rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Status: Not yet recruiting

This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All aims, aged ≥18 - < 99 years old admitted to UCH Burn Center with frostbite injury Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound  Exclusion Criteria:  Pregnant patients Prisoners Anticipated death within 48 hours of admission Inability to obtain consent from patient, legally authorized representative, or proxy Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy). Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection. Aim 3: Anuria due to chronic kidney disease (CKD) - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 99 Years - StdAgeList: Adult, Older Adult
Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study
Status: Recruiting

postoperative sore throat is the most frequent side effects after anaesthesia intubation. Dexamethasone and 10% lidocaine spray used prior to surgery has shown useful in managing these complications at the moment. In order to examine the prophylactic impact of local Dexamethasone and lidocaine on postoperative sore throat, this study was conducted.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  •Patients belonging to ASA physical status I, II  Patients between age18 to 50 years Patients belonging to both genders. patients undergoing shoulder arthroscopic surgeries. Patients with fasting blood glucose &lt;100 mg/dl or random blood sugar &lt;140 mg/dl.  Exclusion Criteria:  Patients who are not willing to give consent for participation in the study  Patients with anticipated difficult airway Patients who are allergic to steroids. Patients with ASA physical status III, IV Diabetic patients. Patients on steroids Patients requiring nasogastric tube or throat pack. Patients posted for head and neck surgeries. patient with GERD Pregnant patients preexisting upper respiratory tract infection. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Nutricity: An mHealth Nutrition Intervention to Improve Diet Quality Among Latino Children
Status: Not yet recruiting

The overall objective of this application is to pilot test an mHealth nutrition intervention within pediatric clinics serving Latino families and evaluate its potential for implementation. The investigators hypothesize the intervention will improve child diet quality and will be feasible for use within the clinic setting. To test this hypothesis, the investigators will pursue 3 specific aims and 1 exploratory aim:

Aim 1: Pilot Nutricity with 40 Latino families (English or Spanish speaking) vs. 40 waitlist control in primary care clinics and estimate differences in child diet quality at 3 month's post Nutricity exposure. Preliminary data will inform power calculations for a future larger Nutricity intervention.
Aim 2: Evaluate other individual (dyad) level factors including reach, engagement, and changes in secondary effectiveness outcomes (e.g. nutrition literacy, BMI, skin carotenoid, psychosocial constructs) at 3 months post exposure.
Aim 3: Evaluate organizational-level factors (adoption, implementation, and organizational-level maintenance) in Latino-serving pediatric clinics that may support or inhibit future uptake of Nutricity. The investigators will seek to understand the context of interventions and scalability to other clinics using mixed methods.
Exploratory Aim 1: Explore the relationship among nutrition literacy, psychosocial constructs and diet quality outcomes; and explore how engagement and satisfaction influence outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age (of parent) > 18 years; Parent or guardian of a child between 1-5 years old; Hispanic/Latino; English or Spanish speaking; Primary food decision-maker for the home; Internet connectivity at home (smart phone is adequate); Owns a device for accessing internet at home.  Exclusion Criteria:  Overt cognitive or psychiatric illness; Visual impairments that preclude viewing educational materials and using a tablet/device; Child illness requiring a highly restrictive diet, such as type 1 diabetes, renal disease, celiac disease, etc.; Child BMI ≥95%ile (obese children are referred for more intensive therapy). - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - StdAgeList: Child, Adult, Older Adult
Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment
Status: Not yet recruiting

Human milk has several well-established benefits but does not adequately meet the increased nutritional demands of the growing preterm infant, necessitating additional nutrient supplementation in a process known as fortification. In U.S. neonatal intensive care units (NICUs), human milk is primarily supplemented using standardized fortification, in which a multicomponent fortifier is added to human milk to achieve assumed nutrient content based on standard milk reference values. However, this method does not account for the significant variability in human milk composition or in preterm infant metabolism, and up to half of all very premature infants experience poor growth and malnutrition using current nutritional practices. Poor postnatal growth has adverse implications for the developing preterm brain and long-term neurodevelopment.

Recent advances allow for individualized methods of human milk fortification, including adjustable and targeted fortification. Adjustable fortification uses laboratory markers of protein metabolism (BUN level) to estimate an infant's protein requirements. In targeted fortification, a milk sample is analyzed to determine its specific macronutrient and energy content, with additional macronutrient supplementation provided as needed to achieve goal values. Emerging data suggest that both methods are safe and effective for improving growth, however information on their comparable efficacy and neurodevelopmental implications are lacking, particularly using advanced quantitative brain MRI (qMRI) techniques.

Through this prospective, randomized-controlled trial, the investigators will compare the impact of individualized human milk fortification on somatic growth and neurodevelopment in preterm infants. Infants will be randomized to receive one of three nutritional interventions: standardized (control group), adjustable, or targeted human milk fortification. Infants will undergo their assigned nutritional intervention until term-equivalent age or discharge home, whichever is achieved first. Brain qMRI will be performed at term-corrected age, and neurodevelopmental follow-up will be performed through 5 years of age.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Birth gestational age (GA) of ≤32 weeks Postnatal age ≤4 weeks at time of enrollment Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply Maternal age > 18 years old  Exclusion Criteria:  Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment - HealthyVolunteers: No - Gender: All - MaximumAge: 4 Weeks - StdAgeList: Child
M. Avium WGS During Mav-PD Treatment
Status: Recruiting

This is a prospective observational study using whole genome sequencing (WGS) to investigate whether new strains (other than the initially identified strain(s)) of M. avium are responsible for persistently culture positive sputum during treatment (refractory disease), or the reversion to culture positive sputum after prior conversion to negative. The study will further investigate for differences between participants living in the Toronto/York region versus participants living elsewhere.

The primary goal of this prospective observational study is to understand why some patients with M. avium lung disease have persistent or recurrent M. avium in their sputum despite treatment. The aim is to understand whether it is usually due to treatment failure or new infection.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 and older Willing to provide informed consent and participate in study procedures Residing continuously in Ontario during the past five years Mav-PD, either initial or recurrent (previously treated patients will be eligible) five years Meet American Thoracic Society (ATS) / Infectious Diseases Society of America (IDSA) NTM disease criteria for Mav-PD  Exclusion Criteria:  Lack of an available pre-treatment M. avium isolate in the PHOL isolate bank The inability to produce sputum either spontaneously or by induction with nebulized hypertonic saline Cavitation >3 cm internal diameter Known macrolide-resistant MAC infection HIV infection Known diagnosis of cystic fibrosis History of solid organ or hematological transplantation Severe comorbid illness that is reasonably expected to limit survival to <24 months Residing in mid/north York region (King, Aurora, Newmarket, Whitechurch-Stouffville, East Gwillimbury or Georgina) Having moved between regions (Toronto/southern York region vs non-Toronto/York region vs mid-northern York region) within the past 5 years - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients at the Toronto Western Hospital (TWH) Nontuberculous Mycobacterial (NTM) clinic who are to be initiated on therapy for Mav-PD. - SamplingMethod: Non-Probability Sample
Metabolomic Profiling of Racial Disparity
Status: Not yet recruiting

Tonsillectomy ± adenoidectomy (T&A) is one of the most common surgical operations with over 500,000 pediatric T&As performed annually in the United States. Unfortunately, despite advances in anesthetic and surgical techniques, moderate-severe post-tonsillectomy pain (PTP) remains a significant problem affecting up to 62% of children. PTP is thought to arise from pharyngeal mucosal inflammation, which produces local nerve irritation and pharyngeal muscle spasm. Patient factors and surgical techniques also play major roles. Race is an important phenotypic risk factor for moderately severe early PTP. The underlying molecular basis of this differential pain experience is presently unknown. This gap in knowledge means that therapies are poorly targeted and often unsuccessful. Indeed, treatment options for PTP have not advanced substantively for many years. Metabolomics provides novel opportunities to investigate common and unique "metabolic signature" of PTP through the analysis of low molecular weight compounds produced in response to tissue injury. Therefore, the central themes of this proposal are that (1) PTP is a complex process that may be determined by molecular level factors such as preoperative systemic inflammation and metabolic profile, and (2) these molecular level factors may explain the excess burden of PTP among minority children. Here the investigators seek to utilize a combined clinical, biological and untargeted metabolomics approach to identify candidate small and large serum molecules that may influence the frequency and severity of PTP in children across racial groups. This approach to exploring the molecular basis of PTP is novel and knowledge from the study should substantially enhance understanding of the mechanisms underlying pediatric PTP - and narrow the racial disparities in post-operative pain.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Consenting (or assenting) patients age 4-17yr and American Society of Anesthesiologist's (ASA) physical status I-III who are scheduled for elective tonsillectomy ± adenoidectomy (T&A).  Exclusion Criteria:  Age > 18 years old Children below 4 years of age because they are routinely admitted following T&A in our institution and may not be able to clearly self-report their pain Children on chronic preoperative analgesic medications Children with Cushing's syndrome, or nephrotic syndrome Children on chronic systemic steroids Children with concurrent surgical procedures that could prolong the duration of anesthesia and surgery Children that do not speak English or cannot self-report their pain after surgery (significant cognitive impairment, anticipated or unplanned postoperative endotracheal intubation, and sedation) - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 17 Years - StdAgeList: Child - StudyPopulation: Children undergoing tonsillectomy ± adenoidectomy at Nationwide Children's Hospital. - SamplingMethod: Non-Probability Sample
IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
Status: Not yet recruiting

The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  AIM 1:  Self-identify as African American, Black, or mixed race with African American or Black Speak English Males must identify as a current caregiver to girl enrolled in the study  AIM 2: All Community Based Organizations (CBO) directors and IMAGE liaisons will be eligible.  Exclusion Criteria:  AIM 1:  Girl refuses to participate Inability to understand the consent/assent process Non-English speaking Does not self-identify as African American, Black, or mixed race with African American or Black If the primary caregiver (female caregiver/mother) does not consent to the girls' participation with the male caregiver the girl chooses, the girl will not be able to participate Girls will be excluded if they participated in other phases of the research  AIM 2:  • Inability to understand the consent process, and non-employment at a partnering CBO. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - GenderBased: Yes - GenderDescription: AIM 1: Girls aged 14-18 years old; Male caregivers > 18 years old. AIM 2: >18 years old. - MinimumAge: 14 Years - StdAgeList: Child, Adult, Older Adult
Evaluating Verbal Communication in Structured Interactions: Theoretical and Clinical Implications
Status: Not yet recruiting

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and age-matched speakers.

The question is, What are the effects of communicative interaction on verbal communication in people with ALS?

Participants will read words and sentences while they are in a solo setting and interactive setting.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Speakers with ALS (PALS)  diagnosis of ALS following the revised EL Escorial criteria no history of other neurological conditions (e.g., stroke) no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA) detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R) the ability to produce single words being a native speaker of American English (AE).  Age-matched Speakers  passing the remote hearing screening having no known speech, language, or neurological disorders per self-report no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA) being a functionally native monolingual speaker of American English.  Unfamiliar Interlocutors  passing the remote hearing screening having no known speech, language or neurological disorders per self-report being a native monolingual speaker of AE having no experience communicating with people with dysarthria being between the ages of 18 and 40.  Exclusion Criteria:  None - if volunteer meets the inclusion criteria, then they will be enrolled - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 90 Years - StdAgeList: Adult, Older Adult
AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
Status: Not yet recruiting

The main goal of this multi-center interventional study is to improve the meal experience of children and adolescents with autism spectrum disorder trough the development of menus for collective catering targeted to their nutritional and sensory needs and the drafting of nutritional indications that can be a reference for collective catering nationwide. After an initial assessment of participants' consumption of meals in the collective service, menus adapted to their nutritional and sensory needs will be administered, and consumption between the initial and adapted menus will be compared. A population subgroup will also be selected whose caregivers will be invited to participate in a nutrition education course with the aim of providing parents of subjects with ASD, with knowledge tools to learn how to identify, manage and reduce their children's attitudes of food selectivity.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age 5-19 years Diagnosis of autism spectrum disorder (grade 1-2 or grade 3) Informed consent signed by their caregivers  Exclusion Criteria:  Subjects who are not autonomous in feeding themselves; Presence of neurodevelopmental disorders and/or pathological conditions that require the use of special diets; - HealthyVolunteers: No - Gender: All - MinimumAge: 5 Years - MaximumAge: 19 Years - StdAgeList: Child, Adult
EVALUATION OF CATS TONOMETER PRISM IN LASIK SUBJECTS
Status: Not yet recruiting

The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:  At least 22 years of age and undergone LASIK treatment Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form  Exclusion Criteria:  Subjects will be excluded from participation if they meet the following criteria:  Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months Pregnant or nursing women Those who have had previous corneal surgery excluding LASIK Keratoconus Corneal scarring Microphthalmos Buphthalmos Dry eyes with clinical epithelial breakdown upon exam Lid squeezers - blepharospasm Nystagmus Corneal or conjunctival infection. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 22 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:  At least 22 years of age and undergone LASIK treatment Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form - SamplingMethod: Non-Probability Sample
Feasibility of a Preoperative, Multimodal Lifestyle Intervention in Patients With Breastcancer
Status: Not yet recruiting

The primary objective of this study is to investigate the feasibility of a multimodal prehabilitation programme consisting of MIET during neoadjuvant intravenous chemotherapy infusion, HITT and strength training during the last six weeks prior to surgery, and optimising nutritional intake throughout the total preoperative period in patients with breast cancer with respect to recruitment, adherence, dropout, safety and acceptance. The secondary objective is to provide a preliminary evaluation of participant responses to a preoperative multimodal lifestyle intervention, on cardiorespiratory fitness, muscle strength, nutritional status, and fatigue in patients with breast cancer receiving neoadjuvant chemotherapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed with stage I-III breast cancer eligible for neoadjuvant intravenous chemotherapy at the MUMC+ Aged ≥18 years Eastern Cooperative Oncology Group (ECOG) Performance Status Scale grade 0-1 (Table 1) Enough understanding of the Dutch language  Exclusion Criteria:  Human Epidermal growth factor Receptor 2 (HER2) - positive tumour Scalp cooling Conditions that seriously hamper physical exercise Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult