Kornimate/medical-research-clean huggingface dataset:
retained urine volume and bacteriuria in traditional versus vented urine drainage systems

Conditions: Bacteriuria

Summary: the purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (foley catheter) in hospitalized patients. the difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. the vented catheter may drain urine better than a standard non-vented catheter. if a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.

during hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.

Eligibility criteria:
inclusion criteria: * scheduled for a planned surgery * anticipated indwelling bladder catheter placement for greater than 24 hours * anticipated post-op admission to a surgical icu exclusion criteria: * unstable renal function as self-reported * anticipated bandaged postoperative suprapubic incisions * anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning * surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature

Keywords: precursor to cauti
home mechanical ventilation in patients with chronic obstructive pulmonary disease (copd) and hypercapnic response

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in copd patients with chronic respiratory failure (crf) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration. we will include clinically stable copd patients with hypercapnic crf who develop a nocturnal hypercapnic response to oxygen (paco2 increase on awakening, at night with oxygen, \>10 mmhg respect to paco2 breathing room air and awake). obstructive sleep apnoea syndrome (osas) will previously have been excluded. patients will be admitted to the pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. arterial blood gas samples will be taken at awakening (7am). patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups: * oxygen therapy group * home mechanical ventilation plus oxygen therapy group home mechanical ventilation will be performed with a bilevel pressure ventilator. functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared. the principal outcome will be the evolution of arterial blood gases (paco2) between the two groups.


Eligibility criteria:
inclusion criteria: * elderly patients \< 80 years old. * copd (ers/ats (fev1 \ 80%)). * oxygen therapy indication (pao2 \< 55 mmhg or 55-59 associated to pulmonary arterial hypertension, chronic cor pulmonale, chronic heart failure, arrhythmias or polyglobulia). * paco2 \> 50 mm hg. * clinically stable at least prior to one month. * hypercapnic response: increasing paco2 \> 10 mmhg at 7 a.m after all night with oxygen compared with paco2 when awake and without oxygen therapy. exclusion criteria: * active smoker. * bronchiectasis or tuberculous after-effects. * chronic respiratory failure secondary to thorax cage or neuromuscular diseases. * bmi \> 35 kg/m2 * osas. * locomotor system problems that disable 6 minutes walking test execution. * patients with tracheostomy. * other serious comorbidity (i.e chronic heart failure functional class \> ii nyha, cancer or chronic renal failure that requires dialysis.

Keywords: nocturnal hypercapnic response to oxygen home mechanical ventilation copd
sp2086 pharmacokinetic study in renal insufficiency patients

Conditions: Renal Insufficiency

Summary: the purpose of the study is to investigate the sp2086 pharmacokinetic in renal insufficiency patients.

this trial adopt in a parallel, open, single dose study design. the subject was divided into one of five groups according to the degree of renal insufficiency, which including normal, mild, moderate, severe, and end-stage. all subjects were given sp2086 50mg, and collected the blood samples before and after the medicine taken.

Eligibility criteria:
inclusion criteria: * with a body mass index(bmi) between 19 and 28 kg/m2;weight:≥50kg(male),≥45kg(female) * the endogenous creatinine clearance of subjects in groups must meet the standards of ccr in renal function in installment:mild renal insufficiency:60-89 - ml/min;moderate renal insufficiency: 30 to 59 ml/min;severe renal insufficiency: 15-29 ml/min;end-stage renal disease: \< 15 ml/min.normal renal function: 90 ml/min or more. * had signed the informed consent himself or herself voluntarily. exclusion criteria: * cannot tolerate oral medicine. * not control or unstable cardiovascular, respiratory, liver, digestive, endocrine, hematopoietic, the mental or nerve system diseases. * had the digestive surgery that could affect drug absorption. * the clinical significance of arrhythmia. * acute hepatitis, chronic liver disease; alt or ast value was 2 times greater than upper normal limit, total bilirubin value was 1.5 times greater than upper normal limit. * hbv surface antigen, hcv antibody, or hiv antibody was positive. * history of drug allergy or allergic constitution or family history of allergy. * had used hormonal contraception within 3 months; * had used dpp - iv inhibitor within 2 weeks; * had used traditional chinese medicine (chinese herbs, chinese patent medicine) within 2 weeks; * had used acid inhibitors within 2 weeks; * alcohol, tobacco, drug abusers;alcohol abuse is defined as a day for regular alcohol consumption more than the following standards: beer 570 ml, light beer 750 ml, red wine 200 ml, white wine 60 ml, which including about 20g alcohol;tobacco is defined as five or more per day. * 2 days before the randomization till to the end ,the patients can not ban alcohol, tobacco, or reference food or drink containing caffeine or xanthine , or vigorous exercise, or there are other factors that can affect drug absorption, distribution, metabolism and excretion * the patient had participated three times or more clinical trial in one year, or one time within 3 months. * pregnancy or lactation women, or a fertility male or female is not willing to contraception during test. * history of blood donation or participate in blood donation, or by blood transfusion in 3 months prior to screening. * researchers considered that there was any situation that may cause the participants can't finish this study or bring any obvious risk to subjects.

Keywords: sp2086 renal insufficiency pharmacokinetic
stretching exercises on symptoms of primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the purpose of this study was to assess the effect of active stretching exercises on reducing pain and the quality of life during menstrual cycle in young adult females.

thirty females with primary dysmenorrhea, aging between 18 to 23 years with bmi of 20-29.9 kg/m2, have a regular menstrual cycle length 28-30 day and cycle bleed from 3 to 7 days, were randomly assigned into three equal groups; two interventions groups (supervised and non-supervised active stretching exercise program) and one control group. the intervention group a practiced a 30 to 45-minute supervised active stretching program three times a week for four weeks, while the other intervention group b practiced non-supervised active stretching home program and the control group c . visual analog scale (vas) was used to measure pain intensity, and verbal multidimensional system (vms) for measuring menstruation characteristics and the effect of pain on quality of life, before (pre) as well as after (post) 4 weeks at the end of the study .

Eligibility criteria:
inclusion criteria: * bmi of 20-29.9 kg/m2, * regular menstrual cycle * length 28-30 day * cycle bleed from 3 to 7 days, exclusion criteria: * contraindication to stretching exercise * taking any hormonal medications: * smoker
pathogenic variants in homologous recombination repair genes in patients with epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: molecular alterations in homologous recombination repair (hrr) genes have been associated with clinical benefit from chemotherapy and/or poly (adp-ribose) polymerase (parp) inhibitors in patients with epithelial ovarian cancer. therefore, the performance of tumor molecular profiling is currently recommended by international guidelines at initial diagnosis, among other reasons, for the modification of the treatment plan. the investigators' hypothesis was that tumor molecular profiling reveals additional parameters that can improve the predictive and prognostic role of the mere presence of hrr gene mutations. the study aimed to investigate the prognostic and predictive role of clonality of pathogenic variants in hrr genes and/or concurrent pathogenic variants in other clinically relevant genes.


Eligibility criteria:
inclusion criteria: * diagnosed with epithelial ovarian cancer * received treatment at hecog-affiliated institutions * have signed informed consent * with adequate tumor tissue for analysis

Keywords: epithelial ovarian cancer next generation sequencing (ngs) pathogenic variants tumor molecular profiling clonality homologous recombination repair
effect of the interleukin-6 receptor antagonist tocilizumab in non-st elevation myocardial infarction

Conditions: Non-ST Elevation Myocardial Infarction

Summary: acute coronary syndromes (acs) are still associated with high morbidity and mortality, despite several improvements in their management. this may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms. based upon previous research, the investigators believe that providing a block in the damaging inflammatory loop though short term inhibition of interleukin-6 receptor signalling, could be an attractive therapeutic target in acs; and of particular interest in patients with non-st elevation myocardial infarction (nstemi), a disease often characterized by widespread coronary inflammation with multiple unstable plaques. the investigators hypothesize that a single administration of the anti-interleukin 6 receptor antagonist tocilizumab, in patients with nstemi, may interrupt the self-perpetuating inflammatory loops which could improve plaque stability, with potential secondary beneficial effects on myocardial damage. this will be investigated in a randomized, double blind, placebo-controlled study, including a total of 120 patients.


Eligibility criteria:
inclusion criteria: * nstemi (esc type 1) * age 18-80 years * troponin t \>/= 30 ng/ml * informed consent to participation exclusion criteria: * stemi * known cardiac disease, except coronary disease (cardiomyopathy, heart failure with known ef \< 45%, severe valvular heart disease attending regular follow-up, recent pci/acb (\< 3 months)) * hemodynamic and/or respiratory instability * cardiac arrest in acute phase * concurrent condition affecting/potentially affecting crp (infection, malignancy, autoimmune disease) * recent major surgery (\< 3 months) * recent/concurrent immunosuppressant treatment (\< 2 weeks, except nsaids) * severe renal failure (egfr \< 30 ml/min) * pregnancy * contraindications to any study investigations and/or medication. * expected non-adherence to study protocol
happy mommy! happy baby! study

Conditions: Pregnancy; Stress, Psychological; Stress, Physiological; Maternal-fetal Relations

Summary: the purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies. women who are asked to participate in this study will fill out forms about their physical and mental health, have 3d ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.

the objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. this study utilizes 3-d ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and trier social stress test (tsst) to assess maternal arousal. this study also utilizes an infant stress test to assess infant arousal.

Eligibility criteria:
inclusion criteria: * aged 18 to 45 years; * able to give written informed consent; * between 8 to 17 weeks at time of recruitment; * attendance at 20 week ultrasound at a uphs site; * healthy full term (35 6/7 weeks) infants; * fluency in written and spoken english. exclusion criteria: * presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy; * presence of a serious medical or neurological illness, requiring treatment during pregnancy; * use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period; * drug or alcohol abuse history within previous 2 years; * life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder * active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist; * hamilton depression rating scale score \> 14; * suicidal ideation within the previous 6 months; * use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal; * a history of preterm birth or history of preterm labor in the active pregnancy.

Keywords: pregnancy stress, psychological stress, physiological maternal-fetal relations
clinical trial to evaluate the efficacy and security of deep brain stimulation in alzheimer´s disease

Conditions: Alzheimer Disease

Summary: approximately one million of spaniards suffer from alzheimer´s disease (ad) and this figure is expected to triple by 20150. the approved treatments modulate neurotransmission in general and are not specific or anatomically directed. in ad there is a dysfunction in cognitive and memory circuits. it has been shown that the deep brain stimulation (dbs) can specially modulate circuits in such a way that is modulable, and this approach is safe. the safety of this treatment and its biological effects are convincing enough to require further study of possible therapeutic effects of dbs in ad. the objectives are: to evaluate the security of dbs in ad (main objective). to study the influence of dbs in the progress of ad, to compare the effects of dbs on the brain metabolism neural connectivity and hubs using meg, and to compare the effects between two different groups: fornix and basal nucleus of meynert (bnm). to achieve this, a prospective, double-blind comparison study between groups will be conducted, to evaluate the effects of dbs in 6 patients: group i (fornix) and group ii ( bnm).


Eligibility criteria:
inclusion criteria: * age: between 50-80 years old * diagnosis criteria of alzheimer disease (dubois criteria) in the previous 2 years * presence of tau, p-tau or aβ in cerebrospinal fluid or positive amiloid-pet scan * clinical dementia rating scale (cdr): 1 * use of cholinesterase inhibitors and/or memantine during one year at least, and worsening in neuropsychologic tests in spite of the treatment * informed consent (patient and caregiver or legal representative) exclusion criteria: * brain structural disorders: primary or metastatic tumor, hydrocephalus, stroke, brain abscess or cerebral malformation * vascular dementia (nincds-airen criteria) * neurodegenerative disease other than ad * psychiatric disease * epilepsy * severe or unstable comorbidity (mellitus diabetes, high blood pressure...)

Keywords: deep brain stimulation alzheimer´s disease fornix basal nucleus of meynert
immune response study of influenza vaccine

Conditions: Influenza Vaccine Allergy; Cell Mediated Reaction

Summary: an observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.

a randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in china. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. all vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time. the clinical program approved by the ethics committee will be performed by the researchers independently. inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Eligibility criteria:
inclusion criteria: * aged 12-60 years old * male or non-pregnant female * volunteers * clinically healthy as determined by: medical history inquiring and physical examination * provide written informed consents before joining the trial exclusion criteria: * infected with influenza a virus subtype h1n1(2009), * vaccinated with seasonal influenza vaccine, * allergic to any ingredient of vaccine, * autoimmune disease or immunodeficiency, * active malignancy, * bleeding disorder, * seizure disorder, * guillain-barre syndrome, * treatment with cytotoxic or immunosuppressive drugs within the past 6 months, * receipt of blood products within the past 3 months, * administration of any other investigational research agents or live attenuated vaccine within 30 days, * administration of subunit or inactivated vaccines within 14 days, * axillary temperature over 37.0℃ at the time of vaccination.

Keywords: influenza vaccine immune response dynamic changes
clinical and biochemical evidence of neurogenic inflammation in women with urinary urgency

Conditions: Overactive Bladder

Summary: the purpose of this study is to gain a better understanding of what causes urinary urgency in women by asking about different symptoms and measuring biomarker levels in their urine. understanding the underlying causes of urinary urgency will allow us to develop treatment options to better take care of women with urinary urgency.

we propose to test the hypothesis that urinary urgency in women is caused by neurogenic inflammation that is manifested clinically as neuropathic pain and associated with the expression of neuroinflammatory biomarkers in the urine.

Eligibility criteria:
inclusion criteria: age \> 18, urinary urgency (at least mild bother on a single item urgency scale), and negative urine dipstick on clean catch. - exclusion criteria:: urinary incontinence (greater than mild on the incontinence severity index), recent (\<6week) urinary tract infection, active or recent(\<3month) nephrolithiasis, prior diagnosis of congenital urinary tract abnormality, known neurological disorder (multiple sclerosis, parkinson's, spina bifid, spinal cord injury), recent pregnancy \< 3 months, prior sacral nerve stimulation or botox injection. -

Keywords: urinary urgency
tolerance and acceptability evaluation of monaco

Conditions: Malnutrition

Summary: to evaluate tolerance and acceptability of 'monaco' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

to evaluate tolerance and acceptability of 'monaco' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of gi effects, compliance, product preference, convenience etc. to obtain data to support an acbs submissions for 'monaco' (to allow for prescription in the community at nhs expense).

Eligibility criteria:
inclusion criteria: * patients (\>18 years) who are able to communicate clearly. * patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement. * patients expected to require oral nutritional supplementation for at least 2 further weeks. * patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement * informed assent/consent obtained. exclusion criteria: * patients with cow's milk protein allergy requiring a milk free diet * patients with inherited metabolic conditions. * patients requiring enteral tube feeding or parenteral nutrition. * patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list) * patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis) * patients with dysphagia requiring stage 1, 2 or 3 thickened fluids. * patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms. * patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements * participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
comparison of optical coherence tomographic findings after balloon angioplasty with two different paclitaxel-coated balloons for the treatment of in-stent restenosis in drug-eluting stents

Conditions: Coronary Artery Disease

Summary: drug-coated balloon technology (dcb) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (isr). optical coherence tomographic finding of restenosis lesions in drug-eluting stents (dess) after balloon angioplasty with two different paclitaxel-coated balloons will be compared between two paclitaxel-coated balloon devices; pantera lux™ and sequent® please.


Eligibility criteria:
inclusion criteria: * patients ≥ 19 years old * patients eligible for percutaneous coronary intervention * single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent * reference vessel diameter of target lesion ≥2.5 mm exclusion criteria: * cardiogenic shock * bifurcation lesion or totally occluded lesion * unprotected left main trunk lesion * allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel * heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions * pregnant women or women with potential childbearing * inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator * inability to understand or read the informed content