Kornimate/medical-research-clean huggingface dataset:
relationship between treatment with bach´s flower remedy and spiritual well-being of people with common mental disorder

Conditions: Mental Disorders; Personal Well Being

Summary: the common mental disorders (cmd) refer to health states involving non-psychotic psychiatric symptoms. part of this broad diagnostic category, symptoms such as difficulty concentrating, forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic complaints, etc. the cmd has a big social impact, and its prevalence in the general population is 25% and graduate students in health care reaches 40%. the bach´s flower remedies are considered a complementary therapy approved and recommended by world health organization and by the brazilian ministry of health and in his theory it has great spiritual nature. in addition, international scientific research have suggested that the strengthening of spiritual well-being can help significantly and positively promoting mental health. this project aims to assess the relationship between treatment with bach´s flower remedies and spiritual well-being of people with common mental disorders in undergraduate health students of a university located in são josé dos campos, state of são paulo, brazil. this research presents a quantitative and qualitative methodology, experimental clinical trial, triple blind. the treatment will take place with two groups of forty people, the group of treatment and the placebo´s. the trial will happen in six sessions at intervals of 30 days, totaling eight months of treatment. statistical analysis will be used chi-square or fisher exact test to study the association between the scale of spiritual well-being and the use of bach flowers for each time point (3 times). to compare the evolution of the results (scales) during the study will set a model for ordinal data with repeated measurements over time. for these statistical tests is assumed a significance level of 5% (p \< 0.005).


Eligibility criteria:
inclusion criteria: * people over 18 years old * people who have read and agreed to participate by signing an informed consent * people who obtain scores equal to or above 8 for women and equal to or above 6 for men in srq - 20 * people who does not ingest medication * people who does not use any type of complementary therapy and integrative such as herbal medicine, aromatherapy, homeopathy, flower essences, reiki, acupuncture, etc. exclusion criteria: * not meet the assumptions of the inclusion criteria

Keywords: common mental disorder efficacy of bach´s flower remedy spiritual well-being
determining patterns in trial experiences of diabetic neuropathy patients

Conditions: Diabetic Neuropathies; Diabetic Neuropathy Peripheral

Summary: historically, participation in clinical studies is highly skewed towards particular demographic groups of people. this study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. the aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy. the data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patient plans to participate in an interventional clinical trial for the condition of diabetic neuropathy * patient has been diagnosed with a type of diabetic neuropathy * patient is a minimum of 18 years of age * patient has access to a home internet connection in order to provide regular updates through the course of the study exclusion criteria: * patient is not able to provide consistent digital updates as per study requirements * patient does not complete or agree to terms outlined in the informed consent form * patient has an ecog score of 4 or higher

Keywords: diabetic neuropathy neuropathy
pulmonary embolism in exacerbations of chronic obstructive pulmonary disease

Conditions: Pulmonary Embolism; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine the prevalence of pulmonary embolism in our population of chronic obstructive pulmonary disease (copd) patients admitted to hospital with dyspnea. the patients will undergo investigation for pulmonary embolism, according to current guidelines.


Eligibility criteria:
inclusion criteria: * known or suspected copd * copd-exacerbation exclusion criteria: * other causes of dyspnea * unable to perform ct pulmonary angio (contrast allergy, pregnancy) * already included in the study (each patient included only once) * use of anticoagulants

Keywords: pulmonary embolism pulmonary disease, chronic obstructive
a study to evaluate imc-002 in neuromyelitis optica spectrum disorder (nmosd) patients

Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)

Summary: the purpose of this study is to evaluate the efficacy and safety of imc-002 in the treatment of nmosd.

this is a phase ib/iii study, including 2 stage, phase ib study to find the dose for phase ii study between 0.8mg/kg、1.2mg/kg dose level, phase iii study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of imc-002 in neuromyelitis optica spectrum disorder (nmosd)

Eligibility criteria:
inclusion criteria: * age 18 to 70 years, inclusive, at the time of informed consent * have a diagnosis of aqp4 antibody seropositive nmosd according to the international panel for nmo diagnosis (ipnd) criteria * confirmation of nmosd diagnosis with aqp4+ antibodies * the edss score should be ≤7.0 * have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening exclusion criteria: * have received rituximab or other anti-cd20 drugs treatment within 6 months * have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug. * females who are pregnant or lactating. * have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(hiv), hepatitis c virus (hcv), or mycobacterium tuberculosis. patients must have negative test results for hcv antibody, hiv 1 and hiv 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
comparison of gastric bypass and sleeve gastrectomy in metabolic and cardiovascular indices

Conditions: Morbid Obesity

Summary: morbidly obese patients undergoing either roux en y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. on each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. at the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.


Eligibility criteria:
inclusion criteria: * bmi \>40 kg/m2 * age between 18 and 65 years * proven failure to lose weight through non-surgical interventions exclusion criteria: * serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy) * patients' inability to adhere to postsurgical instructions * alcohol or other substance abuse * concurrent psychiatric illness

Keywords: bariatric surgery, gut peptides, weight loss, glycemia
impact of physiotherapy intervention for children with ankle sprains

Conditions: Physical Therapy

Summary: this study will investigate whether adding a physiotherapy intervention to standard emergency department care will lead to improved recovery following an ankle sprain in the pediatric and adolescent population as well as to a decrease recurrence of injuries during the year following the initial ankle sprain. children will be allocated to standard care or to the added intervention group. the study hypothesis is that recovery will be better while recurrence of injury will be less in those receiving the added physiotherapy intervention.


Eligibility criteria:
inclusion criteria: * age 7 to 18 * confirmed diagnosis of ankle sprain * ability to speak french or english exclusion criteria: * immobilization at the time of ed discharge
immunogenicity study of insulin glargine ezelin vs lantus in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus

Summary: this is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products insulin glargine (kalbe farma) and lantus (sanofi -aventis) in type 2 diabetes mellitus patients

previous study has revealed that insulin glargine (kalbe farma) has similar efficacy with lantus (sanofi-aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. therefore, the present study is aiming to compare immunogenicity of insulin glargine (kalbe farma) and lantus (sanofi-aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Eligibility criteria:
inclusion criteria: * men or women, 18 years old and above * diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (hba1c \> 7.0 %) * bmi ranged from 19 - 35 kg/m2 * consent from patients of childbearing potential to use contraception method throughout the study * signed informed consent form exclusion criteria: * history of diabetic ketoacidosis more than 2 times in the past 1 year * history of pancreatectomy * estimated glomerular filtration rate \<30 ml/min * positive znt8 antibody * treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study. * any malignant disease, including in medical history * drugs and alcohol abuse, including in medical history * hipersensitivity to insulin glargine or any excipient of the drugs from medical history * mental disorders

Keywords: insulin glargine diabetes mellitus immunogenicity
study on biomarkers of postoperative delirium in elderly cardiac surgery patients

Conditions: Delirium

Summary: to evaluate the relationship between abnormal protein or metabolite expression levels in peripheral blood and postoperative delirium in elderly patients undergoing cardiac surgery.


Eligibility criteria:
inclusion criteria: 1. patients between 55 and 80 years old, 2. american society of anesthesiologists (asa) physical status of ii-iii and new york heart association grade of ii-iii. 3. the planned cardiac surgery. 4. hospitalization duration not less than 5 days. 5. the anesthesia time will be no less than 2 hours.all patients had a normal ability to hear, read and cooperate with neuropsychological tests. exclusion criteria: 1. the pre-operative montreal cognitive assessment (moca) score was less than 25, 2. patients with dementia, history of neurological or psychiatric disease, hospital with anxiety depression scale (hads) over eight points, 3. currently use sedatives or antidepressants, patients with substance dependence on drugs or alcohol. 4. patients with liver and kidney dysfunction, patients with a history of cardiac surgery. 5. admitted to the icu for more than two days within the month preceding the current surgery, 6. unable to cooperate with researcher's investigations.
uppsala study on odontoid fracture treatment in the elderly

Conditions: Spinal Fractures

Summary: a multicenter randomized controlled trial is performed in sweden (uppsala, malmo and stockholm) comparing surgery with posterior c1-c2 fusion and conservative treatment with a rigid collar. follow up will be performed up to one year after start of treatment registering eq5d, ndi and cervical ct scans. mortality will be documented during follow-up. all direct and indirect costs of treatment will be registered and used for cost-effectiveness analysis.

50 patients, based on the following calculation of study size: the standard deviation for neck disability index, ndi, is just under 7, while "minimally clinical important difference" (mcid) is 7 points . that gives that 16 patients are needed in each group to get 80% power with a significance level of 5%. however, in the studied population the one year mortality rate is substantial, especially after a neck injury . in order to be able to draw conclusions from the study the investigators have elected to expand the study to 25 subjects in each group. follow up: 1w, 6w, 3m, 1y with ct, questionaires: ndi, eq5d. bone density measurement at injury. extension flexion x-ray after 1 year.

Eligibility criteria:
inclusion criteria: * acute displaced odontoid fracture type ii according to anderson and d'alonzo, age 75 years or older. displacement defined as 4 mm anterior translator displacement, any posterior translator displacement, or 10 degrees of angulation. exclusion criteria: * any contraindication to surgery, anesthesia class asa 4 or higher (saklad 1941), severe senile dementia (defined as being admitted to a nursing home or hospital because of the dementia), anatomical or other prerequisites that makes an operation unsuitable.
insulin and polycystic ovary syndrome

Conditions: PCOS

Summary: increased insulin levels leads to increased secretion of d-chiro inositol(dci) from the kidneys in women with pcos, but not in normal women. this leads to a reduction in circulating dci and insulin stimulated release of dci-ipg.to determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with pcos 1)decreases the renal clearance of dci and 2) increases the circulating concentration of dci.


Eligibility criteria:
inclusion criteria: * obese women with pcos and normal women aged 18-40, * pcos less than 8 periods/year, elevated total or free testosterone, normal thyroid function tests and serum prolactin, exclusion of adrenal hyperplasia * normal regular monthly periods, no clinical evidence of androgen excess, * all acceptable health on interview, medical history, physical exams and lab tests, signed, witnessed informed consent and ability to comply to study requirements exclusion criteria: * dm, clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic or malignant disease.
the role of the nasal allergen provocation test in starting and monitoring allergen immunotherapy

Conditions: Perennial Allergic Rhinitis; Seasonal Allergic Rhinitis; Local Allergic Rhinitis

Summary: this prospective multicentric academic napt study aims to compile a database of all patients who initiate immunotherapy. the napt will take place before, during and after ait to evaluate the cost and effectiveness of the treatment. the study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years. this study will be conducted in 2 hospitals: uz leuven and az st. jan brugge on the consultation ear, nose and throat diseases (ent) and the department of internal medicine / allergology


Eligibility criteria:
inclusion criteria: * age \>18 and ≤60 years * persistent or intermittent allergic rhinitis complaints, confirmed by spt and/of immunocap for the specific iges. or suspected local allergic rhinitis * patients who start with ait treatment * the patient must be motivated and willing to come to all visits * the patient must be able to understand and sign the informed consent exclusion criteria: * uncontrolled asthma * conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases) * use of β-blockers, immunosuppressants or ace inhibitors * hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in ait * anaphylaxis after allergen challenge in the past * acute rhinosinusitis in the last 12 weeks * recent surgery on the nose and/or paranasal sinuses in the last 12 weeks * pregnancy
non invasive evaluation of bronchial inflammation in infants : a study of the sputum cellularity after hypertonic saline induction

Conditions: Infantile Asthma

Summary: * background: infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. namely, the infants could be classified as transitory, peristent or late and persistent asthma. some risk factors for the persistent asthma phenotype are recognized as atopy. however all peristent asthma are not related to atopy. regarding the pathophysiology, little is known on airways inflammation in these infants, and the current data are mostly based on the bal analyses, or on biopsies. consequently, bla and biopsies should be justified by the need of an indicated fiberbronchoscopy, and therefore limited to severe infantile asthma. airway secretion could be also collected after hypertonic saline induction and chest physiotherapy. this method has been validated in the children, but has not in the younger. * aim : analyses of cell profiles regarding the severity of infantile asthma. * methods : this descriptive study compared 3 groups of infants, the first with acute exacerbation, the second with uncontrolled asthma and the third with controlled asthma. accounting 25% of failure, the number of 40 infants per groups has been calculated. the sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. cellularity and cell profiles were analysed as previously recommended. safety will be evaluated. * inclusion criteria : any infants suffering of infantile asthma (at least 3 episodes of wheezing during the 2 first years of life), aged between 6-12months.asthma control was evaluated on the last 4 weeks, allowing to classify the infants . control asthma was aimed when neither exacerbation nor persistent symptoms were observed. uncontrolled asthma was defined whether the infant presented any symptoms during the last 4 weeks. exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing. * feasibility : a preliminary study has been presented in the vienna ers congress.


Eligibility criteria:
inclusion criteria: * age between 6 and 36 mo. * ambulatory or hospitalized. * with %sao2 ³ 95% * parents information and non-opposition from the parents exclusion criteria: * any underlying chronic disease * been given oral corticosteroid during the last four weeks * known adverse events with nebulized saline solution * with cold during the 4 last weeks for the controled group. * with %sao2 \< 95%

Keywords: infantile asthma induced sputum phenotypes eosinophils neutrophils
optical sensor for photodynamic detection of oral pathology

Conditions: Mouth Diseases

Summary: overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. all different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology and biofilm. thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia. we are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. we will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. imaging modalities to be utilized include: 1. coherence and doppler tomography 2. laser speckle imaging 3. various forms of spectroscopy 4. fluorescence

purpose of the research is to identify optical predictors and biomarkers of health and disease. hypothesis: microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia. researchers of the beckman laser institute (bli) have developed many non-invasive imaging modalities for assessment of oral tissue. this protocol will allow data acquisition with these multiple modalities to allow validation of data. imaging modalities to be utilized include: 1. coherence and doppler tomography (oct) 2. laser speckle imaging (lsi) 3. photon migration spectroscopy (pms) 4. autofluorescence imaging in addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.

Eligibility criteria:
inclusion criteria: * male or female age 18 years and older * have oral lesion or not have oral lesion * have condition of dry mouth * have condition of gum disease * non-smoker exclusion criteria: * age less than 18 years old * advanced gum disease, diseases of oral tissue * untreated cavities * pregnant or breastfeeding * immune compromised individuals

Keywords: oral cancer oral mucositis periodontitis dry mouth gingivitis oral lesions dental hard tissues oral biofilm