Kornimate/medical-research-clean huggingface dataset:
characteristics of critically ill patients with severe acute respiratory syndrome coronavirus 2 infection (covid-19)

Conditions: SARS-CoV2 Infection

Summary: a multicenter observational, prospective cohort study that consisted of a large-scale data source of hospital icu admissions and patient-level clinical data in spain. the main objective is to develop a national database belonging to semicyuc (spanish society of critical care) to describe epidemiological and clinical characteristics and risk factors related to icu mortality in critically ill patients admitted to icu due to severe covid-19 in spain.

design: a multicenter observational, prospective cohort study setting: intensive care units subjects: adult critical patients admitted to icu with severe community-acquired pneumonia due to confirmed sars cov-2 infection (covid-19). data collection and validation data was obtained from a voluntary registry created by spanish society of intensive care medicine-semicyuc. all consecutive cases admitted to the icu were collected. there were no patients excluded from the analysis that was enrolled to participating icu and met criteria. data were collected using a paper crf (case report form). crf collect and record all protocol-required information, which is transcribed from patient source documents, such as hospital records and laboratory reports during the patient's participation in the study. before being sent to the national study coordinator (ar) this data was de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number. we implemented a double data entry model for potential errors in real-time. data was entered twice by two different data entry personnel based on the same set of data collected in the paper crfs. all data were reviewed, and values that appeared incongruent or out of range were manually validated by confirming the accuracy of the data with the study coordinator (ar). the database was validated and cleaned before the statistical analysis and the study database was locked to prevent any further changes, and to ensure data consistency and integrity for the statistical reporting and analysis. sample size calculation: no statistical sample size calculation was performed a priori, and sample size was equal to the number of patients admitted to the participant's icus with confirmed covid-19 during the study period.

Eligibility criteria:
inclusion criteria: 1. severe community-acquired pneumonia due sars cov-2 infection and acute respiratory failure with microbiological confirmation (rt-pcr) according international guidelines 2. age \>= 16 years without upper limit exclusion criteria: 1. age \< 16 years 2. patients with sars-cov-2 infection without acute respiratory failure

Keywords: covid-19 severe sars-cov-2 infection critically ill patients adrs viral pneumonia
pharmacogenetic testing of saliva samples from patients with five or more exposure days to rfviia analogue in the adept™2 trial

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this study is conducted globally. this study describes pharmacogenetic testing of saliva samples from patients who participated in the nn1731-3562 trial (adept™2) (nct01392547). the objective is to determine the hla (human leukocyte antigen) type and polymorphisms in the fvii gene in patients previously exposed to rfviia analogue.


Eligibility criteria:
inclusion criteria: * informed consent obtained before collection of saliva samples * previous participation in adept™2 trial with 5 or more exposure days to rfviia analogue
effect of berberine hydrochloride on blood pressure and vascular endothelial function in patients with hypertension

Conditions: Hypertension; Endothelial Dysfunction; Blood Pressure

Summary: hypertension is a progressive cardiovascular syndrome caused by multiple causes, which can lead to changes in the function and structure of the heart and blood vessels. it is the leading risk factor of cardiovascular disease. berberine (bbr) hydrochloride is an isoquinoline alkaloid (chemical formula: c20h18no4) extracted from traditional chinese herb coptis chinensis. it has been widely used to treat diarrhea and enteritis for hundreds of years in china. bbr has extremely high clinical application value. it is an over-the-counter drug with low price, good safety and few adverse reactions in china. we found that berberine (bbr) hydrochloride tablets have a hypotensive effect in clinical practice. however, there are few clinical studies on the treatment of hypertensive patients with bbr tablets. in addition, the clinical dosage of bbr tablets is not uniform, and its molecular mechanism is still unclear. in order to further evaluate the clinical efficacy of bbr in reducing blood pressure and improving vascular endothelial injury, we carried out this clinical trial of drug intervention for hypertensive population. after signed the informed consent, the subjects are assigned to the lifestyle intervention group (con) and berberine hydrochloride group (bbr). the berberine hydrochloride group (bbr) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months) . we will follow up blood pressure and vascular endothelial function in 1 month and 3 months after taking the medicine.


Eligibility criteria:
inclusion criteria: 1. essential hypertension (office blood pressure: systolic blood pressure 140-159 mmhg and/or diastolic blood pressure 90-99 mmhg 2. 18 to 75 years old 3. no drugs or dietary supplements that affect blood pressure and vascular endothelial function have been used in the past 3 months, mainly including antihypertensive, lipid-lowering, hypoglycemic drugs and natural plant extract antioxidants 4. individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of the study, characters of the disease, drug effects, methods of related examinations, and potential risk/benefits of the study exclusion criteria: 1. individuals with secondary blood pressure rise factors 2. individuals who are hypersensitive or intolerant to the drugs 3. individuals presenting severe constipation 4. individuals with severe heart disease, abnormal liver and kidney function, acute and chronic infections, autoimmune diseases and patients with any history of cancer 5. individuals with mental diseases who are not able to cooperate 6. pregnant women, women during breast-feeding period, or women with expect pregnancy 7. individuals with hemolytic anemia and glucose-6 phosphate dehydrogenase deficiency

Keywords: berberine hypertension vascular endothelial function brachial ankle pulse wave velocity brachial artery blood flow-mediated vasodilation
invasive revascularization or not in intermittent claudication

Conditions: Intermittent Claudication

Summary: peripheral arterial disease (pad) often causes exertion pain in the legs, intermittent claudication (ci) affecting\> 10% of individuals\> 65 years. a recent swedish health technology assessment report identified only limited evidence for the effectiveness of invasive treatment for ic in patients already on exercise training. the prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. invasive treatment can also cause serious complications. coronary artery disease is common in ic patients increasing the risk with invasive treatment. in spite of these uncertain merits and potential risks, invasive procedures for ic are increasing and 37% of all invasive procedures for pad in sweden are performed for ic. the aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (bmt). the primary hypothesis in the study is that invasive treatment in addition to bmt improves health related quality of life and walking performance compared to bmt only.


Eligibility criteria:
inclusion criteria: * patient with intermittent claudication (typical symptoms and abi \<0.9) seeking treatment * significant aortoiliac- and/or femoropopliteal lesion. * age 30-80 years exclusion criteria: * invasive treatment contraindicated because of severe intercurrent disease. * two or more failed vascular reconstructions in the same leg. * employees unable to work because of intermittent claudication. * need for open reconstruction below the tibioperoneal trunc. * thromboembolic etiology (popliteal artery aneurysm; cardiac emboli) * other disease severely affecting walking performance. * body weight \> 120 kilograms. * age \ 80 years.

Keywords: intermittent claudication health related quality of life walking performance daily walking capacity
virtual reality-based relaxation program on pain intensity, anxiety level in patients to be applied with endoscopy

Conditions: Anxiety; Pain

Summary: this study was conducted to evaluate the effect of relaxation exercise with vr (virtual reality) glasses on pain severity, anxiety level, physiological symptoms of anxiety and satisfaction in patients undergoing endoscopy.

beginning 1-2 minute before the start of the procedure, the patients will be watched (30 minutes) with an android mobile phone inserted into the cardboard super flex binoculars glasses.

Eligibility criteria:
inclusion criteria: * being over 18 years old * ability to communicate adequately * absence of psychiatric problems * volunteering to participate in the research exclusion criteria: those who have communication problems * those with psychiatric problems * being unconscious

Keywords: virtual reality glasses pain anxiety endoscopy
empagliflozin addition in modulating metabolic disturbances associated with olanzapine in schizophrenia patients

Conditions: Sodium-glucose Transport Protein Two Inhibitor (SGLT2),Metabolic Deficits Caused by Antipsychotics

Summary: olanzapine is a thieno-benzodiazepine derivate that is effective managing the symptoms of schizophrenia and reducing the psychopathological symptoms of psychosis. it is also effective in controlling the acute manic episodes associated with bipolar disorder, and have provided some therapeutic advantages over other antipsychotic agents (citrome et al., 2019). however, ola administration has been reported to induce profound bwg accompanied with higher incidence of metabolic deficits, such as hypertension, diabetes and hyperlipidemia, as compared to other antipsychotic agents (mauri et al., 2014). adjunctive treatment with other agents that can minimize or normalize ola-induced bwg can enhance the safety and tolerability profiles of an effective antipsychotic, thus highlighting the need to develop improved therapies or interventions to minimize these side effects. a meta-analysis of 12 published studies found that antidiabetic drugs such as metformin improved metabolic parameters in patients treated with antipsychotics (de silva et al., 2016). these studies encouraged the evaluation of other antidiabetic agents as adjunctive therapies to minimize ola-induced bwg. empagliflozin (empa)is the third-generation anti-diabetic drug acting as sodium-glucose transport protein two inhibitor (sglt2), which provides a new mechanism of action to improve glycemic control with modest decreases in systolic blood pressure and body weight (pradhan et al., 2019). the effects of empa on ola-induced bwg have not been determined and require further investigation.


Eligibility criteria:
inclusion criteria: schizophrenia patients treated with olanzapine with ages ranging from 18 to 60 years. exclusion criteria: patients who had any other inflammatory disease (cardiovascular, asthma, bone
re-evaluating triglycerides in coronary heart disease

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Hypertriglyceridemia

Summary: to conduct a comprehensive epidemiologic investigation into the relationship between serum triglyceride (tg) levels and coronary heart disease (chd).

background: the results of this investigation helped to shed substantial light on the controversial relationship between triglycerides and coronary heart disease, a topic of great importance to preventive cardiology. additionally, important methodological information was obtained in the study of interactions and precision of variables in epidemiologic analysis. design narrative: there were three components to the study: 1) an analysis of several existing cardiovascular databases for evidence of a significant association between coronary heart disease and specific lipid interactions involving triglycerides; 2) an analysis of these databases to investigate the role of measurement precision on the association between elevated triglyceride levels and coronary heart disease; and 3) a survey of both expert lipidologists and community clinicians to examine current practices related to screening for and treatment of elevated triglyceride levels for the purpose of reducing coronary heart disease risk. five databases were used in the first two components of this study. these data sets included those of the lipid research clinics prevalence and mortality follow-up studies; the lipid research clinics coronary primary prevention trial; the multiple risk factor intervention trial; the national heart, lung, and blood type ii coronary intervention study; and the coronary drug project. for the first component, detailed statistical analyses of all databases were performed, specifically examining the role of lipid interactions involving triglycerides and their association with coronary heart disease. for the second component, more precise estimates of each subject's lipid levels were recalculated using the multiple lipid measurements already available in each database. each dataset was then analyzed for evidence of an independent relationship between triglycerides and coronary heart disease and to validate the theoretical findings suggesting that measurement imprecision may explain the difficulty of detecting an independent triglyceride-coronary heart disease association. the public health implications of the current state of knowledge surrounding triglycerides were assessed with survey research techniques in the third component. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
pharmacokinetics of afamelanotide in epp patients

Conditions: Erythropoietic Protoporphyria

Summary: the purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult epp patients.


Eligibility criteria:
inclusion criteria: * epp patients aged between 12 and 70 years * bmi between 15 and 30 kg/m2 * \>50 kg exclusion criteria: * any personal or direct family history of melanoma * any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or other local anaesthetics if used * any significant illness during the four weeks before the study screening period * any evidence of hepatic or renal impairment
montelukast in exercise-induced bronchospasm - 2004 (0476-275)

Conditions: Asthma, Exercise-Induced

Summary: the purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.


Eligibility criteria:
inclusion criteria: * patients with mild-to-moderate asthma exclusion criteria: * medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection * patient is, other than asthma, not in good, stable health * the primary investigator will evaluate whether there are other reasons why the patient may not participate
a multi-centre, open labelled, multiple dosing trial investigating safety, pharmacokinetics and pharmacodynamics of nnc 0172-2021 administered subcutaneously to healthy male subjects and haemophilia subjects

Conditions: Congenital Bleeding Disorder; Haemophilia A; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of nnc 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

the present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. initiation of this new trial awaits additional non-clinical data.

Eligibility criteria:
inclusion criteria: * for haemophilia subjects only: subjects diagnosed with haemophilia a with a baseline level of factor viii or factor ix below 2% without inhibitors exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * thrombocyte count below the lower limit of normal range at screening * any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator
habit formation for diabetes self-management

Conditions: Diabete Type 2

Summary: the purpose of the study is to determine the feasibility of interventions which focus on building habits as a method of improving diabetes self-management behaviors for individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * 19 years old * read and write in the english language * have technology capability for virtual or telephone sessions * are reachable by phone or text messaging * have a diagnosis of t2dm * were willing and able to participate in all study-related activities, and * were not currently involved in other diabetes-related education and behavioral interventions. exclusion criteria: * younger than 19 years old * unable to read and write in the english language * did not have technology capability for virtual or telephone sessions * were not reachable by phone or text messaging * were unwilling or unable to participate in all study-related activities, and/or * were currently receiving or involved in other diabetes-related education and behavioral interventions.

Keywords: habit formation occupational therapy self-management diabetes type 2
treatment of bronchial asthma with borage and echium seed oils

Conditions: Bronchial Asthma

Summary: the aim of this trial is to determine the efficacy of a combination of two botanicals oils, borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.

leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. dietary supplementation with gamma linolenic acid (gla) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (aa), which has pro-inflammatory potential. the n-3 fatty acid, eicosapentaenoic acid (epa), prevented the conversion of gla to aa. however, epa is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by gla. stearidonic acid (sda) is a precursor of epa that is extracted from echium plantagineum; it is converted to epa in humans and it does not have the organoleptic properties of epa. we recently completed a dose-ranging study in which we determined the dose of sda that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation. the goal of the present study is to test the efficacy of dietary supplementation with gla and sda (provided in borage seed oil and echium seed oil) in treating bronchial asthma.

Eligibility criteria:
inclusion criteria: * diagnosis of bronchial asthma * male or female 18 years to 65 years of age * fev1 50 to 90% of predicted, or personal best. * improvement of \>=12% fev1 with bronchodilator exclusion criteria: * pregnant or nursing * smoking history of \> 10 pack years or active smoking within the past year. * due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria: * leukotriene modifying drugs, * theophylline * oral steroids. * dietary supplements with fatty acids or other products that may interfere with leukotriene generation. * treatment within the previous three months with omalizumab (monoclonal antibody directed against ige) * subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation. * a history of aspirin-sensitive asthma * significant abnormalities in cbc, differential white cell count, renal function, and liver function, or urinalysis. * any serious co-morbid medical condition.

Keywords: asthma fatty acids leukotrienes diet