Kornimate/medical-research-clean huggingface dataset:
medical checklists in the emergency department

Conditions: Emergencies; Tricyclic Antidepressant Poisoning; Tricyclic Antidepressant Toxicity

Summary: this study aims to investigate whether the use of medical checklists in the emergency department can decrease resuscitation time in critically ill patients.

a scenario evaluating tricyclic antidepressant poisoning will be carried out with and without medical checklist access. emergency physicians from the netherlands who are willing to take part in the study are randomly allocated to perform the scenario with or without checklists.

Eligibility criteria:
inclusion criteria: * emergency physicians recognised by knmg (koninklijke nederlandsche maatschappij tot bevordering van de geneeskunst) working in the netherlands exclusion criteria: * residents (in dutch: aios) emergency medicine * interns (in dutch: anios) emergency medicine

Keywords: medical checklists
european stop tyrosine kinase inhibitor study

Conditions: Chronic Myeloid Leukemia

Summary: the euro-ski is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in chronic myeloid leukemia (cml) patients after stopping tyrosine kinase inhibitor (tki). main goal is the assessment of the duration of major molecular response (mmr) or better after stopping tki therapy. secondary goals include: * identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping tki (e.g. level of complete molecular remission (cmr), risk score, duration of tki treatment, type of tki pretreatment) * evaluation of quality of life (qol) in patients stopping tki * evaluation of medico-economic impact of stopping tki * estimating the number of patients in cmr who are eligible for stopping tki therapy by setting up a screening log * time to recovery of cmr there will be no randomised comparison. based on the experience of the stim trial (mahon et al., lancet onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. an interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. formally, it is planned to test the null hypothesis h0: six-month molecular relapse-free survival probability p ≤ 40% against the alternative hypothesis h1: six-month molecular-relapse-free survival probability p \> 40%. eligible are adult cml patients in chronic phase on tki treatment in cmr for at least one year (\> 4 log reduction of bcr-abl transcripts on is, tki treatment for at least 3 years, confirmed by a pcr within a standardized cmr laboratory). clinical and biological monitoring will be performed during 3 years: associated scientific projects are performed. recruitment period: 2 years; follow up: 3 years. planned patient recruitment in main phase: n=500


Eligibility criteria:
inclusion criteria: * cml in cp under treatment with tki in first line or in second line because of toxicity to first line tki or with tki in combination * duration of tki treatment before enrolment at least 3 years * at least complete molecular remission mr4 * before inclusion confirmation of cmr4 through a eutos-cmr laboratory * baseline data and documentation on treatment before study entry available * both sexes but fertile women only if using effective contraceptive * health insurance coverage * 18 years or older exclusion criteria: * under 18 years old * hospitalized patients without ability to give informed consent * adults under law protection or without ability to consent * previous or planned allogeneic stem cell transplantation

Keywords: tki cml stopping chronic phase in remission
raft - pace &ablate

Conditions: Atrial Fibrillation; Heart Failure; Pacemaker; Arrhythmia Atrial

Summary: atrial fibrillation (af) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. treating af is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. in some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. in these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (av) node. damaging the av node by a procedure called ablation results in the af not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. a complex pacemaker that stimulates both the right and left ventricles simultaneously (bivp) has been used for the last decade prior to av node ablation. more recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called conduction system pacing (csp). there is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. we intend to compare the efficacy of csp with av node ablation to optimal medical therapy for treating af.


Eligibility criteria:
inclusion criteria: 1. patients with permanent af/persistent af (in af) 2. patients with nyha class ii -iva hf symptoms 3. guideline driven medical therapy for hf for at least 3- months with an nt-probnp ≥ 900 ng/l, or ≥ 600 ng/l if the patient has had a hf hospitalization within 1 year exclusion criteria: 1. in hospital patients needing intensive care or intravenous inotropic agent in the last 4 days 2. patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year 3. acute coronary syndrome \<4 weeks or coronary revascularization \<3months 4. unable or unwilling to provide informed consent 5. uncorrected primary valvular disease or prosthetic tricuspid valve 6. restrictive, hypertrophic, or irreversible form of cardiomyopathy 7. severe pulmonary diseases requiring oxygenation 8. patients with a known history of who class i pulmonary hypertension (ph) which includes ph associated with cvd, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, hiv, hemoglobinopathies, schistosomiasis or drug-associated ph as well as those with high suspicion of irreversible pulmonary hypertension 9. patients enrolled in competitive clinical trials that will affect the objectives of this study 10. existing crt/bivp 11. patients who are pregnant or intend to become pregnant 12. guideline indication for crt
clinical study to evaluate the catheter robotics amigo for performing right-sided electrophysiology mapping studies

Conditions: Atrial Flutter; Ventricular Tachycardia

Summary: the purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the catheter robotics remote catheter system to predicate devices when used to perform ep mapping of the right heart (atrium and ventricle).


Eligibility criteria:
inclusion criteria: 1. \> 18years of age. 2. indicated for a right-sided electrophysiology ablation study (e.g., atrial flutter, avnrt, right-sided accessory pathway, or ventricular tachycardia). 3. willingness, ability, and commitment to participate in the procedure visit and a follow-up evaluation including a clinic visit at 7 (-0, +7) days after the study procedure. 4. completion of informed consent. exclusion criteria: 1. any contraindication to cardiac catheterization, including pregnancy. 2. enrollment in any other ongoing cardiac device trial. 3. right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle. 4. corrected or uncorrected atrial septal defect (asd). 5. poor general health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.). 6. medical condition that will require anticoagulation during study or ablation procedure. 7. presence of atrial fibrillation or atrial flutter at time of study procedure. 8. other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject. -

Keywords: atrial flutter avnrt right sided accessory pathway ventricular tachycardia patients who have one or more standard indications for a right-sided diagnostic electrophysiology procedure.
liver biopsy following gene therapy for hemophilia

Conditions: Hemophilia A; Hemophilia B

Summary: this observational study will obtain liver biopsy samples and evaluate the long-term effect of adeno-associated virus (aav)-mediated gene therapy on the liver tissue in adult patients with hemophilia a or hemophilia b who have previously been treated with a factor viii or factor ix gene-containing aav-vector for liver-targeted gene transfer. participants are from a cohort of patients treated with aav-mediated gene transfer and at least 6 months after vector infusion.

to better understand the effect of aav-mediated gene transfer on the liver, eligible participants will have a one-time, standard transjugular liver biopsy (tjlb) under moderate sedation. or, no intervention if prior liver biopsy tissue is available. participants are from a cohort of patients treated with aav-mediated gene transfer and at least 6 months after vector infusion expressing at least 1% of fviii or fix activity, respectively. evaluations will be done on the liver tissue samples regarding transduction frequency, morphology, gene expression patterns, vector genome integrations, epigenetic signature, and consequences of transgene expression on hepatocytes.

Eligibility criteria:
inclusion criteria: * age ≥18 to 80 years * patients, who were enrolled and treated in one of the following clinical trials: * agt4hb (eudract number: 2005-005711-17; nct00979238) - fix aav gene therapy trial (sponsor: st. jude children's research hospital) * go8 (eudract number:2016-000925; nct03001830) - fviii aav gene therapy trial (sponsor: university college, london) * patients with endogenous expression of fviii/fix at \>1% after gene transfer that is stably maintained for more than six months after vector infusion * able to give informed consent * able to comply with study requirements exclusion criteria: * any condition that, in the opinion of the investigator or sponsor of the ongoing clinical trial in which the patient is participating in, would prevent the patient from fully complying with the requirements of the clinical trial and/or would influence or interfere with evaluation and interpretation of subject safety or efficacy result of that ongoing clinical trial * platelet count \<100x10\^9/l * inr \>1.5 * abnormal kidney function with estimated gfr \<50 ml/min (calculated using the ckd-epi equation) * known allergy to iodine-based intravenous contrast agents * known allergy to local or general anesthetics * known allergic reaction to fviii/fix concentrate infusions * presence of fviii/fix inhibitor * evidence of any bleeding disorder other than hemophilia a or b

Keywords: aav-mediated factor viii (fviii) gene transfer aav-mediated factor ix (fix) gene transfer gene therapy hemophilia a hemophilia b transjugular liver biopsy
mirikizumab real world protocol

Conditions: Ulcerative Colitis

Summary: the goal of this observational study is to learn about how effective mirikizumab (omvoh) is when treating patients with ulcerative colitis (uc) does mirikizumab (omvoh) lead to a reduction in symptoms at intervals throughout one year? participants being prescribed mirikizumab (omvoh) as part of their regular medical care for uc will answer online survey questions about their bowel habits for 1 year.


Eligibility criteria:
inclusion criteria: * adult patients, age 18 years or older, with uc, who within 2 weeks have been started on mirikizumab therapy for moderate to severe uc or who plan to begin this therapy within the next 2 weeks. the start of the mirikizumab treatment must have been or be initiated in the setting of standard-of-care therapy. * anticipation that the patient will be followed by the participating center for the next 12 months. * diagnosis of uc must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below. criteria for diagnosis of uc the following diagnostic criteria were developed by the niddk ibd genetics consortium and are provided as guidelines to complete documentation on individuals with ulcerative colitis. a) symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, extraintestinal manifestations, weight loss, or failure to thrive. and b) symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. and c) endoscopic findings compatible with uc: * superficial inflammation and/or ulceration (involving only the mucosa and submucosa) of the colon, which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (relative rectal sparing is allowed for patients receiving topical, rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis). * in patients with proctitis or left-sided ulcerative colitis, there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice. * no inflammation of the small intestine ("backwash ileitis" is allowed - non-stenotic superficial inflammation of the terminal ileal mucosa associated with severe pancolitis, which resolves following medical or surgical treatment of the colitis). * no features of crohn's disease listed above. there is no minimum length of extension of uc required for inclusion in this study. exclusion criteria: patients will be excluded if they meet any of the following criteria: * inability to provide informed consent. * non-english speaking. * patients presenting for a one-time consultation.

Keywords: mirikizumab omvoh mirror
lymph node involvement using extended pelvic lymphadenectomy in clinically localized prostate cancer

Conditions: Secondary Malignant Neoplasm of Lymph Node; Prostatic Neoplasms

Summary: prostate cancer is considered the fourth most common malignancy cancer in america. however, in colombia the incidence is higher, and it is considered the second cause of death among men for malignance diseases. in the framework of clinical localized prostate cancer there is a controversy regarding the best predictors of risk and the best treatment options. the actual literature is discussing the possibility of underestimate the disease and actual tools are not sufficient for proper characterization. is in this context that extended pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real commitment of the disease. the investigators need to know the characteristics that the disease has on the investigators community so the investigators can generate appropriate therapeutic approach. thus, the present prospective observational-descriptive multicenter study, want to determine in three referral centers in bogotá colombia , the frequency of pelvic node involvement in patients with localized clinical prostate cancer from the stratification achieved by pelvic lymphadenectomy extended.


Eligibility criteria:
inclusion criteria: * patients with clinical localized prostate cancer * clinical stage: ct1-ct2-, n0-nx, m0-mx * patients who undergo radical prostatectomy and extended lymphadenectomy in one of the 3 centers of reference. exclusion criteria: * patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.

Keywords: prostatectomy extended lymphadenectomy pelvic lymph node dissection prostatic neoplasm prospective studies
effect of apdt on deep caries in permanent tooth

Conditions: Dental Caries

Summary: the aim of this study is to assess the clinical effect of apdt on deep caries in permanent teeth. half of the deep caries will receive apdt disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure.

the aim of the proposed study is to assess the clinical effect of antimicrobial photodynamic therapy (apdt) using led on dentin with deep caries in permanent teeth. permanent teeth with deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: group 1 -control after incomplete caries removal, washed with sodium 0.9% saline; group 2 - pdt + ch after incomplete caries removal, disinfect the residual dentin with pdt(led + o-toluidine blue). dentin samples will be collected before and after disinfect for microbiological analysis. then the teeth will be capped with ch and restored using resin with clinical and radiographic follow up at 6, 12 and 24 months.

Eligibility criteria:
inclusion criteria: * good general health, without syndromes or chronic systemic diseases * permanent tooth with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits exclusion criteria: * refused to sign the informed consent document * allergic to photosensitizer * unlikely to be able to comply with the study procedures

Keywords: carious dentin photodynamic therapy
covid-19 : stress within hospital workers

Conditions: COVID 19; Depression; Stress, Psychological; Burnout

Summary: as of december 2019, the global pandemic of covid-19 has spread rapidly throughout the world, putting healthcare staff at the frontline. in this context, several factors leading to the appearance of psychiatric symptoms have emerged : work overload, fear of being infected or of infecting, exhaustion... (the lancet, 2020) indeed, post-traumatic stress disorder (ptsd), depressive symptoms, anxiety symptoms, insomnia and increased stress have been reported (rossi et al., 2020). furthermore, the increased anxiety and depression symptoms and stress associated with the covid-19 pandemic may increase the risk of suicide in this already high-risk population. for example, suicidal ideation has been reported in up to 5% of healthcare workers in the united states (young et al., 2021). it is therefore essential to evaluate the incidence of psychiatric disorders (e.g. ptsd, depression, suicide) and their associated risk factors among the hospital staff. to do so, montpellier university hospital healthcare staff was asked their mental state during the first wave of covid-19.


Eligibility criteria:
inclusion criteria: * healthcare staff working at montpellier university hospital during the first wave of covid-19 * having responded to the online survey sent to all healthcare staff exclusion criteria: - refusal to participate

Keywords: psychiatry healthcare staff
a study to determine the recommended dose and regimen and to evaluate the safety and preliminary efficacy of cc-92480 in combination with standard treatments in participants with relapsed or refractory multiple myeloma (rrmm) and newly diagnosed multiple myeloma (ndmm)

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and preliminary efficacy of cc-92480 in combination with standard treatments.


Eligibility criteria:
inclusion criteria: • eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2 for participants in cohorts a, b, c, d, e, f, h, i, j, and k the following inclusions will also apply: * documented diagnosis of multiple myeloma (mm) and measurable disease * documented disease progression during or after their last antimyeloma regimen * achieved a response (minimal response \[mr\] or better) to at least 1 prior treatment regimen exclusion criteria: * plasma cell leukemia, waldenstrom's macroglobulinemia, poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis * known central nervous system (cns) involvement with myeloma * received immunosuppressive medication within the last 14 days of initiating study treatment * uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment other protocol-defined inclusion/exclusion criteria apply

Keywords: relapsed or refractory multiple myeloma newly diagnosed multiple myeloma multiple myeloma cc-92480
comparison for the effect of neuromuscular blocking agents versus sedation alone on severe ards patients due to covid-19

Conditions: COVID-19 Acute Respiratory Distress Syndrome; Sedation Complication; ICU Acquired Weakness

Summary: many questions about management of covid-19 are still not answered. so, we recruit this study aiming to evaluate improvement of oxygenation in covid-19 patients with severe ards, to improve morbidity and mortality of icu covid patients, to participate in understanding of real hidden pathophysiology of covid-19.


Eligibility criteria:
inclusion criteria: * severe ards: pao2/fio2 \ 40 breath/minute) * not relieved by high frequency nasal canula or cpap. * need for invasive mechanical ventilation (uncooperative) exclusion criteria: * patient relatives' refusal * not mechanically ventilated. * combination of female, corticosteroids administration and vecuronium muscle relaxant. * neuromuscular diseases (especially demyelinating diseases).
implementation of a biological sample collection in systemic sclerosis patients

Conditions: Systemic Sclerosis

Summary: systemic sclerosis (ssc) is the most severe of the systemic autoimmune diseases. it is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). there are currently no validated prognostic biomarkers for the progression of ssc, yet it is crucial to better predict the progression of ssc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. the internal medicine department of the lille university hospital is a national and european reference center for the management of patients with ssc. nearly 500 patients are followed annually in the internal medicine department. as part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the lille university hospital for a complete assessment of their ssc. this assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. the purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. the main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of ssc patients.


Eligibility criteria:
inclusion criteria: * patient followed for ssc in the internal medicine or cardiology department of the lille university hospital * fulfilling the acr/eular and/or vedoss criteria for ssc * being insured by the french social security system * having the ability to understand the requirements of the study and provide informed consent exclusion criteria: * administrative reasons: unable to receive informed information, lack of social security coverage * pregnant or lactating women * persons deprived of liberty * minors or protected adults * persons who have refused or are unable to give informed consent * persons in emergency situations

Keywords: systemic sclerosis biomarkers bio-banking