Kornimate/medical-research-clean huggingface dataset:
investigation of pharmacokinetics of bibx 245 cl and safety in healthy subjects

Conditions: Healthy

Summary: aim of this trial is to investigate the single dose pharmacokinetics and the effect of food on single dose of 160 mg 245 cl (two 80 mg tablets) as well as its safety


Eligibility criteria:
inclusion criteria: * written informed consent in accordance with good clinical practice (gcp) and local legislation * age \>= 18 and \<= 50 years * broca \>= -20% and \<= +20% exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ecg)) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of gastrointestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24 hours) (\<= 1 month prior to administration or during the trial) * use of any drugs which might influence the results of the trial (\<= 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (\<= 2 months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on study days * alcohol abuse (\> 60 g/day) * drug abuse * blood donation \> 100 ml (\<= 4 weeks prior to administration or during the trial) * excessive physical activities (\<= 10 days prior to administration or during the trial) * any laboratory value outside the reference range or clinical relevance
covid-19 national survey for assessing viral spread by nonaffected carriers (con-vince)

Conditions: COVID19

Summary: con-vince (covid-19 national survey for assessing viral spread by non-affected carriers) is a national, monocentric, and longitudinal study aiming to evaluate the spread dynamics of the covid-19 disease within the luxembourgish population. participants who are clinically asymptomatic or present with only mild symptoms will be followed up longitudinally, regularly tested for sars-cov-2 by rt-pcr, antibody status, and subjected to an epidemiological, clinical and biological phenotyping to better understand the nature, dynamics of infectivity and spread of the virus in the population. con-vince will also track the psychological and socio-economic impact of long-term containment measures on the general population.

to capture the dynamics and impact of the virus spread in the luxembourgish population, data and sample collection is done every two weeks for two months (4 times in total) with a final follow-up one year after the participant's inclusion in the study. participants complete questionnaires before each sample collection. the baseline questionnaire captures demographic data, medical history, behavioral and psychological data, and socio-economic status. participants provided information on medical history, history of allergies, smoking, and chronic medication taken regularly. covid-19-related data and environmental conditions of the household were obtained.

Eligibility criteria:
inclusion criteria: * subjects aged 18 and older of both genders, with a full capacity of consent. * sars-cov-2-positive individuals with an asymptomatic or oligosymptomatic infection (mild or oligosymptomatic disease course is defined as absence of fever and respiratory distress or cough not attributable to other known chronic disease). * or sars-cov-2-negative individuals at the time of inclusion. * or post-infectious sars-cov-2-negative individuals with acquired immunity to sars-cov-2 and a mild disease course. exclusion criteria: * evolution of the covid-19 disease requiring a hospital admission before inclusion in the study * presence of fever and respiratory distress/cough at the time of inclusion not attributable to other known chronic disease

Keywords: coronavirus covid prevalence
study to assess the efficacy and safety of ibuprofen 50 mg/g gel compared to profenid 25mg/g gel

Conditions: Muscular Atrophy; Sprains; Tendonitis

Summary: the aim of this study is to determine that ibuprofen 50mg/g gel is effective and safety treating patients with muscle aches, joint pains or due to sprains, bruises, tendinitis or myofascial compared to profenid 25mg/g gel.

the main objective of this study is to evaluate the efficacy of ibuprofen 50 mg/g gel in the treatment of patients with muscle, joint pain caused by sprains, contusions, tendinitis, or myofascial compared to profenid 25mg/g gel.

Eligibility criteria:
inclusion criteria: * patients of both sexes, of any race, aged 12 years; * ability to read, understand and sign the informed consent in the case of minors monitoring and consent of a parent; * complaint of clinical muscle pain, joint pain caused by sprains, contusions, tendonitis, or myofascial; * score more than 4 vas symptom reviewed: pain; * patients able to understand and follow the protocol of the trial. * patients with or without ligament injury ligament injury partial and incomplete exclusion criteria: * known hypersensitivity to components of the formula, both the medication and the comparative test; * hypersensitivity to acetylsalicylic acid; * hypersensitivity to ketoprofen, ibuprofen or other anti-inflammatory steroid; * hypersensitivity to acetaminophen; * skin changes in the pathological site of application, such as eczema or acne, or infected skin or wound; * pregnant or lactating women. * patients who require surgery or immobilization; * patients with fractures or ligament rupture; * patients taking anticoagulants; * patients with decompensated concomitant systemic diseases, such as diabetes, congenital or acquired blood disorders, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders and pulmonary disorders; * use of nsaids, corticosteroids or venotherapics, threads or any other form of administration; * history of alcoholism or substance abuse; * conditions in the opinion of the investigator make the patient unsuitable to participate in the study.

Keywords: ibuprofen muscle pain sprains contusions tendonitis
allergic inflammation in rhinitis patients following nasal allergen challenge

Conditions: Allergic Rhinitis; Asthma

Summary: allergic rhinitis is a common condition caused by inflammation of nasal mucosa. the study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma. the study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season. treatment,ie intranasal corticosteroid or placebo, were given four weeks. after two weeks of treatment intranasal allergen challenge was performed. measurements were performed during the full study period. the study was performed out of pollen season.


Eligibility criteria:
inclusion criteria: * monoallergy to grass * symptoms of allergic rhinitis for at least the two most recent grasspollen seasons * asthma symptoms of asthma for at least two of the four most recent grasspollen seasons * age 18 or older exclusion criteria: * pregnancy or lactation * fertile women, not sterilised or using sufficient anticonception * corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment * any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results
shelter cat adoption in families of children with autism (feline friends)

Conditions: Social Skills; Anxiety

Summary: the overall purpose of this study is to investigate the effect of the introduction of a shelter cat into the family of a child with autism spectrum disorder on the social skills and anxiety of the child, and to examine stress in the cat.

many families in the united states live with cats as companion animals, including families of children with autism spectrum disorder (asd). one in 68 children are diagnosed with asd. there is no cure for asd, and no one treatment works for all children. symptoms of asd include a lack of social skills and anxiety. companion animals have been helpful for children with asd. however, no one has studied stress of cats living in families of children with asd. this study will place 64 pre-screened shelter cats in pre-screened homes and monitor the stress of the cats. cats ages 10 months to four years that have been screened for calm behavior using a temperament, test will be adopted by families in the study. families will also be screened for pet issues. no cat will be placed in a home with a child who has a history of aggression to animals. the study will also examine the social skills and anxiety of the children with asd, and bonding of the parents and children with their cats. five to eight million dogs and cats are relinquished to animal shelters in the united states each year. thirty-eight percent of cats are given up for behavioral reasons. studying cat stress and the placement of cats, with calm and non-aggressive characteristics into homes of families of children with asd may help shed light on the likely success of the relationships between shelter cats and these families.

Eligibility criteria:
inclusion criteria: * child with diagnosis of autism spectrum disorder * no cat currently living with the family * willingness to adopt a shelter cat * english speaking * live within 125 miles of columbia, missouri exclusion criteria: * child with autism spectrum disorder having any history of animal aggression * children with cat allergies
a pilot clinical trial study to determine the safety of the application of a wearable medical electromagnetic generator

Conditions: Stroke

Summary: to explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.


Eligibility criteria:
inclusion criteria 1. patients aged 19 to 80 years old 2. those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (ct) or brain magnetic resonance imaging (mri) 3. patients with subacute stroke between 2 weeks and less than 3 months after onset 4. motor function evaluation the total score is 0 to 56 points based on the fma of the upper extremity on the affected side \[1\], and patients show impairment in upper extremity motor function. 5. after receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions. exclusion criteria: 1. cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease 2. cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke. 3. those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year. 4. those with impaired cognitive ability (mmse less than 10 points) 5. if there are difficulties in conducting research 6. if you have difficulty communicating 7. other patients who are deemed difficult to participate in this study by the principal investigator. 8. patients who are participating in other therapeutic clinical studies or who have participated in other therapeutic clinical studies within the past 30 days (observational studies are not relevant) 9. exclusion criteria for repetitive transcranial magnetic stimulation 10. patients with medical devices implanted in the body (e.g. pacemaker) 11. when a metal object is inserted into the skull 12. if there is a wound on the skin at the attachment site 13. history of epilepsy 14. if you have cervical pain or musculoskeletal disease 15. pregnant and lactating women
optical coherence tomography evaluation of retinoschisis and retinal detachment

Conditions: Retinoschisis

Summary: retinoschisis is usually a rare self-limited disease and seldom shows progression. there a splitting of the neurosensory retina occurs usually in the inferior temporal. patients usually have good visual acuity and are asymptomatic. combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. the most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. in clinical examination, both can appear very thin and transparent. therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age. * ophthalmoscopic evidence of rs or rd * written informed consent has been obtained. exclusion criteria: * progression of retinal detachment or retinoschisis requiring surgical treatment * contraindication to pupil dilation, known allergy.
comparisons of inhaled lama or lama+laba or ics+laba for copd with bronchiectasis

Conditions: COPD; Bronchiectasis

Summary: the purpose of this study is to determine which treatment is more effective and safer for the patients in copd c group with bronchiectasis.the research results will help guide physicians to select appropriate individualized treatment and hopefully provide some evidence-based medicine proofs for revising guide.

the diagnosis and treatment of copd and bronchiectasis together seems to be more complicated than the diagnosis and treatment of either condition alone. according to the gold，there are three treatments for patients with copd in group c: ics combined with laba or lama alone or laba combined with lama. however, it has not yet been demonstrated about which method is more effective for the patients with copd in group c and bronchiectasis. this study is designed as a prospective, randomized, case-control trial. patients are divided into three groups, one group inhaled with ics and laba (symbicort), the second group inhaled with lama (tiotropium bromide) and the third group inhaled with lama(tiotropium bromide) and (symbicort).the course of treatment is 12 months. the investigators will also assess other relevant outcomes, including the quality of life (qol) score, pulmonary function test and the incidence of adverse event.

Eligibility criteria:
inclusion criteria: * patients are suitable for inclusion in the study when they are 18 years or older diagnosed with copd c group and bronchiectasis. exclusion criteria: * active tuberculosis * severe respiratory disease (such as lung cancer, ards, pulmonary encephalopathy, respiratory failure) * uncontrollable diabetes * hypersensitivity to any components of ics/laba or lama.

Keywords: lama,ics+laba,lama+laba
intracardiac echocardiography guided slow pathway cryoablation

Conditions: Atrioventricular Nodal Reentry Tachycardia

Summary: atrioventricular nodal reentry tachycardia is best treated with catheter ablation aimed at disruption of conduction of the slow pathway. there are currently two possible options for this ablation: radiofrequency ablation and cryoablation. the first seems to result in superior success rate, however carries a small risk of collateral damage of the heart conduction system, specifically the atrioventricular (av) node. cryoablation seems less effective, but safer as av nodal damage can be avoided. the aim of this study is to prospectively test possible improved efficcacy of cryoablation of the slow pathway with the use intraprocedural intracardiac echocardiography.

we will prospectively enroll all patients that will be referred to our center for ablation of supraventricular tachycardia and will have an electrophysiologically proven atrioventricular nodal reentry tachycardia. in order to prove the mechanism specific maneuvers will be performed during induced sustained tachycardia. navigation in the heart will be performed in a fluoroless fashion, with the use of a three-dimensional electro-anatomic mapping (3deam) system. detailed anatomical definition and navigation in the area of the koch triangle will be done with intracardiac echocardiography (ice). also, in sinus rhythm, when present, the jackman potential will be tagged on the 3deam map. cryomapping will be performed at the presumed location of the slow pathway (position of the jackman potential or only anatomical location as defined with ice) during ongoing tachycardia with the aim to terminate it and continue with cryoablation at the successful site. noninducibility will be tested with programmed and fast atrial stimulation. patients will be followed clinically for up to 12 months.

Eligibility criteria:
inclusion criteria: * ecg or holter ecg evidence of regular narrow qrs complex tachycardia, intraprocedural pacing maneuvers in sinus rhythm and during ongoing tachycardia indicating presence of avnrt exclusion criteria: * terminal or severe medical condition with expected survival of less then 12 months, deep venous thrombosis preventing access to the femoral vein, intracardiac thrombi, anatomical irregularities of pelvic veins and/or inferior vena cava, inability to induce avnrt after the initial induction and diagnosis - enables exclusion of procedures where accidental mechanical termination of slow pathway conduction with the cryoablation catheter occurs

Keywords: atrioventricular nodal reentry tachycardia cryoablation intracardiac echocardiography
local ketamine instillation for postoperative analgesia

Conditions: Postoperative Pain

Summary: this study aims at exploring the analgesic efficacy, and safety of ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (i.m. injection of the same dose) with respect to postoperative vas, first request of analgesia, total opioid consumption, and with respect to possible side effects.


Eligibility criteria:
inclusion criteria: * patients with thyroid cancer scheduled for total thyroidectomy. exclusion criteria: 1. bmi\>35 2. unstable ischaemic cardiac disease 3. increased intracranial pressure 4. increased intraocular pressure 5. hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study. 6. severe psychiatric disease 7. unwillingness or inability to use pca-device 8. inability to use vas scale

Keywords: postoperative analgesia ketamine total thyroidectomy
prevalence of rheumatic heart disease according to revised jones criteria (2015) in assiut governate

Conditions: Rheumatic Fever

Summary: prevalence of rheumatic heart disease according to revised jones criteria (2015) in assiut governate

although acute rheumatic fever (arf) has declined in europe and north america in incidence over the past 4 to 6 decades, the disease remains one of the most important causes of cardiovascular morbidity and mortality especially in the developing countries that are home to the majority of the world's population(1), incidence rates in these countries still reach epidemic levels(2). in general, most patients with rhd do not have documented histories of arf, and they present with late complications, such as heart failure, arrhythmia, stroke, endocarditis, or pregnancy-related complications(3). echocardiographic screening according to revised jones criteria (2015) (1) is the most reliable way of detecting rhd in asymptomatic people, and it can identify large numbers of previously undetected cases(4-6). people with rhd detected by screening can receive appropriate cardiac care, including guideline-recommended secondary prophylaxis(7). this may be a cost-effective approach to managing rhd in groups at high risk in assiut governate(8). nevertheless, large scale screening has not been undertaken, and studies are underway to determine the best models for sustainable targeted screening and to evaluate the impact of screening and treatment on clinical outcomes(9). in this study, we aimed to determine the role of echocardiographic screening for detecting undiagnosed rhd, and to estimate the prevalence of rhd in assiut governate.

Eligibility criteria:
inclusion criteria: - children and young adults aged 5-18 years living in assiut governate ,who are attending general clinics of assiut university children hospital, were invited to participate in echocardiographic screening for rhd in february and october 2021. informed consent will be obtained in writing from participants or their parents after providing explanations of the study in local languages.
efficacy and safety of ypeginterferon alfa-2b in chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study is a multi-center, randomized, open-label and positive controlled phase ii clinical trial to assess the efficacy and safety of ypeginterferon alfa-2b (with ribavirin), once a week, in 3 dose-groups respectively, for treatment of chronic hepatitis c patients, with pegasys 180mcg/week \& ribavirin as positive control. it is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of phase iii trials, and generate the pk data in hepatitis c patients to satisfy regulatory requirements.


Eligibility criteria:
inclusion criteria: * age: 18\~65 years. * pregnancy tests of female patients must be negative. all patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. * chronic hcv infection evidence: hcv rna or anti-hcv positive \>6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis c. * hcv rna≥2000iu/ml. exclusion criteria: * pregnant or lactating women. * mental disorder or physical disability. * wbc\<3000/mm3, or anc \<1500/mm3, or plt \<90,000/mm3. * received interferon treatment within the previous 6 months or shew no response to interferon. * co-infection with hiv, hav, hbv, hev. * evidence of hepatic decompensation. * chest x-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. * history of hypothyroidism or current treatment for thyroid disease. * diabetes mellitus. * uncontrolled significant chronic medical conditions other than chronic hepatitis c or other conditions which in the opinion of the investigator preclude enrollment into the study.

Keywords: hcv chc hepatitis c, chronic liver diseases hepatitis, chronic hepatitis, viral, human hepadnaviridae infections antiviral agents virus diseases peginterferon alfa