Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of fexofenadine in mild to moderate persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg bid compared to placebo in the treatment of subjects with mild to moderate persistent asthma

the incidence of respiratory allergy in the us has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. histamine is an important chemical mediator of inflammation in asthma. the benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment.

Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-breastfeeding females 12 through 80 years of age * fev1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at visit 1 or visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry) * improvement in fev1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry or documented during the previous 12 months at the study site. * use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use) exclusion criteria: * otherwise healthy
comparison of nocturnal hemodialysis (nhd) and short daily hemodialysis (dhd) with the nxstage® system one™

Conditions: Kidney Failure, Chronic; End-Stage Renal Disease

Summary: the purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the nxstage system one in the home setting.

end stage renal disease (esrd) continues to be a devastating clinical condition. the number of patients in 2004 affected by esrd in the united states rose to 472,000. more than 104,000 new patients began therapy for esrd in 2004 (1.5% greater than in 2003), while the prevalent dialysis population reached nearly 336,000 (3.4% higher). total medicare costs for esrd in 2004 rose to $20.1 billion while non-medicare costs rose to $12.4 billion(1). treatment options for esrd patients are currently limited to either transplantation or dialysis. as daily hemodialysis (dhd) continues to gain widespread acceptance in the dialysis community, there is also renewed interest in nocturnal hemodialysis (nhd) therapy. nhd has the potential to provide certain advantages over both dhd and conventional thrice-weekly in-center hd. nhd typically consists of 6 - 10 hour treatments while the patient sleeps, providing more gentle fluid removal, more time for equilibration, improved hemodynamic stability and superior clearance of larger solutes(2). the proposed study plans to explore whether or not nhd is equivalent to dhd on a per treatment basis, using the nxstage system one in the home setting. 1. united states renal data system 2006 annual data report: atlas of end-stage renal disease in the united states, nih, niddk, bethesda, md, 2006 2. lacson e, diaz-buxo j: daily and nocturnal hemodialysis: how do they stack up? american journal kidney disease, vol 38(2) aug 2001: 225-239.

Eligibility criteria:
inclusion criteria: * patients must have a stable prescription in the short daily home environment using the nxstage system one prior to enrollment. exclusion criteria: * patients are not eligible if: * they are currently enrolled in another drug or device study which could impact the successful completion of this study * they are currently on nhd, or less than 3 months since discontinuing nhd * if they were previously enrolled in this study.

Keywords: esrd end stage renal disease daily hemodialysis nocturnal hemodialysis hemodialysis kidney failure kidney disease
catheter ablation for atrial fibrillation in preserved ejection fraction

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) displays high prevalence in heart failure with preserved ejection fraction (hf-pef) and compromises prognosis of affected patients. this study aims to assess catheter ablation (ca) for af in patients with hf-pef compared to af-patients without systolic or diastolic dysfunction. primary endpoints are freedom from af and quality of life at 1 year. furthermore, the study is designed to elucidate mechanistic characteristics distinguishing arrhythmic substrate and predicting af-recurrence in patients with hf-pef. for this purpose, left atrial concentrations of biomarkers for inflammation, fibrosis and neurohumoral activation are determined and hemodynamic measurements are performed periprocedurally. information on benefit from ca in these patients is necessary for clinical decision making and mechanistic investigations may point to tailored approaches in order to increase therapeutic efficiency.


Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction ≥50% * scheduled for catheter ablation of af exclusion criteria: * significant valvular heart disease * coronary artery disease with \>70% stenoses or necessary coronary intervention at time of recruitment * coronary intervention 60 days before recruitment * coronary bypass surgery 90 days before recruitment * cardiomyopathy or cardiac storage disease (e.g. amyloidosis) * reduced left ventricular ejection fraction * pericardiac disease * significant pulmonary hypertension * chronic obstructive pulmonary disease with home-oxygen-therapy, oral steroids, hospitalization due to exacerbations during the last 12 months before recruitment, or suspected severe pulmonary condition based on clinical evaluation * other non-cardiac conditions associated with limited physical capacity (adipositas permagna, severe anemia) * pregnancy * other limitations for adequate performance of stress echocardiography (e.g. orthopedic reasons)

Keywords: catheter ablation
evaluation of accuracy and ease of use of the filmarray™ respiratory panel (rp ez) in a clia-waived clinical setting

Conditions: Upper Respiratory Infections

Summary: the purpose of this study is to assess the accuracy and ease-of-use of a simplified filmarray respiratory panel test (filmarray rp ez) when performed according to the manufacturer's instructions by personnel in laboratories holding clinical laboratory improvement amendments (clia) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with signs and/or symptoms of a respiratory infection. the study data will be used to support an application to the fda for clia-waived categorization of filmarray rp ez. it is hypothesized that the results of the filmarray rp ez test performed in a laboratory with clia waiver with be 95% accurate when compared to filmarray rp testing performed in a lab with a moderate or high complexity clia certification.


Eligibility criteria:
inclusion criteria: * displays signs and/or symptoms of respiratory infections * adult patients must provide informed consent * parental consent for children (\<18) exclusion criteria: * adult patients unable to provide informed consent * children that are currently in foster care, or are wards of the state

Keywords: multiplex, polymerase chain reaction, pcr, biofire, respiratory infection, infectious disease, point of care, clia waived, rapid diagnostics
cranial electrotherapy stimulation (ces) for soldiers with combat-related symptoms

Conditions: Combat Related Symptoms; Irritability; Anger

Summary: the purpose of this double-blind randomized control research study is to determine if ces given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.


Eligibility criteria:
inclusion criteria: * soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements. * soldiers who score 4 or greater on the visual analog scale for irritability exclusion criteria: * seizure disorders. * pregnancy. all female soldiers will verify in the informed consent that they are not currently pregnant. safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study. * concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study * patients with a pacemaker or implanted defibrillator. the alpha-stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.

Keywords: cranial electrotherapy stimulation anxiety depression pain sleep disturbance combat exposure post traumatic stress health status medication use soldiers
mildronate for acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. this study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

a randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. in addition, both groups were given aspirin as basic treatments. modified rankin scale (mrs) score at 2 weeks and 3 months, national institutes of health stroke scale (nihss) score and barthel index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Eligibility criteria:
inclusion criteria: * (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on ct or mri brain imaging.(ii) were between 18 to 80 years of age (patients \>= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the national institutes of health stroke scale (nihss).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value. exclusion criteria: * (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.

Keywords: randomized trial acute ischemic stroke mildronate
dosing intervals of opioid medication for chronic pain

Conditions: Chronic Pain

Summary: this study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain.


Eligibility criteria:
inclusion criteria: * \>18 years old * willing and capable to give written informed consent * diagnosis of chronic pain (\> 3 months) * current prescription for oxycodone controlled release or hydromorphone controlled release or morphine sustained release for pain * using extended release opioids at intervals less than 12 hours/ more than twice daily exclusion criteria: * ongoing acute pain episode * use of immediate release opioids that contribute to more than 20% of their total daily opioid dose * total daily morphine equivalent dose \>400mg * actively tapering their opioid dose * use of multiple extended release opioid products * unstable psychological diagnosis (using the psychosocial screening interview guide) * outstanding or planned litigation related to pain * pregnancy or lactation in women * history of coronary artery disease * active tapering or titration of benzodiazepines or cannabinoids * positive urine drug screen for amphetamines, barbiturates, cocaine, methamphetamine, methadone, phencyclidine, propoxyphene or unexpected opioids or benzodiazepines * using m-eslon * using long acting hydromorphone * using kadian

Keywords: opioid
efficacy and safety of tabetri on osteoarthritis

Conditions: Osteoarthritis

Summary: this study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.

this study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of jaseng hospital of korean medicine (gangnam, haeundae, daejeon, and bucheon).

Eligibility criteria:
inclusion criteria: * male or female 40 \~ 75 years of age * vas (visual analogue scale) over 30mm * kellgren \& lawrence grade i\~ii by x-ray * subject who agrees to participate in this clinical trial by themselves and signs the informed consent form (icf) exclusion criteria: * subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout) * joint space under 2 mm by x-ray * kellgren \& lawrence grade over iii with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by x-ray * subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases * subjects having gastrointestinal diseases * uncontrolled hypertension patients (blood pressure ≥ 160/100mmhg) * uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl) * patients with tsh \ = 10 uiu/ml * subjects have attended abnormal values at ast or alt (3 times excess at upper limit of the normal values) * subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values) * pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months * use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening * psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse) * history of osteoarthritis treatment therapy within 2 weeks prior to screening * have participated in another clinical trial within the 3 months prior to screening * subjects who have hypersensitivity history about investigational product * have difficulty to be participated in this clinical trial by investigator's decision
evaluation of satisfaction regarding patient's management of ocular surface diseases

Conditions: Eyelid Diseases

Summary: multicentric study, open label, uncontrolled phase iv in 30 patients with meibomian glands dysfunction . its objective is to collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how blephasteam ® can be optimized. this study involves 2 visits, visit of inclusion, j0, then end of study visit, d21. between the two visits patients will be treated with blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility criteria:
* signed and dated informed consent. * male or female up to 4 years old. * known and treated symptomatic meibomian gland diseases, and/or dry eye related to mgds stable since at least a month. * without any active pathology requiring a change in ocular treatments within the last month before inclusion. * best corrected far visual acuity (va) \> 1/10

Keywords: meibomian gland dysfunction
elongation longitudinaux avec decoaption osteo-articulaire (eldoa) in lumbar disc protrusion

Conditions: Lumbar Disc Herniation

Summary: the aim of this randomized controlled trial will be to determine the effectiveness of eldoa for treating lumbar disc protrusion. two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given eldoa, in addition. both, male and female patients meeting the inclusion criteria will be included. patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded

the study is aimed at determining the effects of eldoa in treating disc protrusion at lumbar region and is being conducted in max rehab \& physical therapy centre islamabad and pakistan railway general hospital, rawalpindi (march 2019-june 2019). sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. sealed envelope contained total 34 questionnaires, 17 for each group. patients were allocated randomly on the basis of group mentioned on the performa. similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had eldoa exercises in addition. patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). baseline evaluation for demographics and symptomatology was taken. self-reported questionnaire, odi, nprs, lumbar rom and slr were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

Eligibility criteria:
inclusion criteria: * limited rom (hip/lumbar spine) * pain more than 3 on nprs * pain ≥ 3 months exclusion criteria: * recurrent disc protrusion * spondylolisthesis * spondylosis * malignancy * infection * trauma * marked bony deformities

Keywords: lumbar disc protrusion eldoa oswestry disability index
e-learning to improve oral anticoagulant use in hospitalized older people with af

Conditions: Simulation Training; Anticoagulant Drugs; Elderly; Atrial Fibrillation; Drug Prescriptions; Internal Medicine; Geriatrics

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia and the main cause of cardioembolic stroke. oral anticoagulation (oac) has been shown to significantly prevent af-related thromboembolism, however, despite convincing evidences and current guidelines recommendations, oac tends to be underused in clinical practice especially in the oldest. education and training to appropriately select people suitable for oac for stroke prevention could be pivotal in the decision making process. according to the study project, physicians working in internal medicine and geriatric wards, where are mainly admitted elderly people with af, will undergo to a program of e-learning through computer-based simulation method reproducing clinical scenarios of patients aged 65 years or older, with known or newly diagnosed af, admitted to hospital for any medical reason and requesting that a decision about long-term antithrombotic therapy is taken. primary objective of the study is to investigate whether such educational intervention will improve the appropriate use and prescription rate of oac in hospitalised elderly patients with af, multimorbidity and polypharmacy, in comparison to the usual practice. the study will be a cluster randomised controlled trial involving a network of internal medicine and geriatrics wards. thirty-two wards will be recruited based on voluntary participation and randomised to receive an educational intervention through computer-based simulation, (n=16) or to continue with the usual practice (n=16). subjects receiving the intervention will be all the staff physicians of the wards randomised in the intervention arm. the impact of the intervention compared with the usual practice will be evaluated in patients aged 65 years or older admitted to the participating centres with a known diagnosis of af or newly diagnosed with af during the hospitalisation.


Eligibility criteria:
inclusion criteria: * subjects 65 years of age or older, with known or newly diagnosed af, admitted to the internal medicine and geriatric wards of the reposi network, * consent to participate to the study. exclusion criteria: * consent denial to participate to the study, * absolute contraindication to oac, * re-hospitalisation for the subject already included in the study, * life expectancy less than 6 months.
a trial of shr-1210 (an anti-pd-1 inhibitor) in combination with hypofraction radiotherapy in patients with nsclc

Conditions: Non-Small-Cell Lung Cancer

Summary: this is a phase ii clinical trial of shr-1210 （an anti-pd-1 inhibitor） simultaneously combined with hypofraction radiotherapy in patients with previously treated oligometastatic nsclc. it is a single center, single arm, open label trial. subjects with oligometastatic non-small-cell lung cancer who is previously treated will be recruited. 12 subjects will be enrolled at the first part of the study which aims to evaluate the tolerability of shr-1210 in combination with hypofraction radiotherapy. 30 subjects will be enrolled at the second part of the study which aims to evaluate the primary efficacy and safety of shr-1210 in combination with hypofraction radiotherapy.


Eligibility criteria:
inclusion criteria: * subjects will voluntarily participate in this study and sign informed consent. * nsclc subject with 1 to 5 distant metastatic lesions in stage iv. * no clear driven genes (including but not limited to egfr, alk). * previously received more than 1 chemotherapy regimen and progressed/recurred. * at least one lesion is suitable for hypofraction radiotherapy. * there is at least one measurable lesion. * 18 to 75 years old * ecog 0-1 * the function of vital organs meets the following requirements. anc≥1.5×10\^9/l, plt≥100×10\^9/l, hb≥9g/dl, alb≥3g/dl, tsh ≤uln, bilirubin ≤ 1 times uln; alt and ast ≤1.5 times uln. akp ≤ 2.5 times uln. crea ≤1.5 times uln or ccr≥60ml/min。 * the estimated survival period is more than 3 months. * female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment. exclusion criteria: * the subjects had any history of autoimmune disease or active autoimmune disease. * subjects are using immunosuppressive agents, or systemic, or absorptive, local hormone therapy to achieve immunosuppression.it is still in use within 2 weeks of the entry. * subjects with severe allergic reactions to other monoclonal antibodies. * the subjects had a central nervous system metastases of clinical symptoms. * central squamous cell lung carcinoma. * imaging (ct or mri) shows that tumors invade large blood vessels or are indistinct with blood vessels. * imaging (ct or mri) showed significant pulmonary vacuity or necrotic tumors,borderline adenocarcinoma accompanied by a cavity can be considered after discussion with investigator. * failing to properly control the clinical symptoms or disease of the heart. * subjects had active infections. * subjects may receive other systemic antitumor therapy during the study period. * other clinical trials of drugs were used in the first four weeks of the first medication.

Keywords: shr-1210,radiotherapy,oligometastases,nsclc