Kornimate/medical-research-clean huggingface dataset:
surgical excision of the fat pad

Conditions: Osteo Arthritis Knee

Summary: introduction: the infrapatellar fat pad (hoffa's fat pad) is a structure which is located intra-articularly. its function is not well known. during knee replacement surgery, some surgeons would prefer removing the whole of the fat pad as this can improve exposure of the knee joint, as it can affect exposure of the knee joint which will in turn make the procedure slightly more efficient. other surgeons would rather resect the minimum amount and preserve the bulk of the structure as anecdotally this is thought to decrease the level of post operative pain. this surgical step fat pad resection is a very small part of the whole total knee replacement procedure. a previous retrospective review of patients whose fat pad had been removed showed that they were nearly twice as likely to experience postoperative pain (p = 0.0005), while another study showed that they are at a slight risk of patellar tendon shortening. a randomised controlled trial of 68 patients did not show any difference in patella tendon length at six months and no difference in pain relief in both groups 3. however this study did not evaluate the functional outcome in both groups. to our knowledge, there are no rct looking at the effect of the excision or preservation of the fat pad in tkr and the functional outcomes post operatively. study hypothesis: excision of hoffa's fat pad during total knee replacement surgery does not affect functional outcome, pain level after surgery or the patella tendon length at either one or two years.

rct of excision or preservation of fat pad in tkr and the functional outcomes post operatively

Eligibility criteria:
inclusion criteria: * 1- primary total knee replacement for knee osteoarthritis exclusion criteria: 1. revision surgery. 2. primary knee replacement for pathologies other than osteoarthritis. 3. previous knee fractures around the knee. 4. previous confirmed intra-articular infections. 5. non english speaking/reading patients.
a study on paxlovid once in the market, to observe its safety and effectiveness in patients who have a high chance of getting severe covid-19

Conditions: COVID-19

Summary: the purpose of this study is to look at the safety and effectiveness of paxlovid in the real world and not in clinical studies. the study observes patients who have a high chance of getting severe covid-19 in korea. this study is seeking participants who are: * patients with mild-to-moderate covid-19 symptoms and at high chance of getting severe covid-19, including hospitalization or death. * patients who received, are currently receiving, or are going to receive paxlovid according to locally approved label. * patients who have signed informed consent documents after understanding all the important parts of the study. all participants are treated according to routine medical practice and there are no scheduled visits required by this study. all participants will be studied for a follow-up period of 28 days from the last paxlovid treatment to understand the safety and the effectiveness of treatment.


Eligibility criteria:
inclusion criteria: * patients who received, are currently receiving, or are going to receive paxlovid according to locally approved label. * patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment. exclusion criteria: * patients with contraindication according to locally approved label of paxlovid. * patients who are going to receive any investigational medicine during the observation period.

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) paxlovid post marketing surveillance (pms) korea
study of the relationship between clinical and paraclinical markers during situations of cachexia and pre-cachexia in patients over 70 years with colorectal surgery

Conditions: Colorectal Tumor

Summary: cachexia associated with cancer is a grave and most of the time irreversible common situation. it seems independent from the size of the tumor or from its metastatic character. the consequences for the management of the patient are major and exceed widely the frame of the nutrition. undernutrition of patients with cancer is described by a decrease of the energy contributions and a loss of muscular and fat mass, leading to a progressive functional deficiency which can go to the cachectic state. actually, clinical criteria are proposed allowing to characterize the state of pre-cachexia but it remain too indistinct to allow an early and efficient screening and set up effective measures of prevention of the cachexia, to avoid the loss of muscular tissue and the cast iron of the energy reserves. it is necessary to have clinical and biological markers with diagnostic aim and forecasts during the situations precedents the appearance of cachexia. the present study will allow calibrating a longitudinal study, which could confirm the value of measures made for the diagnosis of pre-cachexia.


Eligibility criteria:
inclusion criteria: * aged ≥ 70 years * colorectal tumor resection with/without synchronous metastases exclusion criteria: * emergency resection of colorectal tumor * unresectable colorectal tumor with/without synchronous metastases

Keywords: cachexia nutrition cancer colorectal tumor
essen coronary artery disease registry

Conditions: Coronary Artery Disease

Summary: the ecad registry is a registry of patients undergoing coronary angiography at the west german heart and vascular center. the registry anticipates to determine predictors of patient outcome after coronary angiography.


Eligibility criteria:
inclusion criteria: * patients undergoing invasive coronary angiography at the west german heart and vascular center exclusion criteria: * none
varicella vaccination with pulmicort

Conditions: Asthma

Summary: a study to determine whether treatment with pulmicort in children has any effect on the varicella vaccine


Eligibility criteria:
inclusion criteria: * children between the age of 10 months and 8 years, * have asthma or shown recent signs suggesting asthma, * have a parent or guardian willing to comply with study requirements exclusion criteria: * varicella zoster immune globulin (vzig) within 5 months prior to immunization, * previous varicella immunization, * an immunization or allergy immunotherapy 4 weeks prior to immunization, * severe asthma, * have another persistent lung disease, * have a planned hospitalization for the duration of study

Keywords: children asthma varivax varicella pulmicort budesonide
brivaracetam to reduce neuropathic pain in chronic sci: a randomized, double-blind, placebo-controlled clinical trial

Conditions: Spinal Cord Injuries; Neuropathic Pain

Summary: spinal cord injury (sci) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in sci. based on this and other reports in the literature, sci-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2a (sv2a) within the substantia gelatinosa of the injured spinal cord. furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level sci neuropathic pain and increases parietal operculum (partsop1/op4) connectivity strength measured by resting-state functional magnetic resonance imaging (rsfmri). circulating mirna-485 levels may be associated with change in pain intensity due to brivaracetam treatment. the study aims to determine the efficacy of brivaracetam treatment for sci-related neuropathic pain.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * injured for \&gt; 3 months * completed inpatient rehabilitation and living in the community * chronic sublesional neuropathic pain defined as persistent pain (vas grade 3-10) for three months or more * for people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly). exclusion criteria: * progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia * active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin. * brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent * pregnancy or lactation * epilepsy or active treatment for seizure disorder * past or current suicidality * active treatment for psychiatric disease * drug addiction * moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week) * hepatic cirrhosis, child-pugh grades a, b, and c * impaired renal function (gfr\&lt;60ml/minute) * contraindications to brivaracetam or pyrrolidine derivatives including allergy * active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial. * history of malabsorption or other gastrointestinal (gi) disease that may significantly alter the absorption of brivaracetam * use of any investigational drug 30 days prior to enrollment in this study * enrollment in another clinical trial.
pediatric infectious disease precision medicine using sequencing evaluation of csf

Conditions: Infection; Meningitis

Summary: prospective, multi-site, study to evaluate the diagnosis rate of dna and rna sequencing of cerebrospinal fluid for identification of pathogens directly in patients who have already had a spinal tap to evaluate for infection and were found to have a pleocytosis. diagnostic rate and clinical utility of concurrent standard testing will be compared to diagnostic rate and clinical utility of dna and rna sequencing.

idbydna, inc. has developed a robust sequencing reference database for viruses, bacteria, fungi and parasites and developed novel analysis methods to analyze next-generation (ngs) sequencing data to rapidly identify infectious agents. this technology suite, known as the explify™ platform, holds the promise to improve patient care and efficiently guide provider treatment planning for those suffering from infectious disease. the pipsec trial, developed by pediatric physicians specializing in genomic medicine, is intended to facilitate the acquisition of high quality and clinically annotated biospecimens for the purpose of research discovery. this project intends to advance metagenomics, microbial genetics, bioinformatics and data analytics, for pathogen detection utilizing cerebral spinal fluid (csf) specimens to contribute to the diagnosis of infectious agents impacting the central nervous system among pediatric patients. clinically annotated specimens will facilitate continued development and validation of the explify test and its clinical utility for providers treating central nervous system (cns) infections. the primary objective is to assess clinical utility of the explify test compared to concurrent standard of care testing to identify pathogens from csf fluid within a pediatric patient population.

Eligibility criteria:
inclusion criteria: * age 0-17 years of age (not yet 18) * clinical evaluation for cns infection * csf white blood cell count (wbc) \> 15 cells/µl when there are less than 5000 rbcs on same * admitted to a participating study site * csf obtained per standard protocol * 1 ml of appropriately stored csf is available following completion of all standard of care testing exclusion criteria: * csf red blood cell (rbc) count \> 5000 cells/µl on same csf sample as with pleocytosis * unable to obtain consent

Keywords: pediatric
compare the efficacy and safety of surfolase cr tablet with surfolase capsule in patients with acute bronchitis

Conditions: Acute Bronchitis

Summary: compare the efficacy and safety of surfolase cr tablet with surfolate capsule in patients with acute bronchitis


Eligibility criteria:
inclusion criteria: 1. male or female aged 19 to 65 years, inclusive 2. patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for bronchitis severity score (bss) at screening 3. patients who agreed to participate clinical trial and sign on informed consent form exclusion criteria: 1. patients who are suspicious or diagnosed for pneumonia 2. patients with chronic bronchitis, chronic obstructive pulmonary disease (copd), bronchiolitis, asthma, bronchial asthma 3. patients with active infection who needs administration of antibiotics 4. patients with myocardial infarction, congestive heart failure 5. patients with renal disorder or liver disorder 6. patients with hypotension or hypertension 7. patients with history of epilepsy 8. patients with hyperthyroidism 9. patients with gastroduodenal ulcer 10. patients with sever hypoxemia 11. patients who are in drug or therapy or planned to have; * antibiotics, anti-virus, angiotensin converting enzyme (ace) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial * angiotension ii receptor blocker (arb), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial * analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial 12. smokers 13. patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug 14. patients with pregnant and/or have breast feeding. 15. patients with no intention to use appropriate contraceptives or has a plan to become pregnant 16. patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial 17. patients who are identified as inappropriate by other investigators to participate clinical trial
diagnostic performance of smart supra perimetry (the dpssp study)

Conditions: Glaucoma, Suspect; Glaucoma

Summary: early glaucomatous visual field changes can be missed with the routinely used standard automated perimetry (sap) and the 24-2 test pattern due to limited sampling of the central 10 degrees. while this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients. smart supra perimetry (ssp) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 sap test. this comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of ssp in identifying early glaucomatous visual field loss. a sample of 100 patients with early/suspect glaucoma will undergo sap 24-2 and 10-2 (sita algorithm) using humphrey visual field perimetry and ssp 24+10-2 using henson 9000. eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. the sensitivity and specificity of the sap and ssp tests will be established along with test duration. the size and location of defects established with both the sap and ssp strategies will also be compared.


Eligibility criteria:
inclusion criteria: * reliable sap visual field results (fixation loss \< 33%, false positive \< 15% and false negative \< 20%). * visual acuity better or equal to 0.20 logmar. * spherical refractive error within -6.00 to +6.00d and cylindrical error \<2.00d * no ocular co-morbidity likely to affect the visual field or oct results. * age: 40-80 yrs additional inclusion criteria for glaucomatous group: * optic disc showing glaucomatous changes. * sap md not worse than -6db additional inclusion criteria non-glaucoma group: * normal sap visual field data (md, psd, ght within normal range) * no evidence of glaucoma or other ocular co-morbidity in the eye suitable for the study. exclusion criteria: exclusion criteria glaucomatous and control groups: • anomalous discs, tilted discs, myopic discs.

Keywords: glaucoma
soy protein supplement in preventing prostate cancer in patients with elevated prostate-specific antigen levels

Conditions: Prostate Cancer

Summary: rationale: soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen (psa) levels. purpose: randomized phase ii trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated psa levels.

objectives: * compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated psa (5 to 10 ng/ml) and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo. * compare the effect of these regimens on additional biomarkers of prostate cancer (psa, high-grade prostate intraepithelial neoplasia, induction of apoptosis, sex steroid receptor expression, and loss of glutathione s-transferase-pi) in these patients. * compare the effect of these regimens on quality of life, including urinary and sexual function, in these patients. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to race (caucasian vs african american). after 2 weeks of daily oral placebo, patients are randomized to 1 of 2 arms. * arm i: patients receive oral soy protein supplement daily for 12 months. * arm ii: patients receive oral placebo daily for 12 months. quality of life is assessed at baseline and at 6 and 12 months. projected accrual: a total of 160 patients (80 per arm) will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed absence of prostate cancer * atypical adenomatous hyperplasia or prostatic intraepithelial neoplasia (high-grade or low-grade) allowed * abnormal baseline transrectal ultrasound and digital rectal exam allowed * biopsy may be before or after study entry, but must be within the past 90 days * psa 5-10 ng/ml patient characteristics: age: * 50 and over performance status: * ecog 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no known allergy to soy protein or milk protein * no invasive cancer within the past 5 years except non-melanoma skin cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * no prior hormonal therapy * no prior finasteride * no concurrent hormonal therapy * no concurrent finasteride radiotherapy: * not specified surgery: * at least 6 months since prior transurethral resection of the prostate * no prior orchiectomy * no concurrent orchiectomy other: * no other concurrent soy products

Keywords: prostate cancer
clinical and biological outcomes of human milk and formula intake after gastroschisis repair

Conditions: Gastroschisis

Summary: the purpose of this study is to determine which type of food results in a shorter hospital stay and better overall outcome for babies born with gastroschisis.


Eligibility criteria:
inclusion criteria: * 1) neonates born with gastroschisis * 2) neonatologist, surgeon, and parent (or care provider) willing to have the neonate participate in the study exclusion criteria: * 1) associated anomaly or medical concern that impacts hospital length of stay (i.e. intestinal atresia, very low birth weight(\<1500 grams)) * 2) known major chromosomal abnormality
retrospective chart review of envista toric 0.9d intraocular lenses

Conditions: Corneal Astigmatism

Summary: the primary objective of this study is to evaluate the performance of the envista toric 0.9d vs non-toric iol.

the performance of the envista toric iols will be compared with that of envista non-toric (spherical) iol. at least 384 eyes (n= 192 per lens type) from 3-4 canadian centers will be investigated. this is a retrospective chart review for preoperative and postoperative data conducted at least 4 weeks after iol implantation.

Eligibility criteria:
inclusion criteria: * males and females subjects age 18 or older on the date of surgery * implant of envista toric iol and/or envista non-toric (spherical) iol in at least one eye * data available at least 4 weeks after iol implantation * eyes must qualify for the 0.9d toric lens based on the barrett toric calculator (flipped axis must be less than 0.2d) (https://ascrs.org/tools/barrett-toric-calculator) * study eyes were implanted with the 0.9d toric lens * control eyes were not implanted with the 0.9d toric lens and implanted with a spherical (non-toric) equivalent instead exclusion criteria: * history of uncontrolled or clinically significant ocular comorbidities for the treated eye(s) before the surgery (e.g., dry eyes, retinal pathology, etc.) * bcdva of 20/25 or worse for the treated eye(s) after the surgery * excessive iol rotation \> 10 degrees (toric iols only) for the treated eye(s) after the surgery
optional sub-study to intraoperative imaging with icg registry

Conditions: Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer; Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer; Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer

Summary: the primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. the registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance. in this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. also, we will monitor any side effects or potential toxicities that may occur. this data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility criteria:
inclusion criteria: * adult patients \>= 18 years of age * patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence. * good operative candidate as determined by the treating physician and/or multidisciplinary team * subject capable of giving informed consent and participating in the process of consent. exclusion criteria: * pregnant women as determined by urinary or serum beta hcg within 72 hours of surgery * vulnerable patient populations