Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of efficacy and safety of a medical device for the treatment of toenail onychomycosis

Conditions: Onychomycosis of Toenail

Summary: the efficacy and safety of solver pen (prototype number x92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. subjects are treated with either the test medical device (solver pen) or the comparator (loceryl, 5% amorolfine), respectively, for a period of 90 days. the primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. patients are followed up for a period of 90 days, with visits at d0 (baseline), d30, d60 and d90, respectively.


Eligibility criteria:
inclusion criteria: 1. patient having given her/his informed, written consent. 2. patient cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. 3. patient being psychologically able to understand information and to give their/his/her consent. 4. age: more than 18 years. 5. subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet). 6. patient with positive koh staining. 7. patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion. 8. women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end. exclusion criteria: 1. pregnant or nursing woman or planning a pregnancy during the investigation; 2. patient considered by the investigator likely to be non-compliant with the protocol. 3. patient enrolled in another clinical trial during the test period. 4. subject having a known allergy to one of the constituents of the tested products. 5. patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk; 6. patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, hiv, psoriasis, lichen planus, immunosuppressive pathology... 7. subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
infrared laser and classical ballerinas' feet

Conditions: Pain

Summary: overuse injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance. however, laser application may reduce pain and increase physical conditioning. the aim of the current study was to evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet. the hypothesis investigators was that the infrared laser would be able to reduce pain perception and enhance functional performance in ballerinas.

high risk of injuries and painful symptoms in athletes and dancers (especially classical ballerinas) may lead to reduced functional performance. the use of photobiomodulation may improve functional performance in ballerinas that are affected by foot pain. an aluminum gallium arsenide (algaas) diode laser device was uded. infrared laser (808 nm) was applied on ballerina's feet twice a week during three months. thermography, algometry and unipodal static standing balance test were performed. there were pain relief and improvement of functional performance in ballerinas.

Eligibility criteria:
inclusion criteria: - female adults who perform classical ballet training and feel pain in their foot exclusion criteria: - the occurrence of injuries in the last 6 months

Keywords: pain feet ballerinas
prescribing trends and associated outcomes of antiepileptic drugs in us nursing homes surrounding the covid-19 pandemic

Conditions: Dementia

Summary: since the "national partnership to improve dementia care" debuted in 2012, almost all long-stay psychoactive prescribing has been graded by cms, which has correlated to decreased use. however, some national data suggest that while these psychoactive medications are being used less, prescriptions of mood-stabilizing antiepileptic drugs (aeds) have increased. unlike all other psychoactive medications, aeds prescribed in nursing homes are not mandatorily reported to cms or graded in a quality-measure.

pilot studies from virginia suggest increases in aeds are concentrated entirely in dementia patients with no diagnosis of epilepsy and as a purposeful unmonitored alternative to antipsychotics. aeds are not fda approved for dementia symptoms, have weak efficacy evidence, and convey serious risk. increasingly it seems likely that the partnership's debut was an inflection point where the trend towards unmonitored alternative drugs for dementia symptoms sharply increased. early commonwealth data hints that the covid pandemic represents a second critical point of inflection where the existing transition towards non-superior but unreported drugs is again rapidly accelerating. all outcomes associated with this evolving prescribing phenomenon remain unknown. that said, pilot data suggests that harms may be increasing without benefit, a development with relevance to all invested in improving dementia care including patients, caregivers, and policy makers.

Eligibility criteria:
inclusion criteria: * all long-stay nursing home residents will be included. we define long-stay nursing home residents as all individuals residing in a nursing facility place of service for more than 100 days * all nursing home clinicians prescribing psychoactive drugs will be included. exclusion criteria: * limited to nursing home residents with continuous fee-for-service or medicare advantage plans as well as continuous part d coverage. * residents without continuous fee-for-service insurance (less than 3 percent of nursing home population) will be excluded. * less than 0.2% of nursing home residents are children; still, this study will be restricted to those \> 21 years of age. * nursing home residents who are discharged before the end of the quarterly study periods will also be excluded. * residents with discharges for acute hospitalizations followed by facility reentry on the same record will not be excluded. * non-prescribing clinicians and clinicians that do not prescribe psychoactive medications will be excluded.

Keywords: mood-stabilizing aed's nursing home
the immunogenicity and safety of the vaccination of inactivated enterovirus 71 vaccine and seasonal influenza vaccine

Conditions: Seasonal Influenza; Hand, Foot and Mouth Disease

Summary: the purpose of this study is to evaluate the immunogenicity and safety of the simultaneously vaccination of inactivated enterovirus 71 vaccine (ev71) and seasonal influenza vaccine(siv)

main subjects: the seroconversion rate for each antigen when ev71 is administrated with siv secondary subjects: the positive rate of antibody for each antigen when ev71 is administrated with siv the safety for each antigen when ev71 is administrated with siv

Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent. * participant is aged ≥ 6 month to \<12 months. * participant without preventive inoculation of enterovirus 71 vaccine ,seasonal influenza vaccine vaccine and previous history of enterovirus. * subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures. * body temperature ≤ 37.0#. exclusion criteria: * known allergy to any constituent of the vaccine. * known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever. * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth. * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction. * known bleeding disorder. * receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination. * reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination. * an acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial. * participation in any other intervention clinical trial. * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Keywords: immunogenicity safety enterovirus 71 vaccine seasonal influenza vaccine
an electrophysiological study of e2014 in healthy adult male japanese and caucasian subjects

Conditions: Spasmodic Torticollis

Summary: to evaluate inter-ethnic similarity in pharmacodynamics between japanese and caucasian healthy adult male subjects by comparing electrophysiological reactions after administering e2014 to extensor digitorum brevis muscle (edb).


Eligibility criteria:
inclusion criteria: 1. participants aged between 20 and 44 years at the time of obtaining informed consent. 2. participants whose m wave amplitude potential (between baseline and negative peak) in the edb by stimulating peroneal nerve in the foot joints is 1 mv or more during electrophysiological examinations at the times of screening and immediately before administration. 3. participants who are judged to be eligible for study entry by an investigator or subinvestigator at screening and at immediately before pre-treatment medical examination. 4. participants who are given a full explanation about the objective and details of this study before starting screening and give written consent based on their free will. exclusion criteria: 1. participants who have a complication or history of peripheral neuropathy, nerve root impairment, muscle disease. 2. participants with a disease that may influence the study drug evaluation, such as disorders of the gastrointestinal tract, liver, respiratory, endocrine, hematological, neurological, psychiatric and cardiovascular system, and congenital abnormality in metabolism. 3. participants who have accessory deep peroneal nerve. 4. participants who previously received a treatment with botulinum toxin. 5. participants with a history of hypersensitivity to any component of e2014 (human serum albumin, succinate buffer solution). 6. participants who are positive for urine drug screening at the time of screening or immediately before study drug administration. 7. participants who received prescription drug(s) within 1 month before study drug administration. 8. participants who have been treated with another investigational drug within 4 months before study drug administration. 9. participants who have experienced heavy exercise or hard labor within 2 weeks before study drug administration. 10. participants who underwent blood transfusion within 3 months before, those whose 400 ml of whole blood was collected within 3 months before, or those whose 200 ml of whole blood was collected within 1 month before study drug administration. 11. participants who are positive for hepatitis b surface antigen (hbs antigen), hepatitis c virus (hcv) antibody, or serologic test for syphilis (sts). 12. participants who received a diagnosis of acquired immunodeficiency syndrome (aids) or those with positive result for human immunodeficiency virus. 13. participants who are unwilling or unable to abide by the requirements of this study, or those who may violate the prohibitions and restrictions of this study. 14. participants who are judge to be ineligible for study entry by a principal investigator or subinvestigator.
motor imagery and action observation in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the main objective of this study is to evaluate the effects of an exercise programme combined with motor imagery and action observation, both in the short and long term.


Eligibility criteria:
inclusion criteria: * diagnosed with severe knee oa (according to the clinical and radiographic criteria of the american college of rheumatology guidelines) exclusion criteria: * pain in the contralateral (non-studied) limb (maximum ≥80 of 100 mm on a visual analog scale (vas) during daily activities), * undergone another hip or knee joint replacement in the previous year * any medical condition in which exercise was contraindicated or if they had participated in exercise programs or motor imagery/action observation intervention
high dose, absorbed dose adjusted 90y-ibritumomab with peripheral blood stem cells (pbsc) support in b-cell lymphoma

Conditions: B-cell Lymphoma

Summary: 90y-ibritumomab given with stem cells support, based on absorbed dose escalation to the liver. absorbed dose escalation starts at 12 gy and is capped at 36 gy to the liver.


Eligibility criteria:
inclusion criteria: * written informed concent * age at least 18 years * who performance status 0-3 * histologically verified b-cell lymphoma * diffuse large b-cell lymphoma and follicular grade iii, failing an anthracycline containing regimen and patients not found suitable for a second line chemotherapy consolidated by high dose chemotherapy (hdct) with stem cell support or radiotherapy * transformed b-cell lymphoma, failing first line therapy and not suitable for high dose chemotherapy (hdct) or with a history of hdct with stem cell support * follicular lymphoma grade ii and i, and other indolent lymphomas must have failed second line treatment. * one of these treatments must have contained chemotherapy and rituximab, the latter either together with chemotherapy or as maintenance. * the lymphoma must require treatment, mantle cell lymphoma, failing first line treatment,treatment required * measurable disease and the tumor burden must be acceptable according to the investigator * radiological studies must be performed and a unilateral bone marrow biopsy within 4 weeks before start of treatment * bone marrow reserve likely to give a harvest of at least 2x10 6 peripheral cd34+ stemcells or the existence of such a harvest or a corresponding central harvest * total bilirubin should not exceed 40 micromole/l * a gfr as measured by cystatin c of 50 ml/min * hiv, hepatitis b and c status known * life expectancy of at least 3 months. exclusion criteria: * known or clinical evidence of cns involvement * bone marrow involvement at harvest as measured by biopsy and flow cytometry * subjects with prior radiation to a field that includes over or equal 25% of their red marrow, liver or lung or to both kidneys * prior chemotherapy or radiotherapy within 4 weeks * subjects who are pregnant or nursing * pulmonary involvement, that is not negligible at the discretion of the investigator * liver involvement of lymphoma * history of hepatitis b or c.

Keywords: b-cell lymphoma refractory recurrent 90y-ibritumomab stem cells support dosimetry study
control and treatment of outpatient children with asthma

Conditions: Asthma

Summary: the aim of this study is to comprehensively understand the disease control and management status of children with asthma in china, as well as the types of airway inflammation. the findings of this survey will help improve the asthma control level in chinese children, facilitate future patient education, and guide rational medication use. moreover, it will provide important evidence for health decision-making departments to better allocate and utilize medical resources.

bronchial asthma (hereinafter referred to as asthma) is the most common chronic respiratory disease in children. it severely affects the physical and mental health of children and imposes a huge economic burden on families and society, consuming a large amount of medical and health resources. in recent years, the prevalence of asthma in children worldwide has generally continued to rise. data from the global burden of disease database in 2019 showed that the prevalence of asthma in children aged 0-9 years was 4.21%, in children aged 10-14 years was 4.10%, and in adolescents aged 15-19 years was 3.00%. in china, over the past 20 years, the prevalence of asthma in children has also shown an overall upward trend, increasing from 0.91% in 1990 to 1.54% in 2000, and then to 3.02% in 2010. thanks to the continuous efforts of several generations of pediatricians, the level of standardized diagnosis and treatment of childhood asthma has significantly improved. however, the control of asthma in children still faces many challenges. the purpose of this study is to comprehensively understand the disease control and management status of children with asthma in china, as well as the types of airway inflammation. the findings of this survey will help improve the asthma control level in chinese children, facilitate future patient education, guide rational medication use, and provide important evidence for health decision-making departments to better allocate and utilize medical resources.

Eligibility criteria:
inclusion criteria: * age between 2 and 16 years old；children who have been diagnosed with asthma for more than 3 months;children who have had asthma symptoms or asthma treatment within the past 12 months. exclusion criteria: * children diagnosed with other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, and pneumonia; children who have participated in any interventional clinical studies related to asthma within the 3 months prior to enrollment in this study; children whose parents, legal representatives, or guardians do not agree to participate in this study.

Keywords: asthma children outpatients management control
comparison of i-124 pet/ct for the diagnosis of thyroid cancer

Conditions: Thyroid Cancer

Summary: persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using iodine-131, a therapy which has been shown to be effective and safe. imaging of metastatic thyroid cancer has been performed with whole body i-131 and iodine 123 (i-123) imaging for many decades and use i-123 for staging studies. iodine 124 (i-124) is a radioisotope of iodine which emits a positron and is imaged using pet (positron emission tomography). this is a single arm prospective trial that evaluates the ability of iodine-124 (i-124) to detect metastatic thyroid cancer compared to non-interventional, usual care i-123 and i-131 images.

primary objectives: 1. reclassification rate of i-124 positron emission tomography (pet) compared to i-123 single-photon emission computed tomography (spect). 2. sensitivity and specificity of i-124 pet to detect metastatic thyroid cancer compared to composite standard. secondary objectives: 1. inter-reader variability for i-124 pet and i-123 spect. 2. safety of i-124 pet. 3. participant level detection rate for i-124 in the overall population. 4. participant level detection rate for i-124 in participants who have negative i-123 spect. 5. comparison of lesion detection between i-124 pet and 24 hour i-123 spect. 6. comparison of lesion detection between i-124 pet and post-treatment i-131 spect. exploratory objectives 1) ability to predict lesion absorbed dose using i-124 pet/ct. outline: all participants will have a single pet/ct scan after administration of i-124 and will be followed for up to 3-5 days by phone for evaluation of adverse events. a subset of participants being evaluated for dosimetry will be imaged up to two additional times over five days after administration. data from other scans for comparison will be obtained from the participant's medical record.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years. 2. histopathologically confirmed differentiated thyroid cancer, with clinical concern for metastatic disease, which is based on: 1. metastatic disease seen on i-123 spect, fluorodeoxyglucose (fdg) pet, ct scan or ultrasound. 2. elevated thyroglobulin in participant after total thyroidectomy. i. participants with an undetectable thyroglobulin will be allowed if thyroglobulin antibodies are present. 3. planned i-123 imaging within 45 days after enrollment. 4. ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: 1. unlikely to comply with study procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation. 2. known pregnancy, per institutional policy.

Keywords: imaging studies
comprehensive swallowing rehabilitation in patients with msa

Conditions: Multiple System Atrophy

Summary: the purpose of this study is to investigate the effect of comprehensive swallowing rehabilitation in patients with multiple system atrophy.

multiple system atrophy (msa) is a rapidly progressive neurodegenerative disease characterized by parkinsonism, cerebellar syndrome, and autonomic failure. dysphagia is a clinically significant symptom leading to pneumonia that causes death in patients with msa. although the symptoms of dysphagia in the two subtypes of msa-the parkinsonian variant and the cerebellar variant- are different, there is no significant difference in the latency to onset of tube feeding. therefore, effective intervention is needed to improve the safety and efficiency of swallowing regardless of the subtypes of msa. although swallowing rehabilitation has been widely applied for swallowing disorders in patients with msa, few studies have reported the clinical effect of applying swallowing therapy. comprehensive swallowing rehabilitation has focused on functional muscle training, compensatory swallowing maneuvers, and thermal-tactile stimulation, which is used to treat dysphagia from stroke, parkinson's disease, and head and neck cancer. therefore, this study aims to investigate the effect of comprehensive swallowing rehabilitation in patients with msa.

Eligibility criteria:
inclusion criteria: * age \>19 years * clinically diagnosed with msa according to the guidelines of the 2nd consensus of the gilman criteria * clinically diagnosed to have dysphagia by a physiatrist * two or more points on the penetration-aspiration scale (pas) from the videofluoroscopic swallowing study (vfss) conducted within 3 months exclusion criteria: * moderate to severe cognitive dysfunction with mini-mental state examination score \< 19 * comorbidities or structural abnormalities that may affect swallowing function * other comorbidities that make it difficult to participate in the study

Keywords: multiple system atrophy dysphagia swallowing rehabilitation videofluoroscopic swallowing study