Kornimate/medical-research-clean huggingface dataset:
promoting shared-decision making in opportunistic screening for prostate cancer

Conditions: Decision Making, Shared; Prostate-Specific Antigen; Prostate Cancer

Summary: in this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.

prostate cancer (pc) screening using prostate specific antigen (psa) has led to a reduction in advanced disease and disease-specific mortality. however, screening with psa can also cause harm and is associated with false-positive results and overdiagnosis. shared-decision making (sdm) has been defined as the key to successful patient-centered care. the promotion sdm when deciding on psa screening will have proximal effects such as the development of collaborative deliberation between clinicians and patients, resulting in well-informed patients and in preference-based decisions. as long term effects, it will result in safer, cost-effective, patient-aligned healthcare, and its distant effects will include improvements in resource use, planning processes and improved health outcomes. the project includes a mixed-method approach. the investigators will perform a quantitative survey (cross-sectional design) to evaluate the population, patients' and clinicians' knowledge about the benefits and risks derived from the psa determination and the available recommendations. the investigators will apply qualitative analysis through focus groups, to explore the challenges patients and clinicians face to deep in a prostate screening discussion and to assess the adequacy of different implementation strategies. the investigators will carry out a user-testing design based on mix-methods (questionnaire and semi-structured review) to evaluate the prototype of the initial decision-aid. finally, the investigators will carry out a cluster randomised controlled trial, to assess the results derived from the application of the decision-aid, together with a process evaluation using a combination of both qualitative and quantitative methods to monitor the fidelity of the intervention, the clusters' and patients' response to the intervention as well as the mechanisms of adaptation and change at the intervention.

Eligibility criteria:
inclusion criteria: 1. patients: * men \>40 years old * men who have not had prostate cancer 2. general practitioners: * primary care doctors working in the valencian community, spain. 3. urologists: * urologists working in the valencian community, spain. exclusion criteria: 1. patients: none 2. general practitioners: none 3. urologists: none
prostate hypoxia - tic

Conditions: Prostate Cancer

Summary: prostate cancer is the most commonly diagnosed form of cancer in canadian men. in 2006, greater than 250,000 men were diagnosed with prostate cancer in the united states and canada with more than 32,000 men dying of their disease. using the prognostic variables of t-category, the serum prostate specific antigen (psa), and the pathologic gleason score (gs), men with localized prostate cancer are placed in low, intermediate and high-risk groupings. usually this is treated with surgery, radiation therapy, hormone therapy and/or watchful waiting (also known as active surveillance). while these treatments are quite effective, tumours are likely to recur in about 40% of cases. there is a need for additional prostate cancer treatments. to address this need, many experimental therapies are being developed and tested in mice with prostate tumors. this includes the study of aggressive prostate cancer cells such as stem cells, or tumour initiating cells (tics), or oxygen deprived cells, which may be the ones most likely to re-grow into a tumour or spread throughout the body. researchers want to try and isolate these special cells from the prostate after surgery to study their features, and to see if they can re-grow as solid tumours in mice. researchers would like to test whether the prostate cancer stem cells are more resistant or less resistant to treatments. this will allow researchers to study and test new treatments that specifically target resistant and aggressive prostate cancer cells. the investigators hypothesize that marker-defined tic cells or hypoxic cancer cells have unique genetics in primary prostate cancers and are relatively chemo- and radio-resistant.


Eligibility criteria:
inclusion criteria: * prostate cancer patients with bulky intermediate risk or high-risk disease who have already agreed to undergo an open radical prostatectomy at princess margaret cancer centre-uhn: * clinical stage t2-t3 n0 m0 * pathology of adenocarcinoma of the prostate and * gleason score 7 with \>/= 50 % biopsies involved with tumour; or * gleason score 8 or above (any percentage of biopsies) exclusion criteria: * patients with clinical t4, n1 or m1 disease * patients with histologies other than adenocarcinoma * patients unable to ingest pimonidazole tablets

Keywords: prostate cancer radical prostatectomy
identity oriented psychotrauma therapy on hashimoto in adults

Conditions: Autoimmune Thyroiditis

Summary: the purpose of this study is to evaluate whether identity oriented psychotrauma therapy (iopt) is effective in decreasing the level of autoantibodies of patients with hashimoto thyroiditis. the investigators hypothesize that working constellations of intention will have a positive impact on the biological level, by decreasing the level of autoantibodies, antithyroglobulin antibody (anti-tg) and anti-thyroid peroxidase antibody (anti-tpo), which are the main antibodies detected in chronic autoimmune thyroiditis. secondly, it will have an impact on the psyche by decreasing the level of dissociation, alexithymia, anger, and by increasing the quality of life and than those in the control group.

hashimoto thyroiditis is an autoimmune disease that leads to chronic inflammation of the thyroid gland. this is considered the most common autoimmune disorder, and the most common endocrine disorder. psychological trauma has been suggested as a possible factor in the pathogenesis and development of autoimmune diseases. although a diversity of psychotherapeutic interventions have been studied in adults with autoimmune diseases, there is a lack of psychological research and randomized controlled trials in the field of the hashimoto disease. this study is designed to be a clinical trial with two arms: one experimental and one control group. the experimental group receives iopt and the control group is a waiting list. 70 out-patients with hashimoto disease will be randomly assigned to the two groups. the investigators hypothesize that the therapeutic gains will be more significant in the experimental condition than in the control groups at the completion of the therapy and that this will be maintained at the 3-month follow-up.the iopt group undergoes 10 group modules of iopt once at two weeks.the sessions will be conducted by clinicians or psychotherapists specialized in iopt. if therapy is efficient on the autoimmune disorder, participants in the control group will be reallocated to iopt after the experimental treatment will come to an end.

Eligibility criteria:
inclusion criteria: * aged 18-60 years; * confirmed autoimmune thyroiditis diagnosis * at least one biological marker anti-thyroid peroxidase (anti-tpo) antibodies or thyroglobulin antibodies (tgab) exceeds the reference range exclusion criteria: * the presence of psychotic symptoms * currently receiving another form of psychological treatment; * under psychotropic medication; * neurodevelopmental disorders (intellectual disability, communication disorders, autism spectrum disorders, adhd); * neurocognitive disorders; * substance abuse; * serious legal or health issues that would prevent from regularly attending * patients with autoimmune thyroiditis with biological markers within the reference range

Keywords: hashimoto autoimmune thyroiditis identity oriented psychotrauma therapy intention method
ability to maintain or achieve clinical and endoscopic remission with mmx mesalamine once daily in adults with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with mmx mesalamine/mesalazine 4.8g/day given qd have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with mmx mesalamine/mesalazine 4.8g/day given qd. therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive mmx mesalamine/mesalazine 2.4g/day given qd. remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. the data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 or older 2. male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol 3. diagnosis of active mild to moderate uc (acute flare or newly diagnosed) 4. stable maintenance therapy of 5-asa less than or equal to 3.2 g/day (excluding mmx mesalamine/mesalazine), if 5-asa is being taken at the onset of acute flare. exclusion criteria: 1. severe uc 2. acute flare with onset greater than \>6 weeks prior to baseline while on maintenance therapy. there is no limit to the onset of flare prior to baseline if the flare is untreated. 3. acute flare while on maintenance mmx mesalamine/mesalazine (lialda, mezavant, mezavant xl, mezavant lp) 4. unsuccessfully treated current acute flare using steroids or 5-asa doses \>3.2 g/day 5. acute flare on a 5-asa maintenance therapy of \>3.2 g/day 6. systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening 7. history of biologic (anti-tnf agent) use 8. antibiotic use or repeated use (\>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, cox-2 inhibitors or ibuprofen, within 7 days prior to screening. however, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted 9. current or recurrent disease, other than uc, that could affect the colon, the action, absorption, or disposition of the imp, or clinical or laboratory assessments
predictive models for betalactam allergy

Conditions: Drug Hypersensitivity

Summary: background: ß-lactam (bl) antibiotics represent the main cause of allergic reactions to drugs, inducing both immediate and non-immediate reactions. the diagnosis is well established, usually based upon skin tests and drug provocation tests, but cumbersome. objectives: to design predictive models for the diagnosis of bl allergy, based on the clinical history of patients with suspicions of allergic reactions to bl. methods: the study included a retrospective phase in which records of patients consulting and explored for a suspicion of bl allergy (in the allergy unit of the university hospital of montpellier between september 1996 and september 2012) where used to construct predictive models; a prospective phase, in which we performed an external validation of the chosen models, in patients with suspicion of bl allergy recruited from 3 allergy centres (montpellier, nîmes, narbonne), between march and november 2013. data related to clinical history and allergy work-up results were retrieved and analysed. logistic regression and decision tree method were used to design two models to predict the diagnosis of allergy to bl.


Eligibility criteria:
inclusion criteria: * patients seen in consultation in allergology department for suspicion of allergy to beta lactamines exclusion criteria: * patient refusal to take part in the study * pregnancy * breast feeding women * contraindication to provocation test

Keywords: betalactam decision tree drug hypersensitivity logistic regression predictive modelling
open-label study to assess lacosamide safety as add-on therapy for primary generalized tonic-clonic seizures in subjects with epilepsy

Conditions: Epilepsy

Summary: the purpose is to assess the safety of lacosamide in subjects with uncontrolled primary generalized tonic-clonic (pgtc) seizures with idiopathic generalized epilepsy.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of uncontrolled epilepsy with primary generalized tonic-clonic (pgtc) seizures and idiopathic generalized epilepsy. diagnosis should have been established by an electroencephalogram (eeg) with generalized spike-wave discharges within 5 years of the screening visit * subject has ≥1 pgtc seizure within the 12 weeks prior to the screening visit * subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (aeds) with or without additional concurrent stable vagus nerve stimulation (vns). the vns must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the baseline phase. benzodiazepines will be counted as an aed exclusion criteria: * subject has a history of partial-onset seizures or eeg findings consistent with partial onset seizures * subject has a history of status epilepticus within the 5-year period prior to visit 1 * subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events * subject has any medical or psychiatric condition * subject has any history of alcohol or drug abuse * subject is currently taking felbamate * subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal * subject is on a ketogenic diet * subject has a known sodium channelopathy

Keywords: primary generalized tonic-clonic (pgtc) seizures absence seizures myoclonic seizures idiopathic generalized epilepsy (ige)
hepatocellular carcinoma and rheumatoid arthritis

Conditions: Carcinoma, Hepatocellular

Summary: rheumatoid arthritis(ra) is a disorder with altered immunologic function and increased risk of developing malignancies, while studies examining the association between hepatocellular carcinoma (hcc) and ra remain lacking. the investigators aimed to investigate the risk of hcc between participants with and without ra.

the investigators did a retrospective, observational, nested case-control study in a cohort that was previously recruited from a population-based ra survey. all participants were enrolled prospectively in taiwan's national health insurance between jan 1, 1999, and june 30, 2009, and had follow-up data until dec 31, 2009. ra was diagnosed based on the 1987 american college of rheumatology diagnostic criteria. the investigators matched ra and non-ra subjects by propensity score in a 1:1 ratio. the primary outcome was the risk of developing hcc. cox proportional hazards regression was applied to estimate the hazard ratio (hr) and 95% confidence interval (ci) of hcc for ra and non-ra cohort.

Eligibility criteria:
inclusion criteria: * subjects were required to have ≥2 ra diagnosis (international classification of diseases, ninth revision \[icd-9-cm\]-codes 714.0x), and to be ≥18 years of age on the date of first diagnosis. and inclusion in the registry for catastrophic illness patient database (rcipd) exclusion criteria: * who were diagnosed with ra only once during the study interval, \<18 years of age when first diagnosed with ra, first diagnosed with ra after july 1, 2009, or not registered in the rcipd were excluded
early diagnostic biomarkers of sepsis

Conditions: Critically Ill; Sepsis

Summary: a comparison between crp, ferritin, and serum zinc as early diagnostic biomarkers of sepsis in critically ill patients


Eligibility criteria:
inclusion criteria: * all patients with chest infection and uti. exclusion criteria: * children
urine and stool analysis in kidney stone disease

Conditions: Urolithiasis

Summary: the purpose of this study is to add to the investigators' quest to understanding stone disease, by evaluating the metabolites excretion in urine and its relation to microflora present in the stool.

kidney stones affect up to 10% of the canadian population and can lead to pain, hospitalization, lost of time at work, and surgery. approximately 80% of stones consist of calcium and oxalate, of which both components come from diet and normal bodily processes. individuals who have high levels of oxalate in their urine have a greater tendency to generate stones. one recommendation is to reduce their intake of oxalate-containing foods, but many healthy foods contain oxalate, and an oxalate-free diet is unpalatable and difficult to achieve. some patients, despite reducing their oxalate intake, still have high amounts in the urine. intestinal metabolism is largely affected by the state and composition of the intestinal bacterial flora, with several metabolic diseases being linked to a disrupted "normal" intestinal flora. the investigators believe that calcium oxalate stone disease as well as high urinary levels of oxalate (hyperoxaluria) are triggered by inefficient oxalate metabolism in the intestine, which is linked to a "disrupted" intestinal bacterial flora that lacks certain key components such as o. formigenes. the long-term purpose of this study is therefore, to determine the effect of replenishing the intestinal flora of patients with that of "normal" controls, thereby re-introducing a balanced environment that will lead to the re-establishment of normal metabolic functions and a decrease in urinary oxalate levels and hopefully lower incidence of stone disease.

Eligibility criteria:
inclusion criteria: controls * age \> 19. * no history of kidney stone disease study patient (stone patient) * age \> 19 * radiological evidence indicating presence of a current renal or ureteric stone exclusion criteria: * pregnancy * positive urine culture * active cancer * recurrent urinary infections * gross hematuria * inability to provide informed consent * in the investigator's opinion, the patient would not be good for the study. controls only: * family history of kidney stones * history of kidney stones

Keywords: urine stool kidney stones
the montefiore metoclopramide study

Conditions: Nausea; Extrapyramidal Symptoms

Summary: metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in emergency departments. however, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. we propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

the most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. one pilot study among emergency department patients in australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. in contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. this emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale. in addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. in fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. however, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. this investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ed patients being treated for nausea/vomiting.

Eligibility criteria:
inclusion criteria: * primary or secondary complaints of nausea/vomiting * age 21-65 exclusion criteria: * pregnancy * use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation * previous adverse reaction to study medications * use of opioid medications prior to study start time within that ed visit

Keywords: metoclopramide nausea akathisia emergency department
a safety and immunology study of a dna trivalent influenza vaccine

Conditions: Influenza

Summary: the purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. the study will also test the ability of vaccine to cause particular immune responses in the body.

influenza is a contagious disease of the upper airways and the lungs. it rapidly spreads around the world in seasonal epidemics, killing hundreds of thousands of people and having high economic consequences due to healthcare costs and lost productivity. each year governments recommend groups who are at risk of influenza or its complications to receive influenza vaccination. current vaccine supply is not sufficient to meet the demand if this recommendation were to be taken up by all. this study is part of the clinical development of a particle mediated epidermal delivery (pmed) trivalent dna vaccine for the prevention of influenza.this study will investigate the safety and tolerability of this vaccine as well as assess the humoral and cellular immunogenicity of the vaccine in healthy subjects.

Eligibility criteria:
ages eligible for study: * 18 years - 50 years * genders eligible for study: both * accepts healthy volunteers criteria inclusion criteria: * healthy adult volunteers (women must be of non child-bearing potential) * provided written informed consent exclusion criteria: * no significant concomitant illness * no allergy to gold * no immunosuppression due to disease or treatment * no previous flu vaccination in 2005 or 2006

Keywords: powdermed, dna vaccine, influenza