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NCT06262620 | Not yet recruiting | The Comparisonof Mediastinal/Hilar Lymph Node Biopsies by EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB | The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic efficacy and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBCB, and EBUS-TBFB) in mediastinal/hilar lymph node biopsies.
Participants will divided into EBUS-TBNA group, EBUS-TBCB group, and EBUS-TBFB group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBCB, or EBUS-TBFB according to the group.
Researchers will compare the adequacy of sampling by the three biopsy techniques, their sample quality, diagnostic rate, and incidence of each adverse events. | - EligibilityCriteria: Inclusion Criteria: Age ≥ 15 years; At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure; Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form. Exclusion Criteria: The lesion is a mediastinal cyst or abscess; Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy; EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy; EBUS did not detect lesions in the hilum and/or mediastinum; Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc. - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06262607 | Recruiting | A Study of CLE-400 (Topical Gel) for the Treatment of Chronic Pruritus in Adult Subjects With Notalgia Paresthetica | This is a Phase 2, randomized, double-blind, vehicle-controlled study to assess the efficacy and safety of CLE-400 topical gel for the treatment of chronic pruritus in adult subjects with Notalgia Paresthetica (NP). | - EligibilityCriteria: Inclusion Criteria: Subject has a confirmed diagnosis of Notalgia Paresthetica. Subject has a history of chronic pruritus (itch) due to Notalgia Paresthetica. Subject has moderate to severe pruritus. Subject is able and competent to read and sign the informed consent form (ICF). Exclusion Criteria: Subject has chronic pruritus that is related to a condition other than Notalgia Paresthetica. Subject with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease, including physical/laboratory/ECG/vital signs abnormality that would put the subject at undue risk or interfere with interpretation of study results Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262594 | Not yet recruiting | Lemborexant Treatment of Insomnia Linked to Epilepsy | The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy. | - EligibilityCriteria: Inclusion Criteria: Sleep-related focal epilepsy Contraception Exclusion Criteria: Changes in antiseizure medication 1 month before study protocol or during study protocol Concomitant medications per SUNRISE1 Individuals with hepatic impairment Female participants who are pregnant or breastfeeding Individuals with compromised respiratory function Individuals with a history of complex sleep-related behaviour Individuals with rare hereditary diseases of galactose intolerance such as galactosemia or glucose-galactose malabsorption Individuals with a history of dependence or tolerance - abuse, dependence, rebound insomnia Individuals with psychiatric disorders with abnormal thinking and behavioural changes, depression, or suicidal ideation Individuals with a diagnosis of narcolepsy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262581 | Recruiting | Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery | According to the cancer statistics in 2020, colorectal cancer (CRC) remains a major public health issue worldwide, representing the third common cancer (10%) and second leading cause of death (9.4%) with 5-year survival rate approaching 65%. Meanwhile, 28.8% of the newly diagnosed cases and 30.3% of the CRC-related death occurs in China. Among all the CRC, stage I-III account for 75%. For the standard management for non-late stage(stage I-III) CRC patients, surgery including the primary site and local lymph nodes dissection has been the most important one. But for the high-risk stage II and locally-advanced stage III CRC, neoadjuvant or adjuvant therapy such as chemotherapy and radiotherapy plays a vital role in preventing the residual cancer cells to relapse and spread to distant sites after surgery. For the past decades, immunotherapy like anti-PD-1 and anti-CTLA4 checkpoint inhibitor achieves great process in solid tumor treatment especially for late-stage CRC. And Pembrolizumab and Nivolumab has been proved for dMMR/MSI-H late-stage-CRC by FDA. Combination of Ipilimumab and Nivolumab has achieved great success among the early-stage-CRC in NICHE study. The investigators here to carry out a phase II clinical trial to explore the safety and effect of single anti-PD-1 (Tisleizumab-BGB-A317 ) neoadjuvant treatment for non-late stage CRC patients. | - EligibilityCriteria: Inclusion Criteria: Able to provide consents and agree to follow the trial requirement and assessment; Age >=18 ECOG score: 0 or1 Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required) Measurable and assessible primary tumor sites according to RECIST 1.1 Able to provide 22ml peripheral blood for assessment for ctDNA With all organ function sufficient No bowel obstruction or fistula No previous chemotherapy, radiotherapy and immunotherapy accepted history Distant metastasis excluded before surgery by CT scan Contraception required for women for the whole enrollment time until 3 months after last dose of immunotherapy Exclusion Criteria: self-autoimmune diseases history such as SLE People who using the immune suppressor Severe allergy to other mono-clone antibody Cerebral metastasis which hasn't be managed yet Hypertension(SBP>140mmHg，DBP>90mmHg) Uncontrolled diabetes(FBG>10mmol/L) Accepted anti-PD-1 or anti-PD-L1 immunotherapy in the past Uncontrolled heart diseases such as NYHA II heart failure, unstable angina , cardiac infarction in 1 year and arrhythmia Systemic inflammation which needs whole body treatment Urine routine: protein >=++ or 24hr urine protein>=1g Innate or acquired immune deficiency like HIV and HBV Enrolled in other clinical trial already Confirmed as metastasis before the surgery Other malignancies has been diagnosed before Tuberculosis Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262568 | Recruiting | Effect of Guidelines on Nurses' Awareness Toward HRP and Maternal Near Miss Cases | The current study will evaluate the impact of awareness of maternity nurses toward instructional guidelines and evaluate the knowledge, practice and attitude of nurses toward high risk pregnancy and maternal near miss cases before and after education. | - EligibilityCriteria: Inclusion Criteria: all nurses staff Exclusion Criteria: nurses who refuse participation - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult - StudyPopulation: all nurses - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262555 | Recruiting | Novel Light Delivery Method for Performing Transbronchial Photodynamic Therapy for Peripheral Lung Cancer | This research aims to develop an innovative photodynamic therapy (PDT) for peripheral lung tumors. Current treatments involve surgery, chemotherapy, and radiation. Photodynamic therapy, using light and photosensitizing drugs, is promising but has limitations. Our team proposes using Lipiodol, a contrast agent, instilled into the trachea via bronchoscopy, surrounding the tumor. Preliminary pig model trials showed safety. Clinical trials, building on a U.S. study (NCT02916745), commenced in October 2021, treating three cases. Initial results suggest safety, but efficacy requires further investigation. Based on ongoing trials, we propose a phase I trial with multiple light treatments from different directions and an additional dose after 48 hours to assess safety and efficacy. This study will guide future clinical trials for optimal PDT dosage. | - EligibilityCriteria: Inclusion Criteria: Patients diagnosed with advanced or terminal malignant lung tumors (including primary lung cancer and lung metastases from other cancers). Patients who have failed standard treatments (surgery, radiotherapy, or first and second-line chemotherapy/immunotherapy/targeted therapy) or are unsuitable for standard treatments. Tumor size less than or equal to 3 cm, clearly assessable on chest computed tomography. Patients capable of providing informed consent and willing to undergo regular follow-ups during the trial. Exclusion Criteria: Diagnosis of small cell lung cancer or non-solid malignancies. Tumors located in the central part of the lungs. Previous radiation therapy to the treatment site. Abnormal blood biochemical values. Chemotherapy received within the past 4 weeks. Tumor invading major blood vessels. Allergy to porphyrins or porphyrin-related metabolites, or allergy to Lipiodol or iodine-containing contrast agents. Planning radical surgery for lung tumors within the next 90 days. Potential need for slit lamp ophthalmic examination within the next 30 days due to existing eye diseases. Inability to undergo bronchoscopy due to mental health conditions. Pregnancy, planning pregnancy, breastfeeding, or planning to breastfeed within the next 6 months. Previous photodynamic therapy within the past 1 month. Severe kidney or liver disease with abnormal function. Planning to participate in other cancer treatment clinical trials within the next 3 months. HIV-positive patients. Individuals deemed unsuitable for the trial by the principal investigator and the safety monitoring committee due to severe illnesses. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262542 | Not yet recruiting | Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia | Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.
Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.
Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia. | - EligibilityCriteria: Inclusion Criteria: Patients diagnosed with cancer by Western medicine doctors. regardless of cancer type, gender. aged 20 or above, experiencing WBC < 3000/μL or ANC < 1500/μL for the first time after starting chemotherapy. Exclusion Criteria: Patients not suitable for moxibustion, including those with wounds at moxibustion points. Patients who refuse to sign the consent form. Minors, pregnant women, individuals with mental illnesses, those vulnerable to harm, or in disadvantaged groups. Patients with leukemia, where the disease itself affects changes in blood cells. Patients currently receiving other forms of Traditional Chinese Medicine treatment or alternative therapies that may increase white blood cell counts. - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262529 | Recruiting | Neurocognitive Impairment After Ischemic Stroke | Affecting more than 150,000 patients in France, stroke is a major public health issue and a leading cause of disability worldwide. In western countries, 80-85% of strokes are of ischemic subtype. This study will focus on young adults, aged 18-45, with a diagnosis of ischemic stroke.
Studies assessing post-stroke cognition in young patients reported an alarming prevalence of cognitive impairment, affecting about 60% of stroke survivors between 4 and 12 months after the acute event. However, longitudinal data on neurocognitive trajectories (i.e., the evolution of cognitive impairment over time) in young patients with ischemic stroke are lacking. Collecting such data requires an exhaustive neuropsychological assessment and several functional evaluations, at different times, for the same patient.
Repeated neurocognitive study of young patients with ischemic stroke will enable: a description of the prevalence of impaired global cognitive efficiency, an analysis of the specific neurocognitive domains affected, and the tracing of trajectories of recovery from cognitive impairment over time, in terms of global cognitive efficiency and as a function of specific neurocognitive domains (memory, executive, attentional, social cognition, instrumental functions, fatigability, etc.).
Up to date, the clinic-radiological predictors and associated factors of neurocognitive impairment after ischemic stroke in young patients have not been studied. Ischemic stroke causes acute brain lesions of the gray matter (GM) and white matter (WM). Numerous studies suggest that cognitive health may be more closely linked to the integrity of WM than to GM. Magnetic resonance imaging (MRI), and in particular diffusion tensor imaging (DTI) sequences, analyze WM bundles. By using fiber tracking algorithms image analysis enable the WM fiber bundle reconstruction and allow quantifying the volume of lesions (pre-existing and ischemic stroke-induced) in the WM tract.
The aim of this study is to study whether the extension of pre-existing and acute white matter lesions is associated with poorer cognitive recovery after ischemic stroke, both in terms of global cognitive performance and impairment in specific neurocognitive domains. | - EligibilityCriteria: Inclusion Criteria: Age: 18 to 45 years. Pathology: ischemic stroke diagnosed with brain MRI as per standard clinical practice, with or without occlusion of proximal artery, anterior or posterior circulation. Ability to understand and complete study tests and questionnaires: fluent French speaker and reader. All patients must be affiliated to a social security scheme. Signature of informed consent form. Exclusion Criteria: Pre-existing cognitive impairment (defined as CQI <78 or clinical dementia). Severe functional dependence prior to stroke (defined as Modified Rankin Scale MRS = score 5). Any neurological or psychiatric comorbidity. Sensory disorders: visual impairment, blindness, deafness. Severe acquired phasic disorders: on the expressive oral side, in the presence of an inability to express oneself, which interferes with the collection of responses to neuropsychological tests; and on the receptive oral side, in the presence of an inability to understand the instructions of neuropsychological tests. Phasic functioning is systematically assessed during hospitalization by means of the NIHSS (score ≤ 2 on the "Language" sub-test), and will be rechecked clinically and psychometrically during neuropsychological assessments using the Language Screening Test (LAST) for both expression and oral comprehension. - Severe motor disorders: inability to mobilize the dominant upper limb for written neuropsychological tests. Contraindication to MRI. Pregnant women. HIV-positive patients: interaction of infectious pathology on cognitive functioning. Declarative, no HIV tests will be performed. Withdrawal of informed consent. Consumption of alcohol and/or narcotics on the day of neuropsychological assessments. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult | 2024-03-12 |
NCT06262516 | Not yet recruiting | Nephroureterectomy With and Without Lymph Node Dissection for Upper Tract Urothelial Cell Carcinoma | The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
To determine oncologic outcomes, specifically 2-year recurrence-free survival
To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
To determine time to recurrence and recurrence patterns
To determine use of adjuvant therapies
To determine perioperative complications
Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection. | - EligibilityCriteria: Inclusion Criteria: Adults > 18 years Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade) Planned for nephroureterectomy by their urologic surgeon Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis. No concomitant muscle-invasive bladder cancer Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0) Presence of distant metastases Concomitant muscle invasive bladder cancer The participant is in a reduced general condition or has a life-threatening disease. The participant has a psychiatric disorder that precludes them from understanding the consent process. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262490 | Not yet recruiting | Impact of Pelvic Floor Rehabilitation Combined With Ultrasound Therapy on Osteomyoarticular Symptoms in Chronic Perineal Pain | The purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms . | - EligibilityCriteria: Inclusion Criteria: The age of the subjects will be ranged from 20 to 35 years. All participants had vaginal delivery with episiotomy. They are in late post partum period over 6 months Their BMI will be ranger from 25 to 30 kg/m2. All participants have mechanical low back pain. All participants have perineal pain. The Number of parity Ranged from 2-3 times. Exclusion Criteria: Females will be excluded if they have any spine or lower extremities injuries or previous surgeries. Females with radicular back pain. Inability to understand the written and verbal instruction. Females had irregular menstrual cycle - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - MinimumAge: 20 Years - MaximumAge: 35 Years - StdAgeList: Adult | 2024-03-12 |
NCT06262477 | Recruiting | A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants | The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra. | - EligibilityCriteria: Key Inclusion Criteria: Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m^2), inclusive. Total body weight between 60.0 and 90.0 kg, inclusive. Systolic blood pressure <135 millimeters of mercury (mmHg) or >85 mmHg at Screening, after being supine for at least 5 minutes. No clinically significant (as determined by the Investigator) 12-lead electrocardiogram (ECG) abnormalities, no cardiac pacemaker. Key Exclusion Criteria: History or positive test result at Screening for human immunodeficiency virus (HIV). History of hepatitis C infection or positive test result at Screening for hepatitis C virus antibody. Current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and total hepatitis B core antibody [anti-HBc]). Serious infection (as determined by the Investigator) within the 6 months prior to Screening. History of systemic hypersensitivity reaction to the active drug substance, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study. History of immunodeficiency or other clinically significant immunological disorders, or autoimmune disorders. History of clinically significant (in the opinion of the Investigator) atopic allergy (e.g., asthma, urticaria, eczematous dermatitis, allergic rhinitis), hypersensitivity, or allergic reactions. History of angioedema. A positive diagnostic tuberculosis test result within 35 days prior to Day -1, defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results. Any prior exposure to tocilizumab or to any other agent directly acting on IL-6 or on its receptors including investigational products (e.g., siltuximab, sarilumab etc.). Administration of immunoglobulins for anti-tetanus and anti-rabies post-exposure prophylaxis within 3 weeks prior to administration of study drug. Any live or attenuated immunization or vaccination given within 30 days prior to Day -1 or planned to be given during the study period. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult | 2024-03-12 |
NCT06262464 | Not yet recruiting | OCD Prevention: a Randomized Clinical Trial | The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention. | - EligibilityCriteria: Inclusion Criteria: - age over 18 Exclusion Criteria: clinically diagnosed OCD current psychiatric/psychotherapeutic treatment personality disorder diagnosis suicidal ideation - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262451 | Recruiting | Fecal Microbiota Transplant National Registry | A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits. | - EligibilityCriteria: Recipient Inclusion Criteria : Ability to give informed consent Receiving FMT or other gut-related microbiota product within 90 days after providing consent Access to internet and/or telephone Donor Inclusion Criteria: Ability to give informed consent Providing stool sample for FMT Exclusion Criteria: Incarceration - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participants will be eligible for participation regardless of age, race, ethnicity, or gender. Pediatric patients may participate if consent is given by a guardian. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06262438 | Recruiting | CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients | The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity. The linked Quizartinib trial (CHIP-AML22/Quizartinib) is a phase II, single arm, open label, study on the safety, efficacy, pharmacokinetics and pharmacodynamics of quizartinib in combination with chemotherapy and as single-agent after high dose therapy in newly diagnosed pediatric AML patients with a FLT3-ITD mutation and NPM1 wild-type. | - EligibilityCriteria: Inclusion criteria: Enrollment on CHIP-AML22/Master: Patients must be enrolled on the CHIP-AML22/Master prior to enrollment on CHIP-AML/Quizartinib linked-trial, and may have received a diagnostic work-up according to the master protocol. Induction treatment can be started as standard of care. FLT3-ITD+ and wild-type NPM1: Presence of FLT3-ITD+ and NPM1 wild type in bone marrow or peripheral blood provided by the local laboratories, as part of standard of care diagnostics. The results of FLT3-ITD testing must be obtained prior to the first dose of quizartinib (e.g., Induction course 1, Day 10). Age: Patients must be from 1 month to ≤ 18 years old at initial diagnosis Performance status Karnofsky performance status score of >50% for subjects >16 years of age, and a Lansky performance status score of >50% for subjects ≤16 years of age. Organ function criteria: These criteria must be met based on the results before start of any chemotherapy (e.g., MEC) a. Adequate Renal Function Defined as: • Calculated eGFR ≥ 50 mL/min/1.73 m2 using the Schwartz formula. b. Adequate Liver Function Defined as: Total or direct (conjugated) bilirubin < 1.5xULN for age (≤ 5xULN if related to leukemic involvement), AND Aspartate transaminase (AST) and alanine transaminase (ALT) <5xULN (<10×ULN if related to leukemic involvement) Life expectancy: > 6 weeks Pregnancy test: Serum/urine pregnancy test (for all girls ≥ age of menarche) negative within 2 weeks prior to enrollment on the quizartinib linked-trial. Taking quizartinib: Patients must be able to reliably swallow or administer quizartinib by NG tube. Informed consent: Written informed consent/assent for the quizartinib linked trial from patients and/or from parents or legal guardians for minor patients, according to local law and regulations. General exclusion criteria: Patients with only extramedullary disease Uncontrolled or significant cardiovascular disease, including -Diagnosed or suspected congenital long QT syndrome -History of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes); any history of arrhythmia will be discussed with sponsor, the national coordinator and C.I.the prior to subject's entry into the study. -QT interval corrected >450 ms: QTc interval corrected with Fridericia's formula (QTcF) for subjects ≥ 6 years of age at the time of enrollment. -Left ventricular systolic dysfunction (LVSD), defined as ejection fraction (EF) below 55% during the screening for the CHIP-AML22/Master protocol. -History of uncontrolled angina pectoris or myocardial infarction within 6 months. -History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have nohistory of fainting or clinically relevant arrhythmias while using the pacemaker). -Heart rate <50 beats/minute on ECG during the screening for the CHIP-AML22/Master protocol (In case,adolescents with a normal sinusoidal rhythm and no evidence of other cardiac dysfunction will be discussed with sponsor, the national coordinator and C.I. the prior to subject's entry into the study.) -Uncontrolled hypertension (e.g., systolic blood pressure and /or diastolic blood pressure that is, on repeated measurement, at or above the 95th percentile for sex, age, and height). History of complete left bundle branch block. History of New York Heart Association Class 3 or 4 heart failure. Known history of HIV or active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C) Underlying GI disease that may affect absorption of study drug Use of strong or moderate CYP3A inducers will be prohibited throughout the duration of the study. Strong CYP3A4 inhibitors will be allowed with a concomitant dose reduction of quizartinib with the exception during the safety run-in. History of hypersensitivity to any of the study medications or their excipients. Other serious illnesses or medical conditions, that will likely make it impossible to complete treatment according to protocol (e.g., patients who should not be given any of the study medications based on the SmPC) Currently participating in other investigational interventional procedures, if it interferes with any endpoints of the quizartinib trial. 2) Additional exclusion criteria during safety run-in: Patients with CNS3 disease Using strong CYP3A4 inhibitors (If patient can stop using strong CYP3A4 inhibitors, he/she will be allowed to enroll. In such case, no washout is required for the strong CYP3A4 inhibitor) - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Month - MaximumAge: 18 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06262425 | Recruiting | rTMS Over S1 Enhance Motor Learning in Healthy People | The purpose of this study is to compare the effectiveness of different repetitive Transcranial Magnetic Stimulation protocols for enhancing motor learning in healthy peolple. | - EligibilityCriteria: Inclusion Criteria: Older than 18 years old and younger than 65 Exclusion Criteria: Presenting any neurological pathology Pain during the study Any contraindications to rTMS, such as metal implants, history of epileptic seizures or taking medication that lowers the seizure threshold - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262412 | Recruiting | Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder | The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the 6-month durability of a therapist-guided, Internet-delivered cognitive-behavior therapy programme for children and adolescents with body dysmorphic disorder. | - EligibilityCriteria: Inclusion Criteria: A primary diagnosis of BDD, based on the diagnostic criteria of the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. Confirmed by the assessor at the inclusion assessment using a semi-structured diagnostic interview. In cases where it is challenging to rule out the presence of actual physical defects that are clearly noticeable (e.g., if the area of concern is the genitalia), we will make a referral to an appropriate service for an expert opinion. A total BDD symptom severity score on the BDD-YBOCS-A ≥24. Confirmed by the assessor at the inclusion assessment. Age between 12 and 17 years. Confirmed by the caregiver/parent and subsequently by the medical record. A minimum of one available caregiver/parent being able to co-participate and support the child/adolescent throughout the treatment. Confirmed by the caregiver/parent at the inclusion assessment. Regular access to a computer connected to the Internet and a mobile phone to receive SMS messages (one of each per family is enough). Confirmed by the caregiver/parent at the inclusion assessment. Exclusion Criteria: Previous CBT for BDD for a minimum of five sessions with a qualified therapist within the 12 months prior to the inclusion assessment. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record. Simultaneous psychological treatment for BDD or for any psychiatric comorbidity. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record. Initiation, change of dosage or cessation of any selective serotonin reuptake inhibitors (SSRI) or antipsychotic drugs within the six weeks prior to the inclusion assessment. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record. A diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder, eating disorder, severe depression or alcohol/substance dependence. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment, with supplemental information from the semi-structured diagnostic interview and by the medical record. Immediate risk to self or others requiring urgent medical attention or inpatient care, such as suicidality, or repeated self-injurious behaviours. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment. A previous suicide attempt. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment and by the medical record (if recoded). Child/adolescent and caregiver/parent not able to read and communicate in Swedish. Confirmed by the caregiver/parent at the telephone screening and/or the inclusion assessment. Having a close relationship to an already included participant (e.g., sibling, cousin), to avoid being randomised into two different arms, with the risk of information "leaking" between the groups. Confirmed by the caregiver/parent or assessor at the telephone screening and/or at the face-to-face or video conference inclusion assessment. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 17 Years - StdAgeList: Child | 2024-03-12 |
NCT06262399 | Not yet recruiting | Long-Term Follow-Up (LTFU) of Subjects Treated With NTLA 2002 | This is a follow-up study of subjects who received NTLA-2002 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy. | - EligibilityCriteria: Inclusion Criteria: A subject has completed or discontinued from an Intellia-sponsored or -supported treatment protocol in which a complete or partial dose of NTLA-2002 was received. A subject has provided informed consent for the LTFU study. A subject is willing to attend study visits, complete protocol-required follow-up schedule, and comply with the study requirements. Exclusion Criteria: None - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Participating sites in an Intellia-sponsored clinical study of NTLA-2002. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262386 | Recruiting | Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial | For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.
In our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.
The objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases. | - EligibilityCriteria: Inclusion Criteria: Patients who presented with resectable disease ( Clinical stage 1a to 3a) Patients who received tumor resection Exclusion Criteria: Pathologic stage greater than stage 3b or 4 Pathologic stage less than stage 1a1 Could not complete treatment course Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262360 | Recruiting | Changes in Pulmonary Ventilation Distribution Assessed by Electrical Impedance Tomography in Healthy Children Under General Anesthesia | The incidence of atelectasis is high in patients undergoing general anesthesia. This may cause oxygenation impairment and further contribute to post-operative pulmonary complications. As important airway management devices for general anesthesia, few studies have compared the impact of laryngeal mask airway and spontaneous breathing on atelectasis. Through the study, the distribution of the pulmonary ventilation of children undergoing an elective and standard procedure in our center (H.U.D.E.R.F.) will be studied using electric impedance tomography.
Children from 1 year-old to 6-year-old, ASA physical status I or II who will undergo elective circumcisions under general anesthesia associated with regional anesthesia (Penile Block10) at the One Day Clinic of H.U.D.E.R.F. (Hôpital des Enfants Reine Fabiola - Brussels - Belgium).
Patients will be allocated to three different group in a ration of 1:1:1.
Group 1: spontaneous mask ventilation (20 patients).
Group 2: spontaneous laryngeal mask (LMA) ventilation (20 patients).
Group 3: spontaneous-pressure support LMA ventilation (LMA SV-PS) (20 patients).
Standard monitoring for the inductions of the anesthesia will include non-invasive blood pressure (NIBP), pulse oximetry (SpO2), Electrocardiogram (ECG), End-Tidal CO2 (EtCO2), End Tidal Sevoflurane concentration (EtSev %), inspired fraction of oxygen (FiO2), body temperature (rectal thermometer).
Induction is based as well on the local routine protocols using an inhalation induction of the patient with Sevoflurane (Fet of 6-8%) and a recommended FiO2 from 80-90% maximum until the stabilization of the induction. Then the FiO2 will be decreased at least under 40% and Sevoflurane adapted to the need of the deepness of the anesthesia (both at the discretion of the anesthesiologist in charge of the patient).
Depending on the randomization, the patient will undergo the surgery either with spontaneous face mask ventilation (group 1), LMA spontaneous ventilation (group 2), or LMA SV-PS (group 3) (during which the pressure support will be adapted at the discretion of the anesthesiologist but with a tidal volume included in the range of 6-10ml/kg).
Electrical impedance tomography measurements:
The effects of the spontaneous breathing (mask ventilation or LMA) or the pressure support ventilation (LMA SV-PS) on atelectasis formations and the distribution of the ventilation will be assessed using electrical impedance tomography.
The device used during the study will be the "PulmoVista 500"; it will be provided by Dräger (Lübeck, Germany) free of charge and without any obligation or results/conclusions requested by Dräger. The device is approved CE (European regulation) and will be used in the conditions for which it has been designed.
A reusable belt with 16 evenly spaced electrodes will be placed around the chest of each patient included in the study between the 4th and 6th ribs as recommended by Dräger.
The EIT measurements will be taken of 4 different moments:
T1: Before induction of the anesthesia in the preoperatory waiting room (and at least 30 min after the premedication).
T2: After the induction of anesthesia (GA and penile block), just before the beginning of the surgical procedure.
T3: After the end of the surgical procedure, just before discontinuing the general anesthesia.
T4: Before the discharge of the PACU. | - EligibilityCriteria: Inclusion Criteria: Children undergoing elective circumcision Age 1 to 6 years ASA class I or II Exclusion Criteria: Any history of lung diseases, congenital heart diseases or abdominal diseases that could interfere with lungs dynamic. ASA physical status11 > II. Patients whose weight is less than 10 kg. The use of Jackson-Rees device12. Contraindication for premedication. Contraindication for mask ventilation or laryngeal mask ventilation13. Contraindication for regional anesthesia. Need for opioids administration during surgery. Patients with uncontrollable movements of the body. Inability of parents/tutors to understand French or Dutch. Patients whose parents do not agree with their participation in the study Patients with thoracic perimeters (between 4th and 6th ribs) less than 37.5 cm (minimal size for the pediatric EIT belt) or more than 72 cm (maximal size for the pediatric EIT belt) Patients with damaged skin or impaired skin contact of the electrodes due to wound dressings. Patients with spinal lesions or fractures (acute or recent) Patients with pacemaker, defibrillators, or other electrically active implants - HealthyVolunteers: No - Gender: All - MinimumAge: 1 Year - MaximumAge: 6 Years - StdAgeList: Child | 2024-03-12 |
NCT06262347 | Not yet recruiting | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) for Pregnant and Postpartum Persons in MOUD | The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons. | - EligibilityCriteria: Inclusion Criteria: Potential participants must be: 18 years of age or older; Pregnant or be within 12 months postpartum; Enrolled in MOUD (either buprenorphine or methadone) at the study site or affiliated clinic where enrollment can be confirmed; Able to understand the study, and having understood, provide written informed consent in English Exclusion Criteria: Potential participants must not: 1. have suicidal or homicidal ideation requiring immediate attention. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262334 | Not yet recruiting | Evaluating the Fade to Fitness Program: A Barbershop-based Program for Black Men | The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management.
It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere.
The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. | - EligibilityCriteria: Inclusion Criteria: Self-identify as African American or Black American male - 18 - 90 years of age Able to speak and understand English Exclusion Criteria: Currently participating in another health promotion intervention On a special diet for a serious health condition Intending to move within 6 months of participating in the intervention - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - GenderBased: Yes - GenderDescription: Individuals must identify as male regardless of biological sex. - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262321 | Not yet recruiting | Phase II Trial of Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax | Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy. | - EligibilityCriteria: Inclusion Criteria: • Pathologic diagnosis of Non-Small Cell Lung Cancer (NSCLC) without targetable/oncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement). T1-4(or Tx)N0-3M1a-c, Stage IV disease (using the 8th edition of the AJCC staging manual) or metastatic recurrence of primary Stage I-III NSCLC that had been treated with curative intent therapy, without prior thoracic radiotherapy. Thoracic lung and/or nodal lesion(s) amenable to palliative chest radiotherapy. All subjects are required to have one or more of the following high-risk features: a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria) bulky (≥2 cm) parenchymal lung lesions and/or nodal lesions abutting (within 1 cm) any of the following: Proximal bronchial tree Esophagus Vertebra Heart Brachial plexus or subclavian vessels (if brachial plexus not well visualized) Superior vena cava Prior systemic therapy is allowed. Subjects must be enrolled within 6 months of first cycle of systemic therapy for Stage IV disease. Systemic therapy following the thoracic radiotherapy (on protocol) is allowed. Prior palliative surgical treatment (including airway debridement) is allowed. Concurrent chemotherapy (chemotherapy delivered from ≤2 days of before through ≤2 days after radiotherapy) is NOT allowed. Concurrent immunotherapy therapy is allowed. Subjects may undergo (or may have undergone) standard extrathoracic radiotherapy off protocol, including (but not limited to): Palliation of symptomatic bone metastases Prophylactic palliation of high-risk bone metastases Cranial radiosurgery (with controlled intracranial metastases if performed prior to enrollment) Ablative or non-ablative definitive radiotherapy for oligometastases. Subjects may undergo concurrent palliative thoracic radiotherapy (per study) and palliative radiotherapy for thoracic bone metastases (i.e., painful spine or rib metastases). It is anticipated that the study will be open at multiple sites within the Wilmot Cancer Institute network. Among these sites, subjects may be consulted and consented at any site, simulated and planned at any site, and treated at any site (even if different from the site(s) at which the subject was consulted and simulated). Exclusion Criteria: • Prior radiation therapy to the thoracic region. Active systemic lupus or Sjogren's disease. NSCLC (primary, nodal sites or metastases) causing severe symptoms requiring thoracic palliative radiotherapy for indications other than bone pain. These symptoms include superior vena cava syndrome, active and large volume (>100 ml per day) hemoptysis, airway obstruction (stridor, post-obstructive pneumonia, progressive dyspnea not attributed to other causes), compression of the spinal cord or spinal nerve roots, vertebral compression fracture, brachial plexopathy (from compression). Baseline ECOG performance status of 3-4. For the purposes of eligibility, Karnofsky Performance Score (KPS) will be converted to ECOG/Zubrod performance score, per ECOG guidelines. Brain metastases not amenable to immunotherapy alone, resection or stereotactic radiosurgery (i.e., brain metastases requiring whole brain radiotherapy). Malignant pleural effusion attributable to grossly apparent pleural disease. Subjects with malignant pleural effusion amenable to therapeutic thoracenteses and without radiographic evidence of pleural disease (i.e., studding or masses) are potentially eligible. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262308 | Not yet recruiting | Emotional Support for Women Experiencing PPROM | Preterm Prelabour Rupture of the Membranes is a pregnancy complication affecting 3% of all pregnancies. Outcomes for both the mother and baby are variable including: preterm delivery, fetal infection, cord prolapse, abruption as well as maternal sepsis and even maternal death. The outcomes are not only variable but the stress and uncertainty can be over a protracted period of time. This is a pilot study that aims to provide personalised psychological intervention at the time of PPROM based on Cognitive Behavioural Principles to see whether this improves psychological outcomes for women. | - EligibilityCriteria: Inclusion Criteria: Woman (or birthing person) aged 16 years or over; Is experiencing PPROM Has been admitted to the ward Has capacity to give informed consent to take part in the research Speaks and writes English Exclusion Criteria: • Unable or unwilling to give informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Pregnant women or individuals who are pregnant - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06262295 | Not yet recruiting | National, Observational Registry for Comprehensive Follow-up of All Implementations of the AVEIR VR LP Device in France (France LEADLESS) | Although the idea of a leadless pacemaker was first proposed in the 1970s to eliminate the probes, pockets and connectors required by conventional cardiac procedures and the associated complications, the first devices were not developed until the late 2010s. Leadless pacemakers can also improve patient comfort by replacing surgery with a percutaneous procedure, eliminating the mass and scar visible at the implantation site of a conventional pacemaker, and eliminating the need for activity restrictions to prevent dislodgement after implantation of a conventional lead.
The AVEIR VR LP leadless pacemaker was CE marked in July 2023 and will be implanted in patients in Europe.
The objective of this national registry is to evaluate the safety and performance of the AVEIR VR LP system in a population of patients indicated for implantation of a VVI(R) pacemaker in France. This registry will also allow the collection of patient characteristics and indications under normal conditions of use. | - EligibilityCriteria: Inclusion Criteria: Patient implanted with an AVEIR VR LP device Patient over 18 years old Patient informed of the nature of the study, agrees to participate in the study Exclusion Criteria: Patient under 18 years of age Patient refusing to participate in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients will be included in cardiology departments participating in the study. The study may be offered to any patient undergoing an implantation of leadless pacemaker using AVEIR VR LP device in France. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262269 | Recruiting | Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents | This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows:
Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS.
A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis. | - EligibilityCriteria: Inclusion Criteria: Affiliated to a social security system Having signed the consent after clear and fair information adapted to her age Obtained signed consent from at least 1 of the 2 parents or holders of parental authority, after clear and fair information Subject presenting an AIS defined by the existence of a three-dimensional deformity three-dimensional deformity of the spine associating a frontal deviation measured by by the frontal radiographic angle of Cobb which must be at least 15°, but less than 40°, and a vertebral rotation attested by the presence of a presence of at least 5° of gibbosity on Bunnel's scoliometer. Subject with front and side radiographs of the total spine, according to the EOS EOS technique, under load, less than 3 months old Risser test < 4/5 (EOS radiographs less than 3 months old) Subject not practicing any regular extracurricular physical activity (including regular (regular = at least 1 hour per week), for at least 6 months. Internet connection at home allowing tele-rehabilitation in a dedicated a dedicated room for the time of the session with a free surface of minimum 4m² on the floor, without any obstacle up to the ceiling. Compatibility with the technical requirements: access to a screen screen (computer or laptop, tablet...), with a minimum size of 8 inches (diagonal of 8 inches (diagonal of 20 cm), with an integrated or connected HD webcam connected, and a good quality sound, screen placed on a stable surface surface with a minimum height of 75cm and enough distance to see the to perceive from the camera the whole working area (4m²). Exclusion Criteria: (One criterion is sufficient for non-inclusion) Subject with secondary scoliosis: neurological, orthopedic, malformative... Placement of a corset or rehabilitation for less than 3 months BMI ≤15 or ≥ 30 Partial or total medical contraindication of any kind to the sports practice (examples: heart disease, unbalanced diabetes, juvenile polyarthritis, chronic painful joint pathology limiting physical performance, osteochondrosis of growth type Osgood-Schlater, Sever, Sinding-Larsen, osteochondritis, surgical sequelae limiting physical performance...) Inability to undergo the medical follow-up of the trial for psychological social or geographical reasons. - HealthyVolunteers: No - Gender: Female - MinimumAge: 13 Years - MaximumAge: 17 Years - StdAgeList: Child | 2024-03-12 |
NCT06262243 | Recruiting | The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum | It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success. | - EligibilityCriteria: Inclusion Criteria: 18 years and over, At least primary school graduate The one who is married Primiparous women who gave birth at term, Having the baby with her after birth Those who agreed to participate in the study Exclusion Criteria: Those who gave birth at less than 37 weeks of gestation Mothers with babies weighing less than 2500 grams The newborn has a congenital anomaly, Those with a history of high-risk pregnancy Those who received any food, including water, other than breast milk until the 10th day of follow-up Those with cardiovascular disease problems, those with a history of neurological diseases Mothers with nipple problems Diabetes Mellitus, those diagnosed with gestational diabetes mellitus, Mothers who gave birth with general anesthesia - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262217 | Recruiting | Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke | This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered. | - EligibilityCriteria: Inclusion Criteria: Male or non-pregnant female > or = 18 years of age Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA Consent of patient or legal representative Exclusion Criteria: Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow & Clyde - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262204 | Not yet recruiting | Hallux Valgus Correction Using the Metal Screw or the Human Allogeneic Cortical Bone Screw (Shark Screw). | The goal of this clinical trial is to compare the treatment of Hallux Valgus using the conventional method (metal screw) with the new method (human allogeneic cortical bone screw (Shark Screw®) in adult patients with confirmed Hallux Valgus.
The main questions it aims to answer are:
Can the new method obtain similar results as the conventional method in regard to union rate and time to union? Are the number of complications lower with the new method? Participants will be operated either with the metal screw or with the Shark Screw®. The assignment to the groups is randomized. | - EligibilityCriteria: Inclusion Criteria: between 18 and 85 confirmed Hallux Valgus Exclusion Criteria: <18 years and >85 years Known underlying oncological disease Pregnant women or breastfeeding mothers Alcohol and drug abuse Foreseeable compliance problems Foreseeable loss of responsibility as a study doctor Neoplastic diseases Active osteomyelitis Ulcerations in the area of the skin of the surgical site Immunosuppressive medication that cannot be discontinued - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262191 | Recruiting | Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy | This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy. | - EligibilityCriteria: Inclusion Criteria: Age between 8-35 years old, inclusive Diagnosis of cerebral palsy (CP) Gross motor functional classification score level I, II, or III Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic) Ability to walk for 6 minutes on a treadmill At least 20° of passive plantar-flexion range of motion No concurrent treatment other than those assigned during the study No condition other than CP that would affect safe participation No surgery within 6 months of participation. Exclusion Criteria: -Excessive knee flexion during walking caused by CP - HealthyVolunteers: No - Gender: All - MinimumAge: 8 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06262178 | Not yet recruiting | Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children | The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy). | - EligibilityCriteria: Inclusion Criteria: military connected mother, defined as mothers who are either a female service member or veteran or female spouse of a service member or veteran; with a child aged 2-10 (if more than one child in this age range, the mother will indicate child with most behavioral difficulties); lifetime trauma exposure; screen positive for PTSD defined by scores ≥ 32 on PTSD Checklist-5 (PCL-5) with and without depression (scores ≥ 10 on Patient Health Questionnaire-9 (PHQ-9); able to speak and understand English or Spanish. being the legal guardian for the child with physical and legal custody Exclusion Criteria: high risk for suicide, defined by VA as having intent, means, and a plan; current psychotic symptoms (SCID); communication disability (e.g., deafness); child with diagnosed severe developmental disability Meeting a diagnosis of severe substance or alcohol use disorder (≥ 6 symptoms on SCID) AND not in early remission (≥3 months without meeting any substance or alcohol use disorder criteria (except craving) - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262165 | Not yet recruiting | Evaluation of Liver Damage in Patients With Anorexia Nervosa by Blood Biomarker Analysis | The main goal of the BIocoLlection in Anorexia Nervosa-liver damage evaluation BILAN study the blood biomarkers associated with liver cytolysis. | - EligibilityCriteria: Inclusion Criteria : Patient over 15 years old Diagnosis of Restricted Eating Disorders including Anorexia Nervosa according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Admission to Nantes University Hospital. Exclusion Criteria : Chronic active viral hepatitis Hemochromatosis Other genetic, autoimmune. Treatment with a drug known to induce fatty liver disease (amiodarone, carbamazepine, tamoxifen, valproate, clozapine, anti-retrovirals) unless the dose has been stable for ≥ 3 months Excessive alcohol consumption (≥ 30 grams per day in men, ≥ 20 grams per day in women) Pregnant, parturient or breast-feeding women, persons deprived of liberty, adults under legal protection or unable to express their consent, persons not affiliated or not beneficiaries of a social security scheme, persons under guardianship or curators - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - MaximumAge: 99 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Consecutive inclusion of patients hospitalized in the endocrinology department for anorexia nervosa with malnutrition criteria. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06262152 | Recruiting | Sleep Profile of Patients With Septo-optic Dysplasia | The aim of this study is to evaluate sleep of patients with septo-optic dysplasia compared to patients with an isolated disorder of peripheral visual system and patients with corpus callosum agenesis since both visus defict and agenesis of corpus callosum might be present SOD but associated to other features / structural and functional anomalies.
Included patients and their caregivers will be asked to compile standardize sleep questionnaires and a sleep screening through an interview will be scheduled. Patients will be asked to wear an actigraph on their non-dominant hand wrist for 7 days. | - EligibilityCriteria: Inclusion criteria group A: diagnosis of SOD or SOD plus syndrome with or without a defined genetic diagnosis age 3-18 years availability of at least 2 serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months Inclusion criteria group B: diagnosis of congenital or early acquired isolated peripheral visual deficit with or without a known genetic diagnosis (e.g., congenital cataract, inherited retinal dystrophies, isolated eye maldevelopment). age 3-18 years grating or visual acuity < 3/10 availability of serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months Inclusion criteria group C isolated corpus callosum agenesis at brain MRI age 3-18 years availability of at least 2 serial sleep EEGs performed during clinical follow-up stable drug therapy in the last three months Exclusion criteria group A: absence of informed consent severe Intellectual disability and/or severe motor impairment melatonin assumption Exclusion criteria group B: absence of informed consent CNS involvement ( malformations/ lesions) severe Intellectual disability and/or severe motor impairment melatonin assumption Exclusion criteria group C absence of informed consent severe Intellectual disability and/or severe motor impairment melatonin assumption - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult - StudyPopulation: Three groups of patients will be included: Group A: 15 patients with septo-optic dysplasia Group B: 15 patients with disorder of peripheral visual system Group C: 15 patients with Corpus Callosum agenesis - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262139 | Not yet recruiting | Evaluation of a Targeted Magnetic Resonance Imaging Contrast Agent in Prostate Cancer Patients | This phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of MT218 injection for biomarker targeted MR molecular imaging (MRMI) of prostate cancer in patients scheduled for radical prostatectomy. | - EligibilityCriteria: Inclusion criteria Male subjects aged >18 years. Patients with confirmed Gleason score of 8 - 10 prostate cancer, had at least one prostate mpMRI and one prostate biopsy. Ability to lie still for MRI scanning. Patients must be able to provide written informed consent. Glomerular filtration rate (GFR) > 60 mL/min within a 30 days of the research MRI. Key exclusion criteria Any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections. Patients with uncontrolled diabetes or hypertension. Patients with active non-prostate malignancy. Patients with contraindications for MRI including implantable pace makers, cochlear implants. Patients with uni- or bilateral hip prosthesis. Subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. Major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect MRI result. Subjects who received or will receive any other MRI contrast agent within 48 hours prior to MT218 injection or up to 24 hours after MT218 injection. Is determined by the investigator that the patient is clinically unsuitable for the study. Is incapable of understanding the language in which the information for the patient is given. Participation in a concurrent clinical trial or in another trial within the past 30 days. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262126 | Not yet recruiting | A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain | The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP). | - EligibilityCriteria: Inclusion Criteria: Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain) Negative prior cardiac evaluation (at a minimum, including electrocardiogram) Prior esophagogastroduodenoscopy and/or barium esophagram to rule out severe esophagitis, stricture, or motility abnormality Exclusion Criteria: Initiation of a proton pump inhibitor (PPI) within 8 weeks Major concomitant illness Current drug or alcohol use that that would interfere with adherence to study requirements Symptoms of vertigo or dizziness that would limit tolerability of the VR headset - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262113 | Not yet recruiting | A Decentralized Clinical Trial to Promote Evidence-Based Care for Underserved Patients With Neurofibromatosis 1 | The goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with Neurofibromatosis 1 (NF1). The primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for NF1 patients in primary care settings.
Adults with NF1 and parents/guardians of children with NF1 from across the U.S. who do not go to a specialized NF clinic and who have an upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study. | - EligibilityCriteria: Adult Inclusion Criteria: Currently lives in the United States (including Puerto Rico and other United States territories) Has a clinical diagnosis of neurofibromatosis 1 Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network Has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent Speaks English or Spanish Parent/Guardian of a Child with NF1 Inclusion Criteria: Currently lives in the United States (including Puerto Rico and other United States territories) Cares for a child (age <18 years) with a clinical diagnosis of neurofibromatosis 1 Does not attend an NF clinic within the Children's Tumor Foundation NF Clinic Network Their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent Speaks English or Spanish Exclusion Criteria: Only one person per household may participate in the study Unwilling or unable to give informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262100 | Recruiting | Lubricating Effectiveness of Carragelose Eye Drops in Patients Affected by Mild to Moderate Dry Eye | Patients suffering from dry eye syndrom will treat their eyes with Carragelose® eye drops three times a day for 28 days. Before, in the middle and at the end of the treament period patients will be exposed to adverse conditions to challenge dry eye symptoms. Patient will record their occular symptoms and ophthalmic examinations will be performed by an ophthalmologist. Differences between before and after treatment will be assessed. | - EligibilityCriteria: Inclusion Criteria: Adult patients (aged ≥ 18 years) from any sex or gender who provide written informed consent to participate. Diagnosis of DED by an ophthalmologist having DED-related symptoms lasting at least 3 months. Mild-to-moderate DED as defined above. Patients who do not use or can do without the use of contact lenses from at least 7 (±2) days before the Inclusion visit (Visit 2) and throughout the entire study period. Patients able to administer the study eye drops themselves in both eyes for the intended duration of the study (28 days). Patients willing not to use any other eye drops during the entire study period. Women with childbearing potential must commit to using effective methods of contraception during the entire study period and have a negative result on a pregnancy test at the Screening visit. Exclusion Criteria: Patients with known hypersensitivity, allergy, or intolerance to the IP or any of its components. Patients with any ocular surface disease or condition other than DED. Patients with any other active ocular inflammatory disease or condition, glaucoma or who have received any ocular surgery during the last 6 months. Patients who have received lacrimal punctum occlusion during the previous month, or in whom it is planned during the study period. Patients with any of the following seriousness criteria: fluorescein corneal staining score ≥ 4 in the Oxford scale; lissamine green conjunctival staining score ≥ 4 in the Oxford scale; Schirmer test score < 2 mm; fluorescein TBUT = 0 seconds. Patients receiving any other topical ocular medication, such as non-steroidal anti-inflammatory drugs, etc. within 30 days of inclusion (Visit 2). Patients with clinically relevant or uncontrolled systemic diseases (except for controlled Sjögren syndrome) during the last 3 months that may interfere with study assessments or results. Patients requiring or who have received topical ocular treatment with calcineurin inhibitors (such as cyclosporin or tacrolimus) during the last 12 weeks, corticosteroids during the last 4 weeks, blood derivatives (such as autologous/allogeneic serum, platelet-rich plasma, plasma rich in growth factors or umbilical cord-derived plasma), insulin or amniotic membrane preparations during the last week, during the last month before the Inclusion visit (Visit 2). Patients who have received treatment with any ocular lubricant after the Screening visit (Visit 1) other than the one specified in the protocol (Hydrabak). Patients who have started systemic treatments that may affect DED signs or symptoms, ocular surface or vision, during the last 3 months or if a change in the dose of such treatments is expected during the study. Inability to follow the study procedures, including attending all site visits, tests, and examinations. Mental incapacity that precludes adequate understanding or cooperation. Patients currently participating or who have participated in another investigational study during the last 30 days. Pregnant or breastfeeding women. Patients who, according to the investigator's criteria, are not suitable to participate in the study or comply with the study protocol. - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262087 | Recruiting | The Combined FIFA 11+ and Change of Direction Training | The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+. | - EligibilityCriteria: Inclusion Criteria: Soccer players Exclusion Criteria: Having experience of serious injury such as, ACL injury and chronic ankle instability Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture Having current musculoskeletal injuries such as, muscle sprain Attending other prevention program or similar study especially on lower extremity Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult | 2024-03-12 |
NCT06262074 | Recruiting | Effect of Structured Training Program in Diabetic Patients | Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals. | - EligibilityCriteria: Inclusion Criteria: Diabetes mellitus with moderate to severe DPN Subjects of both gender Age from 40 to 70 years Independent walking MNSI score more than 2 out of 13 Exclusion Criteria: Presence of an active planter ulcer History of surgery during intervention period Neurological diseases other than DPN - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262061 | Not yet recruiting | Propranolol for the Treatment of Traumatic Brain Injury | Traumatic brain injury (TBI) is a leading cause of global disease and directly affects over 1.5 million Canadians, with 165 000 TBIs occurring yearly in Canada. Despite the burden of TBIs, there are limited treatment options available and current treatments generally focus on supportive care. The aim of TBI treatment is reduce inflammation and damage occurring after the TBI (secondary injury).
Beta- blockers (BBs) are medications commonly used to block the actions of endogenous catecholamines- hormones that are thought to contribute to secondary injury within brain tissue. This reduces metabolic demand in the vulnerable, injured brain. BBs have been studied in several retrospective trials and one single-center, non- blinded randomized controlled study. These results point towards a benefit to the use of BBs in TBI but need to be confirmed in a rigorous manner before they are widely adopted.
The current study aims to assess the feasibility of a single centre randomized controlled trial of BBs versus placebo to treat moderate to severe TBI. This feasibility trial will inform the planning of a large multi-center study powered to detect a difference in cognitive outcomes and mortality. It also will allow the investigators to gather biologic samples for measuring serum catecholamines and inflammatory mediators to better understand the basic science mechanisms of BBs in this patient population; and to assess the feasibility of using the Cambridge Battery to assess cognitive outcomes of trial participants. | - EligibilityCriteria: Inclusion Criteria Adult patients (>18/= 18 years of age) who have sustained a TBI Initial GCS during the first 6 hours of assessment of 5- 12 (inclusive) Exclusion Criteria Home beta- blocker therapy New indication for beta- blocker therapy during hospital stay Contraindication to beta- blocker therapy Allergy Severe asthma/ COPD Sinus bradycardia and greater than first degree block Patients in cardiogenic shock Right ventricular failure secondary to pulmonary hypertension Congestive heart failure unless the failure is secondary to a tachyarrhythmia treatable with propranolol Patients requiring any vasoactive medications to maintain their blood pressure at the time of enrollment Patients requiring or are on any of the following medications: Digitalis Anesthetic agents that maintain cardiac contractility by virtue of their effect on catecholamine release (e.g., ether) Epinephrine, noradrenaline, adrenaline, and isoproterenol Antiarrhythmic cardiac depressant drugs such as procainamide or quinidine Thiazide-like diuretics and/or peripheral vasodilators Catecholamine depletion drugs such as reserpine or guanethidine Patients not expected to survive 48 hours >24 hours from trauma at the time of enrollment a. Patients on vasoactive medications at initial trial screening may enter the trial if their vasopressor requirements cease within 24 hours of their trauma Inability to secure enteral access for medication administration Doses of BB will be held under the following circumstances a. HR <45 or MAP <55 for 5 minutes prior to administration time Patients that are pregnant and/or breastfeeding participants - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262048 | Not yet recruiting | Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial | The objectives of this study are to determine the efficacy of tamsulosin compared to placebo in reducing post-operative urinary retention and improving other clinical outcomes in people undergoing pulmonary surgery. | - EligibilityCriteria: Inclusion Criteria ( 2 or more of the following risk factors): Male Sex Age greater than or equal to 40 years History of Diabetes Mellitus Prior pelvic irradiation Use of indwelling Thoracic Epidural analgesia Prior history of urinary retention AND International Prostate Specific Score greater than or equal to 1. Exclusion Criteria: Active treatment of Benign Prostatic Hyperplasia (BPH) Hypersensitivity or allergy to tamsulosin HCL Active treatment with tamsulosin or other alpha-blocker or uses of tamsulosin/ other alpha-blocker within 3 weeks of enrollment date Active urinary tract infection History of urological disorder specified as urethral stricture, BPH, bladder or prostate malignancy. History of urological surgery (Transurethral resection of the Prostate, Transurethral resection of the Bladder, Bladder suspension, prostatectomy) Underlying neurological disorders resulting in impaired bladder function Any known contraindication to the use of tamsulosin HCL - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262035 | Not yet recruiting | Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases | To investigate the transcriptomic profile of periodontitis and peri-implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included to investigate the gene expression profile in tissue affected by periodontitis and peri-implantitis. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and the number of teeth. During surgical intervention, tissue biopsies (two specimens per site) will be collected by a periodontist from site with ongoing periodontitis and site from ongoing peri-implantitis.
To study the microbiome and biomarker profile associated with periodontitis and peri- implantitis. Patients with defined periodontitis, at two non-adjacent teeth and peri-implantitis at ≥ one implant in function of ≥ one year, will be included in this study to determine the bacteria composition, cytokine profile and inflammatory biomarkers profile. Subjects will undergo a full-mouth examination performed by a calibrated examiner, including assessment of caries, bone abnormalities and infections according to intraoral x-ray, plaque index and pocket probing depth, suppuration, bleeding on probing, alveolar bone loss, and number of teeth. Peri-implant crevicular fluid (PICF), gingival crevicular fluid (GCF), saliva and submucosal/subgingival plaque will be collected.The presence and composition of periodontal and peri-implant plaque samples are investigated. | - EligibilityCriteria: Inclusion Criteria: ≥18 years of age Defined periodontitis at two non-adjacent teeth Defined peri-implantitis at ≥1 implant Signed informed consent Exclusion Criteria: Surgical intervention of periodontitis and/or peri-implantitis during last 6 months. Local or systemic use of antibiotics during last 6 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients diagnosed with periodontitis and peri-implantitis, referred from a general clinic in Stockholm County to a periodontist. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06262022 | Recruiting | The Effect of Cold Application on Pain Level, Edema and Drainage Amount | In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:
Is there a difference between the pain levels of patients in the control and cold application arms?
Is there a difference between the knee edema of patients in the control and cold application arms?
Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT). | - EligibilityCriteria: Inclusion Criteria: 18 years and above, Able to communicate verbally and in writing, Turkish speaking, TKA applied for the first time, Unilateral total knee arthroplasty applied, Spinal anesthesia applied, Having a hemovac drainage catheter, Without peripheral vascular disease, Exclusion Criteria: Revision total knee arthroplasty applied, Bilateraltotal knee arthroplasty applied, Those who use alcohol and substances, TKA was performed for a reason other than knee osteoarthritis, General anesthesia applied, - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06262009 | Not yet recruiting | Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment | Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO | - EligibilityCriteria: Inclusion Criteria: Adult or child planning to live in the same household as his/her dog during the three months following inclusion. Planning to live in the same habitat in the next three months following inclusion (except for holidays). Written consent of all adults and of at least one of the two parents for minors under parental authority. A different information note will be elaborated for each age category (6-10 yr-old, 10-15 yr-old and 16-18 yr-old). Owning a dog recorded for a surgery at the National Veterinary School Exclusion Criteria: Lack of signed informed consent Subject in alternating custody Subject under legal protection (guardianship) Subject deprived of liberty under judicial constraint Subject undergoing psychiatric care Lack of affiliation to a social security scheme Volunteers who do not speak/write French - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The healthy volunteers (dog owners) will be recruited at a single recruitment centre, which is the National Veterinary School (Maisons-Alfort). - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261996 | Not yet recruiting | Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation. | The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:
Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications.
Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation. | - EligibilityCriteria: Inclusion Criteria: Aged 18-65 years old Intubation and mechanical ventilation <12h before enrollment Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU). Signed informed consent Exclusion Criteria: parturient, childbirth or lactating mothers acute severe neurological disease or coma chronic renal failure previous mechanical ventilation >12h severe liver dysfunction (Child-Pugh score C) BMI >30kg/m2 (>90kg) dying - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261983 | Recruiting | Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma. | Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique. | - EligibilityCriteria: Inclusion Criteria: Oral squamous cell carcinoma T1-T2, cN0. Absence of alterations to iron metabolism. Exclusion Criteria: Previous neck surgery. Treatment with iron chelators. Pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 29 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients recruited consecutively when diagnosed with oral squamous cell carcinoma at clinical stages I-II by biopsy and magnetic resonance. All patients were intervened by the same surgeon at the Department of Maxillofacial Surgery at Donostia University Hospital. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261957 | Not yet recruiting | A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants 12 Years of Age and Older With Asthma | The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged 12 years and above with asthma. | - EligibilityCriteria: Inclusion Criteria: Participant of 12 years of age or older at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian. Asthma for ≥ 6 months, defined as: Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023] Receiving one of the following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study: Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines [GINA, 2023], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study. Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines [GINA, 2023] plus SABA, which is anticipated to remain stable for the duration of the study. Participants who utilize combination budesonide/formoterol (e.g., Symbicort) as reliever therapy, whether or not this is in addition to a SABA - are not eligible for screening. Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up). Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) Asthma Control Status Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as: Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids. Reversibility of disease evaluated by pulmonary function testing. Participants should be able to withhold SABA for ≥6 hours and LABA-containing medications for ≥24 hours for the purposes of performing screening spirometry. Exclusion Criteria: A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator. Other significant pulmonary diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma. espiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant's asthma status, OR the participant's ability to participate in the study. 4. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. 5. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) 6. Long-acting muscarinic antagonist (LAMA) during the 3 months prior to the start of the study. 7. Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06261944 | Not yet recruiting | A Pivotal Clinical Investigation Confirming the Safety and Accuracy of the Glyconics-DS in Assessment of Glycated Nail Keratin in Individuals With Unknown Diabetes Status and Performance Evaluation of the Glyconics SW Package | The main clinical study objective is to confirm the accuracy of the Glyconics-DS spectrometer when used in its intended medical purpose population, i.e., in individuals with unknown diabetes risk. Additionally, this investigation will serve as a pivotal performance evaluation for the associated software for correct delivery of the algorithm-based analysis of the individual diabetes risk. The study will be considered positive if the backend delivery of the chemometrics output is performed correctly as per the cloud-based analysis and its delivery represents the essential medical software to be evaluated in this investigation. The 'true' diabetes risk will be contrasted against values of an internal biomarker indicative of glycaemia, HbA1c, as measured based on standardised, certified methodology. | - EligibilityCriteria: Inclusion Criteria: Apparently healthy adults (≥18 years of age) with unknown diabetes status willing to participate in and provide a written consent for the study Willingness to undertake assisted assessment of glycaemia: by both the NIR spectral measurements in a chosen middle fingernail, and HbA1c (blood sample) Individuals with at least one visually assessed undamaged, intact (preferably middle) fingernail. Exclusion Criteria: Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as: Severe forms of anaemia (diagnosed iron deficiency, sickle cell anaemia or similar). Haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular (local) laboratory assays for HbA1c. Severe renal impairment (CKD stage III-IV) or decompensated hepatic disease. Severe Vitamin D deficiency (diagnosed or measured 25(OH)D3 < 25 nmol/ml). Known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia. Eating disorders (as per clinical assessment) Recent (within 28 days) blood donation Any other type of known diabetes than T2DM, if diagnosed (T1DM, GDM, MODY, etc.) Any structural, deviating and visually detectable deviations in the appearance of the (only/ to be assessed) middle fingernail potentially impacting the spectra measurement, including: nail dystrophy or deformity severe nail infections (onychomycosis causing visual changes in the appearance of the nail). rare hereditable conditions impacting the structure of keratin. mechanical damage or marks on the surface of the nail after removal of nail polish. use of acrylic or gel nail decoration and polish, which cannot be removed with acetone (use of acetone necessitates a 15 min post-removal wash-out time) Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261931 | Not yet recruiting | Severity Over Time of Early Forms of Spondyloarthritis | Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission. | - EligibilityCriteria: Inclusion Criteria: age >18 years; Diagnosis of SpA confirmed by the rheumatologist with duration of symptoms < 2 years; Signature of the written informed consent to the study Exclusion Criteria: Age < 18 years; Patients suffering from other rheumatic pathologies (even in overlap), or genetic diseases such as Marfan syndrome, Ehlers Danlos syndrome Any medical or psychiatric condition that in the judgment of the investigator would prevent the participant from complying with the protocol or completing the study according to the protocol. Refusal to sign the informed consent to the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: patients with recent onset of SpA (duration of symptoms ≤2 years) and diagnosis made by the rheumatologist. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261918 | Recruiting | Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome | This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells. | - EligibilityCriteria: Inclusion Criteria: Patients will be treated as per standard. Inclusion criteria depend exclusively on compliance with informed consent, tumor size (only advanced stage tumors will be used for the study) and histological diagnosis. Specifically, patients with the following will be included in the proposed study: Histological diagnosis of locally advanced Luminal or HER2+ or Triple negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage II to III disease. Age > 18 years Regular clinical and instrumental follow up Informed consent form signed by enrolled patients - Availability of information from medical records: pre/post NAC blood chemistry tests: blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL + LDL cholesterol); BMI; possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs; Sex hormone hormonal status (pre- or post-menopause); Exclusion Criteria: Prior or synchronous history of systemic malignancy. - History of homo- or contralateral breast cancer. Evidence of metastatic (Stage IV) disease. Neo-adjuvant treatment with hormonal therapy. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261905 | Not yet recruiting | Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System | The research team is investigating Opioid Use Disorder (OUD), a disorder characterized by dysregulated dopaminergic tone, to evaluate the mechanisms of adjunctive treatment with calcitriol. The investigators will recruit 12 subjects with OUD and 12 healthy subjects to participate in a double-blind, randomized study design where subjects will complete up to 2 Positron Emission Tomography (PET) scans using [11C]-PHNO. The investigators will compare subjects in differences between their own study days and in differences between healthy control subjects and subjects with OUD. | - EligibilityCriteria: Inclusion Criteria: Age 18-50 years Voluntary, written, informed consent Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations Meets the criteria for OUD, as determined by the Structured Clinical Interview for DSM-5 (SCID) Stable and receiving buprenorphine treatment for OUD For females, non-lactating, with a negative serum or urine pregnancy (hCG) test Lab results without clinically relevant findings (e.g., renal function, electrolytes, and vitamin D levels) English speaking Exclusion criteria: Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity) History of substance dependence (e.g., alcohol, sedative hypnotics), except for nicotine and opiates. A primary major DSM-5 psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the SCID, except for Opioid Use Disorder and related conditions. A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness Positive answers on the cardiac history questionnaire that may place the subject at higher risk, as determined by the study physician's review of both the questionnaire responses and screening ECG. If there is concern for the subject's safety due to these assessments, research staff will consult a Yale PET Center affiliated cardiologist prior to including the subject for the study. Current use of psychotropic and/or potentially psychoactive prescription medications Receiving medications for OUD other than buprenorphine (e.g., methadone treatment) For females, laboratory (β-HCG) or physical evidence of pregnancy/lactation MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker) History of claustrophobia or feeling of inability to lie still on his/her back for the PET or MRI scans History of any bleeding disorder or current anticoagulant therapy Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first test day. Use of any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements which could have a negative clinical interaction with calcitriol or which could confound scientific results of the study, within 2 weeks prior to each test day (e.g., thiazide diuretics, Mg based antiacids, digoxin, etc,). Serum levels of 25(OH)D3 below 12 ng/ml. Morbid obesity i.e., BMI over 35 (more prone to lower vitamin D levels) Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year. Subjects with current, past or anticipated exposure to radiation in the workplace History of kidney stones within the past 5 years Any degree of renal failure History of parathyroid disorder (hyper or hypoparathyroidism) History of osteoporosis or any pathologic fractures Vitamin D supplementation in any form in the past 3 months Known hypersensitivity to [11C]-PHNO or calcitriol Malabsorption syndromes (i.e., Celiac sprue) Serum corrected calcium > 10.5 mg/dl or phosphate > 4.2 mg/dL - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261892 | Recruiting | Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer-HPV DNA and Other Biomarkers in Urine | The goal of this clinical trial is
To test the sensitivity and specificity of using HPV DNA from urine for the detection of pre-cervical or/and cervical cancer.
If HPV DNA is not a promising biomarker, other biomarkers will be explored.
To develop an effective and non-invasive detection method of the pre-cervical or/and cervical cancer. in Women with menstruation.
The main question it aims to answer is:
To validate whether HPV DNA from urine could be used as a non-invasive means for the detection of pre-cervical or cervical cancer
Participants will
Join the briefing session of the study
Sign the consent form and health questionnaire
Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
Collect the urine sample
If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if HPV DNA from urine is a promising biomarker for the detection of pre-cervical or cervical cancer | - EligibilityCriteria: Inclusion Criteria: Female aged between 18 to 65 Have menstruation Had sex before Can read and write Chinese/ English Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.) Exclusion Criteria: • Subjects who used medication will be excluded from the sample collection. Moreover, subjects with visible signs of gynarcological infections (e.g. gonorrhea, trichomonas vaginalis) or suffered an HIV/ hepatitis B virus (HBV)-infection will be excluded. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261879 | Recruiting | Non-invasive Biomarker Discovery for Pre-cervical or/and Cervical Cancer--ACTN4 and Other Biomarkers in Menstrual Blood | The goal of this clinical trial is
To test the sensitivity and specificity of using ACTN4 from menstrual blood for the detection of pre-cervical or/and cervical cancer.
If ACTN4 is not a promising biomarker, other biomarkers will be explored.
To develop an effective and non-invasive detection method for pre-cervical or/and cervical cancer.
in Women with menstruation.
The main question it aims to answer is:
To validate whether menstrual blood could be used as a non-invasive means for the detection of pre-cervical or cervical cancer
Participants will
Join the briefing session of the study
Sign the consent form and health questionnaire
Submit the cervical medical report(s) within 3 months or perform sponsored pap smear test
Collect the menstrual blood sample
If there is a comparison group: Researchers will compare The diseased group and the healthy group according to the medical reports they provided to see if ACTN4 from menstrual blood is a promising biomarker for the detection of pre-cervical or cervical cancer | - EligibilityCriteria: Inclusion Criteria: Female aged between 18 to 65 Have menstruation Had sex before Can read and write Chinese/ English Without taking any medication (Except nutritional supplements, traditional Chinese medicine, and health care products etc.) Exclusion Criteria: Subjects who used medication will be excluded from the sample collection. Moreover, subjects with visible signs of gynarcological infections (e.g. gonorrhea, trichomonas vaginalis) or suffered an HIV/ hepatitis B virus (HBV)-infection will be excluded. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261866 | Recruiting | Multimodality Imaging and Functional Lesion Assessment in Intermediate Coronary Stenosis in Chronic Coronary Syndrome | The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, FFR) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis. | - EligibilityCriteria: Inclusion Criteria: 18 years or older Chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the Canadian Cardiovascular Society classification or positive ischemia test (exercise test, single photon emission tomography (SPECT) Intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography FFR and OCT examination of the same lesion The patient is willing to participate in the study and has provided a written informed consent Exclusion Criteria: Acute coronary syndrome Proximal left main lesion Ostial right coronary artery lesion Bypass of the assessed vessel Contraindications for adenosine administration Hemodynamic instability Heart insufficiency in New York Heart Association (NYHA) class IV scale Acute renal insufficiency Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergoing coronary angiogram due to chronic coronary syndrome with intermediate grade coronary stenosis. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06261853 | Not yet recruiting | The Impact of 3D-CBCT Imaging on Nerve Injuries During Wisdom Tooth Surgery | The investigators aim to investigate if the additional information available from a 3D scan of the wisdom tooth can reduce the risk of nerve injury during wisdom tooth surgery compared to conventional 2D images.
Wisdom tooth surgery is a common surgical procedures that a significant proportion of the population will undergo. As with any other surgical procedure, there are potential complications, of which, injury to the nerve supplying feeling to the lip, chin, and tongue is the most significant. This can lead to persistent pain, tingling, or numbness that may impact a patient's ability to eat and function.
The risk of nerve injury during wisdom tooth surgery is assessed using X-ray images, which show the position of the nerve and tooth in the jawbone. 2D and 3D scans are used, which have their own advantages and disadvantages such as reduced cost and radiation dose with 2D or more information from 3D images, but it remains unclear which is better at reducing the risk of nerve injuries. | - EligibilityCriteria: Inclusion Criteria: Individuals are seen in the Oral Surgery department with a 2D-OPG x-ray and a diagnosis of a mandibular wisdom tooth that requires surgical treatment. Individuals requiring a 3D-CBCT to further assess the relationship between the wisdom tooth and the inferior alveolar nerve. Individuals who are to undergo surgical treatment for their wisdom tooth regardless of the surgical approach (e.g. coronectomy or extraction) or the anaesthetic technique utilised. Individuals without any pre-existing neurological deficit of cranial nerve V (trigeminal nerve) or medical conditions or medications that may cause changes in neurosensory function. Individuals over the age of 16 and willing and able to provide valid informed consent for themselves. Individuals with adequate English comprehension to read the written PIS and consent form and understand the follow-up call questions. Individuals willing to provide contact details to allow a telephone follow-up call one week after their surgery. Exclusion Criteria: Individuals who do not have the capacity to consent for themselves. Individuals taking medicines or having medical conditions and disorders that impair neurosensory function. Individuals requiring wisdom tooth surgery to manage associated pathology such as cysts, fractures, or tumours where the pathological condition may interfere with the neurosensory function of the trigeminal nerve at 1 week post-operatively. Individuals who are unable to read or speak English. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06261840 | Not yet recruiting | Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole | This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. | - EligibilityCriteria: Inclusion Criteria: Participants must have a positive T. vaginalis rapid antigen test, wet mount, or nucleic acid amplification test (NAAT) within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment, must speak and understand English and be willing to comply with the study protocol, have a method of contact (either phone, email or social media), and be willing to be randomized. Exclusion Criteria: Participants will be excluded if they are pregnant/lactating, have been treated for their trichomonas infection with 5-nitroimidazoles (i.e. MTZ, SEC), used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 28 days, or if they have a history of a hypersensitivity reaction to 5-nitroimidazole medications. They also cannot be taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug interactions with oral MTZ or have been previously enrolled in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261827 | Recruiting | High-dose Inhaled NO Therapy for the pREvenvention of NP After Cardiac Surgery Under CPB | The primary aim of this single-center, prospective, randomized, controlled, study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery under CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB. | - EligibilityCriteria: Inclusion Criteria: Cardiac surgery with CPB at current hospitalization. Age > 18 years. Signed informed consent Exclusion Criteria: Emergency surgery. Acute coronary syndrome 30 days before surgery. Surgery for active infective endocarditis requiring antibiotic therapy. Diagnosed infectious process of another localization (surgical site infection (SSI), acute and chronic urinary tract infection (active), catheter-related bloodstream infection, peritonitis, etc.). Taking antibacterial drugs for 14 days preceding surgery Other complications of the postoperative period (pneumothorax requiring pleural drainage, perioperative myocardial infarction accompanied by pulmonary edema, shock of any etiology during the current hospitalization). Potentially dialysis-dependent stage 2 and higher acute kidney injury (according to KDIGO) in the early postoperative period (the criteria for potentially dialysis-dependent acute kidney injury will include patients with stage 2 acute kidney injury and: oliguria against the background of normo-hypervolemia and resistance to loop diuretics and/ or oliguria against the background of conducting infusion therapy due to hypovolemia and resistance to loop diuretics). Continued mechanical ventilation. Delirium. Presence of tracheostomy. Patient's participation in another clinical trial at the time of screening or within the previous 3 months. Concomitant pulmonary disease with the need for respiratory support before surgery. History of malignancy or other irreversible diseases/conditions with a 6- month mortality rate >50%. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261814 | Not yet recruiting | Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors | This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods. | - EligibilityCriteria: Inclusion Criteria: Scheduled for TACE therapy of a liver tumor Be at least 18 years of age Be medically stable If a female of child-bearing age, must have a negative pregnancy test Have signed informed consent to participate in the study Exclusion Criteria: Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable Patients with known sensitivities to the components of lumason - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261801 | Recruiting | Efficacy of Electroacupuncture Combined With Pregabalin in the Treatment of Trigeminal Herpetic Neuralgia: a Multicenter Randomized Controlled Trial Study Protocol | Trigeminal herpetic neuralgia is a common type of Zoster-associated Pain (ZAP), which troubles individuals in all ages and burdens society all over the world. Eleactroaupuncture (EA) is increasingly used in the treatment of ZAP due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. Therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of EA on ZAP and whether EA can be used as a substitute for pregabalin. | - EligibilityCriteria: Inclusion Criteria: meet the aforementioned diagnostic criteria for trigeminal ZAP, with a disease duration of 1 to 3 months; have a visual analog scale (VAS) score of 4 points ≤ VAS ≤ 7 points; be between 18 and 85 years old, regardless of gender; have clear consciousness, the ability to distinguish pain, and complete basic communication; voluntarily participate in the study, sign a written informed consent form, and fully understand the plan. Exclusion Criteria: do not meet the above-mentioned inclusion criteria; have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster; are pregnant or lactating patients; are allergic to pregabalin or acupuncture stimulation; have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment; have severe skin diseases; have a pacemaker; have been or are currently participating in other clinical studies within the past 3 months. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261762 | Not yet recruiting | Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone | The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:
Is significant alveolar ridge resorption observed at center sites after consecutive extractions
Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
Is a thick or thin wall phenotype associated with the amount of bone resorption
Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
Is the interdental papilla height significantly affected after extractions.
Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks. | - EligibilityCriteria: Inclusion Criteria: 18+ years old Require consecutive (two) teeth replacement in the anterior maxilla Signed informed consent No significant medical conditions Patients with healthy periodontal conditions or previously treated to controlled and stable conditions Exclusion Criteria: General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications Pregnancy or nursing Any interfering medication such as steroid therapy or bisphosphonate therapy Uncontrolled diabetes Autoimmune diseases or inflammatory diseases affecting the intraoral tissues Radiation therapy to head or neck region - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for consecutive (two) teeth extraction in the anterior maxilla. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261749 | Recruiting | Analysis of Scapular Musculature Activation During Targeted Abdominal Contraction With Scapular Stabilization Exercises | Muscle activation of the upper trapezius, lower trapezius and serratus anterior muscles will be measured during prone scapular retraction exercises. Then the same exercises will be performed with abdominal contraction using a stabilizer and muscle activity of the same muscles will be measured. A comparison will be made between the two conditions. | - EligibilityCriteria: Inclusion Criteria: Healthy individuals between the ages of 18-30 Physical activity level of at least 5 on the Tegner activity scale. Exclusion Criteria: Having pathology of the shoulder and spine History of previous upper extremity surgery Body mass index greater than 24.9 Experience with core stability training. - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult - StudyPopulation: The study will include 30 healthy participants regardless of gender. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06261736 | Recruiting | The Effectiveness of Prophylactic Antibiotics for Urethral Bulking | The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections. | - EligibilityCriteria: Inclusion Criteria: Patients scheduled to undergo a urethral bulking procedure Age 18 ≥ over Exclusion Criteria: History of recurrent urinary tract infections Known history of urinary retention Allergies or contraindications to multiple antibiotics Inability to tolerate oral antibiotics Concomitant surgical procedures at the time of urethral bulking Pregnant or breastfeeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261723 | Not yet recruiting | Effect of Non-chirurgical Periodontal Treatment on the Immune System From a Gender Perspective | The goal of this observational study is to evaluate non-surgical periodontal treatment in women and men with periodontitis with and without obesity. The main questions it aims to answer are:
If non-surgical periodontal treatment of patients with chronic periodontitis can modulate the innate and adaptive immune response taking into account patient gender and the coexistence of obesity
If there are specific miRNAs that can regulate this immune response and can be considered as suitable biomarkers and therapeutic targets.
Obese or non-obese participants with periodontitis will receive non-surgical periodontal treatment, consisting of oral health guidance and mechanical periodontal debridement throughout the mouth using an ultrasonic device and manual curettes. Researchers will compare four groups: obese women, non-obese women, obese men, and non-obese men, to clarify the involment of immune response after treatment, considering the coexistence of obesity and potential gender differences. | - EligibilityCriteria: Inclusion Criteria: Men/Women with periodontitis: Periodontitis will be diagnosed according to the definition of the Centers for Disease Control and Prevention / American Academy of Periodontology (CDC/AAP). Men/Women with obesity: Body mass index (BMI) ≥30 kg/m2 (WHO 2000) Exclusion Criteria: Having fewer than fourteen teeth, Having infectious diseases Having other oral inflammatory diseases, Having received periodontal treatment in the past six months or antibiotics in the previous three months, undergoing systemic anti-inflammatory treatment, Pregnancy or lactation Serious illnesses, congenital adrenal hyperplasia, virilizing tumors, hypothyroidism, Cushing's syndrome, prolactinomas, cardiovascular diseases, or diabetes mellitus. Alcohol or drug abuse Psychiatric disorders. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: According to presence of periodontitis and obesity. - MinimumAge: 18 Years - MaximumAge: 69 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Primary care clinic - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261710 | Recruiting | Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations | This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes. | - EligibilityCriteria: Inclusion Criteria: Pregnant women of at least 18 years of age with a singleton in the cephalic position Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted. Exclusion Criteria: Emergency situations such as maternal or fetal bleeding Indication for urgent delivery by caesarean section Pathological cardiotocogram non-cephalic positions under 18 years of age women giving birth who are unable to give consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261697 | Not yet recruiting | Relationship Between Smartphone Addiction and Temporomandibular Joint Disorders Among Adults in Egypt. | Cross sectional study to investigate the relation between Smartphone addiction and temporomandibular disorders among youth population in Egypt. An online- based questionnaire study. A 296 participants who are Egyptians with age between18 and 35 years old without prior neck and upper extremity related diseases, orofacial trauma or surgeries, history of rheumatoid arthritis or congenital musculoskeletal problems. An online- based questionnaire will be sent through different social media platforms, it will include three screens, the first includes the consent form, the second includes the demographic data (year of birth, current educational status, gender and geographic information ), and the third page includes questionnaires
. | - EligibilityCriteria: Inclusion Criteria: both males and females adults Their ages between18 and 35 years old ability to use Smartphone Exclusion Criteria: any neck and upper extremity related diseases orofacial trauma or surgeries history of Rheumatoid arthritis congenital musculoskeletal problems. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult - StudyPopulation: community sample - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06261684 | Recruiting | Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial. | The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
Is Intralesional acyclovir safe for plantar warts?
Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy? | - EligibilityCriteria: Inclusion Criteria: Patients aged 18 years or older, of both genders, with plantar warts Exclusion Criteria: Patients on systemic treatment for warts eg. Acitretin, Acyclovir Hypersensitivity to Acyclovir Previous treatment to the same wart during the last 3 months Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.) Pregnant and breastfeeding females Cognitively impaired patients - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261671 | Not yet recruiting | Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates. | One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes. | - EligibilityCriteria: Inclusion Criteria: Patients undergoing assisted reproductive technology cycles when ICSI is indicated. Patients when Iin vitto fertilization (IVF) is also performed will be included as far as there are enough oocytes for ICSI randomization. However, IVF oocytes will not be used for the study. Maternal age 18-43 years old. PGT-A cycles with only trophectoderm biopsies on day 5/6/7. Patients with more than 6 COCs expected for ICSI. Body mass index <35. Fresh and frozen ejaculated sperm. Exclusion Criteria: PGT-M cycles Fresh and frozen testicular sperm. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - MinimumAge: 18 Years - MaximumAge: 43 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261658 | Recruiting | Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma | The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue. | - EligibilityCriteria: Inclusion Criteria: request for cryopreserved ovarian tissue transplantation; premature ovarian failure or irregular mentrual cycles; negative test for HIV, HBV, HCV, Treponema pallidum; negative PAP test; oncological authorization; absence of neoplastic contamination in the cryopreserved ovarian tissue; Informed consent Exclusion Criteria: neoplastic contamination in cryopreserved ovarian tissue; history of endometriosis; endocrinological disorders present and not treated (uncompensated thyroid dysfunction, diabetes (type 1, type 2); body mass index (BMI) >30 kg/m2; circulating platelet level < 150,000 / mml; bacterial infection; ongoing use of anticoagulants; bleeding diathesis. - HealthyVolunteers: No - Gender: Female - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06261645 | Recruiting | Rotofunc - Non-traumatic Shoulder Instability and Total Rotator Cuff Function | The goal of this clinical trial is to test the effect of a novel assessment and treatment strategy for young adults with severely disabling non-traumatic shoulder instability. The main question it aims to answer is if this treatment will substantially change the patients shoulder function to a more stable and controllable state and thereby give a higher quality of life. Participants failure in active shoulder muscle function will be assessed and exercises will be selected individually. Patients will be asked to perform the exercises twice per day. At clinical visits to a specialized physiotherapist the exercises will be upgraded to restore full dynamic stability throughout shoulder movement range. The active treatment period will be 4 months. Researchers will compare two groups. One group will start directly after a baseline assessment is fulfilled. The other group will receive the treatment with a delay of 4 months to evaluate if the selected exercises can substantially change the shoulder stability compared to no treatment, the natural course of the condition. | - EligibilityCriteria: Inclusion Criteria: young adults, non traumatic as well as non-controllable, positional, functional shoulder instability according to Moroder et al. demonstrating a lack of ≥ 20%, active, dynamic control compared with the total passive range of motion in shoulder rotation with or without previous shoulder stabilizing surgery Understanding the Swedish language well, in speaking, in reading and writing. Exclusion Criteria: Other significant shoulder pathologies, patients diagnosed with severe systemic connective tissue, congenital anatomic abnormalities, or psychiatric diagnoses according to previous medical records <60% adherence to assigned exercises - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06261619 | Recruiting | Superiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Ventilation Alone | Effective respiratory ventilation is achieved by moving the right amount of air to and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this superiority study, the investigators will perform two-group cross over randomized design to test the superiority of the Adult Sotair® device compared to manual ventilation alone. | - EligibilityCriteria: Inclusion Criteria: Adult patients who are scheduled for non-emergency surgery with general anesthesia (w/artificial airway) at Rhode Island Hospital. American Society Of Anesthesiologists Physical Status 1 and 2 Exclusion Criteria: American Society of Anesthesiologists Physical Status >3 (e.g. respiratory disease) Oropharyngeal or facial pathology - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261606 | Recruiting | Feasibility of a Multifaceted Program to Reduce Cardiovascular Complications of Air Pollution | The main goal of this clinical trial is to evaluate the feasibility of conducting a large-scale clinical trial testing a program containing several aspects for reducing the effects of air pollution on cardiovascular health (which is named the hybrid program hereafter) in adult patients (18 years or older) with atherosclerotic cardiovascular disease. Furthermore, we seek to answer how much patients adhere to and are satisfied with implementing the hybrid program, and what problems executing this program will bring for patients. | - EligibilityCriteria: Inclusion Criteria: Adult patients (≥18 years) with documented ASCVD defined as at least one of the following: Coronary artery disease (CAD): Previous or recent documented type I myocardial infarction History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) History of obstructive CAD (>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography Peripheral arterial disease (PAD): Previous or recent acute ischemic limb event (>7 days prior) History of previous endovascular/surgical lower or upper extremities revascularization for an atherosclerotic cause History of ulcer or lower extremities amputation due to ASCVD. Carotid arterial diseases: History of previous endovascular/surgical carotid artery revascularization for atherosclerotic cause History of > 50% carotid artery stenosis based on documented imaging tests (Duplex ultrasonography, CT angiography, magnetic resonance angiography, or conventional angiography) Ischemic stroke: History of recent or previous documented ischemic stroke not due to systemic hypoperfusion/hypotension being treated with low-dose aspirin Willing to participate and able to provide written informed consent Exclusion Criteria: Being within 7 days of acute/unstable ASCVD events (acute myocardial infarction, acute limb event, and acute ischemic stroke) or receiving triple antithrombotic therapy Active bleeding History of upper gastrointestinal bleeding within the past 30 days History of intracranial hemorrhage within the past 30 days End-stage kidney disease with estimated creatinine clearance < 15 mL/min, or undergoing hemodialysis or peritoneal dialysis Known aspirin sensitivity without prior successful desensitization Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician Vascular disease known exclusively to be from causes other than atherosclerosis (spontaneous coronary or peripheral dissection (fibromuscular dysplasia, segmental arterial mediolysis) or vasculitis such as Takayasu arteritis, Buerger's disease (i.e., thromboangiitis obliterans), and Churg Strauss syndrome Inherited or acquired severe coagulopathies including hemophilia and decompensated liver cirrhosis Any other unexpected/unwarranted conditions that make the participants unsuitable for recruitment or follow-up Known allergy to KN-95 or other masks, or citrus fruits Any facial dysmorphia that makes the patient unable or unwilling to wear a face mask Any medical condition necessitating unblinded facemask use for outdoor activities at the discretion of the treating clinician, or based on patient preference Inability to receive/read text messages/phone calls by personal mobile phone Unwillingness to participate, such as hesitation to wear a mask, if randomized - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261593 | Recruiting | Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Ankle Arthropathy | Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, stability, joint pain, joint status and the perception of quality of life in patients with hemophilic ankle arthropathy.
Study design. Randomized, multicenter, single-blind clinical study. Method. 32 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 4 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and stability (The Single Leg Stance Test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, stabilit, and the perception of quality of life in patients with hemophilic ankle arthropathy. | - EligibilityCriteria: Inclusion Criteria: Patients diagnosed with hemophilia A and B People with a medical diagnosis of hemophilic ankle arthropathy Patients over 18 years of age Paceinets in prophylactic or on-demand treatment regimen with FVIII/FIX concentrates. Failure to sign the informed consent document Exclusion Criteria: Patients with neurological or cognitive alterations that prevent understanding of the questionnaires Amputee patients, epileptics or patients with severe vision problems Patients who are receiving physiotherapy treatment at the time of the study - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261567 | Not yet recruiting | A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service | Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.
There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.
This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis. | - EligibilityCriteria: Inclusion Criteria: Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022 Patients who received ≥1 dose of biologic treatment Patients aged ≥18 years at index Exclusion Criteria: Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 130 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The source population for this study will be patients who were treated with a biologic for severe asthma in UK NHS centres between October 2021 and September 2022 - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261554 | Recruiting | Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients | It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy. | - EligibilityCriteria: Inclusion Criteria: Age between 3 and 17 years, IgE-mediated sesame allergy confirmed with positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35-kilo units of Allergen per liter (kUA/l), Allergic reaction to sesame protein during oral food challenge (OFC), Signed Informed Consent by parent/legal guardian and patient aged >16 years old, Patient's and caregivers' cooperation with the researcher. Exclusion Criteria: No confirmed sesame allergy, Negative OFC with sesame protein (maximum dose 4000mg), Severe asthma, uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5. percentile), FEV1/forced vital capacity (FVC)<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months, Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy, Eosinophilic gastroenteritis, A history of severe recurrent anaphylaxis episodes, Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes, Medication: oral, daily steroid therapy longer than 1 month within the last 12 months, at least two courses of oral steroid therapy (at least 7 days) within the last 12 months, oral steroid therapy longer than 7 days within the last 3 months, any biological treatment, therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors, Pregnancy, No consent to participate in the study, Lack of patient or caregiver cooperation. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 17 Years - StdAgeList: Child | 2024-03-12 |
NCT06261541 | Not yet recruiting | Clinical Investigation to Validate the Safety and Performance of the ABLE Exoskeleton Device for Individuals With Multiple Sclerosis in a Clinical Setting | The primary objective of the study is to validate the safety and performance of the ABLE Exoskeleton device in people with multiple sclerosis during a 10-session gait training program in a clinical setting. Furthermore, the potential effects of the training on walking, and balance function, general health status, user satisfaction, and quality of life will be assessed. | - EligibilityCriteria: Inclusion Criteria: 18 to 70 years of age. Diagnosed with MS. Currently receiving treatment as an inpatient or outpatient at one of the investigational site. Ability to give informed consent. Exclusion Criteria: Significant osteoporosis that may increase the risk of fracture. Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years. Spinal instability (or spinal orthoses, unless authorized by a physician). Severe spasticity: Level 4 on the Modified Ashworth Scale. Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes of standing. Uncontrolled autonomic dysreflexia. Medically unstable Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP>140, DBP>90 mmHg), unresolved deep venous thrombosis (DVT). Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study. Skin integrity problems on the contact surfaces of the device or that would prevent sitting. Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton. Colostomy. Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg. Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device. Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting. Heterotopic ossification Known pregnancy or breastfeeding Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261528 | Not yet recruiting | Phase I Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis | The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team. | - EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years old Diagnosis of PPMS or SPMS according to the 2017, or 2010 Revised McDonald Criteria In the opinion of the investigator, able to complete study procedures Must be on a stable dose of an FDA-approved disease modifying therapy for at least 3 months prior to screening Exclusion Criteria: Pharmacological and non-pharmacological mood and fatigue treatment changes within the previous three months prior to screening Based on the Investigator's judgement, patients with a history of significant other medical condition that may interfere with the conduct of the study, or interpretation of the study results History of any clinically significant abnormality in hematology, blood chemistry, or examination not resolved by the baseline visit which according to the investigator can interfere with study participation Positive drug screen for cocaine, or phencyclidine, or known alcohol abuse within 30 days of the trial Females who are pregnant, have a positive pregnancy test, are nursing, or who plan to get pregnant during the course of this clinical trial Patient taking melatonin analogues without appropriate washout, defined as five half-lives of the medication, or within 14 days of screening, whichever is longer New or adjusted prescription medication within 14 days of the baseline An investigator verified MS relapse within the previous year Presence of a gadolinium-enhancing demyelinating lesion within the last year Optic neuritis within the previous 3 months Travel across two time zones within 3 months of study screening - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261515 | Not yet recruiting | Multi-omics Analysis of Oral-gut Microbial Profiles | Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls. | - EligibilityCriteria: Inclusion Criteria: periodontitis Stage III or IV BMI between 20 and 29 kg/m2 free diet presence of at least 20 teeth Exclusion Criteria: systemic diseases (including diabetes, thyroid, liver, or kidney diseases) dietary allergies use of antibiotics or probiotics during the previous 90 days pregnancy or breast feeding - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261502 | Not yet recruiting | Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome | This study focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Most individuals with FXS have moderate to severe intellectual disability (ID), and caregivers are mainly concerned about aggressive behavior and anxiety problems. Since FXS individuals have a normal lifespan, the overall lifetime cost for the Canadian society of a single case is estimated at $1.2 to $4.7 millions reaching $18 billions for all FXS cases. There is no cure for FXS, as all clinical trials so far have been unsuccessful.FXS is caused by transcriptional silencing of the Fragile X mental retardation protein (FMR1) gene, making FXS a simple model to study ASD and ID pathophysiological mechanisms. Of those, neuronal hyperexcitability is largely recognized as a core deficit in FXS, and a critical therapeutic target for the disorder. Using transcranial magnetic stimulation (TMS) in FXS patients, our team provided the first direct evidence of Gamma-aminobutyric acid (GABA) receptor a (GABAa) dysfunctions in humans with this disorder and showed that this inhibitory deficit is linked with cortical hyperexcitability (PMID: 31748507). Concurrent lines of evidence suggest that stimulation of the endocannabinoid (eCB) system with the administration of Cannabidiol (CBD) could upregulate GABAergic function and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. CBD has been shown to increase GABA concentration levels in the brains of healthy individuals, an effect that could help correct the hyperexcitability typically found in FXS. Thus, this trial aims to define the therapeutic potential of the eCB system for FXS, by measuring the impacts of oral CBD administration on the principal inhibitory neurotransmitter system of FXS patients, and the severity of the clinical phenotype. | - EligibilityCriteria: Inclusion Criteria: Molecular diagnosis of FXS Age 7 to 40 inclusively Overall ABC-C score > 20 Taking up to 3 psychoactive drugs No therapeutic change for the last 3 months Exclusion Criteria: Taking valproic acid Taking clobazam History of liver problems aspartate aminotransferase (AST) or alanine transaminase (ALT), > 3 times the reference values Bilirubin > 2 times the reference values Absolute contraindication to the use of TMS and MRI (e.g. presence of metal in the body), will also be considered as an exclusion criterion. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 40 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06261489 | Not yet recruiting | Cannabis (THC vs. CBD) in Multiple Sclerosis | The goal of this clinical trial is to examine the effect of Cannabis components, THC and CBD, on cognition and bladder symptoms in people with Multiple Sclerosis (MS).
Participants will complete questionnaires and cognitive tests. They will be randomly assigned to receive either CBD or THC oil and will take the study drug for 15 weeks. | - EligibilityCriteria: Inclusion Criteria: Age between 18 and 59 years inclusive. Confirmed diagnosis of Multiple Sclerosis as per McDonald criteria (any type) [12] Symptoms of neurogenic lower urinary tract dysfunction (NLUTD) as measured by neurogenic bladder symptom score (NBSS), with a minimum score of 7. If already on a medication for NLUTD, must be stable on this medication for at least 4 weeks. Sexually active men and women of child-bearing potential must agree to use adequate contraception. Written informed consent. Exclusion Criteria: Major psychiatric disorder such as schizophrenia or bipolar disorder Major neurological disorder which could affect cognition such as dementia, traumatic brain injury. Seizure disorder Use of antipsychotic medication Use of benzodiazepines other than exclusively at night/bedtime Experienced a MS relapse in the last ninety (90) days. Current use of cannabis or CBM greater than 3x/week. Currently using cannabis/CBM less than 3x/week and being unwilling to abstain for the duration of the study. Visual acuity (binocular) worse than 20/70 (in order to complete the cognitive outcomes) Significant upper extremity disability that would interfere with the cognitive tests battery. Indwelling catheter use/urinary diversion Pregnant or Breastfeeding - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261476 | Recruiting | Safety of Ashwagandha (Withania Somnifera) Root Extract | The primary objective is to evaluate the laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count, Renal Function Test, Liver Function Test, Lipid Profile and Thyroid Function Test, Fasting blood sugar and HbA1c Test. The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life (QoL) using the SF-36 tool. | - EligibilityCriteria: Inclusion Criteria: Both adults (male and female) aged between 18 and 65 years. Participant should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study. No plan to commence any other alternative treatment modality for their conditions. Willingness to sign an informed consent document and to comply with all study related procedures. Exclusion Criteria: History of Alcohol or smoking abuse. History of hypersensitivity to Ashwagandha. Taking nutritional or energy supplements, medication, or steroids. Any history of drug abuse. Having any clinical abnormalities. Simultaneously participating in any other clinical trial or participated in the past three months. Participants who use medication for blood pressure, use betablockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression. Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania. Patients with post traumatic disorder. Have an established practice of meditation for three or more months. Pregnant and lactating women. Participation in other clinical trials during previous 3 months. Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261463 | Not yet recruiting | Pilot Trial of a Peer-led Family and Social Strengthening Group Intervention for Refugee Families | The proposed study draws on prior research to evaluate the feasibility, acceptability and explore preliminary effectiveness of Coffee and Family Education and Support, Version (CAFES2) using a pilot randomized type 1 hybrid effectiveness-implementation design. CAFES2 is a peer-led family and social strengthening multiple family group intervention that is designed to respond to multi-level needs of refugee families. Results of the trial will contribute to the emerging evidence base on family-based mental health interventions for refugee and newcomer communities. The trial will also generate new insights regarding implementation strategies needed to promote successful delivery of services by peer providers and the unique role of human-centered design practices for adaptation of mental health and psychosocial interventions. | - EligibilityCriteria: Inclusion Criteria for Families: being a resettled refugee family having one or more school-aged children aged 12 years and older living with them one family member (caregiver or youth) screens for moderate emotional distress Inclusion Criteria for Adult Caregivers/Parents: between ages of 18-45 years old arrived to the U.S as a refugee have at least one child currently living with them Inclusion Criteria for Youth: between ages of 12 and 17 years old) arrived as a refugee currently living with at least one caregiver. Exclusion Criteria: not meeting the above inclusion criteria families or individual in the midst of a crisis (e.g. family crisis or mental health crisis) - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 45 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06261450 | Not yet recruiting | Effect of CBD on the Brain | This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients. | - EligibilityCriteria: Inclusion Criteria: Eligibility criteria for FXS participants will include: age between 7 and 55 years, molecular diagnosis of FXS, intelligence quotient (IQ) <70, aberrant behavior questionnaire score (ABC-C) > 20, <3 psychoactive drugs, drug stable for > 3 months. Eligibility criteria for the control group: 18 and 55 years old, be in good general health, with no history of neurological or psychiatric disorders. Eligibility Criteria for all Participants: A minimum weight of 60 kg; no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants). Exclusion Criteria: The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head). Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline, - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 7 Years - MaximumAge: 55 Years - StdAgeList: Child, Adult | 2024-03-12 |
NCT06261437 | Not yet recruiting | Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise | The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters.
The main questions it aims to answer are:
Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR?
Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms.
Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects. | - EligibilityCriteria: Inclusion Criteria: Active-duty male or female military personnel who are actively participating in the 7-day strenuous military training exercise. Willing to consume only foods/beverages provided by study staff during the training exercise, except for coffee and water. Exclusion Criteria: Any injury or health condition limiting full participation in the 7-day Field Training Exercise. Any food allergy, lactose intolerance, or vegetarian practices. Not willing to participate in all study procedures. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06261424 | Not yet recruiting | Effects of a Supervised Rehabilitation Program on Disease Severity in Spastic Ataxias | Spastic ataxias are a group of diseases causing symptoms such as walking difficulties and balance impairments that lead to a high risk of falls. No pharmacological treatments exist to treat these diseases. Unfortunately, little effort is made to develop non-pharmacological treatments specific to spastic ataxias despite the detrimental impact of the disease on several aspects of an individual's life and the high cost of falls for society each year. The three objectives of this project are: 1) to determine the effect of a 12-week rehabilitation program on disease severity as compared with usual care for individuals with spastic ataxias; 2) to identify which factors can help (or not) the implementation of the program in the clinical settings ("reel world"); and 3) to explore the cost-benefits of IMPACT [rehabIlitation prograM for sPAstiC aTaxias]. The team has developed the program to specifically target symptoms present in these patients and was previously pilot-tested. Based on the results obtained in this pilot project, positive effects are expected concerning the disease severity of participants. The investigators want, with this project, provide to health care professionals an option to offer better-suited services to people living with spastic ataxia worldwide. | - EligibilityCriteria: Inclusion Criteria: have a confirmed genetic diagnosis of ARSACS or SPG7 be able to maintain standing position and to transfert be authorized by their treating neurologist speak French or English be able to give informed consent. Exclusion Criteria: have active participation in a rehabilitation program (self-reported information) have another condition causing physical limitations be uncomfortable in a swimming pool be pregnant. - HealthyVolunteers: No - Gender: All - MinimumAge: 16 Years - StdAgeList: Child, Adult, Older Adult | 2024-03-12 |
NCT06261398 | Recruiting | Better Birth Outcomes Through Technology, Education, and Reporting | This is a pragmatic randomized control trial to evaluate the BETTER intervention compared to standard obstetrical care (control) to determine whether it helps to reduce maternal anemia and other adverse pregnancy outcomes. The BETTER intervention includes one motivational interviewing session and bi-weekly text messages to encourage patients to connect with resources that address their social needs, including housing, food, and transportation. Quantitative data will be used to study participant outcomes, including surveys, and electronic health record data. | - EligibilityCriteria: Inclusion Criteria Less than 20 weeks and 6 days pregnant upon enrollment At least 18 years of age Receiving obstetric care at OSU McCampbell Hall or OSU Outpatient Care East Singleton pregnancy and fetus with a heartbeat English speaking Able to receive text messages Exclusion Criteria Has a significant medical condition (eg sickle cell disease) that is a cause of anemia Has a plan for transfusion during pregnancy - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: This study is restricted to pregnant individuals. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261385 | Recruiting | Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial | This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted. | - EligibilityCriteria: Inclusion Criteria (for Ex-smoker) : Have ever habitually used conventional cigarettes in the past year Not using cigarettes for past 7 days Aged 18 years or above No barriers in speaking and listening Chinese Exclusion Criteria (for Ex-smoker) : Have unstable physical or psychological conditions as advised by doctors or counsellors Users of illicit drugs (e.g., heroin, marijuana, ketamine, etc.) Have become pregnant in the past two months Inclusion Criteria (for SC counsellors) : SC counsellors from local SC clinics under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261359 | Not yet recruiting | A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma | The purpose of this study is to evaluate the efficacy and safety of CEND-1 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo as first-line treatment in patients with Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma. | - EligibilityCriteria: Inclusion Criteria: 18~80 years old, male or female; Locally advanced unresectable or metastatic PDAC confirmed by histopathology or cytopathology; Patients who have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; Patients with at least one measurable tumor lesion per RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Expected survival time ≥ 12 weeks; Patients who have adequate organ function; Female subjects who are not pregnant or not breastfeeding. A negative pregnancy test for females of childbearing potential within 7 days prior to first dosing. Male and female subjects of childbearing potential must agree to use highly effective method of contraception during the entire course of the study and within 180 days after the end of the study. Subjects participate voluntarily and sign informed consent. Exclusion Criteria: Concurrent use of other anticancer drugs, including chemotherapy, targeted therapy, immunotherapy, or biologics; The patients who are known to be allergic to the investigatinal drug or its any excipient; Patients with the following conditions: myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention within 6 months before signing the ICF; Patients with high risk for gastrointestinal bleeding or abdominal bleeding as assessed by the investigator, such as tumor invasion of the gastro duodenum finger intestines, large blood vessels, etc.; Patients with symptomatic CNS metastasis, leptomeningeal metastasis, or spinal cord compression due to metastasis. Patients with other active malignant tumors within 3 years before signing the ICF. Patients with cured skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast ductal, and papillary thyroid cancer can be enrolled. Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis or co-infection with hepatitis B and C. Patients who require systemic antibiotics for ≥7 days within 4 weeks prior to first dose, or unexplained fever >38.5°C prior during screening or before first dose; Patients who participated in any other clinical studies; Patients with a known history of psychoactive drug abuse, alcohol abuse, or substance abuse; History of definitive neurological or mental disorder, including epilepsy or dementia; The patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator and/or sponsor. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261346 | Not yet recruiting | Plasma Rich in Growth Factors in Corneal Endothelial Transplantation | The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss. Subjects scheduled for endothelial keratoplasty will be enrolled and randomized to have the graft incubated in PRGF or not prior to graft implantation. The main outcome is the percentage central corneal endothelial cell loss 6 months after surgery. | - EligibilityCriteria: Inclusion Criteria: undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation Exclusion Criteria: History of corneal transplantation in the study eye, BCVA worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil. The following special populations will be excluded. Adults unable to consent Pregnant women Prisoners - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261320 | Not yet recruiting | Mesotherapy Treatment of Irritable Bowel Syndrome | Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.
Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.
Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms. | - EligibilityCriteria: Inclusion Criteria: Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology, Francis score >75/500, i.e. minimal, moderate or severe severity, Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms) Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment Exclusion Criteria: Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology Recent Post Traumatic Stress Syndrome (<1 year), Fibromyalgia syndrome, Known allergy to medications used in mesotherapy treatment, Pregnant or breastfeeding woman - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261307 | Not yet recruiting | Language Development Deficits and Early Interactive Music Intervention | Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated. | - EligibilityCriteria: Inclusion Criteria: 8-12 months old at start of intervention (recruited between 0-11 months) Born healthy and at term (gestational age at least 37 weeks and birth weight at least 2500 g) Normal hearing at birth (evoked oto-acoustic emissions conducted to newborns routinely at the hospital) At least one caregiver living with the child is native speaker of Finnish and speaks Finnish to the child Risk group: At least one biological parent has developmental dyslexia according to a recent (<5 years) diagnostic statement by a health care professional or according to a dyslexia test at study enrollment; symptoms have started in childhood Exclusion Criteria: Medication affecting the central nervous system Sensory deficits Serious health conditions No-risk group: Suspected dyslexia or developmental language disorder due to symptoms that have started in childhood in either of the biological parents; diagnosis of a developmental or language disorder (incl. dyslexia, developmental language disorder, attention-deficit/hyperactivity disorder ADHD, attention-deficit disorder ADD) or neurological disorder in either of the biological parents Risk group: Diagnosis of ADHD, ADD, or other not-language-related developmental disorder in either of the biological parents; in the dyslexic parent, brain trauma in childhood that may indicate a non-heritable cause for the reading deficit or individualized school curriculum that may indicate broader developmental deficits. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 8 Months - MaximumAge: 12 Months - StdAgeList: Child | 2024-03-12 |
NCT06261294 | Recruiting | OncoSweep Cancer Spotlight and Spectrum Product Line | CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line' | - EligibilityCriteria: Inclusion Criteria: Inclusion Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form. Individual is aged 18 years old or above. Individual who is willing to provide information on the given questionnaire. Test group: Individual was diagnosed with pulmonary nodules or masses by low-dose CT (LDCT)/ CT, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged. Control group: Individual is willing to undergo LDCT or CT scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, X-ray, laboratory blood test, and blood drawing. Control group: Individual has no abnormal finding from LDCT or CT scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(FEV1/FVC Ratio≧70%). Individual did not donate blood or receive blood transfusion within two months before joining the study. Exclusion Criteria: Exclusion Individual who is not suitable for participating as per Investigator's judgement. Individual who has undergone gene therapy or related product within one year prior to enrolling in this study. Individual who is attending another clinical study at the time of enrollment. Individual who is known to be pregnant. Individual who has received a vaccine within two weeks. Individual who has a history of any cancer occurrences other than lung cancer. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: This is a two-arm, open-label, non-randomized controlled pilot study intended to screen adults of 18 years or older, who are treatment-naïve for cancers, or who have pulmonary nodules or masses detected by LDCT or standard CT scan, utilizing OncoSweep Lung Spotlight with venous blood sample collected in the healthcare facility where the study is being conducted. - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261268 | Recruiting | Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa | The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with <2 mm of PIKM.
Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS). | - EligibilityCriteria: Inclusion Criteria: Patients older than 18 years Short-span dental implants in the mandible at second stage with inadequate PIKM (<2 mm) with at least one adjacent tooth mesially Periodontally healthy patients with a pristine or reduced periodontium Plaque index (FMPS) less than 20%. Exclusion Criteria: Compromised general health status that contraindicates study procedures (≥ASA III); Drug or alcohol abuse; Smoking of > 10 cigarettes per day; Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose); Pregnant or lactating women; History of previous mucogingival surgeries in the area of interest - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261242 | Recruiting | Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment | This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures. | - EligibilityCriteria: Inclusion Criteria: Provision of signed and dated informed consent form prior to any study procedures. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female with at least 50 years of age. 1 painful VCF which meet all of the following criteria: Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5 points). VCF between T7 and L4. Fracture age < 3 months. VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration of at least 15% but not more than 40% based on X-ray, CT or MRI at baseline. The Index fracture is acute or persistent (not healed), as demonstrated by MRI or bone scan. Patient has failed conservative medical therapy, complementary and alternative medicine, defined as either having a VAS back pain score of ≥ 50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥ 70 mm at 2 weeks after initiation of fracture care. If patients with pain ≥ 70 mm at baseline continued to deteriorate as demonstrated by increasing VAS score and/or progressive vertebral collapse, treatment might be initiated after 1 week of conservative care. Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative. Patient has an ODI score of ≥ 30/100. Exclusion Criteria: Target VCF due to high-energy trauma or underlying/suspected tumor. Target VCF is diagnosed as an osteonecrosis. Segmental kyphosis of target vertebral compression > 30°. Any prior surgical treatment for a VCF or other surgical procedure on the target vertebral body or adjacent level. The patient has uncontrolled systemic diabetes (A1c > 10) and /or uncontrolled hypertension (patient requiring 3 or more anti-hypertensive drugs). Pre-existing or clinically unstable neurologic deficit. Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated. Any physical exam evidence of myelopathy, radiculopathy, or coagulopathy. Disabling back pain due to causes other than acute fracture, or any other condition that requires daily narcotic medication, such as clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis). Patient not able to walk without assistance prior to fracture. Any radiographic evidence of cortical disruption, burst fractures and pedicle fracture. Translation > 4 mm or Spondylolisthesis > Grade 1 at target vertebral body. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.). In the investigator's opinion, a patient with any other medical illness or condition which may not be suitable to participate in the study, including but not limited to: A medical contraindication to spinal surgery and/or general anesthesia, such as Patients on chronic anti-coagulation. (Patients stop the treatment 8 days before surgery with a threshold for normal being INR < 1.1 and platelets > 100,000 are not limited to this.) Prior history of intolerance or allergic reaction to titanium and/or one of the components of the PMMA cement. Active systemic or local infection at baseline. Body mass index > 40. Patients affected by severe cardiopulmonary deficiencies. In the investigator's opinion, a patient with any other medical illness or condition which may not be suitable to participate in the study, including but not limited to: Likely to impair long-term follow-up (e.g., cancer). Any evidence of alcohol or drug abuse. Uncontrolled psychiatric disorders are defined by the DSM V or severe dementia. Currently on anti-cancer therapy or anti-HIV therapy. Life expectancy is less than the study duration or undergoing palliative care. Participating in any other investigational study. On long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months). Known to be involved in spinal litigation. Pregnant women as confirmed by positive pregnancy test or considering getting pregnant during study participation. Presenting loss of vertebral height > 50% compared to estimated pre-fracture height. Interspinous-process widening. Sclerotic fracture or pseudarthrosis. Patient is a prisoner or not in the wards of the court. Patients with contraindications to MRI and bone scan. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261216 | Recruiting | Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy | The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy. | - EligibilityCriteria: Inclusion Criteria: Confirmed diagnosis of wtATTR-CM including sequencing of the TTR gene; or HFpEF; or HFrEF; or healthy proband without a diagnosis of heart failure Initial diagnosis of respective cardiac disease (wtATTR-CM, HFpEF, HFrEF) after the 6th decade of life; or no cardiac disease (healthy control) Willingness and ability to provide signed informed consent form (ICF) Age > 60 years Exclusion Criteria: History of severe chronic illness limiting the ability to perform physical activity during the 3rd to 6th decade A diagnosis of dementia or cognitive impairment Any other reason resulting in the inability to perform the questionnaire and/or interview - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Number of participants: 252 The study population will comprise four subgroups (n=63 in each group) cardiac wild type transthyretin amyloidosis (wtATTR-CM); heart failure with preserved ejection fraction (HFpEF); heart failure with reduced ejection fraction (HFrEF; ischemic or inflammatory origin); healthy controls - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261203 | Recruiting | Low Dose Aspirin for Prevention of Early Pregnancy Loss | Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.
The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries | - EligibilityCriteria: Inclusion Criteria: Singleton pregnancy Before 8 weeks gestation Women at high risk of preeclampsia according to Royal College of Obstetricians and Gynecologists (RCOG) (Robson et al., 2013): Maternal age ≥ 35 years. Nulliparity. BMI ≥ 30 kg/m2. Smoking of r ≥ 10 cigarettes per day. Previous history of small for gestational age (SGA) baby. Previous history of stillbirth. Pregnancy interval < 6 months or ≥ 60months. Chronic hypertension. Diabetes with vascular disease. Willingness to participate in the study and provide informed written consent. Exclusion Criteria: Known allergy or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) Use of any anticoagulant medication (e.g., heparin, warfarin, clopidogrel) Use of low-dose aspirin for any indication prior to the current pregnancy Chronic use of NSAIDs or corticosteroids History of bleeding disorder or active bleeding Any medical condition that may contraindicate the use of low-dose aspirin (e.g., peptic ulcer disease, asthma, liver, or kidney disease) Multiple gestation Inability to provide informed consent or comply with the study requirements. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult | 2024-03-12 |
NCT06261190 | Not yet recruiting | Active Surveillance for Low-risk Papillary Thyroid Carcinoma | This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer. | - EligibilityCriteria: Inclusion Criteria: subjects over 18 years old with a thyroid nodule of ≤ 1.5 cm in maximum diameter and a Bethesda category V or VI diagnosis on cytopathology subjects without high-risk features, including lymph node (LN) metastasis, distant metastasis, signs or symptoms of invasion to the recurrent laryngeal nerve or trachea, Poorly differentiated cancer or variant with a poor prognosis, such as the tall cell, diffuse sclerosing, columnar cell, or solid variants. Exclusion Criteria: subjects who are unable or unwilling to attend regular follow-ups.. subjects with a diagnosis of benign, atypia of undetermined significance, suspicious for follicular neoplasm, or follicular neoplasm (Bethesda category II, III, or IV) based on Fine needle aspiration or, or benign, indeterminate by core needle biopsy. - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects aged older than 18 years with the tumor size of ≤ 1.5 cm papillary thyroid carcinoma, who meet the inclusion criteria from Seoul National University Hospital, National Cancer Center, Seoul National University Bundang Hospital, and SMG-SNU Boramae Medical Center. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06261164 | Recruiting | Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients | The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents. | - EligibilityCriteria: Inclusion Criteria: diagnosis of SIRS, sepsis and/or septic shock, older than 18 years, who are being treated with amikacin and/or vancomycin, length of use of adsorbent at least 12 hours. Exclusion Criteria: contraindication for hemodiafiltration with adsorbents, patients under the age of 18, terminal cancer patients. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult - StudyPopulation: Adult critically ill patients with a diagnosis of SIRS, sepsis and/or septic shock who are hospitalized in the Department of Medical Intensive Care Medicine - SamplingMethod: Non-Probability Sample | 2024-03-12 |
NCT06261151 | Not yet recruiting | Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy | Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.
In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.
Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention. | - EligibilityCriteria: Inclusion Criteria: Patients aged 60-90 years old; Patients with gastric cancer; Patients who underwent radical gastrectomy. - Exclusion Criteria: Patients with other malignancies; Patients with previous gastrointestinal surgery or emergency surgery; Patients with incomplete medical record. - - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients aged 60-90 years old with gastric cancer who underwent radical gastrectomy were retrospectively analyzed from the prospectively collected database of Zhongshan Hospital of Fudan University between March 2024 and December 2024. - SamplingMethod: Probability Sample | 2024-03-12 |
NCT06261125 | Recruiting | Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401) | Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM. | - EligibilityCriteria: Inclusion Criteria: Histologically confirmed hepatocellular carcinoma or diagnosed by American Association for the Study of Liver Disease criteria; Presence of abdominal metastatic lymph nodes confirmed by CT or MRI, the sum of the maximum diameter of lymph nodes ≤10 cm, and at least one of which is measurable according to the RECIST 1.1 Criteria; Previous local treatment for intrahepatic lesion and systemic anti-tumor therapy are allowed; no matter whether the disease progressed or not; Less than 3 active intrahepatic lesions with a total diameter of less than 10 cm; Portal vein invasion is allowed; absence of other extrahepatic metastasis disease except abdominal LNM; Cohort 1: Patients who never received PD-1/PD-L1 antibody therapy; Cohort 2: patients who had tumor progression after previous PD-1/PD-L1 antibody therapy. Age at diagnosis 18 to 75 years; Eastern Cooperative Oncology Group performance status ≤ 2 Child-Pugh class A liver function; Normal liver volume greater than 700 ml; Estimated life expectancy ≥12 weeks; The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 50×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min; Ability to understand the study and sign informed consent. Exclusion Criteria: Diffuse hepatocellular carcinoma; Patients who have previously been treated with lenvatinib or PD-1/PD-L1 antibody but could not be tolerated; Patients with other extrahepatic metastasis disease except abdominal LNM; A history of abdominal radiotherapy; Known or suspected allergy or hypersensitivity to monoclonal antibodies; Patients who have a preexisting or coexisting bleeding disorder; Female patients who are pregnant or lactating; Inability to provide informed consent due to psychological, familial, social and other factors; A history of malignancies other than hepatocellular carcinoma before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer; A history of diabetes for more than 10 years and poorly controlled blood glucose levels; Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia; Active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; A history of interstitial lung disease or non-infectious pneumonia; A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay); Any unstable situation that may endanger the safety and compliance of patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |
NCT06261112 | Recruiting | The Effect of Using a Kaleidoscope on Fear and Pain in Children | The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data. | - EligibilityCriteria: Inclusion Criteria: Being a child in the 6-12 age group, The child's willingness to participate in the study, The parent's volunteering to participate in the study, Absence of intellectual disability of the child and parent, The child and the parent speak Turkish and are open to communication. Exclusion Criteria: The child has a chronic disease that can cause pain, The child has used analgesics within 24 hours before admission to the hospital, The child has visual impairment. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 12 Years - StdAgeList: Child | 2024-03-12 |
NCT06261099 | Recruiting | Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients | Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic. | - EligibilityCriteria: Inclusion Criteria: Between the ages of 30-65, with a history of stroke within the last month, Mini Mental Score ≥ 24, 1-10 after discharge. on the day, patients who can sit for at least 30 seconds, exhibit a hemiparetic condition, and are clinically stable Exclusion Criteria: Flaccid hemiplegia detected by anamnesis and physical examination, Has spasticity in the upper extremity with a severity greater than 1+ according to the Modified Ashworth Scale, patients with severe dementia and dysfunction of the upper extremity joints due to a previous musculoskeletal disease - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult | 2024-03-12 |