilityCriteria: Inclusion Criteria: See NCT######## for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study) Additional Appendix A (IVIG Sub-study) Level Inclusion Criteria: Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms COMPASS-31 Score > 40 Exclusion Criteria: See NCT######## for RECOVER-AUTO: Platform Protocol level exclusion criteria which applies to this appendix (or sub-study) Additional Appendix A (IVIG Sub-study) Level Exclusion Criteria: Current or previous IVIG treatment Contraindication to intravenous immunoglobulin. Known allergic reactions to blood products including IVIG and/or subcutaneous immunoglobulin (SCIG), such as history of clinically relevant hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, severe generalized or severe local skin reactions Selective IgA deficiency Current and recent (within 5 half-lives) use of high-dose corticosteroids (for example for prior solid organ transplant), omalizumab, anti-TNF-alpha inhibitors Use of immunosuppressants such as Plaquenil, or low-dose steroid (prednisone, no more than 10mg a day) will be excluded unless the participant is on stable (>4 weeks) dose Significant thrombotic events after the acute phase of COVID-19 and/or within 6 months of enrollment Veins that are not viable for infusions Not willing to adhere to dosing schedule for IVIG infusions for 9 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305780

Not yet recruiting

RECOVER-AUTONOMIC Platform Protocol

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

- EligibilityCriteria: Inclusion Criteria: ≥ 18 years of age at the time of enrollment Previous suspected, probable, or confirmed SARS-CoV-2 infection, as defined by the Pan American Health Organization12ɸ ɸ Enrollment of participants with suspected or probable SARS-CoV-2 infection will only be allowed if they occurred before May 1, 2021 and be limited to no more than 10% of the total sample size per Study Drug Appendix. Refer to the Manual of Procedures (MOP) for details. Suspected case of SARS-CoV-2 infection - Three options, A through C: A. Meets the clinical OR epidemiological criteria. Clinical criteria: Acute onset of fever AND cough (influenza-like illness) OR Acute onset of ANY THREE OR MORE of the following signs or symptoms: fever, cough, general, weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnea, nausea, diarrhea, anorexia. Epidemiological criteria: Contact of a probable or confirmed case or linked to a COVID-19 cluster; or B. Presents with acute respiratory infection with history of fever or measured fever of ≥ 38°C; and cough; with onset within the last 10 days; and who requires hospitalization); or C. Presents with no clinical signs or symptoms, NOR meeting epidemiologic criteria with a positive professional use or self-test SARS-CoV-2 antigen-Rapid Diagnostic Test. Probable case of SARS-CoV-2 infection, defined as meets clinical criteria above AND is a contact of a probable or confirmed case or is linked to a COVID-19 cluster. Confirmed case of SARS-CoV-2 infection - Two options, A through B: A. A person with a positive nucleic acid amplification test, regardless of clinical criteria OR epidemiological criteria; or B. Meeting clinical criteria AND/OR epidemiological criteria (See suspect case A). With a positive professional use or self-test SARS-CoV-2 Antigen-Rapid Diagnostic Test. Moderate, self-identified autonomic symptoms (defined as COMPASS-31 >25) following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent OHQ/OIQ, question 1 score >2 Exclusion Criteria: Known pregnancy, breast-feeding, or contemplating pregnancy during the study period Known active acute SARS-CoV-2 infection ≤ 4 weeks from enrollment Known renal failure (eGFR <20ml/1.73 m²) Known atrial fibrillation or significant cardiac arrhythmia Known cardiovascular conditions such as heart failure (Class 3-4), severe valvular disease, symptomatic ischemic coronary artery disease, revascularization for PAD/CAD within the past 6 months Clinically significant atherosclerotic disease, defined as history of stroke or myocardial infarction or revascularization 6 months prior to enrollment and/or current symptomatic angina Existing uncontrolled hypertension History of significant hypercoagulability disorders Active or recent thrombosis - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305767

Not yet recruiting

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

- EligibilityCriteria: Inclusion Criteria: Has muscle-invasive urothelial carcinoma (MIUC) Has dominant histology of UC Has high-risk pathologic disease after radical resection Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS) Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization Exclusion Criteria: Has received prior systemic anticancer therapy Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients Has current pneumonitis/interstitial lung disease Has active infection requiring systemic therapy Has active hepatitis B and hepatitis C virus infection - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305754

Not yet recruiting

MK-2870 Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

The purpose of this study is to evaluate MK-2870 versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that MK-2870 is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).

- EligibilityCriteria: Inclusion Criteria: Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC). Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline. Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load. Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. Life expectancy of at least 3 months. Exclusion Criteria: Predominantly squamous cell histology NSCLC. History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. Grade >2 peripheral neuropathy. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. Uncontrolled, or significant cardiovascular disease or cerebrovascular disease. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention. Known active central nervous system metastases and/or carcinomatous meningitis. Active infection requiring systemic therapy. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. Concurrent active HBV and HCV infection. History of allogeneic tissue/solid organ transplant. Participants who have not adequately recovered from major surgery or have ongoing surgical complications. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305741

Recruiting

A Study of an Anxiety Intervention for Latino/Latina/Hispanic Older Adults With Cancer and Their Caregivers

The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.

- EligibilityCriteria: Inclusion Criteria: Older Adults with Cancer (OAC) As per medical record or self-report, is currently age 65 years or older As per medical record or self-report, currently receiving active cancer treatment OR is within eighteen months of completing active treatment which includes surgery, chemotherapy, radiation, and immunotherapy. As per self-report, identifies as Latino and/or Hispanic Ethnicity Per self-report, has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) age 55 or older who is willing and able to participate in the study Scores ≥8 on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) Per self-report, fluent in English and/or Spanish** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study: How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) What is your preferred language for healthcare? (must respond English and/or Spanish) Caregiver Per OAC report, is primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for the eligible OAC patient As per self-report, is age 55 years or older As per self-report, identifies as Latino and/or Hispanic Ethnicity Per self-report, fluent in English and/or Spanish** ** Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify language fluency necessary for participation in the study: How well do you speak English and/or Spanish? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) What is your preferred language for healthcare? (must respond English and/or Spanish) Exclusion Criteria: OAC As per medical record or self-report, currently receiving psychotherapy As per medical record or self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 9 Per research staff judgment and/or self-report, too ill or weak to complete study procedures Per medical record or self-report, receiving hospice care at the time of enrollment Does not have a caregiver who meets study eligibility criteria and is willing to participate in the study. Caregiver As per self-report, currently receiving psychotherapy As per self-report, taking psychotropic medications for < 8 weeks prior to MAC Session 1 and/or anticipates changing their medication during the study As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration score ≥ 9 Per research staff judgment and/or self-report, too ill or weak to complete study procedures - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 55 Years - StdAgeList: Adult, Older Adult

NCT06305728

Recruiting

A Study of Early Cancer Detection in People at High Risk of Developing Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts: The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1 The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

- EligibilityCriteria: Inclusion Criteria: Men and women aged >18 years Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection Able to provide informed consent Exclusion Criteria: Pathologic evidence of pancreatic cancer Pregnant or breast-feeding patients Refusal or inability to tolerate scan (eg anxiety or claustrophobia) Inability to lay flat or meet the standard requirements of traditional MRI Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay Bilirubin > 1.5 x ULN AST/ALT > 2.5 x ULN Albumin < 3 g/dL GGT > 2.5 x ULN if Alkaline Phosphatase > 2.5 x ULN Renal function with Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK). - SamplingMethod: Non-Probability Sample

NCT06305715

Not yet recruiting

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)

This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).

- EligibilityCriteria: Inclusion Criteria Part 1 Age ≥18 years. Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC). An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators. Patient did not previously receive radiation therapy to the primary lung lesion. Previous or concurrent palliative radiation to symptomatic metastatic lesions and definitive radiation to central nervous system metastases are allowable. Patient must have advanced disease, either stage IV or stage IIIB/C that is not amenable to definitive multi-modality therapy. Patient must not have received prior targeted therapy for NSCLC. A subject may receive up to 2 cycles of standard cytotoxic chemotherapy for NSCLC prior to trial enrollment. For example, a cycle of carboplatin and pemetrexed is given once every 3 weeks. Patient must have measurable disease as defined by RECIST v1.1. Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria Part 2 1. Must have an actionable driver mutation for which an Food and Drug Administration (FDA) -approved and/or National Comprehensive Cancer Network (NCCN) -recommended front-line TKI is available. Exclusion Criteria: Anticipated prognosis < 3 months. Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications. Patients with prior or concurrent malignancy are eligible provided the investigator assesses this malignancy does not have potential to interfere with evaluation of the safety or efficacy of the study treatments. Patient must not have any unresolved toxicities from prior cancer therapy greater than CTCAE grade 2 at time of study enrollment. Any grade alopecia is allowable. Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy. Women must not be pregnant or breast-feeding. All females of childbearing potential must have negative blood or urine pregnancy testing within 14 days of study enrollment. Women of childbearing potential and sexually active males must use effective methods of contraception for 14 days prior to study enrollment, while on study treatment, and for 4 months after the last targeted therapy treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305689

Recruiting

Defining Treatment Outcomes and Genetic Architecture in Idiopathic Toe Walking*

To compare and contrast the clinical, gait and parent-reported outcomes following either non-operative (casting) or operative treatment for children with idiopathic toe walking (ITW) and determine whether there are specific genes associated with ITW.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of Idiopathic Toe Walking Persistent (ITWp) Between the ages of 6-18 years Passive dorsiflexion dorsiflexion with knee extension between -10 plantar flexion - + 5 degrees of dorsiflexion, DiGiovanni defined an isolated gastrocnemius contracture as maximum passive ankle dorsiflexion as < 5 degrees with the knee in full extension Exclusion Criteria: Diagnosis of Autism or autism spectrum disorder Presence of any indicators of trauma, neuromuscular influence or neurogenic influence as identified by using the Toe Walking Tool - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06305676

Recruiting

Biomarker Approach to Screening for the Early Detection of HPV-related Oropharyngeal Cancer (BASH OPC)

Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).

- EligibilityCriteria: Inclusion Criteria: Cases: Aged at least 18 years Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV) Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center Aged at least 35 years Have no previous diagnosis of HNC or HPV-related cancer Fully understands study procedures Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center Exclusion Criteria: Not meeting all of the above inclusion criteria for either the case or control group - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh). - SamplingMethod: Non-Probability Sample

NCT06305663

Not yet recruiting

A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children

A Study to Evaluate the Safety and Efficacy of the Bausch + Lomb Myopia Control Lens for the Correction of Myopic Ametropia and Slowing the Progression of Myopia in Children

- EligibilityCriteria: Inclusion Criteria: Male or female aged 8 to 12 years plus 11 months old on the date the Informed Assent and Parental or Guardian Informed Consent are signed and have capacity to provide voluntary informed consent. Subject must meet the following determined by cycloplegic subjective refraction in both eyes at screening: Spherical Equivalent Refractive Error (SERE): between -0.75 D and -4.00 D, inclusive. Astigmatism: ≤ -0.75 D. c. Anisometropia: < 1.00 D. Subject must be myopic and require lens correction from -0.75 D to -4.00 D, at screening, in each eye. Subject must have distance best-spectacle corrected visual acuity (BSCVA) by non-cycloplegic manifest refraction of +0.04 logMAR (20/20 Snellen equivalent) or better in each eye. Subject and Parent or Guardian must be willing to participate in either the test or the comparator assignment. Subject agrees to wear the assigned contact lenses for a minimum of 10 hours per day, at least 6 days per week, for the duration of the 24-month study. Subject must have wearable and visually functioning eyeglasses. Subject must be in good general health according to their and parent's or guardian's knowledge Exclusion Criteria: Subject has previously worn, or currently wears rigid gas permeable contact lenses, including orthokeratology lenses. Current or prior use of bifocals, progressive addition lenses, multifocal soft contact lenses, atropine, pirenzepine or ANY other myopia control treatment. Subject appears to exhibit poor personal hygiene (that in the Investigator's opinion might prevent safe contact lens wear). Per oral inquiry from parents/guardian, the subject was born earlier than 30 weeks or weighed less than 1,500 g at birth. Prior strabismus, intraocular, or refractive surgery. Subject using any systemic or local eye medication that interfere with the wearing of corneal contact lenses, pupil size, adjustment or refractive status, or require the removal of lenses during the day". A known allergy to fluorescein, benoxinate, proparacaine, or cyclopentolate. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjögren's syndrome, lupus erythematosus, scleroderma, or diabetes. At the discretion of the Investigator, any ocular, systemic or neuro developmental conditions that could influence refractive development such as, but not limited to: persistent pupillary membrane, vitreous hemorrhage, cataract, corneal scarring, ptosis, eyelid hemangiomas, Marfan's syndrome, Down syndrome, Ehlers-Danlos syndrome, Stickler syndrome, ocular albinism, retinopathy of prematurity. Subjects with trichiasis, that in the Investigator's judgement does not interfere with contact lens wear, are eligible for this study. Keratoconus or an irregular cornea. Subjects with any Grade 2 or greater finding during the slit lamp examination, or subjects with any scar or neovascularization within the central 6 mm of the cornea, or subjects with corneal infiltrates, of ANY GRADE. Subjects with any "present" finding during the slit lamp examination (biomicroscopy) that, in the investigator's judgment, interferes with contact lens wear. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment does not interfere with contact lens wear, are eligible for this study. The Investigator for any reason considers that it is not in the best interest of the Subject to participate in the study. Subjects participating in any drug clinical investigation within 4 weeks or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or planning to do so during the period of study participation. Immediate family or close relative is a member of site study team members - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06305650

Not yet recruiting

Probiotic Influence on Obesity-Related Lipidemia

This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.

- EligibilityCriteria: Inclusion Criteria: Body mass index (BMI) ≥ 28 kg/m2; Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study; Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures; Exclusion Criteria: Taking items with similar functions to those tested in a short period of time will affect the judgment of the results; Patients with severe allergies and immune deficiency; Women who are pregnant, breastfeeding or planning to become pregnant; Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases; People who have used antibiotics in the past two weeks; Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy; Have used laxatives or fiber supplements in the past 6 weeks; Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 19 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06305624

Not yet recruiting

Implementation of Mobile-based Programs for Alcohol Cessation in Treatment of Alcohol-associated Liver Disease

This protocol describes a randomized controlled trial testing the effectiveness and implementability of the CHESS Health Connections smartphone application among patients with alcohol-associated liver disease (ALD) at two medical centers in Michigan and Wisconsin, in two types of clinics: general hepatology and multidisciplinary that offers care for advanced ALD alongside co-located, integrated mental health and substance abuse treatment. The long-term goal of this and future work is to prevent disease progression and promote healthy behaviors by improving the rate of abstinence among patients with ALD earlier in the course of their disease. 298 participants will be enrolled and can expect to be on study for up to 6 months.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of ALD (any stage) Alcohol use within the last 6 months Receiving care at UW or UM Either the general hepatology clinic or the multidisciplinary ALD clinic Able to read and write proficiently in English Willing and able to use a smartphone app Exclusion Criteria: Actively listed for liver transplant or history of liver transplant In hospice care Has severe cognitive impairment (as described in electronic health record including dementia, delirium, and/or unable to maintain cognitive alertness during screening--as determined by study staff.) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305611

Recruiting

European and North Indian Cohort of KaWasaki dIsease

Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.

- EligibilityCriteria: Inclusion Criteria: Patients aged less than 18 years at diagnosis Diagnosis of KD according to the AHA criteria Exclusion Criteria: Patients who do not meet the criteria for KD Patients for which an alternative infectious diagnosis was not investigated and/or excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: The setting is represented by 1 Asian and 4 European pediatric rheumatology centres which with internationally recognized expertise in the treatment and follow-up of a large number of Kawasaki disease patients - SamplingMethod: Non-Probability Sample

NCT06305598

Not yet recruiting

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years of age Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Histologically confirmed carcinoma of the prostate Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist) Documented castrate level of blood testosterone (< 50 ng/dL) Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) and at least one chemotherapy (by prostate specific antigen [PSA] criteria or radiographically) Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available) Absolute neutrophil count: ≥1,200/µL Platelets: ≥ 100,000/µL Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]): ≤ 3 × institutional ULN Creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault equation) Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Pain with advanced prostate cancer requiring opioid analgesics Greater than 5 sites of visceral disease in lung or liver (nonspecific lung nodules ≤ 1 cm in diameter is permitted) Evidence of disease in sites or extent that, in the opinion of the investigator, would put the patient at risk from therapy with testosterone (e.g., femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction) Active uncontrolled infection, including known history of acquired immunodeficiency syndrome (AIDS) or hepatitis B or C Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule Prior history of a thromboembolic event within the last 12 months and not currently on systemic anticoagulation Hematocrit > 50%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure (per Endocrine Society Clinical Practice Guidelines) Evidence of serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study Known allergy to testosterone cypionate or any of its excipients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305585

Not yet recruiting

Can a Novel Manual Therapy Technique Help Relieve Stress? Assessing Effects of Primal Reflex Release on the Body's Stress Response

Stress, when left unmanaged, can have detrimental effects on both physical and mental health, contributing to conditions such as high blood pressure, anxiety, and even cardiovascular disease. Effective stress management therapies may help maintain overall well-being and reduce the risk of long-term health complications. The Primal Reflex Release Technique (PRRT) is a novel manual therapy that may reduce markers related to stress such as heart rate variability (HRV) and patient-reported outcomes (PROs). Therefore, the purpose of this study is to elucidate the potential for PRRT to improve HRV and PROs.

- EligibilityCriteria: Inclusion Criteria: Subject can refrain from caffeinated beverages in the 6 hours prior to data collection Subject is not currently taking any beta blockers Subject is comfortable with a manual therapy technique where the clinician touches your face and head Exclusion Criteria: Subject has had caffeine within 6 hours Subject is currently taking any beta blockers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult

NCT06305559

Not yet recruiting

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

This placebo-controlled, double-blind, randomized, Phase 3 study is being conducted in adult participants with high-risk atherosclerotic cardiovascular disease (ASCVD) who are not adequately controlled by their maximally tolerated lipid-modifying therapy, to assess the impact of the obicetrapib 10 mg + ezetimibe 10 mg FDC daily on coronary plaque and inflammation characteristics, evaluated using cardiovascular computed tomography angiography (CCTA).

- EligibilityCriteria: Inclusion Criteria: LDL >70md/dL Total coronary plaque > 75mm3 BMI 18-40 Max tolerated lipid modifying therapy eGFR greater/equal to 40 Exclusion Criteria: - HbA1c >10 Contraindications for CCTA History of coronary artery bypass graft Active liver disease - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - StdAgeList: Adult, Older Adult

NCT06305533

Recruiting

Efficacy of Photodynamic Therapy and LASER Disinfection in Periodontal Therapy for Treatment of Periodontitis

The goal of this clinical trial is to Investigate the clinical and microbiological efficacies of Laser disinfection and ICG-mediated aPDT as adjunct to RSD for patients with periodontitis. The main question it aims to answer is: Does the use of laser disinfection or ICG-mediated aPDT as adjunct to RSD are effective in improving clinical parameters and reducing the load of periodontal pathogens. Participants will undergo full-mouth supragingival debridement by using ultrasonic device at baseline. All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of tooth paste and toothbrush, with suitable interdental aids. All the patients will be instructed to attend again after 7 days. One week later, sites randomly allocated to control (Ctrl) group and test groups which will receive, in addition to RSD, either aPDT or periodontal pocket disinfection (Biolase). For all groups, sites with initial PPD 4-6 mm will be treated with RSD using area specific (Graecy) curettes.

- EligibilityCriteria: Inclusion Criteria: Adult subjects (>18 years), non-smoker, with no history of any systemic disease such as diabetes mellitus. Additionally, subjects are not currently under active periodontal therapy or joining other trial in the last 3 months. All patients must be diagnosed with generalized periodontitis with at least 3 teeth in three different sextants (Anterior teeth and premolars) with 4-6 mm PPD and positive BOP. Periodontitis cases will be defined by presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth. Exclusion Criteria: Patients will be excluded if they were not diagnosed with periodontitis, smokers, those consuming antibiotics, regular user of nonsteroidal anti-inflammatory drugs, or receiving periodontal treatment 3-months prior to the study. Additionally, pregnant or mothers in a breastfeeding period, and those not willing to participate will be also excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305507

Not yet recruiting

Differents Laser Applications on Plantar Fasciitis

The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled &#34;Effect of different laser applications on Plantar Fasciitis&#34;, is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep mode in the reduction of pain associated with plantar fasciitis. The main questions it seeks to answer are: What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis? What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis? Participants in this study will perform the following tasks: Undergo low-level laser therapy sessions in local spot mode or sweep mode. Comply with the instructions on the duration and frequency of the sessions. Record the pain levels experienced before and after each session. The investigators will compare the group undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects.

- EligibilityCriteria: Inclusion Criteria: Confirmed Diagnosis of Plantar Fasciitis Exclusion Criteria: Additional Serious Medical Conditions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: subjects who present plantar fasciitis and go to the podiatry clinic within the indicated period - SamplingMethod: Probability Sample

NCT06305494

Not yet recruiting

Genitourinary Syndrome of Menopause in Thai Gynecologic Cancer Survivors

Women often face common cancers like ovarian, uterine, and cervical cancers. Improvements in cancer detection and treatment mean more women survive. However, survivors can encounter challenges like ongoing pain, treatment complications, and fertility issues. Treating these cancers often involves surgeries that might include removing ovaries or using pelvic radiation. This can trigger menopause in younger women, causing problems like vaginal dryness, itching, and urinary issues. Women who've gone through menopause often deal with these symptoms, affecting their daily lives, confidence, and intimate relationships. Though treatments are available, lack of awareness, embarrassment, and not discussing these issues with doctors can make managing them difficult. The main treatment for these symptoms is using vaginal estrogen, but it might not be suitable for some cancer survivors. Non-hormonal options like lubricants and moisturizers are alternatives. This study in Thailand aiming to explore how common these issues are among gynecological cancer survivors, their feelings about it, and how it affects their quality of life.

- EligibilityCriteria: Inclusion Criteria: Participant with gynecologic cancer (cancer of ovary, fallopian tube, uterus, cervix, vagina, and vulva.) Time passed more than 6 months since last cancer treatment. Exclusion Criteria: Participant not entering menopause after cancer treatment. Participant with cancer progression. Participant currently suffer from severe pain, fatigue, or discomfort. Participant deny to participate. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Gynecologic cancer survivors, age more than 18 years old that came to the Gynecology Clinic at Khon Kaen University Hospital for routine cancer surveillance. - SamplingMethod: Probability Sample

NCT06305481

Recruiting

Glaucoma Evaluation With the P200TE

Images captured on the P200TE device on glaucoma patients

- EligibilityCriteria: Inclusion Criteria Subjects were 22 years of age or older on the date of informed consent; Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent; BCVA 20/40 or better in the study eye; History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings: On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or Glaucoma hemi-field test "outside normal limits;" Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue. Exclusion Criteria Subjects unable to tolerate ophthalmic imaging; Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye; Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; No reliable visual field test result within the past year of the study visit, defined as fixation losses > 33% or false positives >33%, or false negatives >33% in the study eye; Presence of any ocular pathology except glaucoma in the study eye. - HealthyVolunteers: No - Gender: All - MinimumAge: 22 Years - StdAgeList: Adult, Older Adult

NCT06305468

Not yet recruiting

Prognosis of Disseminated and Cerebral Toxoplasmosis Hospitalized in Intensive Care in the Era of PCR Diagnosis

Toxoplasmosis is a common infection whose clinical severity can sometimes justify admission to intensive care, especially in immunocompromised patients. This study should make it possible to evaluate the impact of different anti-infective treatment regimens and to highlight clinical-biological and prognostic differences depending on the type of underlying immunosuppression.

- EligibilityCriteria: Inclusion Criteria: Adult patient hospitalized in intensive care At least 1 organ failure (SOFA> or =2) PCR toxoplasmosis on CSF, blood, BAL, or bone marrow positive within 7 days before or after admission to ICU Exclusion Criteria: Post-mortem diagnosis Primary outcome not available Patient living informed and not opposed to the reuse of their data in this research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients hospitalized in intensive care for toxoplasmosis (positive toxoplasmosis PCR) between 2012 (01/01/2012) and 2023 (02/01/2023) - SamplingMethod: Non-Probability Sample

NCT06305455

Not yet recruiting

Resistance Profile of Escherichia Coli in Infections of Community Origin: The Importance of Antimicrobial Stewardship

The main objective of the study is to describe the antimicrobial resistance profile of E. coli isolated in patients from the community - defined as those with cultures collected within 48 hours of hospital admission - and admitted to the intensive care unit.

- EligibilityCriteria: Inclusion Criteria: All 18 years and old patients admitted to the ICU Positive cultures for E. coli Any sample collected within 48 hours of hospital admission Exclusion Criteria: Lack of necessary data - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients with severe Escherichia coli infections, isolated from any culture material collected within less than 48 hours of hospital admission, admitted to the intensive care unit of a tertiary hospital. - SamplingMethod: Probability Sample

NCT06305442

Not yet recruiting

Microbiota Directed Food for Children With Moderate Acute Malnutrition

Moderate acute malnutrition (MAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing MAM is crucial to prevent its progression to severe acute malnutrition (SAM) and to ensure healthy child development. To meet the nutritional requirement of MAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use supplementary food.we propose this efficacy trial to establish the evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with MAM in comparison to the standard RUSF.

- EligibilityCriteria: Inclusion Criteria: Parent(s) willing to sign consent form Children aged 6-24 months WLZ score <-2 to ≥-3 and/or MUAC ≥115 mm to <125 mm without bilateral pedal edema at the time of randomization Exclusion Criteria: Medical conditions: Malnourished children with complications requiring acute phase treatment in a hospital, children with tuberculosis or any chronic illness(es). Any congenital/acquired disorder affecting growth, i.e., known case of trisomy-21 or cerebral palsy; children on an exclusion diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy Severe anaemia (< 8 gm/dl) Antibiotic use (within last 7 days before the onset of intervention) Receiving concurrent treatment for another condition children participating in other food intervention program - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 24 Months - StdAgeList: Child

NCT06305429

Not yet recruiting

Encouraging Positive Parenting Habits Through Digital Media: Feasibility Study

This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content for the feasibility study is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children experiencing behavior difficulties with daily transition routines are invited to participate in the study.

- EligibilityCriteria: Inclusion Criteria: Parents of children, aged 4-10, experiencing behavior difficulties with daily transition routines (parent-report). Exclusion Criteria: Children not living with participating parents at least 5 days per week every week. While participating parents are informed that the program was developed for children demonstrating symptoms of ADHD, the low symptom number will not be used as an exclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 10 Years - StdAgeList: Child

NCT06305416

Recruiting

Randomized, Double-blind, Controlled Study to Compare Efficacy and Safety of Ranibizumab 10mg/ml Injection (Incepta)

Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature. This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema. Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor (VEGF). Vascular endothelial growth factor (VEGF) increases retinal vascular permeability, causes breakdown of the blood-retina barrier and results in retinal edema. Diabetic macular edema (DME) is the most common cause of visual reduction in patients with Diabetes Mellitus. The prevalence of DME globally is around 6.8 %. Diabetic Retinopathy (DR) is the most common microvascular complication of diabetes and the leading cause of blindness worldwide. DME is a complication of diabetic retinopathy that affects the macula, which is located at the center of the retina and responsible for central vision. Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 7.1 million (5.3-12.0). In Bangladesh, it is therefore expected that diabetic secondary complications, like DR, will increase along with the rising trend of diabetes mellitus. The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases. In recent years, millions of patients have been successfully treated with these biological agents. Ranibizumab is one such therapeutic monoclonal antibody for intraocular use. Ranibizumab is a humanized, recombinant, immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A (VEGF-A) and thus prevents choroidal neovascularization. The small size of ranibizumab allows for enhanced diffusion into the retina and choroid.

- EligibilityCriteria: Inclusion Criteria: Ages Eligible for Study: ≥ 18 Years Ability to provide written informed consent and comply with study assessments for the full duration of the study Diagnosis of diabetes mellitus (type 1 or 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: Laboratory reports that prove DM of patient or current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemic agent for the treatment of diabetes. Clinical evidence of retinal thickening due to macular edema involving the center of the macula (can be associated with diabetic retinopathy) Central diabetic macular edema present on clinical examination and OCT testing with central 1mm sub field thickness greater than 300 microns as measured on -OCT Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS/ Snellen chart visual acuity protocol Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Willingness and ability to undertake all scheduled visits and assessments Exclusion Criteria: Prior treatment with any Intravitreal drug, Bevacizumab, verteporfin or photodynamic therapy (except for extra foveal laser photocoagulation) in the study eye within past 3 months before study entry Laser photocoagulation in the study eye within 1 month before study entry Participation in another ocular investigation or trial simultaneously Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception. Blood pressure > 160/100 mmHg (systolic above 160 or diastolic above 100) and Random Blood Sugar (RBS) ≥ 12 mmol/L and/ or HbA1c ≥ 7.5% Evidence of vitreoretinal interface abnormality and optic nerve disease after ocular exam or OCT that may be contributing to the macular edema Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that could contribute to a loss of best corrected visual acuity over the study period (e.g. cataract that might decrease the vision by 3 or more lines, uncontrolled glaucoma, uveitis, previous corneal transplant etc.). The decision regarding exclusion is to be based on the opinion of the investigator. An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of sub retinal fibrosis or geographic atrophy). Presence of suspected ocular or periocular infections, another ocular condition that may affect the visual acuity or macular edema during the course of the study (uveitis, Irvine-Gas) Vitreous hemorrhage preventing visualization of retina History of vitreous surgery, cataract surgery, YAG capsulotomy in the study eye within last 3 months of enrolment Visual acuity <20/400 in the fellow eye Known hypersensitivity to Ranibizumab or any of the components of study medication History of cerebral vascular accident or myocardial infarction within past 3 months. Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized. Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine, tamoxifen, phenothiazine, vigabatrin and ethambutol, and such medications will not be allowed during the study period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305403

Not yet recruiting

VEXUS and NGAL in the Diagnosis and Prognosis of Sepsis-associated Acute Kidney Injury

In this prospective observational study, patients hospitalized in our mixed intensive care unit, aged between 18 and 80, and diagnosed with sepsis and septic shock according to sepsis-3 criteria will be included. To determine whether patients develop AKI during the first five days of ICU admission, creatinine and urine output will be monitored daily for the first five days of ICU admission according to KDIGO criteria. Clinical diagnosis and treatment of AKI will be made according to KDIGO. According to KDIGO, patients will be divided into two groups: those who develop AKI and those who do not. By comparing plasma NGAL and VEXUS scores between groups, the sensitivity and specificity of the VEXUS score in determining AKI will be determined.

- EligibilityCriteria: Inclusion Criteria: sepsis septic shock Exclusion Criteria: Poor abdominal echogenicity, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), life expectancy less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure > 15 mm Hg, obstructive renal failure liver and kidney transplanted patients, liver and kidney tumors, patients receiving dialysis treatment, single kidney and other kidney abnormalities, right heart failure, acute mesenteric ischemia chronic renal failure - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: sepsis and septic shock in ICU - SamplingMethod: Probability Sample

NCT06305390

Recruiting

Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer.

This project aims to evaluate the role of fully hybrid PET/MRI with 18FPSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Our main hypothesis is that adding 18F-PSMA PET to mpMRI prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.

- EligibilityCriteria: Inclusion Criteria: Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy Feasibility to undergo all procedures listed in protocol Ability to provide written informed consent Exclusion Criteria: Prior diagnosis of prostate cancer Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min) Contraindication to prostate biopsy - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Men with clinical suspicion of clinically significant prostate cancer (csPCa). - SamplingMethod: Probability Sample

NCT06305377

Not yet recruiting

Achieving Rapid, Safe and Sustained Glucose Control in Adolescents With Suboptimally Controlled Type 1 Diabetes Using Advanced Hybrid Closed Loop Systems

The rational of this study is to assess if AHCL systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control.

- EligibilityCriteria: Inclusion Criteria: All children met the American Diabetes Association (ADA) criteria for T1D diagnosis with a current HbA1c of ≥8.5%. Age range 12-17 yrs old Exclusion Criteria: Patients with a diagnose of genetic form of diabetes will be excluded. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: diabetics adolescents in not good glicaemic control - SamplingMethod: Non-Probability Sample

NCT06305364

Recruiting

Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.

- EligibilityCriteria: Inclusion Criteria: Males or females Age: 18-75 years, inclusive Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria: Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year); Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history). Able to comprehend and provide informed consent. Exclusion Criteria: Subject who is not a suitable candidate for a colonoscopy Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration Patients with a disability to extend their tongue. Patients with tongue piercings. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 45 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06305351

Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes

This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757 and K-833 when co-administered in overweight/obese patients with Type 2 diabetes mellitus (T2DM)

- EligibilityCriteria: Inclusion Criteria: Understand the trial procedures and agree to participate by providing written informed consent. Be willing and able to comply with all trial procedures and restrictions, including following study diet requirements. Be between 18 to 70 years of age, inclusive, at the Screening Visit. Has T2DM in accordance with American Diabetes Association (ADA) guidelines at the Screening Visit. Is on stable metformin monotherapy (total daily dose of 1,000 to 2,000 mg/day) for at least 3 months and tolerating metformin well in the opinion of the investigator. Note: Both the immediate release (IR) and extended release (XR) formulations of metformin are acceptable. HbA1c of ≤7.5% at Screening. Have a Body Mass Index (BMI) ≥25.0 and <40.0 (kg/m2) at the Screening Visit. Be weight stable (<5% variation) over the last 3 months, by subject report. Be a nonsmoker who has not used tobacco or nicotine-containing products (e.g. nicotine patch, e-cigarettes, vapes) for at least 3 months before administration of the initial dose of trial drug and agrees to abstain from smoking tobacco or the use of nicotine-containing products while on study. Be judged to be in generally good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and before administration of the initial dose of trial drug. Meet the following requirements: Is a male who agrees to all of the following: If partner is a non-pregnant female of child-bearing potential: To use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until 14 days after the last dose of study drug. A male subject who has had a vasectomy procedure must use a condom but is not required to use spermicidal cream or jelly. If partner is pregnant, to use a condom. Note: Contraception/condom requirements are waived if partner is NOT of child-bearing potential (i.e. is male or is a female who is post-menopausal or surgically sterile [post-hysterectomy, post-bilateral oophorectomy, and/or post-bilateral salpingectomy]). To not donate sperm from the first dose of study drug until 14 days after the last dose of study drug. OR Is a female who is of non-childbearing potential defined by at least 1 of the following criteria: Postmenopausal (aged >45 years and with a minimum of 12 months of spontaneous amenorrhea with a Screening serum follicle-stimulating hormone (FSH) level in the menopausal range as established for the laboratory performing the test. Post hysterectomy, bilateral oophorectomy or bilateral salpingectomy, based on the subject's recall of their medical history. OR Is a female of reproductive potential and: agrees to not donate eggs from the first dose of study drug until 14 days after the last dose of study drug agrees to remain abstinent from heterosexual activitya or agrees to use (or have their partner use) a birth control method that is highly effective and has low user dependency. Acceptable methods of birth control are: Progestogen-only implant (e.g. etonogestrel implant) Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomized partner a Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. Exclusion Criteria: Has participated in another interventional investigational study within 30 days of the Screening Visit. The window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the Screening Visit of the current study. If the subject received an investigational medication in the prior study, at least 5 half-lives (or longer if required by local regulations) must have passed between the last dose of the investigational product and the Screening Visit. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site. Has a history of multiple significant and/or any severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food. Has a known hypersensitivity or contraindication to any component of K-757, K-833, including excipients. Has a positive alcohol or drug screen at Screening or admission. Has a positive pregnancy test. Is a lactating/nursing female. Has a positive test result for hepatitis B surface antigen (Ag), hepatitis C virus antibody, or human immunodeficiency (HIV) antibody, at the Screening Visit. Note: Subjects with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative. Does not meet study site COVID-19 admission/study participation restrictions. Has a fever (>38°C)* Had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit* Is unable to refrain from the use of prohibited prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication through completion of study participation. Allowable concomitant medications may include 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), ≤2 permissible anti-hypertensive agents, postmenopausal hormone replacement therapy (HRT), and/or proton pump inhibitors (PPIs). Has been on any GLP-1 receptor agonist, any dipeptidyl peptidase IV (DPP-4) inhibitor, or any approved or investigational medications known to cause weight loss in the prior 3 months. Has a history of type 1 diabetes mellitus (T1DM) or a history of diabetic ketoacidosis or subject assessed by the investigator as possibly having T1DM. Has a history of other specific types of diabetes (e.g. genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post organ transplant diabetes). Has been treated with insulin or any other anti-hyperglycemic agents (AHAs) other than metformin within 4 weeks of screening or within 12 weeks of screening if the AHA was a thiazolidinedione (e.g., rosiglitazone, pioglitazone). At Screening or Day 1 has a site fasting fingerstick glucose of >270 mg/dL. If the Day -1 fasting fingerstick glucose is >270 mg/dL, a re-test may be conducted the morning of Day1 in fasted state prior to randomization. If the result is ≤270 mg/dL, the subject may be randomized if all other entry criteria are met. Has evidence or history of diabetic complications or significant end organ damage, eg, proliferative retinopathy and/or macular edema, eGFR Modification of Diet in Renal Disease (MDRD) ≤60 mL/min, diabetic neuropathy. One or more self-reported episodes of hypoglycemia (fingerstick glucose <60 mg/dL with symptoms consistent with hypoglycemia or <50 mg/dL irrespective of symptoms) within the last 3 months. Is using or anticipates the need for using concomitant medications which are inhibitors of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) or any prohibited medications listed in Section 10.1 from screening until the post study visit. Has excessive consumption of alcohol within 6 months prior to screening (>14 drinks/week for men and >7 drinks/week for women, where l drink= 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) or any use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD)) within 3 months prior to Screening, or hard drugs (such as cocaine) within 6 months prior to Screening. Is unwilling or unable to refrain from consuming alcohol from 7 days prior to the first dose of study medication through the completion of study participation. Has a substance abuse disorder. Had a previous major psychotic disorder. Has a corrected QT interval to Fridericia's formula (QTcF) >450 milliseconds (msec) for males and >470 msec for females at screening or admission. Has a mean value for triplicate semi-recumbent systolic blood pressure >160 millimeters of mercury (mmHg) and/or diastolic blood pressure (BP) >95 mmHg measured after at least 10 minutes at rest at the Screening Visit. Note: If a subject's BP is exclusionary on the first triplicate assessment at the Screening visit, they may have 1 repeat triplicate BP assessment at that visit, after another rest of at least 10 minutes, to qualify for the study. If a subject's BP is exclusionary at screening but the investigator feels that BP is likely to be below the exclusionary thresholds at admission (Day -1), this criterion can be re-assessed at admission. Adjustment of doses of anti-hypertensives already being taken at screening is permissible, but initiation of new agents is not permissible. For subjects whose BP is exclusionary at Screening and at the first triplicate assessment on Day -1, triplicate assessments can be repeated up to twice on Day -1, as needed. Triplicate assessments should occur after a rest of at least 10 min. Also, the first measurement of any triplicate assessment should be separated from the last measurement in a prior triplicate assessment by at least 10 minutes. Has alanine aminotransferase or aspartate aminotransferase (ALT or AST) of >1.5X upper limit of normal (ULN) or total bilirubin >1.5X ULN (isolated bilirubin >1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range) at Screening or admission. (Note: Subjects who do not meet this criterion at Screening or at admission may not be rescreened/retested). Has serum amylase or lipase >1.2X the ULN at the Screening Visit. Has a recent history (within past 3 years) or current diagnosis of any of the following GI (gastro-intestinal) related diseases: intestinal obstruction, GI perforation, GI motility disorders, adhesions, Clostridium difficile colitis or have had recent unexplained GI bleeding within 3 months prior to screening. Has any history of pancreatitis (acute or chronic), gastroparesis, ischemic colitis, inflammatory bowel disease (IBD), celiac disease, irritable bowel syndrome (IBS), or colitis. Has any past surgical history of gastric banding or bariatric surgery or bowel resection. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, neurologic disorder, neoplastic, or genitourinary abnormalities or diseases. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study. note* Subject may be included if they are able to return to the site within 7 days of initial screening and the exclusion criterion is no longer met. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06305312

Not yet recruiting

Community Services Navigation to Advance Health Equity in Breast Cancer Screening

The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.

- EligibilityCriteria: Inclusion Criteria: English and Spanish speakers Received an abnormal result of a screening mammogram Self-reports at least one social need on the B-SINCERE Screener Exclusion Criteria: -Prior diagnosis of breast cancer - HealthyVolunteers: No - Gender: All - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305299

Not yet recruiting

Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells

The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.

- EligibilityCriteria: Inclusion Criteria: Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study: Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. Age ≥ 18 years at the time of consent. Eastern Cooperative Oncology Group (ECOG) of 0-2. The subject must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of a high-grade serous histology based on local histopathological findings. Subject must have recurrent platinum-resistant or platinum-refractory disease defined as: A disease that has progressed by imagining while receiving platinum OR Disease that has recurred within 6 months of the last receipt of platinum-based chemotherapy. Rising CA-125 only is not considered as platinum-resistant or refractory disease. Having received at least 2 prior regimens (including front-line therapy). Exclusion Criteria: Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The subject is not willing and not able to comply with study procedures based on the judgment of the investigator or protocol designee. 10. The subject is not willing to undergo a biopsy prior to treatment, after infusion, and at the time of disease progression ), and the tumor is determined to be safe by the treating investigator for biopsy collection. - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305286

Not yet recruiting

Safety, Tolerability, and Efficacy of Immunomodulation With A in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)

AT-1501 is a monoclonal antibody. Antibodies are Y-shaped proteins that are produced naturally by the subject's immune system to attack and fight foreign substances that cause illness. Monoclonal antibodies are man-made proteins manufactured to serve as substitute antibodies to fight diseases. Monoclonal antibodies can restore, enhance, or mimic (copy) the immune system's attack process; they can also tone down the immune system. AT-1501 is thought to work by dampening down the immune system so that it will be less likely to attack the transplanted cells. For other types of transplants, like kidney, a drug called a calcineurin inhibitor is usually used to prevent rejection. That class of drugs can be toxic to islet cells. AT-1501 is an experimental agent that is anticipated to prevent rejection without harming the islet cells.

- EligibilityCriteria: Inclusion Criteria: Men and women 18-65 years of age. A diagnosis of T1D ≥5 years with onset of disease at <40 years of age. Ability to provide informed consent. Able to comply with study procedures, including the requirement to utilize continuous glucose monitoring (CGM). Involvement in appropriate diabetes management in accordance with the standard of care, as directed by an endocrinologist or diabetologist with at least 4 (quarterly) clinical evaluations within the 12 months prior to Screening; using CGM*: using an insulin pump or multiple daily injection (MDI) of insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs- at least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening. *CGM will be provide to subjects who otherwise qualify for study participation but have not used CGM previously. At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening. HbA1c level 7.0% (48 mmol/mol) to 9.5% (80 mmol/mol), inclusive. Absence of stimulated C-peptide (<0.3 ng/mL) in response to a 240-minute mixed- meal tolerance test (MMTT). Impaired awareness of hypoglycemia (IAH) as defined by a Clarke Score [Clarke 1995] of 4 or more at the time of Screening, during the Screening period, and within the last 6 months prior to the transplant. If female, must be surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use 2 forms of highly effective methods of contraception from Screening, throughout the study, and while receiving immunosuppressive therapy for the functioning graft after the conclusion of the study. Contraception use must continue for 90 days after the last administration of the study drug (see Appendix 5). Male participants must refrain from donating sperm for the duration of the study and agree to not donate sperm for 90 days after last administration of the study drug. Patients with Coronavirus Disease 2019 (COVID-19) Polymerase chain reaction (PCR) negative test result. Exclusion Criteria: Any previous solid organ or islet allotransplant. Body mass index (BMI) >30 kg/m2. Weight ≤50 kg. Insulin requirement >1.0 unit/kg/day or <15 units/day. Treatment with any anti-diabetic medication other than insulin within 4 weeks of Screening. Uncontrolled proliferative diabetic retinopathy. Blood pressure: systolic blood pressure (SBP) >140 mmHg or diastolic blood pressure (DBP) >90 mmHg. Estimated glomerular filtration rate (eGFR) calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation <60 mL/min/1.73 m2. Diagnosis of macroalbuminuria (>300 mg/g creatinine). For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 90 days after discontinuation. For male participants: intent to procreate during the duration of the study or within 90 days after discontinuation or unwillingness to use effective measures of contraception. History of malignancy except for completely resected squamous or basal cell carcinoma of the skin. History of a thromboembolic event (TE), known hypercoagulable state, or condition requiring long-term anticoagulation. a. Participants with a history of clotted venous access not requiring long- term anticoagulation may be included at the Principal Investigator's discretion if they have no other history of TEs or known hypercoagulable state. Known heparin allergy. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for physiologic replacement for example in Addison disease. Presence of ongoing active infection including tuberculosis (TB), human immunodeficiency virus (HIV), hepatitis B, hepatitis C. Laboratory evidence of active infection even in the absence of clinical symptoms of infection is exclusionary. Invasive aspergillus, histoplasmosis or coccidioidomycosis infection within one year prior to Screening. Negative screen for Epstein-Barr Virus (EBV) by immunoglobulin G (IgG) determination. Current treatment with any immunosuppressive regimen, and treatment with biologic immune modulating agents, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor agonists, azathioprine, Mercaptopurine (6- MP), or systemic corticosteroids in the previous 5 years. Persistent elevation of serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 3 times the upper limit of normal (ULN); elevation of total bilirubin >1.5 ULN. Any history of receiving experimental cell or gene therapy. Exposure to any other experimental or investigational agent within 30 days or 5 half-lives; whichever is longer. History of substance abuse within the past 2 years. Allergy to the Boost drink necessary for MMTT Severe cardiovascular disease characterized by any one of these conditions: a) stroke; b) recent myocardial infarction (within past 6 months); c) evidence of ischemia on functional cardiac exam within the last year; d) left ventricular ejection fraction <30%. History of significant gastrointestinal disease such as symptomatic cholecystolithiasis; acute or chronic pancreatitis; symptomatic peptic ulcer disease; severe unremitting diarrhea, vomiting or other disorders potentially interfering with the ability to absorb oral medications. Significant hyperlipidemia despite medical therapy defined as fasting low-density lipoprotein (LDL) cholesterol >130 mg/dL and/ or triglycerides >200 mg/dL. History of any conditions that can interfere in the assessment of HbA1c due to increased red blood cell turnover or requirement for regular blood transfusions such as sickle cell disease (HbSS, hematopoietic blood stem cell (HbSC), HbS/beta thalassemia); Beta thalassemia major; Alpha Thalassemia (HbH) disease, Hemoglobin H-Constant Spring. History of any other acute or chronic medical condition or pre-planned medical/surgical procedure that, in the opinion of the Principal Investigator, would compromise the safety of participants or the integrity of study results; non- compliance with recommended diabetes care in the preceding 12 months. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). Participants with lymphopenia are allowed if the Principal Investigator determines there is no additional risk and obtains clearance from a hematologist. Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after islet cell transplantation (low-dose aspirin treatment is allowed) or participants with an international normalized ratio (INR) >1.5. The use of Plavix is allowed only when portal vein access is obtained using a mini-laparotomy procedure at the time of islet cell transplant. History of factor V deficiency. Administration of live attenuated vaccine(s) within 2 months of Screening. Any previous treatment with AT-1501 or any other anti-CD40L therapy Baseline Panel-reactive Antibody (PRA) over 20% Patients with COVID-19 positive PCR tests. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06305273

Not yet recruiting

Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients

It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height. There is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back.

- EligibilityCriteria: Inclusion Criteria: BMI > 40 kg/m2 age > 18 years scheduled for elective surgery under general anesthesia have the ability to comprehend the rationale for the study and provide consent Exclusion Criteria: pregnancy, risk of aspiration of gastric content patients using glucagon-like peptide(GLP)-1 agonists emergency cases upper airway disease or airway anatomical abnormalities presence of major cardiovascular, respiratory, or cerebral vascular disease if the provider anesthesiologist indicates an awake technique to secure the airway - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305247

Not yet recruiting

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally).

- EligibilityCriteria: Inclusion Criteria : Participants must be ≥18 years of age Participants with histologically confirmed metastatic solid tumour (melanoma, metastatic colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) or head and neck squamous cell carcinoma (HNSCC)) for whom no suitable alternative standard therapy exists. Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm). Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1. Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening Male and female participants Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. Exclusion Criteria Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications. Any evidence of severe active infection or inflammatory condition. Non-adequate cardiac function Have one or more of study defined ophthalmological findings/conditions Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study. Underlying medical conditions that, in the investigator's or sponsor's opinion, will obscure the interpretation of toxicity determination or AEs. Known second malignancy within the last 2 years prior to first dose of study intervention.. Major surgery within 28 days prior to first dose of study intervention. Ongoing AEs caused by any prior anti-cancer therapy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0). Active brain metastases or leptomeningeal metastases Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days. Live vaccine(s) within 28 days prior to first dose of study intervention Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents). Treatment with medications that prolong the QT/QTc interval. Treatment with strong and moderate CYP3A4 inducers Treatment with strong or moderate inhibitors of CYP3A4 Only for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention. Non-adequate bone marrow function Non-adequate renal function Non-adequate hepatic function Non adequate coagulation function. Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C Sensitivity to IPN01194 or any of its components. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305234

Recruiting

A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.

- EligibilityCriteria: Inclusion Criteria: Subjects enrolled at US sites participating in the 165-501 study. Exclusion Criteria: Legal incapacity or limited legal capacity without legal guardian representation. Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling). - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Subjects enrolled at US sites participating in the 165-501 study. - SamplingMethod: Non-Probability Sample

NCT06305221

Not yet recruiting

Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy

The purpose of the intraoperative use of opioids is to reduce the amount of sedative medication and to ensure effective analgesia. But pain is an unpleasant sensory and emotional experience (a cognitive perception) that cannot occur with sufficient depth of anesthesia (even without opioids). So a more reasonable explanation for analgesia should be anti-nociception and the resulting inhibition of the response to surgical stress. Since multiple mediators are involved in nociceptive pathways, antinociception can also be acquired through multiple mechanisms. However, there is no single ideal harm drug to replace opioids, which often requires two or more drugs to meet clinical needs. While regional block attenuates the stress response to surgery and sympathetic activation because of afferents to block nociceptive stimuli, and has an important role in the implementation of OFA. Combined with the clinical characteristics of the LSG, investigators developed the transverse abdominis fascia block (transversus abdominis plane TAP) in combination with esketamine (esketamine), dexmedetomidine (dexmedetomidine, DEX) of opioid-free anesthesia (opioid free anesthesia, OFA) and the analgesic regimen (TEDOFA), Reduce patient pain scores, nausea and vomiting after LSG based on perfect analgesia and adequate anti-sympathetic response, As well as the other complications, Promote the accelerated postoperative recovery of patients undergoing LSG, And reduce the incidence and severity of postoperative chronic pain.

- EligibilityCriteria: Inclusion Criteria: Patients undergoing elective laparoscopic sleeve gastrectomy ASAA I or grade; volunteered in this trial and signed informed consent; ④ age 18-65 years; ⑤ BMI> 30kg / m2. Exclusion Criteria: chronic pain; severe liver dysfunction (total bilirubin 2 mg dl-1); severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2); pregnancy or lactation; preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block; -dementia or significant neurological disorders (such as stroke, epilepsy, intracranial tumors, PD, etc.); history of alcohol or drug abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06305208

Recruiting

A UK Registry for Metabolic and Bariatric Endoscopic Interventions

In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to regain normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. We hope over time this will improve our knowledge about treating obesity with endoscopy and support future access and funding to these treatments.

- EligibilityCriteria: Inclusion Criteria: Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure. Age ≥ 18 years old Able to give written informed consent. Exclusion Criteria: Any bariatric or metabolic endoscopic procedure performed outside the UK. Any bariatric or metabolic endoscopic procedure not currently listed within the registry protocol or agreed by the steering committee. Unable to provide written informed consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients within the United Kingdom (UK) who have, or plan to, undergo a primary or revisional bariatric or metabolic endoscopic procedure for the treatment of obesity or metabolic disease in the UK - SamplingMethod: Non-Probability Sample

NCT06305195

Recruiting

Potential Correlation Between Heart Rate Variability With Cardiovascular Risk at Different Stages of Metabolic Syndrome

The study aims to assess the beat-to-beat Heart rate variability (HRV) in different stages of metabolic diseases, including pre-diabetic and diabetic patients, compared to non-diabetic individuals. Heart rate variability will be compared for some antidiabetic drugs used in different stages of metabolic diseases and correlated to different metabolic and inflammatory mediators.

- EligibilityCriteria: Inclusion Criteria: Non-diabetic individuals: adults (18-70 Years) with glycated hemoglobin (HBA1C)<5.7 and/or Fasting blood glucose <100 mg/L and with no classic symptoms of hyperglycemia Pre-diabetic: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria : glycated hemoglobin (HBA1C) =5.7-6.4% Fasting blood glucose level = 100 mg/dL to 125 mg/dL. Fasting is defined as no caloric intake for at least 8 hours. Diabetic patients: adults (18-70 Years) who fulfil one of the American Diabetes Association (ADA) criteria: glycated hemoglobin (HBA1C) ≥6.5% Fasting blood glucose ≥126 mg/dL. A random plasma glucose ≥200 mg/dL. Random is any time of the day without regard to the meals. Exclusion Criteria: Pediatric and elderly subjects Pregnant subjects Those with active Myocardial infarction Those with acute decompensated heart failure Patients with pacemaker Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients aged 18-70 Years either diabetic, pre-diabetic or non-diabetic should not have one of the following criteria: Pediatric and elderly subjects Pregnant subjects Those with active Myocardial infarction Those with acute decompensated heart failure Patients with pacemaker Patients with persistent Atrial fibrillation, long-standing persistent and permanent Atrial fibrillation Amputated patients - SamplingMethod: Non-Probability Sample

NCT06305182

Not yet recruiting

Metreleptin in Anorexia Nervosa

The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreletpin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight.

- EligibilityCriteria: Inclusion Criteria: Current diagnosis of AN according to DSM-5 (American Psychiatric Association [APA], 2013) diagnosed with SCID-5 (First et al., 2015) BMI > 13 kg/m2; BMI ≤ 17.5 kg/m2; body weight > 35 kg Hospitalisation in the Eating Disorders Unit, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich Ability to understand German language- Age range: 18 - 40 years Depressive symptoms: HAMD-17 ≥ 8 Negative pregnancy test, non-lactating and double birth control Informed Consent as documented by signature Exclusion Criteria: Illicit drug intake within last month; current alcohol use disorder Severe psychiatric and/or severe somatic comorbidities; f. e. lifetime diagnosis of schizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus, autoimmune disorders, pancreatitis, neurological disorders, cancer including lymphoma Acute suicidality or current serious non-suicidal self-injury - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06305169

Not yet recruiting

Measuring the Negative Predictive Value and Specificity of Serum Biomarkers in Gastric Cancer

Atrophic gastritis where the cells of the stomach lining change is the single most important precursor condition for gastric cancer. Helicobacter pylori a bacteria which causes infection in the stomach is the most important causative agent of inflammation of the stomach, and subsequent atrophic gastritis. The difficulty with diagnosing patients with gastric cancer is that a lot of patients will suffer from heartburn and pain around the stomach, but very few of those will have gastric cancer. This makes it difficult for GPs to know who to refer for further testing as the current cancer referral criteria are very broad. To reduce the need for invasive diagnostic methods such as endoscopy where a flexible tube with camera is inserted into the gullet and stomach via the mouth, a commercially available blood test (GastroPanel ®) designed to measure the levels of certain key stomach hormones to detect atrophic gastritis has been developed. It is extremely rare for gastric cancer to develop without there first being gastric atrophy. A real word study is needed assess the performance of this blood test in a group of patients referred via an urgent cancer pathway for endoscopy in the UK. Scoring systems have been created to help us triage referrals to endoscopy in those with difficulty swallowing, but no similar score is available for those presenting with other upper abdominal symptoms. By using this blood test as well as collecting patient information we hope to create an improved referral criteria for those needing investigation for gastric cancer.

- EligibilityCriteria: Inclusion Criteria: Patients referred for a 2 week wait cancer pathway endoscopy for the following indications Or Upper abdominal mass consistent with stomach cancer Or Stable upper gastrointestinal bleeding Or Aged 55 and over with weight loss and any of the following: Upper abdominal pain Reflux Dyspepsia Exclusion Criteria: Referrals for therapeutic OGD (e.g. polypectomy, feeding tube insertion) Previous gastro-duodenal surgery, Any co-morbidity that may impair ability to provide information or give valid consent (e.g. dementia, cerebral vascular disease) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will consist of those patients referred primarily from their general practice for a cancer pathway endoscopy at the study site. - SamplingMethod: Non-Probability Sample

NCT06305156

Not yet recruiting

Protocol Optimization in CT for the Quantification of BMD

Bone mineral density is an important measurement to detect osteoporosis. The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is: How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA How can we optimize the CT scan for bone mineral density Participants will undergo: Clinically indicated CT scan on day of inclusion Study related DXA scan on a separate appointment

- EligibilityCriteria: Inclusion Criteria: Informed Consent signed by the subject Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen) Informed written and oral consent (interpreter present in case of foreign language patients) No contraindication to the clinically indicated CT examination Exclusion Criteria: Patients < 18 years Pregnant women Vulnerable subjects Contraindications to the clinically indicated CT scan Multiple Myeloma Diffuse bone metastasis Fixateur interne in the lumbar spine Kyphoplasty in the lumbar spine Enterally administrated contrast agent Obtaining informed consent is not possible Withdrawal of consent orally or in writing Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject Immobility (patients confined to a wheelchair or to bed) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305143

Recruiting

Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy

The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR). The main questions it aims to answer are: mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment mean changes in BCVA and CMT from baseline to monthly follow-up time point complications and adverse effects

- EligibilityCriteria: Inclusion Criteria: symptomatic patients aged 18 years or above with center involved diabetic macular edema in the involved eye and without clinically significant diabetic macular edema in the fellow eye defined on the basis of spectral-domain optical coherence tomography (OCT) central macular thickness (CMT) ≥300 μm measured by OCT the involved eyes diagnosed as severe non-proliferative diabetic retinopathy (sNPDR) confirmed by two independent experienced ophthalmologists based on the ETDRS standard seven field color fundus photographs Exclusion Criteria: concomitant or previous macular diseases that may hinder visual improvement other than diabetic retinopathy (e.g., retinal vein occlusion, age-associated macular degeneration, uveitis, vitreomacular traction or epiretinal membrane) history of glaucoma or optic neuropathy of any kind previous vitreoretinal surgery or pan-retinal photocoagulation intravitreal injection anti-VEGF drugs within 6 months or intravitreal injection glucocorticoid within 3 months macular focal/grid laser photocoagulation within 3 months - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305117

Not yet recruiting

Virtual RealiTy and mUsic in the Oncology SEtting - Phase 1

The VRtuose (Virtual RealiTy and mUsic in the Oncology Setting) project aims to evaluate the feasibility of implementing in day patient chemotherapy units a distraction strategy combining virtual reality (VR) and music which fits the needs of both breast cancer patients and healthcare providers (i.e., strategy administrators), and to evaluate its impact on patients' (i) perceived anxiety and pain during chemotherapy sessions, (ii) nausea/vomiting and mood disturbances in between chemotherapy sessions, and (iii) quality of life. The present project is a non-randomized non-controlled prospective monocentric feasibility study which will focus on evaluating the feasibility of implementing the strategy in the target population and setting. In the case that implementation of a distraction strategy combining virtual reality and music to improve quality of life of breast cancer patients during chemotherapy is deemed feasible, the efficacy of using this strategy to improve patients' experience of chemotherapy and long-term quality of life will be evaluated in a future randomized controlled trial informed and optimized by the results of the present work.

- EligibilityCriteria: Inclusion Criteria: Histologically confirmed diagnosis of breast cancer; Any disease stage; Patient must be receiving (i.e., with at least 4 remaining cures) or about to start palliative or curative neoadjuvant or adjuvant chemotherapy for their breast cancer at Centre Léon Bérard; Willingness and ability to comply with the study requirements; Patient must be covered by a medical insurance; Patient must understand, speak, read and write French. Exclusion Criteria: History of condition contraindicating the use of virtual reality (e.g., epilepsy, severe motion sickness); Brain metastases; Any medical or psychosocial condition that would compromise the patient's compliance to the study procedures or would likely interfere with the completion of Patient-Reported Outcomes; Patients under tutorship or curatorship; Patients already included in another clinical trial ongoing at Centre Léon Bérard. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305104

Recruiting

Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.

This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old. In the first stage,180 healthy subjects, 140 tuberculosis（TB）subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay（IGRA）.Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis. In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.

- EligibilityCriteria: Inclusion Criteria: For healthy subjects: At the time of enrollment - For healthy subjects:enrollment is 3 ~ 75 years old (including 3 years old and 75 years old), regardless of gender ; Guardians of persons aged 3-7 years , persons aged 8-17 years old and their guardians, persons aged 18-75 years old themselves and/or their guardians (spouse or children) agree to participate in this trial and sign an informed consent form; The person and/or guardian can comply with the requirements of the clinical trial protocol to participate in /accompany the subject to follow- up visits; After medical history inquiry, there is no history of tuberculosis (including intrapulmonary and external tuberculosis ) and close contact history with tuberculosis patients (referring to direct contact with registered tuberculosis patients from 3 months before diagnosis to 14 days after starting anti-tuberculosis treatment); Those who have no clinical symptoms of tuberculosis poisoning and whose chest imaging examination (for subjects aged 15 to 75 years old) is normal or abnormal without clinical significance; Normal or abnormal measurements of vital signs ( axillary temperature, pulse , respiration , blood pressure ) and electrocardiogram have no clinical significance; [ The axillary temperature of all subjects was measured < 37.3°C ; blood pressure was measured in subjects aged 18-75 years (systolic blood pressure <160 millimetres of mercury（mmHg） and diastolic blood pressure <100mmHg) ; pulse and respiration were determined by the researcher based on the subject's age] Physical examinations are normal or abnormal with no clinical significance; Laboratory tests including blood routine, urine routine, and blood biochemistry tests were all normal or abnormal with no clinical significance. For patients with tuberculosis (including pulmonary tuberculosis): Those who was diagnosed with tuberculosis/ pulmonary tuberculosis according to the "People's Republic of China Health Industry Standard Pulmonary Tuberculosis Diagnostic Criteria " combined with the "Technical Guidelines for Tuberculosis Prevention and Control in China ( 2021 Edition )" (accepted clinical comprehensive analysis diagnosis); The age at the time of enrollment is 3 to 75 years old (including 3 years old and 75 years old), regardless of gender ; Guardians of persons aged 3-7 years old, persons aged 8-17 years old and their guardians, persons aged 18-75 years old themselves and/ or their guardians (spouse or children) agree to participate in this trial and sign an informed consent form; The person and /or guardian may comply with the requirements of the clinical trial protocol and participate in follow-up visits. For patients with non-tuberculous lung disease Patients with clear clinical diagnosis of pulmonary disease, and the clinician can rule out pulmonary tuberculosis and extrapulmonary tuberculosis based on the patient's clinical manifestations, imaging and laboratory tests (including IGRA ); Age at the time of enrollment is 18 to 65 years old (including 18 years old and 65 years old), regardless of gender; Those who agree to participate in this trial and sign the informed consent form; Those who may comply with the requirements of the clinical trial protocol and participate in follow-up visits Exclusion Criteria: Those with known or suspected (or high-risk) severe immune diseases, immune function impairment or abnormalities ( except HIV infection /AIDS ), including: who have convulsions, epilepsy, a history of mental illness and / or a family history of mental illness (immediate relatives); People with allergies, such as those who have a history of allergies to two or more drugs or foods, or those who are known to be allergic to the components of this medicine; Those currently suffering from acute infectious diseases (such as measles, whooping cough, influenza, etc.), acute conjunctivitis, acute otitis media, and generalized skin diseases; After consultation, have a history of past or current serious heart, liver, kidney, digestive system, respiratory system, nervous system, mental disorder and metabolic disorders; Those who are currently suffering from acute febrile illness; or those who have used antipyretic, analgesic and anti-allergic drugs within 3 days before the skin test and which may affect the research evaluation as assessed by the researcher ; People with serious infections (such as pyoderma, severe eczema, etc.); who are participating in or participating in any other new drug clinical trials within 3 months; Have received non-live vaccines within 7 days before the skin test , or have received live attenuated vaccines within 28 days ; Lactating or pregnant women, or female subjects of childbearing age who have a positive pregnancy test before enrollment and who have not taken effective contraceptive measures 2 weeks before enrollment. Those with a history of drug abuse; Any other circumstances that the investigator believes may affect the evaluation of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 75 Years - StdAgeList: Child, Adult, Older Adult

NCT06305091

Recruiting

DNA Methylation Markers in Veterans Exposed to Open Burn Pits

Background: The VA and DoD estimate that 3.5 million Veterans and Service Members were exposed to open burn pits used for waste disposal during military deployments to countries such as Kuwait, Afghanistan, and Iraq since 1990. Since the lasting adverse effects of this exposure on health are unknown, the VA Airborne Hazards and Open Burn Pit Registry (AHOBPR) was created. More than 209,000 participants to date have answered the registry questionnaire about the extent of exposure to burn pits and other airborne hazards. The questions attempted to quantify the duration of exposure, the severity of acute health effects, and the relative timing of onset or worsening of chronic respiratory, cardiovascular, neurological, and other illnesses. However, the AHOBPR interview lacks specific inquiry about mental health and biomarkers. The proposed study will recruit AHOBPR participants and non-participant for a follow-up enhanced evaluation of their health in a translational research study to better characterize their psychological, physical health profile, and potentially harmful epigenetic and biochemical exposure-related alterations. Hypothesis: The investigators hypothesize that 1) the severity of individual exposure to burn pits will be positively correlated with levels of persistent organic pollutants in blood and metals in urine and specific epigenetic alterations in DNA methylation; and 2) levels of toxic chemicals and alterations in the methylation of specific genes will be positively correlated with chronic problems involving the cardiovascular, respiratory, neuropsychiatric and other systems. Specific Aims: (1) Describe and quantify relationships of the intensity and duration of exposure with persistent organic chemicals/metals in the registry participants and ascertain their relationships with health outcomes linked to burn pit exposure. (2) Discover and validate DNA methylation marks that best distinguish between individuals exposed to burn pits and those not; then describe and quantify the relationships between DNA methylation, intensity and duration of exposure, and health outcomes. Completion of these aims will allow quantitation of the relationships between toxic chemicals, DNA methylation, and individual health problems. Study Design: A clinical study will be conducted at the Central Arkansas Veterans Healthcare System and the University of Arkansas for Medical Sciences. The AHOBPR registry and non-specific recruitment will be used to enroll OBP exposed (N=220) and age and gender-matched unexposed (N=110) veterans. The unexposed veterans will be given the same questions as in the AHOBPR to determine their open burn pit exposure status with a confirmation of no exposure. A single study visit per participant will strengthen the registry by validating its contents using the electronic patient record and adding new study data on physical and mental function, including effects of epigenetic and toxicant measures obtained from blood and urine samples. Linear and logistic regression modeling will be used to determine the relationships described by the study aims while controlling for confounding variables and false discovery rates. Long-term and Short-term Impact on Patient Populations: The immediate goal of the study is to measure exposure-related differences in levels of potentially toxic chemicals present in blood and urine and differences in DNA methylation. The study will then determine the relationships between exposure, the biochemical and molecular measures, and the presence of health problems. The value of this information is high since the effects of burn pit exposure are largely unknown but potentially serious. The longer-term goal for this line of investigation is to enable personalized and tailored health management for exposed individuals. The investigators believe that the biochemical and molecular measures may become novel biomarkers that enable the prediction of risk for disease and adverse disease outcomes such that preventative measures can be employed. Furthermore, the results will be highly relevant to other occupations in which exposure to airborne pollutants is high.

- EligibilityCriteria: Inclusion Criteria: Age 25-70 years Participants that reside in Arkansas All Veterans that are deployed Participants registered in the AHOBPR burn pit registry mainly for exposed Veterans. However, unexposed participants from the registry could also be included. Participants not listed in the AHOBPR burn pit registry mainly for unexposed Veterans. However, exposed participants not from the registry could also be included. Non-smokers: defined as smoke less than 10 cigarettes during lifetime. Fluent in English Exclusion Criteria: Any occupation and/or hobbies involves diesel exhaust, welding, paint, or other chemical fumes or organic dust Any use of tobacco or nicotine products within the past year, such as smoking (cigarettes, pipes, cigars, e-cigarettes, vaping devices) Self-report and/or chart review that patient is pregnant Self-report and/or chart review that patient weight is less than 110 lbs Participants whom the PI deems to be otherwise ineligible - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Veterans aged 25- 70 years - SamplingMethod: Probability Sample

NCT06305078

Recruiting

Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study

The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial.

- EligibilityCriteria: Inclusion Criteria: Participants for the study must meet all of the following criteria: Consent: A parent or legal guardian must provide written informed consent Assent: Adolescents must provide written assent to participate in the study Ages 11-15 Treated for ADHD by pediatrician First prescribed ADHD medicine more than one year prior to enrollment Filled at least one prescription for a stimulant medication in the past year Uncertainty about continued ADHD medication use Only one child per household can participate in the study. For families who have more than one child who is potentially eligible, they may decide which of their children would be the best fit for the study. Exclusion Criteria: Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria: Do not have reliable access to the internet at their home or another location. Will not permit their child to access the internet for study related activities. Are not able or willing to send or receive text messages. - HealthyVolunteers: No - Gender: All - MinimumAge: 11 Years - MaximumAge: 15 Years - StdAgeList: Child

NCT06305065

Not yet recruiting

Open and Closed Platform Robotic-assisted Versus Conventional Total Knee Arthroplasty

REAL INTELLIGENCE™ CORI™ (CORI Navigation) is a computer-assisted orthopedic surgical navigation and burring system. CORI Navigation is designed to aid surgeons in planning and executing a procedure involving bone preparation for total knee arthroplasty (TKA) procedures. CORI Navigation is comprised of a console control unit, optical tracking camera, primary and secondary input displays (tablet and optional display monitor), and foot pedal. The CORI Navigation software consists of a patient and user management module, a surgical planner, and an intra-operative cutting module. Yuanhua Orthopaedic Robotic Systems, KUNWU, is an open-platform robotic system that does not restrict surgeons in choosing the type of prosthesis implant. It is the only Orthopaedic Robotic System in Hong Kong registered with the HK Department of Health Medical Devices Control Office (MDCO) as an open platform system. Unlike other manufacturer's implant-based robots (closed systems), Yuanhua's objective is to provide maximum flexibility in choosing the best implant for each patient. Closed system robots not only impact the surgeon's choice of implant for an individual patient but also affect the hospital's implant purchases over multiple years without any negotiation power on pricing. This business model is often referred to as a "razor and razor blade" model. The primary objective of this study is to evaluate the use of open and closed platform robotic-assisted TKA procedure in achieving post-operative leg alignment as compared to procedures using standard instruments. The secondary objective of this study is to assess the safety and performance of the robotic-assisted TKA procedure up to 12 months after surgery as compared to procedures using conventional manual instruments.

- EligibilityCriteria: Inclusion Criteria: Subject is a suitable candidate for a robotic-assisted TKA procedure Subject requires a cemented TKA as a primary indication that meets any of the following condition: Degenerative joint disease, including osteoarthritis Rheumatoid arthritis Avascular necrosis Requires correction of functional deformity Requires treatment of fractures that were unmanageable using other techniques Subject is of legal age to consent and considered skeletally mature (≥ 18 years of age at the time of surgery) Subject agrees to consent to and to follow the study visit schedule (as defined in the study protocol and informed consent form), by signing the Ethical Committee (EC) or Institutional Review Board (IRB) approved informed consent form. Subject plans to be available through two (2) year postoperative follow-up. Applicable routine radiographic assessment is possible. Exclusion Criteria: Subject requires a TKA on the index joint as a revision for a previously failed surgery, or has the need for complex implants, or any other implant than a standard TKA (e.g. stems, augments, or custom made devices). Subject has been diagnosed with post-traumatic arthritis. Subject requires bilateral TKA. Subject does not understand the language used in the Informed Consent Form. Subject does not meet the indication or is contraindicated for TKA according to the specific Smith+Nephew Knee System's Instructions For Use (IFU). Subject has active infection or sepsis (treated or untreated). Subject is morbidly obese with a body mass index (BMI) greater than 40. Subject is pregnant or breast feeding at the time of surgery. Subject, in the opinion of the Investigator, has advanced osteoarthritis or joint disease at the time of surgery and was better suited for an alternate procedure. Subject has a condition(s) that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease, or an active, local infection). Subject in the opinion of the Investigator has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse. Subject, in the opinion of the Investigator, has a neuromuscular disorder that prohibited control of the index joint. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06305026

Recruiting

Protocol for a Diagnostic Test Accuracy of Histological Muscle and Skin Biopsies of Rheumatoid Arthritis Patients Revealing Objective Chronic Widespread Pain Phenomena Related to Fibromyalgia

Background: Chronic widespread pain is challenging in the management of the patient with rheumatoid arthritis (RA), affecting approximately one third of this patient population. However, pain is not always caused by disease activity (inflammation) but can be associated to central pain mechanisms as seen in fibromyalgia (FM). FM is characterized by widespread pain and tenderness; often accompanied by disturbed sleep, fatigue, cognitive impairment, emotional distress and multiple symptoms from various organ systems. Among patients with RA the prevalence of concomitant FM is reported to be 12-17% compared to 1-3% in the general population. In general the pain, felt by the fibromyalgia patients is considered to be due to lower pain thresholds because of abnormal central pain processing. Pain reported by RA patients with concomitant FM could potentially be explained by this phenomenon. Little is known about RA patients fulfilling criteria for FM. Muscles-studies of FM patients have not found any histopathological explanation of the pain felt, however an old study of muscle changes in RA patients found changes that could explain muscle pain. Small fiber neuropathy (SFN) is a condition associated with autoimmune diseases, and evidence suggests that SFN is likely to contribute to the pain observed in FM. Objectives: To determine the diagnostic test accuracy (sensitivity and specificity) of both muscle- and skin-biopsies for fibromyalgia phenotyping and detection by clinical referral (RA with concomitant FM) as the reference standard (i.e. fulfilment of 2016 FM criteria). Data collection: Will be done as study subjects are included and stored in REDCAP. Eligibility criteria for participants and settings where the data will be collected: RA patients will be assessed in the daily clinic in Esbjerg and Odense and examined for concomitant FM (I.e. satisfying the 2016 criteria for FM). Patients will afterwards be invited to participate in the study. Inclusion will continue until 25 RA patients fulfilling FM criteria and thus based on the expected prevalence at least 25 (- and maximum 50) RA patients not fulfilling FM critieria has undergone the index tests. Whether participants form a consecutive, random, or convenience series: Participants form a consecutive series. Description of the index test and reference standard: Twenty-five RA patients with concomitant FM and more than 25 (- maximum 50 patients) RA patients not fulfilling FM criteria will undergo the index tests. Muscle and skin biopsies will be performed in each group using standardized techniques. The reference standard will be fulfillment of the 2016 criteria for fibromyalgia. Estimates of diagnostic accuracy and their precision: Regarding muscle- and skin biopsies sensitivity, specificity and positive predictive value will be calculated using two times two table. Regarding skin biopsies, median values in the two groups (RA +/- FM) will be compared using a two-sample t-test.

- EligibilityCriteria: Inclusion Criteria: Age equal to or over 18 RA patient Exclusion Criteria: Alcohol abuse Wheelchair users, and patients who require personal assistance with daily activities. Medication with glucocorticoids within the last 6 weeks. A diagnosis of a systemic autoimmune disease other than RA Peripheral vascular disease manifested by claudication or ischemic rest pain Neuropathy Diabetes Patients with abnormal TSH levels. - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: RA patients with or without concomitant fibromyalgia - SamplingMethod: Non-Probability Sample

NCT06305013

Recruiting

PEA: The Ability of Nurses To Recognize It (PEA: ANTRI)

The Ability to recognize cardiac arrest is crucial in emergency situations and all health care professionals shloud be able to do so. The identification of pulseless electrical activity can be difficult even if the theoretical knowlegde of this state is well known. This research will be performed at the Simulation centre of Medical Faculty, Masaryk Unversity and it will be focused on nurses who will come to the simulation course. All the participants will get prelearning theoretical materials that will contain chapter about pulseless electrical activity and its recognition. In the beginning of the course they will be asked to fill up the questionnaire with four different pictures of patient´s monitor in cardiac arrest. It will be evaluated whether the pulseless electrical activity will be recognized.

- EligibilityCriteria: Inclusion Criteria: Nurse or paramedic Participant of simulation course organised by Department of Simulation medicine, Faculty of medicine, Masaryk university Exclusion Criteria: No experience wiht monitoring patients by vital signs monitor - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Participant of simulation course organised by Department of Simulation medicine, Faculty of medicine, Masaryk university - SamplingMethod: Non-Probability Sample

NCT06305000

Not yet recruiting

Impact of Keratinized Mucosa Augmentation on Treatment Outcomes of Peri-implant Mucositis

This study aims to observe the effects of keratinized mucosa width on peri-implant tissues by evaluating clinical and biochemical parameters. The main question it aims to answer is: Would increasing the width of the keratinized mucosa with free gingival graft (FGG) in peri-implant mucositis be beneficial in terms of clinical periodontal parameters and peri-implant crevicular fluid levels of inflammatory cytokines compared to non-surgical therapy alone? Our study consists of 4 groups: Peri-implant healthy group with sufficient keratinized mucosa (≥ 2mm) (n=16), peri-implant mucositis group with sufficient keratinized mucosa (n=16), peri-implant mucositis group with insufficient keratinized mucosa (< 2mm) receiving only non-surgical treatment (n=16), peri-implant mucositis group with insufficient keratinized mucosa receiving FGG in addition to non-surgical treatment (n=16). Clinical and biochemical measurements will be recorded at the baseline, 1st month, 4th month and 7th month of the study. Peri-implant crevicular fluid samples will be collected at baseline, 1st month, 4th month and 7th month. IL-1β, RANKL, OPG levels, and RANKL/OPG ratio will be analyzed from collected samples. Researchers will evaluate the possible benefits of FGG application in addition to non-surgical therapy by comparing the biochemical and clinical changes in areas with and without FGG application in the treatment of peri-implant mucositis.

- EligibilityCriteria: Inclusion Criteria: Individual dental implants with a fixed prosthetic restoration that has been functional for at least 1 year No systemic disease and medication use that may affect periodontal or peri-implanter tissues Not receiving periodontal treatment in the last 6 months Volunteering to participate in the study Exclusion Criteria: Prosthetic restorations with an excessive contour which do not allow peri-implant pocket measurement Being pregnant or breastfeeding, Autoimmune and/or inflammatory diseases of the oral cavity, Active periodontal disease Smokers (≥ 10 cigarettes per day) Improperly positioned implants - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304987

Not yet recruiting

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

This is a multi-center, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitors and PCSK9 inhibitors in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.

- EligibilityCriteria: Inclusion Criteria: Sign a written informed consent form and voluntarily join this study; Age 18-75 years old, male or female; Pathologically confirmed adenocarcinoma of the rectum; Clinically staged as II~III stage by MRI (according to the 8th edition of AJCC); Tumor lower edge distance from the anal margin ≤10cm; Able to undergo surgical resection; Able to swallow pills normally; ECOG PS 0-1; No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.; Planning to undergo surgical treatment after completing neoadjuvant therapy; No contraindications for surgery; Normal major organ function, including: Blood routine examination (no blood or blood products transfusion within 14 days before the first treatment, no use of G-CSF or other hematopoietic stimulating factors for correction): Neutrophil count ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin ≥90 g/L Blood biochemistry: Total bilirubin ≤1.5×ULN ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN, Serum creatinine ≤1.5×ULN, or creatinine clearance rate ≥50 mL/min (Cocheroft-Gault formula) Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN Activated partial thromboplastin time (APTT) ≤ 1.5×ULN Female subjects of childbearing potential should have a negative serum pregnancy test within 72 hours before the start of study drug administration, and effective contraception should be used during the trial period and for at least 3 months after the last dose (such as intrauterine devices, contraceptive pills, or condoms); for male subjects with female partners of childbearing potential, effective contraception should be used during the trial period and for 3 months after the last dose. Exclusion Criteria: History of allergy to monoclonal antibodies, PD-1 monoclonal antibodies, capecitabine, or oxaliplatin; History of receiving or currently receiving any of the following treatments: Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc., for tumors; Use of immunosuppressive drugs or systemic steroid therapy to achieve immunosuppression (dose >10mg/day prednisone or equivalent) within 2 weeks before the first use of the study drug; inhalation or local use of steroids and adrenal cortical hormone replacement therapy with a dose >10mg/day prednisone or equivalent is allowed in the absence of active autoimmune diseases; Receipt of attenuated live vaccines within 4 weeks before the first use of the study drug; Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug; Active autoimmune diseases or history of autoimmune diseases, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); psoriasis or childhood asthma/allergies that have completely resolved and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchodilators for medical intervention are not eligible for inclusion; History of immunodeficiency, including HIV positive, or acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; Presence of poorly controlled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or poorly controlled after clinical intervention; Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, septicemia, complications of infection, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 14 days before the first use of the study drug or requiring oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics; Active pulmonary tuberculosis infection found through medical history or CT examination, or a history of active pulmonary tuberculosis infection within the past year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year ago but without proper treatment; Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (HCV antibody positive, and HCV RNA higher than the lower limit of detection of the assay); Diagnosed with other malignant tumors within 5 years before the first use of the study drug, unless they have a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma in situ of the cervix, may be considered for inclusion; Pregnant or lactating women; Judged by the investigator to have other factors that may lead to premature termination of the study, such as having other serious diseases (including mental illnesses) requiring concomitant treatment, alcoholism, drug abuse, family or social factors, factors that may affect the safety or compliance of the subject. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304974

Not yet recruiting

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of PD-1/PD-L1 monoclonal antibody in combination with platinum-based chemotherapy.

- EligibilityCriteria: Inclusion Criteria: Voluntarily sign the informed consent and follow the requirements of the protocol; Age ≥18 years old; Expected survival time ≥3 months; Patients with recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology; Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years; Must have at least one measurable lesion according to RECIST v1.1 definition; ECOG 0 or 1; Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; No blood transfusion and no use of any cell growth factor drugs were allowed within 14 days before randomization, and the level of organ function had to be adequate; Urine protein ≤2+ or < 1000mg/24h; A serum pregnancy test must be performed within 7 days before the start of treatment for premenopausal women who are likely to have children, and the result must be negative and must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: Chemotherapy, targeted therapy, biological therapy, etc., had been used within 4 weeks or 5 half-lives before randomization, and palliative radiotherapy and modern traditional Chinese medicine preparations approved by NMPA had been used within 2 weeks; Patients with recurrent esophageal squamous cell carcinoma suitable for radical local treatment should be excluded; Frontline received ADCs with topoisomerase I inhibitors as toxins; History of severe heart disease and cerebrovascular disease; Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; diagnosed with active malignancy within 3 years before randomization; Hypertension poorly controlled by two antihypertensive drugs; patients with poor glycemic control; present with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; A previous history of interstitial lung disease (ILD) or a suspicion of such disease on imaging during screening; Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; patients with active central nervous system metastases; Severe infections within 4 weeks before randomization; Evidence of pulmonary infection or active pulmonary inflammation within 2 weeks before randomization; patients with massive or symptomatic effusions or poorly controlled effusions; Imaging examination showed that the tumor had invaded or wrapped around the large blood vessels in the abdomen, chest, neck, and pharynx; serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; patients with inflammatory bowel disease, extensive bowel resection history, immune enteritis history, intestinal obstruction or chronic diarrhea; patients with a history of allergy to recombinant humanized antibodies or to any of the excipients of BL-B01D1; had a history of autologous or allogeneic stem cell transplantation; Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection; a history of severe neurological or psychiatric illness; received other unmarketed investigational drugs or treatments within 4 weeks before randomization; subjects scheduled for vaccination or who received live vaccine within 28 days before study randomization; Other circumstances in which the investigator considered it inappropriate to participate in the trial because of complications or other circumstances. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304961

Not yet recruiting

A Study to Investigate Relative Bioavailability of Two Different Dosage Forms for Tozorakimab Via Subcutaneous Administration in Healthy Volunteers

The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms.

- EligibilityCriteria: Inclusion Criteria: Healthy male and female participants aged 18 to 55 years. All females must have a negative pregnancy test at the screening visit and on admission to the Clinical Unit. Females of childbearing potential must not be lactating and, if heterosexually active, must agree to use an approved method of highly effective contraception. Females of non-childbearing potential must be confirmed at the screening visit. Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods. Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 55 kg and no more than 100 kg inclusive. Intact normal skin without potentially obscuring tattoos, scars, etc, at the injection site. Exclusion Criteria: History of any clinically significant disease or disorder (including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator). Any clinically significant abnormal findings in vital signs at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator. Any clinically significant abnormalities on 12-lead ECG at the screening visit and/or admission (Day -1) to the Clinical Unit, as judged by the investigator. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 6 months prior to the screening visit, as judged by the investigator. Any clinically important illness, medical/surgical procedure, or trauma within 8 weeks of the screening visit, or any planned inpatient surgery or hospitalisation during the study period. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to enrolment. Suspected malignancy or undefined neoplasms. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection. Any laboratory values with the following deviations at the screening visit or on admission (Day -1) to the Clinical Unit. Any clinically significant abnormal findings in physical examination at screening and/or admission (Day -1), which, in the opinion of the investigator, may put the participant at risk because of their participation in the study or may influence the results of the study, or the participant's ability to complete the entire duration of the study. History of known immunodeficiency disorder, including a positive test for Human immunodeficiency virus-1 (HIV-1) or HIV-2. History or treatment for hepatitis B or hepatitis C or any positive test result on screening for Hepatitis B surface antigen (HBsAg), anti- Hepatitis B core (HBc) antibodies, or anti-hepatitis C antibodies. Evidence of active or latent Tuberculosis (TB). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06304948

Not yet recruiting

The Link Between Human Cytomegalovirus Gene Expression and Glutamate Level in Migraine;Relation to Vitamin D Deficiency

To correlate serum 25(OH)-vitamin D level with duration, frequency, and severity of migraine headache attacks To evaluate the relationship between the serum level of vitamin D and other indices in patients with migraine. To correlate the serum level of glutamate with gene expression of in migraine

- EligibilityCriteria: Inclusion Criteria: Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria. The age of the selected patients ranged between 15 and 55 years of both sexes Able to give informed consent. Exclusion Criteria: b. Exclusion criteria: presence of neurological disease other than migraine presence of other chronic medical conditions Participants in both groups were excluded from the study if they consumed vitamin D supplements in the preceding 3 months (any dose); or if they were taking medications that could affect vitamin D serum level such as glucocorticoids, thiazide diuretics, or statins. 4)patients refuse to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 15 Years - MaximumAge: 55 Years - StdAgeList: Child, Adult - StudyPopulation: Selected patients fulfilled the criteria for diagnosis of migraine headache based on International Classification of Headache Disorders-II (ICHD-II) diagnostic criteria. And The age of the selected patients ranged between 15 and 55 years of both sexes - SamplingMethod: Non-Probability Sample

NCT06304935

Not yet recruiting

Injectable Platelet Rich Fibrin Post Tonsillectomy

To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy

- EligibilityCriteria: Inclusion Criteria: - Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy Exclusion Criteria: children who expected to be unreliable in expressing pain due to behavioural pattern or disorder, developmental delayed, age less than 5yrs residence outside the city or patient unable to come for follow-up. children who have high anaesthetic risk or uncontrolled medical illness. bleeding diathesis. acute infection. unilateral tonsillectomy. Hemoglobin level<10mg/dl positive viral markers - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - StdAgeList: Child, Adult, Older Adult

NCT06304922

Not yet recruiting

BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary

The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.

- EligibilityCriteria: Inclusion Criteria: Age above 18 years, Pathologically proven ovarian cancer,epithelial origin. BRCA mutant/wild Recurrent cases who are eligible to anti-VEGF (Bevacizumab). Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases. Patients with good renal and liver functions. No other malignancy (double malignancy). Performance status 0-2 according to ECOG performance status scale. Exclusion Criteria: Performance status 3-4 according to ECOG performance status scale. Patients refuse to receive chemotherapy, Patients not eligible to receive chemotherapy due to liver or renal impairment. - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Ovarian cancer patients - SamplingMethod: Non-Probability Sample

NCT06304909

Not yet recruiting

Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block

Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.

- EligibilityCriteria: Inclusion Criteria: Patients between 20_60 years old Patients with ASA clinical status I/II Patients scheduled for peripheral nerve block for upper extremity surgery Exclusion Criteria: 1) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine & dexamethasone - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06304896

Not yet recruiting

Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

BASiC-CIC Trial is a multicenter, double-blinded, randomized, placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy, reduction of major adverse cardiovascular events, and all-cause mortality.

- EligibilityCriteria: Inclusion Criteria: Willing and able to provide written informed consent prior to performing study procedures. A cancer patient who is a candidate for a guideline-directed, anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab. Baseline LVEF ≥ 50% without evident structural heart disease by pre-treatment echocardiographic examination. Exclusion Criteria: Critically ill Cancer patients who are admitted to ICU. Ischemic cardiomyopathy with LVEF ≤ 50%. Dilated cardiomyopathy with LVEF ≤ 50%. Advanced valvular heart disease (severe valvular affection in the form of stenosis or regurgitation). Systolic BP < 90 mmHg or diastolic BP < 60 mmHg. Liver cell failure. End-stage chronic kidney disease on regular dialysis. Pregnancy. Lactation. Chronic muscle diseases such as dermatomyositis, polymyositis, or muscular dystrophy. Acute trauma or burns within 2 weeks. History of allergy to the implemented drugs. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304883

Not yet recruiting

Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

- EligibilityCriteria: Inclusion Criteria: Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug. Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities. Exclusion Criteria: Significant worsening of medical conditions that may preclude completion of this study. Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline. Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301). Subject taking any prohibited medications per protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06304870

Not yet recruiting

Impact of Blocking the Glossopharyngeal Nerve on Gastroesophageal Reflux Disease

The goal of this clinical trial is to explore Clinical Effect of Glossopharyngeal Nerve Block on Pharyngeal Dysphagia Induced by Gastroesophageal Reflux Disease. The main question it aims to answer is: • Can Glossopharyngeal Nerve Block improve dysphagia caused by gastroesophageal reflux symptoms on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Glossopharyngeal Nerve Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Rosenbek penetration-aspiration scale, Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, to see if the Glossopharyngeal Nerve Block can help improve the symptom.

- EligibilityCriteria: Inclusion Criteria: Meeting the diagnostic criteria for Gastroesophageal Reflux Disease. Age between 18 and 65 years. Confirmed tongue-pharyngeal nerve injury by electromyography. Esophageal manometry and barium swallow examination confirming the presence of pharyngeal dysphagia. Normal higher brain function, able to cooperate with treatment. Exclusion Criteria: Brain vascular disease diagnosed. Clinical assessment and swallowing videofluoroscopic examination revealing cognitive phase, oral preparatory phase, or oral phase disorders. Concurrent presence of other neurological disorders such as Alzheimer's disease, traumatic brain injury, Parkinson's disease. Esophageal obstruction and severe liver or kidney dysfunction Subjective unwillingness to undergo the treatment and presence of psychiatric abnormalities, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06304857

Not yet recruiting

CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

- EligibilityCriteria: Inclusion Criteria: Age > 18 years and < 80 years. Diagnosis of invasive breast cancer [ stage I-III ] and planned anthracycline treatment within 60 days. Signed Informed Consent to participate in the study. Exclusion Criteria: Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment. Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure. Left ventricular ejection fraction <50% at the time of the screening. Severe valvular heart disease. A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator). A history of stroke. Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic. Pulmonary hypertension. Uncontrolled arterial pressure or systolic pressure <80 mmHg at screening at the discretion of the investigator. BMI>40 kg/m2. Diabetes type 1 or type 2. Pregnancy or breastfeeding. Taking another study drug or drugs from the group of SGLT2 inhibitors. eGFR <25 ml/min/1.73m2 according to CKD EPI Life expectancy <12 months or cancer disease stage IV according to the TNM classification. Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06304844

Not yet recruiting

Risk of CKD in Diabetic Patients With MAFLD

This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.

- EligibilityCriteria: Inclusion Criteria: Type 2 diabetic patients Willing and agreed to be included in the study. Exclusion Criteria: Type 1 diabetic patients or non-diabetic patients. Patient with known glomerulonephritis. Patient with diagnosis of or clinical features that are suspicious for another systemic disease that commonly causes kidney disease (e.g., connective tissue disorders, HIV). Patient with evidence of alternative kidney disease like (Documented obstructive uropathy, etc.) Patient with history of kidney transplantation. Patient with end stage renal disease or on dialysis. Patients with active malignancy. Individuals with a history of hepatitis B surface antigen or hepatitis C antibody positivity. history of excessive alcohol consumption (⩾30 g/day in men and ⩾20 g/day in women) Decompensated liver cirrhosis. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population for this study comprises individuals diagnosed with type 2 diabetes mellitus either with or without MAFLD. The MAFLD group will encompass individuals meeting standardized diagnostic criteria for MAFLD and having a confirmed diagnosis of type 2 diabetes. Participants with comorbidities, such as viral hepatitis, cirrhosis, and cancers, will be excluded to ensure a focused study population. The chosen sample size of 300 individuals will allow for a robust examination of the prevalence of chronic kidney disease and associated risk factors within this specific cohort. - SamplingMethod: Non-Probability Sample

NCT06304831

Not yet recruiting

Use of Facility Ratings to Improve Satisfaction With Heath Care for Children

Despite increasing options for public and private health care providers in Laos, choosing a high-quality health provider or a facility is difficult because timely and reliable information about providers is not readily available. People rely on social networks or previous experiences to select providers. However, in Laos, only 28% describe their recent visit to a health care provider as high-quality suggesting that while there are increasing options for care, people may need support to find providers that meet their quality needs. Rapid adoption of mobile phones in Laos, particularly in urban areas, offer opportunities to enhance people's access to timely quality information about health care providers. We will use mobile phones to collect and disseminate quality information about providers - known to be valued by Laotians - to improve their access to quality care as well as their overall satisfaction with care.

- EligibilityCriteria: Inclusion Criteria: All women 18 years of age and older and enrolled in Vientiane Multigenerational Birth Cohort (VITERBI) with at least one child less than two years old, able to read, have exclusive access to a mobile phone, have a WhatsApp account, understand and sign the ICF will be eligible to participate in the study. The eligibility criteria will be assessed using data collected from VITERBI. Ability to read will be tested using a script in Lao, "I use my mobile phone every day." Exclusion Criteria: Eligible women unwilling to sign informed consent, without exclusive access to a mobile phone, unable to read the test script, or unable operate a mobile phone will be excluded from the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304818

Not yet recruiting

Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.

- EligibilityCriteria: Inclusion Criteria: Voluntarily sign the informed consent form (ICF); Male or female, 18 years old ≤ age ≤ 75 years old; Survival duration more than 3 months; ECOG score ≤ 1 point; Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours; Adequate organ and bone marrow function. Exclusion Criteria: Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases; Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.); History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen; Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence; Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment; Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study; Significant coagulopathy or other evident risk of bleeding; Major surgery or significant trauma within 4 weeks prior to enrollment; presence of unhealed skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures, or if the Investigator deems the participant unsuitable for the study; History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs; History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP; History of organ transplantation or stem cell transplantation; Pregnant or breastfeeding female; women of childbearing potential with positive pregnancy test within 7 days before the enrollment; participants (including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304792

Recruiting

Immediate Versus Postponed Single Blastocyst Transfer in Programmed or Stimulated Cycle Frozen Embryo Transfer

The aim of this randomized controlled trial is to examine whether single blastocyst transfer in the first cycle after oocyte retrieval (immediate) is non-inferior to single blastocyst transfer in a subsequent cycle (postponed) in stimulated or programmed cycle frozen embryo transfer (FET). The primary outcome is live birth rate.

- EligibilityCriteria: Inclusion Criteria: Eligible for FET in a programmed- or stimulated cycle immediately following a fresh embryo transfer or freeze all cycle Oligo-anovulatory women (cycle length > 35 days) Ovulatory women (cycle length 21-35 days) At least one vitrified day 5 or 6 blastocyst with Gardner score of ≥ 3BB at the day of vitrification Exclusion Criteria: Uterine malformation Presence of hydrosalpinx, submucosal uterine myomas or uterine polyps Allergies or contraindication to standard fertility medication Male or female HIV or Hepatitis B or C Preimplantation genetic testing (PGT) in the fresh cycle Testicular sperm aspiration (TESA) Severe OHSS with hospital admission and ascites drainage during the fresh cycle Oocyte donation - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06304766

Recruiting

Open Versus Laparoscopic Ablation of Liver Malignancies: a Randomized, Controlled Multicenter Trial

The purpose of this study is to compare laparoscopic ablation to open ablation of liver malignancies regarding complication rates and ablation response as well as quality of life following the surgery.

- EligibilityCriteria: Inclusion Criteria: One or more tumors not amenable to percutaneous ablation, age ≥ 18, signed informed consent, diagnosis of primary liver cancer or liver metastases from any primary tumor, and tumor suitable for ablation as primary treatment. Exclusion Criteria: Ablation performed in conjunction with resection, patients who cannot cooperate with the study, and patients who do not understand or speak Danish. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304753

Recruiting

ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction

BOT-IMPROVE-HF is a two-center, parallel group study designed to evaluate the efficacy of up-titration of heart failure treatment using digital remote monitoring after hospitalization due to heart failure decompensation. Patient will be randomized before discharge using a simple computer generated sequence to either remote monitoring or usual care group. Patients' condition in the "remote monitoring" arm will be assessed by mini-program based on a personal messenger and laboratory rests results will be asked by phone call. If these measures show safety and tolerability of the doses of the drugs, they will be increased to target or maximally tolerated doses. The follow-up period will be 6 months - 24 weeks. Patients of the usual care group will be followed by their general practitioner and/or cardiologist. All patients will be contacted after 6 months to assess outcomes.

- EligibilityCriteria: Inclusion Criteria: Age > 18 and < 85 years HFrEF diagnosed according to 2020 Clinical practice guidelines for Chronic heart failure of Russian Society of Cardiology (RSC) Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. Stable condition at the time of discharge from the hospital All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mmol/L. At the moment of Randomization either (a) <= ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, <= ½ the optimal dose of beta-blocker prescribed, and <= ½ the optimal dose of MRA prescribed. A smartphone with Internet access Written informed consent to participate in the study. Non-inclusion Criteria: Age < 18 or > 85 years. Stroke or transient ischemic attack (TIA) within the 3 months prior to Screening. Primary liver disease considered to be life threatening. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated white blood cells (WBC) or need for intravenous antibiotics. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months. Alcohol or drug abuse Pregnant or nursing (lactating) women. Serious vision and/or hearing problems Renal disease or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 [as estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or the simplified Modification of Diet in Renal Disease (MDRD) formula] at Screening or history of dialysis. Clearly documented intolerance or contraindication to any of beta-blockers, renin-angiotensin system (RAS) blockers (both ACEi and ARB), angiotensin receptor neprilysin inhibitor (ARNi), mineralocorticoid receptor antagonist (MRAs). Significant pulmonary disease contributing substantially to the patients' dyspnea such as forced expiratory volume during the 1st second (FEV1)< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues, or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures Exclusion Criteria: Unwillingness of the patient to continue participating in the study The development of conditions related to the criteria of non-inclusion - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06304740

Recruiting

Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.

- EligibilityCriteria: Key Inclusion Criteria: Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study. Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception. Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized. Exclusion Criteria: Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. Major surgery ≤ 4 weeks before the Baseline Visit or planned major surgical procedure during the study. Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose. Drug or alcohol abuse. Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose. Hepatitis B, hepatitis C, or human immunodeficiency virus infection. Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection. Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit. Hypersensitivity to study treatment or other biologics Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06304727

Recruiting

Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment

The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization. A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections. A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.

- EligibilityCriteria: Inclusion Criteria: Children being treated according to our Short-Term Enteral Nutrition Protocol Exclusion Criteria: Parents refusal - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Weeks - MaximumAge: 1 Year - StdAgeList: Child - StudyPopulation: Inclusion of all infants under one year old presenting a bronchiolitis with exclusive nutritional impairment and treated in the emergency room of the Hôpital Femme Mère Enfant according to the Protocole de prise en charge de la bronchiolite avec forme digestive prédominante à l'accueil des urgences de l'HFME (Protocol for the management of bronchiolitis with a predominantly digestive form at the HFME emergency department)- ZSBCD. This population will constitute a restrospective cohort in a pediatric tertiary care hospital during the 2022-2023 bronchiolitis season. - SamplingMethod: Non-Probability Sample

NCT06304714

Not yet recruiting

Effects of Bothrops Spp. Snake Envenomation on Willebrand Factor Activity in Martinique and French Guiana

In 2017, the World Health Organization placed snakebites at the top of its list of neglected tropical diseases in an effort to facilitate funding for prevention programs, improve access to anti-venom, and stimulate new research in this area. Between 5 and 25 cases per 100 000 inhabitants are reported per year in French Guiana and Martinique. Before the era of anti-venom immunotherapy, envenomations by Bothrops snake bites in French Guiana and Martinique could quickly become life-threatening with a mortality rate close to 30%. Today, the administration of fragments of Fab or (Fab')2 immunoglobulins gives anti-venoms an excellent capacity to neutralise venom toxins, which has reduced mortality to less than 1% in the case of early hospital treatment In French Guiana, envenomation by Bothrops bites is characterized by local signs such as intense pain, rapidly expanding oedema, haemorrhagic phlyctenes and sometimes muscle necrosis. The local inflammatory and haemorrhagic damage is related to the enzymatic activities of the toxins contained in the venom (metallo-proteinases, disintegrins, and phospholipases A2, in particular). At the systemic level, venom serine proteases and metalloproteinases activate the coagulation cascade by multiple mechanisms (activation of coagulation factors X and V and of protrombin, thrombin-like and fibrinogenolytic enzymatic properties) and are responsible for the collapse of coagulation factors making the blood incoagulable. The metalloproteinases "hemorrhagins" destroy the vessel wall and are the cause of locoregional and systemic hemorrhage. Envenomations by bites of Bothrops lanceolatus in Martinique have particular characteristics. Despite the genetic similarity with their congeners in French Guiana, envenomation by bites of Bothrops lanceolatus is characterized by the development of very intense local inflammatory signs (little haemorrhage) and the occurrence of thrombotic complications such as cerebral, pulmonary or myocardial infarction. The mechanisms behind this thrombotic presentation are not known. The large amount of metalloproteinases in the composition of Bothrops lanceolatus venom is believed to be responsible for destruction of vascular endothelium and pro-thrombotic state. Bothrops lanceolatus bite envenomations have been reported to be frequently complicated by generalized infections, disseminated intravascular coagulation and the occurrence of multi-visceral failure syndrome. This observation suggests abnormalities in endothelial function in which changes in Willebrand factor expression have been implicated. The investigators hypothesize that plasma Willebrand factor (VW) activity and the intensity of endothelial activation are different depending on the Bothrops snake species involved in the bites in Guyana and Martinique. Due to the specific properties of the venoms of each Bothrops species, the activity of the Willebrand factor (VW) and the consequences in terms of endothelial activation would be different and responsible for the clinico-biological characteristics according to the geographical origin of the snakes. The investigators will demonstrate that the accumulation of Willebrand factor (VW) and the increase in its activity are responsible for the endothelial activation and micro-thrombosis observed during envenomations by Bothrops lanceolatus bites, whereas the decrease in its activity induced by the venoms of endemic Bothrops from Guyana is responsible for haemorrhagic phenomena. This study will highlight the importance of changes in Willebrand factor activity on endothelial activation and the initiation of micro-thrombosis in the case of Bothrops lanceolatus envenomations and on primary haemostasis and bleeding disorders in the case of endemic Bothrops in Guyana. This new knowledge is important insofar as individualised therapeutic management can be proposed. Indeed, several studies have shown that adjuvant treatment of thrombotic microangiopathies, such as thrombotic thrombocytopenic purpura, with blood products (fresh frozen plasma) or plasma exchange, improves endothelial dysfunction and the prognosis of patients.

- EligibilityCriteria: Inclusion Criteria: Men or Women, at least 18 years old Be admitted to the Emergency Department of the Martinique University Hospital or the Cayenne University Hospital Be the victim of a confirmed Bothrops snake bite in Martinique or French Guyana. The formal identification of the snake by the patient or his entourage is imperative. Have a confirmed diagnosis of stage III envenomation (regional oedema of the limb and/or moderate general symptoms such as moderate hypotension, malaise, vomiting, abdominal pain, diarrhoea) and stage IV (extensive oedema reaching the trunk and/or severe general symptoms such as prolonged hypotension, shock, anaphylactoid reaction, visceral damage) Be able to receive and understand information related to the research Be able to freely give verbal consent to participate in the proposed research Be able to freely give written informed consent to participate in the plasmathèque Be affiliated to the general social security system Exclusion Criteria: Pregnant or breastfeeding woman People who have been treated for snakebite with Bothrops anti-venom Bothrofav® or Antivipmyn-tri®. Known disorders of haemostasis such as haemophilia A (factor VIII deficiency), haemophilia B (factor IX deficiency), vitamin K deficiency, hepato-cellular insufficiency, presence of circulating anticoagulant factors Disseminated intravascular coagulation (DIC) Constitutional and acquired Von Willebrand disease Constitutional and acquired thrombopathies Idiopathic thrombocytopenic purpura Person under legal protection (guardianship, curatorship, safeguard of justice), and person deprived of liberty. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be patients hospitalized in the emergency and intensive care units of the Martinique University Hospital or the Cayenne University Hospital (French Guiana). Patient recruitment will be organized by center throughout the 18-month study period. Initial data collection (D0) will be carried out on admission to the hospital ward, using a blood sample taken as part of the treatment and for research purposes, to collect indicators relating to plasma Willebrand factor activity and the endothelial response induced by Bothrops bites. These indicators collected on D0 will constitute the reference data specific to each individual. At D1 and D8, these indicators will be collected again. - SamplingMethod: Non-Probability Sample

NCT06304701

Recruiting

Handwritten Text Production in Adults With Autism

The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD. The secondary objectives are: Identifying links between specific deficits of ASD and difficulties in written production. Identifying links between the severity of ASD and difficulties in written production. The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive). The secondary evaluation criteria are: Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters). Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text). Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC).

- EligibilityCriteria: Inclusion Criteria for experimental group only: ASD diagnosis according to DSM-5 criteria and established by an interdisciplinary Inclusion Criteria for both experimental and control groups: Age ≥ 18 years Age ≥ 18 years and matching typical adult subjects to ASD individuals in age (plus or minus 5 years), sex, and education level The person participating in the research has read, understood, and signed the study consent form The person is proficient in the French language The person is affiliated with a social security system Exclusion Criteria for experimental group only: Diagnosis of any other NDD than ASD (e.g., Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder) Exclusion Criteria for control group only: - Diagnosis of any NDD (ASD, Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder) Exclusion Criteria for both experimental and control groups: Refusal of the individual to participate in the study Presence of severe visual impairment Known pregnancy Individual deprived of liberty Individual under guardianship or curators Presence of concurrent psychotropic medication treatments not stabilized, initiated within the last 2 months: antipsychotics, mood stabilizers, antiepileptics, psychostimulants, antidepressants Presence of upper limb motor impairment, with or without devices Presence of diagnosed neurological or psychiatric disorders (e.g., Schizophrenia Spectrum Disorder or other psychotic disorders), presence of a general or metabolic pathology known to have an impact on cognitive efficiency and/or motor skills of the individual (e.g., Epilepsy, Tics and Tourette Syndrome, Neuro-muscular Syndrome, Metabolic Neurological Syndromes, neoplasms) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304688

Recruiting

Yoga on Cognitive, Mental and Functional Abilities in Older Adults

Yoga has emerged as a powerful therapeutic practice for enhancing physical and mental health across all age groups, including older adults and younger individuals. For seniors, yoga aids in maintaining flexibility, muscle strength, balance, and posture, thereby reducing the risk of falls and injuries. It also alleviates chronic pain, enhances sleep quality, and mitigates stress and anxiety, contributing to improved overall mental and emotional well-being in this demographic. As individuals age, they undergo physical and mental changes that impact their quality of life. Yoga offers tailored benefits for older adults by preserving joint mobility and flexibility, lowering the risk of falls, and easing chronic pain associated with conditions like arthritis and osteoporosis. Moreover, it fosters stress reduction, anxiety relief, and depression mitigation, fostering emotional equilibrium. The practice of yoga from a young age yields numerous advantages for both physical and mental health, including enhanced concentration, attention, and memory-beneficial qualities for university students. Moreover, yoga aids in stress and anxiety reduction, fosters positive body image, and bolsters self-esteem, contributing to vitality and active aging. Yoga is efficacious in enhancing quality of life and facilitating healthy aging by offering adaptable, gentle exercise that caters to individual needs and limitations. Its mindfulness and body awareness aspects foster a stronger mind-body connection, fostering overall well-being and balance. With its adaptability and accessibility, yoga transcends socioeconomic barriers and physical conditions, making it a viable option for people of all backgrounds. In a society marked by rising stress and lifestyle-related ailments, yoga emerges as an invaluable therapeutic avenue for promoting health and well-being. Its holistic approach and adaptability to individual needs make it an appealing option for individuals seeking sustainable improvements in physical and mental health. Thus, the integration and promotion of yoga as a therapeutic modality in health and wellness domains are warranted.

- EligibilityCriteria: Inclusion Criteria: To participate in the study, participants will be required to: Who are over 60 years old Who do not participate in any physical exercise program Have sufficient physical autonomy to participate in the physical activities required by the study and are able to understand the instructions, programs and protocols of this project. Exclusion Criteria: All participants with contraindications for performing the physical tests will be excluded. Diseases that limit cognitive performance and physical activity. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06304662

Recruiting

Yoga for Physical and Mental Health

In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.

- EligibilityCriteria: Inclusion Criteria: University students who do not participate in any physical exercise program Sufficient physical autonomy to participate in the physical activities required by the study That they are able to understand the instructions, programs and protocols of this project. Exclusion Criteria:- University students who have serious physical or mental conditions Lack of commitment to regular attendance Extensive previous experience in yoga - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult

NCT06304649

Not yet recruiting

Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients. A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.

- EligibilityCriteria: Inclusion Criteria: Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L) Exclusion Criteria: Participants requiring a surgical intervention Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure. Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions Participants with pathologic fractures e.g., presence of bone cyst Participants who smoke Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion) - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 21 Years - StdAgeList: Child, Adult

NCT06304636

Recruiting

Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15

- EligibilityCriteria: Inclusion Criteria Patients must be 18 years of age or older at the time of enrollment. Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma. Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria. Patients must have clinical performance status of ECOG 0-2. Patients must have adequate vital organ function as defined by: Hemoglobin ≥8 g/dL Absolute neutrophil count > 1000/ mm3 Platelets > 50,000/mm3 ALT/AST levels lower than 3-fold of normal Creatinine clearance ≥45 mL/min/1.73 m2 Normal cardiac and pulmonary function No thromboembolic events in the past 3 months No heparin allergy or active infection Exclusion Criteria Patients who have any active and uncontrolled infection. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent). Patients who have active central nervous system disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304610

Not yet recruiting

Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador

ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations. In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer. At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests. Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador): AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test ELISA protein detection: only available comparison test In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium): • HPV DNA Mole Bioscience test Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes.

- EligibilityCriteria: Inclusion Criteria: have a previous abnormal pap smear/recent diagnosis of cervical dysplasia (<4 months) and therefore have a colposcopy appointment, or a positive HPV test (<4 months) and therefore have a colposcopy appointment, and able to understand the study materials (questionnaire) and informed consent form Exclusion Criteria: women with heavy bleeding at consultation women with known pregnancy at consultation women who are undergoing or have completed chemotherapy in the six months prior to the enrollment, or received LEEP, cryotherapy or another treatment in the six months prior to enrollment women who do not consent - HealthyVolunteers: No - Gender: Female - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06304597

Not yet recruiting

Evaluating PD-1/PD-L1 in Locally Advanced Rectal Cancer by Quantitative Fluorescence Molecular Endoscopy

Colorectal cancer (CRC) claims 10% of global cancer-related deaths annually, with rising incidence. Locally advanced rectal cancer (LARC) requires improved diagnostic techniques. This study focuses on dual-wavelength quantitative fluorescence molecular endoscopy (qFME) using PD-1/PD-L1-targeted tracers for LARC patients undergoing neoadjuvant treatment. Eighteen patients will receive nivolumab-800CW and durvalumab-680LT before qFME procedures, assessing programmed death-1/programmed death ligand-1 (PD-1/PD-L1) expression. We want to test the feasibility of qFME and ex vivo fluorescence imaging after intravenous administration of nivolumab-800CW, targeting PD-1, and durvalumab-680LT, targeting PD-L1, to visualize PD-L1 and PD-1 expression before and after CRT in LARC patients. If successful, this method can potentially be used in the future to see which patients most likely benefit from additional immunotherapy beforehand. The non-randomized, prospective phase 1 intervention explores biomarkers' role in treatment response prediction. Tracer administration poses minimal risks. Patients will not directly benefit, but the study aims to establish the utility of nivolumab-800CW and durvalumab-680LT in determining PD-1/PD-L1 expression during endoscopy.

- EligibilityCriteria: Inclusion Criteria: Diagnosed with LARC (cT3c-4, N1-2, M0); Written informed consent is obtained; (We aim to include only patients who consent to both study procedures, however if some patients (n<9) do not consent to the first or second procedure or withdraw their consent for the second procedure after the first procedure, they can still be included) Be at least 18 years old; Speak the Dutch language. Exclusion Criteria: Concurrent uncontrolled medical conditions according to treating medical physician; Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause); Prior irradical endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of the primary tumor. Received an investigational drug within 30 days prior to administration of nivolumab-800CW and durvalumab-680LT according to the patient's medical history; History of infusion reactions to nivolumab, durvalumab or other monoclonal antibodies according to the patient's medical history; Active episode of inflammatory bowel disease; Use of immunosuppressive agents; Medical or psychiatric conditions that compromise the patient's ability to give informed consent according to treating medical physician. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304584

Recruiting

Cross-sectoral Rehabilitation of Older High-risk Patients With Hip Fracture

The goal of this observational study is to learn about and monitor the cross-sectoral rehabilitation process in older high-risk patients treated for at fragility fracture of the hip. The main questions aim to answer: how patients are doing up to one year after hip fracture surgery on different outcomes across the continuum of rehabilitation being offered what expectations, experiences and satisfaction patients have for the overall rehabilitation process after a hip fracture Participants age 65 and above with home address in Frederiksberg municipality, living in own home, admitted and treated for at hip fracture at Department of Orthopedic Surgery, Bispebjerg Hospital, will be asked for participation.

- EligibilityCriteria: Inclusion Criteria: Undergone surgery for hip fracture and admitted to department M1, Bispebjerg-Frederiksberg Hospital Living in Frederiksberg municipality and being admitted from own home, or a 24 hour temporary setting in the municipality Exclusion Criteria: Living permanent in nursing home or is on the way to a permanent nursing home from a 24-hour setting. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult - StudyPopulation: Patients will be recruited from Bispebjerg Hospital, department M1 - SamplingMethod: Probability Sample

NCT06304571

Recruiting

A Study of HC006 in Subjects With Advanced Solid Tumors

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.

- EligibilityCriteria: Inclusion Criteria: Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(dose escalation only requires at least one assessable lesion) Agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts. Life expectancy ≥12 weeks Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Have adequate organ function as described in the protocol. Agree to adopt effective contraceptive measures. Exclusion Criteria: Prior exposure to CCR8 inhibitor or hypersensitivity to any ingredient of the study drug. Treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug. Use of any live attenuated vaccines within 28 days. With primary central nervous system (CNS) tumors or unstable CNS metastases. Have active or history of autoimmune disease or immunodeficiency disease. With active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. With any mental or cognitive impairment that may limit their understanding, implementation. Major surgery within 4 weeks of study drug administration. Have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion. Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0. History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma. Women who are pregnant or breastfeeding. Other protocol defined exclusion criteria may apply. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304558

Not yet recruiting

"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.

The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants. As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.

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

NCT06304545

Not yet recruiting

Treatment of Rectal Cancer With Long-term Concurrent Chemoradiotherapy Combined With Camrelizumab

This is a single-arm, phase II clinical study aim to evaluate the efficacy and safety of long-term concurrent chemoradiotherapy combined with camrelizumab as a neoadjuvant therapy in the treatment of locally advanced/low rectal cancer requiring anus preservation.

- EligibilityCriteria: Inclusion Criteria: Age: 18 to 75 years old, male or female, Histologically or cytologically confirmed rectal cancer with measurable tumour lesions (Spiral CT or MR scans ≥ 10 mm, meeting RECIST 1.1 criteria), Clinical stage: Rectal cancer cT3-4N0M0 or cT1-4N+M0 and low rectal cancer with need for anal preservation (<5 cm from anal verge; T2N0M0), Expected survival > 3 months, ECOG PS score: 0-1, No peritoneal metastasis or other distant metastasis; Note: the presence of distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT should be performed or laparoscopy should be performed. If brain metastases are suspected, CT or MR should be performed, No previous radiotherapy or immune checkpoint inhibitor treatment for rectal cancer, Function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors during screening): 1)Absolute neutrophil count ≥ 1.5 x 10^9/L; platelets ≥ 80 x 10^9/L; hemoglobin ≥ 8.5 g/dL, 2)Thyroid-stimulating hormone (TSH) ≤1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time; if T3 and T4 levels are normal, they can be enrolled), 3)Bilirubin ≤1.5 times ULN; ALT and AST ≤2.5 times ULN, 4) Serum creatinine ≤1.5 times ULN, 9. Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men who are sexually active with women of childbearing potential must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose, 10. Subjects voluntarily enrolled in the study and signed an informed consent form. Exclusion Criteria: Previous pelvic or abdominal radiotherapy, Tumours that are expected to be unresectable after neoadjuvant therapy, Pregnant or lactating women, or those of childbearing potential who refuse to use contraception, History of other malignancies within the past 5 years, except adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or basal cell carcinoma of the skin that has been substantially controlled, Ineffectively controlled, symptomatic brain metastases or a history of psychosis that cannot be easily controlled or severe intellectual or cognitive dysfunction, Pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis and severely impaired lung function, Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment, Congestive heart failure, difficult-to-control cardiac arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient is chaemic attack, severe hypertension difficult to control with medication, or other patients who cannot tolerate the procedure, Severe active infections requiring intravenous antibiotic treatment occurring during the screening period, Allergy to the test drug, Have received or will receive a live vaccine within 30 days prior to camrelizumab administration, Known history of HIV infection or active hepatitis B or C, Patients who are unable to comply with the trial protocol or are unable to cooperate with follow-up visits, Those who in the opinion of the investigator are not suitable for participation in this trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304519

Recruiting

Identifying the Optimal Dynamic Ankle-Foot Orthosis Bending Stiffness for Individuals Post-Stroke

Ankle braces are commonly prescribed to individuals who have suffered a stroke to help their ankle joints work properly, which allows these individuals to walk better. Currently, there are no standardized guidelines to follow when choosing which brace is best for an individual. Prior work has shown that customizing the level of assistance that these braces provide based on each individual's level of ankle impairment improves the individuals' walking function more than their current brace. The next important step is to fine-tune the customization and work to develop a set of guidelines that can be used by clinicians to help them prescribe the right brace for each patient's needs. The purpose of this study is to test different levels of assistance provided by the brace to determine the optimal customization method. Additionally, this study aims to begin to create a guide to help clinicians choose the best brace for each individuals' needs. To accomplish this goal, individuals will walk with a brace under five different assistance level conditions. The individual's walking function, performance on clinical measures, and response to questionnaires will be examined to determine both the optimal brace for each individual and hopefully identify clinical tools that can be used to guide prescription of the brace. This study is a major step towards developing effective, standardized prescription guidelines that optimize walking of individuals post-stroke.

- EligibilityCriteria: Inclusion Criteria: chronic stroke (> 6 months post-stroke) been prescribed an AFO by a clinician have plantar flexor strength deficits (unable to complete at least 25 standing heel-raises have at least 5 degrees of passive dorsiflexion range of motion (as measured during the clinical evaluation in Visit 1). Exclusion Criteria: Those that will not be included in this study are individuals with 1) Evidence of cerebellar stroke on clinical MRI, 2) Other neurologic conditions in addition to stroke, 3) Sensorimotor neglect, 4) Inability to walk outside the home prior to the stroke, 5) Total joint replacement or orthopedic problems in the lower limbs or spine that limit walking, 6) Coronary artery bypass graft or myocardial infarction within past 3 months, 7) Unexplained dizziness in last 6 months, 8) Inability to communicate with investigators, 9) Lack of decisional capacity. - HealthyVolunteers: No - Gender: All - MinimumAge: 21 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06304506

Recruiting

Effect of Obesity on Extracellular Matrix Composition

The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix. The main questions to answer, - is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men

- EligibilityCriteria: Inclusion Criteria: Healthy men aged [18,35] and BMI [20,25] Obese men aged [18,35] and BMI [30,40] Healthy older men aged [60,75] and BMI [20,25] Exclusion Criteria: Present or former cardiovascular disease and chronical inflammatory disease Consumption of medications and supplements that influence substrate use at rest and/or during exercise - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304493

Not yet recruiting

REMINDers for Incentive Spirometry in PACU (REMIND-IS in PACU)

The purpose of this study is to determine if the frequency of use of incentive spirometry during the stay in the Post-Anesthesia Care Unit (PACU) increases with visual and auditory electronic reminders, as compared to not having those reminders.

- EligibilityCriteria: Inclusion Criteria: be 18 years or older; have undergone a surgical procedure at the University of Colorado Hospital under general anesthesia; have incentive spirometry ordered by their provider, or incentive spirometry must be part of the study site's standard-of-care which is implemented by hospital staff; not have severe hearing or impaired visual acuity deficiency, in that they cannot hear or see the audible and visual signal of the InSee monitor. Exclusion Criteria: have a severe hearing or visual acuity impairment that prevents them from hearing or seeing the audible and visual signals of the InSee monitor; have the inability to perform incentive spirometry due to refusal, cognitive impairment, neuromuscular weakness, anatomical or any other reasons (e.g., tracheotomy, oral surgery, unable to hold incentive spirometry device); are a part of a vulnerable population (e.g., pregnant, minors, prisoners). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult

NCT06304480

Not yet recruiting

Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome

There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods. As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens.

- EligibilityCriteria: Inclusion Criteria: Be able to give written informed consent. Be between 18-55 years of age. Has a BMI between >18.5 and <32.0 kg/m2. Has a stable body weight (≤5 % change) over the past 3-months. Is in general good health, as determined by the investigator. Consuming a single daily portion of red/processed meat in their Western diet as assessed by Food Frequency Questionnaire (meat items) at screening. Willing to avoid lifestyle fluctuations (diet, exercise) for the duration of the study. Exclusion Criteria: Participants who are pregnant or wish to become pregnant during the study. Participants who are lactating and/or currently breastfeeding. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception. Is hypersensitive to any of the components of the Study Product. Participants who have taken oral antibiotics 12 weeks prior to visit 1. Have a significant acute or chronic coexisting illness such as uncontrolled hypertension, uncontrolled hyperlipidaemia, hypercoagulation, inflammatory disorders, or any condition which contraindicates, in the investigator's judgement, entry to the study. Metabolic or chronic diseases (including pre-diabetes and diabetes), metabolic syndrome, obesity (Class 2), uncontrolled high blood pressure or chronic inflammation or any ongoing medical condition that interferes significantly with absorption and digestion and/or gastrointestinal (GI) function. Participants has acute or chronic gastrointestinal and/or infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, etc.), or with a history of such diseases or gastrointestinal surgery (appendectomy in the last 3 months acceptable). Has a malignant disease or any concomitant end-stage organ disease, and are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, or chemotherapy or radiotherapy which, in the Investigator's judgment, contraindicates participation in the study. Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); alcohol/substance abuse disorder). Is a smoker/vaper/consumes or uses nicotine containing products. Taking medications/supplements that the investigator believes would interfere with the objectives of the study. Prohibited medications include: Metformin Proton pump inhibitors Protein supplements Creatinine supplements Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 60 days prior to this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06304467

Not yet recruiting

CM for Patients With ALD After Liver Transplant

Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use. The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility.

- EligibilityCriteria: Inclusion Criteria: Subjects 18 years of age or older Have received a liver transplant Has documented return to drinking (subjective or objective) within the past 30 days. Willing to partake in behavioral treatment for AUD. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Current treatment for another substance use disorder Unwilling to partake in behavioral treatment for AUD Unwilling to provide written informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult

NCT06304441

Recruiting

Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone for Leptomeningeal Metastasis From Epidermal Growth Factor Receptor Mutation-Positive Non-Small-cell Lung Cancer

Intrathecal chemotherapy is one of the mainstay treatment options for leptomeningeal metastases. Pemetrexed is one of the first-line chemotherapeutic agents for non-squamous non-small cell lung cancer (NSCLC). Since 2017, intrathecal pemetrexed has shown good efficacy for patients with leptomeningeal metastases from NSCLC. It has been recommended as the preferred drug for intrathecal chemotherapy by the Chinese Society of Clinical Oncology (CSCO) guidelines. Tyrosine kinase inhibitors (TKIs) play a promising role in the treatment of non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutations. Due to its small molecule properties, it can effectively penetrate the central nervous system barrier and deliver an effective antitumor effect. An international multi-center clinical study published in 2019 confirmed that double-dose of osimertinib showed significant improvement in leptomeningeal metastases from NSCLC with EGFR exon 19 deletion or exon 21 L858R/T790M mutation. It makes TKIs the mainstay of treatment for patients with EGFR-mutant NSCLC with leptomeningeal metastases. However, whether third-generation small molecule TKI drugs (e.g. 'osimertinib') combined with intrathecal pemetrexed could benefit patients with LM from EGFR- mutant NSCLC remains undetermined.

- EligibilityCriteria: Inclusion Criteria: Male or female aged between 18 and 75 years. Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations (L858R or Exon19Del). Confirmed diagnosis of leptomeningeal metastasis according to ESMO/EANO guidelines. Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3. No history of severe nervous system disease. No severe dyscrasia. Exclusion Criteria: Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11. Any evidence of extensive and lethal progressive systemic diseases without effective treatment. Patients with poor compliance or other reasons that were unsuitable for this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304428

Not yet recruiting

Prevention of Injury in Skilled Nursing Facilities Through Optimizing Medications

The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: Which of the three models is more effective in preventing falls with fractures? What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.

- EligibilityCriteria: Inclusion Criteria: Aged 65 years or greater. Admitted to an enrolled SNF after hospitalized fracture. Exclusion Criteria: Non-osteoporotic fracture (e.g. facial, digital, skull, at site of tumor or infection, or due to hardware placement). Receiving hospice or palliative care at the time of screening - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06304415

Not yet recruiting

Elevated Lipoprotein(a) in Hospital Staff

The objective of this study is to investigate the prevalence of elevated Lp(a) in the working general population.

- EligibilityCriteria: Inclusion Criteria: Any hospital staff aged 21 and above. Family members of index cases of high elevated lipoprotein(a) can also participate in this study Exclusion Criteria: - Inability to provide informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Working general population - SamplingMethod: Non-Probability Sample

NCT06304402

Not yet recruiting

Comparing Shoulder Stretching and Percussive Massage on Shoulder Rotation and Attack Speed in Female Volleyball Players

This study aims to investigate the acute effects of PNF modified sleeper stretches and percussive massage treatment on shoulder rotation movements and attack speed in female volleyball players and compare these applications.

- EligibilityCriteria: Inclusion Criteria: Being a volleyball player Age between 14 and 40 years Exclusion Criteria: Presence of shoulder pain History of fracture and surgery in the shoulder girdle Presence of systemic musculoskeletal disease Presence of glenohumeral instability (Positive apprehension, relocation, or subluxation test) Pain in the cervical region with upper extremity movements Experiencing shoulder problems requiring medical treatment within the last year - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 14 Years - MaximumAge: 40 Years - StdAgeList: Child, Adult

NCT06304389

Recruiting

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.

- EligibilityCriteria: Inclusion Criteria: Patients: VNS implanted since at least 3 months age >18-60 years; IQ >55 on Wechsler scale (normal status or mild cognitive impairment) healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease) Exclusion criteria: Patients: other medical implanted devices than VNS, ocular diseases Helthy participants: medical implanted devices, cerebral trauma, ocular disease - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06304363

Not yet recruiting

Braining - Evaluation of Acute Effects of Physical Exercise

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period. The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.

- EligibilityCriteria: Inclusion Criteria: Included in the retrospective study Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety and has given informed consent to participation in a Braining booster session. Exclusion Criteria: Severe psychiatric disorder such as mania and psychosis Medical conditions such as heart- and lung diseases where PE is contraindicated. Unable to understand written and spoken Swedish language. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304350

Recruiting

A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

- EligibilityCriteria: Inclusion Criteria: Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage); Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma; Age range from 18 to 75 years old; There are no surgical contraindications in the preoperative evaluation of various organ functions; The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value; Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years; Expected to achieve R0 resection; Physical state ECOG 0-1; The subjects must understand and sign the informed consent form Exclusion Criteria: Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.); Not suitable for surgery or with surgical contraindications; Have a history of other anti PD-L1/PD-1 treatments; Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug; Individuals with active autoimmune diseases requiring systemic treatment within 2 years; Patients with poor control of heart disease Pregnant or lactating female patients; For patients with drug allergies in the protocol. Exit criteria： Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment: The main indicators are missing, and more than half of the items that can be filled in CRF are missing; The surgical procedure violates the plan; Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics; According to the researcher's opinion, continuing to participate in the study will be harmful to their health; Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported together; Missing subjects. All subjects who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival analysis and toxicity evaluation for the corresponding group. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304337

Not yet recruiting

Application of New Oropharyngeal Airway Management in Patients Undergoing Painless Gastroenteroscopy

The objective of this study was to investigate the application of new oropharyngeal airway management in patients undergoing painless gastroenteroscopy.To see if it can really solve the problem of airway obstruction during anesthesia.The incidence of hypoxia (Spo2<90%, t>10s) and severe hypoxia (Spo2<85%) during anesthesia and sedation, as well as the incidence of cough and laryngeal spasm, as well as the dose, endoscopist satisfaction, and the incidence of various adverse events were observed.To accumulate clinical experience and reference of anesthesia in obese patients.

- EligibilityCriteria: Inclusion Criteria:Voluntary acceptance;Asa1-2 level;Age 18-95y;Mallampati grades Ⅰ or Ⅱ Exclusion Criteria: Patients with blood clotting disorders or a tendency to oropharyngeal bleeding, mucosal damage or space occupation, difficulty in placing oropharyngeal airway, etc., who cannot perform oropharyngeal airway ventilation; Severe cardiac insufficiency (<4mets); Patients with severe renal insufficiency (requiring dialysis before surgery); Diagnosed severe liver insufficiency; Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute or chronic lung diseases, requiring long-term or intermittent oxygen therapy; Increased intracranial pressure; Upper respiratory tract infections such as mouth, nose or throat; Fever (core body temperature >37.5 degrees Celsius); a confirmed diagnosis of pregnancy or breastfeeding; Allergic to sedatives such as propofol or equipment such as tape; Emergency surgery; Multiple trauma; SpO2 < 95% in preoperative breathing air; - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 95 Years - StdAgeList: Adult, Older Adult

NCT06304324

Not yet recruiting

Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

- EligibilityCriteria: Inclusion Criteria: children scheduled for foot/ankle surgery body weight > 5kg Exclusion Criteria: infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06304298

Not yet recruiting

NLR and PLR Levels Following iPACK Block in Knee Arthroplasty

Effect of iPACK block on NLR and PLR following knee arthroplasty

- EligibilityCriteria: Inclusion Criteria: Patients with ASA classification I-III Aged 20-90 years Who will be scheduled for hip arthroplasty under spinal anesthesia Exclusion Criteria: Patients who have a history of bleeding diathesis Take anticoagulant therapy History of chronic pain before surgery Multiple trauma patients unable to assess their pain (dementia) patients operated under general anesthesia patients having an infection in region of the procedure patient who do not accept the procedure - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06304285

Recruiting

A Study Assessing the Effects of Acupuncture in Parkinson's Disease Patients With Chronic Appendicitis

The incidence of PD is high, and when the disease is serious to a certain extent, the effect of drugs to control symptoms decreases, resulting in a significant reduction in the quality of life of patients. Recent studies have found that these PD symptoms are closely related to the intestine. For several cases of PD syndrome patients complicated with chronic appendicitis, our research group conducted acupuncture on points related to constipation and chronic appendicitis, and found that constipation and related motor symptoms of patients could be significantly improved. Clinical studies have shown that acupuncture also has a certain therapeutic effect on non-motor symptoms of Parkinson's disease, such as anxiety and depression, decreased olfactory function, sleep disorders, constipation, early skeletal muscle pain, cognitive dysfunction, etc., which can delay the progression of the disease and improve the quality of life of patients. Starting from intestinal acupuncture, this project further clarified the role of acupuncture treatment in the comprehensive treatment of PD

- EligibilityCriteria: Inclusion Criteria: Patients presenting with bradykinesia, combined with resting tremor and/or myotonia. Appendix CT suggested chronic appendicitis evaluated by two experienced experts. All subjects and their guardians give informed consent to the content of this study and sign informed consent. Normal coagulation function. If the patient had taken oral anti-PD drugs, it had been stable for at least 2 weeks at enrollment. Exclusion Criteria: Treatment with dopamine blockers or dopamine depleters in doses and time courses consistent with drug-induced parkinsonism. Neuroimaging examination of presynaptic dopaminergic system function was normal. Patients who had suffered severe brain trauma or underwent complex craniotomy within 5 years prior to enrollment. Cognitive disorders that are not on the Parkinson's spectrum, such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease, have been diagnosed. People diagnosed with severe neuropsychiatric disorders (epilepsy, bipolar disorder, major depressive episode, etc.) according to DSM-V. Complicated with serious systemic diseases, disorders of consciousness, stroke, serious coronary heart disease, diabetes, liver and kidney diseases, and serious visual and hearing disorders. Patients with severe organic or functional dysphagia;Those who were deemed by the researcher to be unable to complete the visit and auxiliary examination as required by the study protocol. - HealthyVolunteers: No - Gender: All - GenderBased: Yes - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult