Kornimate/medical-research-clean huggingface dataset:
tele-monitoring in chronic obstructive pulmonary disease

Conditions: COPD

Summary: copd is the fourth cause of death worldwide and it is expected to be the third in 2020. non-invasive ventilation (niv) has a positive impact in reducing mortality related to chronic respiratory failure in stable patients with copd. moreover, the addition of home niv to home oxygen therapy reduces hospital admissions and improves patients outcomes. patients monitoring is crucial. it is increasingly recognized the potential of telemedicine in reducing morbidity and mortality, as well as healthcare utilisation and its associated costs. in particular, home telemonitoring (tm)- a technology measuring patients'clinical parameters and symptoms at home and allowing communication between healthcare professionals and patients over distance- has gained much attention. however, despite a growing body of evidence for tm in the management of copd and other chronic diseases, the benefit of telemonitoring for home mechanical ventilation concerning clinical and economic outcomes remains to be clearly demonstrated. the study aims to assess the impact that telemonitoring would have niv efficacy, patient quality of life and satisfaction, through a prospective randomized study.the primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average sato2 to 90% in 24h oximetry.

a prospective randomized study, with 2 branches. the primary endpoint is the time for appropriate adaptation and therapy efficacy, defined as average sato2 to 90% in 24h oximetry. patients with copd (n=100) based in gold 2017. patients with stable copd and pa co2 \> 52 mmhg in blood gases. these patients might have a polygraph or polysomnographic sleep study ahi/rdi \< 15/h 1. 1st hospital visit - d0- inclusion criteria confirmation; randomization to 2 groups (1 - telemonitoring group (tm group) with the equipment lumis 150, stellar 150 or ventilator astral 150 with airview system; 2 - conventional monitoring group (cm group); mode and settings titration will be selected according to patients needs and tolerance; education and adaptation of the patient to vni and optimize ventilation. 2. 2nd home healthcare professionals visit (d 1m)- 3. 3th hospital visit- d 3m- compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); settings adjustment if required; 4. 4th hospital visit - d 6m- compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis) ; settings adjustment if required 5. 5th hospital visit - d 12m- compliance and ventilation effectiveness assessment (24 oximetry and ventilator data analysis); settings adjustment if required

Eligibility criteria:
inclusion criteria: * patients with copd (n=100) based in gold 2017. patients with stable copd and paco2 \> 52 mmhg in blood gases. these patients might have a polygraph or polysomnographic sleep study ahi/rdi \<15/h exclusion criteria: * patients with ventilatory treatment; * without diagnosis of copd * polygraph or polysomnographic sleep study ahi/rdi \>=15/h

Keywords: non invasive ventilation in copd noninvasive ventilation tele-monitoring
a randomized, double-blind, pharmacokinetics study to assess safety, tolerability of levetiracetam 45 minutes intravenous infusion during 4 days of bid dosing in chinese healthy volunteers

Conditions: Human Volunteers

Summary: the part b of n01362 is to assess the pharmacokinetic profile of levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing in chinese healthy volunteers.

the study includes 2 parts, part a is to evaluate the bioequivalence of levetiracetam (lev) 1500 mg intravenous (iv) infusion when compared to oral tablet, part b is to assess the pharmacokinetic profile of lev infusion during repeated dosing in chinese healthy volunteers.

Eligibility criteria:
inclusion criteria: * chinese, age 18-40, weight ≥ 50 kg * healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test exclusion criteria: * history or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication * history or presence of drug addiction or excessive use of alcohol * symptomatic or asymptomatic orthostatic hypotension at screening * current smokers and former smokers * heavy caffeine drinker * history of frequent and severe headache * any drug treatment * subjects who are known to have serum hepatitis or who are carriers of the hepatitis b surface antigen, or hepatitis c antibody or who are hiv positive * subjects on a controlled sodium diet * subject has made a blood donation or had a comparable blood loss

Keywords: keppra levetiracetam intravenous multiple dose safety pharmacokinetics chinese healthy volunteers
gemcitabine in treating children with refractory solid tumors

Conditions: Unspecified Childhood Solid Tumor, Protocol Specific

Summary: phase i trial to study the effectiveness of gemcitabine in treating children who have refractory solid tumors. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. estimate the maximum tolerated dose of gemcitabine in children and adolescents with refractory solid tumors. ii. assess the toxicity of gemcitabine in this patient population. iii. determine the pharmacokinetic profile of gemcitabine in male and female children and adolescents. iv. assess the antitumor activity of gemcitabine within a phase i study. outline: this is a dose escalation study. patients receive gemcitabine iv over 30 minutes weekly for 2 weeks. patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. patients are followed at week 4 and then every 6 months until death.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant solid tumor confirmation made at original diagnosis * no bone marrow involvement * refractory to conventional therapy and other therapies of higher priority according to ccg phase i/ii priority list patient characteristics: * age: 1 to 21 * performance status: 0-2 * life expectancy: at least 2 months * absolute neutrophil count at least 1,000/mm3 * platelet count at least 100,000/mm3 (transfusion independent) * hemoglobin at least 10 g/dl (transfusions allowed) * bilirubin no greater than 1.5 times normal * ast less than 2.5 times normal * creatinine no greater than 1.5 times normal or creatinine clearance or radioisotope gfr at least 70 ml/min * no seizure disorder not pregnant or nursing * negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: * at least 2 weeks since prior cytokine therapy and recovered * no prior bone marrow transplantation * no more than 3 prior combination or single agent chemotherapy regimens * at least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered

Keywords: unspecified childhood solid tumor, protocol specific
comparison of two vaginal tablets, produced at different sites, in postmenopausal women with atrophic vaginitis

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Summary: this trial is conducted in europe. the aim of this trial is to compare the absorption of estradiol after a single dose of two 25 mcg estradiol vaginal tablets, produced at two different production sites, in postmenopausal women with atrophic vaginitis.


Eligibility criteria:
inclusion criteria: * subjects who are able to use the german language, spoken and written * postmenopausal women: 5 years or more after last menstruation; or both ovaries surgically removed 2 years or more prior to trial start * availability of a normal mammogram within 1 year prior to trial start * good general health * no significant illnesses that could interfere with the subject's participation in the trial, based on the judgment of the physician exclusion criteria: * known or suspected allergy to estradiol or related products * known, suspected or past history of breast cancer * abnormal genital bleeding * previous oestrogen and/or progestin hormone replacement therapy * use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including k-y jelly etc., 1 month prior to first planned drug administration * hot flushes which require systemic hormone replacement treatment * known insulin dependent or non-insulin dependent diabetes mellitus * systolic blood pressure (bp) of more than 160 mm hg and/or diastolic bp or more than 100 mm hg, currently treated or untreated * active deep venous thrombosis or thromboembolic disorders or a history of these conditions * active arterial thrombosis or a documented history of this condition * known or suspected liver and/or kidney impairment based on medical history, physical examination, and/or laboratory results * known hiv infection based on laboratory result * porphyria * body mass index (bmi) above 30.0 kg/m2 * cervical smear presenting pap of more than class ii * known or suspected vaginal infection requiring further treatment * known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day) * currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to significantly influence oestrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepine * subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration
pharmacokinetics of lopinavir/ritonavir superboosting in infants and young children co-infected with hiv and tb

Conditions: Acquired Immunodeficiency Syndrome; Tuberculosis

Summary: the purpose of this study is to determine the lopinavir levels in blood of hiv and tb infected children (3-15kg) when given lopinavir/ritonavir in a 1:1 ratio with rifampicin containing tb regimen and its safety.

this is a multicentre, open label, non-randomized, prospective, noninferiority study to compare the pharmacokinetics of lopinavir administered with superboosting (lpv/r 1:1) and concurrent rif treatment or with standard boosting (lpv/r 4:1) without concurrent rif treatment, and to assess the safety, tolerance, and virological effect of superboosting in hiv-tb co-infected infants and children weighing \>3 kg and ≤15 kg. lpv/r will be administered as the liquid 80/20 mg/ml formulation (4:1 standard boosting ratio). during anti-tb treatment, additional rtv liquid formulation will be provided to deliver a 1:1 superboosting ratio of lpv to rtv. actual doses for antiretrovirals and anti-tb drugs will be based on the south african (sa) weight band dosing recommendations and provided as per the site standard of care.

Eligibility criteria:
inclusion criteria: * documentation of a confirmed diagnosis of hiv-1 infection following sa clinical guidelines * weight \>3kg ≤15 kg at enrolment * \> 42 weeks gestational age * on lpv/r-based therapy or about to start a lpv/r-based antiretroviral combination therapy with 2 nrtis \[abc+3tc or azt+3tc or d4t+3tc\] * clinical diagnosis of tb requiring rif-based therapy * parent or legal guardian able and willing to provide written informed consent and able to attend study visits. exclusion criteria: * for neonates, less than 42 weeks gestation and 14 days old * concomitant/chronic treatment with potent enzyme-inducing/inhibiting drugs other than those in the study treatments . see appendix e (minor inducers/inhibitors and drugs used as part of management of the condition are allowed eg. steroids) * anticipation at the start that anti-tb treatment duration will be longer than 9 months * any other condition/finding that, in the investigator's opinion, would compromise the child's participation in this study eg. alanine transferase (alt) more than 10 times upper limit of normal (uln), or chronic renal, hepatic or gastrointestinal disease such as malabsorption. * children with known malignancies and contraindications to taking lpv/r * treatment with experimental drugs for any indication within 30 days prior to study entry; participation in another study may be approved by the study team.

Keywords: human immunideficiency virus tuberculosis superboosting lopinavir/ritonavir 1:1 pediatric tb/hiv co-infection
feasibility study: sleuth monitoring system

Conditions: Arrhythmia; Syncope

Summary: the purpose of the study is to evaluate the safety and performance of the sleuth monitoring system.


Eligibility criteria:
inclusion criteria: * age \> = 18 years at time of enrollment * either of the following: 1. mi \> 30 days prior to enrolment and lvef \< = 35% by echocardiography (or nuclear imaging as necessary) 2. syncope of unknown etiology exclusion criteria: * life expectancy \< 12 months following enrollment * active infection

Keywords: cardiac arrhythmia syncope ecg implantable ecg monitor ilr
influence of kinesio tapping on quadriceps muscle peak torque and bioelectrical activity after meniscectomy

Conditions: Meniscus Tear

Summary: a pretest post-test control group design will be used to investigate the effect of kinesio taping on electrical activity and peak torque of the quadriceps femoris muscle during concentric and eccentric contraction after arthroscopic partial meniscectomy (apm) surgery.

fifty patients after apm of any knee of both sexes will participate in this study after signing a written informed consent form approved. from the ethical committee of jazan university. they are selected according to the following inclusion criteria: 1. all performed apm only without any other knee injury. 2. finished the period of hospital stay (6-8 weeks) 3. their age ranged from 20-40. 4. their body mass index ranged from 20-24.9 kg/m². 2- the subjects will be excluded from the study if they had one of th e following exclusion criteria: a- knee or quadriceps disorders preventing physical stress. b- subjects with cardiovascular or neurological problems. c- smokers. d- heavy caffeine intake subjects. 3- the subjects will be randomly assigned into two groups of equal numbers. group a (study) consisted of 66 subjects who will receive kinesio-taping from origin to insertion on the superficial muscles of the quadriceps femoris (qf) (vastus medialis (vm), vastus lateralis (vl), rectus femoris (rf)). - group b (control) consisted of 66 subjects who will receive a placebo kinesio-taping across quadriceps. anthropometric measures including "weight and height" and body. mass index (bmi) will be measured for all subjects in the first meeting before starting the evaluative procedures. all subjects were asked to shave the hair of their thigh before starting the evaluative procedure using blades, which was essential to prevent artifact during emg evaluation and to facilitate the adherence of the tape to the skin. bioelectrical activity and peak torque of quadriceps muscle of the lower extremity that had apm will be measured. the evaluation will be carried out before tapping, and then after the application of tapping for 10 minutes.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis only with arthroscopic partial meniscectomy 2. must be finished a period of hospital stay (6-8 weeks) 3. must have body mass index ranged from 20-24.9 kg/m². exclusion criteria: a. knee or quadriceps disorders preventing physical stress. b- cardiovascular or neurological problems. c- smokers d- heavy caffeine intake subjects.
zinc and selenium supplementation in atherosclerosis

Conditions: Dietary Selenium Deficiency; Dietary Zinc Deficiency

Summary: the aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. the hypotheses tested in this study were: treatment with rosuvastatin impairs zinc and selenium status in patients with atherosclerosis and stable angina? zinc and selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and anti-inflammatory as well as the status of minerals?

the study included 47 men and 29 women, average age around 60 years, with coronary atherosclerosis diagnosed by angiography. data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. the anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative ldl (ldl(-)), anti- electronegative ldl, ac-ldl(-) immune complexes, gpx and sod activities, il-6 and hs-crp were evaluated in all patients.

Eligibility criteria:
inclusion criteria: * the study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina exclusion criteria: * cardiac complications or other serious diseases such as: * thyroid, * hematologic, * congenital, * autoimmune liver disease, * kidney failure, * cancer, * associated infections, * osteoporosis, * post-operative, * use of: * antacids, * antibiotics and * vitamin-mineral supplements, * alcohol and * current smoking.

Keywords: atherosclerosis zinc and selenium status rosuvastatin oxidative stress biomarkers inflammation biomarkers
bromday versus nevanac eye drops to control pain following photorefractive keratectomy

Conditions: Myopia

Summary: this study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (prk) eye surgery.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age, * no other ocular studies with 15 days prior to dosing, * bcva 20/200 or better, * return for study visits and follow instructions from investigator and staff, * self administer test article exclusion criteria: * ocular inflammation, * hypersensitivity to bromfenac or nepafenac, * any corneal pathology, * have had radial keratotomy, * corneal transplant or corneal refractive surgery in the last two years

Keywords: bromfenac nepafenac prk epithelial healing,
a study to evaluate abuse potential of istradefylline

Conditions: Drug Abuse

Summary: this study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users. subjects will participate in an outpatient medical screening visit, a 5-day qualification (drug discrimination) phase, a 6-period treatment phase, and an outpatient safety follow-up visit. study will be approximately 25 weeks total. within 28 days of the screening visit, eligible subjects will be admitted to the cru (day -1) for the qualification phase. during the qualification phase, subjects will receive single oral doses of phentermine 60 mg and matching placebo in a randomized, double blind, crossover manner, with each drug administration separated by approximately 48 hours (day 1 and day 3), to ensure that they can discriminate and show positive subjective effects of the active controls. following evaluation of eligibility, subjects may be discharged (those who fail qualification criteria) or remain in the cru (those who pass criteria and are eligible) and then proceed directly to the treatment phase. the washout interval between last drug administration in the qualification phase and first drug administration in the treatment phase will be at least 96 hours (4 days). following confirmation of eligibility from the qualification phase, subjects will be randomized to one of 6 treatment sequences according to a 6x6 williams square. subjects will receive single oral doses of each of the 6 treatments in a randomized, double-blind, crossover manner, istradefylline 40 mg, istradefylline 80 mg, istradefylline 160 mg, phentermine 45 mg, phentermine 90 mg, placebo. each drug administration will be separated by at least 21 days. serial pharmacodynamic evaluations will be conducted up to 24 hours after each study drug administration to confirm exposure to istradefylline.


Eligibility criteria:
inclusion criteria: * subjects who will provide written informed consent * healthy volunteer, male and female between 18 and 55 years of age, inclusive * subjects with a body mass index (bmi) within 18.0 to 33.0 kg/m2, inclusive * subjects who are recreational drug user exclusion criteria: * subjects who have an alcohol or substance dependence within the 12 months * subjects who have ever been in treatment for substance use disorder * subjects who consume on average more than 5 servings of caffeinated beverages per day * subjects with a history of or presence of any clinically significant cardiovascular disease * subject with hyperthyroidism or glaucoma.

Keywords: recreational stimulant users recreational drug users
electromyographic study for the help and guidance of bonta administration in the treatment of chronic pelvic floor pain

Conditions: Electromyography; EMG: Myopathy; EMG Syndrome; Pelvic Pain; Pelvic Floor Disorders; Pelvic Pain Syndrome; ElectroPhys: Myopathy

Summary: chronic pelvic pain (cpp) is a common presenting complaint affecting approximately 15-40 % of women aged 18-50 in western countries and 5-43% of women in most developing countries. it is debilitating and has a large socio- economic impact, with a 45%reduction in work productivity, and a 15% increase in absence from work in women with the condition. botulinum neurotoxin type a (bonta) has been suggested to improve pain in muscle spasm, its role in cpp secondary to pelvic floor spasm has gained increasing interest. however, clinicians do not have a diagnosis tool to evaluate the cpp and the bonta treatment results. design and develop an efficient and simple tool for the diagnosis and detection of pelvic floor muscle (pfm) dysfunction based on superficial electromyography (emg) and perform 25 emg registrations sessions in healthy patients and 25 emg sessions in patients diagnoses with pfm that will be treated with bonta to and study the emg signal before and after bonta administration.


Eligibility criteria:
inclusion criteria: i. chronic pelvic floor pain (cpd) is defined as pain lasting longer than six months, with absence of proven organic cause and finding of component myofascial present that has been refractory to conventional medical treatment (nsaids) ii. sign informed consent for the administration of bonta iii. authorize to participate in the study iv. patients who agree not to become pregnant during the duration of the study, using effective contraceptive methods exclusion criteria: i. minor ii. pelvic active infection iii. general or pelvic malignant disease iv. psychiatric disease v. contraindication for the administration of bonta vi. patients who participate in another clinical trial and have been administered a investigational medication within 30 days prior to the planned start of the treatment.

Keywords: bonta electromyography emg pelvic pain pelvic pain syndrome