Kornimate/medical-research-clean huggingface dataset:
a clinical investigation to evaluate the safety and performance of a treatment kit for ingrowing toenail

Conditions: Onychomycosis of Toenails

Summary: this purpose of this study is to evaluate the safety and performance of a treatment kit for ingrowing toenail, primarily by determining the number of subjects who show a reduction in the severity of their ingrowing toenail.


Eligibility criteria:
inclusion criteria: * subjects with one great ingrowing toenail that is rated as either "slightly ingrowing", "somewhat ingrowing" or "very ingrowing" on the investigators ingrowing toenail severity scale. * subjects whose worst pain experienced in the week preceding inclusion, is rated at least 3 on the 10 point subject pain intensity scale. * subjects whose affected toenail has a minimum of 2mm distal edge and a minimum nail width of at least 16mm. exclusion criteria: * subjects with any other toenail pathology (including pincer and spicule toenail) that would compromise the fitting of the toenail clip, or its use. * subjects suspected to be immunocompromised. * subjects who suffer from impaired feeling in the feet due to diabetes, peripheral vascular disease or neuropathy. * subjects with any cutaneous pathology or cuts/abrasions which, in the opinion of the investigator, could compromise safety or affect the outcome of the clinical investigation (for example, interfere with assessments). * subjects with known sensitivity/allergies to any component of the investigational device. * significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease, which, in the opinion of the investigator, would compromise the safety of the subject or affect the outcome of the clinical investigation (as determined from self-reported medical history questionnaire). * use of concomitant medication likely to affect the response to the investigational device or confuse the results of the clinical investigation. regular pain relief is not permitted and subjects must not take any analgesics in the 24 hours preceding any clinic visit. * female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent. * pregnancy or lactating mother.
healthy hydration pilot in elementary schools

Conditions: Hydration; Dental Caries; Body Mass Index

Summary: this study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

adequate water intake plays an important role in maintaining children's overall health, cognitive performance, fine motor skills and visual attention. it also plays a role in the maintenance of healthy weight. many children do not consume sufficient water, especially in school. there is also potential that by providing enhanced access to water, there will be corresponding decreases in sugary beverage intake. sugary beverages have been implicated as major contributors of excessive sugar and calorie intake in children, leading to multiple health concerns, such as type 2 diabetes, overweight and obesity, and dental caries. schools are an optimal environment to increase children's water intake. healthy hydration is a priority for richmond public school (rps), as they recently adopted a new hydration policy into their school wellness policy, with hydration stations installed in all rps schools. the purpose of this study is to determine the feasibility of a school-based hydration intervention. this study will pilot a school-based stakeholder-informed hydration intervention and examine its feasibility and preliminary efficacy.

Eligibility criteria:
inclusion: * lunchroom observations: all students (k-5th) who eat lunch in the cafeteria on assessment days are eligible for lunchroom observations (observing what beverages are selected and presence of water bottles) * bmi and dental caries assessments: 1) student is in the 3rd grade; 2) english or spanish speaking. * student surveys: students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices in their district. * staff surveys: all staff in the target schools will be eligible to complete the school environment survey. exclusion: * lunchroom observations: none. * bmi and dental caries assessments: students are ineligible if they: 1) are non-english or non-spanish speaking; 2) have a medical condition that precludes drinking water or that can put them at risk for failure to thrive or poor weight gain, 2) are unable to complete assessments due to developmental delays, 3) plan to move from the school district during the study period. * student surveys: students in 4th-5th grade who are unable to complete surveys due to developmental delays will be ineligible. * staff surveys: none.

Keywords: hydration water bottle sugary beverages
design and development of an infant's oriented face mask

Conditions: Infant

Summary: face masks are used for many respiratory care applications such as anaesthesia, resuscitation, and aerosol therapy. none of the currently available face mask for infants and young children are specifically designed and developed for infants. the aim of this study is to design, develop and test the first infant's oriented face mask. to achieve this ultimate goal we will first define appropriate sizes of infants' faces that would be used as templates for the design and development of optimally fitted model masks. in the next stage we will use these masks and incorporate the infants' own soother (pacifier) into a new soothermask (sm). in the last part of the study we will compare acceptance levels between soothermask (sm) and a conventional commodity masks without a pacifier.

not all face masks are "born equal" and care must be taken in mask design, particularly for the early pediatric age group. unfortunately, facemasks provided for infants and young children have been merely smaller versions of those used for adults with little consideration given to their special needs we believe that a major advance in answering the needs of infants rely in making the mask more friendly user by making sucking on the infant's soother an integral part of the newly developed mask. this is based on the following premises: 1. sucking is a vital feeding and soothing activity of infants. incorporating sucking into the act of aerosol delivery greatly reduces the fear engendered and inconvenience of putting an obtrusive mask on the infant's face. 2. linking the mask to the sucking action ensures a tight seal between the mask and the face. every time the baby sucks on the pacifier or the bottle nipple, the mask is pressed onto the face by atmospheric pressure thus ensuring a good mask to face seal. this then also ensures that the aerosol that has been sprayed into the holding chamber will be drawn into the baby's lungs through the nose with each inspiration. 3. the material of the mask's rim is relatively wide, soft, corrugated and is thus highly flexible. this makes the mask easily compressible without overdue force on the infant's face. thus, the act of sucking attracts the mask to the child's face, assists in achieving a good seal and compresses it thus substantially reducing the dead space volume of the mask. the ultimate goal of the present study is to answer these specific needs of infants and to develop an appropriate infant's oriented face mask. in order to achieve this goal the study will have three specific objectives. objective #1 define morphometric data of infants' faces objective #2 design and develop an optimally adapted face mask soothermask (sm) based on the morphometric results objective #3 compare the acceptance levels between soothermask (sm) and a conventional commonly used masks without a pacifier.

Eligibility criteria:
inclusion criteria: signed informed consent exclusion criteria: non cooperation with procedure

Keywords: infants, aerosol, acceptance, face mask, drug delivery
parental knowledge of first aid for choking and cardiopulmonary resuscitation in infants under one year of age

Conditions: Choking in Infants; Cardiopulmonary Resuscitation (CPR); First Aid Training; Parental Knowledg

Summary: this study aims to assess the knowledge of parents regarding first aid for choking and cardiopulmonary resuscitation (cpr) in infants under one year of age. the primary objective is to evaluate how well parents understand emergency procedures and identify factors influencing their knowledge and confidence. the study will involve a combination of surveys and practical training sessions conducted both in-person and online.

the study aims to evaluate the level of knowledge and self-confidence among parents regarding first aid procedures for choking and cardiopulmonary resuscitation (cpr) in infants under one year of age. the research will investigate the factors that influence parental knowledge, including previous first aid training, educational background, and prior experience in emergency situations. the study will employ a mixed-methods approach, including both quantitative and qualitative data collection. participants will complete structured surveys before and after training sessions to assess changes in knowledge and confidence levels. the primary training will be conducted through workshops at the andrzej frycz modrzewski krakow university and the stefan żeromski specialist hospital in kraków. additionally, online training will be offered via the zoom platform to reach a broader audience. the results will be statistically analyzed to identify key factors that improve parental first aid readiness. findings are expected to contribute to the development of more effective educational strategies for parents, ultimately enhancing infant safety and emergency response skills.

Eligibility criteria:
inclusion criteria: * parents or legal guardians of infants under 1 year of age. * adults aged 18 years and older. * individuals willing to participate in first aid training on choking prevention. * persons who provide informed consent for participation. exclusion criteria: * lack of consent to participate in the study. * individuals under 18 years of age. * professionals in medical rescue or those with advanced first aid knowledge. * parents of children older than 1 year. * individuals unable to attend in-person or online training sessions. * health conditions that prevent participation in training.

Keywords: infant cpr, first aid, choking, parental knowledge, emergency response, neonatal resuscitation, first aid training
a dose-finding study to evaluate the safety, efficacy and pharmacokinetics of adalimumab in subjects with refractory asthma

Conditions: Asthma

Summary: to evaluate the efficacy of sc injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator fev1 from baseline to week 16 when used in the treatment of refractory asthma.


Eligibility criteria:
inclusion criteria: * documented history of refractory asthma, as defined by the american thoracic society,31 defined as 1 major and at least 2 minor criteria * actual or documented history of reversible airway obstruction * baseline fev1 of 40% - 80% of the predicted for height, age, and sex at screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist * history of at least 1 asthma exacerbation leading to oral, iv or im corticosteroid or er/urgent care center visit or hospitalization within the past year prior to screening. this asthma exacerbation should not have been within 30 days prior to screening * adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits * subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication exclusion criteria: * active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease \[copd\], interstitial lung disease, pulmonary fibrosis) other than asthma * current treatment for corticosteroid-resistant asthma (e.g., methotrexate \[mtx\], cyclosporine, gold salts, troleandomycin, immune globulin intravenous \[igiv\], mycophenolate mofetil) * history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma - in-situ of the cervix. * history of listeria, human immunodeficiency virus (hiv), chronic or active hepatitis b, an immunodeficiency syndrome, central nervous system (cns) demyelinating disease or active tb * females who are pregnant or will not discontinue breast-feeding. * subject with a history of clinically significant drug or alcohol abuse in the last year * subjects with a poorly controlled medical condition. * abnormal, clinically significant screening laboratory and other analyses (including ecg). * subjects with any prior exposure to tysabri® (natalizumab) * prior treatment with any tnf antagonist, including adalimumab
ms relapses during covid-19 pandemic

Conditions: Multiple Sclerosis; Covid19; Relapsing Remitting Multiple Sclerosis

Summary: throughout the covid-19 pandemic, and to our knowledge there have been no studies looking systematically at the occurrence of ms relapses and their subsequent management, during the peak of the first wave of the pandemic. in this study we will explore how ms relapses were reported and managed during april - june 2020, compared to a control cohort who experienced a relapse during the same period in 2019 across 5 uk centers.

multiple sclerosis (ms) is a chronic inflammatory, demyelinating and neurodegenerative condition of the central nervous system (cns) and is considered the most common cause of disability in young adults. it is estimated that the number of adults with ms in the uk has risen to 131,720. the majority of patients (85%) have relapsing remitting ms (rrms), with many later entering the secondary progressive phase (spms). relapse is the cardinal clinical feature of rrms, and can be also prevalent in spms, however the influence of relapses on the long-term disability is not yet fully defined and remains controversial. severe acute respiratory syndrome coronavirus 2 (sars-cov-2) emerged in wuhan, china, in late 2019 and covid-19, a disease caused by sars-cov-2 became a pandemic in march 2020. the impact of sars-cov-2 infection on patients with ms has yet to be elucidated. the main focus of previous studies has been the actual risk of covid-19 inpatients with ms, the risk of ms exacerbation during covid-19 infection and the impact of disease modifying drugs (dmds) in the severity of covid-19 infection. other studies have explored the psychological and behavioural impact of covid-19 pandemic to ms patients; those studies highlighted the risks from missing/cancelling clinic appointments and mris, missing/stopping/changing dmds, delays in dmds infusions, having a relapse and not seeking medical advice or disruptions in rehabilitation services. to the best of our knowledge, there is currently no study that explored the effect of covid-19 on ms patients by looking systematically into ms relapses and their potential consequences. we will study the occurrence and subsequent management of relapses occurring between april - june 2020 at the peak of the first wave of the pandemic, compared to individuals who have relapsed during the same period in 2019. this observational, retrospective study will be performed at 5 uk sites.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of ms or clinically isolated syndrome (cis) and * atleast one clinician confirmed probable relapse between 01/04/2020 and 30/06/2020 or 01/04/2019 and 30/06/2019 exclusion criteria: * age \<16 years
safety and efficacy of oms302 in subjects undergoing intraocular lens replacement with phacoemulsification

Conditions: Intraocular Lens Replacement

Summary: the purpose of this study is to determine the safety and efficacy of oms302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing intraocular lens replacement (ilr) surgery.


Eligibility criteria:
inclusion criteria: * competent and willing to voluntarily provide informed consent * 18 years of age or older * in good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia exclusion criteria: * no allergies to the medications and/or the active ingredients of any of the study medications * no medications with the same activities of the active ingredients in oms302 for defined time intervals prior to and after surgery * no other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication

Keywords: cataract lens replacement
evaluation of the efficacy and safety of lebrikizumab (ly3650150) in moderate to severe atopic dermatitis (advocate1)

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. the study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.


Eligibility criteria:
inclusion criteria: * male or female adults and adolescents (≥12 years and ≥40 kg) * chronic atopic dermatitis (according to american academy of dermatology consensus criteria) that has been present for ≥1 year before the screening visit * eczema area and severity index (easi) score ≥16 at the baseline visit * investigator global assessment (iga) score ≥3 (scale of 0 to 4) at the baseline visit * ≥10% body surface area (bsa) of atopic dermatitis involvement at the baseline visit * history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable exclusion criteria: * prior treatment with dupilumab or tralokinumab * treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit * treatment with any of the following agents within 4 weeks prior to the baseline visit: * immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, ifn-γ, janus kinase inhibitors, azathioprine, methotrexate, etc.) * phototherapy and photochemotherapy (puva) for ad * treatment with the following prior to the baseline visit: * an investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer * cell-depleting biologics, including to rituximab, within 6 months of baseline * other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer * treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study * uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma * evidence of active acute or chronic hepatitis * history of human immunodeficiency virus (hiv) infection or positive hiv serology * history of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin * pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Keywords: eczema dermatitis dermatitis, atopic skin diseases
difference of gastric microbiota in the process of correa's model.

Conditions: Gastric Microbiota; Non-atrophic Gastritis; Atrophic Gastritis; Intestinal Metaplasia; Intraepithelial Neoplasia; Gastric Cancer; Helicobacter Pylori

Summary: helicobater pylori plays an important role in the development of gastric cancer. eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. however, they didn't reach an agreement. correa's model is widely accepted in the development of gastric cancer. the pathological change makes a more suitable environment for bacteria to overgrowth. this study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.


Eligibility criteria:
inclusion criteria: 1. patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer. 2. did not take any antibiotics,ppi,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination. 3. sign the informed consent. exclusion criteria: 1. had been taken helicobacter pylori eradication therapy before. 2. previous gastrointestinal surgery. 3. during the pregnancy and lactation period. 4. with any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result. 5. with any mental problems.

Keywords: gastric microbiota helicobacter pylori non-atrophic gasrititis atrophic gastritis intestinal metaplasia intraepithelial neoplasia gastric cancer
assesment of multiomics profiles in health and disease.

Conditions: Genetic Predisposition to Disease

Summary: this study will determine reference genomic, transcriptomic, proteomic and metabolomic profiles in czech population and will evaluate its correlation with the disease phenotype.

this study will determine reference genomic, transcriptomic, proteomic and metabolomic profiles in czech population. initially, there will be 1000 healthy volunteers, with the planned expansion to 10.000 participants (healthy volunteers and patients with different types of disease). formation of the reference database of healthy volunteers and their parameters will allow a correct interpretation of the potential pathological findings in patients. it is very important to obtain healthy controls from the region of the czech republic, central europe respectively; since it is not possible to reliably compere ethnically and geographically diverse populations, which have generated in a different context and where the diseases manifest with other etiology ad phenotype. although, in the limited measure, the similar molecular data exist in foreign databases, these are not compiled from the inhabitants of the czech republic, central europe not even from slavic population. study participants may volunteer for archiving of remaining biological materials for future studies.

Eligibility criteria:
inclusion criteria: * age 18 - 68 years * (for the first 1100 subjects): * healthy volunteers without genetically dependent disease and without such a disease in a family * healthy volunteer without the preliminary evidence of civilizational diseases such as hypertension, diabetes, autoimmune and tumor diseases or acute infectional diseases; clinically manifesting cardiovascular or pulmonary disability. * subject without permanent of long-term medication in the time of biological sampling. exclusion criteria: * not complying with inclusion criteria

Keywords: genomic profile disease phenotype proteomic profile metabolomic profile transcriptomic profile