Kornimate/medical-research-clean huggingface dataset:
a rws of the farapulse in a chinese population with paf

Conditions: Paroxysmal Atrial Fibrillation

Summary: the real world study is a retrospective and/or prospective, single-center, single-arm observational study to observe the safety and effectiveness of the farapulse pulsed field ablation system for treatment of recurrent, symptomatic paroxysmal atrial fibrillation (paf) in a chinese population.

the primary effectiveness endpoint is the acute procedural success, defined as the proportion of subjects that achieve electrical isolation of all pvs using farapulse pulsed field ablation system only. the primary safety endpoint is defined as the occurrence of the acute serious procedure-related and /or device-related adverse events at 7 days post index procedure. primary endpoints analysis is planned to be conducted after all enrolled subjects have completed data collection at 1-month follow-up visit. all the subjects underwent study device treatment will be followed up to 12 months after the procedure, and the secondary and other endpoints will be analyzed then.

Eligibility criteria:
inclusion criteria: 1. subjects who are ≥ 18 and ≤ 75 years of age on the day of enrollment; 2. subjects whose preoperative diagnosis is paf confirmed by the clinician; 3. de novo ablation procedure for paf with class i or iia recommendations\* according to 2018 chinese expert consensus on atrial fibrillation therapy; 4. subjects who are able and willing to provide the defined observational data and/or participate in baseline and follow-up evaluations for the full study; 5. subjects who are willing and capable of providing informed consent. exclusion criteria: 1. subjects who, in the judgment of the investigator, have a life expectancy of less than one year before the procedure; 2. women of childbearing potential who are, or plan to become, pregnant during the time of the study; 3. subjects with any known contraindication to af ablation with farapulse pulsed field ablation system, anticoagulation therapy, or contrast media in the judgment of the investigator or subjects unwillingness to use systemic anticoagulation 4. subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study.
cycle-length mapping in patients with non-paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation (AF)

Summary: the critical atrial substrates in maintaining persistent atrial fibrillation might be identified by cycle-length mapping (clm) module. based on the results of multicenter study in cycle-length mapping between taipei veterans general hospital (professor shih-ann chen) and irccs san donato policlinic (professor carlo pappone), targeted clm driver-ablation provided significant benefits in terms of arrhythmia freedom in the treatment of persistent af. these findings support a patient-tailored, mapping-based strategy for individuals affected by non-paroxysmal af. the new ultra-high density mapping catheter, optrell, will be available soon in taiwan. therefore, we proposed that the degree of atrial interstitial fibrosis detected by using both unipolar and bipolar voltage map in sinus rhythm and clm in af with optrell™ mapping catheter would be further better characterization of the atrial substrate and could be potentially critical targeted in eliminating the sources of af. as additional substrate mapping provided benefits compared to pvi alone in patients with persistent af, we hypothesize that combination of electrophysiological and substrate-guided ablation strategy using clm module with optrell™ mapping catheter could be used to guide radiofrequency ablation in the patient with non-paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. patients who sign the informed consent forms, and allow to be followed. 2. symptomatic af refractory or intolerant to at least one class 1 or 3 antiarrhythmic medication. 3. patients with persistent/permanent af (sustained beyond seven days, or lasting less than seven days but necessitating pharmacologic or electrical cardioversion). persistent af is defined as an af episode which lasts longer than 7 days, persistent af which lasted longer than 12 months will be defined as long standing persistent af. 4. patients with age equal or greater than 20 years old regardless of gender. exclusion criteria: 1. the presence of an atrial or ventricular thrombus. 2. patients who are allergic to or unsuitable for use with the contrast media. 3. pregnant patients or patients who are unavailable to receive x-ray. 4. patients with severe renal insufficiency. (glomerular filtration rate \[gfr\] \< 15 mg/dl or under dialysis) 5. patients had autonomic nervous system disorder (e.g. respiratory apnea). 6. patients with age less than 20 years old or greater than 90 years old regardless of gender. 7. contraindications to anticoagulation.
biological standardization of blomia tropicalis allergen extract

Conditions: Allergy to Mites

Summary: the objective of this study is to determine the biologic activity of a blomia tropicalis allergen extract in histamine equivalent prick (hep) units, in order to be used as in-house reference preparation (ihrp).

this is an open, unblinded and non-randomized biological assay. the study design is a slight modification of the recommendations proposed by the nordic guidelines. four concentrations of blomia tropicalis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: 1. a documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to blomia tropicalis. 2. subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). 3. subject can be male or female of any race and ethnic group. 4. age \> 18 years and \< 50 years at the study inclusion day. 5. positive skin prick test with a standardized commercially available preparation of blomia tropicalis allergen extract. the skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study 6. a positive test for specific ige to blomia tropicalis(cap-rast ≥ 2). ige results are valid if performed within one year prior to the inclusion of the subject in the study. 7. allergic symptoms during the season of blomia tropicalis. 8. mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm. exclusion criteria: 1. immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., mites group extracts). 2. use of drugs that may interfere with the skin reactions (e.g., antihistamines). see appendix 1 3. treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent). 4. pregnancy. 5. dermographism affecting the skin area at the test site at either study visit. 6. atopic dermatitis affecting the skin area at the test site at either study visit. 7. urticaria affecting the skin area at the test site at either study visit. 8. participation in another clinical trial within the last month. 9. subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)

Keywords: immunotherapy skin prick test standardization blomia tropicalis
celiac disease school for women living on a gluten-free diet

Conditions: Education of Patients; Counseling; Problem-Based Learning

Summary: swedish celiac disease women living on a gluten-free diet for years report poorer subjective health and more bowel complaints than swedish women of same age in general population. the investigators hypothesis is that the women participating in an education programme based on problem based learning will show higher degree of perceived health than the women receiving usual care.

celiac disease is a disorder of the small intestines triggered by dietary gluten, a protein in wheat-containing foods. living with is far from easy and associated with restrictions and various dilemmas in daily life, leading to depressed mood and reduced well-being, particularly in women. we decided to include 100 celiac disease women on a gluten-free diet into a randomized controlled education trial in order to compare problem-based learning with usual care. outcome measures will be two frequently employed questionnaires: pgwb (psychological well-being index) to monitor well-being and gsrs (gastrointestinal symptom rating scale) to measure the rate bowel symptoms as assessed at 6 months after the intervention.

Eligibility criteria:
inclusion criteria: * women aged 20 yrs or above with celiac disease treated for at least five years exclusion criteria: * anticipated inability to comply the trial protocol

Keywords: celiac disease education sweden gluten-free diet
ezio compared to central venous lines for emergency vascular access

Conditions: Catheters, Indwelling; Central Venous Line; Intraosseous Needle

Summary: multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the emergency dept.


Eligibility criteria:
inclusion criteria: over 18 years old requires central access after peripheral access attempts have failed or are not otherwise feasible exclusion criteria: fracture in target bone not able to sign informed consent excessive tissue or absence of adequate anatomical landmarks known or suspected coagulopathies pregnancy patients in custody patients with suspected great vessel injury not fluid in english

Keywords: catheters, indwelling
interest of a specific care pathway for the management of catamenial epilepsy

Conditions: Epilepsy Menstrual

Summary: this is a study of patients with catamenial epilepsy. catamenial epilepsies are defined as epileptic seizures during the menstrual cycle. today, there are no recommendations and no care pathway for these patients. the aim of this study is to assess the number of patients reporting a link between the occurrence of their epileptic seizures and their menstrual cycle.


Eligibility criteria:
inclusion criteria: * adults patients (\>18 years) * no menopausal * patients who have consulted in a neurology department for refractory epilepsy * non opposition patient * affiliation to a social security scheme exclusion criteria: * patients who understand french enough

Keywords: catamenial epilepsy menstrual cycle
accuracy of erclmds in teeth with apical periodontitis

Conditions: Apical Periodontitis

Summary: the aim of this in vivo study is to evaluate the influence of apical periodontitis (ap) on the accuracy of dentaport zx, raypex 5, and i-root electronic root canal length measurement devices.

thirty-two single-rooted teeth scheduled for extraction, consisting of 16 teeth with ap and 16 teeth with normal periapex (np), were selected. access cavity was prepared and coronal portion of the canal was flared. electronic working length (ewl) was determined by each erclmd according to each manufacturer's instructions. each tooth was extracted and actual working length (awl) was determined by inserting a size 15 k-file until the tip could be seen at a position tangential to the major foramen and then 0.5 mm was subtracted from the measurement. the distance from the awl to the file tip was calculated and compared between the two groups by t-test. the accuracy of each erclmd within ±0.5 mm was compared between the groups by fisher's test. statistical significance was set at p \< .05.

Eligibility criteria:
inclusion criteria: * single-rooted teeth * clinical pulp necrosis and periapical index scores of 3, 4 or 5 * pulp vitality and a periapical index score of 1 exclusion criteria: * teeth with metal restorations * teeth with prosthetic crowns * teeth with pulp calcification * teeth with previous endodontic treatment

Keywords: apical periodontitis dentaport zx electronic apex locators i-root raypex 5 working length
regulation of ccl18 by corticosteroids in severe asthma

Conditions: Asthma

Summary: the majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. ccl18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.


Eligibility criteria:
inclusion criteria: 1. control subjects = * non-atopic and non-smoking * cutting to negative pneumoallergens, * total ige levels less than 100 ku / l * no clinical history of asthma * without background treatment 2. patients with intermittent asthma = * being asymptomatic between asthma attacks, * with symptoms less than once a week * having a forced expiratory volume per second (fev1) of at least 80% of the theoretical. * treated by ß2 mimetics on demand and will not have inhaled corticosteroids. 3. severe asthma insensitive to corticosteroid therapy = * continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with ic ≥ 1500 microg beclomethasone dipropionate equivalent (bdp)\] airway obstruction fixed with fev1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone; * followed at the immunoallergology pneumology consultation for at least 1 year will be recruited. 4. severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with ic ≥ 1500 microg beclomethasone dipropionate equivalent (bdp)\] * reversibility of fev1 after treatment with oral corticosteroids. * followed at the immunoallergology pneumology consultation for at least 1 year will be recruited. 5. controlled moderate asthma treated with inhaled corticosteroids \<1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months. exclusion criteria: * existence of a chronic inflammatory pathology other than asthma * active smoking * pregnant or lactating women * have received oral corticosteroid treatment in the previous 3 weeks, * have received non-steroidal anti-inflammatory drugs (nsaids) in the previous 2 weeks.
renal artery denervation in addition to catheter ablation to eliminate atrial fibrillation

Conditions: Atrial Fibrillation; Hypertension

Summary: the objective of this trial is to determine the role of renal sympathetic denervation in the prevention of atrial fibrillation (af) recurrence in patients with hypertension for whom a catheter-based af ablation procedure is planned. patients will be randomized to either af catheter ablation (usual therapy) or af catheter ablation plus renal sympathetic denervation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * history of paf and plans for a guideline-supported catheter ablation procedure. paroxysmal af is defined as af with duration of 30 secs to 7 days. * history of significant hypertension (defined as sbp ≥130 mm hg and/or dbp ≥80 mmhg) and receiving treatment with at least one anti-hypertensive medication * renal vasculature accessible as determined by pre-procedural renal mra * willingness to comply with all post-procedural follow-up requirements and to sign informed consent exclusion criteria: * inability to undergo af catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation) * prior left atrial ablation for an atrial arrhythmia * nyha class iv congestive heart failure * pers or longstanding pers af (duration \> 7 days) * renal artery anatomy that is ineligible for treatment * an estimated glomerular filtration rate (egfr) \< 45ml/min/1.73m2, using the mdrd calculation * life expectancy \<1 year for any medical condition
prevention of adolescent major depression

Conditions: Depressive Disorder

Summary: the main purpose of this study is to assess the effect of a cognitive group intervention on prevention of major depression in 14-15-year-old adolescents. moreover, the effect on other selected mental health parameters are investigated.


Eligibility criteria:
inclusion criteria: * mild to moderate level depressive symptoms (rbdi self-report scale) * adequate knowledge of the finnish language * informed consent from the adolescent (all) and his/her parent (under 15 years) * healthy controls comprise subjects with no depressive symptoms exclusion criteria: * ongoing major depression, dysthymia or bipolar disorder * ongoing other severe psychiatric illness precluding group participation * mental retardation

Keywords: depressive disorder depressive disorder, major mental health prevention
add-on pentoxifylline to losartan versus increasing dose of losartan on nt-pro bnp in type 2 diabetics with nephropathy

Conditions: Diabetic Nephropathies

Summary: this study was designed to assess the efficacy of adding pentoxifylline to losartan in comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy. also the effect of pentoxifylline on n terminal brain natriuretic peptide (nt-pro bnp) and c-reactive protein

addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes patients with nephropathy that might relate to its effect on n terminal brain natriuretic peptide (nt-pro bnp) and c-reactive protein. pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used in type 2 diabetes patients with nephropathy for treatment of diabetes complications. nt-pro bnp, which is released from the heart due to wall stress and pressures, is known as a diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2 diabetes.

Eligibility criteria:
inclusion criteria: * age\>30 and age\<70, urinary albumin excretion (uae) ≥150 mg/24 h exclusion criteria: * any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage, acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/l, glomerular filtration rate (gfr)\<30ml/min/1.73 m and intolerance of pentoxifylline
risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia

Conditions: Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

Summary: this clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.

objectives: i. provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (all) to a specific treatment clinical trial. ii. provide an administrative base to capture classification data for correlative studies accompanying current children's oncology group (cog) all treatment clinical trials. iii. provide a central reference guide for all required and research only all studies that will be conducted at local and reference laboratories. iv. provide a mechanism for optional banking of leukemia and germline specimens for current and future research. outline: patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (fish); and dna ploidy. immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia). after completion of induction therapy, patients are followed once or twice annually.

Eligibility criteria:
inclusion criteria: * newly diagnosed acute lymphoblastic leukemia, defined by any of the following: * at least 25% blasts in the bone marrow * absolute blast count at least 10,000/mm\^3, if bone marrow aspiration is not performed * no prior registration on this study
cav regimen for r/r ph- b-all

Conditions: Acute Lymphoblastic Leukemia

Summary: this study aims to investigate the efficacy and safety of cladribine, venetoclax combined with cytarabine and venetoclax (cav regimen) for relapsed/refractory (r/r) philadelphia chromosome-negative (ph-) b-cell acute lymphoblastic leukemia (b-all).

relapse is common in ph- b-all and a proportion of patients present refractory to initial treatment. treatments for these patients consist immunotherapy and conventional chemotherapy. the former is too expensive and the latter has a low remission rate. treatment for r/r ph- b-all still remains a challenge. the efficacy and safety of cladribine, venetoclax and cytarabine (cav) has not been explored in all. thus investigators design such a clinical trial to investigate the efficacy and safety of cav regimen for r/r ph- b-all.

Eligibility criteria:
inclusion criteria: 1. aged 15-70 years old. 2. patients diagnosed with r/r ph- b-all. 3. patients with all must meet one of the following criteria, a or b: a: refractory all disease was defined as follows: (1) failure to attain cr following exposure to at least 1 courses of standard induction therapy; b: relapsed all disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after cr; or (2) detection of ≥ 5% blasts in the bm not attributable to another cause (e.g., bm regeneration after consolidation therapy); or (3) extramedullary relapse. 4. ecog performance status score less than 2. 5. expected survival time ≥ 12 weeks. 6. patients without serious heart, lung, liver, or kidney dysfunction. 7. able to understand and provide informed consent. exclusion criteria: 1. patients who are allergic to the study drug or drugs with similar chemical structures. 2. pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. active infection. 4. active bleeding. 5. patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. patients with mental disorders or other conditions. 7. liver function abnormalities (total bilirubin \> 1.5 times of the upper limit of the normal range, alt/ast \> 2.5 times of the upper limit of the normal range or patients with liver involvement whose alt/ast \> 1.5 times of the upper limit of the normal range), or renal dysfunction (ccr\<50ml/h). 8. patients with a history of clinically significant qtc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, ii-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. surgery on the main organs within the past six weeks. 10. drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. patients who have received organ transplants. 12. patients not suitable for the study according to the investigator's assessment.

Keywords: venetoclax cladribine cytarabine relapsed/refractory all
ketone supplementation in individuals with ptsd

Conditions: PTSD; Ketosis

Summary: the purpose of this study is to determine if a 6-week period of ketone salt supplementation affects physiological, emotional, cognitive, and/or behavioral health markers in individuals with ptsd.


Eligibility criteria:
inclusion criteria: * diagnosed with ptsd exclusion criteria: * pregnant, younger than 18 or older than 65