Kornimate/medical-research-clean huggingface dataset:
a non-inferiority, comparative study between foraseq®, eurofarma´s formoterol/budesonide and alenia® in asthma

Conditions: Asthma

Summary: the primary objective will be to compare the eurofarma and alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

the primary objective will be to compare the eurofarma and alenia formulations regarding their impact on the pulmonary function of mild to moderate persistent asthma patients and the secondary objective will be to compare the three study formulations regarding the clinical control of the symptoms and the patients' compliance to the treatment.

Eligibility criteria:
inclusion criteria: * sign the icf; * ≥ 12 years old; * have a diagnosis of mild to moderate persistent asthma diagnosis, as per the gina classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month with the acq-7 test \<3,0; * current use of inhaled corticosteroid (equivalent to 1000 µg of beclomethasone dipropionate) whether associated or not with long-term β2 adrenergics and relief medication (salbutamol or equivalent); * initial fev1 of at least 50% of the normal value expected; * serum cortisol evaluation within the normal limits exclusion criteria: * use of oral or parenteral corticosteroid within the last 3 months before the study; * hospitalization needed due to asthma within the last 3 months before the study; * active smokers, defined as the consumption of cigarettes, pipes, cigars, or any other form of smoking in any amount within the last 3 months; * presence of serious co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatologic, neurological, or psychiatric disease, or chronic respiratory disease other than asthma; * recent participation (\<6 months) or expected participation in other clinical trials involving drug products of any nature or in studies consisting of any form of intervention for the treatment of asthma; * intolerance or allergy to any component of the drugs evaluated in the study; * pregnant or lactating women; * chronic use of routine β-blockers orally or intravenously, including ophthalmic solutions.
early diagnosis of postoperative acute renal failure-using biomarker to predict outcome of cardiac surgery associated acute kidney injury

Conditions: Acute Renal Failure; Acute Kidney Injury

Summary: the purpose of this study is to determine soluble hjv could be an early diagnosis urinary biomarker of ischemia/reperfusion injury in post cpb-patients.

acute kidney injury (aki) is a common syndrome on intensive care unit, and renal dysfunction would result in a further morbidity and mortality. critical ills complicated with acute kidney injury are usually accompanied with multi-organ failure. therefore, national taiwan university hospital study group of acute renal failure (nsarf) realizes that the characteristics of aki is resulted from the perfusion less of body fluid and attempt to develop therapies to prevent or attenuate aki, which have had limited success. we attempt to use the novel biomarker soluble hemojuvelin (shjv) to evaluate the iron homeostasis on acute kidney injury and develop new strategies and therapies such as protease inhibitors on kidney function, as safety markers to monitor toxicity and as measures of treatment effect. besides, we will focus on validation the sensitivity and specificity of shjv on the clinical specimen of post-operative patients from nsarf data-bank. merge the renal function and other types of biomarkers as panel to predict the post-operative outcome. based on the different expression of these markers, using a panel of serum and urine markers may potentially help us to distinguish between various types of insults, establish the duration and severity of injury, predict the clinical outcome and help to monitor response to treatment in aki.

Eligibility criteria:
inclusion criteria: * aki is defined as a serum creatinine level greater that 50% more than baseline during the first 3 postoperative days (pods), and non-aki, as a less than 10% increase. exclusion criteria: * patients with chronic kidney disease (baseline estimated glomerular filtration rate \ 100 mg/mmol) are excluded.

Keywords: proteinuria predict outcome bnp and ngal predict outcome pre-operative gfr and proteinuria
arthroscopic debridement versus autologous cytokine rich serum for the treatment of lateral epicondylitis

Conditions: Epicondylitis, Lateral

Summary: this study aims to compare arthroscopic resection (surgical intervention) versus infiltration of cytokine rich serum (crs) (proteins derived from the patient's own blood) for the treatment of lateral epicondylitis (le).

lateral epicondylitis (le) is a common debilitating condition that affects the extensor muscles of the forearm at its junction with the lateral humeral epicondyle. this pathology is commonly treated by a surgical intervention. however, advances in research have allowed the discovery of new and less invasive techniques for its treatment, for example the infiltration of cytokine rich serum. the aim of the study is to compare the common treatment of this pathology, arthroscopic resection (surgical intervention) with a new technique, infiltration of cytokine rich serum (crs) (proteins derived from the patient's own blood) with respect to medium and long-term pain reduction. the study will include a total of 86 patients. patients will be included by randomization into two groups: * group 1: 43 patients will be treated with 2 infiltrations of cytokine rich serum. * group 2: 43 patients will be treated by a regular surgical treatment consisting of arthroscopic resection. the main objective of this study is to evaluate the efficacy of crs as compared to arthroscopic resection in reducing pain in the medium term (6 months) in patients with chronic lateral epicondylitis.

Eligibility criteria:
inclusion criteria: * over 18 years of age * patients with persistent pain (eva \> 5) at lateral epicondyle level of at least 3 months duration. * patients with a diagnosis of chronic lateral epicondylitis confirmed with a complementary diagnostic test such as echo or mri. * availability to follow the study protocol for up to 24 months. * patients with the ability to understand study information and give informed consent. * patients who sign informed consent. * normal hematologic parameters. exclusion criteria: * local infection present. * patients who have been treated with corticosteroid infiltrations in the same area in the past 4 months. * patients who have received treatment with growth factors, prp, cytokines, or new drug treatments in the same area in the last 12 months. * pregnancy or breast-feeding. * neoplastic disease. * patients being treated with immunosuppressants (medical evaluation). * patients undergoing arthroscopic surgery of the same elbow. * active liver disease. * immunosuppressive or immunodeficiency states. * coagulation deficit or abnormalities. * thrombocytopenia. * treatment with anticoagulants. * difficulty understanding and following study procedures. * participation in a clinical trial with medications.
study of hemostasis during the atrial fibrillation ablation procedure

Conditions: Hemostasis

Summary: anticoagulation monitoring is done by monitoring the act (activated clotting time) with an objective greater than 300 s. until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. however, 3 recent randomized studies concerning the 3 doacs available suggest that treatment should not be interrupted during the entire operative period. the operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. under these conditions, act monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. it was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of ufh (unfractionated heparin) during the procedure.


Eligibility criteria:
inclusion criteria: * patients over 18 years-old * with an atrial fibrillation * operated for an atrial fibrillation procedure in the university hospital of strasbourg * without interruption of the direct oral anticoagulant * for whom extended biological assessment has been made in routine practice exclusion criteria: * patients who refused the use of their data for this study

Keywords: atrial fibrillation ablation act heparin direct oral anticoagulant
dose-response effects of whole body vibration on spasticity and walking in sci

Conditions: Spinal Cord Injury

Summary: this study will enroll people with sci who have spasticity and some ability to walk. the goal is to understand if standing on a platform and receiving wbv results in decreased spasticity and improved walking ability. published article is available (pmid: 29959653)

phase 1 of this study has been successfully completed. the results of phase 1 indicate that a single session of wbv lasting for a total of 6 minutes (delivered in eight 45-sec bouts) at a high-frequency (50hz) was associated with the largest decrease in spasticity (as measured by the pendulum test). the goal for phase 2 is to determine whether longer doses of wbv result in greater reductions in spasticity as well as improvements in walking ability. two different doses of wbv, a short dose and a long dose, will be tested.

Eligibility criteria:
inclusion criteria: have spinal cord injury of at least 6 months duration; be between the ages of 16 - 72 years old; be able to sit at the edge of the mat without the assistance of another person; be able to tolerate standing; have at least mild spasticity affecting the lower extremity muscles; be able to understand and provide own consent; you may participate if you use prescription medications, including baclofen pump for control of spasticity, as the dosage is stable; obtain medical clearance for standing if you have been injured more than 1 year and are not regularly walking or standing. exclusion criteria: progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord; neurologic level below spinal level t12; history of cardiovascular irregularities; problems following instructions; orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)

Keywords: spasticity whole body vibration walking
efficacy of clean intermittent catheterization (cic) in multiple sclerosis (ms) patients with bladder dysfunction

Conditions: Bladder Dysfunction; Multiple Sclerosis

Summary: the aims of this prospective, randomized study are: * to assess the effect of clean intermittent catheterization (cic) * to investigate if ms patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using cic in combination with anticholinergic drugs * to identify at what volume of postvoid residual (pvr) urine, starting cic improves bladder control and qol * to increase the evidence of cic, and support clinical guidelines of bladder management in ms patients


Eligibility criteria:
inclusion criteria: * provision of informed consent * male and female patients aged 18 years and over * ms patients that are already currently treated or eligible for treatment with anticholinergic drugs * patient with previously confirmed multiple sclerosis according to mcdonald criteria and level of disability less than 6.5 on the kutzke scale and have been stable for 6 months * the patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, pvr * the patient has frequency symptoms \> 8 voiding per 24 h * the patient has pvr \> 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit * adequate mobility to lower limbs, sufficient hand function and ability to practice cic at least three times daily exclusion criteria: * pregnancy * ongoing symptomatic urinary tract infection (uti) as judged by investigator * involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study site) * the patient practices cic prior the study * the patient has undergone a sphincterectomy * progressive "relapsing- remitting ms" as judged by the investigator * severe non-compliance to protocol as judged by the investigator and/or astra tech * the patient is participating in other study that might have an impact on the outcome of this, as judged by investigator * pvr \> 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if bladder voiding efficiency (bve) at visit 2 (randomization) is 50% or less than visit 1 (screening)
the influence of preventive regimens containing different toothpastes on caries risk of high risk patients: a randomized clinical trial

Conditions: Prevention of Dental Caries

Summary: 66 participants will be divided into three groups according to the tested regimen (a), where (a1) represents participants will be exposed to regimen including dual zinc plus arginine based toothpaste (colgate total), (a2) represents participants will be exposed to regimen including zinc based toothpaste (crest complete) and (a3) represents control group where participants will be used fluoride based toothpaste (signal). the study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: t0) and second visit (after 3 months: t3) . in addition assessment of dmf scores will be done in four visits: first visit (baseline: t0), second visit (after 3 months: t3), third visit (after 6 months: t6) and final visit (after 12 months: t12) to obtain the required data


Eligibility criteria:
inclusion criteria: * • normal adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history. * subjects of mean age 20-50 years. * patients with high caries risk assessment according to cariogram. * non cariogenic diet patient * high plaque index * not under antibiotic therapy either at the time of the study or up to the last month before the start of the study. exclusion criteria: * • patients with a compromised medical history. * cariogenic diet patient. * participants with severe or active periodontal disease. * participants with a history of allergy to any of the drugs or chemicals used in the study. * patients on any antibiotics during the past month
a 1-year study in adolescents to assess the long-term safety of almotriptan malate when treating their migraine headaches

Conditions: Migraine

Summary: the purpose of this study is to evaluate the long-term safety of almotriptan malate (a migraine headache medication) in the treatment of migraine headaches in adolescents for up to one year.

almotriptan malate, and several other treatments for migraine headaches, known as triptans, are approved for the treatment of migraine headaches in adults. to date, none of these have been approved by the food and drug administration (fda) for use in adolescents. this is an open-label, multi-center study that will enroll approximately 450 patients aged 12 - 17 years old with a history of one to 14 migraines per month for the 6 months prior to entering the study. the total study duration will be up to one year. there is a screening phase to determine if the patient is eligible for study entry, followed by an open-label treatment phase that can last up to one year. almotriptan malate 12.5 mg tablets will be used to treat all migraine headaches during the study, as needed. the primary outcome of the study is an assessment of the long-term safety of almotriptan malate in adolescent migraine sufferers. the study hypothesis is that the almotriptan malate will be safe and well tolerated in the treatment of adolescent migraine headaches. safety measurements will be performed at set time points during the study and will include laboratory tests, physical and neurological exams, electrocardiograms (ecgs) and the incidence of adverse events. a diary will be completed by the patient for each migraine headache for which they take almotriptan malate. migraine pain information and almotriptan malate use will be recorded in the headache diary. an equal number of patients in the 12 - 14 year old range as the 15 - 17 year old range will be enrolled. patients will take one 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain. the dose may be repeated once if the pain continues 2 hours after the first dose, but no more than 2 doses can be taken within a 24-hour period. study medication will be taken for up to one year.

Eligibility criteria:
inclusion criteria: * have a history of migraine for at least one year * have an average of 1 - 14 migraines per month for the 6 months prior to study entry * able to swallow oral medication * able to complete a headache diary * only taking one migraine preventive medication and on the same dose of that medication for at least 30 days before entering the study) exclusion criteria: * have an allergy to almotriptan malate or have stopped taking almotriptan malate due to side effects * have 15 or more days within a month in which you have a headache * usually experience migraine aura (most common symptoms being visual disturbances or tingling sensations before migraine pain begins) without a headache * experience more than 6 non-migraine headaches per month

Keywords: migraine almotriptan malate headache triptan
dehydration of omafilcon a contact lenses versus delefilcon a contact lenses

Conditions: Myopia

Summary: the study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

the study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. the primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Eligibility criteria:
inclusion criteria: 1. is at least 17 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months. 5. is able to wear lenses for at least 12 hours a day. exclusion criteria: 1. is participating in any concurrent clinical study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 6. has undergone refractive error surgery; * \*for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
adjuvant chemotherapy for high-risk postenucleation retinoblastoma

Conditions: Retinoblastoma

Summary: the purpose of this study is to determine the effect of 3 cycles of chemotherapy(cev) in the treatment of stage i enucleated retinoblastoma.

this study will be a phase ⅲ open label interventional case series. patients with stage i enucleated retinoblastoma will receive 3 cycles of chemotherapy(cev) oon a monthly basis. patients will be followed for 60 months.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study. * definite pathology signs of retinoblastoma, stage i base on international retinoblastoma staging system. * received enucleation in the study eye. * monocular retinoblastoma. exclusion criteria: * any previous disease in the study eye. * previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals). * history of chemical intervention for retinoblastoma in the study eye.
retrospective data analysis of data from the zurich ph registry

Conditions: Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension; Pulmonary Artery Hypertension

Summary: the collected data from the zurich registry for pulmonary hypertension (ph) are evaluated in a retrospective analysis. this study examines the number of patients and their exact diagnoses who are treated at the university hospital of zurich and potentially other participating in the zurich registry. other demographic parameters such as age, gender and body-mass-index are also part of the evaluation. furthermore, the analysis will focus on the newest guidelines on ph. therefore, it will be checked how many patients would fulfill the therapeutic goals in terms of new york heart classification (nyha), 6-minute walk distance, sign of right heart failure and n-terminal pro-brain-natriuretic peptide(ntprobnp). additionally, the study examines on how the patients are treated. despite the different kind of drugs, the focus lies on the combination therapy (single, double, triple) and the impact the therapy had on the patients.


Eligibility criteria:
inclusion criteria: * patients with pulmonary arterial hypertension (pah) * patients with chronic thromboembolic pulmonary hypertension (cteph) * all prevalent patients (diagnosed \>12 month ago) with pah or distal cteph who had a consultation at the ph centre in zurich between november 2015 and november 2016) exclusion criteria: -