Kornimate/medical-research-clean huggingface dataset:
role of infected blood dendritic cells in heart disease risk

Conditions: Chronic Periodontitis

Summary: the investigators hypothesize that blood dendritic cells harbor pathogens from the oral cavity in chronic periodontitis and disseminate these pathogens to atherosclerotic plaques.

to address this hypothesis, a clinical study in humans with moderate to severe chronic periodontitis has been designed. this is an interventional study involving scaling and root planing and two arms: 1. treatment with po amoxocillin/metronidazole plus chlorhexidine oral rinse; 2. no antibiotics or oral rinse. it is expected that the antibiotics plus chlorhexidine will prevent the dendritic cell response to infection (bacteremia) elicited by scaling and root planing.

Eligibility criteria:
inclusion criteria: * generalized moderate to severe chronic periodontitis exclusion criteria: * diabetes * antibiotics treatment within 3 months * treatment with steroids, phenytoin, cyclosporin, coumadin * presence of conditions requiring prophylactic antibiotics per aha * cancer, hiv, hepb, lupus, prediagnosed heart disease, renal disease * smoker

Keywords: periodontal disease dendritic cells antibiotics
the effect of semaglutide on pituitary function

Conditions: Healthy

Summary: the primary aim of the study is to describe the effect of a single oral dose of semaglutide 7 mg on growth hormone secretion.

the randomized blinded placebo-controlled clinical trial is conducted on 10 healthy volunteers. 5 study subjects receive once 7 mg of oral semaglutide and once placebo. 5 study subjects receive once 14 mg of oral semaglutide and once placebo. the study group and order of administration of study medication are decided on randomization. the placebo and oral semaglutide are administered at least 4 weeks apart. blood samples are taken before and during 4 hours after the study medication administration (at 60, 90, 120, 150, 180, and 240 minutes after study medication administration). the primary endpoint is the peak value of growth hormone measured during the 4 hours after study medication administration.

Eligibility criteria:
inclusion criteria: * age 18-50 years * the body weight \>65 kg exclusion criteria: * presence of chronic illness * the daily use of medications * pregnancy * lactation.
insulin resistance as primary pathogenesis in newly diagnosed, drug naïve type 2 diabetes patients in korea

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

primary objective:to investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in korea secondary objectives:to investigate proportion of patients with severe insulin deficiency at diagnosis,to investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,to investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Eligibility criteria:
inclusion criteria:newly diagnosed, drug naïve type 2 dm patients who gave informed consent, diagnosis of type 2 dm will be made according to ada guideline 2009 exclusion criteria:patients age under 18 years

Keywords: insulin resistance insulin deficiency homa-ir drug naive diabetes mellitus, type ii
study of clinical course of newly diagnosed moderate to severe ulcerative colitis in korea

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to describe clinical course of newly diagnosed moderate to severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral hospitals in korea for 5-year follow-up under usual care.

this is a multicenter (when medical research study takes place in more than one country), prospective (study following participants forward in time), disease-oriented and hospital-based 5-year follow-up longitudinal study in korean participants with newly diagnosed moderate to severe ulcerative colitis who visit tertiary referral hospital. as the study is observational in nature, no intervention will be received by participants. efficacy will primarily be assessed by number of relapses and percentage of participants achieving sustained remission (clinical, endoscopic and combined remission).

Eligibility criteria:
inclusion criteria: * participant is newly diagnosed with moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks prior to enrollment * the diagnosis was based on symptoms consistent with ulcerative colitis lasting for more than 4 weeks, excluding infections and other acute or chronic non-infectious bowel syndrome conditions * participants meet diagnostic criteria for ulcerative colitisif at least 3 out of 4 of the following are met: 1) a history of diarrhea and/or blood/pus in stool, 2) macroscopic appearance at endoscopy, with continuous mucosal inflammation affecting the rectum in continuity with some or all of the colon, 3) microscopic features on biopsy consistent with ulcerative colitis, 4) no suspicion of crohn's disease or indeterminate colitis * participants are willing to participate in regular follow-up visits * participant is willing to participate in the study and has signed the informed consent exclusion criteria: * participants in an interventional clinical trial with systemic corticosteroid, biologics (including, but not limited to, infliximab, golimumab, adalimumab and vedolizumab, etc) and other drugs (sulfasalazine, medalamine, azathioprine, tofacitinib, etc) for ulcerative colitis * having experienced colectomy such as subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, koch pouch, or ileostomy for ulcerative colitis, or planning surgical treatment within 1 year from enrollment * a current diagnosis of indeterminate colitis, or current diagnosis or history of crohn's disease

Keywords: colitis, ulcerative mosaik remicade infliximab
study of dietary patterns and food diversity in russian gerd patients

Conditions: Gastroesophageal; Reflux With Esophagitis; Gastroesophageal Reflux; GERD; Heartburn; Non-erosive Reflux Disease; Esophagitis

Summary: the aim of the study is to assess food diversity and dietary patterns in russian gerd patients

the study of dietary patterns may provide complex vision of an association between consumption of specific foods, or groups of food products and manifestations of gastroesophageal reflux disease (symptoms: heartburn and acid regurgitation; endoscopic findings - oesophagitis). only limited data on this matter are published to the moment and they predominantly concerns outcomes of gastroesophageal reflux disease (oesophageal adenocarcinoma or barrett's oesophagus). taking into the consideration that earlier studies found significant differences in consumption of nutrients in different world regions, new data on food patterns of dietary patterns in russian gerd patients could partly fill in the gap of knowledge on this particular matter.

Eligibility criteria:
inclusion criteria: * willingness to participate (signed the informed consent form); * willingness to follow all the required procedures; exclusion criteria: * pregnant or breast-feeding females; * neoplasms, current or by the medical history (except local skin cancer successfully treated); * history of chest or abdominal surgery, except appendectomy and cholecistectomy (in case when no consequences of these operations like adhesive disease of the abdominal cavity are present); * co-morbid conditions which can influence or mask the symptoms of gerd (including, but not limited to: ischaemic heart disease, severe pulmonary disease, severe depression or anxiety, etc); * the use of concomitant medications that may influence on the symptoms or other manifestations of gastroesophageal reflux disease: nsaids, corticosteroids (except topic ones for no longer than 2 weeks), any medications directly influencing mood and function of central nervous system (antidepressants, anxiolytics, anti-anxiety agents, anticonvulsant etc) at the moment of enrolment and during a 2 half-life period of the certain drug; * the use of medications that influence gastric secretion at the time of enrolment and during 2 week before it; * any condition of the patient which makes the participation of the patient in the study unreasonable or put him at risk of the condition's exacerbation

Keywords: food diversity dietary pattern healthy eating pattern oesophagitis gerd
assessment of right ventricular 2d-strain in acute respiratory distress syndrome

Conditions: ARDS

Summary: assessment of right ventricular (rv) function in patients with acute respiratory syndrome (ards) is warranted because rv failure is frequent and associated with worse outcome. transthoracic echocardiography is the cornerstone of rv assessment but it remains challenging. quantification of rv deformation by speckle-tracking imaging echocardiography (ste) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the rv. this study aims to investigate the accuracy of ste-derived strain parameters in assessing rv function during ards.


Eligibility criteria:
inclusion criteria: * patients with moderate or severe ards (berlin definition) * receiving mechanical ventilation (\>48h estimated length) * transthoracic echocardiography performed during the first 36h after icu admission exclusion criteria: * pregnancy * protected or deprived of liberty major * chronic respiratory disease * history of clinical right heart failure * chronic heart failure with lvef \< 35% * severe valvular heart disease * under 18 or protected-adults

Keywords: echocardiography
effect of urine alkalinazation on urinary inflammatory markers in patients with cystinuria

Conditions: Cystinuria; Renal Lithiasis; Glomerulonephritis; Interstitial Nephritis

Summary: it has recently been described the presence of a urinary inflammatory signature in patients with cystinuria, the most common cause of renal lithiasis of genetical origin. these data are very innovative in this pathology but deserve further studies to establish the specificity of this inflammatory signature in patients with cystinuria compared to other nephropathies and other renal lithiasis diseases. moreover, the effect of the usual treatment of cystinuria (namely urine alkalanization) on urinary inflammatory biomarkers deserves to be tested. the objectives of the present study are: i) to study the urinary inflammatory profile by mass spectrometry (a very efficient tool to detect and identify proteins) in patients with cystinuria and in patients with lithiasis of other origin and in patients with inflammatory renal disease ; ii) to study the potential effect of urine alkalinazation with potassium citrate (usual treatment according to european recommendations) on the inflammatory signature of patients with cystinuria. to this aim, urine of non treated cystinuric patients will be collected before treatement initiation and 3 months after the start of the alkalizing treatment.


Eligibility criteria:
inclusion criteria: * age superior or equal to 18 years * patient able to understand the information note and to sign the informed consent * patient with an health coverage * no current urinary tract infection (assessed by a cytobacteriological examination of the urine) * for the cystinuria group: patient with cystinuria not yet treated or for whom the alkalizing treatment or the cystein binding thiol agents have been discontinuated for at least 3 months and with an estimated gfr (using the mdrd formula) greater than 60 ml/min/1.73m2. * for the control groups: patient presenting either a renal lithiasis not due to cystinuria, or an inflammatory renal pathology confirmed by an anterior renal biopsy (glomerulonephritis or interstitial nephritis) and with an estimated gfr (using the mdrd formula) greater than 30 ml/ min/1.73m2. exclusion criteria: * cystinuric patient already treated (whatever the treatment)

Keywords: mass spectrometry cystinuria inflammation nephrolithiasis
the effect of sevoflurane versus isoflurane on vasopressor need

Conditions: Hypotension

Summary: aim of this study is to determine the effect of isoflurane versus sevoflurane on blood pressure and systemic vascular resistance.

in modern anesthesia a variety of volatile anesthetics is available. in cardiac anesthesiology both isoflurane and sevoflurane are frequently used. at present the number of studies comparing the influence of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is limited. moreover, the results presented in the available literature are inconsistent. the decision as to which of both volatiles should be used during cardiac surgery is not evidence-based, but is based on personal preference of the anesthesist. the most reliable way to compare the effects of isoflurane and sevoflurane on blood pressure and systemic vascular resistance is a randomized controlled trial in patients during cardiopulmonary bypass (cpb).

Eligibility criteria:
inclusion criteria: * competent adult patients (18 years or older)undergoing elective coronary artery bypass grafting with the use of the cardiopulmonary bypass. exclusion criteria: * patients undergoing valve surgery or combined surgical procedures (e.g. coronary artery bypass grafting in combination with valve reconstruction. * uncontrolled hypertension * a poor left ventricular function * renal failure * a body mass index of \> 25 * history of cerebrovascular accident, transient ischemic accident or carotid artery stenosis.

Keywords: hypotension low blood pressure vasopressor need
efficacy of external application of rosemary oil in patients with chemotherapy-induced peripheral neuropathy: a feasibility study

Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)

Summary: chemotherapy can cause sensory disorders in the hands and feet called peripheral neuropathy. typical symptoms are pain, loss of sensation, tingling, numbness, and gait disturbances, which worsen patients' quality of life and increase the risk of falls. little is known about the effect of rosemary oil (applied to hands and feet) on the symptoms of neuropathy. the present study is a feasibility study to see if it is possible to conduct a clinical trial in patients diagnosed with cancer and receiving chemotherapy who report peripheral neuropathy and apply rosemary oil to their hands and feet.

chemotherapy-induced peripheral neuropathy (cipn) is one of the most common severe dose-limiting side effects that accompany treatment with different chemotherapeutic agents. patients with cipn often experience a reduction in quality of life and an increase in fall risk due to symptoms such as pain, sensory loss, paresthesia (tingling, numbness), and gait disturbances. treatment of cipn is based on pharmacotherapy, which may in turn cause side effects such as nausea, dizziness, fatigue and others. in addition, various approaches from integrative medicine are used, e.g. acupuncture, touch therapies, mind-body medicine, dietary supplements, and aromatherapy. little is known about the effect of rosemary oil, applied to hands and feet, on cipn. the present study is a feasibility study to determine the feasibility of a future clinical trial to investigate the efficacy of topical application of rosemary oil in cancer patients undergoing chemotherapy who develop cipn.

Eligibility criteria:
inclusion criteria: * written informed consent * age 18 years or older * cancer diagnosis * assignment to neurotoxic chemotherapy that has not yet started at the time of enrolment * intact, irritation-free skin on the hands and feet * no history of neuropathic pain exclusion criteria: * neurorelevant comorbidities such as diabetes or alcohol abuse * use of medication for neuropathy such as gabapentin, pregabalin, venlafaxine or duloxetine * other relevant treatments for cipn during the study * insufficient knowledge of the german language * history of rosemary oil allergy

Keywords: chemotherapy-induced peripheral neuropathy oncological patients cancer chemotherapy rosemary oil
a study to evaluate safety of long term therapy of certolizumab pegol patients with crohn's disease

Conditions: Crohn Disease

Summary: the primary objective of the study is to assess the safety of long term therapy with certolizumab pegol in those subjects participating in study c87085 \[nct00552058\].

this study consisted of: * induction period (dosing at weeks 0, 2, and 4) * maintenance dosing (dosing every 4 weeks up to week 260) * end of treatment visit that occurred at week 262/withdrawal visit and a safety follow-up visit (sfu; 12 weeks after final dose)

Eligibility criteria:
inclusion criteria: * subject participated in study c87085 \[nct00552058\] in which the subject completed the study at week 6 * subject is capable of providing informed consent, which must be obtained prior to any study related procedures * have a chest x-ray taken at visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active tuberculosis (tb) or old inactive tb * subject has taken a tb survey and is committed to comply with tb prophylaxis if applicable exclusion criteria: * subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable * subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. tb, pneumonia, sepsis, pyelonephritis, fistula abscess) * subject is non-compliant with tb prophylactic treatment (if applicable) * subject has had a chest x-ray at visit 1 that shows an abnormality suggestive of a malignancy or active infection, including tb * female who is pregnant or breast feeding * female of child bearing age or post puberty males not practicing effective birth control * subject is expecting to receive any live virus or bacterial vaccination within 3 months of first study medication administration, during the trial or 3 months after last dose of study drug

Keywords: cdp 870 certolizumab pegol cimzia crohn's disease crohn disease cd induction induction clinical response clinical remission
advance care planning for critical care - a prelude to breaking barriers

Conditions: Advance Care Planning; End of Life Care

Summary: advance care planning (acp) is a process of 'reflection and communication, in which a person with decision-making capacity makes decisions regarding their future health and/or personal care in the event that they become incapable of consenting to or refusing treatment' most canadians have not planned for end-of-life care and are at risk of aggressive medical care that may not be compatible with their wishes. this study aims to systematically evaluate local barriers to making personal choices with regards to life support interventions that can be provided in the contemporary intensive care unit.

hypothesis: the overarching hypothesis is that the average layperson lacks sufficient knowledge about the aggressive life support measures used routinely in contemporary critical care to make informed decisions for themselves and their loved ones. considering that most canadians have not even heard of the term advance care planning, it is likely that there is a gap in their knowledge and expectations of critical care. such a gap can be bridged through education - the only caveat being that the individual should be in full possession of their faculties and can make informed decisions. this point is critical. thus this study uses a mixed methods (qualitative and quantitative) research design to address the following questions: 1) what is the state of knowledge about critical care interventions among healthy elderly laypersons in london, ontario? 2) what are the barriers to formulating acps? 3) what opportunities exist for increasing acp in the healthy elderly population? the primary objective of this proposal is to assess public knowledge of critical care interventions (and their outcomes) from the perspective of making advance care plans. secondary objectives are 1) to evaluate local barriers to advance care planning 2) to determine effective modes of education for advance care planning that could be used for the community and in our hospital setting.

Eligibility criteria:
inclusion criteria: * members from the community who are i) \> 55 yrs of age, ii) living in london middlesex community, iii) not housebound, iv) in apparent good health and iv) have the ability to make independent decisions for themselves exclusion criteria: * factors that preclude a meaningful interview (such as cognitive impairment, aphasia, profound hearing impairment, language barriers) or anticipated emotional burden with the proposed topic.
et190l1-artemis™ t cells in relapsed, refractory b cell leukemia and lymphoma

Conditions: CD19+ Lymphoma, B-Cell; CD19+ Leukemia, B-Cell

Summary: clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of et190l1-artemis™2 t-cells in patients with cluster of differentiation (cd) 19+ b cell leukemia and lymphoma

artemis™ is a novel chimeric t-cell therapy that in pre-clinical studies, functionally matches the efficacy of chimeric antigen receptor (car) t cells, but dramatically reduces the release of cytokines upon killing of target positive tumors. the molecular target for et190l1-artemis™ is cluster of differentiation 19 (cd19), which is expressed on b cell lymphomas and b cell leukemias. et190l1-artemis™ is a second generation artemis™ receptor engineered with a human fab antibody domain against cd19. this clinical study evaluates the safety and pharmacokinetics of et190l1-artemis™ t-cells in patients with relapsed/refractory b-cell lymphoma and b-cell leukemia.

Eligibility criteria:
inclusion criteria: * patients with relapsed/refractory cd19+ b-cell lymphoma or leukemia, with no effective therapy available per national comprehensive cancer network (nccn) guidelines * eastern cooperative oncology group (ecog) performance status ≤2, expected survival time \> 3 months per pis opinion * women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose. * peripheral venous access is available and no issues with apheresis for lymphocyte isolation * serum alanine aminotransferase(alt)\<200 unit/l, alt/aspartate aminotransferase(ast)\<3 normal range; serum creatinine (cr)\<2.5mg/dl * voluntarily signed informed consent form exclusion criteria: * women in pregnancy and lactation * unable to perform leukapheresis and iv infusion * with active infection * major organ failure * patients with dependence on corticosteroids * continuously used glucocorticoids or other immunosuppressive agents within 2 weeks * t cell deficiency or t cells are difficult to be transduced * patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)