Kornimate/medical-research-clean huggingface dataset:
a single dose, 2-period, 2-treatment, 2-way crossover bioequivalency study of balsalazide disodium 750 mg capsules under fasting conditions

Conditions: Ulcerative Colitis

Summary: the objective of this study was to assess the bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with salix pharmaceutical's 750 mg balsalazide disodium capsule, colazal, following a single 750 mg dose, administered under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.
study of rivaroxaban use and potential adverse outcomes in routine clinical practice (sweden)

Conditions: Acute Coronary Syndrome; Venous Thrombosis; Pulmonary Embolism; Atrial Fibrillation

Summary: this prospective cohort study will provide information about: characteristics of rivaroxaban use in patients who are prescribed rivaroxaban for the first time compared to patients who are prescribed standard of care for the first time. the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.


Eligibility criteria:
inclusion criteria: * all male and female patients who have filled a prescription for rivaroxaban, warfarin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor in any pharmacy in sweden, between december 9, 2011 and december 31, 2018 exclusion criteria: - for the af and dvt/pe treatment indications, patients who have filled a prescription for warfarin or another oral anticoagulant at any time between july 1, 2005 and december 9, 2011 will be excluded

Keywords: rivaroxaban venous thrombosis/pulmonary embolism stroke prevention in atrial fibrillation anticoagulants hematologic agents therapeutic uses observational pulmonary embolism venous thrombosis venous thromboembolism intracranial hemorrhages gastrointestinal hemorrhage
the efficacy of different hormone doses in 2019-ncov severe pneumonia

Conditions: 2019-nCoV Severe Pneumonia

Summary: at present, there is no specific and effective antiviral therapy.in this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-ncov severe pneumonia.this study explores effective treatment programs for 2019-ncov severe pneumonia and provides a reliable evidence-based basis for the treatment.


Eligibility criteria:
inclusion criteria: 1.meet the definition of severe pneumonia(comply with any of the followings): 1. shortness of breath,rr≥30 bpm; 2. in a resting state:spo2≤93%; 3. pao2/fio2≤300mmhg. 2.2019-ncov nucleic acid test was positive. 3.ct of the lung conformed to the manifestation of viral pneumonia. exclusion criteria: 1. dying state (i.e. survival time is less than 24 hours); 2. progressive malignant tumor with life expectancy less than 6 months; 3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs) 4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks; 5. pregnancy 6. patients with glucocorticoid taboos
special drug use investigation of glucobay od

Conditions: Diabetes Mellitus

Summary: the objective of this study is to assess the efficacy and safety under practical use of glucobay od. a total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.


Eligibility criteria:
inclusion criteria: * glucobay od naive diabetics. patients with at least one of the following conditions: uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy. exclusion criteria: * patients who are contraindicated based on the product label

Keywords: glucobay od diabetes mellitus
the automated calculation of af cycle length and complexity using a novel ep recording system

Conditions: Atrial Fibrillation

Summary: collect electrophysiological data during atrial fibrillation (af) ablation procedures to assess the performance of a signal complexity visualization algorithm designed to be integrated into the cathvision ecgenius® system.

a prospective, single-center, feasibility study using the cathvision ecgenius® system and a signal complexity visualization algorithm during radiofrequency (rf) ablation procedures to treat persistent af. subjects with persistent af who are indicated to undergo a routine-practice rf ablation may be enrolled in the study. intracardiac signals will be passively recorded using the investigational cathvision ecgenius® system in parallel with a commercial (ce approved) ep recording system. the investigational device will not be used for direct clinical care decisions or therapy. the validation of the signal complexity visualization algorithm will be performed offline and retrospectively.

Eligibility criteria:
inclusion criteria: * subjects undergoing rf ablation indicated by the investigator for the treatment of persistent atrial fibrillation. * male or non-pregnant female aged ≥ 21 years. * able and willing to provide written informed consent prior to any clinical investigation related procedure. exclusion criteria: * current participation in another investigational drug or device study that interferes with this study. * presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. * life expectancy less than 12 month, in the opinion of the investigator. * subjects who, in the opinion of the investigator, are not candidates for this study. * subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Keywords: electrophysiology cardiac ablation persistent atrial fibrillation cycle length
chronic kidney disease in teenagers with congenital cardiac disease

Conditions: Chronic Kidney Failure; Congenital Heart Defects

Summary: the prevalence of chronic kidney injury (ckd) following cardiac surgery during childhood is not known, but there is evidence of ckd in young adults. in the present study assumption is made that ckd can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the kdigo criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. the second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

background. acute kidney injury is a common complication of cardiac surgery in children. the prevalence of chronic kidney injury (ckd) following cardiac surgery during childhood is not known. the only study published to date is that of dimopoulos et al., who has estimated the prevalence of ckd in young adults with congenital cardiac diseases at 40% and the prevalence of stage 2 ckd at 6% (dimopoulos, circulation 2008). the study by dimopoulos et al. also showed that ckd was a risk factor of death in this population. objectives. in the present study assumption is made that ckd can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence. the second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could be predictive of ckd. methodology. the study has been approved by the ethical committee of our institution, and is founded by the departement de la recherche clinique et du developpement, ap-hp, paris this is a prospective observational cross-sectional study which will enroll patients 10 to 15 years with congenital cardiac diseases, who have undergone surgical repair during childhood. only patients who have undergone surgery and follow-up at our institution will be enrolled, to insure complete data. the patients will receive complete information about the study by mail that will be send home prior to the appointment for the cardiologic follow-up. after parental and patient consent, a sample of blood and urine will be collected for purpose of the study. ckd will be diagnosed according to the kdigo criteria in children (hogg, pediatrics 2003). in case of ckd, patients will be informed and given an appointment for nephrological support and follow-up at our institution. the prevalence and stage of ckd will be calculated after completion of inclusions. the risk factors of ckd will be identified retrospectively by chart review and regression analysis.

Eligibility criteria:
inclusion criteria: * patient aged 10 to15 years, having undergone surgery for congenital heart disease during childhood, and cardiologic follow-up at necker-enfants malades hospital * written informed consent by one parent * health insurance exclusion criteria: * documented chronic kidney disease of non cardiac origin * documented kidney or urinary malformation * failure to puncture a peripheral vein

Keywords: kidney failure, chronic adolescent heart defects, congenital
lorcaserin for weight loss management in patients on antipsychotics: a pilot study

Conditions: Weight Gain

Summary: the purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.


Eligibility criteria:
inclusion criteria: * patients currently on atypical antipsychotics * the patient's bmi is greater than or equal to 30 kg/m2 or the patient's bmi is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis. * patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication. exclusion criteria: * pregnancy in women or breastfeeding * the patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation * known hypersensitivity to lorcaserin * the patient is taking another weight loss medication concurrently * dementia * age less than 18 or greater than 65 * no recent substance abuse within 3 months * no suicidal ideation within 3 months * unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent
safety and causal prophylactic efficacy of kaf156 in a controlled human malaria challenge model

Conditions: Malaria

Summary: this study is designed to investigate the safety and causal prophylactic efficacy of kaf156 in healthy subjects using a controlled human malaria infection model.


Eligibility criteria:
inclusion criteria: - healthy male subjects,aged 18 to 40 years of age included and in good health as determined by past medical history, physical examination, vital signs, ecg, and laboratory tests exclusion criteria: * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. * known history or current clinically significant ecg abnormalities or arrhythmias. * symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, or other conditions which could interfere with the interpretation of the study results or compromise the health of the subjects. * sexually active males must use a condom during intercourse while taking drug and for al least 4 weeks after stopping study medication and should not father a child during this period. * history of malaria or residence in a malaria-endemic area over a period of 6 months before study entry. - any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk or render the subject unable to meet requirements of the protocol. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: malaria kaf156 p. falciparum
neurohormonal parameters in hypertrophic cardiomyopathies

Conditions: 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy; 2- Obstructive Hypertrophic Cardiomyopathy; 3- Non Obstructive Hypertrophic Cardiomyopathy

Summary: the primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly bnp and nt-probnp), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak vo2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)

the secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of mri myocardial fibrosis with the degree of exercise functional limitation.

Eligibility criteria:
inclusion criteria: * - age 18 to 75 years * primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac mri with gadolinium late-enhancement * informed consent * patient with a social insurance patient at rest * - age 18 to 75 years * primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive * informed consent * patient with a social insurance exclusion criteria: * - insufficient echogenicity * permanent atrial fibrillation * complete bbb on the ecg * lvef \< 35 % * previous septal ablation (surgical or percutaneous) * simultaneous participation to another biomedical research if exercise needed: * contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (\>220/120 mmhg), severe aortic stenosis * inability to exercise (muscular, pulmonary, elderly patient)

Keywords: 1- hypertrophic cardiomyopathy 2- bnp 3- nt-probnp 4- neurohormons
short non-coding rna biomarkers of predisposition to ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to create new tests to identify biomarkers for ovarian cancer so that a screening test can be developed. for patients who have a diagnosis of ovarian cancer, researchers will use blood samples before and after treatment to see if disease status can be determined by measuring the amount of biomarker.

epithelial ovarian cancer is the most lethal female reproductive malignancy, mainly because 80% of tumors have metastasized beyond the ovary at the time of diagnosis. screening efforts aimed at improved identification of early stage disease have been largely unsuccessful, because of ovarian cancer's propensity for early spread. our hypothesis is that this obstacle can be circumvented by identifying biomarkers for the precancerous stage of this disease. since this pre-cancerous stage is currently undetectable, we instead propose to look for biomarkers in women at very high risk for developing ovarian cancer due to genetic mutations. we hypothesize that identification of markers for genetic predisposition to ovarian cancer will also be informative for detection of biological changes that over time lead to sporadic cancers. given their increasingly recognized role in states of normal and abnormal growth and differentiation, we hypothesize that short non-coding rnas (sncrnas) hold significant promise as biomarkers of ovarian cancer predisposition. we will test these hypotheses in two aims. first, we will identify biomarkers for hereditary ovarian cancer risk by comparing serum-derived sncrnas in women with and without hereditary risk for ovarian cancer. in the second aim we will define serum-derived sncrnas correlates of ovarian cancer disease status. we will compare sera from ovarian cancer patients at times of highest and lowest disease burden to those of control, cancer-free subjects. each aim will provide independent, novel, and important information for future investigations. the sncrnas found to be differentially expressed in both aims will be prioritized for future validation in women under clinical surveillance for hereditary risk of ovarian cancer.

Eligibility criteria:
inclusion criteria: * undergoing medical care at uva * up to date breast cancer screening * subjects must fall into one of the following groups: * women at increased risk of ovarian cancer based on family history, personal history, or genetic factors defined as either brca1 or brca2 mutations who still retain both fallopian tubes and both ovaries. * women at average risk for ovarian cancer * women with known/suspected or recurrent ovarian cancer who are undergoing evaluation and/or treatment at uva cancer center exclusion criteria: * subjects with increased risk for ovarian cancer may not have a history of prior malignancy within the last 10 years excluding cervical carcinoma in situ or basal cell carcinoma * pregnancy (self reported)
effects of mechanical insufflation-exsufflation in preventing respiratory failure after extubation

Conditions: Post-extubation Failure; Persistent Weaning Failure; Secretion Encumbrance; Weak Cough; Ventilatory Failure

Summary: weaning protocols that include the use of noninvasive ventilation (niv), decreases the incidence of re-intubation and icu length of stay. however, the role of niv in post-extubation failure is still not clear. impaired airway clearance is associated with niv failure. mechanical insufflation-exsufflation (mi-e) is an assisted coughing technique that has been proven to be very effective in patients under niv. in this study the investigators assess the efficacy of mi-e as part of a protocol for patients that develop respiratory failure after extubation.

patients under mechanical ventilation (mv) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (sbt) were randomly allocated before extubation, either for (a) conventional extubation protocol (control group) or (b) mi-e extubation protocol (study group). re-intubation rates, icu length of stay and niv failure rates were analyzed. inclusion of mi-e in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation icu length of stay. this technique seems to be efficient in improving the efficacy of niv in this patient population.

Eligibility criteria:
inclusion criteria: * patients older than 18 years and under mechanical ventilation, for more than 48 hours, for acute hypoxemic and/or hypercapnic respiratory failure from a specific etiology exclusion criteria: * facial or cranial trauma, tracheostomy, active upper gastrointestinal bleeding, neurologic instability (inability to respond to direct simple orders), hemodynamic instability, lack of cooperation and confirmed diagnosis of neuromuscular disease.

Keywords: post extubation failure mechanical insufflation-exsufflation noninvasive ventilation weaning
characterization of beta cell failure

Conditions: Diabetes; Metabolic Syndrome

Summary: the purpose of this study is to characterise beta cell function in subjects who despite taking part in a diabetes prevention program (life style intervention with diet and exercise) exhibit impaired glucose tolerance and beta cell dysfunction.

we have identified a subgroup of individuals with a good compliance to lifestyle intervention to prevent diabetes who lose body weight and increase insulin sensitivity, however they remain impaired glucose tolerant. these individuals show a deterioration in insulin secretory function. we will identify a highly selected group of subjects with prediabetes that displays a large defect in insulin secretory function.we will study 50 individuals who display these characteristics and 50 subjects who do not display these characteristics. their insulin secretion capacity in response to different secretagogues (glucose, glp-1, arginine) will be studied. we expect to detect new pathophysiologic aspects that lead to beta cell failure particularly in this group.

Eligibility criteria:
inclusion criteria: * impaired glucose tolerance * bmi 16-40 kg/m² exclusion criteria: * chronic disease * anemia * therapy with insulin or cortisone

Keywords: igt ifg
effect of remote cognitive intervention in patients with parkinson's disease during the covid-19 pandemic

Conditions: Parkinson Disease; COVID-19; Mild Cognitive Impairment

Summary: retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the covid outbreak in subjects with parkinson's disease.

mild cognitive impairment is frequent among people with parkinson's disease. cognitive training seems effective on cognitive status and for mitigating anxiety and depression. with covid-19 outbreak, such therapeutic interventions were delivered online. this retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in covid times and based on the parkinson's-adapted cognitive stimulation therapy, on cognitive domains and mood in 18 older people with parkinson's disease.

Eligibility criteria:
inclusion criteria: * parkinson disease: hoehn \& yahr's scale: 1-3 based on the uk pd society brain bank * mild cognitive impairment * no cognitive training between march and october 2020 * presence of a family caregiver to access and use the online platform exclusion criteria: * other neurological diseases * deep brain stimulation * schizophrenia * depression * sensory deprivations that could interfere with the treatment

Keywords: covid-19 cognitive telerehabilitation parkinson's disease cognition
comparison of refined and crude indigo naturalis ointment in treating psoriasis

Conditions: Psoriasis Vulgaris

Summary: to compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.

our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. however, patient compliance is hindered because the preparation is unsightly and stains clothing. to improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. in this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.

Eligibility criteria:
inclusion criteria: * patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study; * patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years; * patients were in good general health. * female patients of childbearing age agreed to continue using birth control measures for the duration of the study. exclusion criteria: * patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%; * patients had a history of allergy to indigo naturalis. * patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment. * patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.

Keywords: psoriasis, indigo naturalis