Kornimate/medical-research-clean huggingface dataset:
the ripple at-plus study

Conditions: Atrial Tachycardia

Summary: atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. the goal of the ripple at-plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. the main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.

catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. there are numerous methods by which to map atrial tachycardia. isthmus guided ablation using ripple mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia). however, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. at present, the recurrence rate following atrial tachycardia ablation is near 30%. we hypothesise that isthmus guided ablation using ripple mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation. patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by isthmus targeted approach using ripple mapping or conventional approach using local activation time. otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. after the procedure, follow up will occur at 1 year with a further holter montior. any arrhythmia recurrence will be documented and the two arms will be compared for acute success, 12 month success, ablation required and procedure time.

Eligibility criteria:
inclusion criteria: 1. referred for catheter ablation of at by the direct care team, based on clinical indication. 2. male or female, aged \>18 years old. 3. able to consent for recruitment to the trial and the catheter ablation procedure. exclusion criteria: 1. contraindication to catheter ablation as deemed by the clinical team. 2. typical atrial flutter or af on ecg.

Keywords: atrial tachycardia atrial fibrillation mapping ablation
disposition of eslicarbazepine acetate and its metabolites s-licarbazepine and r-licarbazepine

Conditions: Epilepsy

Summary: single centre, open-label, randomised study in four parallel groups of healthy volunteers

single centre, open-label, randomised study in four parallel groups of healthy volunteers: group 1 = 900 mg of eslicarbazepine acetate (esl, bia 2-093); group 2 = 450 mg of s-licarbazepine plus 450 mg of r-licarbazepine; group 3 = 450 mg of s-licarbazepine; group 4 = 450 mg of rlicarbazepine. in each group, the study consisted of a single-dose period (phase a) followed by a repeateddose period of 7 days of duration in which the investigational product was administered once daily (phase b). the repeated-dose phase started 96 h post single-dose.

Eligibility criteria:
inclusion criteria * male or female subjects aged between 18 and 45 years, inclusive. * subjects of body mass index (bmi) between 19 and 30 kg/m2, inclusive. * subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ecg. * subjects who had clinical laboratory tests clinically acceptable at screening and admission. * subjects who had negative tests for hbsag, anti-hcv ab and hiv-1 and hiv-2 ab at screening. * subjects who were negative for drugs of abuse and alcohol at screening and admission. * subjects who were non-smokers or who smoke \< 10 cigarettes or equivalent per day. * subjects who are able and willing to give written informed consent. * (if female) she was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence. * (if female) she had a negative pregnancy test at screening and admission to phase a. exclusion criteria: * subjects who did not conform to the above inclusion criteria, or * subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders. * subjects who had a clinically relevant surgical history. * subjects who had a clinically relevant family history. * subjects who had a history of relevant atopy. * subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine). * subjects who had a history of alcoholism or drug abuse. * subjects who consumed more than 14 units of alcohol a week. * subjects who had a significant infection or known inflammatory process on screening or admission.
a trial to de-prescribe inappropriate medications in the community dwelling elderly

Conditions: Inappropriate Dose of Drug Administered; Health Behavior

Summary: the objective of this trial is to test the beneficial effect of a pharmacist-initiated knowledge transfer intervention to both patients and prescribers on the discontinuation of inappropriate prescriptions, compared to usual care. the investigators hypothesize that the pharmacist-led intervention will reduce inappropriate prescriptions by at least 20% over 6-months compared to usual care. the intervention consists of simultaneously educating consumers and providing physicians with an evidence-based pharmaceutical opinion on inappropriate prescriptions.


Eligibility criteria:
inclusion criteria: * men and women 65 years of age and older (no upper age limit) * individuals for whom prescription claims derive from only one pharmacy identifier * chronic consumption (\> 3 month claims) of one of the target inappropriate prescriptions. (benzodiazepine/non benzodiazepine hypnotic, long-acting sulfonylurea oral hypoglycemic agents, anticholinergic agents (in the form of first-generation antihistamines) or nonsteroidal anti-inflammatory drugs \[nsaids\] ) * patients who are willing to participate in the study. exclusion criteria: * a probable diagnosis of dementia (persons without the capacity to provide informed consent), as determined by a) a prescription for memantine or a cholinesterase inhibitor; b) report from a caregiver or family-member; or c) a baseline screening score on the folstein mini-mental state exam \< 24 * inability to understand and or communicate in english and/or french * patients living in a long-term care facility * concomitant use of any antipsychotic medication

Keywords: inappropriate prescribing health education community pharmacy services medication therapy management preventive health services polypharmacy inappropriate prescriptions aged
qolbet quality of life in patients with early relapsing-remitting multiple sclerosis treated with betaferon® in korea

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study is to describe the quality of life of korean patients with early relapsing-remitting multiple sclerosis during the initial 1 year of treatment with betaferon with several validated questionnaires.


Eligibility criteria:
inclusion criteria: * relapsing-remitting ms (rrms) patients within the first two years after diagnosis according to poser or mcdonald criteria, starting betaferon treatment, including patients switching from other dmds * patients who signed informed consent form exclusion criteria: * age lower than 18

Keywords: multiple sclerosis, relapsing-remitting, interferon beta-1b, quality of life
multimodal approach to the ontogenesis of nociception in very preterm and term infants

Conditions: Procedural Pain; Pre-Term; Venipuncture

Summary: the management of pain related to venipuncture remains insufficient in very preterm infants (vpi. the separation between the mother (father) and her(his) child can aggravate the short-term painful experience of the newborn. accurate diagnosis and treatment of pain is necessary to preserve the well-being and brain development of vpi. a better understanding of the development of pain pathways and the cortical integration of nociceptive messages is essential to reach this goal.


Eligibility criteria:
inclusion criteria: * experimental group: vpis of gestational age less than or equal to 33 weeks on the day of birth and hospitalized in the neonatal intermediate care unit or the neonatal intensive care unit of the neonatal department of the hautepierre hospital (strasbourg university hospital) * control group: healthy full-term babies (\> 37 weeks gestational age) hospitalized in the maternity ward of strasbourg university hospital * consent obtained from both parents * subject affiliated to a social health insurance plan. exclusion criteria: * - any malformation known before inclusion * cerebral lesions discovered on cerebral ultrasound performed as part of the standard management of newborns (intra-ventricular hemorrhages of grade iii or iv of the papile classification, periventricular leucomalacia) * unstable clinical status according to the investigator's judgment * expected transfer of the child to another hospital before the term of 40 weeks pmas.

Keywords: very preterm infants development of nociception cortical hemodynamic responses pain indicators gender maternal voice oxytocin
mortality predictors in coronary care in turkey

Conditions: Death, Cardiac

Summary: this study was undertaken to investigate and document the mortality rates and predictors in coronary care unit (ccu) patients in turkey. it is designed to be a multicenter, observational, cross-sectional, and descriptive study. it will be conducted in 50 centers in 12 regions of turkey. the study does not include any interventional or treatment procedures. at the end of the study, clinicians will have up-to-date information about predictors of mortality in ccu patients.

the morcor-turk study will be conducted as a nationwide registry in 50 tertiary cardiology centers selected from each eurostat nuts region in turkey according to their population sample weight, prioritizing the volume of hospitals in each region. all consecutive patients admitted to the coronary care units (ccu) will be prospectively admitted during a predefined period of 1 month. the study will be conducted by cardiologists in hospitals who regularly treat cardiac patients. led by the cardiology department of kutahya evliya celebi research and training hospital, 50 centers will be included in the study. there has not been any large-scale epidemiological study on coronary care patients in turkey recently. therefore, up-to-date information in this group of patients is lacking. in particular, significant reductions in mortality and morbidity are expected, thanks to improved medical and interventional facilities. in the light of current data, the investigators designed a large-scale study to document mortality rates and predictors in ccu patients. in this study, the investigators will include consecutive patients admitted to ccu with cardiovascular indications in all participating centers. patients will be followed and treated by experienced cardiologists and no further experimental intervention will be planned. in the first part of the study, the investigators will record in-hospital mortality rates and try to identify the best predictors. in the second part of the morcor-turk trial which will have a cohort design, the investigators will follow the successfully discharged patients for 1 year. at the end of the follow-up, investigators will assess the risk factors and predictors of cardiovascular events as secondary endpoints.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * hospitalized with cardiovascular diseases * individuals (or relatives for unconscious patients) who gave written informed consent exclusion criteria: * younger than 18 years of age * rejecting to sign an informed consent * hospitalized to ccu by other departments with noncardiac indications * patients with active severe noncardiac chronic disease (chronic obstructive pulmonary disease, systemic diseases, and malignancy) * no vital signs despite adequate cardiopulmonary resuscitation during hospitalization * rejected to stay in ccu and discharged with his/her own request

Keywords: coronary care unit mortality predictors
comparison between three types of prosthetic feet

Conditions: Amputation; Traumatic, Leg, Lower, Between Knee and Ankle

Summary: one solid ankle cushion heel (sach) and two dynamic elastic response (der) prosthetic feet will be tried six times in random order by the patient. the patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. one-leg standing and 10-meter walking tests will also be performed.

the prosthetic feet will be: one sach foot (by otto bock - foot c, advertised for activity category 1) and two der feet (dynamic motion by otto bock - foot b, advertised for activity category 2-3; and triton by otto bock - foot a, advertised for activity category 3-4). all the prosthetic feet are of the same size and chosen for the patient's weight. they will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used. the study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. the orientational sample size calculation and the randomisation plan were prepared by a statistician. the first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. the patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). after each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors. the three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. they will be blind to the currently used prosthetic foot. they will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.

Eligibility criteria:
inclusion criteria: * active prosthetic foot user who walks several kilometers per day * amputation at the trans-tibial level \>5 years ago exclusion criteria: * other medical problems

Keywords: prosthetic feet gait pattern one leg standing walking speed
day case inguinal hernia repair in children. is laparoscopic approach justified?

Conditions: Inguinal Hernia

Summary: we compare laparoscopic and classic open operation for inguinal hernia in children. attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.

background and objective : in adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. it is not known whether laparoscopic hernia repair produces similar results in children.the objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children. key inclusion criteria: children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. of male patients those with completely descended testes are accepted. study type: the study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children. target sample size: for the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p \< 0.05. recruitment status : from 10/ 2002 to 1/2007 89 patients (laparoscopic repair lh 47, open repair oh 42) are recruited. primary outcome: the time to restore normal activity after surgery . secondary outcomes : the degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.

Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia * age age \> 4 months, \<16 years * fully descended testes * study consent signed exclusion criteria: * previous abdominal or inguinal surgery * testes not fully descended * not healthy enough for day surgery * age \ 16 years * study consent not signed

Keywords: inguinal hernia laparoscopic repair open repair randomized
outcome study of total knee arthroplasty in asian patients

Conditions: Knee Osteoarthritis

Summary: to determine how the lcs mobile bearing knee system works within the asian population.

the objective of this clinical evaluation is to compile a profile of the performance of the lcs mobile bearing total knee system in normal clinical practice within the asian population. performance will be assessed using specific surgeon and patient based outcome scores. total subject enrolled 505; 6 subjects did not receive device. total subjects received device 499. among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study

Eligibility criteria:
inclusion criteria: * administrative - the patient is able to understand the evaluation, is able to give consent and will comply with the postoperative follow up regime. * diagnosis - idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * implant suitability - patients who in the opinion of the clinical investigator are considered suitable for treatment with a mobile bearing knee system (the lcs classic or universal). * bilateral patients - simultaneous bilateral patients are included. staged bilateral patients are included if the second procedure is performed within the one-year recruitment period. staged bilateral patients where the second procedure is performed outside of the one-year recruitment period will only be included if the second procedure is performed within 6 months of the end of the one-year recruitment period. * age - the upper age limit is set at 75 years and expected to live through the 5 years study period.vi. ethnic origin - patients must be asian in ethnic origin * unicondylar / high tibial osteotomy (hto) conversion - patients that are being converted from a unicondylar / hto procedure are included providing the reason for conversion is due to progression of the disease process affecting the other condyle. patients that are converted and have evidence of infection / aseptic loosening / loss of bone stock are excluded. exclusion criteria: * patients with a known history of poor compliance to medical treatment. * patients that require revision surgery * patients with gross ligamentous insufficiency. * patients with a severe valgus deformity (15 degrees or greater) * patients with a severe varus deformity (20 degrees or greater) * patients with a fixed flexion contracture (30 degrees or greater) * patients over the age of 75 years.

Keywords: arthroplasty, replacement, knee,lcs
influence of bottle-type on infant feeding behaviors

Conditions: Conventional Clear Bottle; Opaque Weighted Bottle

Summary: the objective of the proposed research is to conduct a within-subject, experimental study that will describe mothers' feeding practices during typical bottle-feeding conditions and will examine whether removal of visual cues related to the amount of milk/formula in the bottle will alter these feeding practices. the investigators hypothesize that mothers will show higher levels of infant-directed feeding practices and lower levels of mother-directed feeding practices when using opaque, weighted bottles compared to when using standard, clear bottles. the investigators also hypothesize that infants will consume less breast milk or formula when fed from opaque, weighted bottles compared to when fed from standard, clear bottles.


Eligibility criteria:
inclusion criteria: * mothers must be 18 years or older * infants must be between 0- and 6-months of age * infants must be prior to the introduction of solid foods exclusion criteria: * preterm birth * medical conditions that interfere with feeding

Keywords: infant intake satiation mother feeding practices bottle feeding formula feeding maternal responsiveness infant cues
differentiation of asthma/copd exacerbation and stable state using automated lung sound analysis with lungpass device

Conditions: Asthma; COPD

Summary: this observational study evaluates whether lung sound analysis with lungpass device can be used to differentiate exacerbation and stable state asthma and copd.

this is a prospective observational study comprised patients with moderate or severe copd or asthma exacerbation in primary care settings. patients will be examined twice - during an exacerbation of the disease and in a stable phase. patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and lungpass device. moreover, symptoms and anamnesis data, results of symptoms questionnaires (cat for copd and acq-5 for asthma), result of diagnostic questionnaire from the lungpass app, spirometry data, serum procalcitonin (for copd patients), c-reactive protein, white blood cell count and blood eosinophil count, results of sputum cytology examination, х-ray results (if carried out according to indications) will be collected.

Eligibility criteria:
inclusion criteria: for copd patients: * patients able and willing to sign an informed consent to participate in the study; * patient is aged 40 years or older with a smoking history of ≥10 pack years; * patients with copd confirmed previously by a detailed medical history and examination; * patients presenting with moderate or severe exacerbation of chronic obstructive pulmonary disease. * patient is treated by a monotherapy long-acting muscarinic antagonist (lama), or lama plus long acting beta2-agonist (laba), or inhaled corticosteroid (ics) plus laba, or lama plus laba plus ics. for asthma patients: * patients able and willing to sign an informed consent to participate in the study; * patient is aged 3 years or older; * patients with asthma confirmed previously by a detailed medical history and examination; * patients presenting with moderate or severe exacerbation of asthma; * patient is treated by a monotherapy ics or ics plus laba or other controllers. exclusion criteria: * age up to 3 years for asthma patients and up to 40 years for copd patients; * patient refusal to participate in the study; * patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation; * patients with asthma-copd overlap or presence of other known chronic lung conditions such tuberculosis, cystic fibrosis or clinically significant bronchiectasis; * mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure, other known ongoing infection.

Keywords: lung sound analysis asthma exacerbation copd exacerbation