Kornimate/medical-research-clean huggingface dataset:
coagulation and fibrinolysis of estradiol in transwomen

Conditions: Transgenderism; Clotting Disorder

Summary: the specific aim for our study is to measure coagulation system activation and fibrinolysis following transdermal versus sublingual versus oral estradiol versus in transgender women. hypothesis: transdermal estradiol will result in less coagulation system activation and no effect on plasminogen activator inhibitor (pai-1) or tissue-type plasminogen activator (t-pa). oral estradiol will result in the most coagulation system activation and effect on pai-1 and t-pa: oral estradiol \> sublingual estradiol \> transdermal estradiol. a prospective crossover study will include ten subjects given estradiol 1 mg daily and instructed to take it orally, sublingually, or transdermal for 2 months with a 2-week washout period between routes of administration. labs will be measured 7 times during the study.

subjects will report to our adult translational research unit for labs at baseline (2 weeks after hrt washout if needed). both fibrinolysis and testosterone labs have a diurnal variation. therefore, fasting labs will be drawn at approximately 8 am. five subjects will start oral estradiol and 5 will start sublingual estradiol for 8 weeks. froedtert's pharmacy investigational drug service will provide the study estradiol. there will be a 2-week washout period between treatment periods. fasting labs will be drawn at approximately 8 am prior to treatment period 2. the groups will switch therapy. those that took oral estradiol during treatment period 1 will take sublingual estradiol for 8 weeks. those that took sublingual estradiol during treatment period 1 will take oral estradiol for 8 weeks. finally, all subjects will start the transdermal for 8 weeks for treatment period 3. final set of labs will be drawn at approximately 8 am 2 weeks after treatment period 3. the investigators will call subjects every 2 weeks to assess their adherence to the treatment protocol and remind them of the importance of allowing the tablet to dissolve when taking estradiol sublingually.

Eligibility criteria:
inclusion criteria: * 18 years or older * gender identity of male to female or transwoman exclusion criteria: * liver disease * history of blood clot * bleeding disorder * active or recent (e.g., within the past year) stroke * myocardial infarction, * history of orchiectomy * history of breast cancer, * known sensitivity or allergy to any components of the medications used * currently taking a potent cyp3a4 inhibitor or inducer.

Keywords: estradiol estrogens hormones hormones, hormone substitutes, hormone antagonists physiological effects of drugs transgender
describing treatment outcomes and responses in lymphoma-associated hemophagocytic lymphohistiocytosis

Conditions: Lymphoma; Hemophagocytic Lymphohistiocytoses

Summary: the purpose of the study is to describe hemophagocytic lymphohistiocytosis (hlh) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis.

retrospective, multi-institutional study focused on describing the clinical features, laboratory parameters, treatments, and outcomes among individuals presenting with hlh in the setting of a lymphoma

Eligibility criteria:
inclusion criteria: * patients with lymphoma that are fulfilling at least one of the following: a. meeting 5 of 8 hlh-2004 diagnostic criteria or b. are ohi index positive (scd25\>3,900 u/ml and ferritin\>1,000 ng/ml) exclusion criteria: * patients developing hlh\> 1 month after lymphoma diagnosis (for aggressive lymphomas) * patients with incomplete treatment and response documentation
skin testing and elispot assay in patients with a history of non-immediate reactions to cephalosporins

Conditions: Cephalosporin Allergy; Non-immediate Drug Reactions

Summary: this study aims to compare the results of skin testing and elispot assay in patients with a history of non-immediate reactions to cephalosporins

patients with a history of non-immediate reactions to cephalosporins will be tested by patch test and/or intradermal test. peripheral blood mononuclear cells will be collected to analyzed cytokine secretions by elispot assay

Eligibility criteria:
inclusion criteria: 1. patients with a history of non-immediate hypersensitivity reactions to cephalosporins 2. at least 18 years of age exclusion criteria: 1. suffering from severe systemic disease/ in bad health 2. being pregnant 3. patients with a history of immediate reactions to cephalosporin

Keywords: cephalosporins drug hypersensitivity
global burden and treatment trajectiories in italian patients with fabry disease

Conditions: Fabry Disease

Summary: ground study is an italian, multicenter retrospective longitudinal cohort study with a cross-sectional phase with the aim to quantify the severe clinical burden in terms of severe and fatal outcomes and extension of clinical impairment in the italian fabry disease patients' population


Eligibility criteria:
inclusion criteria: 1. adult patients living or deceased of either sex (age ≥18 years) with a documented fd diagnosis in the last 10 years from the beginning of the study. 2. patients with at least 3 years of follow-up or early occurrence of severe/fatal outcomes. also, adult patients who were lost by their care provider or physician and cannot be traced, but for which it is possible to retrieve data for at least 3 years before the last available follow-up visit or from diagnosis to the occurrence of severe/fatal outcomes if earlier, can be included. 3. written informed consent to undergo in the cross-sectional protocol clinical visit and to retrospectively collect genetic/clinical data. in case of deceased or untraceable patients, the written informed consent is not required to collect retrospective clinical data (excluding genetic data). exclusion criteria: * not applicable

Keywords: fabry disease rare retrospective burden
glucometer and mobile-phone based data transfer system in diabetes

Conditions: Diabetes

Summary: to determine if glucometer combined with mobile-phone based data transfer system would be useful for patient diabetes to manage their glycemic control.

patients with diabetes who are advised by their providers to self-monitoring of blood glucose are eligible. patients who decline or are not able to do self-monitoring of blood glucose will serve as controls.

Eligibility criteria:
inclusion criteria: 1. patient with diabetes 2. patients' providers advised self-monitor of blood glucose 3. provided written informed consent. exclusion criteria: 1. patients had other medical condition that were considered not eligible by the medical team members

Keywords: diabetes, glucometer, mobile-phone
safety of avonex treatment in multiple sclerosis patients with neutralizing antibodies to interferon beta therapy

Conditions: Multiple Sclerosis

Summary: this study is to find out the safety and effectiveness of avonex (interferon-beta-1a) therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment

this is a multi-centre, prospective, open label, non-comparative phase iv trial. eligible patients will receive treatment with ifn-beta-1a avonex® 30 mcg i.m. once weekly for 12 months.the patients will be examined clinically and nab titres will be performed at screening and after 12 months. adverse event source verification will be performed during the documentation period.

Eligibility criteria:
inclusion criteria: * relapsing-remitting ms according to poser criteria(cdms or lsdms)30 or ms according to mcdonald criteria * disability equivalent to an edss of 6.0 or less at screening * neutralizing antibody titre \> 20 and \<500 in two consecutive nab tests. one must be from before screening * previous treatment with either subcutaneous administered interferon-b-1b (betaferon®) or interferon-b-1a (rebif tm) prior to enrolment * a priori has been decided to be treated with avonex exclusion criteria: * is nab positive on avonex * history of major depression * cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv), or significant hypertension (bp \> 180/110 mmhg) * renal insufficiency defined as serum creatinine \> 1.5 times the upper normal reference limit * any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability * women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives

Keywords: multiple sclerosis neutralizing antibodies safety low immunogenicity interferon interferon-beta-1a
emotion regulation group study

Conditions: Emotional Dysfunction; Borderline Personality Disorder

Summary: a clinical trial to evaluate the effects of an eight-week emotion regulation group intervention designed for adolescents (16-20 years old) on the levels of emotion dysregulation both self-reported by the adolescent and reported by his/her parent/caregiver (pre-post comparison). the long-term effect will also be measured at a third-time point, three months after the end of the intervention. the intervention will consist of 90-minute sessions once a week for 8 weeks, in groups of eight participants. the intervention proposed for this study is an adaptation from different interventions already in use for adolescents in clinical practice, such as dialectical behavior therapy (dbt), mentalization-based treatment (mbt) and mindfulness-based intervention (mbi).


Eligibility criteria:
inclusion criteria: * aged between 16 to 20 years old. * \> 4 criteria of borderline symptoms (out of the 9 listed in the dsm-5) including emotional liability * french speaking * availability during the whole study * willingness in participating to the intervention and the research * informed consent read and signed exclusion criteria: * current hospitalization * psychotic disorder * severe and persistent substance addiction * antisocial personality disorder * inability to participate in group sessions * current pregnancy * non-french speaking * previous enrolment into the current study
a study to evaluate the efficacy and safety of avtx-009 in patients with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the main purpose of this study is to evaluate the efficacy and safety of avtx-009 compared with placebo in patients with moderate to severe hidradenitis suppurativa (hs).

this is a randomized, double-blind, placebo-controlled, parallel-group, phase 2 study. patients will be randomized to one of two avtx-009 dose regimens or matching placebo in a 1:1:1 ratio. the study will comprise: 1. a screening period which will last up to 28 days. 2. a treatment period up to 16 weeks. 3. a follow-up period of 6 weeks after the last dose of study drug. the maximum clinical trial duration for each participant is 24 weeks.

Eligibility criteria:
inclusion criteria: 1. signs and symptoms of hidradenitis suppurativa (hs) for at least 6 months prior to screening. 2. at least 5 inflammatory lesions in at least 2 distinct anatomical areas, at least 1 of which is hurley stage 2 or 3. exclusion criteria: 1. has a draining fistula count of ≥ 20. 2. has another active skin inflammatory condition, infection (viral, bacterial, or fungal), or another active ongoing inflammatory disease (other than hs) that requires treatment with a prohibited medication, which could interfere with the assessment of hs. 3. history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic lung infection, recurrent urinary tract infection, or open, draining or infected skin wounds or ulcers (not related to hs). 4. has severe, progressive and/or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or immunosuppressive disease.

Keywords: hidradenitis suppurativa hs acne inversa avtx-009 ly2189102 fl-101
safety and performance of vectorio® in conventional trans-arterial chemo-embolization (ctace): a post-market clinical follow-up

Conditions: Oncology

Summary: this study is conducted within the frame of the post-market surveillance (pms) activities, as described in the post market clinical follow-up (pmcf) plan of vectorio®. this study aims at collecting clinical data, to confirm the general safety and performance requirements of vectorio® which is a lipiodol resistant mixing \& injection system for ctace.


Eligibility criteria:
inclusion criteria: 1. female or male adult patient older than 18 years 2. patient with confirmed diagnosis of hcc and eligible for ctace procedure 3. patient affiliated to national health insurance according to local regulatory requirements 4. patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form exclusion criteria: 1. patient with contraindications to ctace procedure 2. patient with known contra-indication(s) to the use or with known sensitivity to lipiodol or chemotherapeutic agent 3. pregnant or breast-feeding female patient. 4. patient unlikely to comply with the cip, e.g. uncooperative attitude and unlikelihood of completing the study
a clinical study of the value of circulating free methylated ebv dna in extranodal nk/t cell lymphoma

Conditions: Extranodal Natural Killer/T-cell Lymphoma

Summary: this study is a prospective, multicenter, open-label, single-arm clinical study. this study plans to enroll 72 newly diagnosed enktcl patients. the enrollment was completed in 2 years, and the follow-up was terminated in 4 years. to observe the accuracy of circulating free methylated ebv dna in predicting 2-year pfs rate, 2-year os rate, and cr rate in newly diagnosed enktcl patients; and to clarify the prognostic stratification ability of pink-cpge compared with pink-e


Eligibility criteria:
inclusion criteria: * newly diagnosed enktcl confirmed by pathological tissue, the diagnostic criteria refer to the 2016 who diagnostic criteria * sign written informed consent and be able to comply with the visits and related procedures specified in the protocol exclusion criteria: * the investigator believes that the subjects may have other factors that may affect the efficacy or safety evaluation of this study
bifidobacterium lactis bb12 and xylitol delivered with a novel slow-release pacifier

Conditions: Dental Caries; Infectious Diseases

Summary: aims: 1. to develop a food supplement containing a health-promoting probiotic bacteria (b. lactis bb12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier. 2. test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence. main hypothesis: the administration of b. lactis bb12 and xylitol affects beneficially the dental health of the child.

xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. by combining in a food supplement xylitol and b. lactis bb12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). though b. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. our study aims to look at caries occurrence in infants who have received the xylitol + bb12 food supplement with a pacifier. recruiting of subjects to the study is completed.

Eligibility criteria:
inclusion criteria: * the infant is healthy * the family agrees to use the novel slow-release pacifier * the infant starts to use the pacifier before the age of 3 months exclusion criteria: * the child is not healthy

Keywords: oral microbiology
study of magnetic resonance imaging (mri) to quantify liver fat in diabetic and pre-diabetic patients (0000-171)

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Summary: this study will assess the inter-center reproducibility and accuracy of hepatic fat fraction measurements using up to two mri-based methods. the intra-class correlation coefficient (icc) for the repeated measurements is expected to be greater than 0.6.


Eligibility criteria:
inclusion criteria: * patient is able to travel to mri centers * all patients have a bmi ≥27 kg/m2 at the prestudy (screening) visit * patient is male or female and at least 18 years of age * at least 5 patients have type 2 diabetes mellitus or pre-diabetes exclusion criteria: * female patient is pregnant or has a positive pregnancy test at screening; * patient has known liver disease other than fatty liver * patient has a history of neoplastic disease * patient is hiv positive * patient has known claustrophobia or other contraindication to mri

Keywords: mri hepatic steatosis study
dci: a community based pre-cardiac surgery diabetes care project

Conditions: Diabetes

Summary: the canadian diabetes association recommends optimizing glycemic control to achieve a glycated hemoglobin (a1c) of less than 7% in patients with diabetes. despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (a1c\>7%). recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. however, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in canada. the objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.

this study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. consenting patients will be randomized to a standard pre-operative diabetes care group (group 1) and a structured pre-operative diabetes optimization group (group 2).

Eligibility criteria:
inclusion criteria: * able to speak and understand english * age \> 18 * able to provide informed consent * a1c\>7% * placed on the waiting list for elective cardiac surgery in manitoba exclusion criteria: * progressive cognitive deficit or disease. * age \< 18 * unable to provide informed consent * a1c\<7% * undergoing emergent cardiac surgery
the feasibility of a dietary intervention in children with adhd

Conditions: ADHD; Diet Modification

Summary: the aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with adhd.

children with attention deficit hyperactivity disorder (adhd) can suffer debilitating symptoms, including problematic behaviour and sleep. research suggests dietary manipulations may be a helpful treatment option for children with adhd, although the most effective are highly restrictive, with little known about why they might work. optimising gut bacteria in individuals with adhd may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. we propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with adhd.

Eligibility criteria:
inclusion criteria: 1. parent-reported diagnosis of adhd. 2. children aged between 8 years - 13 years 11 months at onset of study. 3. children not taking adhd medication (such as methylphenidate) at the time of the study. 4. parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments. 5. both males and females are eligible to take part. 6. children with a co-occurring diagnosis will be accepted onto the trial. 7. children with food allergies/sensitivities/coeliac disease will be accepted onto the trial. exclusion criteria: 1. children undergoing a current course of behavioural therapy. 2. children currently on adhd medication (such as methylphenidate). 3. children who have taken antibiotics in the past 3 months

Keywords: adhd diet modification
betaine supplementation and lipid metabolism in overweight and obese pre-menopausal women

Conditions: Overweight and Obesity

Summary: obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity. this study is designed in a placebo-controlled, double-blinded, randomized fashion. the participants will be overweight or obese pre-menopausal females. upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. the supplementation period will last for 8 weeks. there will be three study meetings: t1 before supplementation, t2 after 4 weeks of supplementation, and t3 after 8 weeks of supplementation. blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings t1 and t3. the t2 meeting will involve only body composition measurement. study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells.


Eligibility criteria:
inclusion criteria: * females * age: 18-45 years * pre-menopausal * overweight or obese: bmi \>25 kg/m2 * waist circumference \> 80 cm exclusion criteria: * males * age \ 45 years * perimenopausal or postmenopausal * bmi \< 25 kg/m2 * waist circumference \< 80 cm * betaine administration for 3 months prior to study * pregnant or breastfeeding
the association of neurotoxin exposure with parkinson's disease and parkinsonism in world war ii veterans and other men

Conditions: Parkinson's Disease

Summary: this program aims to investigate factors associated with development of parkinsonism or idiopathic parkinson's disease in an ongoing cohort of patients established in 1965 who are currently undergoing their sixth examination.


Eligibility criteria:
this is a cohort study. population consist of 8,006 japanese-american men.