rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Effects of Dance and Tai Chi on Balance and Wellbeing on Healthy Adults
Status: Not yet recruiting

The aim of the proposed randomised controlled study is to compare the effects and efficacy between a dance, a Tai Chi and a waiting list control group intervention over an eight-week period on physical functions and mental benefits among non-clinical adults aged between 18 and 59. The study's primary outcome is mental wellbeing and secondary parameters are physical functional and mood. A tertiary outcome will examine how the physical and mental parameters change during the learning and practice phases

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  healthy male and female adults of any ethnicity aged from 18 to 59 no chronic medical conditions and no physical injuries in the past 3 months that could potentially affect physical activities  Exclusion Criteria:  participants who are currently engaging in regular dance or Tai Chi classes currently has a chronic disease or acute illness - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 59 Years - StdAgeList: Adult
INvestigating the Value of Early Sleep Therapy
Status: Not yet recruiting

Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia.

Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment.

This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant is willing and able to give informed consent  Aged 18 years and above  Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or duration, accompanied by other night / daytime symptoms, present for between 2 weeks and 3 months  Newly diagnosed with non-metastatic breast cancer  Primary cancer treatment is surgery  Exclusion Criteria:  Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT.  Pregnancy Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at study screening interview Dementia / Mild Cognitive Impairment Epilepsy Psychosis (schizophrenia, bipolar disorder) Current suicidal ideation with intent or attempted suicide within past 2 months Night, evening, early morning, or rotating shiftwork Current / previous psychological treatment for insomnia during the last 12 months Chemotherapy and / or radiotherapy commenced - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction
Status: Not yet recruiting

Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.

On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.

Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  ischemic heart disease with history of infarction - LVEF> 35% (measured by MRI) sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest - having signed informed consent affiliated to a social security system  Exclusion Criteria:  transient regressive cause of ventricular tachycardia recent myocardial infarction (<2 months) ventricular tachycardia by reentry from branch to branch serious conduction disturbances (with indication of stimulation) contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy <1 year, relevant comorbidities) pregnancy age <18 years Patient under legal protection, guardianship or curatorship - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Efficacy of 20% Autologous Serum Drops in the Treatment of Corneal Epitheliopathy Associated With Antihypertensive Glaucoma Drops.
Status: Not yet recruiting

Introduction: Glaucoma is the second leading cause of blindness globally. Most anti-hypertensive drops contain preservatives harmful to the corneal epithelium, with up to 78% of treated patients reporting dry eye symptoms. Autologous serum eye drops (ASED), contains essential growth factors and nutrients which may promote corneal and conjunctival integrity, offering benefits over traditional treatments. This study investigates the efficacy of 20% ASED over placebo in the treatment of corneal epitheliopathies in patients with glaucoma treated with antihypertensive drops.

Methods: The present study is a triple-blinded, randomized controlled trial that anticipates to enroll 25 patients (50 eyes) with bilateral corneal epitheliopathy secondary to antihypertensive glaucoma treatments. Patients will receive autologous serum eye drops in one eye and placebo in the contralateral eye for two months, in addition to standard artificial tears treatment.

The primary outcome is the comparison of National Eye Institute (NEI) scores between autologous serum drops and placebo-treated eyes at two months. Secondary outcomes include Schirmer's test scores, visual acuity, tear break-up time (TBUT), Ocular Surface Disease Index (OSDI) scores, intraocular pressure, and complication rates.

The study aims to analyze the effectiveness of autologous serum eye drops in treating corneal epitheliopathies in glaucoma patients, potentially offering a new therapeutic avenue.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with glaucoma who developed corneal epitheliopathy secondary to antihypertensive drops; Epitheliopathy refractory to conventional therapies (Artificial Tears, ointment, topical cyclosporine or punctal plug, etc.); National Eye Institute score of 3 or more for both eyes; Adults aged 18 to 90 years inclusively.  Exclusion Criteria:  Corneal epitheliopathy of other origin (ie. mechanical, neurotrophic, toxic, post-infectious, limbal stem cell deficiency); Glaucoma surgery within the last six (6) months; Previous corneal surgery; Active autoimmune disease; Frequent contact lense wear; Pregnant or actively breast-feeding; Known systemic infection with HIV, hepatitis B and C or syphilis; Known severe anemia (Hb < 100 g/L); Inability to give informed consent - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo
Status: Not yet recruiting

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  -patients between 18 and 70 years of age with a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature.  Exclusion Criteria: *Patients aged > 70 years as central vertigo , *patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial, *history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid, *history of syncope or cardiac event, considerations of a central origin for vertigo *evidence of drug-induced vertigo or orthostatic hypotension *history of mental or neurological illness.  - - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Front-of-package Label Effects in Latine and Limited English Proficiency Populations
Status: Not yet recruiting

The goal of this experiment is to examine the effects of 4 types of front-of-package food labels among a sample of Latino adults. The main questions this experiment aims to answer are:

What front-of-package label design is most effective in helping Latino and low English proficiency consumers identify healthier and less healthy food products?

What front-of-package label design is most effective in helping Latino and low English proficiency consumers choose healthier food products?

Additionally, this experiment also aims to answer the following question:

Do the benefits of front-of-package label designs differ by English proficiency and parental status?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs and view their assigned label design on 3 sets of products. Each set will display 3 similar products, each high in either 1, 2, or 3 nutrients of concern. For each set, participants will select the product that they believe to be the healthiest, least healthy, and the product that they would most want to consume. Researchers will compare results across label designs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Identifying as Latino or Hispanic Ages 18-55 years old Residing in US  Exclusion Criteria:  Not identifying as Latino or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Status: Recruiting

Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD  Exclusion Criteria:  Age > 14 years. Patient weighing < 10 kg. History of severe Allergy History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke. Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past. Evidence or history of severe, moderate, or uncontrolled systemic disease. Inability to follow the prescribed dosing and follow-up schedule. Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period. Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study. History of premature birth <35 weeks' gestation. Prior history of stroke in utero or other in utero insult. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 14 Years - StdAgeList: Child
Impact of Front-of-package Labels on Weight Bias Among Latines
Status: Not yet recruiting

The goal of this experiment is to examine the effects on explicit weight bias of a selection task using 4 different types of front-of-package food labels to select healthy or unhealthy foods among a sample of Latine and low English proficiency adults. The main questions this experiment aims to answer are:

Does the use of different front-of-package label designs in a selection task lead to different effects on explicit weight bias among Latine and low English proficiency consumers?
Does the use of different front-of-package label designs in a selection task lead to different effects on attribution of personal responsibility for body weight among Latine and low English proficiency consumers?

Participants will be randomly assigned to 1 of 4 types of front-of-package label designs. They will view 3 sets of products (frozen meals, frozen pizzas, and frozen desserts), shown in random order. For each product set, participants will view 3 products shown in random arrangement, each with participants' randomly assigned label shown on the front of package. After viewing all 3 product types, participants will answer questions about explicit weight bias and attribution of responsibility for body weight. Researchers will compare results across label designs.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Identifying as Latine or Hispanic Ages 18-55 years old Residing in the United States  Exclusion Criteria:  Not identifying as Latine or Hispanic Less than 18 or greater than 55 years old Not residing in the United States - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Pericardial Fluid Analysis in Recurrent Pericarditis
Status: Not yet recruiting

This clinical trial aims to examine the biochemical and cytological features of pericardial effusion during acute and recurrent pericarditis and to understand the molecular factors responsible for pathogenesis. The primary objective of this study is to identify and validate diagnostic criteria in pericardial fluid analysis that can differentiate patients with acute and recurrent pericarditis from those with only pericardial fluid but no inflammation.

This study will enroll patients with acute pericarditis who require pericardiocentesis for either diagnostic or therapeutic purposes. Two control groups will also be included: one consisting of patients who need cardiac surgery with a collection of pericardial fluid, and the other consisting of patients who require pericardiocentesis for non-inflammatory pericardial effusion. The purpose of the study is to compare the cell activation status and cytokines present in pericardial fluid during acute pericarditis with those present during other pericardial pathologies.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with acute idiopathic or post-cardiac injury pericarditis who require diagnostic or therapeutic pericardiocentesis (Interventional arm) Subjects with non-inflammatory pericardial effusion who require diagnostic or therapeutic pericardiocentesis (First control arm) Patients who undergo cardiac surgery that involves a pericardiotomy (Second control arm)  Exclusion Criteria:  Pregnancy or breastfeeding Ongoing infections, including active viral hepatitis or Coronavirus Disease 19 (COVID-19) positivity in the previous 21 days Systemic inflammatory disorders not attributable to pericarditis, excluding inflammatory diseases in remission Solid or haematological malignancies, ongoing or less than 6 months disease-free interval or anti-blastic chemotherapy (excluding the hormone therapy) Immunosuppressive therapy for reasons other than pericarditis treatment. Moderate-severe kidney failure (GFR < 30 ml/min) Moderate-severe liver failure (Child-Pug B or C), active hepatitis Diabetes mellitus Severe hypoproteinemia/malnutrition - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: For the first two arms, patients from the primary care clinic (Emergency room department). For the third arm, patients who need to undergo cardiac surgery with pericardial sac involvement. - SamplingMethod: Non-Probability Sample
Clinical Comparison of a Postbiotic-gel With Placebo Gel for Gingival Inflammation in Patients With Down Syndrome
Status: Not yet recruiting

The aim of the study is to evaluate the efficacy of home treatment with a postbiotic-based gel for the management of periodontal inflammation in patients with Down syndrome.

Patients will be enrolled at the S.C. Odontostomatologia dell'Azienda Ospedaliera "Ordine Mauriziano di Torino", Turin, Italy. After the collection of the periodontal clinical indexes (BoP%, PCR%, dental mobility, mMGI, compliance and satisfaction questionnaire), patients will undergo a professional mechanical debridement with ultrasonic instruments and glycine powders.

Then, they will be randomly divided into two groups according to the home treatment:

in the Trial group Biorepair Plus Parodontgel Intensive (containing microRepair®, hyaluronic acid, Lactobacillus Ferment and Aloe Barbadensis Leaf Juice Powder) will be used once a day for all the duration of the study
in the Control group, a placebo gel without (active ingredients) will be used once a day for all the duration of the study.

Indexes will be re-evaluated after 1 (T1), 3 (T2) and 6 months. The professional mechanical debridement will be performed again at T3 timepoint.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  not bedridden patients with Down syndrome gingival inflammation and bleeding  Exclusion Criteria:  lack of compliance signalled by caregivers other systemic diseases - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Pleurodesis Using Hypertonic Glucose
Status: Not yet recruiting

Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system  Exclusion Criteria:  - None - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
BeFit Toolbox Collaboration: Building Empowerment Through Fitness
Status: Not yet recruiting

This project will identify the causative behavioral factors in low-income African American women leading to sedentarism, a major source of morbidity in HABD communities. Working with our partner, WUCN, we will engage with women in HABD housing to develop and (later) deliver a physical activity education program (BeFit) customized for this population.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Eligibility criteria for participants are as follows: female, at least 18 years of age, mothers of school-aged children (K-12), tenants of HABD in good standing with a minimum of one year of stable living arrangements, and availability during program hours.  Exclusion Criteria:  Inability to understand study instructions - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: This is a women&#39;s health study investigating barriers women heads of household face in engaging in physical activity. - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
A Study Of TL-925 For The Treatment of AC
Status: Not yet recruiting

In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Individuals aged 18 years or older Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study. Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months. Calculated best-corrected visual activity of 0.7 LogMAR or better Positive bilateral CAC reaction  Exclusion Criteria:  Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study. Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months Any ongoing ocular infection (bacterial, viral or fungal) - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult