Kornimate/medical-research-clean huggingface dataset:
bepotastine besilate nasal sprays in the treatment of seasonal allergic rhinitis (sar)

Conditions: Seasonal Allergic Rhinitis

Summary: this study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (sar) and a demonstrated history of allergic sensitivity to mountain cedar pollen for at least 2 years prior to the study.


Eligibility criteria:
inclusion criteria: * the subject is a male or female 12 years of age or older. * have a documented history of sar resulting from exposure to mountain cedar pollen for a minimum of 2 years immediately preceding screening visit 1. * have demonstrated sensitivity to mountain cedar pollen through a standard skin prick test. * have a minimum rtnss of at least 6 units for the morning (am) assessment on the day of visit 2 and visit 3. * have a minimum average rtnss score of at least 6 units for 3 of the worst 4 days prior to visit 3 plus the am assessment on the day of visit 3. * have a minimum stuffy nose score of at least 2 units on the day of visit 3. * have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to visit 3 plus the am assessment on the day of visit 3. * have at least one score ≥ 2 units at visit 3 of any of the rqlq(s) questions #4-#6 regarding sleep. exclusion criteria: * have a nasal condition which, in the opinion of the investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to screening visit 2. * have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist. * is participating or have participated in any investigational drug or device study within 30 days preceding visit 2. * have had nasal or sinus surgery within 12 weeks of visit 2. * have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (ip). * for female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
noninvasive measurement of cardiac output in pulmonary hypertension using inert gas rebreathing

Conditions: Pulmonary Hypertension

Summary: the study hypothesis is that accuracy of co measurement by igr does not differ from classical co measurement methods such as thermodilution or direct fick method. this is why the study aims to determine whether non invasive cardiac output (co) measurement using inert gas rebreathing (igr)is a suitable method in patients with pulmonary hypertension. in order to examine this, the igr method will be used in patients undergoing diagnostic or follow-up right heart catheterization.

inert gas rebreathing method enables non invasive measurement of cardiac output (co) using the single rebreathing method. a mixture of blood soluble (n2o) and blood insoluble gas (sf6) and environmental air is inhaled and the amount of n2o, sf6, o2 and co2 is measured by a photoacoustic analysator. the length of a measurement is about 1 minute. as the gold standard measurement of co is performed invasively, there is an urgent need for the development of non-invasive tools like igr.

Eligibility criteria:
inclusion criteria: * written informed consent * patients who undergo right heart catheterization exclusion criteria: * missing written informed consent
posterior capsulotomy in cataract complicated with primary posterior capsule opacification.

Conditions: Cataract; Posterior Capsule Opacification

Summary: this is a two-arm, parallel group, open-label, randomized controlled trial to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (ppco).

primary posterior capsular opacification (ppco) refers to the posterior capsule opacification which cannot be removed by polishing or vacuuming during cataract surgery. the surgeon may have to decide on primary posterior capsulorhexis or early neodymium-doped yttrium aluminum garnet (nd:yag) laser capsulotomy in these cases. the aim of this study is to compare the visual acuity, visual quality, operative complications and the satisfaction of patients between primary posterior capsulorhexis group and laser capsulotomy group of cataract patients combined with primary posterior capsular opacification (ppco).

Eligibility criteria:
inclusion criteria: 1. cataract patients with primary posterior capsular opacification, which involves the central posterior capsular and interferes with visual axis; 2. aged 18 years or over; 3. with best corrected visual acuity (bcva) less than 0.3. exclusion criteria: 1. history of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery. 2. cases with operative complications, including anterior or posterior capsular rupture, lens suspensory ligament rupture, the falling of lens nucleus into vitreous cavity. 3. unwillingness to participate in the study.

Keywords: phacoemulsification cataract primary posterior capsule opacification posterior capsulotomy randomized controlled trial nd:yag laser capsulotomy
chronic non bacterial prostatitis: a trial of trus guided injection of betamethason

Conditions: Chronic Non Bacterial Prostatitis

Summary: trus guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment

chronic non bacterial prostatitis is usually due to congestion combined with severe inflammatory process of the prostate, it is usually a recurrent bothersome problem, so patients who fail to response to classic medical treatment are expected to benefit from a strong anti inflammatory injection like betamethasone, which has strong anti inflammatory plus anti oedematous properties so limitation of this inflammatory process across the prostate is expected to relieve the patients symptoms

Eligibility criteria:
inclusion criteria: * chronic non bacterial prostatitis who failed medical treatment exclusion criteria: * chronic bacterial prostatitis patients
rhupus syndrome and efficacy of etanercept treatment

Conditions: Rhupus Syndrome, Etanercept

Summary: between march 2013 and march 2014, rhupus patients were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. the follow-up time of the study was 24 weeks.

between march 2013 and march 2014, patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (dmards), with a disease activity score in 28 joints (das28) \>5.1 were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. the follow-up time of the study was 24 weeks.

Eligibility criteria:
inclusion criteria: - rhupus patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (dmards), with a disease activity score in 28 joints (das28) \>5.1 exclusion criteria: - those who had participated in other studies
acrodat prospective evaluation study

Conditions: Acromegaly

Summary: acrodat® is a new software medical device developed by a group of acromegaly experts to help practising endocrinologists assess disease activity in patients with acromegaly. it uses 5 key parameters (igf-i level, tumour status, comorbidities, symptoms and quality of life) to evaluate the patient's health status. the purpose of this post marketing surveillance study is to prospectively evaluate whether patients monitored by acrodat® with appropriate clinical decisions based on disease activity status will benefit from improved treatment outcomes both in the short and in the long term.

this is an international, multicentre, randomised, non-interventional, collaborative post marketing surveillance study to assess the clinical use of the newly developed software medical device named acrodat®. patients newly enrolled will be followed-up over a 2 year period. patients will be assigned to the acrodat® group or the standard practice group according to a central randomisation. patients assigned to the acrodat® arm will be followed up with the treating physician using acrodat® at every visit. the frequency of visits will be according to standard practice in the clinic. patients not followed up with acrodat® will be followed-up in accordance with the standard medical practice of the hospital where they have been recruited, until study completion (standard practice arm).

Eligibility criteria:
inclusion criteria: 1. all patients with a confirmed diagnosis of acromegaly, aged 18 years or over, pre-treated and treatment naïve; 2. a follow-up visit is scheduled or anticipated for the patient at least once every year; 3. evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of and consented to all pertinent aspects of the study. exclusion criteria: 1. patients who are surgically cured and remain controlled for at least 3 years; 2. patients who are unable to understand the nature of the study and/or unwilling to sign an informed consent; 3. patients who are unwilling to abide by the guidelines of the study; 4. patients participating in any clinical trial on an investigational medicine or software medical device/evaluation tool for acromegaly.

Keywords: insulin-like growth factor-i (igf-i) growth hormone (gh) disease control
ascending single doses of erenumab (amg 334) in healthy adults and migraine patients

Conditions: Migraine

Summary: the primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. as part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (pk) profile of erenumab after single subcutaneous (sc) or intravenous (iv) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single sc or iv doses in healthy participants and migraine patients.

this study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts. in part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (ip) as an sc administration and 1 cohort received it as an iv administration. in part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. an additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.

Eligibility criteria:
inclusion criteria: - healthy male and female subjects between 18 and 45 years of age, or male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the amgen physician; exclusion criteria: - history or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the investigator or amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

Keywords: migraine
efficacy, safety, and tolerability study of apremilast to treat early oligoarticular psoriatic arthritis.

Conditions: Arthritis, Psoriatic

Summary: this clinical study will test the effects of a drug called apremilast in oligoarticular psoriatic arthritis with less than 5 years of disease duration. in previous studies, apremilast has been shown to be safe and efficacious in reducing signs and symptoms of psoriatic arthritis, as well as improving physical function. this study will compare the effects of apremilast to placebo on psoriatic arthritis subjects in which the number of affected joints is limited (greater than 1 but less or equal to 4). about 285 patients worldwide will take part in this study.


Eligibility criteria:
inclusion criteria: * ≥ 18 yrs, male or female subject * subjects must have signs and symptoms of psa ≤5 years duration at the time of the screening visit * sjc and tjc must be \>1 and ≤ 4 * for all regions, the local regulatory label for treatment with apremilast must be followed. * stable doses of protocol-allowed psa medications * general good health (except for psoriatic arthritis) as judged by the investigator, based on medical history, physical examination, and clinical laboratories. (note: the definition of good health means a subject does not have uncontrolled significant comorbid conditions). * comply with protocol-required contraception measures * subject meets the classification criteria for psoriatic arthritis \[caspar\] criteria for psa at the screening visit exclusion criteria: * prior use of \>2 csdmard to treat psa * prior exposure to a jak-inhibitor and/or a biologic dmard. * use of intra-articular (ia) or intra-muscular (im) glucocorticoid injection within 8 weeks before the baseline visit. * use of leflunomide within 12 weeks of randomization. subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the baseline visit may enter the study. * prior use of cyclosporine. * prior treatment with apremilast, or participation in a clinical study, involving apremilast. * use of any investigational drug within 4 weeks of the baseline visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).

Keywords: oligoarthritis psa apremilast oral tablet background therapy standard of care
hemodynamic changes during implant surgery with intravenous conscious sedation

Conditions: Blood Pressure; Dental Anxiety

Summary: the goal of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during periodontal/implant surgery compared to receiving local anesthesia during periodontal/implant surgery

monitoring is the global method of observation and data recording in relation to body organ and system function that afford constant information to ensure continuous evaluation of the patient's physical condition. the aim of this study is to determine whether intravenous sedation would contribute to the stabilization of hemodynamics in adult patients during dental surgery. secondary, patient related outcome will be evaluated by a questionnaire to determine the patients' perception, acceptance and comfort during intravenous sedation after assessing the influence of patients' preoperative anxiety. 50 subjects who need implant/periodontal surgery at the university of michigan school of dentistry will be recruited for this study.

Eligibility criteria:
inclusion criteria: * be ≥ 18 years of age * need dental implant/periodontal surgery with or without iv sedation (up to a maximum of 4 implants) exclusion criteria: * you have any reason you cannot comply with the study protocol * you take any medication that may influence hemodynamic changes including anxiolytic medication (last intake \<48 hours before intervention) as well as pain medication (last intake \<48 hours before intervention) * pregnant or unsure of pregnancy (self-reported)

Keywords: dental surgery intravenous sedation
predicting the lens capsular bag size using pre-operative biometry

Conditions: Cataract Senile

Summary: aim of this study is to assess whether a high-resolution scan of the crystalline lens before surgery may be helpful in predicting post-operative capsule bag diameter.

most of the measurement procedures used in this study are non-invasive and all are used in standard routine clinical practice, the benefit/risk ratio appears acceptable. however, a capsule tension ring will be used. a ctr is not used routinely, usually only in cataract operations in which the lens capsule is not stable enough - in other words, for stabilization. the insertion of the ctr is problem-free in most cases. in extremely rare cases, however, the lens capsule may be injured. and document complications will be collected, report them in a final paper. the ctr used in the study is a standard device and ce-marked device. studies using ctr showed that it is beneficial in difficult cases. gonioscopy after cataract surgery will be performed after 1 week. at this time point the wound is already sealed and there appears to be no increased risk to the patient. in the first study performed in a similar fashion in 1999 gonioscopy was performed one day after surgery. aim of this study is to predict the diameter of the capsular bag using pre-operative optical biometry findings. this is a prospective, observer-blind and monocentric study that includes patients scheduled for cataract surgery. recruitment will take part on the day of pre-assessment. for each patient only one eye will be included. in total 50 eyes of 50 patients will be included, of which at least 5 eyes with an axial eye length below 22.5mm and 5 eyes with an axial eye length above 25.0mm.

Eligibility criteria:
inclusion criteria: * patient scheduled for cataract surgery * well dilated pupil at the pre-assessment visit (dilated pupil size at least 6.0mm) * age 21 and older * pre-operative visual acuity of at least 0.25 snellen exclusion criteria: * parameters that influence the capsular bag stability (pseudoexfoliation syndrome, st. p. severe eye trauma, phakodonesis) * in women of childbearing age, a pregnancy test will be performed before inclusion into the study.

Keywords: capsular bag
etiology of anemia

Conditions: Anemia

Summary: this study looks at the causes of anemia in adults of all ages who are referred by their primary care physician.

this study is being done to determine if the range of causes of anemia changes with advancing age. the goal of this study is to apply research methods to see if causes of anemia can be determined in patients where a clear cause is not found with routine clinical testing available to all patients in physician offices. participants in this study will be evaluated at the nia-astra unit at harbor hospital in baltimore. testing will consist of both diagnostic and research blood and urine testing along with history and physical exam. an optional bone marrow aspirate or aspirate and biopsy may be performed if the patient permits and it is indicated for either research or clinical diagnostic purposes. all study information supporting a specific diagnosis will be provided to the patient and, at their request, to their primary care physician if specific treatment is indicated.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * hemoglobin (hgb) less than 13 in males and females exclusion criteria: * pregnant or nursing women * participation within the past six weeks in another research study which the principal investigator believes is incompatible with this study

Keywords: aging
pilot trial of surfactant booster prophylaxis for ventilated preterm neonates

Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Summary: a research study that will evaluate if giving surfactant medication to premature babies weighing \< 1250 gm at birth during the second and third weeks of life will help their lungs. we are enrolling those premature babies who continue to require the breathing tube and the mechanical ventilator at days 7-10 of life.

pulmonary surfactant is required for normal lung function. data from a previous study suggest that as many as 75% of chronically ventilated extremely low birthweight premature infants have at least one episode of surfactant dysfunction beyond the first week of life, as measured in vitro, associated with a low surfactant protein b content. furthermore, episodes of surfactant dysfunction are significantly associated with clinically significant respiratory decompensations. we hypothesize that booster doses of surfactant given during the second and third week of life to extremely low birth weight premature infants requiring persistent intubation and mechanical ventilation will improve their respiratory status during the first 28 days of life. we propose to enroll premature infants \< 1250 gm birthweight, between days 7 and 10 of life who are intubated, and mechanically ventilated. infants requiring persistent intubation and mechanical ventilation for respiratory support at 7-10 days of life will receive a total of 3 doses of infasurf surfactant, 3 days apart, at the standard dose of 3 ml/kg. primary outcome is the change in area under the respiratory severity score curve between days 7 and 28 of life. total sample size is 88 infants, study duration is 36 months, and recruitment of study patients will occur at the hospital of the university of pennsylvania, in philadelphia pa, women and children's hospital in buffalo, st. louis children's hospital in st. louis mo, mercy children's hospital in kansas city, oakland children's and alta bates medical center in berkeley, ca and long island jewish medical center, ny.

Eligibility criteria:
inclusion criteria: * less than or equal to1250 gm birthweight * day 7-10 of life * intubated and mechanically ventilated at day 7-10 of life exclusion criteria: * infants intubated solely for apnea * serious congenital malformations * life expectancy \< 7 days from enrollment * pulmonary hemorrhage at time of enrollment * active air leak syndrome at time of enrollment * bilateral grade iv intracranial hemorrhage * postnatal systemic steroid therapy for lung disease note: prior surfactant therapy at birth is neither an inclusion nor exclusion criterion.

Keywords: prematurity lung disease hyaline membrane surfactant
comparing two different modes of ventilation in pretem neonates bilevel vg and prvc

Conditions: Newborn Morbidity; Respiratory Failure; Bronchopulmonary Dysplasia; Mechanical Ventilation Complication

Summary: intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with prvc ventilation mode, basal blood gases and work of breathing will measured. after that mode will shift to bilevel volume guarantee mode for two hours than clinical and other parameters will be checked again. after this intervention, patients will allocated to prvc or bilevel vg group for remaining time.


Eligibility criteria:
inclusion criteria: * need for mechanical ventilation * 800-1200 grams of birthweight * surfactant received * under 32 weeks of gestational age exclusion criteria: no need to intubation congenital anomalies -
investigation of anatomical correlates of speech discrimination

Conditions: Sensorineural Hearing Loss

Summary: understanding speech is essential for good communication. individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. the purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. this information may be used as a predictor of hearing aid benefit. the investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.


Eligibility criteria:
inclusion criteria: * normal hearing to moderate sensorineural hearing loss * sufficient english proficiency to complete speech discrimination testing in english exclusion criteria: * hearing loss less than a 45 db hl pure tone average (average hearing thresholds at 500, 1000 and 2000 hz) * conductive hearing loss * neurodegenerative disease

Keywords: "hair cell" "hearing aid" "hearing loss" "auditory nerve" synaptopathy "outer hair cell" "otoacoustic emission"