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NCT06299410

Not yet recruiting

PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects

The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor in healthy subjects. Subjects will enroll in one of the 2 cohorts, will have a baseline PET/CT scan, will receive a single dose of ITI-1284, and undergo one postdose PET/CT scan.

- EligibilityCriteria: Inclusion Criteria: Healthy male and female subjects between 18 and 50 years old (inclusive); BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg; Willingness to remain in the hospital research unit for the duration of the inpatient period. Exclusion Criteria: Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy; Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or pulse rate > 100 bpm or < 45 bpm at Screening; History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study; Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners); Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET/CT scan. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06299384

Not yet recruiting

The Use of Voice-Based AI in 988 Crisis Counseling

Effective training requires repeated opportunities for skills practice with performance-based feedback, which is challenging to provide at scale. This research study focuses on developing an AI-based, coding and feedback tool ("LyssnCrisis") for implementation in a nationally utilized crisis call center, training counselors (call-takers) in suicide risk assessment skills, and evaluating LyssnCrisis to improve services and client outcomes. Our goal is to maximize the human capacity of call-takers to help assess their callers for risk of suicidality, and thus, a core aspect of the current research is developing a novel training process that supports human call-taker capacities.

- EligibilityCriteria: Inclusion Criteria: Must be employed at Protocall Services, Inc. Exclusion Criteria: Call-takers who participated in Stage 2 research will not be able to participate in Stage 3 research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299371

Not yet recruiting

Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations

This is a prospective, single-arm study to investigate the efficacy and safety of Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring driver gene mutations

- EligibilityCriteria: Inclusion Criteria: Male or female aged ≥18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. Resectable non-small cell lung cancer harboring driver gene mutations. At least one measurable disease based on Response Evaluation Criteria in Solid Tumors 1.1. Have adequate organ function. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication；Females should not be breastfeeding；Female subjects of childbearing potential as well as males sexually active with women of childbearing potential must be willing to use an adequate method of contraception. Voluntarily comply with the treatment protocol. Exclusion Criteria: Previously treated with any anti-tumor therapy; Subject with known autoimmune disease Subject with known history of testing positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known active hepatitis B or C. Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites). Subject with severe liver and kidney dysfunction. Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapy for systematic treatment within 14 days before the first administration of the study Subject with previous malignancies within 5 years, except for cured in situ cancer. Subject with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to lung function. Subject with uncontrolled hypertension. Prior organ transplantation including allogenic stem-cell transplantation. Known hypersensitivity to the study drug or any of its excipients. Other situations that the investigator considers unsuitable for the enrollment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299332

Recruiting

Safety and Efficacy of Bi-Polar Radiofrequency for the Treatment of Erectile Dysfunction

The goal of this prospective pilot study is to learn about the Safety and Efficacy of Radiofrequency (RF) for the Treatment of Erectile Dysfunction. This research study is trying to determine if RF therapy is safe and effective in patients with symptoms of erectile dysfunction (ED).

- EligibilityCriteria: Inclusion Criteria: Adult male between ≥40 and ≤80 years of age Subjects with a history of self-reported erectile dysfunction lasting for over 6 months and not more than 5 years. The subject is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i The subject has been in a stable heterosexual relationship for over 3 months prior to enrollment. A minimum of 4 sexual attempts during the last two weeks prior to enrollment. Abstinence from taking PDE5 for two weeks (washout) after enrolment and 2 weeks before each follow up visit/call. IIEF-EF score between 11 and 25. Testosterone level 300-1000 mg/dL within 1 month prior to the enrollment/baseline. A1C level ≤ 8.5% within 1 month prior to enrollemnt/baseline. Subject has at EHS score ≥ 1 (natural tumescence during sexual stimulation). The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and are willing to sign the Informed Consent Form If the FirmTech Ring is provided, the participants must be willing to use the ring according to the instructions. The subjects should be willing to comply with the study procedure and schedule, including follow up visits. Agreement/ability to abstain from erectile dysfunction medications or any device treatments for the duration of the study, i.e., the time between the treatment visit and the final study visit. Exclusion Criteria: Evidence of co-existing Neurological disease or other systemic disease conditions such as Alzheimer or Parkinson disease which affects erectile function (at the discretion of the investigator) History of radical prostatectomy or extensive pelvic surgery ever Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator. Anatomical malformation of the penis, including Peyronie's disease. Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment. Diabetes type I Diabetes Type II with A1C level > 8.5% within 1 month prior to enrollment. Unwillingness to abstain from systemic medications known to cause ED for the study duration. Internal defibrillator, pacemaker or any other implanted electrical device anywhere in the body Permanent metal implant in the treatment area Any surgery in the treatment area in the last 3 months Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles in the facial area Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes and rash. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin Severe concurrent conditions, such as cardiac disorders, sensory disturbances. Use of Isotretinoin (Accutane®) within 30 days prior to treatment. Participation in another study within 30 days prior to screening. - - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: 20 heterosexual males clinically diagnosed with Erectile Dysfunction - MinimumAge: 40 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299319

Not yet recruiting

Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms.

- EligibilityCriteria: Inclusion Criteria: Adults 18 to 65 years old; Are outpatients Must be deemed to have capacity to provide informed consent; Must sign and date the informed consent form; Stated willingness to comply with all study procedures; Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent; Primary The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of obsessive compulsive disorder (OCD) based on medical records and assessment using the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit; Participants diagnosed with treatment-resistant OCD defined as individuals with a score of ≥ 16 on the YBOCS (i.e. moderate symptom severity) and that have not responded to two or more separate pharmacological interventions and one or more trials of cognitive behavioural therapy (CBT); there is no upper limit on the number of treatment failures; Individuals with an estimated glomerular filtration rate (eGFR) above 40mL/min/1.73m2 and all blood work within normal limits as assessed by clinical laboratory tests at Screening (V1) Ability to take oral medication; Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation; Individuals who are willing to and have tapered off current OCD medications for a minimum of 2-weeks prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; Individuals who are willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so; and Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration. Exclusion Criteria: Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individuals that intend to become pregnant during the study or are breastfeeding; Treatment with another investigational drug or other intervention within 30 days of Screening (V1); Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1); Have a DSM-5 diagnosis of substance use disorder (use of tobacco and prescribed opioids are permitted) within the preceding 6 months; Have active suicidal ideation as determined by the C-SSRS and/or clinical interview. Significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS; Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview; Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant; Have contraindications to transcranial magnetic stimulation (TMS) as determined by the transcranial magnetic stimulation adult safety screen (TASS) questionnaire; Have a history of seizures; Are taking anticonvulsants or benzodiazepines (Lorazepam up to 2mg/day is acceptable); Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment; Use of classic psychedelic drugs within the previous 12 months; OR Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06299306

Not yet recruiting

REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma

This is a multi-center, single-country, single-arm, prospective, disease study to collect real world data of patients with severe uncontrolled asthma in Germany.

- EligibilityCriteria: Inclusion Criteria: ≥18 years of age at the time of consent Therapy within GINA/NVL steps 4 or 5 and uncontrolled disease in the previous 12 months as per the healthcare provider's assessment Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate Able to read, understand, and speak German sufficiently to complete all the questionnaires Exclusion Criteria: According to the assessment of the study physician: cognitive impairment, psychiatric diseases, severe hearing or vision impairment, insufficient knowledge of the German language, if these factors could influence the ability to provide written consent and correct completion and assessment of the questionnaires. Current participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 30 days. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 120 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population is composed of severe asthma patients within GINA/NVL (Global Initiative for Asthma/ Nationale Versorgungsleitlinie) steps 4 or 5 with uncontrolled disease (including patients on biologics but without any prescribed oral corticosteroids). - SamplingMethod: Non-Probability Sample

NCT06299280

Not yet recruiting

The Effect Of Dual-Task Training On Motor And Cognitive Performance In School-Age Children

The aim of the study is to investigate the effect of dual task training on performance in school-age children. Although studies on this subject in the world are limited, a comprehensive study on school-age children is needed. MATERIAL AND METHOD: Evaluation will begin by applying demographic information and the Physical Activity Survey for Children. The evaluations to be made will primarily evaluate the child's performance on a single cognitive task in a supported sitting position on a chair, without a motor task. To evaluate single motor performance, a 2-minute walk test and a 30-second sit-stand test will be applied. Dual task evaluations will be carried out by adding a cognitive task while applying the 2-minute walk and 30-second sit-to-stand test. Walking speed will be evaluated with the 10m walk test. Balance parameter will be evaluated with functional reaching test. Using the Visual Analog Scale (VAS), participating children will be asked to score the difficulty of cognitive and motor performance as a number between 0 and 10. Walking speeds will be normalized by measuring lower extremity lengths. The children will be randomly divided into two groups and the study group will be given dual-task training by creating dual-task situations during the activities carried out in physical education classes. After 4 weeks, appropriate analyzes will be made with the data obtained as a result of the evaluations performed by the same evaluator. As a result of this study, motor and cognitive performance in single-task conditions in typically developing children will be revealed. Additionally, changes in this performance will be detected in dual-task situations. The gains to be obtained as a result of the training will also reveal the importance of implementing dual task training in school-age children.

- EligibilityCriteria: Inclusion Criteria: Being between the ages of 7-15, Not having a chronic disease Volunteering to participate in the study and signing a consent form. Exclusion Criteria Experiencing a health problem that will affect the musculoskeletal system in the last year, Having a condition that prevents participation in physical education class. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 15 Years - StdAgeList: Child

NCT06299267

Not yet recruiting

The Effect of Dual Task on Manual Skill Performance in Children and Adolescents

The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18. MATERIAL AND METHOD: Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children. The evaluations will primarily evaluate the child's performance on a single cognitive task The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent. Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10. the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph. Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph. In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds. As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations.

- EligibilityCriteria: Inclusion Criteria: Be between the ages of 7-18, Not having a chronic disease. Exclusion Criteria: Participants must have had a health problem or had an operation that would affect the musculoskeletal system or dexterity performance in the last year (EX: Distal radius fracture). Having concentration problems such as attention deficit hyperactivity disorder (ADHD). Not volunteering to participate in the study and not signing a consent form. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06299254

Recruiting

Placebo Effect About Fatigue in Obesity

Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels.

- EligibilityCriteria: Inclusion criteria: • Right-handed diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30). Exclusion criteria: • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 50 Years - StdAgeList: Adult - StudyPopulation: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital - SamplingMethod: Non-Probability Sample

NCT06299228

Not yet recruiting

Is Sensorimotor Training Effective Following a Distal Radius Fracture?

The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist.

- EligibilityCriteria: Inclusion Criteria: Distal radius fracture with volar plate fixation Understand English 18 years or older Available to attend skilled occupational therapy visits a minimum of 1x per week. Exclusion Criteria: Prior surgery to the involved wrist/hand Cognitive impairment Distal radius fracture managed by casting or by another means of fixation - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299215

Not yet recruiting

Factors and Prognosis of Obstructive Pyelonephritis Patients

Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit. Most of the available data on this condition comes from small, retrospective, single-centre series. To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis. The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients.

- EligibilityCriteria: Inclusion Criteria: Patients over 18 years of age Hospitalized in intensive care for management of acute obstructive pyelonephritis Patients affiliated to a Social Security System Exclusion Criteria: Pregnancy Opposition to data use Persons under legal protection (curatorship, guardianship), legal safeguards - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients meeting the eligibility criteria over the period 2015-2022 will be included in the study. - SamplingMethod: Non-Probability Sample

NCT06299202

Not yet recruiting

Contrast-enhanced Spectral Mammography (CESM) Early Quantitative Evaluation of Tumoral Response and Pathologic Complete Response Prediction for Localized Breast Cancer Treated by Neoadjuvant Chemotherapy

Some types of localised breast cancer, including stage II and III, HER2 positive (Human Epidermal Growth Factor Receptor) or triple negative cancers are treated with primary or neoadjuvant chemotherapy prior to surgical treatment (mastectomy or conservative treatment). Follow-up with neoadjuvant or primary chemotherapy is usually done by breast Magnetic Resonance Imaging (MRI).Tumour response to treatment is assessed on morphological size criteria. Angiomammography (also called CESM : Contrast Enhanced Spectral Mammography) is an innovative and validated imaging technique consisting of dual energy mammography with injection of iodinated contrast medium; two images are generated, one comparable to a standard mammography and a second image highlighting the structures enhanced by the contrast medium. The characteristic neo angiogenesis of the tumour process thus allows good visualisation of the tumour compared to the underlying mammary gland. A classical morphological analysis is therefore possible thanks to standard mammographic acquisition coupled with a quantitative functional analysis linked to the study of enhancement. During angiomammography, several images are acquired in succession, starting with the cranio caudal view and ending with the profile view. On the same examination, these acquisitions are carried out at different injection times, making it possible to study the type of enhancement of a given area (Progressive/ Plateau/ Wash out). Angiomammography has several advantages over breast MRI in the follow-up of chemotherapy: shorter examination time, shorter appointment time, better tolerated by the patients and without injection of Gadolinium chelates, which have recently been shown to cause definitive brain deposits during repeated injections. Currently, angiomammography is validated in the follow-up of breast cancers treated with neoadjuvant or primary chemotherapy, with an analysis of tumour response currently only morphological, as in breast MRI. Here, the hypothesis is that the study of tumour enhancement by angiomammography may constitute a new predictive element of histological response: indeed, the performance of an initial angiomammography before treatment (baseline) and then a second angiomammography performed early in relation to the start of chemotherapy, could allow early prediction of which patients will have a complete histological response at the time of the closing surgery. This prospective study is to compare the variation in tumour enhancement, assessed on each of the two examinations using dedicated X-ray consoles, to the final histological result after closure surgery: it is hoped that the relative variation in tumour enhancement would be greater in responding patients.

- EligibilityCriteria: Inclusion Criteria: With a histological diagnosis of stage II or III localised breast cancer, with an indication for first or neoadjuvant chemotherapy validated by the RCP: HER2+, Triple negative Affiliated or beneficiary of a social security scheme or similar Having signed an informed consent for participation in the study. Exclusion Criteria: Patients considered to be at very high risk (BRCA 1 and 2 mutation, Li Fraumeni syndrome, Lynch syndrome, previous thoracic irradiation for lymphoma) and high genetic risk as determined by an oncogenetic consultation Pregnancy, breastfeeding Contraindication to the injection of iodinated contrast material: hypersensitivity to the active substance or to one of the excipients of the contrast material, renal insufficiency with glomerular filtration rate < 35ml/min Patients who do not master the French language Patient who is an adult protected by law, under curatorship or guardianship Patient who has participated in another research study with a current exclusion period - HealthyVolunteers: No - Gender: Female - MinimumAge: 35 Years - StdAgeList: Adult, Older Adult

NCT06299189

Recruiting

A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care

The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on: i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.

- EligibilityCriteria: Inclusion criteria: | Age ≥18 A self-reported diagnosis of ADHD Access to and ability to use a computer, smartphone and the Internet. Speaks, writes and reads Norwegian Exclusion criteria: In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis. Ongoing psychological treatment for ADHD or other psychiatric illnesses. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299176

Not yet recruiting

Whole Heart Radiotherapy for End-stage Heart Failure

End-stage heart failure (ESHF) causes recurrent hospitalizations, cardiac arrhythmias, and intolerance to standard HF therapies are common as the disease progresses. Management focuses on controlling symptoms, correcting precipitants, avoiding triggers, and improving quality-of-life. The combination of recent preclinical and clinical data suggests that localized cardiac RT is relatively safe and has positive conductive and anti-proliferative effects in the "sick" heart. In this Phase 1 study, the investigators aim to assess the feasibility and safety of 5 Gy whole heart radiotherapy in six (6) ESHF participants with limited options for further medical therapy to control their disease. The investigators hypothesize that 5 Gy whole heart radiotherapy can improve LVEF and decrease blood markers of heart failure and inflammation including B-type natriuretic peptide (BNP), C-reactive protein (CRP), and troponins, while also having a very tolerable side effect profile.

- EligibilityCriteria: Inclusion Criteria: at least 65 years of age End-stage heart failure NYHA class 3-4, LVEF ≤ 30% on maximum medical therapy with progressive symptoms/disease as defined by their primary cardiologist Exclusion Criteria: previous RT in the treatment field that precludes further RT active connective tissue disease interstitial pulmonary fibrosis Participants who are unable to be positioned in a manner where treatment can be safely delivered - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06299163

Recruiting

NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.

- EligibilityCriteria: Inclusion Criteria: Patients with histologically confirmed, advanced-stage protocol-specified solid tumors. Confirmed ROR1 tumor expression. Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy. Exclusion Criteria: Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy. Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668. Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299150

Not yet recruiting

Clinical Evaluation of Three Different Techniques Restoring Ellis Class II Traumatized Central Incisors In Children

Dental trauma (DT) of the incisors and their supporting tissues, which is one of the most challenging dental emergency situations, requires immediate assessment and management due to psychological and physical reasons. (8) This is especially important for young permanent teeth because of continuing development in order to minimize undesired complications. The treatment of dental trauma is sometimes neglected. (9,10) although it might lead to pain, difficulty in articulation and mastication as well as having considerable negative effects on patient's self-esteem. (11) However, aesthetics of the anterior teeth are very important aspects of human appearance and could be affected by many factors including the presence of fillings, tooth color, position, alignment, shape and number. (12) Rasmussen ST et al. discovered in 1981 that most children suffer from tooth trauma. (13) According to their research, 25% of all schoolchildren and 33% of adults have undergone trauma, with the majority of cases occurring before the age of 19. (14) As the maxillary incisors are the most commonly injured teeth due to their exposed position, a functional, aesthetic and time-efficient restoration is frequently demanded.(15) According to the current International Association of Dental Traumatology guidelines, crown fractures confined to enamel and dentine may be treated either with a direct composite restoration or with an adhesive reattachment of the fractured fragment.(16) As long as the fragment is intact, reattachment is often preferred in dental practice. This technique facilitates the restoration of the tooth with its original anatomy, color and function in a minimum amount of time. (17,18) Unfortunately, clinical studies regarding the survival of reattached fragments are scarce, and results from laboratory investigations cannot be transferred to clinical settings without limitations. (19) Furthermore, longevity data of direct composite restorations in fractured anterior teeth are restricted to a few clinical studies. (20, 21) In addition to the aforementioned restorative alternatives, the use of small partial glassy restorations-partial laminate veneers (PLVs), sectional veneers, or ceramic fragments-has become increasingly popular over the last few years. (22,23) PLVs are thin pieces of glass-matrix ceramic fragments without a defined shape that are used to restore small defects in the anterior teeth. As tooth preparation is not required for this type of restoration, as for conventional laminate veneers, and minimal to no prep is accepted, the maximum amount of enamel surface structure is conserved. (24) Thus, retention relies completely on adhesion, which is primarily achieved by bonding to the conditioned glassy surface. (25,26) Despite their growing popularity, available data in the literature on PLVs are limited to a few in vitro studies (27,28) and case reports (29, 30, 31), without any clinical information available at present. Patients in all groups will receive a minimally invasive restoration with high esthetic advantages and long-term success of their fractured incisors (either conventional composite restoration, fragment reattachment or partial laminate veneers) that require minimal to no preparation depends on the type of restoration will receive and doesn't require local anesthesia.

- EligibilityCriteria: Inclusion Criteria: 8-18 years old Ellis Class II traumatized central incisors Controlled dental disease - no active caries or periodontal diseases Patients will be available to be clinically reviewed up to 1 year Exclusion Criteria: All Ellis Classification traumatized central incisors except Ellis Class II Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing). Poor oral hygiene and motivation. Patients with parafunctional habits (e.g., bruxism, biting on hard objects). Patients with debilitating illnesses or complicating medical conditions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 8 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06299137

Not yet recruiting

Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures

The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are: Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours. Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours. Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures.

- EligibilityCriteria: Inclusion Criteria: Radiology confirmed anterior or lateral rib fractures either on X-ray or chest computed tomography CT pain score of 5/10. Patients must be able to verbalize how much pain they are having on an 11-point Numeric Rating Pain Scale perform an incentive spirometry and be able to cough on command Exclusion Criteria: isolated rib fractures that do not include ribs T3-T9 penetrating trauma, pregnancy requiring immediate surgical or procedural intervention known allergy to amide-type local anesthetics have a painful distracting injury - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299124

Recruiting

A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors

This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.

- EligibilityCriteria: Inclusion Criteria: Male or female ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred. Estimated life expectancy of at least 12 weeks Exclusion Criteria: Presence of visceral metastases with severe organ dysfunction Known active hepatitis B or C infection Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299111

Not yet recruiting

A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement. The study is looking at several other research questions, including: What side effects may happen from taking the study drug How much study drug is in your blood at different times Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

- EligibilityCriteria: Key Inclusion Criteria: PICC is anticipated to remain in place for at least 14 days Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol Body weight ≥50 kg and ≤130 kg during the screening period International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period Platelet count ≥100 x 10^9/L during the screening period as described in the protocol Key Exclusion Criteria: Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant History of prior venous thrombosis in the arm in which the PICC is to be placed History of known thromboembolic disease or thrombophilia Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (eg. Hemophilia A or B, von Willebrand's disease) Note: Other protocol defined inclusion/exclusion criteria apply - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06299098

Not yet recruiting

A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss and Fat Loss

This study is researching experimental drugs called trevogrumab and garetosmab (called "study drugs") in combination with another drug, semaglutide (Wegovy®). Part A of the study, the sponsor is only researching trevogrumab. Part B of the study the sponsor is researching trevogrumab, garetosmab, and Wegovy either alone or in different combinations with each other. Part A of the study is focused on healthy participants. Part B of the study is focused on participants with obesity. The aim of Part A of the study is to see how safe and tolerable the study drug is in healthy participants. The aim of Part B of the study is to see how safe and effective the study drug is when combined with Wegovy. Parts A and B of the study are looking at several other research questions, including: What side effects may happen from taking the study drug How much study drug is in the blood at different times Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

- EligibilityCriteria: Key Inclusion Criteria Part A Male or female participants age ≥18 to ≤55 years of age at the time of screening BMI ≥18 and ≤32 kg/m2, at the screening visit Part B Male or female participants ≥18 to ≤80 years of age at the time of screening BMI ≥30 kg/m2 History of 1 or more self-reported unsuccessful dietary attempts to lose weight Key Exclusion Criteria History of diabetes (Type 2 or Type 1). History of gestational diabetes is permitted Previous bariatric surgery or planned bariatric surgery History of hypertrophic cardiomyopathy Abnormal electrocardiogram (ECG) findings at screening that meet Cornell voltage criteria for left ventricular hypertrophy Any malignancy in the past 5 years prior to screening (except for nonmelanoma skin cancer that has been resected with no evidence of metastatic disease for 3 years prior to screening) History of poorly controlled hypertension, as defined in the protocol Have a history of any other condition (such as known drug abuse, alcohol abuse, diagnosed eating disorder, or a severe mental illness) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol Have history of use of marijuana/tetrahydrocannabinol (THC) within 3 months of enrollment and are unwilling to abstain from marijuana/THC use during the trial Note: Other protocol-defined Inclusion/ Exclusion Criteria apply - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299085

Not yet recruiting

Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.

By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 and ≤ 60 years. BMI (Body Mass Index: expressed as weight ratio in kg/height in m2) ≥ 35 kg/m2 with comorbidities or BMI ≥ 40 Kg/m2 without comorbidities. Absence of diagnosis of primary obesity. Absence of medical-psychiatric contraindications. Previous diet therapy and/or pharmacological history verified. Signing of the informed consent for the study. Patients who are clinical candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass). Exclusion Criteria: Presence of chronic diseases of the digestive system, such as chronic intestinal diseases, malabsorption syndrome, diverticulosis of the colon. Current pregnancy and/or breastfeeding via self-declaration. Subjects suffering from endocrine pathologies (e.g. Cushing's disease, uncontrolled thyroid disease). Presence of known renal insufficiency or creatinine levels above 1.8 mg/dl and eGFR < 60 ml/min. Presence of chronic liver disease or ALT and AST levels above two standard deviations from normal levels. Presence of malignant pathology. Alcohol or drug abuse. Previous bariatric surgery. Severe psychological-psychiatric disorders. Difficulty adhering to the protocol due to language barriers or other reasons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06299059

Not yet recruiting

Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients

The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

- EligibilityCriteria: Inclusion Criteria: age ≥ 18 years; meeting the diagnostic criteria of stroke; any degree of dysphagia at admission; steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment. transferred out within three weeks of hospitalization in the neurology department. Exclusion Criteria: complicated with other neurological diseases; damaged mucosa or incomplete structure in nasopharynx; tracheostomy tube plugged; unfeasible to the support of parenteral nutrition; simultaneously suffering from liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06299033

Recruiting

A Safety and Tolerability Study of Human Forebrain Neural Progenitor Cells Injection (hNPC01) in Subjects With Chronic Ischemic Stroke

The principal aims of the clinical investigation involve assessing the safety profile and MTD of human forebrain neural progenitor cells (hNPC01) administered at escalated doses via single-dose intracerebral injection to subjects with stable chronic ischemic stroke.

- EligibilityCriteria: Inclusion Criteria: Subject or his/her legal guardian must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedure being conducted; Age 30-65 years old, male or female; at the time of signing the ICF; Female patients with negative blood pregnancy test and women in the reproductive period need to adopt effective contraceptive methods; Or has become infertile (menopausal for at least 2 years or has undergone hysterectomy, oophorectomy, or sterilization surgery); Male patients who have no plans to donate sperm or have children within 30 days before the trial and six months after the trial end need to adopt effective contraceptive methods; Documented history of completed ischemic stroke in the subcortical and/or cortical regions of the middle cerebral artery (MCA) or lenticulostriate arteries confirmed by head CT or magnetic resonance imaging; 6 - 60 months since the acute onset of ischemic stroke, accompanied by unilateral limb motor dysfunction, with/without aphasia; Modified Rankin Score 3, or 4 points at time of screening; FMMS scores lower than 55 and score changes no greater than 5 points in two assessments at least 3 weeks apart before surgery; NIHSS score change is no greater than 4 points in two assessments at least 3 weeks apart before surgery; Subject must have maintained regular physical therapy and rehabilitation prior to enrollment and be able to continue physical therapy and rehabilitation after treatment. Exclusion Criteria: Has any psychological or psychiatric condition that would significantly interfere with the study; History of more than one symptomatic stroke [transient ischemic attacks (TIAs) are not exclusionary]; Has signs and symptoms of intracerebral hernia or elevated intracerebral pressure; History of epilepsy or current use of antiepileptic drugs, including any seizures in the 3 months prior to screening; Intracerebral aneurysm or arteriovenous malformation; hemorrhagic transformation of ischemic loci within 2 weeks of screening; moyamoya disease (MMD); autosomal dominant cerebrovascular disease with subcortical infarction and leukoencephalopathy; patients with giant cerebral infarction (MRI confirms that the infarct size is greater than 150 cm^3); CT angiography (CTA) shows severe stenosis in vital vessels in head or neck; Patients with severely impaired motor function of one limb caused by previous neurological diseases (such as PD, motor neuron disease, arthritis, or anatomical deformity, etc.); Patients who have undergone any major surgery 8 weeks prior to screening; Severe muscular atrophy or muscular dystrophy; Patients with severe cardiovascular diseases within 3 months of screening, such as malignant arrhythmia, atrial fibrillation, acute myocardial infarction, congestive heart failure, etc. (cardiac function grade III-IV using the New York Heart Association (NYHA) classification for heart failure); Patients participating in other drug or device clinical trials within the last 3 months or 5 half-lives of the drug, whichever is longer; Receiving other cell transfusions or alike other than transfusion in the past 5 years; Any of the following diseases or conditions: Severe coagulopathy, preoperative INR (International Normalized Ratio)>1.4; Patients with positive HLA (Human Leukocyte Antigen) before surgery; Severe active infection with poor drug control before surgery; Severe dermatitis or severe skin damage in the operation area; History of tumors other than benign tumors; history of brain tumors, including meningiomas; Laboratory values meeting any of the following criteria (a second retest can be performed for patients with a first test result outside the specified range, and the patients can be included in the study if the second test results are evaluated by the investigator as normal): Hemoglobin <90 g/L White blood cell count (WBC)<3.5×10^9/L Neutrophil count <1.5×10^9/L Platelet count <100×10^9/L Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) 2 times the upper limit of normal (ULN) Serum creatinine >1.2 × ULN Uncontrolled or poorly controlled hypertension despite medicine (systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg) or hypotension requiring pressor therapy; Uncontrolled or poorly controlled diabetes despite medicine (glycosylated hemoglobin A1c > 8%); Active gastrointestinal bleeding; Positive active pulmonary tuberculosis (if positive γ-interferon release test in screening period and the safety risk is within a controllable range after evaluation by the investigators, the participant can be enrolled); Active hepatitis B patients, including positive Hepatitis B surface antigens (HBsAg), and patients who had hepatitis B virus (HBV) infection in the past and whose HBV infection has disappeared (defined as hepatitis B core antibody [HBcAb] positive and HBsAg negative) meet the inclusion criteria; Hepatitis C virus antibody positive; Syphilis infected subjects (subjects who test positive for Treponema pallidum serology need to undergo further non-Treponema pallidum serology tests. If the test result is negative, the investigators determine that patients who have previously been infected with syphilis but have recovered meet the inclusion criteria); HIV antibody positive Primary or secondary immunodeficiency; or any medical condition involving immunosuppressants intake; Persistent MRI artifacts, no clear MRI images can be obtained before or after surgery; patients with contraindications to MRI or PET scans; Contraindications to cyclosporine or methylprednisone sodium succinate or prednisone; Neither able or willing to participate in physical and/or professional therapy as scheduled, nor to return to the hospital on time for follow-up visits as planned; Inability to discontinue antiplatelet or anticoagulant medications within the perioperative period; Existence of recent drug abuse or alcohol abuse or any other medical conditions that, in the opinion of the investigator, could interfere with the clinical study results or compromise the clinical condition of the subject, or which in the opinion of the investigator, could increase procedural complications. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06299020

Not yet recruiting

Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency

In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).

- EligibilityCriteria: Inclusion Criteria: Primary adrenal insufficiency Disease duration of at least one year Substituted with hydrocortisone and fludrocortisone Wishing to fast during the month of Ramadan 2024 Exclusion Criteria: Diabetes mellitus Renal insufficiency Hepatic insufficiency Cardiac insufficiency Respiratory insufficiency Use of hypoglycaemic agents Use of diuretics Use of glucocorticoids other than those prescribed for replacement Poor control of the disease (asthenia, malaise, melanoderma, discontinuation of treatment, etc.) Pregnancy Breast-feeding. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298994

Not yet recruiting

Determination of Body Awareness and the Functional Movement in Patients With COPD

The aim of this study is to investigate body awareness and functional movement in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to healthy controls.

- EligibilityCriteria: Inclusion Criteria for Chronic Obstructive Pulmonary Disease Group Being under 55 years old To be literate, Having volunteered to participate in the research, Stage 1-2-3-4 according to the Classification of Airflow Limitation in COPD (GOLD) system, Being clinically stable for the last 2 weeks. Exclusion Criteria for Chronic Obstructive Pulmonary Disease Group Having history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery, Communication problems, Having a severe psychiatric disorder. Inclusion Criteria for Healthy Control Group Not having any cardiopulmonary system disease or chronic systemic disease, To be literate, Being under 55 years old Be willing to participate in the study. Not having balance problems, musculoskeletal, neurological and psychiatric disorders that could prevent performing the test procedures. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult - StudyPopulation: Patients with COPD and aged matched healthy controls will be included in this study. - SamplingMethod: Non-Probability Sample

NCT06298981

Recruiting

Pulse Rate and Breathing Rate Accuracy

The purpose of this study is to conduct a Breathing Rate and Pulse Rate accuracy validation comparing the NuraLogix AMC-SDK to the Reference devices, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and a standard ECG (GE Datex-Ohmeda) derived heart rate reference. This will be done by manually scoring the collected waveform for data analysis.

- EligibilityCriteria: Inclusion Criteria: Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate Participant must be 18 to 81 years of age (≥ 18 age to < 82) Participant must be willing and able to comply with study procedures and duration Participants or legally authorized representative must be able to read or write in English Exclusion Criteria: Participants who refuse or are unable to provide to sign an informed written consent for study Participants evaluated by the Investigator and Clinical Staff and found to be medically - unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.) Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self- reported) Other known health condition, should be considered upon disclosure in health assessment form - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 81 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute inclusion of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, and Obesity). An attempt will be made to enroll a variety of skin tones. - SamplingMethod: Non-Probability Sample

NCT06298968

Recruiting

Combined Therapy Using Gemcitabine and Cisplatin Chemotherapy, Lenvatinib and Adebrelimab for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma

In this phase 2 study, the investigators aim to evaluate the efficacy and safety of combined therapy using gemcitabine and cisplatin chemotherapy, Lenvatinib and Adebrelimab for patients with advanced and unresectable intrahepatic cholangiocarcinoma

- EligibilityCriteria: Inclusion Criteria: The patient must be required to sign an informed consent form; Age 18-75 years old, male or female; Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1; Child-Pugh score A; Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions; Advanced and unresectable ICC patients; The expected survival is longer than 12 weeks; At least 1 measurable liver lesion or non-liver lesion (according to RECIST 1.1); Functional indicators of vital organs meet the following requirements a Neutrophils ≥1.5*109/L; platelets≥100*109/L; hemoglobin≥9g/dl; serum albumin≥3g/dl; b Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal value(ULN), T3, T4 are in the normal range; c bilirubin ≤ 2 times ULN; Alanine aminotransferase （ALT） and Aspartate aminotransferase （AST） ≤ 2 times ULN; serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60ml / min; Non-lactating or pregnant women, contraception during or after 3 months of treatment. Exclusion Criteria: Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer and other non-cholangiocarcinoma malignant tumor components; Patients who have received previous treatment with PD1 antibody, programmed death ligand -1 （PD-L1） antibody or cytotoxic T lymphocyte-associated antigen-4 （CTLA4） antibody; With other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active; Have an active, known or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled; Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy; Long-term systemic hormones (dose equivalent to >10 mg prednisone/day) or any other form of immunosuppressive therapy are required. Subjects using inhaled or topical corticosteroids may be enrolled; Severe cardiopulmonary and renal dysfunction; Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg); Abnormal blood coagulation (PT>14s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; Hepatitis B virus （HBV） DNA>2000 copies/ml, hepatitis C virus （HCV） RNA>1000; Significant clinically significant bleeding symptoms or a clear tendency to appear within 6 months prior to enrollment; Active infections requiring systemic treatment; Human immunodeficiency virus (HIV) positive; History of psychotropic substance abuse, alcohol abuse or drug abuse; Has a history of allergy to platinum; Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06298955

Recruiting

Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria

The purpose of this study is to assess the long-term safety and tolerability of repeat-dose OMS906 5 mg/kg IV administration at 8-week intervals in patients with PNH.

- EligibilityCriteria: Inclusion Criteria: Have completed the last dosing visit of the prior OMS906 PNH study. Female patients of child bearing potential must have a negative result from a highly sensitive urine pregnancy test prior to each dose of OMS906. Females must use highly effective birth control to prevent pregnancy during the clinical trial and for 20 weeks following their last dose of study drug. Males must use highly effective birth control with a female partner to prevent pregnancy during the clinical trial and for 20 weeks after last dose of study drug. Have current vaccination status for Neisseria meningitidis, Streptococcus pneumonia and Hemophilus influenza and agree to maintain vaccination throughout the study. Have provided informed consent Exclusion Criteria: Platelet count <30,000/µL or absolute neutrophil count <500 cells/µL at the start of the Evaluation Period. Elevation of liver function tests, defined as total bilirubin > 2 x ULN, direct bilirubin > 1.5 x ULN, and elevated transaminases (alanine or aspartate aminotransferase), > 2 X ULN unless due to PNH-related hemolysis. History of any severe hypersensitivity reactions to other monoclonal antibodies or excipients included in the OMS906 preparation. Patients with unresolved serious infections caused by encapsulated bacteria including H. influenzae, S. pneumoniae and N. meningitidis. Pregnant, planning to become pregnant, or nursing female patients. History of any significant medical, neurologic, or psychiatric disorder that in the opinion of the investigator would make the patient unsuitable for participation in the long-term extension. Unable or unwilling to comply with the requirements of the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult

NCT06298942

Not yet recruiting

Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

- EligibilityCriteria: Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study Exclusion Criteria: patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 65 patient with previous upper abdominal surgery either for obesity or other diseases revisional bariatric procedures - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298929

Recruiting

Medial Rectus Fenestration vs Recession for PAET

This prospective comparative study aims to compare medial rectus (MR) muscle fenestration and recession in patients with partially accommodative esotropia (PAET). The main question it aims to answer is whether MR fenestration is equally effective as MR recession for PAET. All patients will receive complete ophthalmic and orthoptic assessment. Patients will be randomly allocated using a random table to one of two groups; Group 1 will receive conventional MR recession, and Group 2 will receive MR fenestration.

- EligibilityCriteria: Inclusion Criteria: patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is > 15PD. Exclusion Criteria: convergence excess esotropia. paralytic or restrictive strabismus. previous strabismus surgery neurologic, ocular, or developmental disorders or follow-up less than 6 months - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06298916

Not yet recruiting

64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

- EligibilityCriteria: Inclusion Criteria: Part 1 Patients are eligible to be included in the study only if all of the following criteria apply: Patient must be ≥ 18 years of age and must have provided written informed consent. Patients with suspected FAP-expressing metastatic sarcoma. Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma). Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation). Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug. Inclusion Criteria: Part 2 Patients must be ≥ 18 years of age and must have provided written informed consent. Patients must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging). Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation). Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug. Exclusion Criteria: Part 1 Patients are excluded from the study if any of the following criteria apply: Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation. Known pregnancy or breastfeeding. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention. They are participating as patients in another clinical study with an Investigational Product or another systemic therapy administered in the last 3 weeks. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking medications known to cause QT/QTc prolongation. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). Have history of QT prolongation or is taking a medication known to cause QT prolongation. Exclusion Criteria: Part 2 Patients who have received or are scheduled to receive neoadjuvant anti-cancer therapy. Evidence of metastatic or advanced, inoperable disease. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation. Known pregnancy or breastfeeding. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention. They are participating as patients in another clinical study with an Investigational Product or another systemic therapy administered in the last 3 weeks. Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, > 450 milliseconds) or taking medications known to cause QT/QTc prolongation. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) Have history of QT prolongation or is taking a medication known to cause QT prolongation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298903

Recruiting

Impact of Hip Activation Compared to Hip Plus Balance Training on the Forward-Step-Down Test

The purpose of this research is to determine the impact of a hip activation home exercise program (HEP) compared to a hip activation + single leg balance HEP on performance of the Forward-Step-Down Test (FSDT) in healthy females. Participants will be assigned to the control (hip activation HEP only) or experimental (hip activation + single leg balance HEP). Following the pre-test data collection, participants will complete their HEP for 8 weeks. They will return to the lab for post-test measurements.

- EligibilityCriteria: Inclusion Criteria: first or second year students at the institutions's School of Allied Health Professions healthy female Exclusion Criteria: participating in another research study current knee pain or pathology on the dominant leg known diagnosis of vestibular impairment known pregnancy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298890

Recruiting

The Pattern of Dry Eye Disease After Cataract Surgery

This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.

- EligibilityCriteria: Inclusion Criteria: Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon. Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others). Patients who previously did not undergo any ophthalmic surgery. Exclusion Criteria: Patient expressed his wish to not participate in the study or discontinue it when already enrolled. Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining. Glaucoma. Diabetes mellitus. Systemic connective tissue disease, autoimmune disease. Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction. Patients who underwent refractive surgery (LASIK or PRK). Contact lens users. One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement. Patients who are already regularly using topical drops or ointments. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Participation in this study is voluntary. Research participants will be recruited during a routine visit to an ophthalmologist at Lithuanian University of Health Sciences Hospital Kaunas Clinics, Ophthalmology Department. - SamplingMethod: Non-Probability Sample

NCT06298877

Not yet recruiting

Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer

Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma. Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment. In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are >75 years. Despite these circumstances guidelines on patient-selection are lacking. Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality. The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment.

- EligibilityCriteria: Inclusion Criteria: Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent Age ≥18 years Signed written informed consent Exclusion Criteria: Not able to understand the Swedish or English language Other diagnosis than ovarian cancer on final pathology - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298864

Not yet recruiting

Internet-based Behavioral Intervention Following ACS

The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention.

- EligibilityCriteria: Inclusion Criteria: ACS ≥ 6 months before assessment (type 1 MI STEMI/NSTEMI or unstable angina [UA]) Age 18 and older Clinically significant cardiac anxiety that leads to distress and/or interferes with daily life (Cardiac Anxiety Questionnaire; CAQ: ≥18 Able to read and write in Swedish Exclusion Criteria: Heart failure New York heart Association class IV or ejection fraction ≤ 30% Significant valvular disease Planned coronary artery bypass surgery or percutaneous interventions Any medical restriction to physical exercise Severe medical illness or an acute health threatening disease (e.g., cancer) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic) Severe mental illness requiring urgent psychiatric hospitalization or intervention, or risk of suicide Alcohol or substance use disorder that would impede ability to complete study protocol Ongoing psychological treatment - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298851

Not yet recruiting

Comparative Effects of Lower Body Quadrant Neural Mobilization and Stretching in Collegiate Football Players

Neural mobilizations (NM) are defined as interventions that aim to directly or indirectly affect neural structures or surrounding tissue through manual techniques or exercise. Neural mobilizations have been studied in both patients and healthy populations. In the study, individuals in the amateur football team will be divided into three groups and will be given pre-training warm-up periods, including neural mobilization, dynamic and static stretching.After the warm-up period, its effect on flexibility and performance will be examined and compared.

- EligibilityCriteria: Inclusion Criteria: Between the ages of 18-25 Not having had a lower or upper extremity injury in the last 3 months Not having had surgery in the last 6 months Playing amateur football regularly for at least 1 year Exclusion Criteria: Orthopedic, neurological, rheumatological or cardiorespiratory health problems that would prevent them from performing the tests - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 25 Years - StdAgeList: Adult

NCT06298838

Not yet recruiting

High-resolution Intra-operative PSMA PET-CT in Prostate Cancer

This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) . The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.

- EligibilityCriteria: Inclusion Criteria: Male patient, 18 years of age or older. Patient is confirmed with high risk prostate cancer. Patient is indicated to undergo radical prostatectomy and ePLND. Patient is estimated compliant for study participation by the investigator. Patient has freely given his/her informed consent to participate in this study. Exclusion Criteria: Patient has general or local contra-indications for radical prostatectomy. Patient has active viral or fungal infection. Patient previously received radiotherapy of the prostate. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) according to the European Association of Urology (EAU) guidelines. - SamplingMethod: Probability Sample

NCT06298825

Not yet recruiting

S-ADHF：Sarcopenia in Patients With ADHF

This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue. At least two of the signs of heart failure (HF): Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure. Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion). Peripheral edema. Elevated B-type natriuretic peptide (>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (>300 pg/ml). Willingness to provide informed consent and cooperate with the follow-up Exclusion Criteria: Unable to understand and comply with protocol or to give informed consent End-stage diseases other than heart failure, life expectancy <1 year, such as malignant tumors Current or planned participation in a clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minmum of of 195 cases each for patients with and without sarcopenia - SamplingMethod: Non-Probability Sample

NCT06298812

Not yet recruiting

REFLECT Scoliosis System Post Approval Study

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECT™ Scoliosis Correction System, as a condition of HDE approval

- EligibilityCriteria: Inclusion Criteria: Diagnosis of progressive idiopathic scoliosis Preoperative major Cobb angle 30°-65° Preoperative flexibility to ≤30° on side bending radiograph (left or right) Skeletally immature at the time of surgery with Risser sign <5 or Sanders score <8 Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging Failed or intolerant to bracing Signed informed consent and/or assent forms specific to this study Exclusion Criteria: Prior spinal surgery at the level(s) to be treated Documented poor bone quality, defined as a T-score of -1.5 or less Presence of any systemic infection, local infection, or skin compromise at the surgical site Any medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06298799

Recruiting

GENETIC VARIABILITY TO GLP1 TREATMENT

The goal of this retrospective study is to assess whether a selection of genetic variants may allow us to identify individuals who will have a satisfactory response after GLP-1 treatment in terms of weight loss, sugar level reduction, and adverse events. Participants will The study consists of a single visit at the diabetes unit clinic at the involved study sites. The following will be performed for every subject at the study screening enrollment visit: Informed consent Study eligibility (Inclusion / Exclusion criteria) Collection of demographic data (age (date of birth), gender, ethnic origin) General and T2DM medical history review (per subject file) Concomitant medication review (at enrollment) Physical attributes (Body Weight, Height, BMI) Allocation to study cohort and study subgroup Saliva and blood collection for genetic tests Self-reported questionnaire for Ozempic (Semaglutide) experience

- EligibilityCriteria: Inclusion Criteria: Diagnosed with type 2 diabetes (for participant in Cohort A) or Obese (for participant in Cohort B) and treated with Ozempic (Semaglutide) S.C. injection for at least 24 weeks. Subject is male/female between 18 to 80 years old (both inclusive) at the time of enrollment. Subject BMI above 30 kg/m2 at treatment initiation. Subject does not belong to any vulnerable population, is willing and able to provide written informed consent prior to any study procedure. Participant understands the nature of the procedure and is willing and able to comply with all requirement of the protocol. Exclusion Criteria: Subject falls under contraindications to Ozempic (Semaglutide) label Subject known or suspected for hypersensitivity to any GLP-1RA or related products, or allergic constitution Subjects suffers from any other condition affecting body weight. Subject with history of chronic or acute pancreatitis Subject have a history of a major cardiovascular and/or cerebrovascular disease within the 6 months before screening. Presence or history of malignant neoplasm within 5 years prior to screening day. Subject suffers from any renal impairment (Cr > 2 mg/dl). Subject suffers from any impaired hepatic function (ALT, AST or GGT 2-fold higher than normal upper limit). Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol. Subject is a female who is pregnant, breastfeeding or intends to become pregnant or is of child bearing potential without medically acceptable methods of contraception. Participation in another clinical study in prior 4 weeks. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06298786

Not yet recruiting

Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).

Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice. The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.

- EligibilityCriteria: Inclusion Criteria: Women and men of legal age With or without TMDs symptoms and With or without self-reported jaw fatigue when eating Exclusion Criteria: Subjects treated with any type of treatment requiring infiltration of the mandibular region Participants undergoing dental interventions in the last 3 months Individuals missing two or more teeth in the same quadrant. Inability to understand or speak catalan, spanish or english. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Residents from the Central region of Catalonia, and patients from the Hospital Sagrat Cor of Barcelona. - SamplingMethod: Non-Probability Sample

NCT06298773

Not yet recruiting

Spatial Profile of Tumors

The research project focuses on analyzing the spatial organization of cells within various solid tumors, utilizing advanced technologies enabling in-depth multi-parametric analysis of tumor and immune cells. The primary objective is to understand the spatial distribution of cellular subpopulations within each type of tumor, while secondary objectives include correlating these data with clinical aspects and identifying potential therapeutic targets. The study involves 1000 patients with primary or metastatic tumors and spans a duration of 5 years, from 2024 to 2028. No experimental treatments are planned; rather, only spatial imaging analyses with multiple markers will be conducted. Data analysis involves descriptive statistical methods and hypothesis testing to generate hypotheses for subsequent studies. The analyses will be performed using SPSS® version 21.0 software for Windows®.

- EligibilityCriteria: Inclusion Criteria: male or female subjects aged 18 years primary or metastatic tumors Diagnosed by histology and/or radiological evidence, RNM, or endoscopic signature of informed consent substitute declaration to the consent form where applicable Exclusion Criteria: previous unrelated tumour disease significant acute or chronic infections (HIV, HCV and HBV infections) and/or ongoing bacterial and viral infections active autoimmune disease pregnant or breastfeeding patients who do not sign informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will be 1000 adult male and female patients with primary or metastatic neoplastic pathology of the following types of cancer: lung cancer, colon cancer, salivary gland cancer, hepatocarcinoma, sarcomas, osteosarcomas, breast cancer, glioblastoma, kidney cancer, pancreatic cancer, neck cancer. The patient samples that will be examined in the study are derived from biopsies that patients have been subjected to according to their treatment plan. - SamplingMethod: Probability Sample

NCT06298734

Not yet recruiting

Exercise and Diet Interventions During Immunotherapy in Melanoma Patients

The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy. The names of the groups in this research study are: High-Intensity Exercise (EX) High-fiber Diet (DT) Combined High-Intensity Exercise and High-Fiber Diet (COMB) Attention Control (AC)

- EligibilityCriteria: Inclusion Criteria: Age ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included. Histologically diagnosed with advanced melanoma. Having been or newly receiving immune checkpoint inhibitor, including anti-PD1, antiCTLA4, and/or anti-LAG3 monoclonal antibodies, with palliative intent for at least one month with a plan to continue immunotherapy for at least 8 weeks (i.e., study intervention period) at the time of recruitment. Not receiving other concurrent tumor-directed systemic treatment (e.g., chemotherapy or targeted therapy). Medically cleared to participate in high-intensity exercise and high-fiber diet by their treating oncologist. Not having medical conditions that could exacerbate with exercise, such as bone disease at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases (e.g., uncontrolled hypertension or diabetes). Currently not meeting the physical activity guideline (i.e., more than 150 minutes per week of moderate-to-vigorous intensity, regular, structured aerobic exercise) over the past month at the time of recruitment. Currently not meeting the daily dietary fiber intake guideline (i.e., 30 grams/day) over the past month at the time of recruitment. Ability to communicate and complete written forms in English. Ability to understand and the willingness to sign informed consent prior to any study- related procedures. Willing to travel to DFCI for necessary data collection. Exclusion Criteria: Receiving other concurrent systemic treatment for advanced melanoma such as chemotherapy or targeted therapy. This study is to exclusively target patients receiving immune checkpoint inhibitors where other treatments may impact the study outcomes of intervention efficacies and feasibilities. Participating in more than 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention outcomes. Consuming more than 25 and 38 grams of dietary fiber per day for women and men, respectively over the past month. This study targets persons who insufficiently take dietary fiber to assess the effect of the described dietary intervention, where additional dietary fiber intake will contaminate the intervention outcomes. Having unstable comorbidities or medical conditions that prevent participation in high intensity exercise or high-fiber diet interventions. Patients with unstable medical conditions may develop unexpected adverse events from exercise and dietary changes. For the purpose of patients' safety, patients with unstable medical conditions are excluded. Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. Development of second malignancy (except for basal cell carcinoma or squamous cell carcinoma of the skin) that requires concurrent treatment, which would interfere with this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298721

Not yet recruiting

Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes

This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).

- EligibilityCriteria: Inclusion Criteria: Adult subject (Age >18 and < 80 years of age) The subject is proficient in the English language The patient is voluntarily prepared to sign the 'Informed Consent Form' The patient is scheduled for a unilateral primary TKA TKA PROMs Phenotypes with higher risk of dissatisfaction Patient is willing and able to complete the protocol required follow-up Exclusion Criteria: Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart Patients undergoing revision TKA Inflammatory arthritis History of infection in the joint undergoing TKA Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06298708

Not yet recruiting

Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents

Hepatitis A virus (HAV) vaccine is an effective strategy to prevent natural HAV infection. In Thailand, there are 2 types of HAV vaccine available, including inactivated HAV vaccine and live-attenuated HAV vaccine. This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years.

- EligibilityCriteria: Inclusion Criteria: Age between 18 months and 18 years Has healthy status Has no history of hepatitis A infection or previous hepatitis A disease Has never received hepatitis A vaccine (from vaccine booklet or parental history) Participants and/or caregivers gives written inform consent/assent form Exclusion Criteria: Has acute illness within 4 weeks before enrollment Has fever with jaundice within 4 weeks before enrollment Has underlying disease of thrombocytopenia, coagulopathy, hemophilia A or B, neurologic disease, immunocompromised condition, chronic liver disease, chronic hepatitis B or C infection Has received immunosuppressive agents or immunomodulatory agents, corticosteroid >2 mg/kg/day or 20 mg/day within 6 months before enrollment Has received blood or blood component, or intravenous immunoglobulin within 6 months before enrollment Has received any lived-attenuated vaccine within 30 days before enrollment Has history of severe allergy to vaccine or vaccine component, including aluminum hydroxide, 2-phenoxyethanol, neomycin, formaldehyde, gentamicin sulfate, or has history of anaphylaxis or severe allergic reactions following vaccination Women planning for pregnancy, pregnant women or lactating women Women in childbearing age who cannot use contraceptive methods during study participation Is concurrently involved in other clinical trials in which receiving an investigational vaccine or study drug as part of study participation Have any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06298695

Not yet recruiting

Schema Therapy for Treatment-resistant Anxiety Disorders

The aim of this study is to assess the cost-effectiveness of schema therapy compared to treatment as usual (TAU) in patients with treatment-resistant anxiety disorders. In a multicenter randomized controlled trial, patients will be assigned to receive individual schema therapy (maximum of 40 sessions) or treatment as usual (control group) within one year. The primary outcome is the difference between ST and TAU conditions in anxiety symptoms as measured with the Beck Anxiety Inventroy (BAI) at post treatment. Secondary outcomes include quality of life, societal costs, general mental health, remission from the anxiety disorders and/or comorbid affective disorders, positive and negative effects of psychotherapy, schemas and schema modes, and satisfaction. Measurements take place at baseline and after 1, 3, 6, 12, 24 and 36 months (follow-up of two years).

- EligibilityCriteria: Inclusion Criteria: Primary diagnosis of an anxiety disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder and specific phobia) based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Fulfilling the criteria of treatment-resistance based on a systematic literature search by Bokma and collegues: i) at least one unsuccessful CBT treatment of ≥ 8 weeks; and ii) at least one unsuccessful pharmacological treatment with a serotonergic antidepressant of ≥ 8 weeks, and iii) moderate to severe anxiety symptoms (BAI > 11). The adequacy of previous treatment will be checked. Exclusion Criteria: Substance use dependence Acute suicidality Has received schema therapy in the past Has insufficient language skills in Dutch and/or English - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298682

Recruiting

Characterization of Exosomes Platelets-released

Extracellular vesicles (EVs) play a key role in cell-to-cell communication. They are small vesicles that contain rich molecular cargo. Recently, they have been proposed as biomarkers for clinical diagnostics. EVs include three classes: small EVs (exosomes), large EVs (microparticles), and apoptotic bodies. Platelet-derived EVs (PEVs) are the most abundant class in human blood and can actively participate in numerous physiological and pathological processes. The information about the role of platelet exosomes in cardiovascular disease and the effect of antiplatelet agents on their release and content is very limited.

- EligibilityCriteria: Inclusion Criteria: subjects without known pathologies Exclusion Criteria: individuals with gastrointestinal diseases, individuals with history of hepatic diseases, individuals with history of urogenital diseases, individuals with history of hematological diseases, individuals with history of immunological diseases, individuals with history of renal diseases, individuals with history of metabolic diseases individuals with history of respiratory diseases individuals with history of cancer individuals with history of cardiovascular disease individuals having permanent organ damage individuals with major trauma in the last 6 months prior to enrollment individuals with surgery in the last 6 months prior to enrollment individuals taking medication in the 15 days prior to enrolment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: subjects without known pathologies - SamplingMethod: Probability Sample

NCT06298656

Not yet recruiting

Acute hemodynamiC Response To Carvedilol Predicts Survival in ACLF Patients

Clinically significant portal hypertension (CSPH) is defined as HVPG >10 mmHg. Patients with CSPH are at risk of developing esophageal varices and clinical decompensation (variceal bleeding, ascites, jaundice, encephalopathy), which mark the transition from compensated stage to a stage of the disease (decompensated) associated with higher mortality (1). HVPG is calculated by subtracting the free hepatic venous pressure (FHVP), a measure of systemic pressure, from the wedged hepatic venous pressure (WHVP), a measure of hepatic sinusoidal pressure. HVPG is surrogate marker in many clinical applications such as gold standard test to evaluate presence and severity of portal hypertension (PHT) diagnosis, risk stratification, monitoring of the patients on beta blockers (2). Non selective beta-blockers like propranolol and carvedilol are indicated in adults for primary and secondary prophylaxis of variceal hemorrhage. Acute hemodynamic response to intravenous propranolol with HVPG values coming down to <12 mm Hg or reduction to >20% from baseline have been shown to be associated with reduced long term risk of variceal bleed. Hence we are planning the current work to study the Acute hemodynamiC response To Carvedilol predicts survival in ACLF patients - "ACT - C ACLF study

- EligibilityCriteria: Inclusion Criteria: Age 18-70 yrs ACLF diagnosis (AARC criteria) Exclusion Criteria: Contraindications to NSBB (Heart rate < 65 /min, BP < 110/65 mm Hg, Asthma, Heart failure, AKI, Large ascites, SBP, S. Na < 125meq/l) PVT HCC BCS HE grades 2-4 NSBB therapy within 5 days Pregnancy Lactation Planned for LT in the next 12 weeks No consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients of age 18 to 70 years with ACLF fulfilling the conditions as per inclusion and exclusion criteria - SamplingMethod: Non-Probability Sample

NCT06298630

Not yet recruiting

Long-term Follow-up Study of BRL-101 for TDT

Observe long-term safety risk and long-term efficacy after intravenous infusion of BRL-101 in TDT subjects.

- EligibilityCriteria: Inclusion Criteria: Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s) Treated with BRL-101 for therapy of transfusion-dependent β-thalassemia. Exclusion Criteria: - There are no exclusion criteria for this study - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult - StudyPopulation: Subjects with transfusion-dependent β-thalassemia who have been treated with BRL-101. - SamplingMethod: Non-Probability Sample

NCT06298604

Recruiting

Motorized Fine Needle Biopsy vs Standard Needles

Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.

- EligibilityCriteria: Inclusion Criteria: Patients between 18 and 99 years Patients referred to our center who require EUS-guided liver or pancreas biopsy. Male or female patients. Patients able to give consent Exclusion Criteria: Pregnancy or nursing Patients with coagulation disorders (platelets <50.000/mm3, international normalised ratio (INR) >2) Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult

NCT06298591

Not yet recruiting

The Efficacy of Combination Therapy in Atrophic Scars

There are more than 100 million patients who develop scar formation caused by various factors, such as post-inflammatory acne and trauma (1). They often have physical, aesthetic, psychological, and social barriers. Scar tissue is naturally a stage of wound healing. Abnormal wound healing produces a spectrum of scar tissue types such as atrophic, hypertrophic, and keloid scars (2). Atrophic scars are dermal depressions, which are commonly caused by the destruction of collagen following inflammatory process. This permanent disfiguring sequelae correlates with the duration of pathology, severity of lesion, and delay in therapy (3). Treatment of atrophic acne scars remains a therapeutic challenge, yet there is no standard option as the most effective treatment (4). A range of possible options has been investigated including surgical techniques (subcision, non-ablative laser treatment, resurfacing techniques (ablative laser treatment, dermabrasion), and injection or dermal fillers or fat, and a combination of two or more modalities (5). Ultrasound is a unique non-invasive and non-radiating medical imaging tool in the investigation of dermatological diseases by providing detailed anatomic and physiologic data of skin lesions and deeper soft tissue changes. Lesion size in three dimensions-lengths, width, and depth, morphology, the detailed anatomic information provided by sonography is useful to assessment of effect of different types of treatment modality to improve atrophic scar and avoid invasive assessment tools as punch biopsy for histopathological examination (6)

- EligibilityCriteria: Inclusion Criteria: - Patients aged from 12 to 60 years with post inflammatory atrophic scar. post traumatic atrophic scar. post operative atrophic scar Exclusion Criteria: post acne scar. active skin infection. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 12 Years - MaximumAge: 70 Years - StdAgeList: Child, Adult, Older Adult

NCT06298578

Not yet recruiting

The Utility of Mobile Based Application for Patient Reported Outcome Measures In Patients With Acetabular Fractures : A Randomized Clinical Trial

The primary objective of this study is to validate the feasibility of a remote patient monitoring (RPM) system using Mobile App in terms of the frequency of data interruptions and patient acceptance. The secondary objective is to Improve quality of life and early prediction of the complications.

- EligibilityCriteria: Inclusion Criteria: All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital. Exclusion Criteria: Patients younger than 18years old - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All patients aged more than 18 years who will have a surgery for an acetabular fracture at assiut university hospital. - SamplingMethod: Probability Sample

NCT06298565

Not yet recruiting

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment Have provided appropriate written informed consent Exclusion Criteria: None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with gMG - SamplingMethod: Non-Probability Sample

NCT06298552

Not yet recruiting

A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod. Study will consist of: Screening Part A: participants will be randomized to receive either efgartigimod IV or placebo Part B: participants completing part A will receive open-label efgartigimod IV

- EligibilityCriteria: Inclusion Criteria: The participant is at least the local legal age of consent for clinical studies when signing the ICF. The participant is capable of providing signed informed consent and following with protocol requirements. The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the study drug. The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following: History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment Exclusion Criteria: Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk History of malignancy, cancer, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histological findings of prostate cancer Clinically significant active infection that is not sufficiently resolved in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and received at least 1 dose of the study drug Known hypersensitivity to study drug or one of its excipients (inactive ingredients) History of or current alcohol, drug, or medication abuse as assessed by the investigator Pregnant or lactating state or intention to become pregnant during the study Live or live-attenuated vaccine received <4 weeks before screening Worsening muscle weakness secondary to concurrent infections or medications Received a thymectomy less than 3 months before screening or thymectomy is planned during the study Use of some medications before screening (more information is found in the protocol). The complete list of exclusion criteria can be found in the protocol. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06298513

Recruiting

Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI

Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).

- EligibilityCriteria: Inclusion Criteria: recent first acute myocardial infarction Exclusion Criteria: severe diabetes - HealthyVolunteers: No - Gender: Male - MinimumAge: 25 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: All consecutive patients meeting the eligibility criteria will be proposed to participate in the study - SamplingMethod: Non-Probability Sample

NCT06298500

Not yet recruiting

Clinical Performance of HISTOACRYL® LAPFIX - CANNULA for Laparoscopic Inguinal Hernia Repair

The goal of this retrospective study is to identify the incidence of hernia recurrence following the application of Histoacryl® Lapfix - Cannula for laparoscopic mesh fixation in patients undergoing hernia repair surgery. All adult patients who underwent laparoscopic inguinal hernia repair with Histoacryl® Lapfix - Cannula in the period June 2018 - March 2021 at Hospital San Juan de Dios will be analysed. The investigator team will access electronical medical records for the cohort of patients identified.

- EligibilityCriteria: Inclusion Criteria: Adult patients (≥18 years old) treated between June 2018 and March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery. Exclusion Criteria: No exclusion criteria has been set. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients (≥18 years old) treated in the period June 2018 to March 2021 at the Hospital San Juan de Dios for laparoscopic mesh fixation with Histoacryl Lapfix - Cannula after inguinal hernia repair surgery. - SamplingMethod: Non-Probability Sample

NCT06298487

Not yet recruiting

Evaluation of the Impact of Therapeutic Education Workshops for COPD Patients in the North-West Val d'Oise Area

The aim of this study is to assess the impact of the Patient Therapeutic Education (PTE) workshops offered by the Maison de Prévention de la Santé et d'Accompagnement Thérapeutique (MPSAT) on the follow-up and feelings of the COPD patients who take part. These workshops are organised outside the hospital environment and supervised by hospital and town professionals in the NOVO zone.

- EligibilityCriteria: Inclusion Criteria : Patient aged 18 or over Patient living in the NOVO hospital area and the border towns of Yvelines, Oise and Eure Patient with a diagnosis of COPD confirmed by EFR, whatever the stage For PTE group : - Patient who has already attended at least 3 PTE workshops offered by MPSAT For Control group : - Patient on waiting list for PTE workshops offered by MPSAT Exclusion Criteria : Patient refusing to take part in study Patient under legal protection Patient with cognitive disorders, unstable clinical conditions, language barriers or other conditions that prevent them from understanding the study and answering the questionnaires - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298474

Not yet recruiting

The BRAIN App (Phase 2 SBIR)

There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050 (Rajan et al., 2021). There are about 46,000 long-term care (LTC) facilities in the U.S. (Harris-Kojetin et al, 2016). More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable themes (Woods, et al, 2012). While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials (Rai, et al, 2018). One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence. The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs.

- EligibilityCriteria: Inclusion Criteria: 65+ years old, dementia diagnosis (any type), and able to speak conversational English; Exclusion Criteria: completely unable to communicate verbally, serious visual or hearing impairments, and/or signs of rapid decline over the last three months (based upon staff report) - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06298461

Not yet recruiting

Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.

The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).

- EligibilityCriteria: Inclusion Criteria: Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy. Age > 18 years Out-patients Exclusion Criteria: Prior subtotal or total colorectal resection Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance. Colonoscopy being repeated because of poor preparation in the preceding six months. Allergies to the employed bowel preparations Toxic megacolon, ileus, suspected or diagnosed bowel obstruction. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients. Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298448

Recruiting

eGPA and Local Inflammation Within the Ear, Nose and Throat Area

Rationale: Eosinophilic Granulomatosis with Polyangiitis (eGPA), eosinophilic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are airway diseases where eosinophils and interleukine-5 are involved in the pathogenesis. eGPA differs from the other diseases with respect to involvement of other organs. The investigators hypothesize that nasal microbiome dysbiosis with a central augmenting role for S. Aureus plays an important role in disease expression. The investigators expect that anti-interleukin-5 treatment with mepolizumab restores the changes of the nasal microbiome and immune responses to a healthy control phenotype. To study this, the nasal microbiome, the local and systemic immune response and the effect of mepolizumab treatment will be assessed.

- EligibilityCriteria: Inclusion Criteria: 18 years of age able to give informed consent In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan In Severe asthma group: clinical diagnosis of asthma with forced expiratory volume at one second(FEV1) <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml) In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017) In GPA group: fulfilling the American College of Rheumatology (ACR)/EULAR GPA criteria (Robson et al., 2022) In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness Exclusion Criteria: unable to give informed consent Active smoking < (less than) 6 months from baseline visit Concomitant use of dupilumab within 6 months of baseline visit pregnant or breastfeeding woman in CRSwNP group: current use of asthma medication, eGPA in healthy controls: chronic use of local anti-inflammatory agents in healthy controls: use of immunosuppressive medication in healthy controls: use of antibiotics within the last month (before start study/screening/) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with eosinophil driven inflammation for which mepolizumab might be considered for treatment - SamplingMethod: Non-Probability Sample

NCT06298435

Not yet recruiting

Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements

• Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings. Main research question To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex. Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes.

- EligibilityCriteria: Inclusion criteria: Adult patients having undergone surgery under general anesthesia with Intermittent Positive Pressure Ventilation in the UMCG between 01-01-2018 and 01-04-2023. Exclusion criteria: age <18 years; no use ofIntermittent Positive Pressure Ventilation; not under general anesthesia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Inclusion criteria: Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023. • - SamplingMethod: Non-Probability Sample

NCT06298422

Recruiting

Oxygen Saturations Across Tones of Skin

Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis.

- EligibilityCriteria: Inclusion criteria: >18 years old Any gender Any ethnic background Admitted to UC San Diego La Jolla or Hillcrest campus ICU Mechanically ventilated Has a clinical ABG ordered by the critical care team responsible for clinical care Exclusion Criteria a. <18 years old b. Medical history of or acute diagnosis of sickle cell disease c. Normally protected individuals under 45 CFR 46 (pregnant individuals, prisoners, and children) - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Critically ill patients on mechanical ventilation. - SamplingMethod: Probability Sample

NCT06298409

Recruiting

Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®

We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)

- EligibilityCriteria: Inclusion Criteria: Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit. ASA Classification 1 or 2. For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Positive for at least one clinical symptom consistent with SIBO. Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria. Prescribed, but has not started, a two-week course of Rifaximin for SIBO. Exclusion Criteria: History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia. Actively taking a proton-pump-inhibitor medication within 30 days of enrollment Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: SIBO patients - SamplingMethod: Non-Probability Sample

NCT06298396

Not yet recruiting

Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

- EligibilityCriteria: Inclusion Criteria: Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422) At least three months after activation of the cochlear implant. Eighteen years or older at the time of consent. User of 900Hz ACE (Advanced Combination Encoder) strategy MAP. Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear. Fluent speaker in English. Willing and able to provide written informed consent. Exclusion Criteria: One or more electrodes turned off in the MAP used regularly. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298383

Not yet recruiting

The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain

Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.

- EligibilityCriteria: Inclusion Criteria: Patients with symptomatic irreversible pulpitis. Patients with active pain (moderate-to-severe) in mandibular molars. Males and females. Patient with the ability to understand and use pain scales. Patient who accepts to enroll to the study Exclusion Criteria: Patients' allergies or any other contraindication to any of the used medications or mepivacaine. Pregnant and lactating females. Patients have been taking pain medication 12 hours earlier. Patient has more than one symptomatic mandibular tooth in the same quadrant. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. Patients with contributory medical history (ASA>II). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298370

Recruiting

The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty

This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.

- EligibilityCriteria: Inclusion Criteria: Aged between 18 and 90 years American Society of Anesthesiologists (score ranging from 1 to 4) Anterior hip arthroplasties Exclusion Criteria: Patients with a history of opioid addiction Individuals under the age of 18 Those aged 90 and above Allergies to morphine, fentanyl, bupivacaine, or tramadol Coagulopathy Infection at the injection site Severe cardiac, renal, or hepatic dysfunction Cases unable to provide informed consent Body Mass Index >40 kg/m2 Known neurological or anatomical deficits in the lower extremities Patients requiring a transition from spinal anesthesia to general anesthesia - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06298357

Not yet recruiting

Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).

- EligibilityCriteria: Inclusion Criteria: >7 years of age medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant a caregiver who can assist the child with the study procedures Exclusion Criteria: complete blindness or deafness inability to operate the hand-held controllers susceptible to motion sickness in virtual reality inability to communicate in English - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - StdAgeList: Child, Adult, Older Adult

NCT06298344

Not yet recruiting

The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease

Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions.

- EligibilityCriteria: Inclusion Criteria: Patients aged 6 months - 18 years. Patients diagnosed with left to right shunt lesion CHD with heart failure based on ROSS or NYHA criteria. Patients who will undergo intervention with transcatheter closure. Exclusion Criteria: Patients who experienced acute infections before the procedure. There are other heart defects that require surgery. There is a hereditary, genetic disorder, syndrome or other chronic disease. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Months - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06298331

Not yet recruiting

Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation

The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial.

- EligibilityCriteria: Inclusion Criteria: Being between the ages of 18-65 Diagnosed with chronic constipation according to Rome IV criteria No new treatment for constipation in the last 3 months Absence of any condition that would prevent compliance with the interventions and assessments in the study Exclusion Criteria: Presence of secondary constipation ( uncontrolled metabolic disease (uncontrolled DM, hypothyroidism), hyperparathyroidism, neurologic disease or use of anticoagulants, anticholinergics, antihistamines, antipsychotics or opioids) In individuals over 50 years of age, the presence of alarm symptoms (new-onset constipation, rectal bleeding, involuntary weight loss, nausea and vomiting, fever and anemia) having BMI > 30 kg/m² having cancer diagnosis being pregnant or breastfeeding, being within the first year postnatally having irritable Bowel Syndrome, Hirschprung's Disease, Crohn's Disease, Inflammatory Bowel Disease, Megacolon diagnosis, Megarectum diagnosis, Rectocele and enterocele stage 3 and above presence of advanced systemic disease (e.g. cardiovascular, respiratory, renal or hepatic diseases) history of abdomino-pelvic or gastrointestinal surgery in the last 6 months presence of open wound, disruption of skin integrity, local tumor, cholestomy or abdominal hernia at the massage site Presence of orthopedic (e.g. lumbopelvic pain, advanced knee joint degeneration) and cardiovascular diseases (e.g. acute coronary syndrome, stage 3-4 heart valve diseases) that may prevent aerobic exercise training - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298318

Recruiting

Metabolic Changes in Healthy Subjects With Acute Binge Drink

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are: 1. if acute binge drink could alleviate liver injury and hepatic steatosis.

- EligibilityCriteria: Inclusion Criteria: Sign informed consent Exclusion criteria a. Neurological disorders b. Alcohol allergy c. Alcohol addiction d. Gastrointestinal diseases e. Liver, kidney, cardiovascular or systemic diseases f. Antibiotics were administered within 2 weeks prior to the trial g. Participants who ate a vegetarian diet h. Unable to use a smartphone or computer with Internet access i. Participate in another intervention study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06298292

Not yet recruiting

Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies

The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years.

- EligibilityCriteria: Inclusion Criteria: Diagnosis of Tyrosinaemia type I, II III or Alkaptonuria requiring a tyrosine- and phenylalanine-free protein substitute. Diagnosis of Homocystinuria requiring a methionine-free, cystine-enriched protein substitute. Diagnosis of MSUD requiring a valine-, leucine- and isoleucine-free protein substitute. Subjects who are already taking a protein substitute for one of the specified rare metabolic disorders and are willing to try the study product for 7 days. Children aged 7 years and over. Written informed consent obtained from parental caregiver. Exclusion Criteria: Presence of serious concurrent illness Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. Any children having taken antibiotics over the previous 2 weeks leading up to the study. Children less than 7 years of age. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: 15 children out of a patient pool with proven tyrosinaemia type I, II, III or alkaptonuria, homocystinuria, or MSUD will be recruited from two specialist metabolic centres. - SamplingMethod: Non-Probability Sample

NCT06298279

Not yet recruiting

Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel

This study is a randomized factorial trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet delivered cognitive behaviour therapy tailored for public safety personnel with tunneled of personalized course delivery and with or without the incorporation of social learning resources.

- EligibilityCriteria: Inclusion Criteria: At least 18 years of age Current or former public safety personnel (or public safety personnel trainee) Residing in Canada at time of enrollment Has regular access to the internet Confirms intent to participate in study Exclusion Criteria: Not 18 years of age or older Not a current or former public safety personnel (or public safety personnel trainee) Not residing in Canada at time of enrollment Does not have regular access to the internet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298266

Not yet recruiting

To Assess Safety, Tolerability, and Efficacy of Anti-GPRC5D-CD19-CAR-T in Relapsed/Refractory Multiple Myeloma

To evaluate the safety and tolerability of anti-GPRC5D-CD19 CAR-T cells infusion in subjects with relapsed and refractory multiple myeloma

- EligibilityCriteria: Inclusion Criteria: 1. The patient or their legal guardian understands and voluntarily signs the informed consent form and is expected to complete the follow-up examinations and treatments. 2. Age between 18-75 years, regardless of gender. 3. Diagnosed with multiple myeloma according to the IMWG diagnostic criteria, and GPRC5D expression in bone marrow is positive (>10%). 4. Has failed treatment with at least three different mechanisms of drugs (including chemotherapy, proteasome inhibitors, immune modulators, etc.), or has experienced disease progression or relapse within 6 months after the last treatment. 5. Measurable lesions are present based on any of the following criteria during screening: (1) Serum monoclonal immunoglobulin (M-protein) level ≥1.0 g/dL; (2) Urine M-protein level ≥200 mg/24 hours; (3) Diagnosed with light chain multiple myeloma with no measurable lesions in serum or urine: Serum free light chain ≥10 mg/dL and abnormal serum free light chain κ/γ ratio. 6. The patient has recovered from toxicities associated with previous treatment, i.e., CTCAE toxicity grade <2 (unless the abnormality is related to the tumor or stable, with no significant impact on safety or efficacy as determined by the investigator). 7. ECOG performance status of 0-2 and an expected survival of more than 3 months. 8. Adequate organ function: Alanine transaminase (ALT) ≤3 times the upper limit of normal (ULN); Aspartate transaminase (AST) ≤3 times ULN; Total bilirubin ≤1.5 times ULN; Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min; Indoor oxygen saturation ≥92%; Left ventricular ejection fraction (LVEF) ≥45%, confirmed by echocardiography with no clinically significant pericardial effusion or clinically significant electrocardiogram findings; No clinically significant pleural effusion. 9. Able to establish the required venous access for sample collection, with no contraindications for white blood cell collection. Exclusion Criteria: 1. Diagnosed with or treated for invasive malignant tumors other than multiple myeloma. 2. Previously received anti-tumor treatments including targeted therapy, epigenetic therapy, experimental drug therapy, or invasive experimental medical devices within 14 days or at least 5 half-lives (whichever is shorter) before the collection and preparation of CAR-T cells. Also, received monoclonal antibody therapy for relapsed/refractory multiple myeloma within 21 days, received cytotoxic therapy within 14 days, received proteasome inhibitor therapy within 14 days, received immunomodulatory agent therapy within 7 days, or received radiation therapy within 14 days (except for bone marrow reserves with field coverage ≤5%). 3. Suspected involvement of multiple myeloma in the central nervous system or meninges confirmed by MRI or CT, or presence of other active central nervous system diseases. 4. Screening criteria include plasma cell leukemia (according to standard classification, plasma cells >2.0×109/L), Waldenstrom macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or secondary AL amyloidosis. 5. Positive for hepatitis B surface antigen (HBsAg) and positive for HBV-DNA; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test. 6. Positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV) antibody; cytomegalovirus (CMV) DNA test result ≥500 copies/mL; positive for syphilis test. 7. History of severe allergies defined as grade II or above reactions, with clinical manifestations including airway obstruction (runny nose, coughing, wheezing, difficulty breathing), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiratory or cardiac arrest, or known allergy to any active ingredient, excipient, murine-derived product, or xenogeneic protein contained in this trial (including the CleenRx regimen). 8. Severe cardiac diseases including but not limited to severe arrhythmias, unstable angina pectoris, extensive myocardial infarction, New York Heart Association Class III or IV heart failure, myocardial infarction within 6 months before screening or coronary artery bypass graft (CABG), unexplained history of syncope unrelated to vasovagal or dehydration, severe non-ischemic cardiomyopathy, or uncontrolled hypertension (defined as failure to achieve blood pressure goals despite using ≥3 antihypertensive drugs, including diuretics, for ≥1 month or effective blood pressure control requiring ≥4 antihypertensive drugs). 9. Unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases requiring medication. 10. Acute/chronic graft-versus-host disease (GVHD) within 6 months before screening or patients requiring immunosuppressive therapy for GVHD. 11. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barré syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically significant active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)). 12. Presence of tumor emergencies (e.g., spinal cord compression, intestinal obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment during screening or before cell infusion. 13. Uncontrolled bacterial, fungal, viral, or other infections requiring antibiotic treatment. 14. Underwent major surgery (excluding diagnostic surgery and biopsies) within 4 weeks before CleenRx or planned major surgery during the study, or incomplete healing of surgical wounds before enrollment. 15. Received (attenuated) live virus vaccines within 4 weeks before screening. 16. Presence of severe mental disorders. 17. Alcohol or substance abuse history. 18. Pregnant or breastfeeding women, and female subjects or male subjects with partners planning pregnancy within 2 years after cell infusion, and subjects who plan to become pregnant within 2 years after cell infusion. Additionally, according to the investigator's judgment and/or clinical criteria, patients with contraindications to any study procedures or other medical conditions that may expose them to unacceptable risks. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06298253

Not yet recruiting

Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2

This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients. Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries.

- EligibilityCriteria: Inclusion Criteria: Food pantries enrolled in the study will be partner agencies of the Greater Boston Food Bank that are maximum client choice, are located within approximately 1 hour driving time of Boston (for logistical feasibility), and are not actively using traffic-light nutrition ranking. Food pantry clients that complete assessments must be 18 years or older and speak English or Spanish. Exclusion Criteria: Food pantries that are not affiliated with the Greater Boston Food Bank and are not maximum client choice. Food pantry clients that do not speak English or Spanish. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult

NCT06298227

Not yet recruiting

Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy

Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries. US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs. This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

- EligibilityCriteria: Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for living donor laparoscopic nephrectomy under general anesthesia Exclusion Criteria: history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, patients who refuse the procedure or participation in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06298214

Not yet recruiting

Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby. The main question[s] the study aims to answer are: Can the Her Health program increase access to healthcare in the first year postpartum? Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system? Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum. Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.

- EligibilityCriteria: Inclusion Criteria: At least 16 years old at the time of consent. Gave birth within 7 days before randomization Medicaid enrolled Address of residence within a disadvantaged area (ADI>5). Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent Exclusion Criteria: Use of private health insurance exclusively Does not speak English. Plans to move out of state during the study time period Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records. Unwilling to provide informed consent Unwilling to be randomized. - HealthyVolunteers: No - Gender: Female - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult

NCT06298201

Recruiting

E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity

Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life. Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus. Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid. Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions.

- EligibilityCriteria: Inclusion Criteria: Confirmed MS diagnosis as per the 2017 MS criteria. [3] Expanded Disability Status Scale (EDSS) assessment score of less than 7.0 at baseline. Adults aged 18 years or above. Commitment and mental ability to participate in a 6-month e-based physical exercise program, supervised bi-weekly by a physiotherapist. Exclusion Criteria: 5. Change in prophylactic DMT within the last 3 months 6. Steroid treatment in the past month. 7. Drug or alcohol abuse. 8. Pregnancy. 9. Active systemic infection - - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298188

Not yet recruiting

Risankizumab in Children With Crohn's Disease (RisaKids)

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD. This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.

- EligibilityCriteria: Inclusion Criteria: Children under the age of 18 years, Patients diagnosed with CD. Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease. Exclusion Criteria: * There will be no exclusion criteria to this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 6 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06298136

Recruiting

The Effects of an Online Mindfulness-based Intervention for Children With Attention-Deficit/Hyperactivity Disorder

This study will investigate the effects of an online mindfulness-based intervention with a randomized controlled trial.

- EligibilityCriteria: Inclusion Criteria: parents of children diagnosed with ADHD by a psychiatrist and psychologist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Ed (DSM-5) Children with ADHD aged 6 to 12. Parents who have served as the primary caregivers of their children in the last year and children with ADHD who speak and understand Cantonese Chinese. Children either not taking any medication or maintaining a stable dosage of the same ADHD medication for at least 3 months prior to study enrollment and having no plans to change medication and dosage during the study period. Exclusion Criteria: parents diagnosed with developmental disabilities, psychosis, or cognitive impairment, who may thus have difficulty comprehending the content of the project. Children with another developmental disability such as autistic spectrum disorder or intellectual disability. Parents who completed an eight-week MBI or equivalent program. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06298110

Not yet recruiting

The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy

To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.

- EligibilityCriteria: Inclusion Criteria: - Female patients aged >18 years. Patients undergoing abdominal hysterectomy. Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking. Exclusion Criteria: - Patients with hemoglobin (Hb) < 10 g/dL. Patients with platelet levels < 110 × 103/uL. Patients with coagulation disorders (on anticoagulant). Patients with malignancy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298097

Recruiting

Brain Connectivity Measured With High-density Electroencephalography

Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.

- EligibilityCriteria: In this study 125 stroke patients and 45 healthy participants will be recruited at the Institute for Research and Healthcare with a Scientific Character (IRCCS) San Camillo hospital. Inclusion Criteria (patients): right or left hemisphere damage unilateral stroke compliance with magnetic resonance imaging (e.g., no claustrophobia) Inclusion Criteria (healthy participants): • compliance with magnetic resonance imaging (e.g., no claustrophobia) Exclusion Criteria (both patients and healthy participants): • no comorbidities with psychiatric disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298084

Not yet recruiting

Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd

ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC. The first 2 modules will evaluate: i. safety and efficacy of HER3-DXd with olaparib in patients with HER2-low and HER2-positive ABC progressed on T-DXd (Module 1) and HER3-DXd monotherapy in patients with HER2-low ABC progressed on T-DXd (Module 0). The main objective of Part 1 is to assess the safety and tolerability of HER3-DXd monotherapy and combination and to determine the recommended phase 2 dose (RP2D) of the combination containing HER3-DXd. The main objective of Part 2 is to assess the efficacy of study therapies in each module based on investigator assessment as evaluated by the objective response rate (ORR) at 6 months.

- EligibilityCriteria: Inclusion Criteria: Patients must have received prior treatment with T-DXd and presented disease progression while on T-DXd treatment or within 2 months from T-DXd interruption/discontinuation for any reason, without requiring to be the last line of treatment. Patients who have received other lines of treatment after T-DXd and before study entry is capped at 10 patients for each cohort. Patients with HER2-positive tumors must have received prior treatment with trastuzumab and taxanes. They may have received prior treatment with T-DM1 and pertuzumab. Patients with HER2-low tumors must have been treated with taxanes. Patients with HR-positive tumors must have received ET and CDK4/6 inhibitors (patients may have received prior treatment with sacituzumab govitecan) If a patient has a tumor that was previously HER2-pos and became HER2-low, she/he will be included in cohort 2 and meet the inclusion criteria for HER2-low tumors. If a patient has a tumor that was previously HR-pos and became HR-neg, prior therapy with CDK4/6 inhibitors is not mandatory. Patients with germline pathogenic BRCA1/2 mutations and HER2-positive or HER2-low breast cancer are eligible to the study but must have received a prior treatment with PARP inhibitor (olaparib or talazoparib) Female or male patient aged ≥18 years on the day of the ICF signature Patient who has histologically confirmed diagnosis of breast cancer with unresectable loco regional or metastatic disease Patient must have an ECOG PS ≤1 at the time of screening Patients must have HER2-pos (IHC 3+ or IHC2+/ISH positive) or HER-2 low (IHC2+/ISH negative or IHC 1+) tumors with any HR status, any time before T-DXd exposure Patient must have at least one radiologically measurable lesion (different from the biopsy site) according to response evaluation criteria in solid tumors (RECIST) V1.1 criteria. At least one predominantly lytic or mixed lytic-blastic bone lesion with identifiable soft tissue component that can be evaluated by Computerized Tomography (CT)/Magnetic Resonance Imaging (MRI) must be present in patients with only bone metastasis Patient must have a tumor site easily accessible to biopsy, avoiding bone biopsy when possible. Patients must have accepted to perform pre-treatment, on-treatment, and end-of-treatment biopsies Patient must have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1, defined per the protocol Female patients of reproductive/childbearing potential must have a negative pregnancy test at screening (serum test within 24 hours before C1D1 or urine test within 72 hours of C1D1) and must and must agree to use a highly effective form of contraception or avoid intercourse during and till the end of treatment and for at least 8 months after the last dose of study drug. The following contraception methods are considered highly effective: Intrauterine device (IUD) Bilateral tubal occlusion Vasectomized partner Complete sexual abstinence defined as refraining from heterosexual intercourse during and till the end of treatment and for at least 8 months for females after the last dose of study drug. Periodic abstinence not an acceptable method of contraception Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 8 months after the final study drug administration Male patients must be surgically sterile or must withhold heterosexual intercourse, or must be willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 5 months following the last dose of study drug Male patients must not freeze or donate sperm starting at screening and throughout the study period, and for at least 5 months after the final study drug administration. Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol Patient must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: The following exclusion criteria are applicable for all modules. Patients will be excluded if they present one of them: Patient with a breast cancer amenable for resection or radiation therapy with curative intent Patient with any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have ILD as assessed by imaging during screening Patient with clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: Any underlying pulmonary disorder (eg, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion) OR Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) OR Prior pneumonectomy Patient receiving chronic systemic corticosteroids dosed at >10 mg/day prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Patients who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study Patient with evidence of any leptomeningeal disease Patient with clinically significant corneal disease Patient with any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patients with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patients must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1 Inadequate washout period prior to Cycle 1 Day 1, defined as: Whole brain radiation therapy or stereotactic brain radiation therapy <14 days Previous treatment with T-DXd < 28 days Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study <14 days or 5 half-lives, whichever is longer Endocrine therapy <21 days Monoclonal antibodies <28 days including immune checkpoint inhibitors (ICIs) Major surgery (excluding placement of vascular access) <28 days Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation <28 days or palliative radiation therapy <14 days Live virus vaccination <28 days Prior treatment with an anti-HER3 antibody Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patients with chronic Grade 2 toxicities (defined as no worsening to Grade >2 for at least 3 months prior to enrollment and managed with standard of care treatment) that the Investigator deems related to previous anticancer therapy, comprising the following, may be enrolled at the discretion of the Investigator: Chemotherapy-induced neuropathy Fatigue Residual toxicities from prior immuno-oncology treatment: Grade 1 or Grade 2 endocrinopathies provided they are clinically stable and receiving hormone replacement therapy when applicable which may include: Hypothyroidism/ hyperthyroidism Type I diabetes Hyperglycemia Adrenal insufficient Adrenalitis Skin hypopigmentation (vitiligo) Has known hypersensitivity to either the drug substances or the inactive ingredients of HER3-DXd and/or T-DXd Patient with a history of severe hypersensitivity reactions to other monoclonal antibodies or PARP inhibitors Has any malignancy other than locally advanced or ABC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer or curatively treated in-situ disease or other curatively treated solid tumors Documented uncontrolled or significant cardiovascular disorder prior to Cycle 1 Day 1, including: Corrected QT interval >450 ms according to Fridericia's formula (QTcF) based on triplicate 12-lead ECGs, approximately 1 minute apart LVEF <45% by either ECHO or MUGA or cardiac MRI if clinically indicated according to the investigator or consulting cardiologist Resting systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg Myocardial infarction within 6 months Symptomatic congestive heart failure (NYHA class from III to IV) Uncontrolled angina pectoris within 6 months Cardiac arrhythmia not controlled by ongoing antiarrhythmic treatment Diagnosed or suspected long QT syndrome, or known family history of long QT syndrome History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes Patient has bradycardia of less than 50 bpm (as determined by central reading) unless the subject has a pacemaker History of second or third degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers, and have no history of fainting or clinically relevant arrhythmia with pacemakers Coronary/peripheral artery bypass graft within 6 months Complete left bundle branch block Active Hepatitis B and/or Hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of Cycle 1, Day 1. Patients with past or resolved Hepatitis B virus (HBV) infection are eligible if: Hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive; OR HBsAg positive and HBV deoxyribonucleic acid (DNA) viral load is documented to be ≤ 2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases (in the absence of liver metastasis); OR HBsAg positive and HBV DNA viral load is documented to be ≤2000 IU/mL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with liver metastasis and abnormal transaminases AST/ALT <3 ULN For patients with HBsAg positive, if abnormal liver function is detected during study drug treatment, viral load should be tested to rule out reactivation. Patients with a history of Hepatitis C infection will be eligible for enrollment only if the viral load according to local standards of detection, is documented to be below the level of detection in the absence of anti-viral therapy during the previous 12 weeks (ie, sustained viral response according to the local product label but not less than 12 weeks, whichever is longer) Female patient who is pregnant or breastfeeding or intends to become pregnant during the study Has a known human immunodeficiency virus (HIV) infection that is not well controlled. All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of >350 cells/μL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the patient's viral RNA load and CD4+ cell count should be monitored per local standard of care (eg, every 3 months). Patients with a well-controlled HIV infection may only be enrolled into Part 2 (dose expansion) of the study. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results Adult under legal protection: guardianship, curatorship, or legal protection; or patient deprived of his/her liberty by a judicial or administrative decision; or patient incapable of giving his/her consent, or patient under psychiatric care Participation in another clinical trial evaluating an experimental drug during the last 4 weeks (except non-interventional research) Specific exclusion criteria for each module Module 0: There are no specific exclusion criteria for module 0 (HER3-DXd monotherapy). Module 1 (olaparib) History of hypersensitivity to excipients of olaparib Inadequate washout period prior to Cycle 1 Day 1, defined as: Strong CYP3A inhibitors < 1 week CYP3A inducers for olaparib and phenobarbital < 5 weeks and for any other drug < 3 weeks - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06298071

Recruiting

A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.

- EligibilityCriteria: Inclusion Criteria: Willing and able to give informed consent. Male and female aged between 18 and 70 years old , regardless of gender. Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30)； The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol/L at screening； Patients whose serum uric acid level could not reach the target after standard treatment with conventional uric acid-lowering drugs or who were contraindicated or intolerant to conventional uric acid-lowering drugs； Patients who were willing to stop taking any uric-acid-lowering drug at least 7 days before using methotrexate during the run-in period; Could tolerate the prescribed dose of methotrexate during the run-in period; Patients were able to attend and complete the visit on time. Exclusion Criteria: Patients had active systemic infection within 2 weeks before enrollment，including an infection for which treatment was being received； Having a chronic or recurrent infection, such as recurrent pneumonia or chronic bronchitis; Patients with active or severe lung disease or pulmonary insufficiency on chest imaging, or current pulmonary fibrosis or bronchiectasis； Patients who are on anti-TB treatment or have active TB； Diagnosis of osteomyelitis； Ongoing or long-term use of immune system modulating drugs, such as methotrexate, mercaptopurine, mycophanolate, long-term use (≥3 months) of prednisone ≥10 mg/ day or equivalent dose of corticosteroids; Or have a history of transplant surgery requiring long-term immunotherapy; Or a known history of autoimmune disease, allergic disease; Known allergy to recombinant proteins or porcine products, or history of allergy to uricase, pegylated products, corticosteroids and antihistamines, or known intolerance to methotrexate, fexofenadine, acetaminophen or contraindications to methotrexate, fexofenadine, acetaminophen; Patients who are known to be intolerant to all gout attack management regiments (participants must be able to tolerate at least one: Colchicine and/or Nsaids and/or Prednisone 0.5 mg/kg daily； Patients who have previously been treated with pegyluricase or other recombinant uricase, or who have been treated with other pegylated biological products; Participation in other clinical study with a drug intervention within 4 weeks before initiation of methotrexate or the drug was still in the elimination phase before screening (within 5 half-lives), whichever is older; Patients with chronic liver disease such as hepatitis, cirrhosis, alcoholic liver disease; Patients have unstable angina, severe arrhythmias requiring drug intervention, congestive heart failure (NYHA grade≥Ⅱ), uncontrolled hypertension (over 150/95 mmHg), poor glycemic control in diabetics ( HbA1c≥7%), acute stroke, Severe or chronic hemorrhagic digestive disease, pleural and abdominal effusion; A history of hypoxanthine-guanine phosphoribosyltransferase deficiency, such as Lesch-Nyhan and Kelley-Seegmiller syndrome; Glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD test values below the lower limit of normal; Estimated glomerular filtration rate (eGFR) ≤40 mL/min/1.73m2, or currently receiving dialysis, or end-stage renal disease (CKD4-5); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal value or albumin below the lower limit of normal value during screening (before methotrexate treatment); Use of any blood component, short-acting or long-acting growth factor drugs within 14 days prior to screening, or white blood cell count < 4×109/L, hematopoietic volume < 32%, or platelet count < 75×109/L; Receiving anticoagulant therapy or international normalized ratio (INR) > 1.5×ULN or activated partial thromboplastin time (APTT) > 1.5×ULN before enrollment; Receiving systemic or local radiotherapy for tumors, or history of malignancy within 5 years other than non-melanoma skin cancer or in situ carcinoma of cervix; Any acute illness that was considered by the investigator to be likely to affect the study occurred within 1 month before screening; Donated (or lost) blood and donated (or lost) ≥400 mL or received blood transfusion within 3 months before screening; If any one of the five serological tests of hepatitis B was positive except for hepatitis B surface antibody, or hepatitis C antibody positive, treponema pallidum antibody positive or HIV antibody positive in serum virology examination; History of drug or substance abuse, or a positive drug screening test; History of alcohol abuse in the 3 months before screening [drinking more than 14 units of alcohol per week (1 unit ≈360 mL of beer)] or 45 mL of 40% spirits or 150 mL of wine)]; or positive alcohol breath test on admission; Lactating women, as well as male participants (or their partners) or female participants 30 days before the study to the end of the study, who have plans for pregnancy or sperm or egg donation within 6 months and are unwilling to take effective contraceptive measures; Patients have serious mental and psychological disorders, cognitive disorders and the existence of a history of mental illness. The investigator considered it inappropriate to participate in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06298058

Not yet recruiting

A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients.

To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

- EligibilityCriteria: Inclusion Criteria: Age range from 18 to 75 years old (including boundary values), regardless of gender. The clinical diagnosis of enrolled participants should meet the following criteria: Dose escalation and dose expansion stage: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology and judged by the researcher to be unable to benefit from available standard treatment, or intolerant. Indications expansion stage: Queue 1: Non-small cell lung cancer (NSCLC) confirmed by histology or cytology, with disease progression and EGFR mutation during or after treatment with third generation TKI and platinum containing therapy. Queue 2: Breast cancer (BC) confirmed as HER3 positive by histology or cytology after standard treatment failure. Queue 3: Patients with recurrent/metastatic advanced HNSCC confirmed by histology or cytology, unsuitable for radical surgical resection, and standard treatment failure. At least one measurable lesion must be selected as the target lesion (according to RECIST v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion). The patient has not previously used anti-HER3 antibodies or other HER3 targeted treatments (such as Deparezumab (HER3-DXd). Drugs that have not received any form of topoisomerase I inhibitor in the past, including antibody drug conjugates (ADCs) . ECOG score 0-1. Expected survival time ≥ 3 months. During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug): Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9/L, platelet (PLT) count ≥ 90 × 10 9/L, hemoglobin (HGB) ≥ 90 g/L. Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: Participants with the following tumors: The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ). The participant has untreated imaging confirmed central nervous system metastasis. Meningeal metastases. Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled. Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period: Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration; Patients undergoing adjuvant therapy within 6 months after surgery; Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss); Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs. Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients). The dose (prednisone>10 mg/d or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug. Participants with a history of previous illnesses or laboratory tests that show the following abnormalities: Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration. Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. Screening period for syphilis spiral antibody positive individuals; Individuals with active HBV and HCV infections; Except those with stable hepatitis B (DNA titer below the lower detection limit) and cured hepatitis C (HCV RNA test negative) after drug treatment. Patients with ascites, pleural effusion, and pericardial effusion accompanied by clinical symptoms during the screening period who require drainage, or those who have undergone serous cavity drainage within 4 weeks before the first administration. The screening period is accompanied by severe, progressive, or uncontrollable diseases, and the researcher's evaluation determines that the participation of the participants in the study will increase the risk. Including but not limited to: Cerebrovascular accidents or transient ischemic attacks (within the first 6 months of screening); Suffering from heart disease judged by the researcher as unsuitable for participation in this trial, with a severity of cardiac or renal dysfunction ≥ Level II. According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study. Hypertension that cannot be controlled clinically. Diabetes with poor drug control. Clinically significant thyroid diseases judged by researchers as unsuitable for inclusion. Serious infections that occurred within 4 weeks prior to initiating research treatment. Individuals with a history of severe allergies to protein products, Chinese hamster ovary cell (CHO) cell products, and other recombinant human or humanized antibodies, or to the components of the investigational drug. Pregnant and lactating women. Patients deemed unsuitable for inclusion by researchers. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06298045

Recruiting

Effectiveness of a Combination of Trimetazidine With One Hemodynamic Agent in Patients Recently Diagnosed With Stable Angina and Still Symptomatic Despite First Line Hemodynamic Therapy

The purpose of this study is to assess in recently diagnosed stable Angina patients symptomatic despite first line hemodynamic therapy, the effect of a combination of this hemodynamic agent with a metabolic one (trimetazidine). The treatment effect will be measured by the reduction of patients' angina symptoms, physical limitation and an improvement of quality of life using the Seattle Angina Questionnaire-7 items (SAQ-7) Patients will be also proposed to complete a BEAMER (BEhavioral and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe) questionnaire which will contribute to a separate research project developed by the Innovative Medicines Initiative (IMI). Analysis of the BEAMER questionnaires will be performed outside the study by the IMI BEAMER Consortium for BEAMER purposes only.

- EligibilityCriteria: Inclusion Criteria: Male and female recently diagnosed symptomatic stable Angina patients Age ≥18 years old Patient already treated by one first line antianginal haemodynamic agent (ß-blocker or Ca-channel blocker) (according to CCS management guidelines 2019) and still symptomatic after initiation of this antianginal treatment. Patient for whom the physician intends to prescribe trimetazidine based on her/his daily medical practice in the management of symptomatic Angina pectoris, respecting the SmPC in force in the country. Such treatment decision must be taken independently from the participation of the patient in the study. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Any contra-indication to trimetazidine according to SmPC Patient already treated with trimetazidine before entry into the study. Pregnancy or intention to become pregnant or lactating women during the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Male and female recently diagnosed symptomatic stable Angina patients. - SamplingMethod: Non-Probability Sample

NCT06298032

Recruiting

A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons

Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.

- EligibilityCriteria: Inclusion Criteria: Men ≥18 and ≤45 years of age at screening In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1 Exclusion Criteria: History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06298019

Not yet recruiting

Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis

The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease. The main questions the study intends to answer are: Understanding how well patients tolerate undergoing this therapy in terms of side effects; Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;

- EligibilityCriteria: Inclusion Criteria: Diagnosis of probable or definite (>55%) IIM and subgroup classification as dermatomyositis according to the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myopathies. Age > 25 years and < 72 years at time of signing informed consent Refractory disease: subject with previous failure (or intolerance) to glucocorticoids and at least two non-glucocorticoid immunosuppressive therapies (including mycophenolate mofetil or mycophenolic acid, cyclophosphamide, azathioprine, methotrexate, calcineurin inhibitors, tofacitinib or other JAK inhibitors, rituximab, or IVIG) administered for at least 12 weeks within 24 months prior to screening. .Moderate-to-severe dermatomyositis as per EITHER: muscle weakness, defined as Manual Muscle Testing (MMT-8) score <142/150; or cutaneous disease as per Cutaneous Dermatomyositis Assessment and Severity Index-activity subscore (CDASI-a)>=19. PLUS at least 2 other abnormal IMACS Core Set Measures (CSMs) from the following: Patient global VAS≥2 cm. Physician's global VAS ≥2 cm. Global extramuscular activity score ≥2 cm. Elevation of at least one of the muscle enzymes (CK, AST, ALT, aldolase, LDH) >1.5 times upper limit of normal. HAQ-DI≥0.25. 2.For patients enrolling on the MMT-8 criterion, muscle disease must be active, as deemed by one of the following: Creatine kinase, aldolase, LDH, AST, or ALT (if deemed due to muscle inflammation by investigator) ≥2×ULN. MRI evidence of active myositis within last 3 months. EMG evidence of active myositis within last 3 months. Other inclusion criteria: Subject must sign a written ICF prior to any screening procedures. Subject must be ≥25 and ≦72 years of age. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function as per table below. Haematology Haemoglobin: ≥10.0 g/dl (without prior red blood cell transfusion within 7 days before the laboratory test)a Platelets: ≥100,000/ μL (without transfusion support within 7 days before the laboratory test). Absolute Lymphocyte Count (ALC):≥700/μL Absolute Neutrophil Count (ANC) 1,500/μL (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test) Hepatic AST and ALT: ≤2.5×upper limit of normal (ULN) unless deemed by the investigator to be secondary to DM. Total bilirubin ≤1.5×ULN; except in subjects with congenital bilirubinaemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required) Renal Creatinine clearance Calculated creatinine clearance ≥45 mL/min/1.73 m2 (measured by Cockcroft-Gault equation) Pulmonary Grade≤1 dyspnoea Oxygen saturation measured by pulse oximetry ≥92% on room air a .For subjects who meet the inclusion criteria at screening, transfusion of red blood cells is permitted after screening as needed to maintain a haemoglobin level ≥8.0 g/dL. Must be up to date on all recommended vaccinations, including against COVID-19/ SARS CoV-2, per Centers for Disease Control and Prevention or institutional guidelines for immune-compromised individuals. Women of childbearing potential must have a negative pregnancy test at screening using a highly sensitive serum pregnancy test (β-human chorionic gonadotropin [β-hCG]). Women of childbearing potential are defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months. Female subjects of childbearing potential who have a fertile male sexual partner must agree to use a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) from the time of signing the ICF until 1 year after the KYV-101 infusion. Examples of highly effective method of contraception include: Established use of hormonal methods of contraception associated with inhibition of ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or male subject's female partner plans to remain on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness. Correctly placed copper containing- intrauterine device or intrauterine hormone-replacing system. Male sterilization with absence of sperm in the post-vasectomy ejaculate. Female sterilization (bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure (provided that occlusion has been confirmed). Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject. Male subjects, if not surgically sterilized, must agree to use highly effective method of contraception and not donate sperm from the time of signing the ICF until 1 year after the KYV-101 infusion. For females: a negative pregnancy test at screening and prior to lymphodepletion chemotherapy. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a KYV-101 infusion. EXCLUSION CRITERIA: DM-related exclusion criteria Evidence of any of the following: Severe muscle damage as per one of the following criteria: Myositis Global Damage Index (MDI) ≥5. Severe proximal muscle atrophy of upper or lower extremity on MRI. Severe proximal muscle atrophy of upper or lower extremity on clinical examination. Wheelchair-bound at home. MMT-8 of ≤80. MDA5-positive rapidly progressing interstitial lung disease (subjects with stable ILD not requiring supplemental oxygen are eligible). Findings of muscular inflammation or myopathy other than the indication, such as polymyositis (PM), immune mediated necrotizing myopathy (IMNM), inclusion body myositis (IBM), cancer-associated myositis (myositis diagnosed within 2 years of cancer), drug-induced myopathy, amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease (overlap myositis), except with Sjogren's syndrome. Generalized, severe musculoskeletal or neuro-muscular conditions other than DM that prevent a sufficient assessment of the patient by the investigator. Subject with any of the following: Patients with ILD associated with any of the following oRequiring O2 therapy and/or FVC ≤45% of predicted or DLCO ≤40% of predicted at screening oEvidence of PH as defined as estimated RVSP or ≥45 mmHg or right atrial or ventricular enlargement or dilatation, unless subsequent RHC shows no PH. oPAH on right heart catheterization requiring PAH specific treatment. •Current gangrene of a digit Other exclusion criteria: Prior treatment with cellular immunotherapy (eg, CAR T) or gene therapy product directed at any target. History of allogeneic or autologous stem cell transplant. Systemic autoimmune disease, other than DM, requiring systemic immunosuppressive therapies Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, like the flu vaccine, are allowed). Unable to washout or interrupt autoimmune disease therapy prior to apheresis as specified in Table . Positive hepatitis B surface antigen (HBsAg) and hepatitis C serology confirmed by polymerase chain reaction (PCR) (except hepatitis C cured with pharmacotherapy); subjects who are HBsAg negative and hepatitis B core antibody (HBc) positive with no detectable DNA will be allowed into the study but will require regular monitoring of hepatitis B virus (HBV) DNA. Positive serology for human immunodeficiency virus (HIV). Positive screening test for SARS-Cov-2. Primary immunodeficiency. History of splenectomy. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject. Impaired cardiac function or clinically significant cardiac disease including: Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis. New York Heart Association (NYHA) stage III or IV congestive heart failure. History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block. History of severe nonischaemic cardiomyopathy. Left ventricular ejection fraction (LVEF) <45% as assessed by echocardiogram (ECHO) Previous or concurrent malignancy with the following exceptions: Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening). In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening. Serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, such as: Active, uncontrolled, viral, bacterial or systemic fungal infection (including human T cell lymphotropic virus [HTLV], human polyomavirus 2 [JC virus], or syphilis); or recent history of repeated infections. Requirement of supplemental oxygen to maintain oxygen saturation. Clinical evidence of dementia or altered mental status. A thromboembolic event within 6 months prior to apheresis. Ongoing toxicity from previous therapy that has not resolved to baseline levels or to Grade 1 or less, except for alopecia, fatigue, nausea, and constipation. Major surgery within 4 weeks prior to apheresis or planned within 4 weeks after KYV-101 administration. For surgery planned after 4 weeks post KYV-101 administration, discuss with the sponsor. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to KYV-101 or its excipients, including dimethyl sulfoxide; or to CYC (or to fludarabine if relevant), or to tocilizumab. Pregnant or breastfeeding; or plans to become pregnant or breastfeed, or father a child within 1 year after receiving the KYV-101 infusion. - HealthyVolunteers: No - Gender: All - MinimumAge: 25 Years - MaximumAge: 72 Years - StdAgeList: Adult, Older Adult

NCT06298006

Recruiting

A Two Year Longitudinal Clinical Study of Neurocognitive and Psychiatric Symptoms in Post COVID-19 Patients

The prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after COVID-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers.

- EligibilityCriteria: Inclusion Criteria: neurocognitive symptoms after lab-verified COVID-19 infection Exclusion Criteria: severe illness e.g cancer with a short expected survival time ongoing alcohol abuse ongoing drug abuse. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The patients: who have been referred for neurocognitive symptoms after Covid-19 infection to secondary health care at Örebro University Hospital (USÖ) or who themselves sought assessment at USÖ who meet inclusion criteria and do not meet exclusion criteria who agreed to study participation with a written informed consent. - SamplingMethod: Non-Probability Sample

NCT06297993

Not yet recruiting

Adult Patients With Primary Sclerosing Cholangitis

Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.

- EligibilityCriteria: Inclusion Criteria: Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF). Confirmed clinical diagnosis of large duct PSC based on current AASLD Guidelines (Bowlus 2023). Exclusion Criteria: Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH). Small-Duct PSC. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll. UDCA dose >28 mg/kg Evidence of current or historical decompensated cirrhosis based on the following clinical events: Ascites > Grade 2 and requiring treatment Esophageal or gastric variceal bleeding requiring hospitalization Hepatic encephalopathy (as defined by a West Haven score ≥ 2) Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count >250/mm3 in the absence of an intra-abdominal source of infection AKI-HRS according to AASLD Guidelines (Flamm 2021) Prior liver transplantation MELD-Na Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account. Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 48 weeks. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent. Prisoners or participants who are involuntarily incarcerated. Participants who are currently participating in an interventional clinical study. Absence of data in medical records to assess inclusion and exclusion criteria. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult - StudyPopulation: 2000 adult participants with confirmed diagnosis of large duct PSC - SamplingMethod: Non-Probability Sample

NCT06297980

Recruiting

Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes

The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.

- EligibilityCriteria: Inclusion Criteria: Women 18-45 who have had type 1 diabetes for at least 12 months Premenopausal with either menstrual cycles or currently using oral contraceptives Exclusion Criteria: Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06297967

Not yet recruiting

Acetic Acid 2% Solution for Skin Ulcers

The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®). Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.

- EligibilityCriteria: Inclusion Criteria: Patients over 18 years of age. Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units. Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region). Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center. Ability to cooperate in necessary evaluations. Informed consent for inclusion in the study, either from the participant themselves or from their legal representative. Exclusion Criteria: Participants diagnosed with any of the following conditions: Ulcers with exposed bone tissue. Neoplastic-origin ulcers. Ulcers lasting more than 18 months. Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297954

Recruiting

Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

A prospective, randomized, double-blind study will be conducted, including all patients with upper gastrointestinal bleeding, defined as vomiting blood or black bowel movements, within 12 hours prior to admission. Patients will be randomized to receive intravenous metoclopramide 20 mg or placebo, a placebo is a look-alike substance that contains no active drug. Then endoscopy will be performed in the following 120 minutes, evaluating endoscopic visualization with the modified Avgerinos scale.

- EligibilityCriteria: Inclusion Criteria: Hospitalized patients ≥18 years of age with variceal and non-variceal upper gastrointestinal tract bleeding (hematemesis and/or melena). ≤12 hours of bleeding evolution. Hemodynamic stability at the time of upper endoscopy. Exclusion Criteria: Patients <18 years old. Pregnant patients. Metoclopramide allergy. Refusal to be part of the study protocol. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297941

Not yet recruiting

Study of REM-422 in Patients With AML or Higher Risk MDS

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with Higher Risk MDS and relapsed/refractory AML

- EligibilityCriteria: Inclusion Criteria: Be able to provide informed consent. Be 18 or older at the time of informed consent. Disease criteria: Histologically confirmed diagnosis of either: R/R AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or reinduction treatment or to initial treatment with hypomethylating (HMA)-based combinations, relapse after initial treatment, or otherwise considered relapsed or refractory in the opinion of the Investigator. High-risk and very-high-risk (VHR) MDS (higher-risk) per the International Prognostic Scoring System-Revised (IPSS-R) and/or International Prognostic Scoring System-Molecular (IPSS-M). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Has agreed to undergo serial blood and bone marrow sampling. Participants must have completed systemic non-investigational therapy at least 14 days prior to initiating REM-422. Hydroxyurea is permissible for controlling peripheral leukemic blasts prior to enrollment and for up to 28 days following initiation of REM-422. Toxicities from prior therapy must be either stable or recovered to ≤ Grade 1. Participants must be able to swallow and retain oral medications. Oxygen saturation > 92% on room air or up to 2 L/min supplemental oxygen by nasal cannula with ≤ Grade 1 dyspnea. People of childbearing potential (POCBP) must have a negative serum beta-human chorionic gonadotropin test result. POCBP must agree to use acceptable, effective methods of contraception and not donate ova from screening until 6 months after discontinuation of REM-422. Women who have undergone surgical or ablative sterilization or who have been postmenopausal for ≥ 2 years are not considered to be of childbearing potential. Men must agree to use acceptable, effective methods of contraception and must agree not to donate sperm from the start of receiving REM-422 until 6 months after discontinuation of REM-422. Adequate organ function and laboratory parameters Exclusion Criteria: Active central nervous system (CNS) leukemia or a confirmed diagnosis of CNS leukemia. Has undergone hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of REM-422 or is receiving immunosuppressive therapy post HSCT at the time of screening, or has GVHD requiring systemic treatment (topical steroids for ongoing skin GVHD is permitted). Has immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation. Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients. Clinically significant active infection. Note: Patients with simple urinary tract infection or uncomplicated bacterial pharyngitis responding to active treatment are permitted. Note: Patients receiving intravenous (IV) antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals, or antifungals are permitted). Evidence of active HIV infection. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Primary immunodeficiency. Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent. Note: Patients who are receiving topical or inhaled corticosteroids with minimal systemic absorption are eligible for enrollment and may continue with minimal corticosteroid use as long as they are on a stable dose. Live vaccine ≤ 6 weeks prior to the start of REM-422. Use of strong CYP3A inhibitors (except azole antifungals) or CYP3A inducers Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (eg, omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration or during the study. Currently pregnant, have intentions to become pregnant during the study duration, or are currently lactating. Has dysphagia, short-gut syndrome, gastroparesis, or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs. Current use of prohibited medication ≤ 1 week before starting REM-422. Clinically significant cardiovascular disease: Has undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, or meninges or surgical procedures requiring general anesthesia) < 4 weeks prior to enrollment. History of organ transplant that requires use of immunosuppressive agents. History or current autoimmune disease requiring systemic treatment (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus). Radiation therapy ≤ 7 days prior to the start of REM-422. Concurrent or previous other malignancy ≤ 2 years of enrollment, except curatively treated malignancies including basal or squamous cell skin cancer, breast cancer, prostate intraepithelial neoplasm, and carcinoma in situ of the cervix. Receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment. Unwillingness or inability to follow protocol requirements. Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297928

Recruiting

Metabolomics and Bariatric Surgery in Patients With Metabolically Unhealthy Obesity

The goal of this observational study is to investigate metabolic changes in individuals undergoing bariatric surgery, specifically focusing on those with obesity and varying metabolic health statuses. The main questions it aims to answer are: Can metabolic markers predict the transition from metabolically unhealthy obesity to metabolically healthy obesity after bariatric surgery? How do metabolic profiles change in individuals with metabolically healthy obesity after bariatric surgery? What are the metabolic differences between individuals with metabolically healthy and unhealthy obesity before and after bariatric surgery? Participants will undergo routine evaluations and blood tests before and after bariatric surgery. These tests will include assessments of metabolic health markers and sampling of blood plasma for metabolomic analysis. The study will study changes in metabolic profiles between individuals who transition to metabolically healthy obesity and those who remain metabolically unhealthy after surgery.

- EligibilityCriteria: Inclusion Criteria: Patients undergoing bariatric surgery at the Hospital del Mar in Barcelona. Criteria for bariatric surgery are: Ages between 18 and 60 years. Body Mass Index (BMI) equal to or greater than 40, or equal to or greater than 35 kg/m2 with at least one obesity-related comorbidity (type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnea syndrome). Previous failure with conventional treatment involving diet and exercise. Exclusion Criteria: History of previous bariatric surgery. Presence of severe psychiatric disorders, severe eating disorders, alcohol or drug abuse. Contraindications for major abdominal surgery, active gastric ulcer, severe liver disease. Pregnancy or lactation. - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: The study population will consist of patients who have undergone bariatric surgery at the Hospital del Mar in Barcelona and meet the aforementioned inclusion criteria. These patients will be consecutively selected and must agree to participate in the study. - SamplingMethod: Non-Probability Sample

NCT06297902

Not yet recruiting

RAdiotherapy With FDG-PET Guided Dose-PAINTing Compared With Standard Radiotherapy for Primary Head and Neck Cancer-3

The objective of the RADPAINT-3 trial is to investigate whether dose painting is safe compared to standard radiotherapy. RADPAINT-3 is a randomized, non-inferiority, multi-center phase II study, initiated at the Section for Head and Neck Cancer, Department of Oncology, Oslo University Hospital, accruing from first half of 2024. The primary endpoint is frequency of grade ≥ 3 (CTCAE v5.0) mucosal ulcers one year after treatment. The expected inclusion period is three years, total study duration is six years and planned inclusion number is 100 patients. The collaborating sites are St Olav´s Hospital and Haukeland University Hospital. The patients will be randomized 1:1 to either standard radiotherapy (2 Gy x 34; total dose 68 Gy) or experimental radiotherapy (dose painting). All patients will have 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission computed tomography (FDG-PET/CT) prior to radiotherapy. In the experimental arm, we will escalate the dose to the hypermetabolic part of the tumor (maximum point dose 83.3 Gy), shown in pre-treatment FDG-PET images. Dose escalation will be applied to these regions during the first half of the fractionated treatment (17 of 34 fractions). The patients in both arms will receive concomitant nimorazole (hypoxic radiosensitizer) and concomitant cisplatin if indicated according to standard treatment. The main inclusion criterion is patients with human-papillomavirus (HPV)-unrelated head and neck cancer with poor prognosis. The RADPAINT-3 trial includes a translational sub-study where we aim to elucidate underlying mechanisms related to the radiotherapy effect, by investigating blood samples. Analysis of cytokines in repetitive blood samples may predict both tumor response and toxicity. The data derived from this sub-study, will be further explored using artificial intelligence. If RADPAINT-3 shows that there is no excess toxicity, we will continue the study after a new protocol has been approved. The new primary endpoint will be local control at 1 year after radiotherapy. Power analysis show that we will need in total 182 evaluable patients including the 100 patients from RADPAINT-3. The translational sub-study will then be extended to investigate genetic expression data from pre-therapy routine tumor biopsies and correlate this with the analysis of blood samples and tumor control.

- EligibilityCriteria: Inclusion Criteria: Histologically or cytologically verified invasive squamous cell carcinoma of the head and neck region; Sinonasal cancer, oral cavity cancer, hypopharynx cancer, larynx cancer, HPV negative oropharyngeal cancer and T4 (any N) HPV positive oropharyngeal cancer. Patients planned for standard curative RT (with or without concomitant chemotherapy [cisplatin, or cetuximab], with or without nimorazole hypoxic cell radiosensitizer) Age > 18 years WHO performance status 0-2 Signed informed consent Ability to understand information about the study and to complete questionnaires Exclusion Criteria: All diagnoses, cT1 cN0-N1 cM0 Glottic cancer cT1-T2 cN0 cM0 HPV positive oropharyngeal carcinoma T1-T3 (any N) Diabetes mellitus Use of anticoagulant medication Active smoking and/or alcohol abuse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297889

Recruiting

Effect of Core Strength Training on the Physical Fitness and Skills of Youth Field Hockey Players in China

Hockey, tracing its origins back to 2000 BC, has undergone substantial evolutionary transformations throughout the centuries. Initially known by various names, the game transitioned to its modern form approximately 50 years ago, when matches were conducted on grass fields with wooden sticks. In contemporary international hockey, there has been a notable shift towards artificial grass, cultivating a dynamic and fast-paced game that places heightened demands on individual skills, tactical acumen, and physical fitness. This evolution reflects a continuous adaptation, seamlessly blending tradition with cutting-edge equipment and hybrid playing grounds. Against this backdrop, modern-day hockey programs have metamorphosed into rigorous and demanding training regimes. Athletes engaged in these programs are required not only to demonstrate outstanding physical fitness but also exhibit a high level of proficiency in the nuanced skills essential for competitive play. As hockey continues its progressive trajectory, athletes partaking in these programs must meet elevated standards, underscoring the imperative integration of both exceptional fitness levels and precise skill execution. Despite the growing emphasis on the physical and skill dimensions of hockey, a literature review uncovered a dearth of research specifically focusing on core strength training for hockey players. While core strength training has demonstrated efficacy in improving physical fitness and skill performance among athletes in other team sports, its applicability to hockey players remains underexplored. Moreover, no studies have systematically examined the impact of core strength training on the two critical variables of physical fitness and skill performance in hockey players. To address this research gap, the present study sought to investigate the effects of core strength training on the physical fitness and skill performance of youth hockey players in Gansu Province, China. By doing so, this study not only contributes valuable insights to the existing body of literature but also furnishes theoretical support for the development of hockey sport programs. The findings are anticipated to inform targeted interventions aimed at enhancing athletes' physical fitness and skill performance, ultimately fostering the progression of hockey programs within the sporting landscape of China.

- EligibilityCriteria: Inclusion Criteria: - This study was conducted with male hockey players from Gansu Sports School and Linxia Sports School. Before recruiting the subjects, the researcher needed to inform the subjects of the proposed study and what they needed to participate in. After informing the subjects, the subjects will be allowed to ask questions. Various criteria and requirements for participation in this study are explained during the session. The inclusion criteria for potential participants were as follows: Male Aged 15 to 17 years Reside in Gansu Province, China Healthy Two years of training experience Exclusion Criteria: on medication which may affect body composition and muscles activity like Diabetes Mellitus Currently participating in regular resistance training - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 15 Years - MaximumAge: 17 Years - StdAgeList: Child

NCT06297876

Recruiting

COVIDVaxStories: Randomized Trial to Reduce COVID-19 Vaccine Hesitancy in Populations of Color

Pilot randomized controlled trial testing the investigator's previously developed storytelling method to create an interactive, multi-media storytelling intervention to address community-identified reasons for vaccine hesitancy among Black and Hispanic individuals in Central Massachusetts

- EligibilityCriteria: Inclusion Criteria: >= 18 years of age identifies as Black and/or Hispanic lives in Massachusetts vaccinated for COVID-19. Exclusion Criteria: Unable to provide consent in English or Spanish Has not completed the primary series of COVID-19 vaccinations (2 shots for Moderna or Pfizer, one shot for Johnson & Johnson). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 105 Years - StdAgeList: Adult, Older Adult

NCT06297863

Not yet recruiting

Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke

The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy. This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment). The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).

- EligibilityCriteria: Inclusion Criteria: Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1) Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis) Informed consent obtained from patient or patient's next of kin, or emergency consent procedure Exclusion Criteria: Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive. Vomiting upon stroke onset. History of glaucoma. History or imaging findings of intracranial hypertension of any aetiology Major breath disorders, defined as follows: oxygen saturation ≤92% in room air at admission severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy. severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest). Severe obesity, defined as body mass index (BMI) > 35. Patients participating in another interventional trial that would interfere with this study. Female patients who are pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06297850

Not yet recruiting

Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study

The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment. The main questions it aims to answer are: • Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment? Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.

- EligibilityCriteria: Inclusion Criteria: Medical history with diabetes mellitus requiring antidiabetic drugs Age ≥18 years Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index <1.5 Exclusion Criteria: Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc) Known allergy to plaster used in the CGM device - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: To the answer of our two research questions, we include both patients with diabetes undergoing surgery, and patients with diabetes admitted to the intensive care unit with circulatory impariment, as described in the criteria above. We aim to exclude only patients with direct contraindications to the wear of the CGM. - SamplingMethod: Probability Sample

NCT06297837

Not yet recruiting

ADAPT-AST (Adaptive Antimicrobial Susceptibility Testing)

The goal of this study is to improve the way urinary tract infections (UTIs) are tested for antibiotic resistance. The main questions it aims to answer are: Can the investigators use a method called Bayesian causal inference to create or check clinical prediction models that help predict if certain antibiotics will work for a urinary infection, using patient information from the National Health Service (NHS)? Can this new ADAPT-AST method, which uses data and a smarter approach, do a better job of testing for urinary infection than the old methods? Will it help doctors make quicker decisions and save resources by being more efficient? Participants in this study will not be receiving treatments. The study will involve: Using statistical methods to predict UTI test results based on patient data. Evaluating whether this new approach can provide doctors with more timely and useful information for treating UTIs. Assessing whether it can help save money and resources in the lab and pharmacy.

- EligibilityCriteria: Inclusion Criteria: o The specimens for which AST predictions & recommendations will be made are urine specimens processed by LCL Microbiology laboratory taken from patients ≥ 18 years old in LUHFT and/or GP locations that grew organisms within the period of the study dataset; these are the only specimens for which AST results will be available to train and test ADAPT-AST. Predictions will be made for all urine specimen types, including mid-stream urines, catheter specimens of urine and nephrostomy urine. Exclusion Criteria: Urine specimens processed by LCL that did not grow organisms within the period of the study dataset Urine specimens taken from patients < 18 years old Predictions will be made for asymptomatic bacteriuria screening specimens in pregnant women who have had specimens sent from a GP, but not those which have been sent from Liverpool Womens' NHS Foundation Trust (LWfT) Predictions for non-bacterial organisms grown in urine (i.e., fungi) will not be made. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with a suspected Urinary Tract Infection - SamplingMethod: Non-Probability Sample