Kornimate/medical-research-clean huggingface dataset:
evaluation of the relationship between serum selenium level and glycemic control in pregnant patients*

Conditions: Gestational Diabetes; Pregnancy Related

Summary: gestational diabetes mellitus (gdm) occurs in approximately 15% of all pregnancies worldwide.gdm can lead to the development of type 2 diabetes mellitus (t2dm) later in a woman's life. babies of mothers with gdm have a greater risk of developing t2dm and cardiovascular disease than infants of women without gdm. the degree of insulin resistance is directly proportional to the accumulated free radicals. selenium functions as an active site component of an antioxidant enzyme, glutathione peroxidase, and helps scavenge free radicals. in addition, an experimental study has shown that selenium provides activation by binding to insulin receptors and lowers blood sugar by increasing glucose uptake by cells. according to all this information, we aimed to evaluate the effect of selenium on blood sugar regulation in pregnant patients.

pregnant patients with no known chronic disease / drug use and who had an oral glucose tolerance test between 24 and 28 weeks of gestation will be included in our study. the presence of one or more of the fasting blood glucose values ≥ 92, 1st hour ≥ 180 and 2nd hour ≥ 153 will be considered as gestational diabetes. our patients diagnosed with gestational diabetes in the second step will be divided into two groups. the first group will be started with diet only, the second group diet + 200 mcg selenium supplement per day. patients will continue these treatments for 4 weeks, and at the end of 4 weeks, they will follow their fingertip blood sugar for 5 days (fasting, 1st hour satiety and 2nd hour satiety) while the treatment continues. in patients with gestational diabetes diagnosis, our targets for fingertip blood glucose follow-ups at home are fasting \<95, 1st hour \<140, 2nd hour \<120. the 5-day measurements of both groups will be averaged for fasting, 1st hour and 2nd hour, and it will be evaluated whether there is a significant difference in blood sugar regulation between the groups that take selenium supplements and those that do not.

Eligibility criteria:
inclusion criteria: * presence of one or more of the values of fasting blood glucose ≥ 92, 1st hour ≥ 180 and 2nd hour ≥ 153 among pregnant patients for whom we had an oral glucose tolerance test between 24 and 28 weeks of gestation * single pregnancy * 18 to 45 years old exclusion criteria: * chronic disease (thyroid dysfunction, acute/chronic liver disease, acute/chronic kidney disease, hypertension ) * patients with a diagnosis of insulin resistance or diabetes * those who use drugs other than iron, vitamin d and multivitamin support * multiple pregnancy * patients under 18 years old * patients over 45 years old

Keywords: selenium gestational diabetes mellitus glycemic control
a phase ii study to evaluate the efficacy of ides to desensitize transplant patients with a positive crossmatch test

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to evaluate the effectiveness of the study drug ides in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. at study entry, the patients will have an available deceased or live donor with a positive crossmatch test. the study will assess ides efficacy and safety in removing donor specific antibodies (dsas) and thereby convert a positive crossmatch test to negative.

the study will assess the ides efficacy in creating a negative crossmatch test (xm) in patients who exhibit donor specific antibodies (dsa) and have a positive crossmatch test to their available live or deceased donors. the first 3 patients in this study will receive a kidney from a deceased donor. the study will primarily examine the efficacy of ides in creating a negative xm. the first 3 patients will receive one dose of 0.25 mg/kg bw ides on study day 0. if it is considered safe and negative crossmatch test is not achieved after the first dose, an additional ides infusion can be given within 2 days of the first infusion. the dose schedule may be increased to 0.5 mg/kg bw given once or twice after the first 3 patients have been tested. the decision to escalate the dose will be done after evaluation of safety and efficacy.

Eligibility criteria:
inclusion criteria: * patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. the breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation. * patients with a live or deceased donor with a positive crossmatch test. exclusion criteria: * previous treatment with ides * previous high dose ivig treatment (2 g/kg bw) within 28 days prior to ides treatment * lactating or pregnant females * women of child-bearing age who are not willing or able to practice fda-approved forms of contraception * hiv-positive patients * patients with clinical signs of hbv or hcv infection * patients with active tuberculosis * a significantly abnormal general serum screening lab result according to the investigator's judgement. hgb cannot be \< 6.0 g/dl * severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> nyha (new york heart association) grade 3, unstable coronary disease or oxygen dependent copd * individuals deemed unable to comply with the protocol * patients with clinical signs of cmv or ebv infection * patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions * patients should not have received investigational drugs within 4 half-lives (or similar) * known allergy/sensitivity to ides infusions * patients who have a live donor and test positive for immunocap anti-ides ige
efficacy rate of unipolar polarity switch for lesion assessment in pulmonary vein isolation

Conditions: Atrial Fibrillation

Summary: the technique of intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable pvi, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally.

one initial study reported that unipolar atrial egm modification was a useful end point for rf energy delivery. they compared 2 groups of patients with paroxysmal af undergoing pvi facilitated by an electroanatomic mapping system, merged preprocedural la computed tomographic scan, and a circular mapping catheter. they were the first to use intraprocedural electrogram morphology as a measure of lesion effectiveness in an attempt to achieve durable pvi. the technique, clearly led to shortened procedural time, radiation exposure, and superiority in outcomes, with the implementation of a reproducible, readily available intraprocedural tool that can be applied universally. as there is scant data is this area with lack of randomized human trials, planned on building and further validating evidence from bortone et al in demonstrating that loss of unipolar negative component during pvi can serve a great adjuvant tool for achieving durability of pvi with overall lesser procedural time and no significant increase in adverse events.

Eligibility criteria:
inclusion criteria: * all patients ≥ 18 years of age * undergoing pulmonary vein isolation for de-novo atrial fibrillation. exclusion criteria: * patients unable to give consent * who do not have de-novo af.
effect of infant placement on iron stores in infancy: a pilot study

Conditions: Iron Deficiency; Anemia

Summary: this is a pilot study designed to assess the safety of placing an infant on the mother's abdomen at the time of delivery, prior to clamping the umbilical cord and the effect of placing the infant on the mother's abdomen on the infant's iron stores. it is possible that placing the infant on the mother's abdomen (above the placenta) may lower the infant's iron stores during early infancy.


Eligibility criteria:
inclusion criteria: * healthy pregnant women * 37 - 42 weeks of gestation * vaginal delivery * prenatal care initiated prior to 20 weeks of gestation exclusion criteria: * maternal diabetes * intrauterine growth restriction * hypertensive disorders of pregnancy * chronic hypertension requiring medical therapy * apgar score less than 7 at 5 minutes * unusual bleeding prior to delivery * alloimmunization * maternal hemoglobinopathy * need for immediate infant resuscitation preventing adherence to protocol

Keywords: iron stores anemia iron deficiency infancy placental transfusion iron deficiency in infancy anemia in infancy placement of neonate
integrative approach to identify environmental risk factors for cc-17 group b streptococcal neonatal infection

Conditions: Vaginal Colonization With GBS

Summary: streptococcus agalactiae (gbs) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world. early onset (eod) and late onset (lod) diseases are defined in neonates by their occurring within or after the first week of life, respectively. molecular epidemiological studies have identified a capsular serotype iii clone, referred to as cc-17 by multi locus sequence typing, as accounting for the vast majority of neonatal invasive diseases and for almost all cases of meningitis in lod. the investigators working hypothesis is that host-environmental interactions may contribute to the colonization and persistence of the hypervirulent cc-17 gbs in the neonate. in this project the investigators will determine if reciprocal interactions between the intestinal microbiota and the innate and adaptive immune system may specifically facilitate the colonization of the neonate by the hypervirulent gbs cc-17 clone.

four specific tasks will be addressed to: (i) understand whether and how the gut microbiota may influence growth and colonization of gbs cc-17 within the intestine of neonates. (ii) study the contribution of different diets and immune system constituents enabling the persistence of gbs cc-17 in the gut of neonates. (iii) determine whether the adaptive immune response elicited by maternal gbs colonization and transmitted to the infant is different for gbs cc-17 versus non-cc-17 gbs. (iv) determine whether or not gbs strains isolated from the mothers and from their babies are identical and whether the environment (ie. the vagina or the milk for the mother, the intestine or the oral cavity for the baby) influence the expression of specific virulence factors of cc-17.

Eligibility criteria:
inclusion criteria: * patient having a negative vaginal swab for gbs at 35-37 weeks * patient aged over 18 years * patient who received information and agreeing to sign informed consent * patient affiliated or beneficiary of an insurance exclusion criteria: * patient does not speak and does not understand french

Keywords: streptococcus agalactiae group b streptococcus neonates colonization meningitis clonal complex cc17 microbiota next generation sequencing (ngs)
the motion study - treatment of lss with the mild procedure

Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Summary: prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (lss) patients with neurogenic claudication who are treated with the mild procedure plus conventional medical management (cmm) compared to those treated with cmm alone, as the control. subjects in the control group are able to crossover and receive mild after completion of 12-month follow-up. the study will provide objective functional improvement data for patients treated with the mild procedure as first-line therapy in a real-world setting.

the study will follow participants treated in the mild plus cmm group and crossover participants for up to 5 years on annual bases.

Eligibility criteria:
inclusion criteria: * patients experiencing neurogenic claudication symptoms for at least 3 months duration. * lss with neurogenic claudication * radiologic evidence of lss with unilateral or bilateral ligamentum flavum ≥ 2.5mm confirmed by pre-op mri or ct performed within 12 months of baseline visit. * patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis (grade i without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. * stable opioid intake with no change during 30 days prior to enrollment. * available to complete all follow-up visits. exclusion criteria: * odi score \< 31 (0-100 odi scale). * nprs score \< 5 (0-10 nprs scale). * lumbar epidural injections during eight weeks prior to study enrollment. * baseline analgesic medication greater than 90 milligram morphine equivalent (mme). * prior surgery at the same treatment level. * previously received interspinous spacer at the same treatment level. * previously received intradiscal procedure at the same treatment level. * previously received vertebral augmentation procedure at the same treatment level. * previously received the mild procedure at the same treatment level. * received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment. * history of spinal fractures with current related pain symptoms. * grade ii or higher spondylolisthesis. * motor deficit or disabling back and/or leg pain from causes other than lss neurogenic claudication (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). * unable to walk ≥ 10 feet unaided before being limited by pain. in this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance. * previously randomized and/or treated in this clinical study. * epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). * on (or pending) workman's compensation or known to be considering litigation associated with back pain.
cardiac remote ischemic preconditioning before elective major vascular surgery

Conditions: Peripheral Arterial Disease

Summary: vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. the occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. the main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.


Eligibility criteria:
inclusion criteria: * eligible patients would be those undergoing elective major vascular surgery at the minneapolis va medical center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. all patients must be ≥ 18 years of age and provide written informed consent. exclusion criteria: * exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmhg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (\<1 year), and hemodialysis with a fistula in the upper extremity.

Keywords: peripheral arterial disease myocardial infarction
effect of turmeric on diabetic nephropathy

Conditions: Diabetic Nephropathy; Proteinuria

Summary: the purpose of this study is to investigate whether turmeric is effective in improvement of diabetic nephropathy and in decrease in the amount of proteinuria and cytokine levels.

diabetic nephropathy is leading cause of esrf that many therapy recommended for it. in this study, we investigate effect of turmeric on diabetic nephropathy, thus we selected diabetic nephropathy patients and divided them into 2 groups. one group received turmeric + ace inhibitor + angiotensin ii receptor blocker (arb) and the second group received only ace inhibitor + arb.

Eligibility criteria:
inclusion criteria: * diabetic nephropathy * more than 300 mg proteinuria/day * age more than 18 years old exclusion criteria: * dm type 1

Keywords: diabetes nephropathy turmeric serum il8 serum tgfb seruminf urinary il8 urine tgfb
adherence interventions for hiv youth via text & cell phone - sequential multiple assignment randomized trial (smart)

Conditions: HIV Infections

Summary: the purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mhealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (art) and achieve and maintain viral load (vl) suppression in youth living with hiv (ylh) while increasing understanding of the context for wide-scale implementation of cell phone support (cps) and text messaging support (sms), with and without incentives.

the study will consist of two points of randomization. the first step involves randomization of participants to receive either cps or sms using a 1:1 allocation ratio. both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of cps or sms). the second step involves a stratified randomization in blocks with 8 possible intervention trajectories. within each condition, participants are categorized into two groups - responders with vl\<200 (rsp) and non-responders with vl ≥200 (nrsp). responders in the cps condition will be randomly assigned to receive either 3 months of cps tapered (cps-t) intervention followed by standard care (sc) or only sc. similarly, responders in the smscondition will be randomly assigned to receive either 3 months of sms tapered (sms-t) intervention followed by sc or only sc. non-responders in both cps and sms conditions will be randomly assigned to receive either 3 months of incentivized cps (cps-i) followed by 3 months of cps-t and 3 months of sc or 3 months of incentivized sms (sms-i) followed by 3 months of sms-t and 3 months of sc.

Eligibility criteria:
inclusion criteria: * hiv diagnosis * viral load ≥ 200 copies/ml within 3 months prior to enrollment or self-reported adherence ≤ 80% * art medication regimen prescribed minimum of 3 months prior to eligibility vl or self-reported adherence * sole owner of device capable of sending/receiving calls and text messages * willingness to permit research team to communicate with their hiv care provider team exclusion criteria: * mental, physical, or emotional capacity prevents completion of protocol as written * inability to understand written/spoken english * concurrent participant in any adherence behavioral research intervention

Keywords: interventions youth living with hiv mhealth art adherence adaptive intervention cell phone text messaging
diagnosing extremity fractures and/or dislocations using ultrasound presenting to the emergency department

Conditions: Fractures; Dislocations

Summary: the purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations. hypothesis: can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? is there a difference in amount of pain experienced prior to and after the ultrasound?

this prospective, multicenter cohort study. the sampling method will be a convenience sample of all adult patients presenting to the ed with symptoms concerning a fracture and/or dislocation of an extremity. once a patient has been deemed an appropriate candidate for the study, written consent will be obtained from one of the associate investigators. once consent has been obtained, a resident physician will perform the ultrasound examination on the affected extremity(s) and note their findings.

Eligibility criteria:
inclusion criteria: * clinical suspicion of a fracture and/or dislocation of an extremity * age greater than 18 years * english speaking * able to give consent exclusion criteria: * age less than 18 years, including emancipated minors * unstable patients with b/p below 90mmhg systolic * open, unstable, or suspected compound fracture * physician has reviewed x-rays and made diagnosis before ultrasound could be done * x-rays will not be ordered * patient is pregnant * patient cannot give own consent * english is not the patient's primary language
use of mometasone eluting stent in choanal atresia

Conditions: Choanal Atresia

Summary: this study is to find out how well drug-eluting stents work as part of treatment for choanal atresia repair. participants will be receiving surgical choanal atresia repair; half will get a drug-eluting stent placed, the other half will not.

objective: to determine the utility of mometasone eluting stents in the treatment of choanal atresia. setting: cincinnati children's hospital medical center (cchmc), division of pediatric otolaryngology, head and neck surgery study design: randomized, single blind control trial methods: this study will be a randomized, prospective single-blinded control trial. inclusion criteria will include all subjects less than 11 years of age who are diagnosed with either unilateral or bilateral choanal atresia. following enrollment, the patients will be randomized to either a control arm (no stent) versus an intervention arm (placement of drug eluting stent). subjects will then undergo surgical repair of the choanal atresia with either no stent or a drug eluting stent placed. multiple postoperative nasal endoscopies will be performed to assess size which will be reviewed and graded by two independent reviewers. analysis: descriptive statistical analysis and multivariate analysis will be performed.

Eligibility criteria:
inclusion criteria: * subjects who are under 11 years old and have a diagnosis of choanal atresia will be included in this study. exclusion criteria: * those subjects who are 11 years of age or greater or who do not have choanal atresia will be excluded.
the fluydo nc post market clinical follow-up study

Conditions: Coronary Artery Disease; Coronary Disease; Vascular Diseases

Summary: the aim of the present observational study is to collect clinical data on the medical device non-implantable medical device fluydo nc: coronary angioplasty non-compliant balloon dilatation catheter in the daily use in a not selected population.


Eligibility criteria:
inclusion criteria: * turkish citizen, * ≥18 years of age, * has indication for percutaneous transluminal coronary angioplasty (ptca), * has indication to treat obstructive lesions of a native coronary artery or aortocoronary bypass or needs post dilatation of coronary stent * fluydo nc using in the primary lesion treated during the procedure by the decision physician, * has signed and dated the informed consent. exclusion criteria: * has a previous diagnosis of coronary artery spasm in the absence of a significant stenosis. * needs the device use in an unprotected left main coronary artery * device use has not consistent with instructions for use. * participating in another medical device or pharmaceutical clinical trial.