Kornimate/medical-research-clean huggingface dataset:
comparing patient-centered outcomes after treatment for uterine fibroids

Conditions: Uterine Fibroids

Summary: the purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.


Eligibility criteria:
inclusion criteria: * female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period * at least 1 of the procedures of interest occurring between january 1, 2005 - december 31, 2011 * ≥ 18 years and \< 55 years of age at the index date exclusion criteria: * patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical) * first recorded diagnosis of uterine fibroids occurring beyond four weeks after the index date only for patients who underwent endometrial ablation or hysterectomy * patients with a record of any procedures of interest occurring before january 1, 2005
to investigate blood lipid changes and safety after litorvazet® tablets in dyslipidemia patients

Conditions: Dyslipidemia

Summary: this study aims to investigate the lipid-lowering effects and safety of administering litorvazet tablets (ezetimibe/atorvastatin) over a 24-week period in patients with dyslipidemia scheduled to receive litorvazet tablets in a real-world clinical setting.

in a real-world clinical setting, litorvazet® tablets will be administered to patients based on the investigator's medical judgment in accordance with the approved prescribing information (indications, dosage, and administration, precautions for use, etc.). participants for data collection in this study will be patients diagnosed with dyslipidemia as determined by the judgment of their attending physician. all treatments, including drug administration and clinical laboratory tests conducted after the administration of litorvazet® tablets, will be carried out based solely on the investigator's (attending physician's) medical judgment and will not be influenced by the patient's participation in the study. information relevant to this observational study will be collected for up to 24 weeks.

Eligibility criteria:
inclusion criteria: * male and female adults aged 19 years or older at the time of the screening visit. * patients with dyslipidemia who are scheduled to receive litorvazet® tablets based on the investigator's (treating physician's) medical judgment and in accordance with the approved indications. * individuals who have voluntarily provided written consent to participate in this study. exclusion criteria: * individuals who meet any contraindications for litorvazet® tablets as specified in the product labeling: * those with hypersensitivity to any components of this medication. * patients with active liver disease or those with persistently elevated serum transaminase levels of unknown cause. * patients with muscle disorders. * pregnant women, women who may be pregnant, or breastfeeding mothers. * women of childbearing potential who are not using appropriate contraceptive methods. * patients receiving glecaprevir and pibrentasvir. * patients with genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. * individuals with a history of receiving litorvazett® tablets prior to participating in this study. * individuals deemed unsuitable for participation in this observational study by the investigator (treating physician) for reasons beyond those listed above.
maxillary sinus irrigation in the management of chronic rhinosinusitis

Conditions: Sinusitis

Summary: the purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.

effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis. a prospective randomized controlled trial is being conducted in carmel medical center, haifa, israel. patients are being randomized into one of two arms. one arm receives sinus irrigation with saline in conjunction with iv antibiotics, the control arm receives the same regimen of iv antibiotics without the sinus irrigation. quality of life, ct scans and nasal endoscopy parameters are collected before and after treatment.

Eligibility criteria:
inclusion criteria: * chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a ct scan) * over 18 years of age * signed informed consent * not participating in another clinical study exclusion criteria: * a previous sinonasal surgery or craniofacial trauma * isolated frontal or sphenoidal sinusitis * immunosuppressed (diabetes, cancer, etc.) * craniofacial deformity * allergic fungal sinusitis * nasal polyposis * rhinosinusitis of dental origin * bleeding tendency (e.g., chronic coumadin treatment) * patients participating in other clinical study * patients with penicillin allergy * patients with augmentin resistant bacteria in cultures

Keywords: chronic rhinosinusitis sinus irrigation
plasma and platelet micrornas in clopidogrel low response patients

Conditions: Coronary Artery Disease

Summary: clopidogrel is an important anti-platelet agent.however, about 30% of the coronary artery disease patients presented clopidogrel low response (clr).previous studies showed that the cardiovascular event ratio of the clr patients was 4.4 times of the normal responders. it is known that the plasma and platelet mirnas are determined by different disease status when platelets are released from the megakaryocyte, and the platelet mirnas can adjust the expressions of the platelet's receptors and proteins.the purpose of this study is to find multiple platelet mirnas involved in the development of clr, and platelet mirnas cause clr through adjusting the expressions of the key receptors and proteins in the adp activating pathway and consequently reducing their responses to clopidogrel. the clr will be detected by light transmission aggregometry (lta) and vasodilator-stimulated phosphoprotein phosphorylation (vasp-p). differential expressions of plasma and platelet mirnas profile in clr patients will be screened by deep sequencing and validated to investigate the association between plasma and platelet mirnas profile and clr as well as the patients' prognosis.the study results would serve as markers for individualized anti-platelet treatment, and supply new targets for the treatment of coronary artery disease.

a multiphase, case-control study was designed to identify plasma and platelet mirnas as surrogate markers for clr . all patients take 300mg loading dose clopidogrel plus 100mg daily asa and 75mg daily clopidogrel after admission. patients are recruited after percutaneous coronary intervention (pci). light transmittancy aggregation (lta) in response to 5μm adp is to measured 5 days after taking the loading dose clopidogrel.than clr patients were selected. in the initial biomarker-screening stage, plasma and platelet samples from 20 clr patients and 20 controls underwent solexa sequencing to identify mirnas that showed significant differences between the clr cases and matched controls. subsequently,we performed a biomarker confirmation analysis with a hydrolysis probe-based rt-qpcr assay to refine the number of plasma and platelet mirnas in the clr signature. this analysis was carried out in 2 phases: (a) the biomarker-selection phase, in which plasma and platelet samples from 20 clr patients and 20 control individuals formed the training set, and (b) the biomarker-validation phase, in which plasma and platelet samples from an additional 80 clr patients and 80 controls formed the validation set.

Eligibility criteria:
inclusion criteria: * patients who receive stent implantation; * patients who take 100mg daily asa and 75mg daily clopidogrel * patient age \>18 years and \<80 years old; * signed inform consent exclusion criteria: * allergy or intolerance to asa,clopidogrel; * patients who are planning to take warfarin or drugs that potentially could interfere with the anti-platelet effects of asa,clopidogrel.

Keywords: microrna platelet clopidogrel low response
photodynamic therapy alone versus combined with intravitreal bevacizumab for age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: the purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * choroidal neovascularization caused by age-related macula degeneration * no previous treatment * a follow-up at least 12 months * a baseline visual acuity ranging from a letter score of 0 to 70 on the early treatment diabetic retinopathy study chart exclusion criteria: * choroidal neovascularization caused by other eye diseases * ocular surgery within the past 3 mouths * history of uveitis * intraocular pressure higher than 25 mmhg, or glaucoma * history of systemic or ocular thromboembolic events.
sars-cov-2 antibodies based ivig therapy for covid-19 patients

Conditions: COVID-19

Summary: severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase i/phase ii study. each group shall receive particular single dose of intravenously administered immunoglobulins (ivig) developed from convalescent plasma of recovered covid-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.

passive immunization using intravenous immunoglobulins (ivig) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. recently researchers from china reported satisfactory recovery of critically ill corona virus disease 2019 (covid 19) patients when high dose intravenous immunoglobulin (ivig) were administered. research team at dow university of health sciences has purified immunoglobulin (both sars-cov 2 antibodies and existing antibodies) from convalescent plasma of covid19 individuals and pooled to prepared ivig formulation to treat severe and critically ill covid-19 patients. to evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed. it is intended to assess safety and efficacy of experimental the ivig treatment in severe and critically ill covid 19 patients through phase i/phase ii randomized single blinded clinical trial with fifty study participants. fda outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.

Eligibility criteria:
inclusion criteria: * above 18 years of age * have positive sars-cov-2 pcr on nasopharyngeal and/or oropharyngeal swabs * admitted in isolation ward and icu of institutes affiliated with duhs * have severe or critical covid 19 as judged by the treating physician * consent given by the patient or first degree relative exclusion criteria: * pregnancy * previous allergic reaction to immunoglobulin treatment * ig a deficiency * patient requiring 2 inotropic agents to maintain blood pressures * known case of any autoimmune disorder * acute kidney injury or chronic renal failure * known case of thromboembolic disorder * aseptic meningitis

Keywords: covid19 ( corona virus disease -2019) sars-cov-2 (severe acute respiratory syndrome coronavirus 2) passive immunization intravenous immunoglobulin (ivig) pooled convalescent plasma critically ill covid-19 patients severe covid-19 patients antibody
observational study of kibow biotics in chronic kidney failure patients on dialysis

Conditions: Chronic Kidney Disease

Summary: a specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "enteric dialysistm". however, it is also referred to as enteric toxin reduction technology. our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (kibow® biotics/renadyltm) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

probiotics are increasingly utilized clinically. as their safety and health benefits are established, it is reasonable to anticipate that probiotic bacteria will be incorporated into a growing number of clinical regimens, as a dietary supplement. extensive in vitro r\&d investigations in kibow's laboratories bacterial strains studied were a mixture of patented and proprietary strains of streptococcus thermophilus (kb27), lactobacillus acidophilus (kb31) and bifidobacterium longum (kb35). oral administration of these bacterial formulations, tested in the 5/6th nephrectomized rat model (at thomas jefferson university, phila., pa) and minipig model (at indiana university, indianapolis, in), decreased both blood urea nitrogen (bun) and serum creatinine (scr) levels. two independent veterinarians investigated the effect of kibow biotics® in cats and dogs (of both genders and varying body weights) with moderate to severe kidney failure. based on positive results, this formulation, marketed and distributed as azodyltm, is currently licensed for veterinary applications to vetoquinol usa. pilot scale studies, double blind, placebo controlled, cross-over studies for six months conducted in 45 patients in usa, canada, argentina, and nigeria demonstrates reduction of bun (p\>95%) and improved quality of life (p\>95%). decrease in creatinine and uric acid levels were also observed. however, these studies were based on correlating the age of geriatric cats and dogs with moderate to significant kidney failure to human geriatric conditions.

Eligibility criteria:
inclusion criteria: * currently on hemodialysis * 18 to 75 years of age * willing to give informed consent * baseline serum creatinine \>2.5 mg/dl exclusion criteria: * pregnant or nursing women * refusal to sign the informed consent form * documented to have hiv/aids/liver disease * active dependency on drugs or alcohol * currently on anticoagulant therapy

Keywords: probiotics kibow biotics dialysis gut based uremic toxin removal
fit physicians: use of activity monitors and activity integration program in first year medical students

Conditions: Motor Activity; Body Weight Changes

Summary: using fitbit activity monitors, physical activity levels will be monitored in first year medical students. body composition will be measured as well.

using fitness trackers and exercise testing, it will determine if participating in a novel program that incorporates wellness into the academic term will improve fitness. an estimate, 120 students will enroll in this study. men and women aged 18-55 years of age that are just entering medical school. students who are currently pregnant will not be allowed to participate in this study. participation will involve 2 visits at the start of the academic school year, and two visits at the end of the academic school year. these visits will entail you undergoing a body composition scan measured by an duel energy x-ray absorptiometry (idexa) machine. the scan takes approximately 15 minutes. subjects may be asked to perform an exercise stress test on a treadmill. the exercise test is approximately 40 minutes. subjects may be asked to participate in a fitness program 2x a week, and may be asked to wear a fitbit flex™ activity tracker on the wrist for the duration of the school year. investigators will be accessing academic grades to use for statistical purposes only. subject names will never be given to any other party other than the investigators involved.

Eligibility criteria:
inclusion criteria: * first year medical students * must have smartphone exclusion criteria: * medical conditions that prohibit exercise * pregnancy

Keywords: medical student activity monitor medical school fitness
a study of mk-4827 for the treatment of mantle cell lymphoma (mk-4827-002)

Conditions: Lymphoma; Mantle-Cell

Summary: this study will investigate the efficacy and safety of mk-4827 in participants with relapsed mantle cell lymphoma (mcl) and in a subset of participants with inactivation of the ataxia-telangiectasia mutated (atm) gene.


Eligibility criteria:
inclusion criteria : * participant must have a diagnosis of mcl that has relapsed after at least one prior chemotherapy regimen or for which the participant has refused standard therapy * participant has measureable disease defined by lymphadenopathy, organomegaly, bone marrow involvement and/or circulating lymphoma cells. at least one lesion must be \> 2 cm in the longest diameter and measurable in 2 perpendicular dimensions * participant has a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) performance scale * female participants of child-bearing potential agree to use two approved contraceptive methods or remain abstinent throughout the study * male participants agree to use an adequate method of contraception throughout the study * participant has no history of prior cancer except certain cervical, skin, or prostate cancers, or has undergone potentially curative therapy with no recurrence for five years, or is deemed at low risk for recurrence * participant has not had any platelet or red blood cell transfusions or colony stimulating factor support during the month prior to treatment * participant has a pre-study diagnostic formalin fixed paraffin-embedded tumor tissue sample available exclusion criteria : * participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of screening * participant has a history of central nervous system (cns) lymphoma * participant requires the use of corticosteroids * participant is pregnant, breastfeeding, or expecting to conceive or father children during the study * participant is known to be human immunodeficiency virus (hiv)-positive * participant has a history of hepatitis b or c

Keywords: poly (adp-ribose) polymerase (parp) inhibitor
community health worker intervention to improve post-hospital outcomes

Conditions: Chronic Disease (Physical); Mental Disorder

Summary: this study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. the intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.

this study will test the efficacy of a brief intervention delivered to adults with co-occurring medical and mental health conditions by community health workers designed to avoid 30-day readmissions following medical hospitalization. adult inpatients of a university hospital will be randomly assigned to the intervention plus services as usual versus services as usual alone, and assessed at baseline and 30 days following discharge. chi square will be used to assess the primary outcome of admission within 30 days of discharge and changes in patient activation, mental health symptoms, medication adherence, and perceived competence for health maintenance. also examined will be study condition differences in post-discharge inpatient service utilization and cost.

Eligibility criteria:
inclusion criteria: * receiving inpatient treatment for chronic medical condition * evidence of a mental health diagnosis * age 21- 60 years * expected to return to community residence * residing within a 30-mile radius of the hospital * expected to remain in hospital for 2 or more days * able to provide informed consent exclusion criteria: * terminally ill * unable to communicate in english * expected to be discharged to skilled facility or nursing home * participating in another transitional care intervention * hospitalized for behavioral health disorder

Keywords: 30-day readmission primary care community health worker health education
effectiveness of a marketed one-step peroxide lens care solution in symptomatic contact lens wearers

Conditions: Refractive Error

Summary: the purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of clear care®.


Eligibility criteria:
inclusion criteria: * current biweekly or monthly silicone hydrogel contact lens wearer (excluding air optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to visit 1 (daily wear use only). * symptoms of contact lens discomfort as defined by the protocol. * habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to visit 1. * mild to severe (grade 2-4) investigator rated palpebral roughness in one or more zones of either eye. * other protocol-specified inclusion criteria may apply. exclusion criteria: * extended (over-night) contact lens wearer. * any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * topical ocular over the counter (otc) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment. * other protocol-specified exclusion criteria may apply.

Keywords: silicone hydrogel contact lenses multi-purpose solution lid papillae palpebral roughness