Kornimate/medical-research-clean huggingface dataset:
bacterial colonization with and without iodophor-impregnated adhesive drapes in hip surgery: a prospective, randomized trial

Conditions: Surgical Wound Infection

Summary: this is a prospective, randomized control trial evaluating the efficacy of iodophor-impregnated adhesive drapes for reducing bacterial count in hip surgery.


Eligibility criteria:
inclusion criteria: * primary femoroacetabular osteoplasty (fao) patients * primary periacetabular osteotomy (pao) patients exclusion criteria: * total hip arthroplasty (tha) patients * revision fao surgery * septic or septic arthritis patients * patients with systemic or topical allergy to iodine
women with epilepsy: pregnancy outcomes and deliveries

Conditions: Epilepsy

Summary: this is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (wwe) compared to an age-matched group of women without epilepsy (wwoe).

this is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (wwe) compared to an age-matched group of women without epilepsy (wwoe). the investigators will determine if pregnancy rates differ in wwe compared to wwoe. covariates of interest include proportion of ovulatory cycles, sexual activity, and type of anti-epileptic drug (aed). the investigators will compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest (aed type, aed ratio-to-target concentrations, and epilepsy syndrome). the investigators will also observe interactions between seizures/epilepsy, aeds, and sex steroid hormones during this opportune time when women are not on birth control. patterns of seizures will be evaluated for accepted catamenial patterns with consideration of ovulatory and anovulatory cycles, aed concentrations, and epilepsy type.

Eligibility criteria:
inclusion criteria: * between ages 18 and 40 * planning pregnancy * stopped birth control or planning to stop birth control * for women with epilepsy: receiving at least one aed (lamotrigine, levetiracetam, carbamazepine, phenytoin, oxcarbazepine, phenobarbital, topiramate, rufinamide). if on polytherapy, aeds cannot include lamotrigine, levetiracetam or valproate. exclusion criteria: * use of hormonal therapies for contraception * demonstrated infertility with the same partner (more than 12 months of unprotected intercourse without achieving pregnancy) * diagnosis of infertility * polycystic ovarian syndrome * severe endometriosis * currently breastfeeding * male factor infertility * surgical or medical menopause * smokers who have more than 10 cigarettes per day * untreated thyroid disease * hyperprolactinemia or other pituitary disease * recently trying to achieve pregnancy for more than 6 months with having regular vaginal sexual intercourse without contraception

Keywords: fertility women epilepsy pregnancy seizures seizure frequency ovulation menstruation hormones progesterone
multimodal biocollection linked to the french register of intracranial aneurysms

Conditions: Aneurysm; Brain Aneurysm; Congenital Disease

Summary: the purpose of the bcan study is to create a prospective collection of multimodal data and human samples, linked to the french intracranial aneurysm registry (fran). the aim of bcan is to enable risk stratification of ruptured icas by redefining "intracranial aneurysm disease". the description of genotypically and phenotypically specific subgroups of cases will pave the way for improved patient management based on new diagnostic/prognostic strategies among aic carriers, either in a familial context, or at the level of the general population.

the main objective of bcan study is to build a predictive model of intracranial aneurysm phenotypes through the combination of information on genetic mutations, imaging findings and ica rupture characteristics. the secondary objectives of the bcan study are (i) to study morphological characterization of ica and vascular bifurcations, (ii) to deepen knowledge of genotype/clinical and biological phenotype relationships according to the genes identified in the different families, (iii) to research and validate the relationships between genotypes and phenotypes (including rupture) of ica in a large population of sporadic ica cases.

Eligibility criteria:
inclusion criteria for sporadic ica cases: * any adult patient consulting for a definite and typical bifurcation aic authenticated on mri and/or cerebral arteriography * aneurysm discovered less than a year ago, with initial imaging (mri and/or cta and dsa) available * written consent obtained for study participation * patient covered by a social security plan inclusion criteria for index and related cases (familial forms) of intracranial aneurysms (ica): * index case: any adult patient consulting for a definite and typical bifurcation ica presenting at least one other case with ica related to the 1st or 2nd degree (child, parent, brother, sister) detected by mri with at least one time of flight (tof) sequence. * family relatives: all 1st- and 2nd-degree relatives (children, parents, brothers, sisters), of legal age, of patients with a family history of definite, typical bifurcation aic (≥ 2 affected), screening to be performed using mri with at least a time of flight (tof) sequence. * written consent to participate in the study * patient and relatives covered by a social security plan exclusion criteria: * syndromic diagnosis known to cause ica: marfan syndrome, osa with smad 3, elhers danlos syndrome type ii and iv, autosomal dominant cystic fibrosis, moya-moya syndrome * aic with : dissecting or fusiform, associated with arteriovenous malformation, blister-like, mycotic * cerebral white matter pathology detected on mri evoking : col4a1 mutation * patient under guardianship or conservatorship * person under court protection * contraindication to an mri scan

Keywords: intracranial aneurysm phenotype genetics imaging multimodal data
corehip - post market clinical follow-up study

Conditions: Degenerative Osteoarthritis; Rheumatic Arthritis; Fractures, Hip; Necrosis, Femur Head

Summary: the study is designed as a prospective, non-interventional multicentre cohort study. the product under investigation will be used in routine clinical practice and according to the authorized instructions for use (ifu). aim of this observational study is to collect clinical and radiological results of the corehip® endoprosthesis system in a standard patient population and when used in routine clinical practice.

the corehip® system has a range of different stem designs to address most of the indications and anatomical conditions met in primary tha patients within one implant and instrument system.

Eligibility criteria:
inclusion criteria: * patient age ≥ 18 years * indication for tha with a corehip® stem * written informed consent exclusion criteria: * pregnancy * patient age \< 18 years * patient not able to regularly participate at the follow-up examinations

Keywords: hip arthroplasty hip prosthesis
comparison of nn1250 with sitagliptin in subjects with type 2 diabetes never treated with insulin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial will be conducted in africa, asia, north america and south america. the aim of this clinical trial is to compare nn1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (oad) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 oads (metformin, sulphonylurea, glinides or pioglitazone).


Eligibility criteria:
inclusion criteria: * type 2 diabetes (diagnosed clinically) for at least 6 months * ongoing treatment with 1 or 2 of the following oads (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -metformin: alone or in combination (including fixed combination)1500 mg or maximum tolerated dose (at least 1000 mg daily) -insulin secretagogue (sulfonylurea or glinide): minimum half of the maximal daily dose according to local labelling -pioglitazone: minimum half of the maximal daily dose according to local labelling or maximum tolerated dose * body mass index (bmi) below or equal to 40.0 kg/m\^2 * hba1c 7.5-11.0 % (both inclusive) by central laboratory analysis exclusion criteria: * use within the last 3 months prior to visit 1 of: exenatide, liraglutide, rosiglitazone or acarbose * cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty * uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (hg) and/or diastolic blood pressure at least 100 mmhg) * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate * cancer and medical history hereof (except basal cell skin cancer or squamous cell skin cancer)
effects of mifepristone on biomarkers of metabolic function and neuropsychological performance among middle-aged and older individuals

Conditions: Depression

Summary: the purpose of this study is to study the effect of cortisol,a stress hormone in the body, on memory and attention in people with a history of depression, but who are not in the midst of a current depressive episode. cortisol may affect parts of the brain associated with memory and attention directly. it may also indirectly affect the brain by controlling how much insulin the body makes. insulin is thought to impact cognition by changing the amount of sugar available in certain parts of the brain. the investigators are studying this question by giving patients a medication, called mifepristone, which reduces cortisol's effect on the brain. the investigators will compare results from several groups of people, including differences between men and women, and between those with and without insulin resistance.

the specific aims of this study are threefold: 1. to evaluate the association between glucose utilization and neuropsychological performance on tests of verbal memory and attention among patients with a history of depression, but who are euthymic, at baseline; 2. to evaluate changes in neuropsychological test performance among patients with a history of depression and who have insulin resistance who are treated with open-label mifepristone and, 3. to explore interactions between changes in patients' glucose tolerance profiles and changes in verbal memory and attention. an exploratory aim is to explore the interaction of changes in cortisol awakening response and changes in verbal memory and attention within subjects with and without igt, as well as the potential mediating effects of gender.

Eligibility criteria:
inclusion criteria: * ages 50-70 * history of depression, not currently depressed. exclusion criteria: * history of type 1 or type 2 diabetes. * use of a medication that interacts with mifepristone.

Keywords: cognition prediabetes mood
a novel oral natural extract for the treatment of senile purpura

Conditions: PURPURA

Summary: a randomized, double-blind, placebo controlled study to assess the safety and effectiveness of a novel oral natural extract to improve the appearance of the skin of patients with senile purpura.


Eligibility criteria:
inclusion criteria: * patients with evidence of purpura on physical exam exclusion criteria: * preexisting condition that would not allow the patients to take oral calcium supplement

Keywords: purpura senile purpura bateman's purpura
identification of an asthma susceptibility gene on 3p

Conditions: Asthma; Lung Diseases

Summary: to identify susceptibility genes associated with asthma and asthma related phenotypes.

background: asthma is an increasingly common disease caused by bronchial inflammation and characterized by bronchial hyperresponsiveness and intermittent airways obstruction. the development of asthma is most likely determined by an interaction between host susceptibility and environmental exposures. bronchial hyperresponsiveness (bhr) and elevated total serum ige levels, characteristic findings in asthma, have been shown to have strong genetic components. the identification of the genetic factors that regulate susceptibility to asthma has important public health consequences, and may lead to an improved understanding of the pathogenesis of asthma. this may lead to improved preventive measures and new therapeutic approaches. the study is in response to a request for applications on "positional candidate gene approaches in asthma gene discovery" issued in october 1999. design narrative: in an effort to delineate genetic susceptibility to asthma, dr. bleecker and colleagues have identified several regions of the genome that contain potential asthma susceptibility genes using a dutch population of 200 families ascertained through a proband with asthma. the two regions with the strongest evidence for linkage after completing a genome screen were located on chromosomes 3p14-p21 and 5q31. they will identify the asthma susceptibility gene located on chromosome 3p using the dutch families and determine its contribution to this disease in other populations. there are six specific aims in the study. the first is to develop a high-resolution genetic map of the candidate region on chromosome 3p14-p21. the second aim is to construct a correlated genetic and physical map of the candidate region on chromosome 3p. the third aim is to genotype an additional cohort of dutch trios (one affected child and both parents) to identify haplotypes and to confirm case-control candidate gene studies. the fourth aim is to analyze known and novel genes from the candidate region using a case-control study design in the same population. the fifth aim is to determine the contribution of the chromosome 3p asthma susceptibility gene in other populations including the u.s. collaborative study for the genetics of asthma (csga) and dr. ober's hutterite population. the sixth aim is to characterize the identified single nucleotide polymorphism (snp) or haplotype that contributes to asthma susceptibility. there will be interaction with other investigators to determine the impact of each genetic locus and to investigate gene-gene interactions.

Eligibility criteria:
no eligibility criteria
does post operative pancreatic fistula, after left sided resections, heal faster after the introduction of a pancreatic stent?

Conditions: Healing Time of Post Operative Pancreatic Fistulas

Summary: dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. proper drainage of pancreatic juices is the primary treatment. effective drainage reduces healing time. a pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further. pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation. in an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a b och c fistula (according to the international study group on pancreatic fistula, isgpf) is diagnosed by randomizing between pancreatic stent with drains versus only drains.


Eligibility criteria:
inclusion criteria: * signed informed consent * left sided or distal pancreatic resection * grade b or c fistula on postoperative day 3 or later exclusion criteria: * do not want to participate in study * can not read patient information in swedish * the papilla can not be endoscopically reached

Keywords: post operative pancreatic fistulas pancreatic stenting
effects of topical insulin on levels of tear inflammatory mediators

Conditions: Dry Eye

Summary: 60 samples are take to determine the effects of topical insulin on tear inflammatory mediators interleukin 1a, interleukin 6 and matrix metalloprotenase 9 in diabetics with dry eye disease.

tear samples are taken to compare the levels of inflammatory markers (il 1a, il6 and mmp 9) pre-and post treatment with topical insulin in normal saline compared to standard therapy and normal saline in diabetics with dry eyes and also to correlate the il 1a, il6 and mmp 9 levels with clinical outcomes in diabetics with dry eyes treated with topical insulin in normal saline, standard therapy and normal saline

Eligibility criteria:
inclusion criteria: * all diabetics aged 18 - 50 years of age with at least mild osdi scores exclusion criteria: * diabetics on contact lenses * diabetic with history of ocular surgery in the preceding 3 months * post menopausal women * known mild dry eye with prior usage of topical therapy who are unable to discontinue * known case of allergic eye disease * sjogren's syndrome patients * unwilling or unable to attend 6 follow up and sampling sessions
developing an us-mri biomarker fusion model for endometriosis

Conditions: Endometriosis; Reproductive System Disorder

Summary: single centre, prospective, observational, cohort study looking to develop a database representing the variability of disease and imaging seen in women with clinically diagnosed endometriosis, awaiting laparoscopic surgery.

in the united kingdom (uk), endometriosis is one of the most common gynaecological diseases needing treatment. the prevalence of disease is often underestimated, however it is believed to affect at least 1 in 10 women in the uk. within the nhs, endometriosis costs the uk economy approximately £8.2 billion a year in treatment, loss of work and healthcare costs. currently, the first diagnostic recommendation for endometriosis is and ultrasound (us) scan or a mri, followed by a diagnostic surgery called laparoscopy. accurate diagnoses is usually limited to specialist tertiary centres, therefore a delayed diagnosis is a significant problem for women with endometriosis. limited experience in the disease area can also lead to misdiagnosis and the latest report from the national institute of clinical excellence (nice) reports a time delay of around 7.5 years before a confirmed diagnosis of endometriosis. a model that could accurately predict surgical findings of endometriosis would be of significant clinical and economical benefit. the main aim of this study is to curate a database of patients with varying levels of endometriosis. this database will contain fully anonymised mr and us images alongside clinical data for further use in research. there will be no intervention outside of standard of care. us and clinical data will be collected during routine visits and patients will be offered an additional visit to have a mri. the ultimate aim is to then use this data to develop a widely available diagnostic tool based on mri and us imaging modalities using computer modelling. validating the predictive model with surgical findings will increase confidence and access to advanced imaging for non-experts, allowing clinicians to accurately predict surgical findings as well as reduce time to diagnosis.

Eligibility criteria:
inclusion criteria: * women aged between 18-40 years * clinically diagnosed endometriosis and awaiting surgery * bmi 20-35 kg/m2 * no past abdominal surgical history * participant willing and able to give informed consent for participation in the study exclusion criteria: * previous surgery in 12 months prior to consent: * abdominal surgery * surgery for endometriosis * the participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard mr exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). * any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study.

Keywords: reproductive health diagnostics magnetic resonance imaging ultrasound biomarkers
a study to evaluate the accuracy of a breast cancer locator (bcl) in patients with palpable cancers

Conditions: Breast Cancer

Summary: in this study, the investigators will enroll women with palpable cancers to assess the accuracy of the breast cancer locator (bcl) and the concomitant procedure as a vehicle to optimize and validate the approach in such surgical cases. this approach of adopting palpable cancer patients before initiating an evaluative trial of the bcl in non-palpable breast cancer cases ensures that the bcl does not substantially alter or modify the standard-of-care procedure.

the investigators propose to test whether the breast cancer locator (bcl) accurately defines the edges of the tumor. twenty patients with palpable invasive breast cancer will undergo preoperative supine mri, the creation of a bcl, and breast-conserving surgery using the bcl as an adjunct to palpation-guided tumor resection. participants will also have the tumor position on their skin localized with the supine mr/optical scan/tracker method. the primary objective is to measure the distance from the center of the spots made by the bcl to the cancer edges.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ * patient desire to undergo breast surgery * ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted * the cancer enhances on breast mri imaging. exclusion criteria: * absolute contraindication to mri, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * severe claustrophobia * contraindication to use of gadolinium-based intravenous contrast, including life-threatening allergy or compromised renal function (creatinine \> 2.0) * history of median sternotomy * pregnancy. patient attestation that they are not pregnant will be acceptable as per standard policy for mris at dhmc.

Keywords: breast conserving surgery breast imaging breast diagnostics
a phase 2, 12-week, double-blind, efficacy and safety of gx-g6 in patients with uncontrolled type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: gx-g6-002 is a phase 2, 12-week, randomized, parallel group, multi-centre, double blind, placebo-controlled and an open-label active comparator study.

this study aims to establish the dose-response relationship of 4 dose cohorts of gx-g6 compared with double-blind placebo. these treatment cohorts will also be compared with open-label active control.

Eligibility criteria:
inclusion criteria: 1. diagnosis of t2dm ≥ 6 months prior to screening 2. hba1c level of 7-10% (inclusive) exclusion criteria: 1. have known type 1 diabetes mellitus (t1dm) 2. history of severe hypoglycaemia defined as ≥ 2 episodes of severe hypoglycaemia within 6 months prior to screening 3. have had ≥ 2 episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening 4. has fasting serum tg ≥ 500 mg/dl or 9 mmol/l at screening. 5. patients receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months