Kornimate/medical-research-clean huggingface dataset:
tranexamic acid for total knee arthroscopy

Conditions: Blood Loss, Surgical

Summary: the purpose of this investigation is to determine the most effective regimen of administration of tranexamic acid to improve clinical outcome among patients undergoing total knee arthroplasty.

tranexamic acid (txa) is synthetic lysine analog, which acts as anti-fibrinolytic agent by preventing conversion of plasminogen in to plasmin. various regimens of txa administration (routes, doses, timing) have been used to decrease perioperative blood loss and improve clinical outcomes among patients undergoing different orthopedic surgeries. we are conducting this prospective randomized placebo controlled trial to compare the effect of the two most common regimens of txa administration on hemostasis and clinical outcomes among patients undergoing total knee arthroplasty. all recruited patients receive the first dose of 15mg/kg of iv txa prior to skin incision. the second dose of 15mg/kg iv txa or identical placebo is administered prior to the release of the tourniquet. the assessment of hemostasis is performed using whole blood sample via viscoelastic testing by rotational thromboelastography (rotem). a blood sample is collected in the preoperative area and after the administration of each dose of txa. clinical data is collected until 90 days after surgery.

Eligibility criteria:
inclusion criteria: - adult patients who are scheduled to undergo total knee arthroplasty will be approached to participate. exclusion criteria: * known allergy to txa * history of venous or arterial thrombosis within 12 months * history of thromboembolic event within 12 months * acute ischemic event (stroke, transient ischemic attack, myocardial infarction, ischemic retinopathy) within 6 months * known congenital thrombophilia relative contraindications: * history of seizures * impaired kidney function (glomerular filtration rate \< 30 ml/min)
revaccination with pollinex® quattro

Conditions: Allergic Rhinitis

Summary: the purpose of this non interventional study (nis) was to observe the efficacy of pollinex® quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.

the increasing prevalence of allergies represents a major problem for the health care system. approximately 500 million people are suffering worldwide from allergic rhinitis (ar). allergic rhinitis is a type 1 hypersensitive disorder, initiated by ige antibodies. whereas seasonal allergic rhinitis (sar) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (par) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair. specific immunotherapy (sit) presently constitutes the only causal therapy available and is common practice. sit is indicated in cases of ige-mediated allergic diseases and includes two forms of treatment options: subcutaneous (scit) and sublingual immunotherapy (slit). both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them. even though allergy vaccinations have been applied for a century, the commonly used scit requires up to 90 injections over three to five years. pollinex® quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. the immunological effect associated with pollinex® quattro shows an increase of allergen-specific igg antibodies and a decrease of allergen-specific ige antibodies as well as a shift from a th2 to a more th1 type-immune reaction. previous studies on the therapeutic efficacy of pollinex® quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. as an ultra-short course scit, pollinex® quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy. in this non-interventional study, patients who were treated with pollinex® quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from may to july. for this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia

Eligibility criteria:
inclusion criteria: * adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (sar) caused by grass pollen. a previous specific immunotherapy finished at least five years ago had to be successful. exclusion criteria: * contraindications according to the patient information leaflet

Keywords: recurrent grass pollen allergy pollinex® quattro
a study to determine the efficacy and safety of fasinumab for the treatment of adults with chronic low back pain

Conditions: Low Back Pain

Summary: the main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily low back pain intensity (lbpi) numerical rating scale (nrs). secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: * change from baseline in the roland morris disability questionnaire (rmdq) total score * change from baseline in the patient global assessment (pga) of low back pain (lbp) score * change from baseline in the average daily lbpi nrs score


Eligibility criteria:
key inclusion criteria: 1. male or female ≥35 years of age at the screening visit 2. clinical diagnosis of chronic moderate to severe lbp (nonradiculopathic)for ≥3 months 3. history of regular analgesic medication 4. history of inadequate pain relief or intolerance to analgesics used for chronic lbp 5. willing to discontinue current pain medication key exclusion criteria: 1. history of lumbosacral radiculopathy within the past 2 years 2. evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions 3. recent use of longer acting pain medications 4. evidence of destructive arthropathy 5. other medical conditions that may interfere with participation or accurate assessments during the trial
in-hospital electronic registry of severe trauma of the fondazione i.r.c.c.s. policlinico san matteo

Conditions: Patients Who Are Victims of Major Trauma

Summary: the objective of establishing an in-hospital trauma registry, aimed at collecting data on patients who are victims of major trauma and treated at our center, is to develop a comprehensive and in-depth tool for the analysis and monitoring of clinical activity within a level i trauma center. the purpose of building such databases-specifically the proposed trauma registry-is to provide the hospital with a unique instrument for analyzing and monitoring the epidemiology and management of a specific patient population. in light of recent developments in the hospital's newly implemented clinical care pathway (pdta) for the management of polytrauma patients, and the strategic enhancement offered by the opening of a dedicated helipad for the reception of such patients, our working group is committed to promoting a tool that may, both in the short and long term, foster clinical and scientific advancement at the fondazione i.r.c.c.s. policlinico san matteo in pavia. our general objective is the prospective collection of data on major trauma patients admitted to and treated at the fondazione i.r.c.c.s. policlinico san matteo. our primary objective is to evaluate in-hospital mortality, used as a qualitative indicator of the trauma center's performance, among patients with severe trauma managed at our institution.


Eligibility criteria:
inclusion criteria: all consecutive patients presenting to the emergency department of the fondazione i.r.c.c.s. policlinico san matteo who meet at least one of the following criteria will be included in the registry: * they were transported to the emergency department by emergency medical services (areu - regional emergency and urgency agency) with a diagnosis of severe trauma / major trauma or - they arrived at the emergency department and were admitted with a diagnosis of "trauma", and were found, upon completion of the secondary assessment, to have an injury severity score (iss) \>15 exclusion criteria: there are no exclusion criteria.
topical voltaren in otitis externa

Conditions: Otitis Externa

Summary: voltaren being a non-steroidal anti-inflammatory drug (nsaid) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.

anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids

Eligibility criteria:
inclusion criteria: * adults having otitis externa as single diagnosis mild to moderate exclusion criteria: * diabetes * children * pregnant women * immune compromise * starting other treatment * moderate to severe otitis externa
efficacy and safety study of stx209 (arbaclofen) for the treatment of social withdrawal in children with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: there will be four study periods: screening (up to 14 days in length), the treatment period (8 weeks), the withdrawal period (22 days), and follow-up period (up to 31 days). subjects will be randomized to receive either stx209 (5 mg twice daily \[bid\], 10 mg bid or 10 mg three times daily \[tid\]) or placebo. efficacy,safety and tolerability assessments will be performed periodically


Eligibility criteria:
inclusion criteria: * molecular documentation of the full fmr1 mutation * current pharmacological treatment regimen has been stable for at least 4 weeks prior to screening. * subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. * if the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to screening exclusion criteria: * subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * subjects who have taken another investigational drug within the last 30 days. * subjects who are not able to take oral medications
montelukast use in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: montelukast is widely used in patients with asthma. several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators. considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csdmards in ra patients with moderate and high disease activity.


Eligibility criteria:
inclusion criteria: * adult patients ages ≥ 18 years old. * patients diagnosed with ra according to american college of rheumatology/european league against rheumatism (acr/ eular) 2010 criteria (25) presented with disease activity score-28 based on c-reactive protein (crp) levels (das-28-crp) \>3.2. * patient received stable regimen of one or more csdmards for at least the past 3 months. exclusion criteria: * patient taking biological dmards. * known hypersensitivity to montelukast. * patients receive montelukast for any other indications. * patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits). * patients with impaired kidney (estimated glomerular filtration rate (egfr) \< 30 ml/min). * pregnancy and lactation. * patients with active or severe infections. * patients with other inflammatory or autoimmune diseases and malignancies. * patients with any psychiatric disorder. * patients taking iv, im, orally (dose \> 10 mg daily) or intra articular corticosteroides, * smokers.
the effect of the 3/7 vs 3x9 method in resistance training on metabolic stress in cardiac rehabilitation

Conditions: Heart Failure; Resistance Training; Coronary Artery Disease

Summary: the study proposes to measure the effect of resitance training (rt) (3/7 method) on biological markers of muscle hypertrophy in a cardiac population. 3/7 method consisting of five sets of an increasing number of repetitions (3 to 7) during successive sets and brief inter-set intervals (15 s). this method is compare to 3x9 method, 3 series of 9 repetitions with inter-set (1min).the training exercise consisted of contraction on machine (leg press, triceps press, leg curl, traction, leg extension) with load of \~ 70% of one repetition maximal (1rm). before these trainings all subject perform hiit on bicycles (2 min high intensity (80% wmax) and 2 min low intensity (50% wmax) during 30 minutes. the investigators collect blood sample before exercice, after hiit and after rt. it is randomized cross-over study.

the subjects come on two different days minimum 2 days and maximum 10 days between the two tests. they were instructed to avoid exercise the day before they participated in the study. the investigators collect blood 2 minutes after endurance training (hiit) and 2 min after rt training.

Eligibility criteria:
inclusion criteria: * clinical coronary artery diseases * heart failure with reduced ejection fraction exclusion criteria: * angina * acutely decompensated heart failure * electrocardiographic evidence of ischemia * significant valvular disease * orthopedic/neurologic disorders that limited exercise

Keywords: cardiac rehabilition exercise therapy metabolic stress
a clinical study to assess the safety of peg-hirudin (spp200) compared to heparin in patients who are on haemodialysis

Conditions: Chronic Kidney Failure; Vascular Graft Occlusion

Summary: the study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant peg-hirudin (spp200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.


Eligibility criteria:
* patients undergoing chronic haemodialysis via an arteriovenous graft * arteriovenous graft in place for at least 3 months * duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session * women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception * women patients must have a negative serum pregnancy test within one week of randomisation * able to provide written informed consent prior to study participation

Keywords: haemodialysis peg-hirudin vascular graft occlusion renal replacement therapy hemodialysis
a study evaluating safety and efficacy of biod-123 compared to insulin lispro (humalog®)

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of biod-123 compared to insulin lispro (humalog®) when used as part of a basal-bolus regimen in patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * established clinical diagnosis of type 1 diabetes, consistent with ada classification criteria (diabetes care 35: s64-s71, 2012), for more than 1 year. * age: 18 years old, or older. * body mass index: between 18 and 35 kg/m2, inclusive. * willing to use insulin glargine as the only basal insulin throughout the duration of the trial. * willingness not to use insulin pump treatment and only use the study glucose meter and cgm devices during the duration of the trial. exclusion criteria: * history of known hypersensitivity to any of the components in the study medication * treatment with pramlintide or glp-1 analogs within 30 days of screening or anticipated use of these medications during the course of the study. * treatment with oral or intravenous corticosteroids in the last 3 months prior to screening. standard doses of inhalational corticosteroid used as part of a long term treatment regimen are allowed. * consistent recent hypoglycemic unawareness within the last six months * history of more than two severe hypoglycemic events within six months prior to screening

Keywords: mealtime insulin ultra-rapid acting insulin prandial insulin
expanded access use of omegaven® in the treatment of parenteral nutrition induced liver injury in children

Conditions: Parenteral Nutrition-Associated Liver Disease

Summary: this is an expanded access study to assess the safety profile and changes in serum direct bilirubin levels in infants with pn associated cholestasis. eligible patients will receive therapy with omegaven on an expanded access basis by method of continuous infusion. omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. the same standards of care provided to all patients receiving parenteral nutrition solution will be followed.

this expanded access protocol provides a mechanism for critically ill infants with parenteral nutrition-associated liver disease (pnald) to receive omegaven for compassionate use situations for which there are no satisfactory alternative treatments.

Eligibility criteria:
inclusion criteria: * greater than 4 weeks (28 days) old and less then 5 years of age * diagnosis of pnald as defined by serum direct bilirubin greater than 2 mg/dl on 2 consecutive occasions * expected to require intravenous nutrition for at least an additional 28 days * have been pn-dependent for at least four weeks prior to planned omegaven initiation * pn-dependent and unable to meet nutritional requirements by enteral means * have failed standard therapies to prevent progression of pnald * hospitalized at time of omegaven initiation exclusion criteria: * have a congenitally lethal condition (e.g. trisomy 13). * have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis. * have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves. * have been in another clinical trial within 30 days prior to enrollment or received an investigational drug within 30 days prior to enrollment or scheduled to receive an investigational drug other than omegaven during the study period. * severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease * bleeding disorder * biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.

Keywords: cholestasis
ivacaftor for acquired cftr dysfunction in chronic rhinosinusitis (edspd protocol)

Conditions: CRS

Summary: the purpose of this study is to establish the novel endoscopically-directed sinus potential difference (edspd) assay as an endpoint for therapy of sinus disease.

the purpose of this study is to establish the novel endoscopically-directed sinus potential difference (edspd) assay as an endpoint for therapy of sinus disease. this assay provides a means to measure cl- secretion across the sinus epithelium in human subjects with chronic rhinosinusitis (crs) and test the relationship between this data and endoscopic findings of inflammation. the technique is appropriate for investigating acquired cftr dysfunction in sinus epithelium and examining the therapeutic potential of cftr potentiators for crs.

Eligibility criteria:
patient eligibility criteria are designed to limit enrollment otherwise healthy individuals who are scheduled for standard-of-care nasal endoscopy in the clinic or sinus/skull base surgery. inclusion criteria: * age \> 18 years * able to give consent * a diagnosis of crs, as determined by the sinus and allergy health partnership criteria * has cultured out at least one gram negative bacteria (e.g. pseudomonas aeruginosa, escherichia coli, stenotrophomonas maltophila) within the previous month * is scheduled for either routine endoscopic surgery or has previously undergone endoscopic surgery and presents to clinic for routine endoscopic evaluation exclusion criteria: * age \< 18 years * unable to give consent * active diagnosis of cancer, autoimmune disease, or any know immunodeficiency * women who are pregnant or breastfeeding
the clinical performance of the biofinity contact lens (comfilcon a) with two lens care systems

Conditions: Myopia

Summary: this will be a controlled and randomized, single-masked, crossover study in which 48 subjects will use the biofinity contact lens (comfilcon a) with each of the two lens care products ('solutions'), (synergi and biotrue multi-purpose solution) for one month each. follow-up visits for each solution will take place at one week, two weeks and four weeks: with a one-week 'wash-out' period between the solutions. key outcome measures for this study include biomicroscopic and subjective responses to the lens/solution combinations.


Eligibility criteria:
inclusion criteria: 1. they are of legal age and capacity to volunteer. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they agree not to participate in other clinical research for the duration of this study. 5. they have a contact lens spherical prescription between - 0.50 to - 6.00 (inclusive) 6. they have a spectacle cylindrical correction of -1.00d (diopters) or less in each eye. 7. at dispensing, they can attain at least 0.10 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. 8. they currently use silicone hydrogel soft contact lenses. 9. they are willing to comply with the wear schedule (at least 5 days per week, ≥8 hours/day). exclusion criteria: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they have had cataract surgery. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or lactating. 8. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. 10. they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.