Kornimate/medical-research-clean huggingface dataset:
the ucap 2 pilot study

Conditions: COPD; Asthma

Summary: our research group has found that canadians with undiagnosed asthma or chronic obstructive pulmonary disease (copd) have increased respiratory symptoms and worse health-related quality of life. the investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals. the investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or copd. those at risk will be invited to participate in our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or copd will improve their quality of life and clinical outcomes.


Eligibility criteria:
inclusion criteria: * individuals at least 18 years old * individuals must be symptomatic with respiratory symptoms * individuals must complete the ucap-q questionnaire and score a ≥ 6% probability of having either asthma or copd. * individuals who have given written informed consent to participate in this trial in accordance with local regulations; * individual must be able to perform pre and post bronchodilator spirometry to measure lung function additional inclusion criteria for the randomized controlled trial (rct): * individuals who have undiagnosed airflow obstruction (i.e. asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (fev1) improves by \> 12% and 200 ml after bronchodilator and copd will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to participate in the rct. exclusion criteria: * individuals who report a previous diagnosis of asthma, copd, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease. * individuals currently under the care of a respirologist * individuals currently using inhaled corticosteroids or long-acting bronchodilators. * individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated) * individuals who are in the third trimester of pregnancy * individuals involved in another interventional trial
comparison of topical and intravenous tranexamic acid in total hip arthroplasty

Conditions: Blood Loss

Summary: recently, there has been interest in applying tranexamic acid topically before the closure of surgical wounds in total hip replacement. it has the advantages of ease of application, maximum concentration at the site of bleeding, minimising its systematic absorption and, potentially , decline the risks for systematic side-effects 。

objectives:to assess the efficacy and safety between the two different applying routes. patients in this project are randomly divided into three groups , one group is a blank group and the rest two groups receive either the topical or the intravenous form of tranexamic acid during unilateral tha(total hip arthroplasty).the total blood loss(tbl) will be calculated as the primary outcome for efficacy while the events of deep vein thrombosis、pulmonary embolism、acute myocardial infarction 、 acute kidney infarction and cerebral infarction will be recorded to assess the safety of the tranexamic acid during a six-week follow-up for each patient. all surgery are under general anesthesia, through direct lateral approach with cementless prosthesis. for all patients, the drain tube is clamped and closed completely for 2 hours; then the clamp is fully opened.

Eligibility criteria:
inclusion criteria: 1. consented to join in our project. 2. adult patients (greater than 18 years old) 3. patients scheduled for primary unilateral hip arthroplasty patients for ruijin hospital, shanghai, china exclusion criteria: 1. patients who refuse to sign the inform consent 2. had an allergy to txa. 3. long-term bed \>=3 weeks. 4. using anticoagulant drugs within a week. 5. coagulopathy (preoperative platelet count \ 1.4, prolonged activated partial thromboplastin time，prothrombin time ，or thrombin time (\>1.4 times longer than normal) 6. pregnancy 7. breastfeeding 8. major comorbidities: severe ischemic heart disease(class iii and iv of new york heart association); sleep apnea syndrome; renal dysfunction ( glomerular filtration rate\ 80 or glutamic oxalacetic transaminase\>80).retinopathy (disturbances of color vision). 9. history of thromboembolic disease: . 10. been participating or been participated within a year in another clinical trial

Keywords: tranexamic acid blood loss topical administration intravenous administration
efficacy, safety and pk/pd of mor202 in anti-pla2r+ membranous nephropathy (amn) (newplace)

Conditions: Glomerulonephritis; Membranous Nephropathy; antiPLA2R Positive

Summary: this 2-arm, multi-center, open-label, parallel-group phase ii trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody mor202 in subjects with anti-pla2r antibody-positive membranous nephropathy indicated for immunosuppressive therapy

after treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months. study sponsor, originally hi-bio, inc., is now hi-bio, a biogen company.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[icf\]). * urine protein to creatinine ratio (upcr) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h * estimated glomerular filtration rate (egfr) ≥ 50 ml/min/1.73 m² (egfr \>30 and \< 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (ifta) score of \< 25% in a kidney biopsy) * not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (acei), angiotensin receptor blockers (arbs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. if the subject is intolerant to acei and arbs, the reason must be documented and approval for enrollment be obtained from the medical monitor. * systolic blood pressure (bp) ≤150 mmhg and diastolic bp ≤100 mmhg after 5 minutes of rest. * serum anti-pla2r antibodies ≥ 50.0 ru/ml determined by euroimmun elisa. * female subjects: a female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. not a female of childbearing potential (fcbp) 2. a fcbp who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of mor202 key exclusion criteria: * hemoglobin \< 80 g/l. * thrombocytopenia: platelets \< 100.0 x 10\^9/l. * neutropenia: neutrophils \< 1.5 x 10\^9/l. * leukopenia: leukocytes \< 3.0 x 10\^9/l. * hypogammaglobulinemia: serum immunoglobulins ≤ 4.0 g/l. subjects may receive supportive therapies to meet the above criteria * b-cells \< 5 x 10\^6/l * diabetes mellitus type 2: subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows mn without evidence of diabetic nephropathy and diabetes is controlled, as shown by: 1. glycated hemoglobin (hba1c) \<8.0 % or 64 mmol/mol. 2. no diabetic retinopathy known. 3. no peripheral neuropathy known. * total bilirubin, aspartate aminotransferase or alanine aminotransferase \>1.5 x uln, alkaline phosphatase \>3.0 x uln.
a first in human evaluation of a novel approach to painless cardioversion (napc) in patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: an assessment of the use of cold therapy to terminate atrial fibrillation.


Eligibility criteria:
inclusion criteria: * subject must be ≥ 18 years or older * male of female * subject has documented paroxysmal, or persistent atrial fibrillation (af) with a history of less than one-year duration * must be in af at time of surgery, or inducible using manual or electrical stimulation * subject is willing and able to provide written informed consent * subject has a life expectancy of at least 1 yearexclusion criteria: exclusion criteria: • long-standing af (duration \> 1 year) * prior af ablation * left main coronary artery occlusion \> 70% * critical aortic stenosis (gradient \> 50mm hg) * inability to induce patient into af without drugs at time of surgery * female subjects who are pregnant at time of surgery * subjects with a medical condition or comorbidity that could adversely impact study participation, safety or conduct of the study * permanent pacemaker or implantable cardioverter defibrillator * current cancer treatment that includes radiation of the heart * inability to give informed consent * significant intra-cardiac thrombus * subjects not eligible for or considered high risk for anticoagulation
prevalence of long-term respiratory complications of severe sars-cov-2 pneumonia - covid-19

Conditions: Severe SARS-CoV2 Pneumonia

Summary: studies performed after coronavirus epidemics (severe acute respiratory syndrome coronavirus, sars-cov and middle east respiratory syndrome coronavirus, mers-cov) have shown a long-term impact on respiratory morbidity, musculoskeletal and psycho-social repercussions. patients with sars-cov pneumonia had fibrotic pulmonary sequelae at 45 days (lower dlco in 27.3% of cases and radiological lesions in 21.5% of cases). in the mers-cov pneumonia study, patients had radiological sequelae in 33% of cases and the 12-month evaluation showed persistence of radiological abnormalities in 23.7% of the cases despite an improvement in respiratory function. clinical presentation and therapeutic management of severe sars-cov-2 infection are in part similar to those induced by sars-cov and mers-cov. long-term respiratory complications are therefore expected.

objective is to evaluate prevalence of long-term respiratory complications after severe sars-cov2 pneumonia.

Eligibility criteria:
inclusion criteria: * adult patient * patient with with severe sars-cov2 pneumonia * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program exclusion criteria: * patient under 18 years

Keywords: sars-cov2 long term complication pneumonia
a 3d tablet sensor approach to the measurement of a lymphedema

Conditions: Lymphedema

Summary: up to now, the diagnosis of lymphedema remains hard and delayed. it suffers from many limitations such as lack of coordination and formation of the health-care network. the diversity of used tools is another obstacle because all provided solutions on the market are either costless with poor accuracy, or highly expensive but with excellent accuracy. therefore, we decided to evaluate an affordable and open-source 3d ipad sensor sharing the same technology used in kinect sensors.


Eligibility criteria:
inclusion criteria: - unilateral lymphedema exclusion criteria: * minor patient, * bilateral lymphedema, * trophic disorders: acute or recent skin infection (\<1 month after the end of antibiotic therapy), unhealed wounds. * predictable difficulties in carrying out the measurements due to the patient's physical limitations (maintenance of orthostatic or sitting position \<5 minutes) * single or bilateral edema with a different etiology than lymphedema.

Keywords: 3d sensor lower extremity upper extremity body regions measurement monitoring water displacement volume
the effects of anesthetics on brain network connectivity in patients with supratentorial glioma

Conditions: Brain Network Connectivity; Postoperative Delirium; Dexmedetomidine; Propofol

Summary: perioperative anesthesia can affect postoperative cognitive function. in our previous study, intraoperative dexmedetomidine (dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. however, the mechanism is still unclear. with the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.


Eligibility criteria:
inclusion criteria: * diagnosed as unilateral supratentorial glioma by mri * selective operation * age over 18 years old * asa i-ii * right handedness exclusion criteria: * history of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs * history of intracranial surgery * drug and/or alcohol abuse * history of dementia or mental illness * pregnant or lactating women * contraindications for mri * severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block * severe hepatic or renal dysfunction
epa supplementation on vascular inflammation, and gene expression of pon2 in patients with type ii diabetes mellitus

Conditions: Diabetes Mellitus Type II

Summary: the aim of this study is to determining of the effects of eicosapentaenoic acid (epa) supplementation on serum activities of paraoxonase-1 and homocystein thiolactonase, and serum levels of some indicators of vascular inflammation, and the gene expression of pon2 in the peripheral blood mononuclear cell (pbmc) in the patients with type ii diabetes mellitus.

the aim of this study is to determining of the effects of eicosapentaenoic acid (epa) supplementation on serum activities of paraoxonase-1 and homocystein thiolactonase and several indicators of vascular inflammation and the gene expression of pon2 in the peripheral blood mononuclear cell (pbmc) in the patients with type ii diabetes mellitus. in this randomized, double-blind clinical trial, placebo-controlled, single-center, 36 men and women aged 35-50 years with type 2 diabetes are enrolled in the study from the iranian diabetes association. after signing informed consent, all individuals complete a general information form. a 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. two groups will be classified (blocked) based on sex. the supplement group, will receive 2 g/day epa for 8 weeks and the placebo group will also receive placebo (containing 2 g of edible paraffin) (similar in terms of color, shape and size). patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. blood samples will be collected after 8-12 hours fasting and anthropocentric variables, biochemical parameters, target gene expression and physical activity before and after the trial will be measured.

Eligibility criteria:
inclusion criteria: * willingness to collaborate in the study * aged 35-50 years * having a history of at least 1 year of type 2 diabetes mellitus before the participation in the study based on fbs ≥126 mg/dl or 2hpg ≥200 mg/dl (2-hour plasma glucose), * 25≤bmi\<30 kg/m2 exclusion criteria: * pregnant and breastfeeding women * using insulin, alcohol consumption, smoking and other drugs * taking drugs (lipid-lowering, β-blockers, diuretics, estrogens, progesterones, vitamin supplements and ω-3 fatty acid supplements * followers of the special diet * history of diabetic retinopathy or diabetic nephropathy * type 1 diabetes mellitus and other disorders * any need to take insulin, change in the dose (s) and type of medication or physical activity

Keywords: epa paraoxonase 1 paraoxonase 2 type 2 diabetes
subjective and objective outcome of septoplasty with or without infundibulotomy

Conditions: Nasal Blockage; Nasal Obstruction; Septum; Deviation

Summary: septoplasty is one of the most common procedures in rhinology. in many centers and private institutions, an infundibulotomy is performed in addition to septoplasty without evidence of significant improvement for the patient. often the reason given for this is the improvement of the functional outcome in terms of better nasal breathing, although there is no evidence for this. if a significantly better outcome can be shown, one would have a first evidence for the extended procedure.


Eligibility criteria:
inclusion criteria: unilateral breathing impairment due to septal deviation
effect of vitamin d supplementation on inflammation and cardiometabolic risk factors in obese adolescents

Conditions: Obesity

Summary: large studies of children show that over half of the children in the united states of america do not have enough vitamin d stored in their bodies. in children who are overweight or obese, the percentage of children who do not have enough vitamin d is even higher. vitamin d is essential for the body to maintain normal calcium levels and strong bones. recent research shows that through the actions of inflammatory markers, levels in the blood that measure inflammation in the body, vitamin d plays many other important roles in the body like helping to regulate the immune system, blood sugar levels, blood pressure, and body fat. the purpose of this study is to determine the effect of vitamin d supplementation on inflammatory markers in obese and overweight adolescents. as a secondary goal, we would like to evaluate cardiometabolic risk factors and the correlation between body mass index, vitamin d stores and inflammatory cytokines. in an observed, randomized controlled trial over 6 months we will provide observed vitamin d supplementation or placebo to healthy obese and overweight adolescents and measure changes in inflammatory markers, lipids, blood pressure, and mean blood sugars. we hypothesize that administration of vitamin d to these patients will improve their inflammatory profile and cardiometabolic risk factors (blood glucose, blood pressure, and lipid profile).

supplementation with vitamin d at 150,000 iu every 3 months failed to increase serum 25-hydroxy vitamin d (25ohd) or alter inflammatory markers and lipids in overweight and obese youth. further studies are needed to establish the dose of vitamin d required to increase 25ohd and determine potential effects on metabolic risk factors in obese teens. during the course of the study, blood pressure removed from the prespecified outcome measures.

Eligibility criteria:
inclusion criteria: 1. ages 11 years to 17.99 years old 2. bmi: 85 percentile for age and gender exclusion criteria: 1. patients who currently receive: * vitamin d supplementation \>= 400 iu/day * daily glucocorticoids or anti-epileptics 2. patients who currently have or history of: * 25-oh vitamin d level \ 60 ng/ml * rickets * diabetes mellitus * liver or kidney disease * malabsorptive disorders * genetic syndromes associated with obesity (i.e. prader-willi) * lactose deficiency or insufficiency * galactosemia

Keywords: adolescents, vitamin d
emd 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer

Conditions: Prostate Cancer Metastatic

Summary: the primary objective of the trial is to evaluate the clinical anti-tumor activity of emd 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (pfs) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate (gleason score) * bisphosphonate treatment * stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) \<= 50 nanogram per deciliter \[ng/dl\]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists) * other protocol defined inclusion criteria could apply exclusion criteria: * prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mcrpc * chronic and ongoing treatment with opioids * acute pathologic fracture, spinal cord compression, or hypercalcemia at screening * visceral metastasis, brain metastasis * radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. any kinds of major elective surgery within 30 days prior to trial treatment * other protocol defined exclusion criteria could apply

Keywords: asymptomatic mildly symptomatic metastatic castrate-resistant prostate cancer mcrpc
bioequivalence study of torrent pharmaceuticals ltd's pioglitazone hydrochloride tablets under fed conditions

Conditions: Healthy

Summary: objective: subjects to compare the single dose bioavailability of torrent's pioglitazone hydrochloride tablets 1 × 45 mg and actos® tablets 1 × 45 mg of takeda pharmaceuticals america, inc. dosing periods of studies were separated by a washout period of 12 days and 11 days respectively. study design: randomized, two-way crossover, single-dose, and open-label


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines,cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
performance of plr as predicting preload responsiveness

Conditions: Stroke Volume

Summary: we aimed to establish current practice of correct application and interpretation of the plr in critical care patients.

the points of concern for plr include the following: the indication and contraindication of plr; the choice of initial position: starting from a semi-recumbent position or supine position for plr; how to interpret and apply the changes of co, blood pressure, and central venous pressure (cvp) to identify fluid response during plr; and how to identify spontaneous variation and sympathetic stimulation during plr.

Eligibility criteria:
inclusion criteria: * all critical care physicians of different medical disciplines exclusion criteria: * not completely responses

Keywords: passive leg raise