Kornimate/medical-research-clean huggingface dataset:
perioperative management of factor xa inhibitors

Conditions: Atrial Fibrillation; Anticoagulant-induced Bleeding

Summary: this study aims to analyze the safety and effectiveness of the discontinuation/resumption protocol of factor xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are at risk of minor bleeding in actual clinical settings

* study design this is a multicenter, non-randomized, investigator-initiated prospective cohort study. the study will analyze the bleeding risk and incidence of cardiovascular events according to the discontinuation/resumption of factor xa inhibitors before and after invasive procedures/surgeries in non-valvular atrial fibrillation patients who are prescribed factor xa inhibitors for stroke prevention and have minor bleeding risk. * study population patients who are over 20 years old, have non-valvular atrial fibrillation, and are taking rivaroxaban, apixaban, or edoxaban (active ingredients), and are facing a procedure defined as having minor bleeding risk. * study protocol for patients with non-valvular atrial fibrillation who are prescribed rivaroxaban, apixaban, or edoxaban for stroke prevention and are at risk of minor bleeding, when they visit the prescribing physician (physician a) for consultation and to obtain a medical opinion regarding the discontinuation/resumption of the medication in relation to an invasive procedure, the physician will explain the protocol for discontinuing/resuming the medication and provide a written explanation to ensure that the patient fully understands it. in addition, the physician in charge of the procedure (physician b) will be notified that the patient has enrolled in this study and will collect information on 1) the type of surgery or procedure performed, and 2) physician b's opinion on the severity of procedure-related bleeding. thromboembolic and bleeding events will be assessed through patient follow-up 30 days after the procedure.

Eligibility criteria:
inclusion criteria: * aged \>20 years * with rivaroxaban, apixaban, or edoxaban * history of non-valvular atrial fibrillation * scheduled minor bleeding risk procedure(s) (dental procedure, cataract/glaucoma surgery, diagnostic gi endoscopy) exclusion criteria: * pregnancy * with rivaroxaban or edoxaban at afternoon * mental disorder * contraindication to rivaroxaban, apixaban, edoxaban * moderate or severe valvular heart disease, or with prosthetic heart valves * with antiplatelet drugs * history of systemic embolism or ischemic stroke within the last 12 months * scheduled therapeutic endoscopic procedure(s)

Keywords: atrial fibrillation perioperative management factor xa inhibitor
pilot study freeze and transport immune cells

Conditions: Diphtheria; Hepatitis B; Pertussis; Poliomyelitis; Tetanus

Summary: to evaluate and standardize umbilical cord specimen collection and laboratory procedures to evaluate cellular and serological immune responses in neonates and young infants

to evaluate: 1) the procedures for obtaining umbilical cord blood; 2) the methods for ensuring immune cell viability, freezing, and shipping; 3) the conditions for optimization of immune cell isolation procedures.

Eligibility criteria:
inclusion criteria: for the portion of the pilot study conducted at the ucla cvr, an umbilical cord blood sample will be obtained from approximately 8 to 12 healthy pregnant women who are delivering neonates at the obstetrical delivery ward of harbor- ucla medical center. informed consent will not be obtained because the blood will be obtained after delivery from a clamped umbilical cord attached to the placenta (afterbirth) that otherwise would be discarded. exclusion criteria: a cord blood sample will not be collected from women who have requested special arrangements for a cord blood registry service.

Keywords: umbilical cord blood, vaccine, pregnant women
effects of various bariatric surgical procedures on intestinal triglyceride-rich-lipoprotein (trl) metabolism in obese patients

Conditions: Obese Patients; Production Rates of These TRL Before and After the Bariatric Surgery; Cardiovascular Diseases

Summary: morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. cardiovascular diseases are the first cause of morbidity and mortality. an excess of trl particles is one of the characteristics, represents a major cardiovascular risk factor. the overproduction of the intestinal trl (which apoprotein b48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal trl has been shown. in front of this important overmortality, the bariatric surgery quickly developed. three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).

it is a monocentric, prospective, comparative study. after identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal trl will be performed in the hospital, using a stable isotope method (5,5,5-d3-l-leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery

Eligibility criteria:
inclusion criteria: * men or women from 18 to 65 years old * subject having a bmi included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery * subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months * subject without contraindication for 3 studied surgical techniques * subject without cardiovascular events 6 months ago * subject is informed and is consented * subject having a biologic balance dating less than 3 months exclusion criteria: * subject with contraindication for 3 studied surgical techniques * women pregnant * subject did not consent and is not informed

Keywords: obese patients trl the bariatric surgery
opera database - crohn's protocol

Conditions: Inflammatory Bowel Disease; Crohn's Disease

Summary: the investigators believe that patients with crohn's disease are able to report details of their own medical history accurately and record changes in clinical status effectively over time. using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.


Eligibility criteria:
inclusion criteria: * adults (over 18 years of age) with physician diagnosed crohn's disease * a current or past prescription of anti-tnf * access to medical record for validation of clinical information exclusion criteria: * unwilling or unable to provide informed consent for study participation * unable to access or use the internet * ulcerative colitis or ibd-u * illiterate or does not possess minimum level of literacy required to complete questionnaire

Keywords: ibd crohn's
congenital transmission of lineages i and ii of trypanosoma cruzi

Conditions: Chagas Disease

Summary: t. cruzi has been divided into two main lineages: t. cruzi i (tci) and t. cruzi ii (tcii, including all non-tci). tci is predominant in mexico and central america, while tcii (non-tci) is predominant in most of south america, including argentina. in recent studies from argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. by contrast, we know very little about the congenital transmission of tci. it has been suggested that congenital transmission of t. cruzi is strain related, and there is an urgent need to know if tci transmits differently than tcii (non-tci). our primary hypothesis is that congenital transmission rates are different for tci versus tcii. our secondary hypothesis is that the characteristics of t. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where tci is predominant versus regions where tcii (non-tci) is predominant. to test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in mexico, 7,500 women in honduras, and 10,000 women in argentina. we will measure transmitted maternal t. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. we will also perform standard pcr, real-time quantitative pcr, and t. cruzi genotyping on maternal blood, standard pcr and t. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. we will estimate the exposure to vectors in the household. in addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. the specific aims of this study are: 1) to determine the rate of congenital transmission of tci compared to tcii (non-tci); 2) to compare the t. cruzi infected mothers' characteristics and exposure to vectors in regions where tci is predominant and regions where tcii (non-tci) is predominant; and 3) to describe the birth outcomes of infected and uninfected infants born to tci and tcii seropositive women.


Eligibility criteria:
inclusion criteria: * women 18 years old or more, informed consent, live birth. exclusion criteria: * women residing outside of the follow-up area.

Keywords: congenital transmission trypanosoma cruzi chagas disease
the influence and effects of the covid-19 pandemic on orthopaedic resident training

Conditions: Educational Problems; Covid19; Burnout, Student; Depression

Summary: orthopedic residents, like all other healthcare professionals, face unique challenges during the coronavirus disease 2019 (covid-19). the rapid spread of covid-19 has forced healthcare systems around the world to adapt. as in many other specialties, it has led to many changes in the training of orthopedic residents including restructuring of surgical training, a reduction in elective surgery cases, and re-assignment of residents to covid-19-related clinical duties. as a result, the standard training curriculum has been interrupted and the number of surgical cases has decreased, limiting the ability of the residents to meet the range and number of patient follow-up and treatment requirements set by the turkish orthopedics and traumatology education council (totek). the already stressful work environment of orthopedic residents has become more stressful and anxious with the covid-19 pandemic. there are no well-designed survey studies that have shown the impact of the covid-19 pandemic on orthopedic resident education and well-being from the resident's perspective. therefore, the purpose of this nationwide survey study was to document and analyze the effects of the covid-19 pandemic on the real-life experiences of orthopedic residents in turkey.


Eligibility criteria:
inclusion criteria: volunteering to answer survey questions exclusion criteria: incomplete answers to survey questions or refusing to participate in the survey
study to evaluate sodium phenylbutyrate in pre-symptomatic infants with spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: in this single-center trial, we will evaluate the effects of napb on presymptomatic spinal muscular atrophy (sma) type i (cohort 1)and presymptomatic sma type ii (cohort 2) infants. a variety of outcome measures will be performed at each study visit to follow the course of the disease. total duration of the study for type i infants will be 18 months, for type ii infants, 24 months.

perform a phase i/ii study to evaluate effects of sodium phenylbutyrate (napb) in a cohort of presymptomatic infants, predicted to develop either sma type 1 or sma type 2 given genotype and family history of an older sibling with the respective sma type. primary outcomes: 1) to collect additional safety and pharmacokinetic data in neonates and young infants administered napb within the dosing guidelines already in use for urea cycle disorder therapy, and 2) to determine possible benefit of early treatment intervention with regard to status of denervation and functional motor status at specific time points for which we have matched natural history data to perform a comparison between cohorts and between each cohort and participants from our natural history database matched for age, smn2 dosage and gender.

Eligibility criteria:
inclusion criteria: * laboratory documentation of homozygous absence of smn1 exon 7. * confirmation of no more than 3 smn2 copies for cohort 1; no more than 4 copies for cohort 2. * family history of affected sibling with sma type i for cohort 1 and sma type ii for cohort 2. * age ≤ 3 months, cohort 1; age ≤ 6 months, cohort 2. * written informed consent of parents/guardian. * laboratory results demonstrating normal values for age. exclusion criteria: -evidence of hepatic insufficiency, renal insufficiency, edema with sodium retention, known seizure disorder, urea cycle disorder, cardiac arrhythmia, congenital heart defect, hypertension, significant central nervous system (cns) impairment, or neurodegenerative or neuromuscular disease other than sma. history of allergy/sensitivity to sodium phenylbutyrate (napb). * use of napb within 30 days of study entry. * serious illness requiring hospitalization ≤ 14 days prior to study entry. * use of medications intended for the treatment of sma including riluzole, valproic acid, hydroxyurea, oral use of albuterol, napb, butyrate derivatives, creatine, growth hormone, anabolic steroids, probenecid, oral or parenteral use of corticosteroids at entry, or agents anticipated to increase or decrease muscle strength or agents with presumed histone deacetylase (hdac) inhibition within 30 days prior to study entry. * unwillingness to travel for study assessments.

Keywords: spinal muscular atrophy sma sodium phenylbutyrate
multimodal analgesia with nsaid vs. narcotics alone after shoulder instability surgery

Conditions: Shoulder Pain

Summary: this will be a single-center, prospective observational study. the study will compare post- operative pain scores and narcotic consumption between two groups of patients - one cohort will receive ibuprofen (motrin) and percocet (to be used as needed) while the other cohort will receive only percocet. both pain management options are considered to be standard of care.


Eligibility criteria:
inclusion criteria: * asa class i-ii * patients scheduled for arthroscopic shoulder instability surgery exclusion criteria: * contraindication to ibuprofen or oxycodone/acetaminophen (e.g. hypersensitivity, history of gi or bleeding disorder) * legally incompetent or mentally impaired (e.g. minors, alzheimer's subjects, dementia, etc.) * younger than 18 years of age or older than 65 * any patient considered a vulnerable subject * patients on pain medication prior to surgery
skin lipid profiles in term and preterm infants

Conditions: Preterm Infants

Summary: this study is designed to compare the skin lipid and protein composition between term and premature infants and determine how the skin composition changes over the first four weeks of life. the investigators hope to elucidate the unique characteristics of premature skin by measuring the lipid and protein content in skin, how it changes during the first month of life, and how it varies with formula feeding versus breast feeding. additionally, the investigators will study the relationships among diet, skin composition and plasma lipids in premature infants over the first four weeks of life.

infants in the ucdmc neonatal intensive care unit with no congenital or acquired diseases of the skin or cardiovascular system will be enrolled after informed consent has been obtained from their parents. this is an observational study with no intervention. procedures: at enrollment, 2 weeks and 4 weeks of age, skin lipids will be collected using three methods. first two small pieces of blotting paper (2 cm x 2 cm) will be placed on the infant's skin, one on the left side of the abdomen just above the umbilicus and one on the left inner thigh. the blotting paper will be left in place for 15 seconds and then removed. second, two adhesive discs will be placed on the skin, one just below the umbilicus and one on the right inner thigh. the discs will be left in place for 30 seconds and then removed. third, two areas of skin, one on the right side of the abdomen just above the umbilicus and the other on the inner right thigh, will be gently swabbed with sterile cotton swabs (one for each location). the intent is to remove a thin layer of oil/lipid from the skin upon removal of the paper or the adhesive disc or with swabbing without disrupting the skin surface (similar to taking a fingerprint). blood specimens will be obtained three times, each time 1 ml : once at enrollment, at 2 weeks and the last one at 4 weeks of age, to generate a plasma lipoprotein profile and size distribution (hdl, ldl, vldl, total cholesterol). for infants that are fed expressed human milk, we will also obtain a sample of mother's milk for analysis of lipid profile (about 2 ml).

Eligibility criteria:
inclusion criteria: * infants who are likely to be inpatients in the nicu for at least 4 weeks exclusion criteria: * congenital or acquired skin disease, * cyanotic congenital heart disease, * neonates that are not viable and * those with lethal anomalies such as anencephaly, trisomy 13, trisomy 18, renal agenesis

Keywords: premature, preterm, premie, skin
role of hysterectomy in the treatment of borderline ovarian tumors

Conditions: Hysterectomy

Summary: borderline ovarian tumors (bot), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. surgical treatment of perimenopausal and postmenopausal bot requires bilateral adnexectomy. although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes. determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early figo stage bot is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

borderline ovarian tumors (bots), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. serous bots, which account for 67% of all bots, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. in 30% of cases, bots are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. patients with bot are diagnosed at figo stage i in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients. surgical treatment of perimenopausal and postmenopausal bot requires bilateral annissiectomy. otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage bot remains unclear. although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes. determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early figo stage bot is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

Eligibility criteria:
inclusion criteria: * women in menopause clinically defined as absence of menstrual cycle for 12 months * primary diagnosis of bot confirmed by pathological examination * surgical treatment of bot by bso with (group 1) and without (group 2) hysterectomy * informed consent acquisition exclusion criteria: * occurrence of bot at index intervention * stage iv * metastatic disease * patients with previous hysterectomy * cancer synchronous of the endometrium * patients who have not had follow-up before 5 years (excluding those who have not reached the 5 year follow-up for the following events: death from any cause, death from bot, recurrence of bot)

Keywords: borderline ovarian tumours gynaecology perimenopause postmenopause
ablate versus pace: pvi or av node ablation and pm implantation for elderly patients with persistent af

Conditions: Atrial Fibrillation

Summary: as patients age, symptom control and treatment of atrial fibrillation become equally difficult, often leading to increased hospitalization. ablate versus pace is a prospective, randomized clinical trial comparing pacemaker implantation with av node ablation with pulmonary vein isolation in terms of rehospitalization and quality of life in patients with persistent af aged 75 years and older.

atrial fibrillation is the most common cardiac arrhythmia and is a major public and represents a major public health problem with increasing healthcare costs and increased mortality risk. in case of recurrent symptomatic atrial fibrillation current guidelines recommend pulmonary-vein isolation (pvi) as invasive treatment option. however, 5-year arrhythmia-free survival estimate is 29% after single catheter ablation. although the long-term success rates in maintaining sinus rhythm are higher than with drug-based rhythm control, they are still moderate, especially in older patients with comorbidities. therefore, repeated interventions are often necessary. an effective method for frequency control is atrioventricular (av) node ablation after implantation of a pacemaker ("ablate-and-pace"). in this case, the ventricular rate is only set by the pacemaker and can be programmed according to the patient's needs. there are some theoretical disadvantages of this treatment option (pacemaker dependency, reduction of cardiac outpout due to lack of atrial contraction) which is why this method nowadays is almost exclusively used in older (and physically less active) patients. the ablate versus pace trial is a prospective randomized clinical trial comparing at 196 these two treatment options in terms of rehospitalizations due to cardiovascular causes and quality of life in elderly patients (≥ 75 years) with normal ejection fraction (≥ 50%).

Eligibility criteria:
inclusion criteria: * persistent af according to current esc guideline (2020) * symptoms ehra classification ii - iv despite guideline indicated medical therapy * age ≥ 75 years * capability of giving written informed consent exclusion criteria: * impaired systolic left ventricular function (ejection fraction \< 50%) * high-grade (iii°) left cardiac valvular disease * pre-implanted pacemaker * bradycardia-indication for pacemaker * surgical coronary revascularization (within the last 90 days) or current triple therapy after stent pci * contraindication for pvi or pacemaker-implantation * contraindication for oral anticoagulation * body-mass-index bmi \> 40 kg/m2 * inability to give written informed consent * concomitant participation in another registered trial * life expectancy \< 12 months * reversible cause of af (e.g. thyrotoxicosis, alcohol ingestion)