Kornimate/medical-research-clean huggingface dataset:
exclusive breastfeeding improves puerperal glucose metabolism in pregnant women with gestational diabetes mellitus and links to lipids composition

Conditions: Gestational Diabetes; Breast Feeding; Lipid Metabolism Disorders

Summary: breastfeeding could effectively be associated with a lower risk of future type 2 diabetes (t2d) in women with gestational diabetes mellitus (gdm), but the short-term protective impact of puerperal breastfeeding on maternal metabolic recovery of gdm women remains unascertained. the investigators recruited gdm participants at 6-9 weeks postpartum and retrieved clinical diagnoses of gdm from electronic medical records. feeding patterns were collected via phone calls. glucose metabolism parameters and lipid profiling were performed on fasting plasma samples collected from patients 6-9 weeks postpartum (20 breastfeeding cases vs. 15 formula feeding cases).


Eligibility criteria:
inclusion criteria: 1. 18-35 years old; 2. gestational age greater than 37 weeks; 3. body mass index (bmi) before pregnancy 18.5-28kg/m2; 4. have normal listening and speaking skills, can communicate, and are willing to participate in this study. exclusion criteria: 1. abnormal glucose metabolism or diabetes has been diagnosed before pregnancy; 2. assisted reproduction; 3. gdm patients requiring drug treatment; 4. the use of blood lipid regulation drugs; 5. other pregnancy complications and complications; 6. suffering from heart, malignant tumor, kidney and other major organ diseases; 7. associated with neurological dysfunction and cognitive impairment; 8. failure to cooperate with follow-up observers.
a randomized trial of early detection of clinically significant prostate cancer (proscreen)

Conditions: Prostate Cancer

Summary: a population-based randomised trial of prostate cancer screening will be carried out. a total of approximately 117,200 men aged 50-63 in helsinki and tampere are randomised to intervention (screening) or control arm. a reduction in harms of screening in the form of overdiagnosis is sought, while retaining as much as possible of the mortality benefit (reduction in prostate cancer mortality). novel methods that have been shown to increase specificity for clinically relevant prostate cancer but never tested in a randomised setting will be employed in screening and diagnostics. the main end-point is prostate cancer mortality at 10 and 15 years of follow-up.

frequent adverse effects have so far tipped the balance of benefits and harms against prostate cancer screening, and therefore the investigators will focus on employing the best possible means for reducing them. the project introduces a novel concept for pc screening that minimises overdiagnosis and overtreatment, while retaining the mortality benefit to shift the balance of screening benefits and harms to a favourable net effect. the strategy for implementation as a randomised screening trial utilises three levels of risk assessment (psa, kallikrein panel and mri) before the diagnostic procedure (prostate biopsy), each aimed at eliminating detection of indolent disease. the study hypothesis is that by virtue of the novel three-tiered screening algorithm, the beneficial screening effect (prostate cancer mortality reduction) can be retained, while the overdiagnosis can be largely eliminated. the impact of an integrative approach has never been evaluated - each of the methods has only been assessed in isolation. the breakthrough potential of the proposal lies in combining the three novel approaches and taking them to the forefront of applied research through a randomised trial. the key impact of the study is in defining whether the overall balance of benefits and harms of prostate cancer screening can be reversed by applying the best possible methods to detect only clinically important disease. if the study hypothesis is affirmed, it opens the way to introduction of prostate cancer screening. if the balance of harms and benefits is still unfavourable, the problem of overdiagnosis in prostate cancer may be intractable.

Eligibility criteria:
inclusion criteria: * 50-63-year-old men (age in 2018) residing in tampere or helsinki exclusion criteria: * prevalent prostate cancer

Keywords: prostate cancer screening randomised trial kallikrein magnetic resonance imaging prostate-specific antigen
impact of primary language on treatment and outcomes in inflammatory bowel disease

Conditions: Inflammatory Bowel Disease

Summary: a thorough discussion of treatment options to manage inflammatory bowel disease (ibd), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. further, in addition to language, cultural differences can also play into treatment acceptance. this study aims to determine the impact of primary language on the selection of treatment for ibd and on disease outcomes.


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * confirmed diagnosis of ibd (cd, uc or indeterminate colitis) * willing to provide consent for participation * managed at an outpatient clinic either the yale new haven hospital system or the university of texas at austin hospital system. exclusion criteria: * patients \<18 * no confirmed diagnosis of ibd * not planning to continue care at either study site (i.e. presenting for a consultation only) * unwilling to provide signed consent
decreasing antibiotic prescribing in acute respiratory infections through nurse driven clinical decision support

Conditions: Acute Respiratory Infection

Summary: this study evaluates the effects of a novel integrated clinical prediction tool on antibiotic prescription patterns of nurses for acute respiratory infections (aris). the intervention is an ehr-integrated risk calculator and order set to help guide appropriate, evidence-based antibiotic prescriptions for patients presenting with ari symptoms.

the proposed project will fill a critical gap in the evidence base and answer the important question: can pivoting ari cds tools towards nurses overcome established implementation barriers to reducing antibiotic use? the proposal is highly innovative in three ways: it uses cds tools to embed evidence-based risk stratification to enable nurse-led ari management. it creates a nurse training program to support this nurse-led ari treatment pathway. it will be evaluated and optimized using evidence-based implementation frameworks that will guide assessment of the fidelity, acceptability, adoption, cost, and sustainability of the tool. this will provide comprehensive implementation measures, formative and summative, and enable a rigorous understanding of barriers and facilitators to implementing nurse-led cds tools for reducing antibiotic overprescribing. this study will provide much needed guidance on how to implement cds-enabled, nurse-led ari assessment and treatment to reduce antibiotic overprescribing.

Eligibility criteria:
inclusion criteria: clinics: * must be primary care and/or urgent care clinics * should have a minimum of one registered nurse (rn) full time equivalents (fte) nurses : * be licensed to see patients and prescribed and/or recommend prescriptions for patients * work a minimum of 0.5 fte to ensure that they are seeing sufficient numbers of patients to maintain competency * have access to the clinic ehr system, and use regularly as part of patient care patients: * patients must have been seen at a participating clinic with a complaint of cough or sore throat. * ages 3-70 will be included for sore throat and ages 18-70 for cough exclusion criteria: * are unable or unwilling to provide informed consent * are unable to participate meaningfully in an intervention that involves self-monitoring using software available in english (e.g., due to uncorrected sight impairment, illiterate, non-english-speaking, dementia) * clinics will be excluded if phone call triage of patients with sore throat and cough is not performed by rns * nurses will be excluded if they do not work with the clinic ehr as part of their workflow * patients with a history of chronic lung disease or immunosuppression will be excluded since the cprs were not validated in these groups
the role of immunomodulatory treatment in success of icsi in patients with autoimmune thyroiditis

Conditions: Infertility; Autoimmune Thyroiditis

Summary: the aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing ivf-et.


Eligibility criteria:
inclusion criteria: * infertility patients who have autoimmune thyroiditis with positive autoimmune thyroiditis and tsh level above 2 iu. exclusion criteria: * all patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease. patients who have any medical disorders ( eg. d.m. htn .epilepsy ....)
erector spinae plane block for postoperative analgesia for laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: erector spinae plane block is a newly defined regional anesthesia technique. its use for many indications has been identified by case reports in the literature. as the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * 25 - 75 years of age * asa i - ii * undergoing elective laparoscopic cholecystectomy exclusion criteria: * obesity * asa iii - iv * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * recent use of analgesic drugs

Keywords: erector spinae plane block laparoscopic cholecystectomy postoperative pain
mechanism of action of travatan 0.004% in subjects with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the primary objective of this study is to describe the effect of travatan 0.004% ophthalmic solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (oag) or ocular hypertension (oht).


Eligibility criteria:
* subjects 18 years of age or older * of either sex * of any race * diagnosed with ocular hypertension or open angle glaucoma

Keywords: glaucoma ocular hypertension
mk0518 in the treatment of hiv-infected patients switched from a protease inhibitor regimen (0518-032)(terminated)

Conditions: HIV Infection

Summary: the purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with hiv.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient is human immunodeficiency virus (hiv) positive * patient has documented human immunodeficiency virus (hiv) ribonucleic acid (rna) \<50 copies/milliliter (ml) for at least 3 months while on a kaletra based regimen * patient has been on a kaletra based regimen for at least 3 months without a change in background antiretroviral therapy * patient has no documentation of hiv rna \>50 copies/ml for at least 3 months while on the kaletra based regimen exclusion criteria: * patient is or plans to become pregnant, or nursing a child * patient plans to donate eggs or impregnate/donate sperm * patient is receiving stavudine (d4t) as a component of the background antiretroviral therapy * patient is currently receiving a second protease inhibitor in addition to kaletra * patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids * patient has used another experimental hiv-integrase inhibitor * patient has a current (active) diagnosis of acute hepatitis due to any cause * patient has used systemic immunosuppressive therapy within one month prior to treatment in this study

Keywords: treatment experienced
genetic biomarkers in saliva samples from patients with ewing sarcoma

Conditions: Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)

Summary: this clinical trial studies genetic biomarkers from saliva samples in patients with ewing sarcoma. studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (dna) and identify biomarkers related to cancer.

primary objectives: i. to determine the association between the length of ewing sarcoma breakpoint region 1-friend leukemia virus integration 1 (ews-fli1) fusion protein binding sites (microsatellites) and risk of ewing's sarcoma (es). ii. to determine the frequency and commonality of caucasian ancestral markers in cases of es self-identified as non-caucasian (african-american, asian, hispanic). iii. to determine the association between genomic variants in es-related genes and hernia development (i.e. the integrin signaling pathway) and risk of es. outline: genomic dna is extracted from participants' saliva samples and analyzed for expression of ews-fli1 and other es-target genes.

Eligibility criteria:
inclusion criteria: * the patient is enrolled on accrn07 * the patient has a diagnosis of ewing sarcoma (international classification of diseases \[icd\] code morphology 9260; topography c40.0-c41.9, c76.0-c76.8, c80.9) and is registered with children's oncology group (cog) by a north american member institution * the patient must be diagnosed with ewing sarcoma between december 24, 2007 and december 31, 2015 * the patient must have at least one biological parent alive and willing to participate * all questionnaire respondents must understand english or spanish * concomitant treatment on a therapeutic trial is not required
effects of simvastatin and micronized trans-resveratrol treatment on polycystic ovary syndrome (pcos) patients

Conditions: PCOS, Insulin Resistance

Summary: polycystic ovary syndrome (pcos) is the most common endocrinopathy affecting women of reproductive age. hyperandrogenism is the central feature of pcos. studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production. this study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on pcos. methods: a randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with pcos at an academic hospital. pcos is defined according to the rotterdam criteria. evaluations are performed at baseline and repeated after 3 and 6 months of treatment. the main outcome is a change of the serum total testosterone and the fasting insulin level.


Eligibility criteria:
inclusion criteria: * pcos * insulin resistance * normal prolactin, tsh, 17 oh progesterone no evidence of androgen producing malignancy, cushing's syndrome or acromegaly exclusion criteria: * use of oral contraceptives and/or other steroid hormones 3 months prior to the study
a pilot study to explore the role of gut flora in epidermolysis bullosa

Conditions: Epidermolysis Bullosa; Epidermolysis Bullosa Simplex; Epidermolysis Bullosa Dystrophica

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to epidermolysis bullosa

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages. (interest is given to children who present with autism or crohn's and whose parents wish to analyze their children's gut flora. also of interest analysis of development of the child's microbiome. in the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) 3. diagnosis of epidermolysis by at least one of the following i. biopsy ii. genetic testing exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition
flunisolide hfa in children with small airway disease

Conditions: Childhood Asthma

Summary: the purpose of this study is to see how two doses of flunisolide hfa (an fda approved inhaled medication to treat asthma) affect the small airways in children with asthma.

this is a prospective, randomized, parallel, open label study. the primary aim is to compare the average change in spirometric values (forced expiratory volume 1 (fev1) and forced expiratory flow 25-75% (fef 25-75%) and impulse oscillometry system (ios) values (resistance at 5 hz (r5), resistance at 20 hz (r20), area of reactance (ax), resonant frequency (fres)) from baseline to week 6 from participants randomized flunisolide hydrofluoroalkane (hfa) 1 inhalation bid and to flunisolide hfa 2 inhalations bid. the change in scores from baseline to six week follow up will initially be compared using paired t-tests and chi-squared tests for trend. repeated measurements will be analyzed using generalized linear mixed-effects regression modeling (glmm) techniques. for continuous outcomes (e.g. fev1, fef 25-75%, fres, reactance at 5 hz (x5), ax, r5-r20). the identity link function and normal distribution will be used. for count data (e.g., use of beta-agonists, episodes of coughing, episodes of wheezing, etc.) the log link function and the poisson distribution will be used. if we dichotomize outcomes (e.g., a beta-agonist was used, coughing occurred, etc.) the logit link function and bernoulli distribution will be used.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma * informed consent by parent or legal guardian * 6 years to 18 years of age at screening visit * ability to comply with medication use, study visits and study procedures as judged by the site investigator * fef 25-75% \<65% of predicted as a marker for small airway disease exclusion criteria: * acute wheezing at screening visit or at baseline visit * acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding screening visit or 3 weeks preceding baseline visit * oxygen saturation \<95% at screening visit or at baseline visit * clinically significant upper airway obstruction as determined by the site investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea. * severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy * physical findings that would compromise the safety of the subject or the quality of the study data as determined by site investigator * inhaled corticosteroids (ics) use within 7 days of baseline visit; systemic steroids within 30 days * cystic fibrosis, interstitial lung disease (ild) history of severe bronchopulmonary dysplasia (bpd) or other underling significant respiratory disease apart from asthma * potential subjects who are pregnant may not enroll in the study
femoral peri-arterial local anesthetic injection via peri-arterial perineural catheter reverses tourniquet associated ischemic hypertension

Conditions: Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion

Summary: the goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (la) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

this is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet. depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). this is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. the rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. you will be enrolled in this study for 24 hours.

Eligibility criteria:
inclusion criteria: patients that will be included in the study are english speaking 18-75 year old asa 1-3 patients undergoing total ankle arthroplasty. exclusion criteria: 1. asa 4 or 5 2. diagnosis of chronic pain 3. daily chronic opioid use (over 3 months of continuous opioid use). 4. inability to communicate pain scores or need for analgesia. 5. infection at the site of block placement 6. age under 18 years old or greater than 75 years old 7. pregnant women (as determined by standard of care day-of surgery urine bhcg) 8. intolerance/allergy to local anesthetics 9. weight \<50 kg 10. suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 11. uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance. 12. current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Keywords: perifemoral tourniquet mepivacaine tourniquet hypertension