Kornimate/medical-research-clean huggingface dataset:
single ascending dose study of safety and tolerability of sph3127 tablet in chinese healthy volunteers

Conditions: Hypertension

Summary: 1. to evaluate safety, tolerability and pharmacokinetics (pk) and pharmacodynamics (pd) characteristics of sph3127 dose escalation, a single oral dose in chines healthy volunteers. 2. to explore the appropriate dose and provide the basis for the subsequent clinical trials.

48 healthy volunteers will participate in this trial. participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. in each group, 6 participants will take sph3127 tablet, while 2 participants will take placebo randomly. safety data and pk/pd data will be collected as protocol described.

Eligibility criteria:
inclusion criteria: * healthy adults,age \>=18 years.single gender should no less than a third of total subjects in each group. * bmi should be18 to 24 kg/m2 (including threshold), allowing the lowest weight 50 kg (including threshold) for the male and 45 kg (including threshold) for the female. * understand details of significance, benefit, inconvenience and potential danger of the research program, voluntarily signed informed consent. exclusion criteria: * during pregnancy, nursing mothers, and plans to test in the first 6 months (grant) pregnant; * abnormal results in physical examination, laboratory examination and have clinical significance (such as: liver function examination - aspartate aminotransferase (ast)/alanine aminotransferase (alt) is more than 1.5 times of the upper limit of normal). * with cardiovascular, liver, kidney, gastrointestinal, nervous system, blood system and familial blood disease, thyroid dysfunction or abnormal mental illness; * has a history of drug allergy and allergic constitution; * took birth control pills within 6 weeks; * used any drugs (including chinese herbal medicine) within 1 week; * participated in blood donation within 2 months ; * participated in any drug clinical trials (as subjects) within three months; * any positive result in virus serology check: human immunodeficiency virus antigen antibody (hiv ag/ab) 、hepatitis c virus (hcv) - igg antibody to igg, hepatitis b surface antigen (hbsag) and treponema pallidum antibody (tp); * addicted to cigarettes, alcohol, drink coffee, strong tea and drug abuse; * researchers think that exists any unfavorable factors to participate in the test.
efficacy of acupuncture and moxibustion treatment in patients with quiescent crohn's disease:evaluation with fmri

Conditions: Crohn's Disease; CAM

Summary: the purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of crohn's disease. meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.

the purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of crohn's disease. meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging. through treating quiescent crohn's disease by electroacupuncture or moxibustion therapies for 12 weeks, compare the different brain activation by the different therapies and observe the correlation between brain activation and efficacy.

Eligibility criteria:
inclusion criteria: * age 18-50 years; * right-handed; * clinical remission (crohn's disease activity index \[cdai\]≤150) for at least 6 months prior to the study; * c-reactive protein(crp)\<10 mg/l; * erythrocyte sedimentation rate (esr) \<20 mm/h * signing awritten informed consent form. exclusion criteria: * use of corticosteroids and psychotropic medications in the previous 30 days; * current or prior history of neurological or psychiatric disease based * on physicians' examination and questionnaires; * current or prior history of neurosurgery, head injury, cerebrovascular * insult, or brain trauma involving loss of consciousness; * learning disability; * claustrophobia; * presence of metallic implants in the body; * being pregnant or during lactation.

Keywords: crohn's disease acupuncture moxibustion fmri gut
a comparison between bms-690514 and erlotinib in patients who were previously treated for nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using bms-690514 over erlotinib


Eligibility criteria:
inclusion criteria: * ecog ps of 0 or 1 * histologically confirmed nsclc * adequate amount of tumor (archived or fresh) for biomarker evaluation * received one to two regimens of chemotherapy (with at least one platinum-containing) * serum creatinine of less than 1.0 mg/dl or a 24 hour creatinine clearance of greater than 60 ml/min * stable control of blood pressure on agents other than calcium channel blockers * women of child-bearing potential must avoid pregnancy or maintain adequate contraception * must be able to swallow pills and take the medications at the same time every day on an empty stomach exclusion criteria: * ecog ps 2 or greater * women unwilling to avoid pregnancy or use adequate contraception * symptomatic brain metastases * recent history of tia, cva, or thrombotic/thromboembolic event (within 6 months) * history of hemoptysis greater than 10 ml/day * significant cardiovascular disease * uncontrolled diarrhea, crohn's disease, ulcerative colitis, or any malabsorptive disease * history of use of other tkis * uncontrolled hypertension * hiv+
acute airway vascular smooth muscle effects of inhaled budesonide

Conditions: Asthma

Summary: glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. one of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).

inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. this practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. however, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. the purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. as a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.

Eligibility criteria:
inclusion criteria: twenty lifetime nonsmokers moderate or severe asthmatics; fev1≥50 of predicted on the screening day exclusion criteria: women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women; cardiovascular disease and/or use of cardiovascular medication; subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; use of systemic glucocorticosteroids within 4 weeks prior to the study; daily ics dose (fluticasone or budesonide) \> 500ug; diabetes mellitus

Keywords: asthma, airway blood flow, budesonide, glucocorticosteroid.
unmodulated 5 kilohertz currents versus tens: effect on pain thresholds, tactile threshold, and nerve conduction

Conditions: Pain

Summary: the purpose of this study is to determine whether the transcutaneous application of unmodulated 5 kilohertz (khz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in peripheral nerve conduction. moreover evidence whether the effect and comfort of this current is greater than conventional tens (transcutaneous electrical nerve stimulation) commonly used for the treatment of clinical pain.

in the last years several animal experimental studies have evidenced that high frequency unmodulated currents about 5 khz can cause a peripheral nerve block. however electric currents with these high frequencies that are usually used for the treatment of pain in humans are interrupted or modulated (i.e. interferential currents) this evidences in animals could have application in pain treatment, characterized by overactive nervous system. for this reason it was decided to compare the effects on experimental pain and peripheral nerve conduction of this new electric current versus sham stimulation and tens (transcutaneous electrical nerve stimulation). the scientific literature on transcutaneous electrical stimulation in humans and changes in nerve conduction and / or somatosensory thresholds focuses mainly on tens (transcutaneous electrical nerve stimulation). therefore tens is a good reference standard to compare the effect of this new currents.

Eligibility criteria:
inclusion criteria: * participants will be volunteer healthy students of physiotherapy, university of castilla - la mancha, older than 18 years. exclusion criteria: * neuromuscular disease. * epilepsy. * trauma, surgery or pain affecting the upper limb, shoulder girdle or cervical area. * osteosynthesis material in the upper limb. * diabetes. * cancer. * cardiovascular disease. * pacemaker or other implanted electrical device. * take any drug (nsaids, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days. * presence of tattoos or other external agent introduced into the treatment or assessment area. * pregnancy. * sensitivity disturbance in upper limb.

Keywords: transcutaneous electric nerve stimulation electric stimulation therapy unmodulated alternating currents neural conduction pain threshold
does preoperative administration of oral doxycycline decrease the colonization rate of propionibacterium acnes in the dermis of the shoulder?

Conditions: Propionibacterium

Summary: the purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of propionibacterium acnes in the dermis of the shoulder.


Eligibility criteria:
inclusion criteria: -all male patients (\>18 years of age) undergoing shoulder arthroscopy exclusion criteria: * female patients * patients with active acne * patients who have taken antibiotics in the past month * doxycycline allergy * benzoyl peroxide allergy * clindamycin allergy * patients with psoriatic/eczematous or other lesions on the shoulder girdle.
effects of lactobacillus pentosus kca1 on the gut and vaginal microbiome of women with bacterial vaginosis

Conditions: Bacterial Vaginoses

Summary: bacterial vaginosis (bv) is under-reported, misdiagnosed and inappropriately treated in nigeria. treatment option rely on antibiotics that eliminates both good and pathogenic bacteria, with gross impact on the gut and vaginal microbiome. our primary objective in this study is to determine the effects of lactobacillus on the gut and vagina when taken orally.

antibiotics reduces in considerable proportion both the healthy bacteria especially lactobacilli and those associated with bv, thus the vaginal microecology and gut is adversely affected. it is widely acknowledged that lactobacilli and other genera that produces some metabolites such as lactic acid, contributes to vaginal health by maintaining the low ph of the vagina. the objectives of this study are three folds, first to determine the effects before and after 14 days oral feeding of lactobacillus pentosus kca1 on the vaginal and gut microbiota compositions of women diagnosed with bv. second to measure the level of two proinflammatory cytokines il-1 beta and il-6 before and after kca1 consumption and third to determine in silico, the relative abundance of microbial genes involved in metabolic functions using the 16s rrna datasets.

Eligibility criteria:
inclusion criteria: * not on antibiotic therapy within the last one month * not menstruating at the time of inclusion. exclusion criteria: pregnant, use of antibiotic medication, declined informed consent, menstruating and those that used douches, sprays, spermicides in the last 48 hours -

Keywords: lactobacillus microbiota nigerian women gut vagina 16s rrna sequencing metagenomics
dietary intake and eating behaviors in adolescents who undergo bariatric surgery

Conditions: Adolescent Obesity; Eating Behavior; Dietary Intake

Summary: to study the dietary intake and eating behaviors of adolescents who undergo bariatric surgery

the dietary and eating behavior outcomes for adolescents who undergo bariatric surgery are virtually unknown. the main trial of the teen-labs consortium is not studying dietary intake and eating behavior before and after bariatric surgery. the consortium, however, provides a unique opportunity to investigate these issues in a large and diverse sample through the context of the proposed ancillary study.

Eligibility criteria:
inclusion criteria: * 19 years old or younger * have a bmi \> 30 kg/m2 * have attained or nearly attained physical maturity and have a history of unsuccessful, organized attempts at weight management. * must demonstrate reasonable decision making abilities * must also fit the following criteria: (1) no prior bariatric surgical procedure, (2) no physical illness not due to obesity, and (3) no full-time special education (due to the high reading demand of study participation). * participants will be from all racial and ethnic groups and be both male and female. exclusion criteria: * we will not exclude participants from this trial based on health status or medication usage. instead, we will track medical conditions and medication usage at every assessment point throughout the investigation to assess the possible influence of these variables on changes in weight, dietary intake, and eating behavior.

Keywords: adolescent obesity eating behavior dietary intake
vitamin d status and bone metabolism status in children with congenital epidermolysis bullosa

Conditions: Bullosa Epidermolysis; Vitamin D Deficiency; Osteoporosis; Osteopenia; Phosphorus and Calcium Disorders

Summary: this retrospective prospective study is aimed at studying the level of vitamin d supply and identifying markers of bone tissue remodeling in order to develop approaches to the prevention of osteopenia and osteoporosis in children with congenital epidermolysis bullosa.

this retrospective prospective interventional study will examine vitamin d availability and its relationship with clinical disease, patient gender and age, and season. the mechanisms of impairment of phosphorus-calcium metabolism and bone tissue metabolism will be analyzed on the basis of biochemical parameters and instrumental research methods in children with dystrophic epidermolysis bullosa in order to develop personalized approaches for correcting vitamin d status and bone metabolism disorders in children with epidermolysis bullosa, followed by an assessment of their clinical efficacy.

Eligibility criteria:
inclusion criteria: * verified diagnosis of epidermolysis bullosa; * signing by parents (legal representatives) of informed consent to participate in the study and fulfill the requirements of the study exclusion criteria: * not planned

Keywords: children, only
acute effect of salbutamol on heart rate and blood pressure during exercise in patients with moderate or severe asthma and healthy subjects

Conditions: Asthma; Heart Rate Fast

Summary: contextualization: exercise is a common triggers of bronchospasm in patients with asthma and healthy subjects. to prevent these symptoms frequently they have to use short-acting beta2-agonists. however, the cardiovascular effects of salbutamol during and after exercise remain poorly known. objective: to evaluate the effect of salbutamol on heart rate and blood pressure during exercise in patients with moderate or severe asthma and healthy individuals. methods: a randomized, double-blind, crossover study will be conducted which 13 individuals with moderate or severe persistent asthma and 13 healthy individuals aged between 20 to 59 years. patients will perform a maximal effort test on 2 nonconsecutive days, with either 400mcg salbutamol or 4 placebo puffs. the order of use of placebo or salbutamol will be drawn. during the protocol, heart rate, blood pressure, perception of exertion and peak expiratory flow will be monitored.


Eligibility criteria:
inclusion criteria for asthmatics: * have the diagnosis of moderate or severe asthma according to the clinical criteria described in the literature * be between 20 and 59 years of age * being from the asthma assistance and research center (napa) of university of são paulo faculty of medicine clinics hospital * have treatment at the outpatient clinic for at least 3 months, * have a stable clinical condition for at least 30 days * make use of the optimized medicine daily * read and signed the tcle approved by the ethics and research committee of the ibirapuera university (unib) under opinion nº 1,574,833 exclusion criteria for asthmatics: * individuals diagnosed with another lung disease, * have psychiatric, musculoskeletal or cardiovascular diseases, * being smokers * being pregnant * practice regular physical activity. criterion for inclusion of healthy individuals * be between 20 and 59 years of age * healthy individuals * both genders * age between 20 and 59 years * read and signed the tcle approved by the ethics and research committee of the ibirapuera university (unib) under opinion nº 1,574,833 criteria for the exclusion of healthy individuals * pregnant women * smokers * psychic diseases * osteomuscular diseases * practitioners of regular exercise * physical activity readiness questionnaire (par-q)

Keywords: asthma salbutamol exercise heart rate blood pressure
serious games for parkinson's disease

Conditions: Parkinson Disease; Parkinson

Summary: importance: rehabilitation games have been shown to improve cognitive function among people with various disorders but they have not been explored in home settings for patients with parkinson's disease. objective: to collect pilot data regarding the therapeutic benefits of self-administered rehabilitation games among patients with parkinson's disease. methods: the investigators will recruit 20 patients with parkinson's disease into a pilot randomized controlled trial. patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in addition to conventional care or undergo only usual care. patients will be evaluated at baseline, after 12 weeks of treatment, and at 24 weeks. improvements in cognitive function, depression, quality of life, and mobility will be assessed. relevance: identifying whether self-administered rehabilitation games can lead to clinical improvements could have significant implications for the management of the disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis of mild to moderate pd (hoehn \& yahr 1-3) 2. baseline moca score \<26 3. ≥ 18 years-old 4. ability to communicate and read in english 5. have self-reported technological literacy (ie answer yes to the question asking if they are comfortable using technological devices) exclusion criteria: 1. comorbid conditions that could affect the performance of the tasks (e.g. severe uncorrected vision impairment) 2. severe cognitive impairment that would prevent the patient from understanding the tasks (moca\<16) 3. if the subject does not want to be video recorded during the assessments or interview sessions 4. if the subject does not have access to wifi
low vision occupational therapy in parkinson's disease

Conditions: Parkinson Disease

Summary: the primary aim of this study is to determine whether low-vision occupational therapy improves quality of life in parkinson's disease (pd) patients. low-vision occupational therapy has not been previously studied in pd patients, and we suspect that this is a beneficial treatment option for pd patients as vision impairment is common in the pd patient population. our primary objective will assess whether quality of life was improved following a low-vision occupational therapy session.

this project will be an exploratory study that will evaluate the benefits of low vision occupational therapy in the treatment of pd using the revised self-report assessment of functional visual performance (r-srafvp) as the primary outcome measure. this tool assesses 33 vision-dependent adls ranging from personal care, leisurely activities, clothing management, meal preparation, etc. patients are able to rank their ability to complete these tasks as independent, minimally difficult, moderately difficult, greatly difficult, unable, or not applicable. this will allow us to capture potential changes in the patient's ability to complete vision-specific adls following low vision occupational therapy. in addition, we will also evaluate quality of life using the parkinson's disease questionnaire (pdq-39), to compare this broad outcome measure with the r-srafvp.

Eligibility criteria:
inclusion criteria: * 18 and older * seen at uab movement disorders clinic * diagnosis of idiopathic parkinson's disease * able to read, speak, and understand spoken english. exclusion criteria: * minors * cognitively impaired
effects of hydrogen gas inhalation on adults of various ages

Conditions: Alzheimer Disease

Summary: herein, investigated the effects of 4 weeks of h2 gas inhalation on community-dwelling adults of various ages.

molecular hydrogen (h2) is a versatile therapeutic agent. h2 gas inhalation is reportedly safe and has a positive impact on a range of illnesses, including alzheimer's disease (ad). herein, investigated the effects of 4 weeks of h2 gas inhalation on community-dwelling adults of various ages. fifty-four participants including those dropped out (5%) were screened and enrolled. the selected participants were treated as a single group without randomization. evaluated the association between total and differential white blood cell (wbc) counts and ad risk at individual levels after 4 weeks of h2 gas inhalation treatment. furthermore, evaluation of dementia-related biomarkers such as beta-site app cleaving enzyme 1 (bace-1), amyloid beta (aβ), brain-derived neurotrophic factor (bdnf), vascular endothelial growth factor a (vegf-a), t-tau, monocyte chemotactic protein-1 (mcp-1), and inflammatory cytokines (interleukin-6).

Eligibility criteria:
inclusion * age ranges 40-70 years * healthy participants * patients who are willing or able to follow the doctor's instructions * fully understand the purpose and procedure of this clinical trial exclusion criteria * participants excluded those who have any disease * pregnant and lactating women