Kornimate/medical-research-clean huggingface dataset:
reduced opioid prescription after laparoscopic hysterectomy

Conditions: Pain, Postoperative; Opioid Misuse; Opioid Use; Pain

Summary: given the nationwide epidemic of opioid use and abuse (in part due to over prescription), this study aims at addressing the need for opioid prescription after laparoscopic hysterectomy.

currently, there is a nationwide epidemic of opioid abuse and overdose deaths. one source of excess opioids is overprescribing in the postoperative period. given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether non-opioid multimodal medications are adequate in treating postoperative pain after laparoscopic hysterectomy and would not increase the need for additional prescriptions or unscheduled patient contacts. this study aims to find the optimal prescriptions for pain after laparoscopic hysterectomy in an attempt to eliminate opioid use.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 undergoing outpatient laparoscopic (conventional or robotic) hysterectomy for benign indications exclusion criteria: * allergy or other contraindication to the prescribed medications such as acetaminophen, ibuprofen, or oxycodone * known opioid use or abuse (defined as reported use or treatment for abuse within the last 3 months) * chronic pain patients * conversion to laparotomy * malignancy as the indication for surgery
a study of zn-c3 in combination with gemcitabine in subjects with osteosarcoma

Conditions: Osteosarcoma

Summary: this is a phase 1/2 study of zn-c3 in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

this is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of zn-c3 in combination with gemcitabine in relapsed or refractory osteosarcoma.

Eligibility criteria:
inclusion criteria: * age ≥ 12 years at the time of informed consent * bodyweight ≥ 40 kg * histologically documented relapsed or metastatic osteosarcoma. * must have measurable disease according to recist guideline version 1.1 criteria. * adequate hematologic and organ function. * female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation. * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: * unresolved toxicity of grade \>1 attributed to prior therapies (excluding: grade ≤2 neuropathy, alopecia, or skin pigmentation) * prior therapy with a wee1 inhibitor * a serious illness or medical condition(s). * pregnant or lactating females. females of childbearing potential with a positive serum pregnancy test \<14 days to day 1. * subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy. * 12-lead ecg demonstrating a corrected qt interval using fridericia's formula (qtcf) of \>470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the qt measurement invalid. * history or current evidence of congenital or family history of long qt syndrome or torsades de pointes (tdp). * taking medications with a known risk of tdp. * administration of strong and moderate cyp3a4 inhibitors/inducers and strong and moderate p-gp inhibitors.
insync model 8040 (insync) and insync iii model 8042 (insync iii) registry

Conditions: Heart Failure; Cardiomyopathy

Summary: heart failure is a progressive disease that decreases the pumping action of the heart. this may cause a backup of fluid in the heart and may result in heart beat changes. when there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat. in certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (crt) may be prescribed. crt is similar to a pacemaker. it is placed (implanted) under the skin of the upper chest. crt is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (soft insulated wires) that are inserted through the veins to the heart. the purpose of this study is to monitor the long-term performance of the insync model 8040 (insync) and insync iii model 8042 (insync iii) systems for cardiac resynchronization therapy (crt).

condition of approval study for cardiac resynchronization therapy with pacemakers, and for the attain left ventricular leads 2187, 2188, 4193, and 4194.

Eligibility criteria:
inclusion criteria: * patients implanted with an insync model 8040 or insync iii model 8042, a right ventricular lead, and a medtronic market-released left ventricular lead as part of a system to deliver cardiac resynchronization therapy. exclusion criteria: * patients with a history of a previously failed placement of a currently investigational medtronic left ventricular lead within 30 days of enrollment in the insync registry

Keywords: heart failure cardiomyopathy cardiac pacing cardiac resynchronization therapy
vitaria registry study

Conditions: Congestive Heart Failure

Summary: this registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.

observational prospective clinical registry in patients with symptomatic heart failure and implanted with the vitaria system. assessments will be made during 12 months of post-titration chronic stimulation. the registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.

Eligibility criteria:
inclusion criteria: 1. willing and capable of providing informed consent according to national data privacy regulations 2. patients with nyha class ii/iii 3. lvef≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of vitaria system 4. receiving optimal pharmacological heart failure therapy for at least 3 months 5. recent implantation of the vitaria system, prior to device activation exclusion criteria: 1. hospitalization for heart failure and/or required the use of heart failure intravenous therapy in the past 30 days 2. severe mitral and/or any aortic valve dysfunction 3. history of acute coronary syndrome (acs) in the past 90 days 4. stroke or transient ischemic attack (tia) in the past 90 days 5. coronary artery bypass surgery (cabg) in the past 90 days 6. pci in the past 90 days 7. surgery for valve replacement (aortic or mitral valve) in the past 90 days 8. left ventricular end diastolic diameter (lvedd) \> 80 mm 9. patients who have had a cardiac resynchronization therapy (crt) device implanted and have been actively treated with crt for \< 12 months 10. patients that are scheduled for crt 11. patients who are listed for heart transplant or expected to be candidates for heart transplant 12. patients on hemodialysis or peritoneal dialysis 13. patients with diabetes (type i or type ii) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin a1c (hba1c) above 8.0% in the past 3 months
eltroxin administration to patients with extremely low t4 values in the intensive care unit

Conditions: Thyroid; Functional Disturbance

Summary: nonthyroidal illness (formerly called sick euthyroid syndrome) is a common condition in patients hospitalized in the intensive care unit, and it is caused by changes in the levels of thyroid hormones in the blood . these changes are correlated to the severity of the critical illness, morbidity and mortality. this condition is characterized by low serum t3 levels, high rt3 levels, normal or low t4 levels, and normal or low tsh levels. previous studies have shown a relationship between ntis (nonthyroidal illness) and poor therapeutic outcomes in patients admitted with sepsis, multi trauma, ards, acute respiratory failure, septic shock and mechanically ventilated patients in intensive care . in general, the recommendation is not to routinely take blood tests to evaluate thyroid function in critical patients in the intensive care unit, unless they were previously known to have a thyroid disease or there is a clinical suspicion that such a disorder developed during hospitalization in the intensive care unit. also, studies so far have not shown an advantage for eltroxin administration to intensive care patients with low t3 and/or t4 levels when the laboratory tests indicate ntis. however, there is a specific group of patients, with ntis and extremely low t4 levels (less than 50% of the lower limit of the normal range) who have a particularly high mortality rate in intensive care (over 85%) and in whom it has not been investigated whether the administration of eltroxin will improve the therapeutic outcomes ( , i.e. was such a low t4 level in them considered a marker for the severity of their general critical illness, or is it another disorder in itself, the treatment of which would benefit the patient) . we would like to examine whether the administration of eltroxin in this specific group of patients, which has not been studied so far, will be beneficial in improving the therapeutic outcomes


Eligibility criteria:
inclusion criteria: all patients aged 18--99 who were admitted to the general intensive care unit from january 2016 to november 22, 2023 for any reason, and who during their hospitalization in the intensive care unit had lower than normal t4 levels measured. it is about 350 patients. of these, we will specifically examine the group of patients for whom an extremely low level of t4 was measured (less than 50% of the lower limit of the norm). - exclusion criteria: patients who were known to have a chronic thyroid dysfunction prior to their hospitalization in the unit, patients who were regularly treated with eltroxin prior to their hospitalization -
feasibility and effectiveness of an internet-based intervention to manage fatigue in breast cancer survivors

Conditions: Breast Cancer; Fatigue

Summary: the purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, energy conservation and activity management intervention among women who report cancer-related fatigue following breast cancer treatment.


Eligibility criteria:
inclusion criteria: * breast cancer diagnoses * not currently receiving active treatment in the form of chemotherapy or radiation therapy * at least 18 years of age * fatigue severe enough to limit daily activities (score ≥ 4 on 7-point fatigue severity scale)(krupp, larocca, muir-nash, \& steinberg, 1989); * functional english fluency and literacy; * participant has a smart device that operates on the android or apple platform * participant is able to use the ecological momentary assessment application before going to bed every night exclusion criteria: * self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment, * disability due to a diagnosis other then breast cancer * currently taking medication for depression, sleep issues, or fatigue.

Keywords: breast cancer fatigue intervention
abdominal versus vaginal hysteropexy

Conditions: Uterine Prolapse

Summary: this study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

this study compares the unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using mersilene suture for the management of uterine prolapse

Eligibility criteria:
inclusion criteria: * uterine prolapse exclusion criteria: * previous prolapse surgery hereditary connective tissue disorders
low concentration atropine in the prevention of myopia in children.

Conditions: Myopia, Progressive

Summary: this double-blind, randomized controlled clinical study is to evaluate the effectiveness and safety of low concentration atropine in preventing myopia in pre-myopia children, and to explore whether there is a dose effect relationship between different concentrations of atropine in preventing myopia.

the main questions this double-blind, randomized controlled clinical study aims to answer are: 1. to evaluate the effect of low concentration atropine on the incidence of myopia in pre myopia children. 2. to evaluate the effectiveness of low concentration atropine in controlling refractive and axial progression. patients are randomly divided into three treatment groups with different atropine concentrations(0.01%, 0.02%, 0.04%) and one control group with atropine dissolvant. patients are required to use the eye drops every night for one year and record after daily usage.

Eligibility criteria:
inclusion criteria: 1. the age of the screening stage is 6-9 years, both sexes; 2. one eye met the diagnosis of pre-myopia, the spherical equivalent was between -0.50d and +0.75d, the astigmatism was ≥-1.50d, and the best corrected far vision was at least 1.0; 3. at least one of parents suffers from myopia (se of at least one eye \<=-3.00d); 4. parents have signed informed consent and agree to participate in screening and follow-up. exclusion criteria: 1. parents disagree to sign the informed consent; 2. presence of strabismus, amblyopia, or other ocular abnormalities, or have a history of eye surgery; 3. presence of other eye or systemic diseases; 4. allergies to low concentration atropine or sulfuric acid drugs; 5. histories of using other preventive measures, such as using red light within 6 months or atropine within 1 month; 6. presence of other situations that the researchers think is not appropriate for patients to be included in the project.
infant antibiotic resistance and implications for therapeutic decision-making

Conditions: Bacterial Infections and Mycoses

Summary: escalating resistance to antibiotics among disease-causing community bacteria increasingly threatens our ability to treat patients' infections. at the level of the physician-patient encounter, incentives at the patient level often take priority to society; this is often the case with antibiotic prescribing. each patient level antibiotic treatment decision is based on how we value potential outcomes, including short-term benefits and risks and longer-term risks, including those related to future bacterial resistance to antibiotics. unfortunately, antibiotics are often prescribed for illnesses unlikely to have a bacterial etiology; even a very small likelihood of benefit seems to outweigh an increased risk of future antibiotic resistance. while short-term effects of antibiotics on colonization with resistant bacteria have been demonstrated, the overall implications of each treatment for future individual, family and societal-level resistance remain difficult to quantify, and are often steeply discounted or ignored during decision-making. knowledge regarding the longer-term effects of personal and household antibiotic use could better quantify these future resistance-related risks, and help guide antibiotic decision-making for physicians and patients. infants are born with sterile nasopharyngeal and gastrointestinal tracts and yet, during the 1st year of life, become important reservoirs of resistant organisms; this creates an opportunity to study colonization and resistance starting from a microbiological tabula rasa. in this proposal, we will use an observational cohort to following newborns' antibiotic exposure and longitudinal colonization with specific bacterial pathogens and related antibiotic resistance in the 1st year of life. our hypothesis is that during the 1st year of life, infants with personal and household antibiotic exposure will have greater colonization with resistan organisms than infants without antibiotic exposure. this project will help us understand the development of bacteria that are resistant to antibiotics within the community, and help to inform judicious decision-making regarding antibiotic prescribing.


Eligibility criteria:
inclusion criteria: * infant in regular nursery at university hospitals cwru * mother has legal custody * mother is \>=18 years old * mother's and baby's physicians have granted permission for possible enrollment * mother speaks, reads and understands the english language exclusion criteria: * does not fit inclusion criteria
screening for neonatal jaundice with a mobile health device: a validation study in oaxaca, mexico.

Conditions: Jaundice, Neonatal

Summary: the performance and accuracy of the smartphone application (app) picterus jaundice pro (picterusjp) will be validated by a cross-sectional study conducted in low resource settings in mexico. physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.

a cross-sectional prospective study is taken place at hospital general de zona 1 in the city of oaxaca, mexico. participants are recruited from the maternity ward and emergency room and data collection is conducted by one experienced pediatrician and one paediatrics' resident. after informed consent is obtained, background data including time and date or birth, birth weight, gestational age, parent's skin type according to fitzpatrick scale and newborn's skin color according to neomar's scale is being collected. visual assessment is performed by the researchers using kramer's scale. to obtain the bilirubin measurements with the smartphone app picterus jaundice pro (picterus jp), the calibration card is placed on the newborn's chest and a set of six images, 3 with and 3 without flash, are captured. the smartphones used to capture the images are samsung a23, iphone 11 and iphone 15 pro. total serum bilirubin (tsb) levels are measured with a blood sample obtained within one hour of capturing the images and analyzed at the hospital laboratory facilities. demographic and clinical characteristics will be analyzed by descriptive statistic. bilirubin measurements correlation between picterus jp using both models and tsb will be determined by pearson's correlation coefficient. systematic over or underestimation of bilirubin levels will be evaluated using bland-altman plots. accuracy measurements will be determined using receiver operating characteristics (roc) and area under the curve (auc) analysis. to compare the correlations from both models, fisher's r to z transformation approach will be applied

Eligibility criteria:
inclusion criteria: * gestational age of 37 weeks or more * birth weight of 2500 g and above * newborns in whom a blood test had been ordered for any reason, irrespective of the study exclusion criteria: * newborns with congenital diseases * newborns transferred to pediatric wards for reasons unrelated to neonatal jaundice * newborns who had undergone phototherapy

Keywords: neonatal jaundice screening mobile health low resource settings
efficacy of additional osteotomies to correct hallux valgus

Conditions: Hallux Valgus

Summary: deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called hallux valgus. in case of significant pain especially due to a conflict with the shoes, surgery could be indicated. angle between the first metatarsal (m1) and the first phalangeal (p1) is named hallux valgus angle (hva). angle between m1 and the second metatarsal (m2) is named intermetatarsal angle (ima). angle between m1 distal articular surface and m1 shaft axis in a frontal plane is named distal metatarsal articular angle (dmaa). insufficient surgical correction is a risk factor of recurrence (hva\>20° after surgery). according to okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : hva\>40° before the surgery and hva\>15° with an ima\>10° 10 weeks (3-24) after the surgery. currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a akin procedure on p1. nevertheless this procedure does not correct deformation in all plans. hva and ima are corrected but dmaa and m1 pronation angle are not. surgeons can add three different osteotomies in this type of chevron. in the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. no studies have tried to assess these three possibilities. the investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up


Eligibility criteria:
inclusion criteria: * patient older than 18 years. * informed consent exclusion criteria: * associated lesser metatarsals surgery. * associated surgery on midfoot, hindfoot or ankle. * neurologic diseases (charcot marie tooth disease, poliomyelitis, compartment syndrome sequelae) * clinical or x-ray degenerative signs (hallux rigidus) or irreducible deformations (mtp1 arthrodesis indications). * patient who declined the study.
determining the safety of l-serine in als

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: the purpose of this study is to determine the safety of l-serine in subjects with amyotrophic lateral sclerosis (als) at varied doses.

previous studies into the guamian als-parkinson's dementia complex has identified β-methylamino-l-alanine (bmaa), as a potential neurotoxin responsible for this disease. bmaa is a non-essential amino acid and is produced by a cyanobacterium which is present in all ecosystems. subsequently several groups have identified high concentrations of bmaa in brain tissues of patients from north america and europe with several neurodegenerative diseases including als, parkinson's disease and alzheimer's diseases. it has been hypothesized that chronic intake of bmaa in the diet leads to mis-incorporation of the amino acid into brain proteins, where it produces slow neuronal damage and recent evidence has shown that bmaa is mis-incorporated into proteins in neuronal cell lines via seryl trna synthetase, thereby producing protein mis-folding and protein aggregates, leading to cell death. it has been demonstrated in mammalian neuronal cell cultures that exogenous l-serine could prevent the bmaa neurotoxin from being mis-incorporated into proteins, thereby preventing cell death and that very high doses of l-serine may compete with the transport of a number of non-essential amino acids across the blood-brain barrier via the y+ transporter. these findings have led us to believe that high doses of l-serine could possibly stop the mis-incorporation of bmaa into brain proteins which in turn would slow or even abate the progression of als. this study will determine the safety of different doses of l-serine given to als subjects at 0.5 gm twice daily (bid), 2.5gm bid, 7.5g bid or 15 grams bid for six months.

Eligibility criteria:
inclusion criteria: 1. age 18-85 2. male or female 3. clinically diagnosed with probable or definite als based on el escorial criteria 4. alsfrs-r \> 25 5. able to provide informed consent to and comply with all medical procedures exclusion criteria: 1. outside age range of 18-85 2. subjects with forced vital capacity (fvc) below 60% 3. evidence of any motor neuron disease for over 3 years

Keywords: als l-serine bmaa