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NCT06304272

Not yet recruiting

Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound. It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast. There are no high level evidence to support one type of solution over other, systematic review have found no difference in wound infection between irrigation with normal saline vs tap water. There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016. These RCT are analyzed in three systemic review and meta-analysis published on 2016, 2019, 2022, which showed that tap water and normal saline has no difference in terms of infection rate. The infection rate observed in various studies ranges from 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference.

- EligibilityCriteria: Inclusion Criteria: Laceration wound presenting within 6 hours of duration Lacerations involving upper and lower limbs, scalps, head and neck Exclusion Criteria: Lacerations involving, lips, ears, mucosal surface, perineal and peri anal region Punctured or penetrating wound Bite wounds by human or animals or snakes Dirty wound requiring surgical debridement Patient requiring irrigation of wound with more than 1 liter of fluid Wounds involving tendon, joint or bone Wound associated with open fracture Patient on corticosteroid, antibiotics or immunosuppressant Patient who are not able to come for follow-up Immunocompromised patient Patient with history of significant peripheral vascular disease - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06304259

Not yet recruiting

Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis

Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

- EligibilityCriteria: Inclusion Criteria: Older than age of 18 years Participants willing to commit for the entire period of the trial and Both genders agreed to sign the written consent after full explanation of the study Having a mandibular single rooted premolar tooth with vital pulp These patients were also suffering from symptoms of symptomatic irreversible pulpitis and apical periodontitis, intermittent or continuous sharp pain that lasts longer after removal of the stimulus. on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale) Exclusion Criteria: Vulnerable group; prisoners, pregnant females, mentally ill, etc… Teeth with open apices A previous root canal treatment Sinus tracts Presence of periodontal pockets >3 mm in the affected tooth - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304246

Not yet recruiting

The Relationship Between Preoperative Serum Asprosin Level and Postoperative Analgesic Consumption in Patients Undergoing Caesarean Section

Adipokines are bioactive substances secreted from adipose tissue and have various functions on appetite, energy, lipid, carbohydrate metabolism, regulation of blood pressure, and inflammation. One of these is asprosin, discovered in 2016, which is secreted from white adipose tissue. It has been shown that the level of asprosin encoded by the Fibrillin 1 gene can vary in metabolic syndrome associated with obesity, diabetes, and insulin resistance . Some adipokines such as leptin, adiponectin, or resistin are found in increasing levels in the blood and placenta as pregnancy progresses. The detection of high concentrations of adipokines in cord blood has shown that they play an important role in fetal development and metabolism, can interfere with placental development, and affect pregnancy outcomes and fetal growth. Adipokines associated with appetite, energy, lipid, and carbohydrate metabolism have been shown to be effective in modulating pain in recent years. High levels of leptin have been shown to be associated with decreased preoperative pain threshold and increased postoperative analgesic consumption. Recent studies have indicated that asprosin also exhibits analgesic effects in neuropathic pain models and may have clinical benefits in alleviating chronic pain associated with diseases and injuries originating from peripheral structures. It is known that one of the most important factors affecting mothers' approach to anesthesia technique in Cesarean section is their fear of intraoperative and postoperative pain. Almost one in five patients experiences severe acute pain after Cesarean section. Pain can be perceived differently by patients, and even with the same anesthesia technique, some patients may experience more severe pain. Patients' perception of pain is influenced by many factors such as pain threshold, mood, hormonal balance, central sensitization, and genetic factors. We hypothesized that the increased preoperative serum asprosin levels might be associated with increased acute labor pain and that asprosin levels might lead to increased analgesic use in the postoperative period. Additionally, we assumed that patients could alter their preoperative pain threshold and report higher pain scores after surgery due to hyperalgesia caused by high asprosin levels. In this study, we aimed to investigate preoperative serum asprosin levels in patients undergoing Cesarean section with and without acute labor pain and to determine whether there is a relationship between preoperative asprosin levels and postoperative analgesic use.

- EligibilityCriteria: Inclusion Criteria: pregnant women who are scheduled for elective cesarean section and request spinal anesthesia for cesarean surgery, Exclusion Criteria: Being under the age of 18 Having an abnormal pregnancy with preeclampsia, eclampsia, gestational diabetes, or hypertension Having a comorbid desease, systemic diseases, cardiovascular disease Having diabetes, obesity, or infection - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: pregnant women - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult - StudyPopulation: Pregnant women who applied to the Obstetrics and Gynecology Clinic at Fırat University Hospital and were planned for elective cesarean section and requested spinal anesthesia for cesarean section will participate. - SamplingMethod: Non-Probability Sample

NCT06304233

Recruiting

The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.

- EligibilityCriteria: Inclusion Criteria: Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29) Both inpatient and outpatient Capable of giving informed consent Exclusion Criteria: Current or previous diagnosis of cancer Current or previous treatment with chemotherapy Current pregnancy Mothers less than 6 months post-partum - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The cohort with schizophrenia will be recruited from outpatient and inpatient population from a single centre. The cohort without mental health diagnosis will be selected from an existing population registered in the HUNT data and biobank and be matched for age (± 2 years) and sex of the patients. - SamplingMethod: Non-Probability Sample

NCT06304220

Not yet recruiting

Comparison of Two PPOS Models for Pituitary Suppression

The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.

- EligibilityCriteria: Inclusion Criteria: BMI of 18-29,9 kg/m2 Ultrasound count of antral follicles prior to COH ≥ 12 follicles Meeting the criteria for inclusion in the egg donation program Normal karyotype and no active sexually transmitted diseases No use of combined hormonal contraceptives one month before COH Exclusion Criteria: Patients excluded from the egg donation program Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis. Oligomenorrhea (<1 menstrual cycle in 3 months) Use of combined hormonal contraceptives before COH - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - MinimumAge: 18 Years - MaximumAge: 34 Years - StdAgeList: Adult

NCT06304207

Recruiting

Telehealth and Onsite Maintenance Exercise in COPD

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with COPD. The specific aims of the study are: To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with COPD following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention. To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with COPD following discharge from traditional onsite outpatient rehabilitation. Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.

- EligibilityCriteria: Inclusion Criteria: All adult patients 40 years and older with physician diagnosed COPD within 2 months of discharge following completion of a traditional onsite outpatient rehabilitation or physical therapy or exercise program for their condition Meeting the COPD criteria of postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio of less than 0.70 Able to walk independently with or without mobility devices Able to complete a six-minute walk test at discharge with or without supplemental oxygen maintaining an oxygen saturation at or above 85% Able to follow commands and instructions in the English language Have ability to connect to the internet Exclusion Criteria: • Those with significant mobility limitations such as those with a history of stroke, neurological comorbidities such as Parkinson's disease or relapsing multiple sclerosis, or significant degenerative osteoarthritis, or any other joint impairments that compromise ability to walk independently with or without an assistive device. Patients who primarily rely on a wheelchair for mobility Patients with or without supplemental oxygen who are unable to complete a walking test without a drop in oxygen saturation to below 85% at discharge from traditional outpatient rehabilitation Patients with baseline hemodynamic compromise, unstable angina, a recent myocardial infarction within a week, uncontrollable atrial fibrillation not managed with medications, advanced stage heart failure (New York Heart Association class 4), or those with mechanical circulatory assist devices for the heart such a ventricular assist device (VADs) Inability to communicate in the English language - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - StdAgeList: Adult, Older Adult

NCT06304194

Recruiting

Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology

Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region. In order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future. This will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.

- EligibilityCriteria: Inclusion Criteria: Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease Availability of biological material Signature of informed consent Age between 0 and 30 years Exclusion Criteria: Failure to sign the consent Insufficiency of biological material for analysis Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior. - HealthyVolunteers: No - Gender: All - MinimumAge: 0 Years - MaximumAge: 30 Years - StdAgeList: Child, Adult

NCT06304181

Not yet recruiting

Effect of Paracetamol and Mannitol Injection on Postoperative Analgesia in Patients With Thoracoscopic Lobectomy

This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.

- EligibilityCriteria: Inclusion Criteria: Obtain informed consent； Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia； Classified as American Society of Anesthesiologists (ASA) physical status I~II； Age over 18 years； Patients voluntarily participate and sign the informed consent form Exclusion Criteria: Systolic blood pressure ≥180 mm Hg or <90 mm Hg, diastolic blood pressure ≥110 mm Hg or <60 mmHg heart rate <50 beats/min； Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one >2 times the upper limit of normal severe kidney dysfunction: creatinine clearance <60 ml/min)； Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)； Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease； History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse； Neuromuscular diseases； Tendency towards malignant hyperthermia； Allergy to the study drug or other contraindications； Participation in another drug clinical trial within the past 30 days； Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months； Unstable angina, myocardial infarction in the last 3 months； Undergone another surgery within the last 3 months； Coagulopathy - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06304168

Recruiting

Validation of DNA Methylation Markers for Universal and Site-specific Guided Cancer Detection, VANGUARD Study

This study explores the potential value of a new blood test approach for early detection of cancer.

- EligibilityCriteria: Inclusion Criteria: Aim 1 Tissue Cases: Patient has a biopsy confirmed diagnosis of target histology Tissue samples from synchronous or metachronous primary cancers may be used as long as they are clearly of a different target organ. Tumors from patients with an underlying genetic disorder pre-disposing to cancer may be included as long as they are stratified from those without Controls: Patient does not have the diagnosis of target histology Aim 2 Blood Cases: Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma) Controls: Patient does not have a diagnosis of the target histology Aim 3 Urine Cases: Patient has a biopsy confirmed diagnosis of target histology or radiographic criteria that are unequivocal for diagnosis (example, meets radiographic criteria for hepatocellular carcinoma) Controls: Patient does not have a diagnosis of the target histology Exclusion Criteria: Aim 1 Tissue Cases and Controls: Patient has had any transplants prior to tissue collection Patient has received chemotherapy class drugs within 5 years prior to tissue collection Cases: Patient has had radiation to the current target lesion prior to tissue collection Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient) Patient has bilateral breast cancer/Ductal carcinoma in situ (DCIS) Aim 2 Blood Cases and Controls: Patient has known cancer outside of the target cancer 5 years prior to blood collection (not including basal cell or squamous cell skin cancers) Patient has received chemotherapy class drugs in the 5 years prior to blood collection Patient has had any prior radiation therapy to the target lesion prior to blood collection Patient has had a biopsy to the target organ and/or lesion within 3 days before blood collection Cases: Patient has had an intervention to completely remove current target pathology The current target pathology is a recurrence Patient has multi-centric/multi-focal breast cancer with differing genetic profiles (ER/HER2/PR status differ; if multiple masses are present and not all are tested then exclude patient) Patient has bilateral breast cancer/DCIS Aim 3 Urine Patient has known cancer outside of the target cancer 5 years prior to urine collection (not including basal cell or squamous cell skin cancers) Patient has received chemotherapy class drugs in the 5 years prior to urine collection Patient has had any prior radiation therapy to the target lesion prior to urine collection Patient has had a biopsy to the target organ and/or lesion within 3 days before urine collection The current target pathology is a recurrence Patient has chronic indwelling urinary catheter Patient has had a urinary tract infection within the 14 days prior to sample collection If patient does not have a primary bladder, ureter or urethral cancer, patient has a history of bladder ureter, or urethral cancer Cases: Patient has had an intervention to completely remove current target pathology The current target pathology is a recurrence Patient has multi-centric/multi-focal breast cancer with differing genetic profiles [estrogen receptor (ER)/human epidermal growth factor receptor 2 (HER2)/progesterone receptor (PR)] status differ; if multiple masses are present and not all are tested then exclude patient) Patient has bilateral breast cancer/DCIS - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Cancer and control patients who will be seen or treated at Mayo clinic. - SamplingMethod: Non-Probability Sample

NCT06304155

Recruiting

Application of FDG Combined With FAPI PET Dual Imaging in the Diagnosis and Staging of Oropharyngeal and Laryngeal Cancer

According to statistics, in 2020, new head and neck malignancies in the world accounted for 4.9% (931931 cases) of malignant tumors in the whole body, and the new death cases were 467125, accounting for 4.7% of malignant tumors in the whole body. The high incidence rate and mortality brought great burden to the medical system. In addition, due to various types of head and neck cancer, hidden location, impact on function and quality of life, and low overall survival rate, this type of disease has seriously threatened human health and social development. The incidence of oropharyngeal cancer and laryngeal cancer is more subtle. Traditional examination methods include CT, MR, and laryngoscopy, but they cannot make accurate judgments on the systemic TNM staging of oropharyngeal cancer and laryngeal cancer. 18F-FDG PET/CT examination can better diagnose and stage compared to traditional examination methods. However, due to the interference of more inflammatory lesions or physiological uptake in the pharynx, the false positive rate of 18F-FDG PET/CT examination is significantly increased, 18F-FAPI is a novel broad-spectrum tumor imaging agent that can be specifically uptake by fibroblasts in the tumor microenvironment, and has lower physiological uptake and acute inflammatory lesion uptake in the larynx. 18F-FAPI PET/CT examination can more accurately stage tumors throughout the body than 18F-FDG PET/CT examination. Combined with PET/MR local scanning, it will further improve the accuracy of T and N staging of local tumors. Therefore, It is of great significance for clinical diagnosis and treatment to effectively and reliably determine the systemic TNM staging of oropharyngeal and laryngeal cancer through non-invasive methods.

- EligibilityCriteria: Inclusion Criteria: Patients with high clinical suspicion of oropharyngeal and laryngeal cancer: CT and MR examinations reveal space occupying lesions in the oropharynx and laryngopharynx, with high suspicion of laryngeal cancer; Recently diagnosed patients: patients who have recently been diagnosed with oropharyngeal cancer and laryngeal cancer, have not undergone surgical resection but are willing to undergo surgery; Patients who have been diagnosed with oropharyngeal and laryngeal cancer and have undergone concurrent radiotherapy, chemotherapy, or immunotherapy, and are preparing to undergo preoperative staging in the near future; Patients with high suspicion of oropharyngeal and laryngeal cancer through imaging examination, and later confirmed by pathology as non oropharyngeal or laryngeal cancer; Patient age ≥ 18 years old; The patient voluntarily participates and signs an informed consent form. Exclusion Criteria: Patients who refuse to undergo surgery; Patients highly suspected of lymphoma or metastasis in clinical or imaging studies; Patients with multiple neck metastases identified through imaging examination that cannot be surgically treated; Patients with malignant tumors in other parts of the body found through imaging examination that cannot be operated on; Pregnancy or lactation period; The imaging quality is poor and cannot be used for diagnosis and evaluation; Patients with contraindications for MR examination. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn. - SamplingMethod: Probability Sample

NCT06304142

Not yet recruiting

Effect of Lidocaine Block on Gastroesophageal Reflux Disease

The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is: • Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom.

- EligibilityCriteria: Inclusion Criteria: Gastroesophageal Reflux Disease diagnosis aged between 18 and 80 years old. subjects who tolerate cervical movements in sitting position. stable vital signs. normal consciousness Exclusion Criteria: contraindications for stellate ganglion block. peptic ulcer. previous or present gastric cancer. previous gastric surgery. recent fractures or cervical trauma. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06304129

Not yet recruiting

Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers

.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are: to define a threshold value for each of the plasma, to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia, to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.

- EligibilityCriteria: Inclusion Criteria: Man or woman aged 18 or over Person affiliated to a social security scheme or beneficiary of such a scheme Person who has received full information on the organization of the research and has signed an informed consent form Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease Exclusion Criteria: Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) An adult unable to give consent Persons deprived of their liberty by judicial or administrative decision Persons under psychiatric care under articles L. 3212-1 and L. 3213-1. Pregnant, parturient or breast-feeding women Persons staying in a health or social establishment for purposes other than research. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304116

Not yet recruiting

Effect of Lidocaine Block in Traumatic Brain Injury

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

- EligibilityCriteria: Inclusion Criteria: age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury; presence of no contraindication for Stellate Ganglion Block; with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders. informed consent form was obtained from the patient's family members, indicating their full - understanding of the study and agreement to participate. Exclusion Criteria: unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; complicated with other intracranial lesions, such as stroke; with severe consciousness disorders caused by other diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06304103

Not yet recruiting

A Study of Efficacy and Safety of AND017 in Patients With Myelodysplastic Syndrome

This is a Phase 2, multicenter, randomized, open-lable study to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to lower risk Myelodysplastic syndromes (MDS)in patients subjects who are Red blood cell (RBC) non-transfusion dependent (NTD) and low transfusion burden (LTB).

- EligibilityCriteria: Inclusion Criteria: Diagnosed of primary myelodysplastic syndrome with a PISS-R grading of very low, low or intermediate risk and a bone marrow primitive cell count < 5%, the time frame for this grading assessment should be at least 12 weeks prior to the first dose Non-5q(del)-associated myelodysplastic syndrome. Two non-transfused hemoglobin ≥ 6.0 g/dL and < 10.0 g/dL, averaged over the screening period, at least one week and more apart, and with no more than 1.3 g/dL difference between the two Hb. Non-transfused subjects (NTD cohort) defined as no red blood cell transfusion in the 16 weeks prior to randomization or low transfusion load subjects defined as 3-7 pRBC units transfused in the 16 weeks prior to randomization and at least two different time points (LTB-1 cohort) or 1-2 pRBC units transfused at one time point in the 16 weeks prior to randomization ( LTB-2 cohort) (except in the case of transfusion for treatment of other comorbidities such as blood loss, surgery, etc.); Baseline EPO level ≤ 500 mU/mL Platelets ≥ 30,000 /mm3 and absolute neutrophil count ≥ 800/mm3 Adequate liver function with: Total bilirubin <2 x upper limit of normal (ULN) (subjects with Gilbert's syndrome, i.e., unconjugated hyperbilirubinemia, have a total bilirubin <3 x ULN) Aspartate aminotransferase (AST) <3 x ULN Alanine aminotransferase (ALT) <3×ULN Exclusion Criteria: Diagnosed of secondary myelodysplastic syndrome or concurrent anemia from a cause other than the primary myelodysplastic syndrome. Significant myelofibrosis (fibrosis ≥ 2+). Planned clearing chemotherapy or whole brain spinal cord radiotherapy during the study period. Previous diagnosis of MDS IPSS-R high or very high risk. Prior or planned hematopoietic stem cell transplant during the study period. Received granulocyte colony-stimulating factor (G-CSF), or thrombopoietin, or thrombopoietin receptor agonist therapy within 8 weeks prior to the first dose; Treatment with antithymocyte globulin, azacitidine, decitabine, cyclosporine, thalidomide, or lenalidomide within 12 weeks prior to the first dose. The presence of active infection or inflammatory disease requiring systemic anti-infective therapy, including concomitant autoimmune disease with inflammatory symptoms (e.g., generalized erythema, ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, dry syndrome, celiac disease, etc.) Concurrent retinal neovascularization requiring treatment (diabetic proliferative retinopathy, age-related exudative macular degeneration, retinal vein occlusion, macular edema, etc.) Inability to take oral medications, or a history of gastrectomy, concomitant gastroparesis, or other conditions that may have an impact on the absorption of gastrointestinal medications (excluding gastric polyps or colonic polypectomy) Clinically significant bleeding (including transfusions required to treat bleeding or bleeding resulting in a decrease in hemoglobin ≥ 2 g/dL) within 4 weeks prior to the first dose, or a bleeding constitutional or bleeding risk that has not been medically or surgically corrected. Uncontrolled hypertension (more than one-third of identifiable diastolic blood pressure values ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg at 16 weeks prior to and including screening testing) Comorbid heart failure (New York Heart Association [NYHA] class III or higher) Medical history of significant liver disease or active liver disease at screening assessment Have been treated with any other hypoxia-inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) in the 8 weeks prior to the first dose Have been treated with an erythropoietic ESA within 8 weeks prior to the first dose Have been treated with an androgenic anabolic steroid, testosterone enanthate or methandrostenolone within 8 weeks prior to the first dose Have been treated with an iron chelator within 8 weeks prior to the first dose - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06304090

Not yet recruiting

Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

- EligibilityCriteria: Inclusion Criteria: meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation; age between 4 to 7 years; diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy; Exclusion Criteria: with dysphagia caused by other diseases or factors; progressive neurological disease or degenerative neurological disease; with severe heart disease, liver or kidney dysfunction, hematological disorders; with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; with poor compliance. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 7 Years - StdAgeList: Child

NCT06304077

Recruiting

Restorative Environments for Gait Therapy With VR

The aim of our study is to investigate the effects of landscapes during gait therapy. The investigators will evaluate the impacts of restorative landscapes as they occur in urban, rural and forest environments. Older people will experience those landscapes using virtual reality (VR) goggles during their gait training. The investigators expect the landscapes to have an effect on the following three aspects: (1) stress reduction, (2) restoration of attention and (3) change in gait parameters. For this purpose, volunteers who are currently inpatient in one of our study centers and already participating in gait therapy will be assigned to a group. The control group will receive the standard therapy. The participants of the intervention groups will receive five additional VR training sessions to the standard therapy. In these sessions, the participants will walk through urban, rural and forest landscapes and perform balance improvement exercises. The five training sessions will take place within ten days. Allocation to the control or intervention groups and their landscapes is random. At the start and end of participation, tests defining stress levels and gait parameters are carried out so that comparisons can be made between before and after treatment. The goal of the study is to find out which type of landscape supports restoration and can therefore contribute to greater gait stability. The investigators expect that improved gait stability will be promoted by stress reduction and increased attention induced by the virtual environments. The investigators are investigating the consequences of repeated application of virtual landscapes and the relationship between the effect of the landscape and the preferences and habits of the study participants.

- EligibilityCriteria: Inclusion Criteria: age: > 65 years german-speaking ability to give informed consent attends gait safety training (usual care) inpatient for a duration of min. 2 weeks in one of the study sites items 7 - 15 of the De Morton Mobility Index (DEMMI): min. 2 points, max. 9 points 3-minute walking distance: > 30 m without rest, with or without walking aids, overground walking on flat surface Exclusion Criteria: epilepsy Partial weight bearing or conservatively or surgically treated billing with weight bearing as determined by symptoms Severe hearing impairment (if not corrected with hearing aid) Injuries to the eyes, face, or neck that prevent comfortable use of VR glasses. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06304025

Not yet recruiting

Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment

Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs). The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib.

- EligibilityCriteria: Inclusion criteria: Aged between 18 and 65 years. With a diagnosis of malignant hemopathies, who have undergone allogeneic HSCT and who are diagnosed with acute GVHD refractory to second-line treatment. Patients who have received bone marrow and/or peripheral blood as a source of cells. Patients who have received cells from a family or unrelated donor Myeloablative or non-myeloablative conditioning method. Adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure, angor pectoris, or acute myocardial infarction in the 6 months prior to the process. Adequate lung function without evidence of severe obstructive or restrictive lung disease. Informed consent signed by the patient. Exclusion Criteria: Patients from the Transplant Unit of the FOSCAL. Patients with a diagnosis of hemopathy that has not been controlled by the transplant or is progressing at the time of treatment. Bacterial, viral, or fungal infection that is not being controlled with adequate treatment. Cardiac and/or pulmonary function in uncontrolled altered conditions. According to medical criteria, patients who are not in an adequate situation to tolerate the treatment. Pregnant women or women at risk of pregnancy due to inadequate contraceptive measures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06303986

Recruiting

Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process

Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS). The prevalence of opioid use during pregnancy has increased by 333% from 2013 to 2014 and continues to rise. Approximately 1 in 3 women were prescribed opioids during pregnancy from 2008 to 2012. In the US, NAS was diagnosed every 25 minutes in 2014. By 2019, it became every 15 minutes. Although there are medication-based interventions for the treatment of NAS, used in up to 80% of opioid-exposed infants, these treatments carry risks of toxicity and drug interactions. Despite the steep medical costs and the risks of treatment, current tools to assess the severity of NAS are subjective and suffer from examiner bias, resulting in poorer clinical outcomes, such as longer lengths of stay in the Neonatal Intensive Care Unit (NICU), for these babies. Studies have shown that continuous vital sign monitoring improves outcomes and decreases the length of stay in general practice. Preliminary machine learning models have been able to predict pharmacological treatment for Neonatal Opioid Withdrawal Syndrome (NOWS). This project will collect physiological and behavioral data of NAS patients to develop an AI algorithm and establish the advantages of continuous monitoring in NAS. The AI algorithm, processed by machine learning, will help predict NAS symptoms, automate scoring, and provide healthcare personnel with predictive analytics to guide suggested treatments.

- EligibilityCriteria: Inclusion Criteria: The subject selection criteria per site will be 80% term neonates affected by neonatal abstinence syndrome (NAS) and 20% term neonates without any health complications. The eligible screening process for the NAS neonates in the study will include neonates affected by NAS, newborn infants diagnosed with NAS, infants with confirmed history of prenatal exposure to opioids or other drugs that can cause NAS, and infants who meet specific diagnostic criteria for NAS based on standardized clinical assessments. The eligible screening process for neonates without any health complications include newborn infants without any known health complications or medical conditions, infants with a normal physical examination and absence of clinical signs or symptoms suggestive of NAS or other health issues. Given the simple nature of the study, wards of the courts will also be enrolled upon evaluating the appropriateness, identifying an advocate if required, and providing an approved consent for the ward subject. Exclusion Criteria: The investigators are NOT purposefully excluding or including any gender or race in our studies. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MaximumAge: 4 Weeks - StdAgeList: Child - StudyPopulation: NAS affected neonates and healthy neonates. - SamplingMethod: Non-Probability Sample

NCT06303960

Recruiting

Bilateral or Unilateral Cerebellar Deep Brain Stimulation for Chronic Post-stroke Motor Rehabilitation

Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.

- EligibilityCriteria: Inclusion Criteria: Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery. Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42 Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension). Exclusion Criteria: Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) Severe cognitive impairment (Mini Mental State Examination < 24) - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06303947

Not yet recruiting

Effect of Oral Enteral Nutrition Feeding in Parkinson Disease

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding. Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

- EligibilityCriteria: Inclusion Criteria: Age >18 years. Meeting the diagnostic criteria for Parkinson's disease. Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. Water swallow test> Level 3. Stable vital signs, conscious, able to cooperate with assessment and treatment. Exclusion Criteria: Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. Complicated with severe liver and kidney failure, tumors, or hematological disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303921

Recruiting

Pilot Study of 11C-M503

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). We will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

- EligibilityCriteria: Inclusion Criteria: Patients in all cohorts will be male or female adults from 40 to 85 years of age. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits We will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study. Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control) Exclusion Criteria: Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 11C -M503, 11C-PiB or 18F-Florbetaben Forms of parkinsonism other than PD, PSP and MSA as defined above Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician Contraindication to MRI, such as non-compatible implanted medical device Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 40 Years - MaximumAge: 85 Years - StdAgeList: Adult, Older Adult

NCT06303908

Not yet recruiting

How Traditional Chinese Medicine Exercise Improves Parkinson Disease

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

- EligibilityCriteria: Inclusion Criteria: Age >60 years. Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006. Exclusion Criteria: Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. Complicated with severe liver and kidney failure, tumors, or hematological disorders. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06303895

Not yet recruiting

How Acupuncture Therapy Improves Dysphagia in Parkinson's Patients

We are currently conducting a randomized controlled study in China, specifically in three hospitals' rehabilitation medicine departments, focusing on dysphagic participants with Parkinson's disease. The aim of our study is to evaluate the effectiveness of acupuncture therapy as an additional intervention for these participants. Participants were randomly assigned to either the experimental group or the control group, with 56 individuals in each group. Both groups are receiving standard treatment and swallowing rehabilitation training, while the experimental group is also receiving acupuncture therapy. Our study aims to provide valuable insights into the potential benefits of acupuncture in improving swallowing difficulties in Parkinson's disease participants.

- EligibilityCriteria: Inclusion Criteria: Age >18 years. Meeting the diagnostic criteria for Parkinson's disease. Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. Water swallow test> Level 3. Stable vital signs, conscious, able to cooperate with assessment and treatment. Exclusion Criteria: Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. History of mental diseases or use of antipsychotics. Complicated with cognitive impairment or consciousness dysfunction. Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303882

Not yet recruiting

Effect of Computer-based Cognitive Function Training on Cognitive Dysphagia After Stroke

This is a multicenter randomized controlled study. The study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland China as the participants (study subjects). The study duration for each participant was 15 days. The subjects were randomly divided into an experimental group and a control group. During the treatment, all patients received routine rehabilitation treatment. In addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

- EligibilityCriteria: Inclusion Criteria: Age ≥ 18 years. Meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging. Montreal Cognitive Assessment score < 26 and > 18 (adjusted by 1 point if the educational level is high school graduation or above). Confirmed swallowing disorder through Fiberoptic Endoscopic Examination of Swallowing. Duration of illness greater than three months. Patients or their family members are aware of and consent to participate in the study. Exclusion Criteria: Presence of other intracranial lesions, such as stroke. Cognitive impairment caused by other diseases. Mental abnormalities. Inability to complete treatment and assessments due to other impairments. Concurrent severe injuries. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303869

Not yet recruiting

Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke

The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.

- EligibilityCriteria: Inclusion Criteria: Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a result. Participants must be between the ages of 18 and 70 years old. (Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing). Native English speaker. Patients with moderate to severe dysarthria (50-89% intelligibility in the Assessment of Intelligibility of Dysarthric Speech test). Exclusion Criteria: Patients who refuse participation in the study. Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic areas Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments. Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect their ability to participate in this study. Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding. Participants must not be receiving anticoagulants. Severe claustrophobia. Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study. Participants who have been deemed inappropriate for participation based upon results from the Brief Symptoms Inventory (BSI-18) and discussions with the Principal Investigator and a study physician Evaluation to sign consent form score <12. MRI contraindications (excluding subjects who are pregnant, who have metal in any portion of their body, have medical complications, cardiac pacemaker, cochlear implant, aneurysm clip, certain IUDs, or known problems of claustrophobia). Medications with common cognitive side-effects Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage) Hypersensitivity to barium sulfate (for barium swallow test) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06303856

Not yet recruiting

How Active Breathing Training Improves Dysphagia in Elderly People

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

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

NCT06303804

Not yet recruiting

Prevention of Opioid Misuse and Overdose Deaths Among Hispanic/Latinx Adolescents: A Family-based Perspective

The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores

- EligibilityCriteria: Inclusion Criteria: Must identify as Hispanic/Latino/a descent Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time Have English or Spanish proficiency Exclusion Criteria: Adolescent or parent currently in opioid treatment Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303778

Not yet recruiting

Combining a Smartphone App With Medications to Manage Heavy Drinking

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

- EligibilityCriteria: Inclusion Criteria: To be eligible, Veterans must be: 1) diagnosed with an AUD and report 4 HDD (defined as 5 standard drinks per day for men and 4 standard drinks per day for women) in prior 30-days 2) enrolled in VA primary care 3) planning to initiate MAUD, as determined by a medication order 4) between ages 18-80 5) willing to be randomized 6) Android or iPhone smartphone owners Exclusion Criteria: 1) past 30-day participation in VA or non-VA SUD treatment 2) prior episode of MAUD receipt in the last 30 days (initiation of a new episode of MAUD in the 7 days prior to screening allowed) 3) plans to be or are pregnant 4) severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol, as determined by the referring provider. Veterans aged >80 were excluded because ownership and use of mHealth apps decreases with advancing age. Participants who enter SUD specialty care following randomization will be allowed to continue in the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06303765

Recruiting

Evaluating the Practice Resource for Driving After Stroke

After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning.

- EligibilityCriteria: Inclusion Criteria: Occupational therapists are eligible to participate if they currently practice on an acute stroke unit. Exclusion Criteria: To avoid threats to treatment fidelity, occupational therapists are ineligible to participate if there is already a participant enrolled from their local workplace (same physical building), or if they have viewed a copy of the PReDAS previously. - HealthyVolunteers: No - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06303752

Not yet recruiting

Tissue Therapy of Transsphincteric Anal Fistula

This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.

- EligibilityCriteria: Inclusion criterion: Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are: able to communicate with Danish language able to provide informed consent having address in the region of southern Denmark during the study Exclusion criteria: Signs of suppuration/cavitation around the fistula Simple or low anal fistula, which can be treated by simple surgical incision Ano-vaginal and recto-vaginal fistula The presence of more than one fistula tract, more than two external orifices or more than one internal orifice Inflammatory Bowel Disease Immunosuppression (due to clinical condition or medical therapy) Malignancy within 5 years Previous radiotherapy of the abdomen and pelvis BMI under 18.5 Allergy against the antibiotics: Penicillin and streptomycin. Coagulopathy Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test) Verified syphilis, HIV, or hepatitis on screening test - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303739

Not yet recruiting

Psilocybin-Assisted Therapy in Treatment-Resistant Depression

The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: Does psilocybin with assisted therapy help improve symptoms for people with depression? How long do the effects of this treatment last? Participants will: Take part in a couple of screening and preparation visits. Be given psilocybin in one or two treatment sessions. Attend a series of follow-up sessions over the following year. Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.

- EligibilityCriteria: Inclusion Criteria: Provision of signed and dated informed consent form. Willingness to comply with all study procedures and availability for the study. Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) diagnosis of major depressive disorder. Currently experiencing a major depressive episode, lasting at least 3 months Failure to respond or inability to tolerate at least 2 guideline-concordant pharmacological treatments from different pharmacologic classes during the current major depressive episode Good health evidenced by medical history and routine lab tests No central nervous system (CNS) or neurocognitive impairment Ability to take oral medication and to follow to the psilocybin-assisted therapy protocol Identified support person to accompany patient home after dosing Use of effective contraception throughout the study by those with child-bearing potential Use of condoms or other effective contraceptive methods by males with reproductive potential Fully vaccinated and up to date on vaccination against COVID-19, as defined by Center for Disease Control guidelines Following Lifestyle Considerations throughout study (no nicotine containing products in clinical unit, refrain from operating heavy machinery for the duration of treatment day, no more than two servings 8 hours prior to treatment, no psychoactive drugs 72 hours before treatment, refrain from consuming foods that would interfere with drug absorption, minimize interaction with household immunocompromised contacts) Exclusion Criteria: Family history (first- or second-degree relatives) or diagnosis of bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, hallucinogen-induced psychosis, anti-social personality disorder, or other psychotic disorder. Borderline personality disorder, defined by DSM-V criteria, that in the judgement of the Investigator is likely to complicate the assessment of clinical response to study treatments or limits the patient's ability to comply with study procedures. Alcohol or other substance use disorder (except tobacco/nicotine) that has been active within the 6 months prior to enrollment. Recent use (within past 6 months) of esketamine, ketamine or classic hallucinogens (psilocybin-containing mushrooms or LSD) or use of psychedelics more than 10 times in lifetime. Participants with active suicidal ideation or plan with a Columbia Suicide Severity Rating Scale (C-SSRS) score greater than or equal to 4. Current active self-injurious behavior, requiring medical attention or per investigator discretion. Diagnosis of Obsessive-compulsive disorder or post-traumatic stress disorder. Within 72 hours of psilocybin administration, use of nicotine, alcohol, or other controlled substances. Current delirium, dementia, amnestic disorder, or other cognitive disorders. Any current or past medical or neurological illness (including chronic pain syndromes and/or history of cerebrovascular event (excluding migraine)) that, in the opinion of the investigator, may confound the interpretation of study assessments Known allergic reactions to components of psilocybin. Medically instability at screening, including hepatic, renal, circulatory, cardiac (arrhythmia, uncontrolled hypertension, systolic BP > 140 mmHg or diastolic BP > 90 mmHg, abnormal QTc), pulmonary or CNS (seizure disorder or treatment with antiepileptic drugs) impairment. Current pregnancy or lactation. Febrile illness in last 3 weeks. Current use or use within 4 weeks of psilocybin administration of Monoamine oxidase inhibitors (MAOIs), alcohol dehydrogenase inhibitors and antipsychotics (concomitant medications will be allowed per investigator discretion). Current treatment with buproprion greater than 300mg/day. Current use of tramadol. Prior participation in psilocybin-assisted therapy trial and or regular use of hallucinogens Treatment with another investigational drug or other intervention during study period. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult

NCT06303713

Not yet recruiting

LuCarbo - a Study of 177Lu-PSMA-617 Plus Carboplatin in Metastatic Castrate-resistant Prostate Cancer

The purpose of this study is to see whether the combination of a chemotherapy drug, carboplatin, along with the radioligand treatment, 177Lu-PSMA-617, is safe in treating prostate cancer and whether the combination is effective in shrinking or preventing growth of prostate cancer. The names of the study drugs used in this research study are: Carboplatin (A type of chemotherapy) 177Lu-PSMA-617 (A type of radioligand therapy)

- EligibilityCriteria: Inclusion Criteria: Participants must have histologically or cytologically confirmed prostate adenocarcinoma without histologic variants comprising >50% of the sample as determined by pathology review at an academic medical center; men without histologic or cytologic confirmation are eligible provided there is unequivocal evidence of prostate cancer (eg. very high PSA) in the view of the treating physician. Age ≥ 18years. Children under age 18 are excluded as prostate cancer is a disease of adults. Progressive disease at study entry, as defined by either one of the following: Sequence of at least 2 rising PSA values at a minimum of 1-week intervals with the last result being ≥1.0 ng/mL if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen (flutamide, bicalutamide or nilutamide) must have PSA progression ≥4 weeks after the last dose. Radiographic progression per RECIST 1.1 for soft tissue and/or per PCWG3 for bone (i.e. appearance of ≥2 new bone lesions), with or without PSA progression. Presence of ≥1 metastatic lesion metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy. Prior receipt of at least one taxane chemotherapy (docetaxel or cabazitaxel) and at least one ARPI (abiraterone, enzalutamide, apalutamide or darolutamide) in the localized, recurrent or metastatic setting. Prior treatment with a PARP inhibitor(s) is permitted. Prior treatment with Ra-223 is permitted, providing that the last dose of Ra-223 was ≥90 days prior to study entry. Presence of ≥1 PSMA-avid lesion (with uptake > liver) on baseline/screening 68GaPSMA-11 PSMA-PET. Serum testosterone level must be ≤50ng/dL (1.73 nmol/L) at the screening visit. Participants who have not undergone bilateral orchiectomy are required to continue LHRH/GnRH agonists/antagonists) throughout the study. Use of relugolix is permitted. ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A). Adequate organ and marrow function as per the below table: --System Laboratory Value Hematologic ANC ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥9g/dL (≥90g/L), independent of transfusions Hepatic Total bilirubin ≤1.5 × ULN OR <2 × ULN if known or suspected Gilbert's syndrome ALT and AST ≤3 × ULN OR ≤5 × ULN if liver metastases present Renal --eGFR ≥30 mL/min/1.73 m2 (based on Cockcroft-Gault formula OR 24 hour urine collection Presence of a recurrent/metastatic lesion (bone or soft tissue) amenable to image-guided percutaneous biopsy adequate for next generation sequencing (NGS), and planned to undergo core biopsy after trial registration but prior to cycle 1 day 1 of therapy. Confirmation of adequacy of this biopsy material for NGS is NOT required for initiation of therapy. Willingness to undergo core biopsy of a recurrent/metastatic lesion adequate for NGS after approximately 12 weeks of study treatment. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The effects of 177Lu-PSMA-617 and carboplatin on the developing human fetus are unknown. For this reason and because chemotherapies and radioligand therapies are known to be teratogenic, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation, and at least 14 weeks following the last dose of 177Lu-PSMA-617.Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. Female partners of child-bearing potential should also use highly effective birth control methods throughout the male participant's study treatment and for at least 14 weeks following the last dose of 177Lu-PSMA-617. Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged) Exclusion Criteria Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment. Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy. Participants who are receiving any other investigational agents. Participants who have previously received 177Lu-PSMA-617. Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-PSMA-617 and carboplatin. Participants with untreated brain metastases. Participants with treated brain metastases are eligible if follow-up brain imaging at least 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and ongoing corticosteroids are not required. Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of the investigational regimen. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are permitted to enroll. The participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303661

Recruiting

Non-ablative Radiofrequency and Low Intensity Shock Wave Therapy in Fibrotic Plaque in Men With Peyronie's Disease

The goal of this one arm clinical trial is to evaluate the safety and describe the clinical response of non-ablative radiofrequency treatment associated with shockwave therapy in men with Peyronie's disease. The main question[s] it aims to answer are: • is the treatment safe? • is there any clinical response to the proposed treatment? Participants will respond to five validated questionnaires: International Index of Erectile Dysfunction (IIEF-5), Medical Outcomes Study 36 - Item Short - Form Health Survey (SF-36), Peyronie's Disease Questionnaire (PDQ), Scale Hospital for Anxiety and Depression (SHAD) and the Erection Quality Questionnaire (EQQ); will undergo a physical assessment that includes palpation of the fibrotic plaque on the penis, pharmacological induction of erection, and assessment of the size of the fibrotic plaque through ultrasound. Every five sessions, the participant's degree of satisfaction will be measured using a 5-point Likert scale, as well as the evolution of symptoms will also be observed, using a 10-point Visual Analogue Scale (VAS) and penile pain, if present. The entire evaluation protocol will be applied before (pre-test), after treatment (post-test) and 1 month after the end of treatment. Volunteers will be monitored by telephone to verify the long-term response after 3, 6, 9 and 12 months of completed treatment in relation to the Likert scale and VAS. The treatments they'll be given are • of monopolar non-ablative radiofrequency associated with • low-intensity shock wave therapy.

- EligibilityCriteria: Inclusion Criteria: Clinical complaint related to Peyronie's disease; At any stage of the disease (acute or chronic). Exclusion Criteria: Users of a pacemaker, cardiac defibrillator implant or any other electromagnetic implant; Metallic implants over or under the area to be treated. - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06303648

Not yet recruiting

A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects

This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.

- EligibilityCriteria: Key Inclusion Criteria: Healthy adult male or female aged 25 to 55 inclusive Normal resting ECG Normal hematologic and hepatic function Normal renal function Key Exclusion Criteria: Vital sign abnormalities Positive urine drug screen at screening and / or Day -1 Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 55 Years - StdAgeList: Adult

NCT06303635

Not yet recruiting

Safety of UFRJvac, Trivalent COVID-19 Vaccine

Phase I study to evaluate the safety and immunogenicity of the vaccine booster with the trivalent UFRJvac COVID-19 vaccine.

- EligibilityCriteria: Inclusion Criteria: Male or female. Age from 18 to 65 years old, inclusive. Complete primary vaccination for COVID-19 with one of the vaccines approved by ANVISA for use in Brazil, and at least one booster, the last of which must be with Comirnaty Bivalente BA.4/BA.5 between 4 and 18 months before vaccination. inclusion. Body mass index (BMI) between 19.0 and 35.0 kg/m2, inclusive. Female participant with a negative pregnancy test on the day of vaccination. Consent form voluntarily signed before any procedure. Exclusion Criteria: Confirmation of active SARS-CoV-2 infection in rapid antigen test screening. History of serious adverse reaction to any vaccine, medication or component of the investigational product. History of immunodeficiency, autoimmune diseases and cardiomyopathies. History of medium or major surgery within 3 months before inclusion. History of malignancy within 1 year before screening (except basal cell carcinoma of the skin or in situ carcinoma of the cervix, which have already resolved). History of uncontrolled coagulopathy or blood disorders that contraindicate intramuscular injection. History of uncontrolled epilepsy or other progressive neurological disorders such as Guillain-Barré Syndrome. Any decompensated chronic disease at the time of inclusion. Treatment with immunosuppressive medications in the 3 months prior to the first vaccination or 6 months for chemotherapy. History of systemic steroids (prednisone ≥ 20 mg/day or equivalent for >14 consecutive days) within 3 months prior to screening. Topical, inhaled, intranasal, and intra-articular corticosteroids are permitted regardless of dose. Use of any other vaccine less than 14 days before or planning to use up to 29 days after V0. Use of blood products in the 3 months before inclusion. Use of another investigational product within 1 year before inclusion. Pregnancy or breastfeeding at inclusion or planned during the study. Fever or any acute illness within 1 week before inclusion. Participants who do not meet this criterion may be rescheduled for a new inclusion visit. Presence of tattoos, scars, skin discoloration or any other skin disorders at the injection site that, in the opinion of the investigator, may impair the assessment of local reactogenicity. Any condition that, in the opinion of the investigator, endangers the safety or rights of the participant or makes the participant unsuitable for the study. Clinically significant changes in safety examinations, defined as: Hb ≤ 10.9 g/dL; Leukocyte count < 2500 cells/mm3; Absolute neutrophil count < 1000 cells/mm3; ESR outside normal values (18 to 65 years old, male - 2 to 28 mm; 18 to 65 years old, female - 2 to 36 mm); ALT, AST and FA > 1.25 x ULN; Total bilirubin > 1.1 x ULN; Creatinine > 1.1 x ULN; Glycated hemoglobin > 5.6%; Troponin 1 > 0.16 ng/mL; TP and aPTT > 1.1 x ULN; CPK outside normal values (male adults - 38 to 174 U/L; female adults - 26 to 140 U/L); C-reactive protein > 1.0 mg/dL. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study will include 156 male or female participants aged between 18 and 65 years, with complete primary vaccination for COVID-19 and at least one booster dose, the last being carried out with the Comirnaty Bivalent BA.4/BA vaccine. 5. - SamplingMethod: Probability Sample

NCT06303622

Not yet recruiting

A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

- EligibilityCriteria: Inclusion Criteria: Men ≥18 years of age Clinical suspicion of prostate cancer and indicated for prostate biopsy Serum Prostate-specific antigen (PSA) < 20 ng/mL Digital rectal examination ≤ cT2 (organ-confined cancer) Able to provide written informed consent MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5 Exclusion Criteria: Prior prostate biopsy in the 2 years before screening visit Prior diagnosis of prostate cancer Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted) Patient refusal for biopsy - HealthyVolunteers: No - Gender: Male - GenderBased: Yes - GenderDescription: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303609

Not yet recruiting

Effects of Non-ablative Radiofrequency on Female Genito-pelvic Pain Disorder

The goal of this randomized clinical trial is to verify the response of genito-pelvic pain disorders in women associated with inability to penetrate to the treatment with non-ablative radiofrequency. The main question it aims to answer is: Does non-ablative radiofrequency have a positive effect on the symptoms of genito-pelvic pain disorders associated with inability to penetrate? Before starting the intervention and at one week, one-, three- and six months after the end of the study, participants will be evaluated with 03 questionnaires (Female Sexual Function Index, Sexual Quality of Life and Perceived Stress Scale-10) and will score the visual analogue scale the level of pain with the penetration (from 0 to 10); participants will then undergo digital evaluation of the pelvic floor muscles, using vaginal dilators and electromyographic evaluation. After being randomized, participants will be divided into the Experimental Group and the Sham Group, being submitted to • the use of non-ablative radiofrequency in the anal and urogenital triangles, • the positioning of the vaginal dilator at the end of each session • and participants will be instructed to use the vaginal dilator at home daily. The researchers will compare the groups in relation to the ability to penetrate with reduced vaginal pain, sexual function, quality of sexual life and the correlation between pelvic muscle activity and perceived stress.

- EligibilityCriteria: Inclusion Criteria: Women with genito-pelvic pain disorder associated to penetration. Exclusion Criteria: Participants with chronic degenerative disease, cognitive impairment, genital agenesis, with a history of vaginal cancer or genital radiotherapy, with the use of pelvic or lumbosacral prostheses, cardiac pacemakers, pregnant women, infections in the genital or systemic region, or who are undergoing some type of treatment for genito-pelvic pain disorder, unstable relationship with the same partner, partner with sexual complaints. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 45 Years - StdAgeList: Adult

NCT06303596

Not yet recruiting

Hippotherapy in Patients With Schizophrenia

This study will determine the efficacy of hippotherapy (horseback-riding) program, as an adjuvant to standard psychiatric treatment, on the outcomes of patients with schizophrenia. A randomized controlled trial is conducted in a Community Mental Health Center. All participants are randomized into two groups (experimental and control groups) using blocked randomization. All participants received the standard psychiatric treatment, while the experimental group is additionally provided with a 16-session hippotherapy program for 8 weeks. All participants will be evaluated using the Positive and Negative Syndrome Scale, State-Trait Anxiety Inventory, Quality of Life Scale, UCLA Loneliness Scale at both baseline and after the intervention.

- EligibilityCriteria: Inclusion Criteria: Being diagnosed with schizophrenia, Being at an age of older than 18 years, Being registered with and treated at the Community Mental Health Center, Being at remission period (a stable condition) at the time of enrollment and throughout the study. Being able to provide written informed consent and comprehend the instruments. Exclusion Criteria: The participants who suffer from other comorbid psychiatric disorders (depression, personality disorder, substance addiction, etc.), The participants who are not willing to sign the consent. The participants who have physical health problems that would prevent horseback-riding. - HealthyVolunteers: No - Gender: All - MinimumAge: 19 Years - StdAgeList: Adult, Older Adult

NCT06303570

Not yet recruiting

A Study to Evaluate the Efficacy and Safety of CBL-514 Compared to Placebo in Participants With Dercum's Disease Lipomas

This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.

- EligibilityCriteria: Inclusion Criteria: Male or female, aged 18 years to 64 years old (at screening), inclusive. Body mass index (BMI) >18.5 kg/m2 at screening and Day 1. Has confirmed DD and/or fulfills the following clinical criteria of DD in localized nodular form. The final diagnosis of disease is in the opinion of the Investigator. Chronic pain (>3 months) in the adipose tissue specific to the presence of lipomas and/or Pain in and around multiple lipomas. Has at least 4 and up to 10 painful and well-defined lipomas with dimension of ≥10 mm and ≤50 mm as measured by ultrasound (read by the Investigator) at screening. The selected lipomas to be treated must meet the following conditions at screening. At least 4 lipomas among the 10 lipomas should have greatest dimension of ≥ 20 mm but ≤50 mm. Pain level is ≥4 scores as assessed by Comparative Pain Scale. Excluding lipomas in proximity to vulnerable anatomic structures, including the salivary glands, lymph nodes, muscles, and along the anatomic landmarks of the marginal mandibular nerve. Isolated form and not connected with other lipoma(s). Generally considered healthy according to medical history, physical examination, ECG, and laboratory evaluation. Voluntarily signs the informed consent form (ICF) and, in the opinion of the Investigator or designee, is physically and mentally capable of participating in the study, and willing to adhere to study procedures. Exclusion Criteria: Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive regimen from the time of screening and throughout study participation until 90 days after the last IP dose, or who is currently pregnant or lactating. Female participant of childbearing potential who is breastfeeding or anticipates breastfeeding from the time of screening and throughout study participation until 90 days after the last IP dose. Male participant who is not willing to commit to using of a condom and refraining from sperm donation from the time of the first dose of IP, throughout study participation until 90 days after the last IP dose. Note: Participants who are not of childbearing potential are not required to use contraception. Females not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (defined as at least 50 years of age with ≥12 months of amenorrhea with a follicle stimulating hormone >30 IU/L). Unable to tolerate SC injections. Diagnosed with another disorder with similar characteristics as DD as follows. Madelung's disease: multiple symmetric lipomatosis only localized in the upper body ie, shoulders, neck, or head. Panniculitis: inflammation of the SC adipose tissue, characterized by tender nodules and systemic signs. Proteus syndrome: disproportionate and asymmetric overgrowth of skin, and fatty and connective tissue. PTEN hamartoma syndrome: multiple hamartomas which includes segmental overgrowth, lipomatosis, arteriovenous malformation, and epidermal nevus. Gardner syndrome: multiple digestive adenomas with osteomas and multiple skin and soft tissue tumors. Diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which inhibit coagulation or platelet aggregation. Has fasting glucose concentration >200 mg/dL, delayed wound healing, bleeding risk, or any diabetic risks which, in the opinion of the Investigator or designee, is inappropriate to participate in the study. Any clinically significant cardiac, hepatic, renal or neurologic/psychiatric disorders that in the opinion of the Investigator places the participant at significant risk, including but not limited to any of the following: Participants with cirrhosis or with inadequate liver function at screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin >3.0 upper limit of normal (ULN). Participants with renal impairment, defined as both serum creatinine and blood urea nitrogen >1.5× ULN, or estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2, or who are currently on dialysis. Note: Participant with an eGFR ≥60 and <90 mL/min/1.73 m2 at screening should be evaluated by the Investigator for pre-existing renal disease or associated dysfunction. If mild decrease in eGFR is deemed not clinically significant or not related to dysfunction by the Investigator, the participant will not be excluded unless the Investigator deems it necessary. Participant with a history of human immunodeficiency virus (HIV)-1 infection or participant with active HIV infection at screening with positive HIV antigen/antibody (Ag/Ab) combo test. Participant is undergoing chronic steroid or immunosuppressive therapy, with the exception of oral steroid inhalation indicated for asthma management or topical steroid application for skin conditions that are not directly applied to or indirectly affect the treatment area. Participant with active or prior history of malignancies within 5 years before screening or currently being evaluated for a possible malignancy, with the exception of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin at Investigator's discretion. Abnormal skin, local skin conditions, or body modifications at the treatment area, which in the opinion of the Investigator, is inappropriate for participation in the study, including but not limited to any of the following: Prior wound, scar tissue, or infection in the treated area. Tattoo in the treated area. Use of any analgesic including Cannabis within 14 days prior to Screening Requiring continual use of any medication that is known to strongly inhibit or induce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index during the study that, in the opinion of the Investigator, may affect the evaluation of the study product or place the participant at undue risk. Note: If a participant needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 2 days prior to dosing and until 1 day postdose. Participant who has undergone the following procedures: Liposuction or aesthetic surgery to the region to be treated before screening or during the study, Aesthetic procedure for body contouring, eg, cryolipolysis, ultrasonic lipolysis, low level laser therapy, lipolysis injection to the region to be treated within 12 months before screening or during the study. Unable to receive local anesthesia. Known allergies or sensitivities to the study drug or its components. Use of other investigational drug or device within 12 weeks prior to screening. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 64 Years - StdAgeList: Adult

NCT06303557

Recruiting

Effect of ESPB on Intraoperative Remifentanil Consumption

In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery. General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifantanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients. As a result of all these; it was aimed to compare the intraoperative remifantanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.

- EligibilityCriteria: Inclusion Criteria: 18 to 65 years old ASA physical status I-II-III BMI 18 to 40 kg/m2 Elective LDH surgery Exclusion Criteria: Patient refusing the procedure Patients who have previously undergone spinal surgery Chronic opioid or analgesic use Patients who will operate under emergency conditions Patients who will not undergo LDH surgery - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06303544

Not yet recruiting

More Outside Your Door: A Diet/Physical Activity Intervention to Decrease Risk of Obesity in Alaska Native Preschoolers

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

- EligibilityCriteria: Inclusion Criteria: parent who identifies as Alaska Native (AN) parental consent enrolled in preschool in one of the12 participating Head Start programs present at school for health screenings Exclusion Criteria: lack of parental consent does not have a parent who is AN - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 5 Years - StdAgeList: Child

NCT06303518

Not yet recruiting

End Tidal Carbon Dioxide Concentration and Depth of Anesthesia in Children

Carbon Dioxide (CO2) is a by-product of metabolism and is removed from the body when we breathe out. High levels of CO2 can affect the nervous system and cause us to be sleepy or sedated. Research suggests that high levels of CO2 may benefit patients who are asleep under anesthesia, such as by reducing infection rates, nausea, or recovery from anesthesia . CO2 may also reduce pain signals or the medication required to keep patients asleep during anesthesia; this has not been researched in children. During general anesthesia, anesthesiologists keep patients asleep with anesthetic gases or by giving medications into a vein. These drugs can depress breathing; therefore, an anesthesiologist will control breathing (ventilation) with an artificial airway such as an endotracheal tube. Changes in ventilation can alter the amount of CO2 removed from the body. The anesthesiologist may also monitor a patient's level of consciousness using a 'Depth of Anesthesia Monitor' such as the Bispectral Index (BIS), which analyzes a patient's brain activity and generates a number to tell the anesthesiologist how asleep they are. The investigator's study will test if different levels of CO2 during intravenous anesthesia are linked with different levels of sedation or sleepiness in children, as measured by BIS. If so, this could reduce the amount of anesthetic medication the child receives. Other benefits may be decreased medication costs, fewer side effects, and a positive environmental impact by using less disposable anesthesia equipment.

- EligibilityCriteria: Inclusion Criteria: Children aged 3 - 11 years undergoing non- or minimally-stimulating elective procedures, defined as anesthesia without skin incision or painful manipulation (e.g., non-invasive imaging, auditory brainstem response testing), middle ear surgery, surgery with effective local or regional anesthesia before surgical incision (e.g dental procedures with local anesthetic infiltration, urology with regional block). American Society of Anesthesiologists (ASA) physical status I and II TIVA technique appropriate throughout induction and maintenance of anesthesia Controlled ventilation via endotracheal tube Anticipated surgical time ≥ 90 minutes: to allow time for anesthetic induction and subsequent testing and washout periods at all three EtCO2 levels. Exclusion Criteria: Need for inhalational induction of anesthesia Sedative premedication Use of ketamine intraoperatively Unable to place BIS electrodes due to surgical site or other contraindications (e.g., MRI) Allergy to study drugs (propofol, remifentanil, lidocaine) Depression of conscious level for any reason BMI <5th or >95th centile for age History of obstructive or central sleep apnea Known or suspected raised intracranial pressure Recent or historical traumatic brain injury - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 11 Years - StdAgeList: Child

NCT06303505

Not yet recruiting

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.

- EligibilityCriteria: Inclusion Criteria (for all patients) Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent. Disease not amenable to curative intent treatment. Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated. Eastern Cooperative Oncology Group (ECOG) 0-1. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression. Patients must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening. Adequate organ function Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy). Patients of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients assigned female at birth. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception. In the opinion of the investigator, the patient must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations. The patient must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative. The patient must be willing to sign and date the informed consent form (ICF) Exclusion Criteria (for all patients) The patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload. Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion. Patients are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices. Patients with spinal cord compression or active central nervous system disease. Prior radiotherapy <2 weeks from trial inclusion. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis. Has an oxygen saturation of <93% on room air at rest. Has a forced vital capacity of <60% and diffusing capacity of the lung for carbon monoxide <70%. Has a QTcF >470 ms History of nephrotic syndrome Active corneal disease, or history of corneal disease within 12 months prior to enrollment. Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of protocol therapy. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome. Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV). Any concurrent chemotherapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), immunotherapy, or corticoid therapy. Live vaccines within 30 days prior to study entry. Patients with acute or chronic infections such as: Patients who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization. Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening. HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening. History of severe and recurrent infections per INV judgment. History of progressive multifocal leukoencephalopathy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303492

Not yet recruiting

Aspiration Risk Assessment by Gastric Ultrasound in eMErgency Surgery and ANesThetic Decision-making: The ARGUMENT Study

Pulmonary aspiration of gastric contents is a serious patient safety problem accounting for 50% of anesthesia-related mortality. The risk is higher in patients undergoing emergency surgery as the gastric content is uncertain which poses a challenge to anesthetic decision-making. Standard clinical assessment to identify at-risk patients primarily relies on preoperative fasting guidelines and is not adequate for patients undergoing emergency surgeries. Point-of-care gastric ultrasound (GUS) has emerged as an accurate bedside tool providing information regarding the type and volume of gastric contents. When GUS was added to standard clinical assessment, anesthetic management plan changed in 71% of adult elective and 37% of pediatric emergency surgical procedures. Such data is lacking in adult patients undergoing emergency surgeries. The investigators propose a multicentre mixed-method study to evaluate the impact of GUS on aspiration risk assessment and subsequent Anesthetic Plan before emergency surgeries. The evidence from this study will improve patient safety by accurately identifying patients at risk of aspiration and tailoring anesthetic techniques and airway management to prevent pulmonary aspiration in patients undergoing emergency surgeries.

- EligibilityCriteria: Inclusion Criteria: Age >18 years American Society of Anesthesiologists' (ASA) physical status I-III Patients scheduled for non-elective non-cardiac surgery. Exclusion Criteria: Abnormal anatomy of the upper gastro-intestinal tract (including hiatus hernia, gastric tumors, and previous surgeries of the upper gastrointestinal tract). Extrinsic gastric compression obtained from the medical history or during the actual ultrasound examination. Pregnancy. Attending anesthesiologist refusal to include the patient for participation in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303479

Not yet recruiting

The Effect of Telerehabilitation-Based Respiratory Exercise Programs on Lung Capacity

It is a prospective randomized controlled trial. In this project, it is aimed to examine the effect of telerehabilitation-based instrumental and noninstrumental respiratory exercise program on lung capacities. For this reason; Contributing to the literature by comparing the effect of breathing exercises with and without instruments on lung capacities, It is aimed to be a resource for the effective use of respiratory exercise, which has a high effect on lung capacities, in treatment. In addition, with the data obtained, it is aimed to decide and apply the exercise that is more effective in the treatment of respiratory diseases quickly. Socio-demographic data will be questioned by using the Demographic Data Form; participants, age, gender, height, weight, marital status, smoking and alcohol use, presence of disease, whether they are included in a different exercise program, dyspnea, severe nausea and vomiting. The cases will be randomized into two groups: non-instrumented breathing exercises group and instrumented breathing exercises group. The physical activity status of the individuals participating in the study will be questioned using the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at the beginning and end of the study. Pulmonary Function Test (PFT) will be used to measure the lung capacity of the participants. Instrumented breathing exercises will be performed for 8 weeks, 2 days a week with the telerehabilitation program, 3 days a week as a home program, 5 days a week in total, starting with 1 set of 15 repetitions and the program will progress with progression. Diaphragmatic breathing and thoracic extension exercises will be applied as non-instrumented breathing exercises. For 8 weeks, 2 days a week with telerehabilitation method, 3 days a week as a home program, 5 days a week in total, 1 set of 10 repetitions for each exercise and the program will progress with progression. At the end of 8 weeks, all evaluations of the participants in both groups will be repeated.

- EligibilityCriteria: Inclusion Criteria: Female/male young adult between the ages of 18-30 December, Who volunteered to participate in the study, Without a known disease Volunteers who do not have psychological, cognitive and emotional problems Exclusion Criteria: Cigarette and alcohol users People with severe cardiopulmonary disorders People with postural disorders (such as scoliosis,kyphosis...) Unstable angina, has it been recently, pulmonary embolism People with obesity/diabetes Mental or cognitive impairment that will affect mental cooperation People with severe nausea, vomiting attacks People with dyspnea People with orthopedic disorders that will affect exercise performance - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06303453

Recruiting

Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy.

The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.

- EligibilityCriteria: Inclusion Criteria: Patients diagnosed with DNP with score ≥ 2.5 on Michigan neuropathy screening instrument of both genders. Age between 40 to 65 years. Patients having the minimum history of diabetes is 7 years. History of mild to moderate neuropathy . The patients ability to do resistance and aerobic exercises. Exclusion Criteria: History of taking anti-inflammatory drugs. History of recent surgical operations of joints in lower extremities. Patients suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy. Patients having any disability, fracture, or dislocation of at least six months before the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 40 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06303440

Recruiting

Effects of Virtual Reality Training Versus Motor Imagery in Children With Cerebral Palsy

Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

- EligibilityCriteria: Inclusion Criteria: Children of 7-12 years. CP children of both genders. Children with Mini Mental Scale score >24. Children with Gross motor function classification system (GMFCS) level I and II. Able to follow and accept verbal instruction. Exclusion Criteria: History of any Visual and Hearing Impairments. Virtual game phobia. History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs. Children with history of severe cardiopulmonary disease, History of epilepsy History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06303427

Not yet recruiting

Effects of Modified Constraint-induced Movement Therapy With and Without Electrical Stimulation in Erb's Palsy

ERB's palsy is an injury of upper section of the brachial plexus (C5-6) leading to an internally rotated and adducted shoulder and a pronated forearm. Modified constraint-induced movement therapy improves the functionality of the affected limb, while electrical stimulation helps in the improvement of active range of motion and muscle strength in ERB's palsy patients. This study aims to investigate the effects of modified constraint-induced movement therapy with and without electrical stimulation on range of motion, muscle strength, and motor functions in patients with ERB's Palsy.

- EligibilityCriteria: Inclusion Criteria: Children with a confirmed diagnosis of ERB's palsy. Muscle power of the affected limb should be between 1 to 4. Active finger range of motion,10-degree wrist extension, and thumb abduction. Exclusion Criteria: Children having contracture and stiffness of affected limb. Muscle power of affected limb 0 or 5. Children with cerebral palsy, visual, hearing, and cognitive problems, or any neuromuscular, and skeletal disorders. Previous history of neurological and orthopedic surgery - HealthyVolunteers: No - Gender: All - MinimumAge: 2 Years - MaximumAge: 6 Years - StdAgeList: Child

NCT06303414

Recruiting

Revascularization for Symptomatic Non-acute Carotid Artery Occlusion

The short-term and long-term efficacy of recanalization therapy needs to be further confirmed by large-sample prospective studies. The comparison of success rate, complication rate and efficacy among the three recanalization modalities also needs to be further explored. The purpose of this cohort study is to observe the success rate, efficacy and safety of recanalization treatment for non-acute occlusion, and to further compare the advantages and disadvantages of CEA, endovascular intervention and hybrid surgery.

- EligibilityCriteria: Inclusion Criteria: Older than 18 years old; Sign the informed consent form; Carotid occlusion at least 24h; Patients with clinical localization symptoms: ipsilateral hemisphere ischemia symptoms or ipsilateral eye ischemia symptoms or cognition impairment, with or without anterior circulation blood supply area infarction; DSA confirmed common carotid artery or internal carotid artery (mTICI=0) occlusion; Perfusion imaging confirms the presence of hypoperfusion in the corresponding area(CBF decrease); The optimal medical treatment for patients who still have ischemic symptoms; Routine DWI and ADC sequence examinations are performed before surgery no new infarction; Exclusion Criteria: Intracranial arteriovenous malformation or aneurysm; Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months; Uncontrolled diabetes mellitus defined as glucose > 300 mg/dL (16.67 mmol/L); Patient is expected to have the ADP antagonist therapy interruption within 3 months after the procedure; Pregnant or in the perinatal period; Severe concomitant disease with poor prognosis (life expectancy < 3 years); Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel; Allergy to iodine or radiographic contrast media; Concomitant vascular conditions precluding endovascular; Patients with large cerebral infarction within 2 weeks; History of ipsilateral vocal cord paralysis; Those with severe skin diseases who are expected to have difficulty healing the incision; Poor functional status before onset (mRS score 4-5 points). The area of infarction in the occluded vascular area exceeds half of the vascular supply area; Already have dementia or psychiatric illness and are unable to complete neurological and cognitive assessments. Any condition that in the surgeon's judgment suggests the patient an unsuitable surgical candidate. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult - StudyPopulation: People diagnosed with non-acute carotid occlusion, fulfilled the above eligible criteria in tertiary medical centers in China additionally will be enrolled consecutively. - SamplingMethod: Non-Probability Sample

NCT06303401

Recruiting

Comparison of Thrust Manipulation of Sacroiliac Joint and Pelvic Stabilization Exercises in Post Partum Low Back Pain

compare the effectiveness of SI joint thrust manipulation and pelvic stabilization exercises on Modified OSWESTRY Low Back pain Index (ODI) and Numeric Pain Rating Scale (NPRS) in patients with post-partum lower back pain.

- EligibilityCriteria: Inclusion Criteria: age 20-40 years Postpartum women (after 6 weeks)(3, 12) Postpartum LBP patient Patient pain increased by provocation test i.e. Faber test, High thrust test and Gaenslen test Exclusion Criteria: C-section inflammatory or malignant type of pain Neurological deficit Severe trauma Pelvic fracture Osteoporosis, spinal stenosis, spondylolysis, spondoloesthesisi - HealthyVolunteers: No - Gender: Female - MinimumAge: 20 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06303388

Recruiting

Effects of Bruegger's Exercises Versus Egoscue Exercise on Lower Cross Syndrome

This study aims to find effects of Bruegger's Exercise versus Egoscue exercise on pain and hyperlordosis on patient with lower cross syndrome. This is interventional study which recruits 34 participants ,14 in each group.

- EligibilityCriteria: Inclusion Criteria: • Females and males aged between 16 to 65 years Participants had to present with low back pain Participants had to meet the criteria for lower crossed syndrome indicating tight hip flexors (Modified Thomas test) and erector spinae (visual assessment through toe touching) together with weak glutei (Prone Hip Extension Co-ordination/Strength Test) and abdominals (Trunk Flexion Co-ordination and Strength Test)and thoracic kyphosis. Angle of anterior pelvic tilt > 10 degrees Exclusion Criteria: • Participants who would be undergoing other forms of treatment that may interfere with the study, for the duration of the study, including other manipulative and physical therapies specific to back pain. Presence of other conditions that may mimic low back pain, e.g. nerve entrapment. Participants taking any medication that may interfere with the results of this study including, pain medication, anti-inflammatory medication, and muscle relaxants. Surgery on the back, pelvis, or sacrum is indicated or has previously occurred LBP having localised or radiating pain. Practiced any kind of exercise or sports activity during the last 6 months. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 16 Years - MaximumAge: 65 Years - StdAgeList: Child, Adult, Older Adult

NCT06303375

Recruiting

Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome

Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome.

- EligibilityCriteria: Inclusion Criteria: Age- 30 to 50 years. Female patients. Anterior pelvic tilting > 7-10 degrees. Postural imbalance characterized by anterior pelvic tilt, lumbar hyper lordosis, and associated muscle imbalances. Discomfort, pain, or limitations related to the lower back, pelvis, and hips attributed to LCS. Willing to provide informed consent to participate in the study. Exclusion Criteria: Musculoskeletal pathologies affecting the lower back, pelvis, hips, or lower extremities (e.g., herniated disc, lumbar radiculopathy, lumbar stenosis, hip labral tear). Kinesiotaping interventions for LCS in the past 3 months. Allergies to tape materials or skin sensitivities that might prevent safe tape application. Pregnant individuals due to potential discomfort. Open wounds, infections, or skin conditions at the taping application site. Severe cardiovascular, pulmonary, renal, or neurological diseases. In other clinical trials involving interventions for LCS. - HealthyVolunteers: No - Gender: Female - MinimumAge: 30 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06303349

Not yet recruiting

Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.

The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage. Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier. Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient. The measurement of biomarkers and cerebral vasospasm will be blinded to each other.

- EligibilityCriteria: Inclusion Criteria: Subarachnoid hemorrhage (of aneurysmal or non-aneurysmal etiology) less than 4 days prior to admission to neuro-resuscitation, diagnosed on clinical presentation and confirmed by brain imaging. Free, informed and written consent signed by the patient (or, failing this, his or her representative). Patient entitled to or affiliated with social security Exclusion Criteria: Significant vasospasm on admission to the department, diagnosed on initial imaging Patient whose short-term survival (48 hours) appears compromised Contraindication to perfusion CT scan Pregnant or breast-feeding women Patient under legal protection (persons deprived of liberty or under guardianship) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303336

Recruiting

Effects OF NMES With and Without Dynamic Bracing on Spasticity and Movement Quality in CP

The study aims at comparing Neuromuscular electrical Stimulation with and without dynamic bracing on spasticity and movement quality of lower limb in Children with Cerebral Palsy

- EligibilityCriteria: Inclusion Criteria: Age between 5 to 12 years. Able to walk with or without an assistive device. Classification as level I-II on the Gross Motor Functional Classification System (GMFCS). Able to stand with or without support for 1 minute. Classification as levels I-III on the Manual Ability Classification System (MACS); and the ability to follow and accept verbal instructions. Muscle tone scored ≥2, according to Modified Ashworth Scale. Exclusion Criteria: Orthopedic Surgical intervention (e.g. tendon lengthening in lower limb) within the previous 12 months Treatment with botulinum toxin in the calf muscles within the previous 6 months Presence of structural deformities at the lower limbs and trunk, or instability in the ankle joint, which could compromise the child's safety and performance of the motor task Severe affective or psychiatric impairments; Serious vision or hearing problems Any neurological impairment (epilepsy or any other disease that would interfere with physical activity) - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06303323

Not yet recruiting

Comparative Effectiveness of Qigong Exercise Versus Wu Dang Tai Chi Chuan in CVD Risk Individuals

To compare whether the Qigong exercise or Wu Dang Tai Chi Chuan will be effective in improving exercise capacity and reducing stress in CVD-risk individuals. Based on preliminary data, Qigong and Tai-Chi may help treat anxiety and depression symptoms in patients with chronic illnesses as well as in healthy adults. Without the need for specialized equipment, Qigong and Tai-Chi are both readily adjustable mind-body exercises that may be done whenever and wherever. For this reason, Qigong and TaiChi should be extensively encouraged as ways to enhance emotional wellbeing

- EligibilityCriteria: Inclusion Criteria: According to the Framingham risk calculator 10% to 20%+ for moderate to high-risk Patients at risk of CVD (last 6 months) Patients with either HTN, dyslipidemia, or diabetes Patients with less than 45 scores on the Berg Balance scale Stress from moderate to severe on PSS No regular physical exercise for at least 1 year Willing to take part Exclusion Criteria: History of stroke, CVD Acute Infection Acute injury Any diagnosed psychological issue MSK disorders Member of marital arts, dance - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 50 Years - StdAgeList: Adult

NCT06303310

Recruiting

Comparative Effects Of Gaze Stability Exercises And Optokinetic Exercises In Patients With Vestibular Hypofunction

This randomized clinical trial will occur at Bahawal Victoria Hospital, Bahawalpur within 7 months after the approval of synopsis. The sample size for this trial will be 40 participants. Participants fulfilling the inclusion criteria will be recruited by using the convenience sampling randomly allocated into two groups by computer generator method. 20 participants will be assigned to Group A receiving gaze stability exercises and 20 to the Group B receiving optokinetic exercises, both alongside routine physical therapy. Each group will undergo 5 weekly sessions of treatment for 4 weeks.The assessment tools include Dizziness Handicap Inventory for dizziness; Mini-BESTest and modified-Clinical Test of Sensory Interaction of Balance for balance assessment while Vestibular Disorders Activities of Daily Living Scale for daily activities.

- EligibilityCriteria: Inclusion Criteria: Participants will be of both genders. Participants age will be between 23 to 63 years. Participants diagnosed with unilateral vestibular disorders by ENT specialist. Individuals who have MOCA score ≤26. Participants with positive head thrust test. Participants with positive supine roll test. Participants have one or more of the following characteristics: Related burden symptoms that affected their daily activities. A history of dizziness/vertigo triggered by head or body movement. Exclusion Criteria: Individuals with a history of neurological or psychological deficit. Individuals with the diagnosis of benign paroxysmal positional vertigo as individuals. Individuals who had a previous surgery that could affect balance or cause dizziness. Individuals with orthopedic problems that prohibited the performance of the exercise and that impact one's balance and walking pattern. Individuals who report spontaneous episodes of dizziness, which are not worsened by movements Individuals which are completely dependent on the assistive device during mobility. Imbalance due to diabetic neuropathy. - - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06303297

Recruiting

Effects of Reflexology and Generalized Stretching in Postmenopausal Females.

To determine the combined Effects of reflexology and generalized stretching on insomnia, vasomotor symptoms and quality of life in postmenopausal females

- EligibilityCriteria: Inclusion Criteria: BMI less than 30 kg/m2 Residents of rural areas Stable vital signs Participants with natural cessation of menstrual periods for at least 12 months Moderate and severe hot flash Exclusion Criteria: Participants with history of hysterectomy surgical menopause females Participants with orthopedic disorder Participants taking sleeping pills Women suffer from pathological conditions for example cardiac disease, cancer impaired skin integrity Participants with history of recent bone fracture Severe pathology(eczema) of feet - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: post partum females - MinimumAge: 50 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06303284

Not yet recruiting

Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs. There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications. The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed. This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.

- EligibilityCriteria: Inclusion Criteria: Our study will include men and women over 60 years of age presenting to the emergency department with low energy ankle fractures (fall from standing height) requiring surgical treatment and who have one or more of the following risk factors, diabetes, osteoporosis, renal disease, steroid use, smoking history, peripheral neuropathy and/or vascular disease. Exclusion Criteria: Individuals will be excluded if they have received previous Teriparatide therapy, or they have hypercalcemia or hyperparathyroidism, as these are precautions to the use of Teriparatide. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult

NCT06303271

Recruiting

Transcutaneous Auricular Vagus Nerve Stimulation on Dizziness & Balance in Elderly Population

The objective of the study is to determine the effects of transcutaneous auricular vagus nerve stimulation on dizziness and balance on elderly population with unilateral vestibular hypofunction. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. Intervention Group A received Vagus Nerve Stimulation (VNS) and Caw Thorne Cooksey exercise while Group group B received Caw Thorne Cooksey exercise only. Both groups received intervention of 30 minutes daily for 4 weeks (16 sessions). Assessment was done at the baseline, after 2 weeks and after 4 weeks

- EligibilityCriteria: Inclusion Criteria: Able to give consent Age 60 and above Diagnosed patient of unilateral(Left) vestibular hypo function Both Genders BBS with 20-41 Exclusion Criteria: Patient with any neurological impairment (Epilepsy, stroke ALS etc.) Central cause of vestibular hypo function History of vestibular neuritis, concussion, head injury or tumor. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06303258

Recruiting

Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain

Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.

- EligibilityCriteria: Inclusion Criteria: 2nd Trimester of Pregnancy Multigravida Patients having Lumbopelvic pain Working women and housewives Exclusion Criteria: Hx of Metabolic Disease Hx of Pelvic Fracture and Surgery Radiculopathy Participants with absolute contraindications for the exercise - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Female - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult

NCT06303245

Recruiting

Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section

To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section

- EligibilityCriteria: Inclusion Criteria: Participants on early puerperium period having constipation and willing to participate. Primigravida Body mass index (BMI) less than 30 kg/m2 Exclusion Criteria: Laxatives-induced patients History of chronic constipation Post cesarean abdominal suture infection. People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision. Participants with inability to tolerate the binder. Participants who show unwillingness to participate in the study - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: PUERPERIUM PERIOD AFTER CESAREAN SECTION - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06303232

Recruiting

Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement

To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.

- EligibilityCriteria: Inclusion Criteria: Both primiparous or multiparous breastfeeding women BMI: ≤30-≥25 (14) Immediate puerperium with normal or C - section non-premature childbirth (19) Postnatal lactating mother with symptoms of breast engorgement Exclusion Criteria: any breast infection, abscess, mastitis, breast cancer torn/bleeding or crack nipples any skin condition like dermatitis, psoriasis etc non-lactating mothers having heart pacemaker - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: POST - PARTUM WOMEN - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06303219

Recruiting

Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome

To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome

- EligibilityCriteria: Inclusion Criteria: Participants with BMI greater than 25kg/m2 Oligo- or anovulation/irregular cycles i.e 35 days Married women Primary infertility A diagnosis of polycystic ovaries based on ultrasound results Exclusion Criteria: Use of psychiatric or psychotropic medications. Unresolved gynecological conditions i.e Cervical Dysplasia, Pelvic floor prolapse, Uterine Fibroids, Urinary Incontinence Diabetes, pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: POLYCYSTIC OVARIAN SYNDROME - MinimumAge: 18 Years - MaximumAge: 35 Years - StdAgeList: Adult

NCT06303206

Not yet recruiting

TEC4Home Blood Pressure Randomized Controlled Trial

The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED). The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED? Secondary research questions will address: How do these interventions (telemonitoring and case management) improve medication adherence? Do these interventions reduce physician and ED visits? Are these interventions safe? How do these interventions influence patient experience? Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education.

- EligibilityCriteria: Inclusion Criteria: Adult patients aged ≥ 18 years of age Elevated triage BP AND increased average BP in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg) Own a smart phone Willing to measure and tele-transmit home BP readings Exclusion Criteria: Hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome Pregnant women Acute intoxication Acute surgical or trauma patients Psychiatrically unstable patients Advanced cognitive impairment Patient requiring admission to hospital Inability to use or care for home BP monitor correctly From nursing home Unstable housing Non-English speaking or no family members who can help translate - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303193

Not yet recruiting

Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms

Background: Myelodysplastic syndrome (MDS) and myelodysplastic/myeloproliferative neoplasm (MDS/MPN) are blood disorders that can cause serious complications in children and adults. MDS and MDS/MPN can also progress to acute myeloid leukemia. Treatments for these disorders are risky and not always effective. Better treatments are needed. Objective: To test a study drug (pacritinib) in adults and children with MDS or MDS/MPN. Eligibility: Children (aged 12 to 17 years) and adults (aged 18 years and older) with MDS or MDS/MPN. Design: Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart function. They may have a bone marrow biopsy: An area over the hip will be numbed; a needle will be inserted to remove a sample of soft tissue from inside the hipbone. Pacritinib is a capsule taken by mouth. All participants will take the study drug 2 times a day, every day, in 28-day cycles. They will write down the date and time they take each capsule. Doctors will assign varying dosages of the drug to different participants. Participants will have clinic visits each week during cycle 1; every 2 weeks during cycle 2; and gradually increasing to every 3 months after cycle 13. Treatment will continue for up to 8 years. Bone marrow biopsies, heart tests, and other tests will be repeated at intervals throughout the study. Participants will also fill out questionnaires about their quality of life, the symptoms of their disease, and other topics.

- EligibilityCriteria: INCLUSION CRITERIA: Participants must have histologically or cytologically confirmed MDS or MDS/MPN, including therapy-related MDS or MDS/MPN, and MDS or MDS/MPN with germline predisposition, by the Department of Laboratory Medicine Hematology Laboratory, CC or by the Laboratory of Pathology, NCI as defined according to the 2016 WHO criteria, 2022 WHO criteria, or 2022 International Consensus Classification Age 12-17 years for phase I and age >= 18 years for phase II Participants >= 18 years of age with HR-MDS must have resistance to hypomethylating agents as defined as failure to show improvement after at least 4 cycles of treatment (primary resistance) or relapse in participants with initial response to long-term treatment (secondary resistance) OR have intolerance to hypomethylating agents OR have a contraindication to hypomethylating agents Participants >= 18 years of age with LR-MDS must be refractory to or ineligible to receive standard of care therapies, i.e. erythropoietin-stimulating agents, lenalidomide, luspatercept, and present with one of the following characteristics: Severe neutropenia defined by absolute neutrophils count <=0.5(SqrRoot) 10^9/L without the use of granulocyte colony-stimulating factors Symptomatic anemia defined by hemoglobin 16-week average <10 g/dL and symptoms that may include fatigue, weakness, reduced exercise tolerance, dyspnea on exertion, palpitations, (orthostatic) hypotension, near syncope and restless legs Thrombocytopenia defined as platelets <20(SqrRoot) 10^9/L or platelets <50(SqrRoot) 10^9/L and a history of clinically relevant non-major or major bleeding according to the ISTH classification Participants 12-17 years of age with MDS must be relapsed/refractory OR ineligible to receive immunosuppressive therapy and hematopoietic stem cell transplantation --Ineligibility to receive hematopoietic stem cell transplantation will include participants who are not anticipated to be candidates to receive transplantation within the next 3 months due to medical comorbidities, lack of appropriate donor, or logistical barriers to transplant Participants with MDS/MPN must be relapsed/refractory (failed a minimum of 1 standard of care therapy) OR ineligible to receive standard of care OR without known life-prolonging therapy options OR have a diagnosis for which no known standard of care exists Participants 12-17 years of age must weigh >= 35 kg If any of the prior therapies noted below were given to the participant, they must have been completed within the following timeframes: >= 7 days from last dose of short-acting myeloid growth factors (i.e., filgrastim) and >= 14 days for long-acting (i.e., pegfilgrastim) >= 14 days from last dose of short-acting thrombopoietic growth factors (i.e., eltrombopag) and >= 28 days for long-acting (i.e., romiplostim) >= 14 days or 5 pharmacokinetic half-lives from biological therapy agent >= 21 days from myelosuppressive chemotherapy >= 28 days from last dose of immunosuppressive therapy (e.g., ATG, cyclosporine, steroids greater than physiologic replacement) >= 28 days from last dose of lenalidomide >= 28 days from last dose of venetoclax >= 28 days from any other investigational agent >= 42 days from last dose of erythropoiesis stimulating agents >= 56 days from last dose of luspatercept >= 100 days from stem cell transplant with no evidence of active graft vs. host disease in participants who relapsed following transplant >=150 days from total body irradiation Performance status: For participants >= 16 years of age, ECOG performance status < 2 (Karnofsky >= 60%) For participants < 16 years of age, Lansky >= 60% Participants must have adequate organ function as defined below: Total bilirubin: <= 1.5 X institutional upper limit of normal OR <= 3 x institutional upper limit of normal in participants with Gilbert s syndrome AST(SGOT)/ALT(SGPT): <= 2.5 X institutional upper limit of normal Creatinine clearance: >= 50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal PT and PTT: <= 1.5 X institutional upper limit of normal, except in the setting of PTT elevation due to lupus anticoagulant, in which case these participants would be exempt from meeting this inclusion criterion Women of child-bearing potential and fertile men must agree to use one (1) highly effective form of contraception (e.g., intrauterine device [IUD], hormonal, surgical) or two (2) effective forms of contraception (e.g., barrier method) while on study drug and for 30 days after the last dose of study drug Breastfeeding participants must discontinue breastfeeding and/or not begin breastfeeding until 2 weeks after the last dose of study drug Ability of participant or parent/guardian (for participants 12-17 only) to understand and the willingness to sign a written informed consent document EXCLUSION CRITERIA: Participants with platelet transfusion-refractory thrombocytopenia, with inability to keep platelet threshold above 10 K/mcL with transfusions Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe (grade >= 3) unprovoked bleeding complications in the one year prior to enrollment, or any unprovoked grade 2 bleeding complications in the 3 months prior to enrollment Use of anti-platelet or anticoagulant medication other than low-dose aspirin (100 mg daily or less) in the 14 days prior to enrollment, or any ongoing requirement for these medications Participants who are unwilling to accept blood transfusions Participants with ANC < 500 cells/mcL AND hospitalization for a fungal infection in the 12 months prior to enrollment History of allergic reactions attributed to compounds of similar chemical or biologic composition to pacritinib Concomitant administration with sensitive substrates/narrow therapeutic index drugs of CYP3A4, CYP1A2, P-gp BCRP, and OCT1 should be avoided. Concurrent use of strong inhibitors and inducers of CYP3A4 are not allowed. Prior use is allowed as long as medication is stopped two weeks prior to study drug initiation. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Participants with the following cardiac conditions at screening: Symptomatic congestive heart failure Unstable angina pectoris Uncontrolled cardiac dysrhythmias QTc(F) prolongation >450 ms, or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome) Grade >= 3 cardiac complication in the 6 months prior to enrollment Left ventricular ejection fraction <= 50% by transthoracic echocardiogram (TTE) at screening Participants with any active, uncontrolled viral, bacterial, or fungal infection, including active HIV-1, Hepatitis B (HBV) and/or Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody); history of HIV, HBV, or HCV is allowed if there is no uncontrolled viral infection Pregnancy Presence of another known cause of cytopenia or dysplastic marrow that is untreated and may limit interpretation of results Uncontrolled intercurrent illness or any significant disease, evaluated by history, physical exam and chemistries or social situations that may limit interpretation of results, limit compliance with study requirements, or that could increase risk to the participant - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - MaximumAge: 120 Years - StdAgeList: Child, Adult, Older Adult

NCT06303180

Recruiting

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Background: Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them. Objective: To collect biological samples for a repository that will be used for research. Eligibility: People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech. Design: Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. No extra tissue will be taken. Information on each participant s age, diagnosis, and previous treatments will also be collected. Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek. Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth. Samples may be used for genetic testing.

- EligibilityCriteria: INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf. Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. have a condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: Part 1: -Are unwilling to share waste specimens for research purposes. Part 2: Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol: have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects' risk in participating. This will be determined at the discretion of the principal investigator. Participants ages 3 to <18 are excluded from nasal secretion collection, oral mucosal biopsies and skin biopsies. 3 years of age. - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 99 Years - StdAgeList: Child, Adult, Older Adult - StudyPopulation: 1000 subjects of any age, any race, ethnicity and gender. Only viable neonates will be enrolled. We are hoping to accrue about 100 subjects a year over 10 years. NIH employees and staff participating in an approved NIH protocol. There will be no collection or recruitment of healthy volunteers. - SamplingMethod: Non-Probability Sample

NCT06303154

Not yet recruiting

Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.

- EligibilityCriteria: Inclusion Criteria: Females aged 18 years and older. Patients who have undergone conserving surgery for breast cancer. Patients scheduled to undergo radiation treatment of the breast/chest wall within the next 12 weeks after surgery. Patients with a morphology compatible with the proposed sizes of the devices, including bust girth and cup size. Patients who have signed an informed consent form prior to any study intervention. Patients with full legal capacity and enrolled in a social security system or covered by a similar health insurance. Exclusion Criteria: Patients with an A cup bra size. Patients with infected or acutely inflammatory skin on the chest. Patients who require chemotherapy during the follow-up period. Pregnant women or women of childbearing age without adequate contraception or in the lactation period. Participation in other clinical trials that impact the primary endpoint. Patients with a known allergy to the investigational device components. Patients with psychiatric, psychological, or neurological disorders that are incompatible with the conduct of a clinical trial. Patients unable to be followed for 12 months. Vulnerable patients, or those subject to a judicial protection measure or unable to provide informed consent freely. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303128

Recruiting

Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is: - In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge? Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.

- EligibilityCriteria: Inclusion Criteria: Expresses interest in participating by calling or filling out information form on study website Reports an allergy to one of the following medications: penicillin VK, penicillin G, amoxicillin, ampicillin, dicloxacillin, flucloxacillin, nafcillin, oxacillin, amoxicillin- clavulanate, ampicillin-sulbactam. Subjects with an unspecified penicillin allergy are also eligible to participate. Exclusion Criteria: Penicillin allergy deemed to be more than "low-risk" per PEN-FAST (score ≥ 3 points) History of acute kidney injury (acute interstitial nephritis), severe liver impairment (drug- induced liver injury), serum sickness, or isolated drug fever attributed to a penicillin- based antibiotic Anaphylaxis for any reason in the last year Cognitive impairment where a collateral history could not be obtained and/or patient does not have capacity to consent for themselves Pregnant (self-reported) Any illness or condition that would increase the risk of participation in the study, per the evaluating clinician's judgment Active treatment of or history of acute angle closure glaucoma On H1- or H2-blockers (i.e. diphenhydramine, hydroxyzine, chlorpheniramine, cetirizine, levocetirizine, loratadine, fexofenadine or famotidine, ranitidine, cimetidine, nizatidine, respectively) within 72 hours of initiating direct oral challenge (will be counseled to discontinue prior to testing) Actively receiving greater than stress dose steroid (hydrocortisone >50mg four times a day or steroid equivalent) Actively receiving any antibiotic Relative contraindication: Patients on beta blockers and angiotensin converting enzyme inhibitors (ACE inhibitors) will have an open dialog with the study team regarding the risks and benefits of testing a low-risk penicillin allergy patient. A joint decision will be made based on the patient's preference and the physician's comfort level. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 89 Years - StdAgeList: Adult, Older Adult

NCT06303115

Not yet recruiting

CSD231005 Nicotine Pouch Biomarkers of Exposure

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

- EligibilityCriteria: Inclusion Criteria: Able to read, understand, and be willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent. Smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm in length. Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke for at least six months prior to Screening. Brief periods of abstinence due to illness, a quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI. Self-reports that cigarettes are their primary tobacco- or nicotine-containing product use within 30 days of Screening. (Note: occasional use of other tobacco- or nicotine-containing products may be acceptable in consultation with the Sponsor); Agrees to use assigned IP throughout the study period. Expired breath carbon monoxide (ECO) level ≥ 10 ppm and ≤ 100 ppm at Screening and at CheckIn on Day 2. Positive urine cotinine test at Screening. Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "630 minutes." (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991). Willing to switch from current UB cigarette to either nicotine Pouch IP, or abstain from smoking, for approximately 5 days during in-clinic confinement; Females must be willing to use a form of contraception acceptable to the PI from the time of signing the informed consent until the End of Study (EOS). Examples of acceptable means of birth control are, but not limited to: Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion, bilateral oophorectomy, bilateral salpingectomy); Established use of oral, implantable, injectable or transdermal methods of contraception associated with inhibition of ovulation (see Section 6.10 regarding the use of hormonal methods of contraception in females aged ≥ 35); Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with spermicide; Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena) (see Section 6.10 regarding the use of hormonal methods of contraception in females aged ≥ 35); Vasectomized partner; Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and Post-menopausal and not on hormone replacement therapy. Males must be willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they had undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children. Willing to refrain from consuming cruciferous vegetables and grilled, smoked, fried or barbequed food, and to avoid being in the presence of the cooking of these foods. Subjects should also be willing to refrain from consuming cured sandwich meats, bacon, salami, and sausages 48 hours prior to CheckIn on Day 2. Agrees to inclinic confinement of 8 days (7 nights). Exclusion Criteria: The presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the subject unsuitable to participate in this clinical study. History, presence of, or clinical laboratory test results indicating diabetes. Fasting plasma glucose > 126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values > 126 mg/dL but < 200 mg/dL. Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor. Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day 2. Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day 2. History or presence of bleeding or clotting disorders. Any history of cancer, except for primary cancers of the skin, such as localized basal cell/squamous cell carcinoma, that have been surgically and/or cryogenically removed. Systolic blood pressure (BP) of > 160 mmHg or a diastolic BP of > 95 mmHg, measured after being seated for 5 minutes at Screening and CheckIn on Day 2. Body Mass Index (BMI) < 18.0 or >40.0 kg/m2 (weight of ≤ 110 pounds) at Screening. Hemoglobin level < 12.5 g/dL for females or <13.0 g/dL for males at Screening. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study. A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or CheckIn on Day 2. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBbsAg), or hepatitis C virus (HCV). Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing of the ICF. Postpones a decision to quit using tobacco or nicotinecontaining products to participate in this study or has made a previous quit attempt within (≤) 30 days prior to the signing of the ICF. Any daily use of aspirin (≥ 325 mg/day) or anticoagulants (e.g., Clopidogrel [Plavix®], Warfarin [Coumadin®, Jantoven®]). Individuals ≥ 35 years of age currently using systemic, estrogencontaining contraception or hormone replacement therapy. Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of the ICF. NOTE: Subjects will be advised against scheduling a whole blood donation for at least 7 days following study completion. Plasma donation within (≤) 7 days prior to the ICF. NOTE: Subjects will be advised against scheduling a plasma donation for at least 7 days following study completion. Employed by a tobacco or nicotine company, the study site, or handles tobacco or nicotinecontaining products as part of their job. Participation in another clinical trial within (≤) 30 days prior to the signing of the ICF. The 30day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study. Drinks more than 21 servings of alcoholic beverages per week. Has a positive alcohol result at Screening or CheckIn on Day 2. Determined by the PI to be inappropriate for this study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06303089

Not yet recruiting

Tobacco Exposure and Influencing Factors of Smoking Cessation Among Chronic Kidney Disease Patients

The purpose of this study is to describe the tobacco exposure and characteristics of patients with Chronic Kidney Disease (CKD) who quit smoking, to identify patients' tobacco-related knowledge, attitude, and practice (KAP) and explore the influencing factors of smoking cessation.

- EligibilityCriteria: Inclusion Criteria: Participants aged 18 years or older; Participants with a confirmed diagnosis of Chronic Kidney Disease; Participants were able to speak and read Chinese.; Exclusion Criteria: Participants who with psychiatric illness, disorders of consciousness, communication impairments, were unable to communicate effectively; Participants who have acute and life-threatening exacerbations which require urgent treatment; Patients who currently involved in other smoking cessation programs. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Chronic Kidney Disease Patients - SamplingMethod: Non-Probability Sample

NCT06303076

Not yet recruiting

Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

The study's primary objective is to evaluate the effectiveness of Tinazidine compared to Zolpidem in enhancing sleep quality, with secondary objectives including the assessment of adverse effects, safety profile, and patient tolerance with each treatment. The trial will be conducted as a double-blind RCT, with participants randomly assigned to receive either Tinazidine (0.1 mg/Kg/HS) or Zolpidem 10 mg HS, for 12 weeks. Eligible participants, aged 18-60 years, diagnosed with primary insomnia as per DSM-5 criteria, will be recruited from an outpatient sleep clinic affiliated with Al-Masara Hospital. Data on sleep quality, and side effects, will be collected using the Sleep Pittsburgh Sleep Quality Index (PSQI), Clinical Global Impression (CGI), sleep diaries, actigraphy, polysomnography, and regular clinical interview though OPD follow-up visits. The primary outcome considered was the mean global PSQI score before and after the treatment. The primary outcome will be measured four times (baseline, 4 weeks, 8 weeks, and 12 weeks), We considered an attrition rate (dropout/lost follow-up) of 10%. Therefore, the sample size is 90 subjects (45 in each group). Group comparisons for mean scores will be conducted using independent samples t-tests, and within-group comparisons will be assessed using paired samples t-tests. Changes in sleep quality over time between treatment groups will be evaluated using repeated measures ANOVA. Associations between categorical variables will be examined using Chi-square tests (including Fisher's exact or Likelihood ratio tests as appropriate). Statistical significance will be considered for p-values less than 0.05. All analyses will be performed using IBM SPSS Statistics (Version 29.0). The findings of this study seek to elucidate the comparative efficacy and safety profiles of Tizanidine and Zolpidem in treating primary insomnia. The study aims to offer insights into the effectiveness of Tizanidine versus Zolpidem in improving sleep quality among patients with primary insomnia. Through the evaluation of efficacy, adverse effects, and safety profiles. This study aims to inform clinicians and healthcare practitioners about the optimal treatment choices for individuals with primary insomnia.

- EligibilityCriteria: Inclusion Criteria: Age and Gender Adult participants of either gender, aged 18-60 years old. Diagnosis: Diagnosed with primary insomnia by a psychiatry specialist, based on DSM-5 criteria. Consent: Able to provide written informed consent. Compliance: Willing to comply with study procedures and follow-up assessments. Medical Clearance: Participants must undergo a medical checkup by a medical officer affiliated with Al-Masarah Hospital before the randomization process. This checkup includes: Medical history review. Physical examination, including ECG. Vital signs check. Random blood sugar test. Laboratory evaluation (CBC, LFT, RFT, TFT, Lipid profile). Enrollment: Receiving medical clearance for enrollment in the study. Exclusion Criteria: Secondary Insomnia: Individuals diagnosed with secondary insomnia. Substance Abuse History: Those with a history of substance abuse. Significant Medical or Psychiatric Disorders: Individuals diagnosed with significant and/or unstable medical or psychiatric disorders or mental retardation. Pregnancy or Lactation: Pregnant or lactating mothers, or those of childbearing potential not using an adequate method of contraception (excluding natural birth spacing methods). Drug Allergy: Known hypersensitivity or allergy to Tinazidine or Benzodiazepines. Communication Barriers: Individuals unable to understand or communicate with researchers. Recent Participation in Clinical Trials: Those who have participated in other clinical trials involving investigational drugs within the past 30 days before participation. Recent Use of Sleep Medication: Participants must not have taken any over-the-counter or prescription sleep medication within the past 30 days before participation. Use of Substances Affecting CNS: No intake of any substance with central nervous system (CNS) effects known to affect sleep within 30 days before participation. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06303063

Recruiting

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

- EligibilityCriteria: Inclusion Criteria: Age 18 years to 80 years. Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm. Modified Rankin Scale (mRS) ≤ 2. Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm. Exclusion Criteria: Target aneurysm is an aneurysm requiring staged procedure. Target aneurysm that has been previously treated with vascular embolization or surgery. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery. Acutely ruptured aneurysm within 14 days of enrollment. Hunt and Hess (H&H) scale ≥3. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device. Platelet count <50*103/mm3 (50*109/L) or any known coagulation deficiency, or International normalized ratio (INR)>3.0. Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants. Life expectancy < 1 year, and unable to complete the required follow-ups; Female who was pregnant or breastfeeding, women/men planning to havve children in the next year. Currently enrolled in another investigational device or drug study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06303050

Recruiting

Additional Effects of Mental Imagery Along With Task Oriented Training on Kinesiophobia in Patients With Stroke

The objective of this study to determine the effect of mental imagery and task oriented training on Kinesiophobia in stroke patients. And to determine the association of Kinesiophobia with gait and balance in stroke patients. Patients will be divided into experimental and control group. Randomized participants will be allocated into control and experimental group. The experimental group will receive 20 minutes of MI training followed by 25 minutes of TOT for a total of 45 minutes, 5 days per week for 6 weeks.

- EligibilityCriteria: Inclusion Criteria: Hemiplegic stroke patients Age above 45 Both genders Patients having score >17 on Tempa Scale of Kinesiophobia Patients of score >21 on Berg Balance Scale Exclusion Criteria: • Communication deficits and unable to follow instructions A history of serious or unstable cardiac condition Severe musculoskeletal problem and unable to stand or walk History of other neurological diseases or unilateral neglect - HealthyVolunteers: No - Gender: All - MinimumAge: 45 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06303037

Not yet recruiting

Effect of Esketamine on 95% Induction Dose of Remimazolam

As an invasive operation, gastroscopy will cause children's nervousness, anxiety and uncooperative behavior, and even lead to the risk of bleeding and perforation, which will also affect the accuracy of the examination results.The purpose of this study is to explore the influence of different doses of esketamine on the induced dose ED95 of remazolam during gastroscopic placement in children, and to provide theoretical basis for the combined use of remimazolam besylate and esketamine in gastroscopic anesthesia in children.

- EligibilityCriteria: Inclusion Criteria: with American Society of Anesthesiologists (ASA) physical status I or II#; aged 3#12 years#; children with weight for age within the normal range#; were scheduled to have a gastroscopy; Exclusion Criteria: Children who had gastrointestinal,Cardiovascular or endocrine dysfunction; contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to remimazolam and esketamine; recently respiratory infection, mental disorder; other reasons that researchers hold it is not appropriate to participate in this trial. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 3 Years - MaximumAge: 12 Years - StdAgeList: Child

NCT06303024

Recruiting

Targeting Subclinical Motor and Cognitive Impairment in Patients With Early Onset Multiple Sclerosis

Our project proposal is based on an individualized rehabilitation approach in patients with early stage relapsing remission (RR) MS. This approach will be based on risk stratification obtained using several clinical and demographic parameters that are not commonly used in clinical practice. This risk score will be obtained from an extensive neuropsychological, psychosocial and physical assessment to which patients will undergo at baseline and at one-year follow-up.The risk score will allow a better stratification of patients' risk of disease worsening/progression and the application of a preventive and personalized strategy.

- EligibilityCriteria: Inclusion Criteria: diagnosis of RRMS based on the 2017 McDonald criteria; age ≥ 18 years; EDSS ≤ 2.0; disease duration ≤ 5 years; verification of MS subtype, duration of disease and EDSS will be accomplished by obtaining a signed consent form for the release of medical information from the treating neurologist. Exclusion Criteria: history of relevant psychiatric comorbidities. Severely depressed subjects assessed through the Beck Depression Inventory (scores ≥ 29); relapses or corticosteroid treatment in the 30 days before inclusion; history of substance abuse; presence of non-MS related physical or cognitive impairment that could make the patient unable to complete the study assessments. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06303011

Recruiting

Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.

Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.

- EligibilityCriteria: Inclusion Criteria: Age between 14 -35year Only females Laxatives at least once or more for 2weeks Non pregnant Chronic Constipation more then 6 months Exclusion Criteria: Organic dysphasia or secondary constipation caused by laxatives for unrelated conditions. Pregnant females suspected pregnant subjects, as well as those who were breast-feeding Non co-operative patients Female with underlying disease - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: Females experience more constipation - MinimumAge: 14 Years - MaximumAge: 35 Years - StdAgeList: Child, Adult

NCT06302998

Not yet recruiting

Dexmedetomidine and Vasopressin in Septic Shock

Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients. The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.

- EligibilityCriteria: Inclusion Criteria: Adult patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence of sepsis (≥2 SIRS criteria plus suspicion or confirmation of infection). Exclusion Criteria: Patient refusal or inability to obtain consent Failure of hemodynamic stabilization or hemoglobin <7 g/dL at the time of inclusion Severe cardiac dysfunction [i.e., ejection fraction (EF) <30%] History of heart block or patient on pacemaker Severe valvular heart disease Chronic liver disease (Child-Pugh classification C) Pregnancy Patients with traumatic brain injury - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302985

Not yet recruiting

Atomized Inhalation ICG for Treatment of Congenital Lung Malformations

To investigate the safety and effectiveness of preoperative aerosol inhalation ICG solution for thoracoscopic accurate resection of congenital lung malformations in children.

- EligibilityCriteria: Inclusion Criteria: children with congenital lung malformations diagnosed by CT or MRI scan Exclusion Criteria: 1. ages <3 months and >14 years 2. complicated other life-threatening disease; 3. complicated severely pulmonary infection - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Months - MaximumAge: 14 Years - StdAgeList: Child

NCT06302972

Recruiting

Effects of IASTM Along With Comprehensive Corrective Exercise Program in Upper Cross Syndrome.

This study will see the effects of IASTM along with comprehensive corrective exercise program in upper cross syndrome through their effects on pain and cervical ranges as well as postural improvement. Our study targets both male and female population. In the reference study only male population was targeted which did not show effects of both techniques on the female population though females have high stress levels which may alter results.

- EligibilityCriteria: Inclusion Criteria: Age 18-40 years. Diagnosed patients with the upper crossed syndrome who have chronic neck pain for more than 3 months. Having neck pain scoring more than 3 on the Numeric Pain Scale were included in this study. Any abnormality in the position and rhythm of the scapula, as measured by the scapular dyskinesis test, having postural changes such as excessive thoracic kyphosis (≥42°), forward head (≥44°) or round shoulder (≥49°) as measured by flexicurve and photogrammetry. Both male and female population will be included Exclusion Criteria: The subjects with any previous surgery, any type of Infection Hypersensitive skin Diabetes Mellitus type II Having Traumatic Injury Psychological disorder Manual Therapy contraindication like osteoporosis, infection, Disc- Herniation acute Inflammation, burn scars, closed /non-complicated fractures and open wound. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06302959

Not yet recruiting

Clock Proteins as a Prognostic Marker for Disease Progression

Asthma is a chronic inflammatory disease of the airways that follows a strong circadian rhythm: Signs of inflammation and symptoms worsen especially in the early morning hours. The molecular circadian clock, which is a complex machinery of transcriptional and translational feedback loops, seems to reflect the inflammatory environment of peripheral blood leukocytes. Therefore, in this observational study we will monitor the molecular circadian clock in patients with severe eosinophilic asthma before and during mepolizumab treatment. Our major goal is to evaluate the potential of the molecular circadian clock to serve as a prognostic marker for disease progression, treatment response or remission in patients with severe eosinophilic asthma. The molecular circadian clock will be monitored in blood and sputum leukocytes from patients with severe eosinophilic asthma before mepolizumab treatment, after 4 month of mepolizumab therapy, and once they reach remission under mepolizumab treatment. Effects will be compared to healthy controls and patients with mild-moderate asthma without mepolizumab treatment.

- EligibilityCriteria: Inclusion Criteria: Written consent of the participant after being informed Age 18-65 Both sexes (male:female ratio of 2:3) Mild-to-moderate asthma, severe eosinophilic asthma according to GINA guidelines and healthy controls Exclusion Criteria: Respiratory tract infections during the last 2 months severe comorbidities oral corticosteroids during the last month Shift workers Subjects with sleep disorders and/or receiving sleep medication Pregnant or breast-feeding women Control subjects with atopy and/or allergies - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with mild-to-moderate or severe eosinophilic asthma and healthy controls will be recruited for this study. Three individual groups within an age-range of 18 to 65 years and a male:female ratio of 2:3 will be studied: 20 age and gender matched healthy controls (1 visit) 20 patients with mild-to-moderate asthma (1 visit) 20-60 patients with SEA before mepolizumab treatment (visit 1) under mepolizumab treatment for 4 months (visit 2) after reaching remission under mepolizumab treatment (visit 3) - SamplingMethod: Non-Probability Sample

NCT06302946

Recruiting

Effect of Neuromuscular Stimulation and Mindfulness Breathing in Patients With Stroke

It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and divided into two groups. The experimental group will receive neuromuscular stimulation , mindfulness breathing and traditional physiotherapy while the control group will stick to traditional physiotherapy only.

- EligibilityCriteria: Inclusion Criteria: The subject selection will be according to the following criteria: All Patients of this study will be diagnosed as stroke and the diagnosis will be confirmed by computed tomography or MRI (El-Tamawy et al., 2021). Age of patients will be ranged from 50 to 65years (males and females). All patients will be hemodynamically stable. Patients with good cognition that enables them to understand the requirements of the study. Patients with following features: (Abiodun and Dolapo , 2021) FVC : 60-69% (moderate) FEV1 : 60-69% (moderate) FEV1/FVC : 50-59% (moderate) PEF : 50-80% (yellow zone) Exclusion Criteria: • The potential participants will be excluded if they meet one of the following criteria: Patients who cannot follow instructions as sensory aphasia, blindness, dementia, and deafness. Patients with any orthopedic, neurological, or chest disorders that affect trunk muscles control or cause respiratory disorders as COPD. Patients with cognitive and psychiatric disorders. Patients with unstable cardiovascular conditions. Patients with contraindications to neuro electrical stimulation as: Cardiac pace maker. Acute abdominal surgery. - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06302933

Not yet recruiting

Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms

The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives: Immunological aspect: lack of humoral response or immune activation Virological aspect: Reduced HIV reservoir size Determine the HLA phenotype in the different groups of children included and the KIR genotypes.

- EligibilityCriteria: Inclusion Criteria: Case control study Children included and followed in the ANRS 12225 study - Pediacam III Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up. Control (4 groups) HIV-infected children with positive serology and viral load (VL) <400 copies /ml HIV-infected children with positive serology and VL ≥400 copies / ml HIV-uninfected children born to HIV-positive mothers HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature <37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010). Cross sectional study Inclusion criteria All children still followed in the ANRS - Pediacam III cohort Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study. Exclusion Criteria: Refusal by one of the parents or the guardian for the child's participation in the study No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult

NCT06302920

Not yet recruiting

Effect of Kinesiotaping on Pain,Edema and Kinesiophobia in Patients With Complex Regional Pain Syndrome

Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.

- EligibilityCriteria: Inclusion Criteria: Clinical diagnosis of reflex sympathetic dystrophy Ability to be included in a physical therapy program Exclusion Criteria: Hemiplegia Malignancy Polyacrylamide allergy Open wound in the area to be applied - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult

NCT06302868

Recruiting

Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.

- EligibilityCriteria: Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Is an adult ≥ 18 years old Has a self-reported fear of dogs, snakes, and/or spiders Indicates Subthreshold or Present Specific Phobia symptoms as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Specific Phobia Module Has access to the internet AND a computer OR smartphone with video conferencing capabilities Will reside in the state of Florida for the duration of the study Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Is participating in ongoing mental health therapy from a non-study therapist Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial Reports active suicidal and/or homicidal intent or plan as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Risk Assessment Module Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question Reports a history of epilepsy or seizures - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302855

Not yet recruiting

Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care

Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test). Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it. The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.

- EligibilityCriteria: Inclusion Criteria: Type 1 or type 2 diabetes Exclusion Criteria: last dental visit<1 year patient unable to give consent - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302829

Recruiting

Comparison of IMES Versus DN on ATrPs of AC

The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis. This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy. Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis.

- EligibilityCriteria: Inclusion Criteria: • Age 40 to 60 year of both genders Diagnosed patients of stage 3 Adhesive capsulitis with type I and II diabetes Involvement of at least 3 shoulder girdle muscles in Active MTrPs (subscapularis, latissimus dorsi, deltoid (anterior, middle, posterior) Active MTrPs in shoulder girdle muscles (subscapularis, supraspinatus, deltoid (anterior, middle, posterior), teres minor, latissimus dorsi) Reproduction of the patient's symptoms at active trigger point, Taut band, Hypersensitive spot, Referred pain pattern, local twitch response Minimum 60 degrees of active/passive shoulder abduction range of movement. Exclusion Criteria: Systemic inflammatory joint disease of shoulder joint (RA, OA polymyalgia rheumatic) Cerebral Vascular Accident Fibromyalgia, neurological deficits of upper limb (Nerve root entrapment, Cervical radiculopathy, Thoracic outlet syndrome) History of Fracture, Dislocation, Acute soft tissue injury, Acute bursitis Avascular necrosis of humeral head or visceral referred pain to shoulder Pregnancy, Hypothyroidism, skin infection Patients who are using Antiplatelet Therapy with in past 3 days of study Extreme fear of needles - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 60 Years - StdAgeList: Adult

NCT06302816

Recruiting

Effects of Tupler and Scoop Exercises in Diastasis Recti

To compare the effects of tupler and scoop exercises on inter recti distance, low back pain, abdominal strength and urogynecological symptoms in diastasis.

- EligibilityCriteria: Inclusion Criteria: BMI 25kg|m^2 to 30kg\m^2or greater multiparous women Participants included will be 3 months post-partum females Caesarean delivery who will have with the presence of DRA >2 finger width and >2cm Exclusion Criteria: patients who had hernia trauma to bowel or bladder malignancies neurologic disease and its associated balance disorders, pelvic or abdominal surgery (except for a caesarean section) were considered as the exclusion criteria of this study - HealthyVolunteers: No - Gender: Female - GenderBased: Yes - GenderDescription: DIASTASIS - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06302803

Not yet recruiting

Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.

- EligibilityCriteria: Inclusion Criteria: Man or women aged 18-75 years; Body mass index (BMI)of 28.0 to 45.0 kg/m2; Exclusion Criteria: History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis; Diagnosis of type 1 and type 2 diabetes; History of malignant tumors; Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2); History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months; History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; Being a smoker or having been a smoker in the 3 months prior to their screening visit; Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ; Women who are pregnant or plan to become pregnant; Patients who cannot be followed for 24 months (due to a health situation or migration); Patients who are unwilling or unable to give informed consent. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult

NCT06302790

Recruiting

Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy

The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.

- EligibilityCriteria: Inclusion Criteria: volunteering to participate in the study Having a diagnosis of spastic CP 1 or 2 on the Gross Motor Classification System (GMFCS) Between the ages of 4-18. Exclusion Criteria: Having GMFCS 3,4,5 Botulinum Toxin A performed before 3 months or surgical intervention before 6 months Having an invasive medical pump (baclofen, insulin, etc.) - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult

NCT06302777

Recruiting

MAIN-IMAGE Registry

All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.

- EligibilityCriteria: Inclusion Criteria: patients undergoing pre-intervention optical coherence tomography imaging Exclusion Criteria: - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: ACS or SAP patients - SamplingMethod: Non-Probability Sample

NCT06302764

Recruiting

Emergency Medical Staff Workload Analysis

The aim of this study is to identify trauma determinants and leverage this understanding to develop solutions applicable to the prevention and treatment of PTSD among emergency medical personnel. By categorizing stimuli associated with traumatic professional experiences, the study aims to enhance existing therapeutic protocols through exposure therapy. The specific objectives are as follows: Analysis and characterization of occupational workloads among doctors and emergency medical personnel, focusing on the scale of burdens associated with PTSD symptoms. Development of categories for aggravating and potentially traumatizing stimuli within the medical staff of rescue teams. Examination of the feasibility of incorporating the obtained results into cognitive-behavioral therapy protocols. Assessment of the potential for implementing the results in solutions utilizing virtual reality technology. Formation of an interdisciplinary international research team.

- EligibilityCriteria: Inclusion Criteria: completed medical studies or emergency medical course assistance in life-threatening conditions Exclusion Criteria: Intellectual disability Inability to self-complete the research questionnaires - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 21 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Medical staff involved in treating life-threatening conditions - SamplingMethod: Non-Probability Sample

NCT06302751

Recruiting

A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions.

- EligibilityCriteria: Inclusion Criteria: Patients aged more than 18 years old. Patients scheduled for elective curative colorectal resection, including right (or extended) colectomy, left colectomy, rectal resection (with or without ileostomy), total colectomy, recanalization, or multiple colon resection. Patients willing to comply with the study procedures. Proficient understanding of the Italian language Exclusion Criteria: Any condition that, in the opinion of the investigator, may interfere with the study procedures. Patients scheduled for palliative surgery. Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study. Pregnant or breastfeeding women. Inability to comply with the study procedures. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult

NCT06302738

Recruiting

Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention. It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications. The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown. The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension.

- EligibilityCriteria: Inclusion Criteria: >18 years old; arterial hypertension defined as: a) office systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg AND either 24-hour ambulatory systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg OR b) the presence of antihypertensive treatment; non-dipper pattern at 24-hour BP monitoring (confirmed on repeated ABPM including one performed within 3 months prior to enrolment and one after enrolment, both on the same antihypertensive treatment, if any), defined as a nocturnal decrease systolic and/or in diastolic BP values <10% compared to the corresponding daytime values; signed written informed consent; Exclusion Criteria: shift workers atrial fibrillation/flutter; pregnancy and lactation; terminal malignant disease, life expectancy <6 months; limb amputation; dementia. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with non-dipper status with or without nocturnal hypertension - SamplingMethod: Non-Probability Sample

NCT06302725

Not yet recruiting

Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases

Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity).

- EligibilityCriteria: Inclusion Criteria: Women aged 30 to 65 years old presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, Evans syndrome) Susac syndrome Followed in the internal medicine department of Bichat Hospital, Paris At least 1 scheduled visit between December 2023 and December 2025 Not up to date with gynecological follow-up (i.e., cervical cancer screening more than one year old or undatable) Exclusion Criteria: Patient under legal protection, guardianship, or trusteeship History of colpohysterectomy Not affiliated with a social security scheme (general or CMU) Absence of informed and written consent - HealthyVolunteers: No - Gender: Female - MinimumAge: 30 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult

NCT06302712

Not yet recruiting

RCT of Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims With OCD in Pakistan

The current study aims to determine the effectiveness of the first culturally adapted Traditional Islamically Integrated Psychotherapy (TIIP) for Muslims with OCD in Pakistan along with the module effectiveness in reducing OCD symptoms with comorbidities like anxiety, depression, stress, thought control, thought-action fusion, and enhancing the spiritual quality of life of participants.

- EligibilityCriteria: Inclusion Criteria: The client diagnosed with OCD according to DSM-5-TR; ii) The minimum score on Y-BOCS is 08 (i.e., indicating moderate level of symptoms), iii) the age range is from 18 to 40 years iv) the client has a minimum of eight years of formal education. Exclusion Criteria: The client is having a comorbid diagnosis of severe psychiatric illness (e.g., psychotic disorders, personality disorder, substance use disorder, neurocognitive disorder), ii) the client is having a comorbidity of chronic physical illness, iii) the client refused to sign the informed consent form, and iv) the client has experience undergoing manualized faith-based CBT. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 40 Years - StdAgeList: Adult

NCT06302699

Recruiting

Detecting Minimal Residual Diseases (MRD) and Monitoring Clonal Evolution Using Ultrasensitive Chromosomal Aberrations Detection (UCAD) in Multiple Myeloma

The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while copy number variation (CNV) is a widely accepted biomarker used for multiple myeloma (MM). Detecting MRD and monitoring clonal evolution by monitoring CNV using low-pass whole genome sequencing is promising due to its high analytical sensitivity. To evaluate the correlation between MRD detected by flow cytometry and low-pass whole genome sequencing, nearly 200 samples were collected for this study. We applied ultrasensitive chromosomal aberrations detection to detect CNV for each patient. The follow-up samples were then collected and sequencing used the same method.

- EligibilityCriteria: Inclusion Criteria: Subjects diagnosed with MM. With available baseline and sequential next-generation flow-MRD data. Exclusion Criteria: Subjects without baseline and sequential next-generation flow-MRD data. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Multiple myeloma patients with baseline and sequential next-generation flow-MRD data are included in this study. - SamplingMethod: Probability Sample

NCT06302686

Recruiting

engAGE: Managing cognitivE decliNe throuGh Theatre Therapy, Artificial Intelligence and Social Robots drivEn Interventions

The objectives of the engAGE project are to counteract and slow down cognitive decline progression, to enhance the intrinsic capacity of the users, and to support the wellbeing of older persons with mild cognitive impairment (MCI) by providing an ecosystem of services based on an innovative system that integrates social robots.

- EligibilityCriteria: Inclusion Criteria: mild cognitive impairment (MCI); Montreal Cognitive Assessment (MoCA) score 21 - 25; Memory Assessment Clinics - Questionnaire (MAC-Q) ≥ 25; Reisberg scale 2 - 4; Clinical Frailty Scale score 1 - 3; 4-items GDS score ≤ 1; have an informal caregiver to support in carrying out the main daily activities. Exclusion Criteria: lack of informal caregivers; significant visual or hearing impairment. - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult

NCT06302673

Recruiting

The Role Of Laserpuncture For Prevention Of Nausea And Vomiting Post Strabismus Surgery With General Anesthesia In Adult Patients

This study to determine the effectiveness of a combination of pre-surgical laserpuncture with standard anti-emetic therapy for PONV symptoms in adult patients after strabismus surgery under general anesthesia compared to a combination of pre-surgical placebo laserpuncture with standard anti-emetic therapy. Research design using a double blinded randomized controlled trial (RCT) where research subjects and data takers who will be disguised. The research will be carried out in the Operation and Inpatient Room, Kirana Building, RSUPN Dr. Cipto Mangunkusumo (RSCM) with research subjects as adult patients undergoing strabismus surgery under general anesthesia. Assessment of nausea and vomiting using AVS ( Analog Visual Scale) consists of scoring using a score from 1-5 which indicates the severity of nausea and vomiting.

- EligibilityCriteria: Inclusion Criteria: Adult patients aged 18-59 years. Patients undergoing simple strabismus surgery involving no more than two muscles without transposition under general anesthesia. Meets the ASA (American Society of Anesthesiologists) score of 1-2. Complete the surgical preparations according to the presedation sheet. Sign the informed consent sheet. Patients who can communicate with the research team. Patients undergoing surgery <3 hours. Exclusion Criteria: The patient is pregnant. Patients who have a history of drug or drug abuse. Patients with hypersensitivity to laser light. There are wounds or skin disorders at the radiation site (skin TB, SLE(Systemic Lupus Erythematosus) skin Patients who have gastrointestinal diseases (intestinal obstruction, peristaltic disorders gastrointestinal tract, gastroenteritis, irritable bowel syndrome, dyspepsia,gastroesophageal reflux disease/GERD, appendicitis, hepatitis, cholecystitis, inflammatory bowel synchrome, pancreatitis, peptic ulcer, peritonitis, food poisoning). Patients with metabolic diseases (acid-base imbalance, metabolic diseases calcium, glucose metabolism disease, hyperlactemia, mitochondrial disease, phenylketonuria) Patients with conditions of high intracranial pressure, head trauma, migraines, disease with symptoms of seizures, vestibular diseases, malignancies, mental and psychogenic diseases, diseases arising from consumption of drugs, nephrolithiasis, other kidney diseases, myocardial infarction, as well as the occurrence of nausea and vomiting before surgery. Infection accompanied by high fever (temperature >38°C) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult

NCT06302660

Recruiting

Profiling Microbiome Associated Metabolic Pathways in oesophageaL cancEr Survivors

The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are: Study the changes in gut bacteria by examining saliva, stool and blood. Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria. Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors. Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires. Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above.

- EligibilityCriteria: Inclusion Criteria: Male and female patients aged 18-90 years Patients who underwent oesophagectomy for oesophageal adenocarcinoma with curative intent Disease free patients (CT with no evidence of recurrence within last 6 months or more than 5 years post oesophageal resection) Patients more than 1 year post oesophageal resection Exclusion Criteria: Patients with Siewert III gastro-oesophageal junctional tumours Patients with evidence of disease recurrence Patients who are unable or unwilling to provide informed written consent Patients who have received antibiotic therapy within the last 4 weeks - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma - SamplingMethod: Non-Probability Sample

NCT06302647

Not yet recruiting

STUDY TO EVALUATE THE WILLINGNESS OF HEALTHY VOLUNTEERS, PATIENTS, DOCTORS AND PHARMACEUTICAL/BIOTECHNOLOGY INDUSTRY TO USE A PLATFORM (WEB OR APP) TO FACILITATE RECRUITMENT AND ENGAGEMENT IN EARLY PHASE CLINICAL TRIALS . A SURVEY STUDY.

Study objective: To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials. Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry. Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.

- EligibilityCriteria: Inclusion Criteria: Participant will be over 18 years old. Male, female or do not want to specify. Participants will be capable to understand spanish language. Subjects able to communicate with the investigator and able to read and write and follow all study instructions. Exclusion Criteria: Individuals not willing to complete the eraly phase clinical trial platform Study survey Individuals who do not meet eligibility criteria - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult