Kornimate/medical-research-clean huggingface dataset:
use of single versus double foley's catheter in pre-induction cervical ripening

Conditions: Post Date; Induction of Labor

Summary: cervical ripening should be present before labor induction, which can generally be divided into two categories: pharmacological and mechanical

with appropriate decision and timely intervention, labor induction decreases the risk of fetal and maternal morbidity and mortality. the single balloon catheter (i.e. foley catheter \[fc\]) and cook cervical ripening balloon have been the most commonly used mechanicalwith a minimal increase in risk of cesarean section. the single balloon catheter (i.e. foley catheter \[fc\]) and cook cervical ripening balloon have been the most commonly used mechanical method. the fc applies pressure on lower uterine segment and cervix in the direction from the uterus to the vagina. the cook cervical ripening balloon is composed of a cervicovaginal balloon and a uterine balloon. its mechanism is similar to that of the foley balloon, but it can apply pressure in two directions simultaneously, on both the external and internal os. although many studies have shown that the cook cervical ripening balloon and fc have similar efficacy and safety. they each have district advantages and disadvantages in labor induction. in addition to the cost advantage and wide avail- ability of the fc, the safety of labor induction with the fc has been proven by many studies. however, some study have shown that the fc results in a higher pain score, and consequently, higher maternal request for cesarean section and higher cervical laceration incidence compared with the cook cervical ripening balloon.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 34 years old 2. postdate primigravida 3. single viable fetus. 4. cephalic presentation. 5. normal biophysical . 6. bishop score of four or less. 7. rh positive women. exclusion criteria: 1. premature rupture of membranes (prom). 2. oligo or polyhydramnios 3. antepartum hemorrhage and placenta praevia. 4. current cervical cerclage. 5. invasive cervical carcinoma. 6. known fetal anomaly. 7. previous uterine scar due to myomectomy or metroplasty. 8. cephalopelvic disproportion due to pelvic contraction or macrosomic baby. 9. active genital herpes infection. 10. chronic maternal illness.

Keywords: primigravida pregnants cervical ripening single and double foley's catheter
a high protein egg white pudding for people with kidney failure (hipe kf)

Conditions: Kidney Failure; Frailty; Kidney Disease, Chronic

Summary: the goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. the main questions it aims to answer are: * to determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. * to determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements. * to determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. participants will receive either the egg white pudding (experimental) or control (ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the trial * male or female aged ≥18 years with ckd * on chronic in-center hemodialysis for \> 3 months * serum albumin \<35 g/l * no expected change in dialysis modality or relocation outside of winnipeg during the intervention period (12 weeks) exclusion criteria: * allergy to eggs * history of renal transplant * serum albumin ≥ 35 g/l * bowel diseases * cancer * pregnancy * receiving chemotherapy treatment * inability to consume treatment product * allergy to study treatment ingredients * planning on starting an exercise program during the duration of the trial * inability to obtain written informed consent
orif versus crif of completely displaced and rotated lateral condylar fractures of the humerus in children

Conditions: Humeral Fractures

Summary: open reduction and internal fixation has been widely used in treating completely displaced and rotated lateral condylar fracture in children and it usually produces good results. only a few studies reported closed reduction and internal fixation is an effective treatment for completely displaced and rotated lateral condyle fractures of the humerus, but evidence on its effectiveness and safety is scarce. the aim of the trial was to compare functional and outcome use in patients treated completely displaced and rotated lateral condylar fracture with orif versus crif.

lateral condylar humerus fractures are the second most common elbow fracture in children, accounting for approximately 17-20% of pediatric elbow fractures. jakob et al. first described a novel classification based on the presence of cartilage bridging. it was modified by foster et al. who identified the differences in outcomes between fractures with \< 2 mm and ≥ 2 mm displacement. most surgeons preferred open reduction and internal fixation (orif) to insure anatomic reduction of these unstable intra-articular fractures. only a few reports have focused on closed reduction and percutaneous pinning (crpp) of lateral condylar humeral fractures. in most studies, this technique was used only in cases with displacement between 2 and 4mm. crpp has shown several advantages over orif, including less dissection of soft tissue around the fragment, low risk of vessel damage, low risk of non-union and avascular necrosis (avn) of distal humerus physeal, shorter operating room times, and avoidance of an open incision with an unaesthetic scar. song et al. introduced a new classification and an internal oblique view to better assess the displacement of the fragment, and they managed to achieve closed reduction of the fracture, even in cases with displacement exceeding 4mm or those with rotational displacement (graded as stage 5 according song classification and type iii according to jakob classification). because the study was not controlled, we could not tell the difference between cases treated with crpp and the cases treated with orif directly. since may 1, 2019, at our institution, we have been treating type iii lateral condyle fractures with crpp. the primary objective of this study was to report the efficacy and safety of crpp of lateral condyle fracture. the secondary aim was to compare the outcomes between crpp and orif.

Eligibility criteria:
inclusion criteria: * completely displaced and rotated lateral condyle fractures of the humerus (jakob stage 3) exclusion criteria: - presented more than 7 days after the fracture , capitulum humerus cannot be clearly identified on x-ray， had experienced a previous lateral condyle fractures on the same limbs, pathological fracture， open fracture， combined with other fractures at the same time，

Keywords: open reduction and internal fixation closed reduction and internal fixation completely displaced and rotated lateral condylar fracture
continuous glucose monitoring for glucose and weight management in prediabetes and non-severe type 2 diabetes: a prospective community-based (workplace) cohort study

Conditions: PreDiabetes; Diabetes Mellitus, Type 2

Summary: this study aimed to evaluate the effectiveness of use of continuous glucose monitoring (cgm), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.


Eligibility criteria:
inclusion criteria: * subjects over the age of 19 * patients with type 2 diabetes * fasting blood glucose ≥ 126 mg/dl or * hba1c ≥ 6.5% or * type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle modifications * patients with prediabetes * fasting blood glucose 100-125 mg/dl * hba1c 5.7-6.4% * willing to participate in the study exclusion criteria: * subjects less than 19 years old * patients with type 1 diabetes * pregnant at the time of screening or planning to become pregnant during the study * severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot * diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year * severe liver disease (e.g., cancer, liver cirrhosis, hepatitis b, hepatitis c) * diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections * planning to be admitted to a hospital within 2 months * unable to participate in the mobile intervention study as determined by the investigator
the catalonia suicide risk code epidemiology study: an epidemiological study of suicide attempts in catalonia, spain

Conditions: Suicide, Attempted; Suicide; Suicide and Self-harm

Summary: suicide attempts (sa) constitute a major public health issue worldwide. research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%. sa are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide. suicide attempts are also related to persistent physical and mental health issues, psychiatric hospitalizations, impaired academic performance, unemployment, partner abuse victimization and perpetration, having children removed by social services, loneliness, relationship difficulties, impaired social functioning and low life satisfaction. despite this considerable societal impact, there is a lack of epidemiological research focussing on providing suicide attempt surveillance in the population, to inform public health action aimed at reducing risk for suicide attempts in the population, and to provide data-driven support for suicide risk assessment across healthcare settings. to address this shortcoming, the investigators designed the catalonia suicide risk code epidemiology study. using centralized electronic healthcare record data from the entire public healthcare system of catalonia, spain, the csrc-epi study aims to estimate reliable suicide incidence rates, identify suicide attempt risk factors, and develop validated suicide attempt risk prediction tools.


Eligibility criteria:
inclusion criteria: * catalan residency during 2014-2019 * age 10 or more at end of observation period exclusion criteria: * none

Keywords: nested case-control study electronic healthcare records register-based study incidence risk factors risk prediction machine learning techniques inverse probability weighting public health surveillance population-attributable risk proportions
the effect of priming of questionnaire content on grip strength in patients with hand and upper extremity illness

Conditions: Hand and Upper Extremity Illness

Summary: objectives: to determine the association between priming and measurements of hand function such as grip strength primary null hypothesis: there is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard pain catastrophizing scale (pcs) compared to patients that complete the positively adjusted pcs. secondary null hypotheses: there is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard pcs compared to patients that complete the positively adjusted pcs. there is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard pcs compared to patients that complete the positively adjusted pcs.

priming affects all aspects of human behavior. prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (pcs) primed patients to report less disability on average than completing the standard pcs. the influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.

Eligibility criteria:
inclusion criteria: * all english-speaking adult patients visiting the orthopaedic hand and upper extremity service exclusion criteria: * unable to complete enrollment forms due to mental status or language problem
the effects of denosumab on the pharmacokinetics (pk) of midazolam

Conditions: Postmenopausal Osteoporosis

Summary: this is a multi-center, open-label, drug-drug interaction study in postmenopausal women with osteoporosis.

approximately 27 subjects (group a: 18; group b: 9) will receive a 2 mg oral dose of midazolam on day 1 followed by a 24 hour pk collection. subjects randomized to group a will receive a single 60 mg subcutaneous (sc) dose of denosumab on day 2 administered in the abdomen. on study day 16, another 2 mg oral dose of midazolam will be administered to all subjects (groups a and b) followed by a 24 hour pk collection. the primary analysis to determine the effect of denosumab on the pk of midazolam will be based on data from subjects in group a only.

Eligibility criteria:
inclusion criteria: * between 45 to 75 years of age * postmenopausal women * osteoporosis exclusion criteria: * use of any known inhibitors of cytochrome p450 3a4/p-gp (cyp3a4) within 14 days or 5 half lives, whichever is longer; or grapefruit juice or grapefruit containing products within 7 days prior to investigational product administration * use of any known cyp3a4 inducers within 30 days or 5 half-lives, whichever is longer, prior to investigational product administration * use of any herbal medicine with a known impact on cyp3a4 (eg, st. john's wort) within 30 days prior to investigational product administration * current use of medications prescribed for osteoporosis treatment * use of midazolam within 14 days prior to investigational product administration * influenza or other vaccination within 28 days of screening * previous exposure to denosumab

Keywords: amgen phase 1 postmenopausal osteoporosis
a study to evaluate the safety and tolerability of mk0217 in women (0217-219)

Conditions: Postmenopausal Osteoporosis

Summary: this study is to assess the safety and tolerability of mk0217 being evaluated to treat women with postmenopausal osteoporosis.


Eligibility criteria:
inclusion criteria: * women with postmenopausal osteoporosis exclusion criteria: * high risk for fractures * esophageal abnormalities * upper gastrointestinal symptoms that are not relieved with medication * metabolic bone disease (example - vitamin d deficiency) * medications that would affect the breakdown or build-up of bone
study of pr5i, a pediatric combination vaccine with enhanced hepatitis b component given concomitantly with prevnar®

Conditions: Diphtheria; Pertussis; Polio; Hepatitis B; Tetanus

Summary: pr5i, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by h. influenzae type b, hepatitis b virus, corynebacterium diphtheriae, clostridium tetani, bordetella pertussis, and poliovirus types 1, 2, and 3. primary objective: to evaluate immunogenicity of pr5i with the adjuvant composition enhancement to the hepatitis b component when administered concomitantly with prevnar® secondary objectives: to assess the safety and immunogenicity of pr5i when administered concomitantly, or one month apart with prevnar® or separately with licensed vaccines used for routine infant vaccination in canada.


Eligibility criteria:
inclusion criteria: * infants aged 42 to 89 days inclusive on the day of inclusion. * born at full term of pregnancy (\>37 weeks). * informed consent form signed by the parent(s) or legally authorized representative. * able to attend all scheduled visits and to comply with the study procedures. * parent or legally authorized representative has access to a telephone. * parent or legally authorized representative able to read and write in english or french. exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy. * known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s). * chronic illness that could interfere with trial conduct or completion. * received blood or blood-derived products since birth. * any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination). * previous vaccination with any acellular pertussis- (dtap) or whole cell pertussis- (dtwp) based combination vaccines, haemophilus influenzae type b (hib)-conjugate, poliovirus, hepatitis b, or pneumococcal conjugate vaccines. * coagulation disorder contraindicating im vaccination. * clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion). * developmental delay or neurological disorder. * any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject. * documented hepatitis b surface antigen (hbsag) seropositivity in the child or his/her mother. * history of hib, hepatitis b, diphtheria, tetanus, pertussis or poliovirus disease.

Keywords: hepatitis b pertussis diphtheria tetanus h. influenzae type b polio
glycemic index of pasta from traditional and current wheat varieties

Conditions: Diabetes Type 2

Summary: this randomized, cross-over study compares pasta produced with three different wheat varieties (senatore cappelli, korasan, claudio). patients with type 2 diabetes with no pharmacological treatment will be randomized to three different sequences, and asked to eat a standard portion of pasta on three different occasions, four days apart. 3-hour post-prandial interstitial glucose profiles will be recorded using trans-cutaneous sensors.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * body mass index (bmi) \> 20 kg/m2 * hba1c \< 58 mmol/mol exclusion criteria: * current pharmacological therapy for diabetes (of any kind) * pregnancy or lactation
ct18 infant influenza priming study in vaccine naive infants

Conditions: Influenza

Summary: this study evaluates whether priming influenza naive infants, age six to 23 months, with a mf59-adjuvanted (oil in water emulsion) influenza vaccine is preferred to priming with an inactivated unadjuvanted influenza vaccine. all participants will receive a priming vaccine, either mf59-adjuvanted trivalent influenza vaccine (ativ) or unadjuvanted quadrivalent influenza vaccine (qiv). for the booster shot the following year, two thirds of participants will receive qiv and one third will receive mf59-adjuvanted vaccine.

children under 24 months of age suffer from an influenza burden (high morbidity and mortality) similar to that of the elderly, and have been identified as a high priority target for vaccination programs by canada's national advisory committee on immunization. there is evidence that a person's first exposure to influenza antigens may have long-term implications for protection. this is a randomized, controlled, observer-blind study that will assign participants to one of three groups. group 1 will receive mf59-adjuvanted influenza vaccine (two doses one month apart) in the fall of year 1, followed by qiv (one dose) in the fall of year 2. group 2 will receive qiv (two doses one month apart) in the fall of year 1, followed by qiv (one dose) in the fall of year 2. group 3 will receive mf59-adjuvanted iv (two doses one month apart) in the fall of year 1, followed by mf59-adjuvanted iv (one dose) in the fall of year 2.

Eligibility criteria:
inclusion criteria: * parent/lar is willing and able to give informed consent for participation in the trial. * male or female, aged six months to 23 months. * in the investigator's opinion, is able and willing to comply with all trial requirements. exclusion criteria: * any significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. * participant in another research trial involving an investigational product or medical device in the prior 12 weeks. * prior receipt of an influenza vaccine * history of laboratory-confirmed influenza infection, by parent/lar report * hypersensitivity to any vaccine component of products used in this study (see product monographs) * immunodeficiency or autoimmune disease

Keywords: infants priming fluad fluzone
exacerbation prevention gold iv copd with non invasive mechanical ventilation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstructive pulmonary disease (aecopd) in patients with frequent aecopd (frequent exacerbations defined more two or more aecopd) and in gold iv stage (very severe copd). the design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.

background: * there are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with the use of non invasive mechanical ventilation, in bipap modality with ipap pressures \<18h2ocm (low intensity), in copd patients. * in subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on bipap mode in copd patients ( it should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation). * however, there are other recent studies that described some benefits of high intensity bilevel modality of non invasive mechanical ventilation (inspiratory pressures \>18cmh2o) specially on gas exchange, quality of life and functional status. * there are some issues that do not yet have a clear answer like the optimal inspiratory pressure (ipap) or the ventilation modality (bipap or other) to obtain the maximal benefit on copd patients. additionally, is not clear also if the use of non invasive mechanical ventilation on copd patients helps to reduce the frequency and severity of acute exacerbations of copd (aecopd). this study have some characteristics that are different to the previous reports: * the inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials * the intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (\>18h2ocm and \<24h2ocm) * the use of placebo maneuver (cpap "sham") * the home titration in three phases, over a week * the long-term use of the intervention and sham maneuver

Eligibility criteria:
inclusion criteria: * clinical and spirometric diagnosis for copd (fev1/fvc \<70%) * clinical phenotype of frequent exacerbations * must sign the informed consent * former smokers * stable copd * fev1 \<35% * optimal medical treatment exclusion criteria: * osas diagnosis * other indications for non invasive mechanical ventilation * arterial pressure for dioxide carbon \>45mmhg * lung cancer * impossibility for doing spirometry or going to the medical visits * be included in another study

Keywords: acute exacerbation of copd number acute exacerbation of copd severity