Kornimate/medical-research-clean huggingface dataset:
study to investigate the effectiveness of pregabalin for management of patients undergoing total hip replacement

Conditions: Pain, Perioperative

Summary: the purpose of this study is the investigate if pregabalin started a day before surgery and continued for 14 days post-operatively can reduce post-operative pain, relieve pre- and post-operative anxiety and sleep disturbances.


Eligibility criteria:
inclusion criteria: * the patient is undergoing a routine (i.e., expected to be uncomplicated) total primary or secondary hip replacement surgery performed under a standardized regimen of spinal anesthesia, and is expected to experience moderate to severe post-surgical pain in the absence of post-operative analgesia exclusion criteria: * the patient is undergoing a revision to a previous hip replacement procedure, hip replacement procedure further to a road traffic accident with multiple injuries, or a procedure expected to last longer than 4 hours * the patient has a history of uncontrolled chronic disease or a concurrent clinically significant illness or medical condition, which in the investigator's opinion, would contraindicate study participation or confound interpretation of the results

Keywords: perioperative pregabalin total hip replacement post-operative pain
kalifilcon a toric compared to commercially available lenses

Conditions: Astigmatism

Summary: approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. all subjects will be seen for a screening/dispensing visit at which informed consent will be obtained and eligibility will be assessed. if study eligibility is met, subjects will have lenses inserted in random, successive order. subjects will be receiving each of the study lens types once, in a randomized order. the subject will wear each of the study contact lenses for approximately 10 minutes.

Eligibility criteria:
inclusion criteria: 1. be 18 years or older on the date the informed consent form (icf) is signed and have capacity to read, understand and provide written voluntary informed consent. 2. have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. have no active ocular disease or allergic conjunctivitis. 4. not be using any topical ocular medications. 5. be willing and able to follow instructions. 6. have signed a statement of informed consent. exclusion criteria: 1. participating in a conflicting study in the opinion of the investigator. 2. considered by the investigator to not be a suitable candidate for participation

Keywords: contact lens
colonization and persistence capacity of a multi-strain probiotics in pediatric food allergy to milk or egg.

Conditions: Food Hypersensitivity; Probiotic

Summary: this study evaluates the addition of three probiotics (bifidobacterium longum, bifidobacterium breve and bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. the allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.

this study evaluates the colonization capacity of three probiotics (bifidobacterium longum, bifidobacterium breve and bifidobacterium infantis) in milk and/or egg allergic children. it is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (group 1). furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (group 2) will be recruited and about 10 healthy individuals (group 3). for all 40 patients: 1. baseline presence of bifidobacterium longum bb536, bifidobacterium breve m-16v and bifidobacterium infantis m-63 will be evaluated; only for group 1 children it will be also evaluate: 2. the presence of the same strains during 30 days of administration of multi-strain probiotics containing 3.5 x 109 ufc of bifidobacterium longum bb536, bifidobacterium breve m-16v and bifidobacterium infantis m-63 and after 60 days from the suspension of the administration. quantification of b. breve, b. longum subsp. longum and b. longum subsp. infantis in faecal samples was carried out by qrt-pcr using the light cycler 480 platform (roche diagnostics, mannheim, germany). the assays were performed with a 20 µl pcr amplification mixture containing: 10 µl lightcycler 480 probe master mix (roche diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µm and 0.1 µm, respectively), 3 µl molecular-grade h2o and 5 µl dna template. each sample was tested in duplicate to ensure data reproducibility. the rt-pcr temperature profile consisted of an initial denaturation at 95°c for 10 min, 45 amplification cycles at 95°c for 10 sec, 60°c for 30 sec and 72°c for 1 sec followed by a final cooling step at 40°c for 30 sec. absolute quantification was performed using the "second derivative maximum method" statistical analyses: wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.

Eligibility criteria:
inclusion criteria: - age between 10 and 14 months exclusion criteria: * gastrointestinal disease in progress or appearance in the last 30 days * metabolic diseases * antibiotic treatment in the 2 weeks prior to the start of the study; * intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.

Keywords: probiotic food allergy
vitamin d deficiency as independent predictor for plaque vulnerability

Conditions: Vitamin D Deficiency; Carotid Artery Diseases

Summary: role of vitamin d in cardiovascular disease is controversial. here the investigators aimed to investigate the association of vitamin d deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy. 332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin d levels were determined prior to surgery using chemiluminescence-immunoassay.

role of vitamin d in cardiovascular disease is controversial. here the investigators aimed to investigate the association of vitamin d deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy. 332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin d levels were determined prior to surgery using chemiluminescence-immunoassay. there is insufficient data on cardiovascular outcome in participants with cas and vitamin d deficiency. vitamin d would be an easily modifiable factor. primary goal was to investigate the influence of vitamin d levels on plaque vulnerability, major adverse cardiovascular events (mace) and all-cause mortality in patients with carotid artery disease undergoing carotid endarterectomy.

Eligibility criteria:
inclusion criteria: * carotid arteriostenosis * patient eligible for carotid artery surgery exclusion criteria: * oncologic disease * patients with hemorrhagic, lacunar or cardioembolic stroke
neoadjuvant radiotherapy for hcc involving type i pvtt

Conditions: Hepatocellular Carcinoma

Summary: the rate of patients with hepatocellular carcinoma (hcc) involving portal vein tumor thrombus (pvtt) is up to 50% in guangxi province, china. some of them will receive hepatic resection, especially those with type i or ii pvtt. however, 5-years recurrence rate is up to 75% after surgery. some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. moreover, few retrospective studies also found neoadjuvant radiotherapy (pmid: 27317960) may improve overall survival for hcc patients involving type ii/iii pvtt. however, the safety and efficacy of neoadjuvant raidotherapy for hcc involving type i pvtt is unknown.


Eligibility criteria:
inclusion criteria: * age 18-75 years; * patients with resectable primary hepatocellular carcinoma and cheng's type i portal vein tumor thrombus; * child-pugh a or b (7 score) liver function; * with more than 3 months expected survival; * the volume of residual liver more than 30%; * patients agree to take part in. exclusion criteria: * patients with primary hepatocellular carcinoma and cheng's type ii/iii/iv portal vein tumor thrombus * previous history of epigastric radiotherapy * with extrahepatic metastasis * with radiotherapy contraindication; * pregnant woman or sucking period; * with repture tumor; * with other cancer in previous five years; * with chemothrapy, target therapy or immunosuppressive drugs therapy.
fgf-23 (fibroblast growth factor 23) regulation in chronic kidney disease

Conditions: Secondary Hyperparathyroidism

Summary: fgf-23 is a newly described protein that is an important regulator of phosphorus in the body. this protein increases in people with kidney disease and people who need dialysis have very high levels of fgf-23 in the blood. however, although some studies have indicated that fgf-23 levels go up with increased intake of phosphorus, no one knows if fgf-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. this study is designed to see what happens to levels of fgf-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. since high levels of fgf-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.


Eligibility criteria:
inclusion criteria: * inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with ckd stages 2-4 (gfr 15-90 ml/min/1.73m2). exclusion criteria: * exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(oh)vitamin d or 1,25dihydroxyvitamin d, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.
telemedicine follow-up for patients with cervical dystonia treated with neurotoxin injections

Conditions: Cervical Dystonia; Telemedicine

Summary: many cervical dystonia (cd) patients are limited in their ability to travel to the clinic for follow-up in between injection visits. a telemedicine visit at the time of peak effectiveness of neurotoxin treatment may be valuable in informing the neurologist's choice of muscle selection and/or dose for the next injection visit. the primary objective of this study is to investigate both patient and physician satisfaction with the use of our telemedicine tool for this type of follow-up. after assessment of the subject, the neurologist will decide whether or not the telemedicine visit was informative to the upcoming injection visit. subjects will answer questions at the end of the visit regarding their satisfaction with the follow-up and overall telemedicine communication. the principle investigator will complete a similar survey with additional questions about information gathered from the visit to assess the primary objective. a secure video communications platform will be used for the visit, which will occur 2-4 weeks after the patient's last neurotoxin injection (around the time of peak effectiveness). the investigating neurologist will remotely assess the patient and make notes for the next injection visit.


Eligibility criteria:
inclusion criteria: * male or female subjects of any race, aged 18 and above * diagnosed with cervical dystonia and being treated with neurotoxin injections at vanderbilt university medical center * the subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent. * email and internet access * personal computing device with audio/video capability exclusion criteria: * subjects for whom participation in the study may cause medical harm

Keywords: cervical dystonia telemedicine telehealth
algorithm for vertical placement of implantable collamer lens

Conditions: Myopia

Summary: the objective is to develop and evaluate an algorithm for implantable collamer lens (icl) sizing that uses high frequency ultrasound biomicroscopy (ubm) for vertical placement.

this study is a single-arm, clinical evaluation study of vault height and refraction, after successful icl implantation. subjects will be assessed pre-operatively, operatively, at 1 week postoperatively, and 1, 3, and 6 months post-operatively. clinical evaluations will include measurement of monocular and binocular visual acuity, manifest refraction, and vault height.

Eligibility criteria:
subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in each study eye. inclusion criteria: * presenting for uncomplicated icl implantation, either toric or non-toric lens, with vertical placement of the icl * gender: males and females. * age: 23 or older. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error) * potential postoperative visual acuity of (20/25 snellen) or better in the study eye exclusion criteria: if any of the following exclusion criteria are applicable to the subject or study eye, the subject should not be enrolled in the study. * irregular astigmatism (e.g. keratoconus) * unstable refractive error * low endothelial cell count * anterior chamber depth \<2.8mm * any cataract in operative eye or nontraumatic cataract in the fellow eye * narrow anterior chamber angles (grade 2 or less) * difficulties comprehending written or spoken language * patient with physical or intellectual disability (e.g. down's syndrome, parkinson's disease; unable to fixate) * subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity. * participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating). the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: implantable collamer lens
the status of parathyroid hormone secretion in covid-19 patients

Conditions: COVID-19 Infection; Parathyroid Gland; Parathyroid Hormone; Calcium; Phosphorus; Alkaline Phosphatase

Summary: covid-19 infection causes a hypersensitive immune reaction and widespread inflammation in various organs of the body, especially through cytokines in the lungs. this cytokine-mediated widespread inflammation can also affect the parathyroid glands, resulting in impaired parathyroid secretion. researchers evaluated the levels of parathyroid hormone, calcium, phosphorus, and alkaline phosphatase in patients hospitalized for covid-19 infection. researchers excluded patients on intensive care therapy and patients with known parathyroid disease. the researchers examined the association of parathyroid hormone secretion with covid-19 disease, white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and d-dimer in these patients. the researchers compared the parathyroid hormone level of healthy people without covid-19 infection and known parathyroid disease with the parathyroid hormone level of covid-19 patients.

the coronavirus-2 (sars-cov-2) virus, which can cause severe acute respiratory syndrome through the droplet, has caused the global coronavirus 19 (covid-19) pandemic. covid-19 infection can be asymptomatic or lead to serious illness and even death. this virus causes a hypersensitive immune reaction and varying degrees of widespread inflammation through cytokines in various organs of the body, mainly the lungs. cytokine-mediated widespread inflammation caused by the virus may also affect the parathyroid glands, causing their functions to deteriorate. thus, it may cause changes in parathyroid hormone secretion. the researchers evaluated the results of serum parathyroid hormone, calcium, phosphorus, alkaline phosphatase tests in patients who were symptomatic and hospitalized with covid-19 infection. participants also evaluated the relationship of parathormone with white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and d-dimer in these patients. the researchers compared the parathyroid hormone levels of patients with covid-19 infection with the parathyroid hormone levels of healthy individuals without covid-19 infection and parathyroid disease. so the investigators looked for differences in parathyroid hormone levels between both groups. researchers did not include patients in the intensive care unit and patients with known parathyroid disease.

Eligibility criteria:
inclusion criteria: * to accept research. * being over the age of 18. * covid 19 test results to be positive. * not taking parathyroid disease medication before. * receiving inpatient treatment in the covid service in the hospital. exclusion criteria: * not accepting research. * be under the age of 18. * negative covid 19 test results for patients. * covid patients treated as outpatient. * parathyroid disease in the healthy control group.
assessment of safety, tolerability and blood concentrations of single doses of azd3839 in healthy volunteers

Conditions: Alzheimer's Disease; Safety; Tolerability; Blood Concentration; Healthy Volunteers

Summary: the purpose of the study is to assess the safety, tolerability and blood concentration of azd3839 following oral administration of single doses in healthy men and women of non-childbearing potential


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture * have a body mass index (bmi) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive) * creatinine clearance in the normal range (\>80 ml/min estimated according to cockroft-gault) * healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/l at screening (visit 1) and on admission to the study centre (day -1) * clinically normal findings on physical examination in relation to age, as judged by the investigator exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study * history of psychotic disorder amongst first degree relatives * significant orthostatic reaction at enrolment as judged by the investigator * prolonged qtcf greater than 450 msec or shortened qtcf less than 340 msec or family history of long qt syndrome or sudden death * healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in part 2

Keywords: phase 1 healthy volunteers double-blind placebo-controlled azd3839 pharmacokinetics alzheimer's disease
apricot-b: study to evaluate apricoxib in combination with lapatinib and capecitabine in the treatment of her2/neu+ breast cancer (tp2001-202)

Conditions: Breast Cancer

Summary: this study will compare the anti-tumor efficacy of apricoxib and lapatinib/capecitabine with placebo and lapatinib/capecitabine as measured by time to disease progression and evaluate urinary pge-m measurements or baseline cox-2 expression in tumor tissue by ihc as a surrogate selection criterion for patients who will benefit from future treatment with apricoxib.


Eligibility criteria:
inclusion criteria: * females with pathologically determined locally advanced or metastatic human epidermal growth factor receptor 2 positive (her2/neu+) breast cancer * have progressed after treatment with chemotherapy including a taxane and trastuzumab * must have measurable disease by recist * ecog ps of 0,1, or 2 * muga scan or echocardiogram results show left ventricular ejection fraction greater than or equal to 50% exclusion criteria: * radiation therapy within 2 weeks, chemotherapy within 3 weeks, or noncytoxic investigational agents within 4 weeks of initiating study treatment * evidence of new york heart association class iii or greater cardiac disease * history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality * history of congenital qt prolongation * concurrent severe or uncontrolled medical disease * symptomatic central nervous system metastases * pregnant or nursing women * hypersensitivity or intolerance to apricoxib, lapatinib, capecitabine, 5-fu, sulfonamides, aspirin, or nsaids * severe renal insufficiency * history of upper gi bleeding, ulceration, or perforation- concurrent use of potent cyp3a4 inhibitors and cyp3a4 inducers * prior treatment with capecitabine * patients on anti-arrhythmic treatment * prior lapatinib therapy

Keywords: her2/neu positive locally advanced or metastatic
somatosensory tinnitus rct

Conditions: Tinnitus

Summary: the purpose of this study is to learn more about a type of tinnitus (ringing in the ears) known as "somatosensory tinnitus." this type of tinnitus is suspected when the tinnitus perception changes following head and/or neck movements. this study is also exploring a possible way to treat somatosensory tinnitus.

the purpose of this study is to: (1) develop a screening tool for somatosensory tinnitus and (2) perform a randomized clinical trial comparing different treatment approaches for somatosensory tinnitus. the investigators want to find out if individualized physical therapy, alone or in combination with audiology-based sound therapy, is beneficial for treating somatosensory tinnitus.

Eligibility criteria:
inclusion criteria: * constant, chronic tinnitus (6-months in duration) * bothersome tinnitus based on tfi score and self-reported loudness * able to modulate tinnitus perception with head, neck, and/or jaw maneuvers exclusion criteria: * middle ear pathology * not a candidate for physical therapy * injury to the temporomandibular area in past 3 months * active pathology in the orofacial region

Keywords: tinnitus