rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Exploring the Effectiveness of Dance as an Intervention to Promote Social-Emotional Health in Children With Autism Spectrum Disorder (ASD)
Status: Not yet recruiting

This study will explore the effectiveness of dance as an intervention to promote social-emotional health within children with ASD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria for Youth Participants  Elementary school children ages 7-11.  Parent/caregiver/guardian must provide proof of an Individualized Education Plan (IEP) with a Primary Eligibility of Autism.  o Parent/caregiver/guardian must provide proof of IEP and eligibility.  Will speak and understand English. Able to physically participate in the dance program without the use of adaptive equipment.  Answer yes to the following Skillset Checklist (Per parent/caregiver/guardian report):  Follow 1- and 2-step instructions. Follow structured activities with supervision (e.g., visual schedule, routine). Previous participation in extracurricular group activities over the last 6 months - 1 year (e.g., structured sports). Minimum 5-minutes of attention to task.  Exclusion Criteria:  No IEP Primary Eligibility of Autism. No children participants younger than 7. No children participants older than 11. - HealthyVolunteers: No - Gender: All - MinimumAge: 7 Years - MaximumAge: 11 Years - StdAgeList: Child
A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Status: Recruiting

The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  The study participant has a diagnosis of generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP) at screening. For GPP, a diagnosis must be classified based on the criteria for diagnosis of GPP by the Japanese Dermatological Association (JDA); for EP, has a history of plaque-type psoriasis. In addition, has an involved body surface area (BSA) of lesion greater than or equal to (>=) 80 percent (%) at baseline Candidate for phototherapy or systemic treatment for psoriasis (either naive or history of previous treatment) A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and have a negative urine pregnancy test at Week 0 prior to administration of study intervention A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention  Exclusion Criteria:  The study participant has a total score of JDA severity index for GPP >=14 at baseline if participants have a diagnosis of GPP The study participant has a differential diagnosis of the erythroderma (for example, erythroderma caused by lymphoma or drug eruption) other than EP The study participant has a history of or current diagnosis or signs or symptoms of severe, progressive, or uncontrolled liver, renal; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances The study participant has a history of amyloidosis Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients The study participant who doesn't meet the criteria of prior/current concomitant therapy and/or history/conditions of infections - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult
A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease
Status: Recruiting

The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult participants ≥ 18 years of age. Participants or participant's legally authorized representative has provided informed consent to participate in this study. Participants who meet one of the following: Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.  OR  Already received SOC treatment prior to enrollment. Participants with ANY of the following. Diagnosis of MI OR stroke within 2 years before enrollment. 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment. Diagnosis of (MI OR stroke) AND diabetes. Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as > 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography). Diagnosis of symptomatic peripheral arterial disease. Most recent fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (≥ 2.6 mmol/L) within 6 months prior to enrollment. Most recent fasting triglycerides ≤ 400 mg/dL (≤ 4.5 mmol/L) within 6 months prior to enrollment.  Exclusion Criteria:  Stroke within past 1 month. Known hemorrhagic stroke at any time. Stroke due to thromboembolic event. Any prior use of Repatha® or other proprotein convertase subtilisin/kexin type 9 inhibition treatments within past 6 months prior to enrollment. Participants currently enrolled in another study involving any investigational procedure, device or drug. Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 150 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population comprises Chinese participants with established ASCVD treated with Repatha® in combination with SOC or with SOC alone in a clinical setting which includes any primary through tertiary healthcare setting where Repatha® is prescribed. - SamplingMethod: Non-Probability Sample
Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
Status: Not yet recruiting

The objective of this study will be to assess the efficacy of the peri-implant mucosal thickness enhancement following either subepithelial connective tissue grafts or Amnion Chorion Membrane placed simultaneously with dental implant placement.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with good systemic health with no contraindication for periodontal surgery. No history of any medications in the previous 6 months that may interfere with periodontal tissue health or healing. Ability to maintain good oral hygiene as evidenced in recall visits. Aged 30 to 55 years. Stable periodontal condition and missing one single tooth (maxillary anterior teeth and premolars) with adjacent teeth present and thin mucosal phenotype (< 2mm bucco- lingual thickness).  Exclusion Criteria:  Medically compromised patients and systemic conditions precluding periodontal surgery. Smokers. Severe hematologic disorders (e.g., hemophilia or leukemia), uncontrolled infectious or metabolic diseases that could compromise normal healing, liver, or kidney dysfunction/failure. Patients subjected to irradiation in the head and neck area. Patients treated or under treatment with intravenous amino bisphosphonates. Patient affected by active periodontitis or has poor oral hygiene and motivation. Uncontrolled diabetes mellitus. Pregnant women or planning become pregnant, and nursing mothers. - HealthyVolunteers: No - Gender: All - MinimumAge: 30 Years - MaximumAge: 55 Years - StdAgeList: Adult
Relative Contribution of Brain Insulin Action for Postprandial Metabolism
Status: Recruiting

The goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women.

Therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  BMI < 24 kg/m2 no known primary diseases no hormonal contraception  Exclusion Criteria:  Alcohol or drug abuse Smoking At screening: Hb < 12 g/dl for women and Hb < 14 g/dl for men Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson's Disease
Status: Recruiting

The purpose of this clinical trial is to assess the preliminary safety and efficacy of the ARC-IM spinal cord stimulation therapy in alleviating locomotor deficits in individuals with Parkinson's disease. The ARC-IM Therapy employs epidural electrical stimulation (EES) to modulate leg muscle recruitment, with the aim of improving mobility deficits. The ultimate goal is to enhance the quality of life of people with Parkinson's disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Typical form of Parkinson's Disease with III-V Hoehn-Yahr stage with standard therapy, Suffering from debilitating locomotor deficits, including gait impairments of either postural instability and/or freezing of gait, despite optimal medical management, 18 years of age or older, Able to understand and interact with the study team in French or English, Must use safe contraception for women of childbearing capacity, Must agree to comply in good faith with all conditions of the study and to attend all required study trainings and visits. Must provide and sign the study's Informed Consent prior to any study-related procedures.  Exclusion Criteria:  Atypical forms of Parkinson's Disease (such as Multiple System Atrophy or Progressive Supranuclear Palsy), Secondary causes of gait problems independent of Parkinson's Disease, Inability to follow study procedures, Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator, History of major psychiatric disorders or major neurocognitive disorder as considered by the Investigators in accordance with treating physician and treating neurologist, Major change in PD treatment planned until the end of the main study phase (such as Deep Brain Stimulation or dopamine-pump implantation), Diseases and conditions that would increase the morbidity and mortality of the implantation surgery, Spinal anatomical abnormalities precluding surgery, History of drug or alcohol abuse in the past 5 years, Life expectancy of less than 12 months, Pregnant or breast feeding, Intention to get pregnant during the course of the study, Indication requiring frequent Magnetic Resonance Imaging (MRI), Experimental treatment taken in the past 5 years, Participation in another interventional study, Enrolment of the investigator, his/her family members, employees, and other dependent persons. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Telerehabilitation Based Motor Imagery and Action Observation Training in Multiple Sclerosis
Status: Not yet recruiting

This study aims to investigate the effects of the treatment combination consisting of motor imagery and action observation therapy on balance, functional mobility, lower extremity muscle strength, fatigue and quality of life.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Being diagnosed with mulltiple sclerosis according to the McDonald criteria Expanded Disability Status Scale<5.5, Being between the ages of 18-65, Mini mental test score>24, Have a phone that can adapt to participating in a video call  Exclusion Criteria:  Having another additional neurological disease that may cause balance and coordination disorders, Receiving physical therapy in the last 6 months, Having an attack in the last 3 months Refusal to participate in the study. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Clinical Trial of the Seaweed Supplement Fucoidan in Survivors of Cancer
Status: Not yet recruiting

To determine the feasibility of an 8-week fucoidan supplement intervention for patients with fatigue post-cancer treatment and assess changes in fatigue, frailty, and inflammation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Survivors of cancer Age 18 or older Speak and understand English Have completed surgery, radiation, and/or systemic intravenous anticancer therapy (e.g., chemotherapy, targeted therapy, immunotherapy) ≤10 years prior to enrollment. Have a baseline level of fatigue, as determined by reporting a score of 4 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?" Be willing to commit to the fucoidan supplement dosing and delivery method, to complete evaluation instruments, and to attend all study visits. Completed Informed Consent  Exclusion Criteria:  Current warfarin or other anti-coagulation medication use. Current use of supplements that contain fucoidan Any allergy to fucoidan Be diagnosed with a major psychiatric illness requiring hospitalization within the last year. Be diagnosed with dementia. Be pregnant or nursing - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea
Status: Not yet recruiting

This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  apnea-hypopnea index ≥ 15 hr-¹  Exclusion Criteria:  the presence of pulmonary, cardiac, neurologic, or other active severe medical or psychiatric diseases current use of continuous positive airway pressure therapy use of drugs that might interact with the investigational medication or known to affect sleep during the trial or 1 month before the study known allergy to the investigational medication current smoking heavy alcohol drinking (male > 14 drinks and women >7 drinks per week) pregnant or lactating periodic limb movement index ≤ 15hr-1 the presence of sleep-related hypoventilation - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - StdAgeList: Adult, Older Adult
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Status: Recruiting

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent. Aged 18-75 years (inclusive). Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20. At least one evaluable tumor lesion according to Lugano 2014 criteria.  Response to prior therapy is consistent with one of the following:  Primary refractory. Relapsed or refractory after 2 or more lines of therapy.  For LBCL, 3B FL. t-iNHL:  Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;  Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;  7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria  Exclusion Criteria:  Subject eligible for this study must not meet any of the following criteria:  Prior antitumor therapy with insufficient washout period ; Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;  5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).  6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.  7. Pregnant or lactating women;  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children
Status: Not yet recruiting

The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old) At least 6 years old and up to 12 years old at time of informed consent and assent Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval [-10.00, +0.75] Cylindrical refractive error between 0 and 4.00 D on both eyes Corrected binocular visual acuity in distance vision at least 6/9  Exclusion Criteria:  Incapable of expressing consent All categories of persons particularly protected by law Subject in another study which might have an influence on vision or interfere with study assessment Less than 6 years old, or 13 years old or above at time of informed consent and assent Amblyopia, Cataract, Strabismus. Aphakic or pseudophakic (intraocular implant) Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye. Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…), Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 6 Years - MaximumAge: 13 Years - StdAgeList: Child
Heat Waves and the Elderly With COPD
Status: Recruiting

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  65 years old or older Diagnosis of COPD  Exclusion Criteria:  Known heart disease Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram Current smokers Participant with a body mass index ≥31 kg/m2 - HealthyVolunteers: No - Gender: All - MinimumAge: 65 Years - StdAgeList: Older Adult
Observational Study of the Association Between Food Intake and Endometrial Polyps
Status: Not yet recruiting

There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consistent with the international clinical diagnosis of endometrial polyps.Can complete content recall alone.  Exclusion Criteria:  No other mental diseases. Not associated with other major diseases, including tumors, immune system diseases - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - StdAgeList: Child, Adult, Older Adult - StudyPopulation: The study period will include all patients who attended gynecological outpatient clinics between March 1, 2024 and May 1, 2024 - SamplingMethod: Non-Probability Sample