Kornimate/medical-research-clean huggingface dataset:
type 1 diabetes prediction and prevention (dipp) study

Conditions: Type 1 Diabetes Mellitus

Summary: the type 1 diabetes prediction and prevention (dipp) study in finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in finland to understand the pathogenesis of type 1 diabetes (t1d), predict the disease, and find preventive treatment.

briefly, cord blood samples are collected and hla-dr-dq genotypes are determined from newborn babies. families with a newborn baby carrying a dr-dq genotype associated with increased risk for t1d are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until t1d is diagnosed. clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of t1d are measured. children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin a1c (hba1c), oral glucose tolerance tests (ogtt) and intravenous glucose tolerance tests (ivgtt). in the dipp study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical t1d. it has been estimated that 5% of children in the follow-up will develop t1d and 60% of future t1d cases will be reached by the current screening and follow-up strategy.

Eligibility criteria:
inclusion criteria: * newborn babies with hla-conferred genetic susceptibility to type 1 diabetes born in three university hospitals in finland exclusion criteria: * newborn babies without hla-conferred genetic susceptibility to type 1 diabetes
non invasive pressure support ventilation (nippv) versus recruitment maneuver (rm) and preoxygenation

Conditions: Obesity

Summary: the purpose of this study is to compare the effects of noninvasive pressure support ventilation and early alveolar recruitment maneuver during anesthesia induction of morbidly obese patients on both oxygenation and functional residual capacity modifications.

atelectasis formation during general anesthesia, leading to reduced end-expiratory lung volume, is an important cause of intrapulmonary shunt leading to impaired gas-exchange and hypoxemia. during general anesthesia and the immediate postoperative period, morbidly obese patients, who develop a larger amount of atelectasis than non-obese patient, are more likely to present impairment of gas exchange and respiratory mechanics. noninvasive positive-pressure support ventilation (nippv) and positive end-expiratory pressure (peep) are effective to provide oxygenation during intubation of hypoxemic patients. recent data suggest that nippv enhances preoxygenation in morbidly obese patients. moreover, the application of peep during induction of anesthesia prevents atelectasis formation and increases nonhypoxic apnea duration in obese patients despite the use of high-inspired oxygen fraction. however, the use of both nippv is widely used in the operating room, because of technical and materials constraints. several trials have demonstrated that alveolar recruitment maneuvers (rm) are effective to remove atelectasis and improve lungs mechanics and gas-exchange. the purpose of this randomized and controlled study is to compare the effects of two ventilatory strategies during anesthesia induction of morbidly obese patients on both gas-exchange and functional residual capacity (frc) modifications: 1- control group: preoxygenation using 100% o2 via a face-mask and peep 10 cmh2o after intubation; 2- nippv group: preoxygenation using nippv and peep 10 cmh2o after intubation; 3- rm group: preoxygenation using 100% o2 via a face-mask and early rm plus peep 10 cmh2o after intubation.

Eligibility criteria:
inclusion criteria: * body mass index (bmi \> 30 kg/m2) * age \> 18 years * asa i-iii exclusion criteria: * age \< 18 years * patient refusal * pregnancy * emergency surgery * copd with fev1 \< 50% * history of pneumothorax * severe asthma * cardiac failure (nyha \> 2) * ischemic heart disease

Keywords: anesthesia induction obese patients noninvasive ventilation alveolar recruitment
clinical effectiveness of self-management education post-mild stroke

Conditions: Stroke; Chronic Disease

Summary: individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the united states. self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. the critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. the overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.


Eligibility criteria:
inclusion criteria: * a mild stroke as nihss total scores 0-5 * 18-90 years of age * english speaking * identified as having at least one other chronic condition besides stroke exclusion criteria: * severe aphasia (nihss aphasia score=2) * moderate to severe cognitive impairment (moca \< 21) * history of dementia * hemorrhagic stroke * neurological diagnoses other than stroke * major psychiatric illness (a diagnosis of bipolar disorder, obsessive compulsive disorder, panic disorder, schizophrenia, post-traumatic stress disorder, and borderline personality disorder) * a score of no-higher than 20 on the phq-9 indicating significant depressive symptoms * terminal illness

Keywords: self-management rehabilitation occupational therapy
hdl acute lipid optimization in homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia; HoFH

Summary: assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated hdl/preβ enriched plasma following use of hdl therapeutics pds-2™ system

the pds-2™ system is intended to reduce coronary atheroma in patients with homozygous familial hypercholesterolemia (hofh). subjects will receive serial infusions of autologous selectively delipidated hdl/preβ enriched plasma following use of hdl therapeutics' pds-2 system.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of homozygous familial hypercholesterolemia (hofh) due to a defect in the ldl receptor, or the identification of a defect in apob-100, or a gain of function of pcsk9, or a genetic defect resulting in the hofh clinical phenotype * no other condition that would preclude the subject from successfully completing the series of plasmapheresis visits in the investigator's opinion * at least one (1) coronary artery study segment will be identified for each subject and all will remain constant throughout the study. the qualifying study segment(s) will have 20% to 40% stenosis. key exclusion criteria: * planned change in current lipid lowering therapy * use of oral anticoagulants, unless the dose has been stable for 4 weeks * ldl or plasma apheresis within 1 week prior to enrollment and through 8-week primary endpoint * new york heart association (nyha) class iii or iv or last known left ventricular ejection fraction \< 30% * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months of enrollment
thrombin generation in beta-thalassemia major

Conditions: Beta Thalassemia Major Anemia

Summary: this study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait


Eligibility criteria:
inclusion criteria: * patient with de beta-thalassemia major * patient with regular blood transfusion regimen (every 4 - 6 weeks) * informed and signed consent * weight \> 30kg * hemoglobin \> 7g/dl exclusion criteria: * emergency situation * patients receiving antithrombotic drugs (anticoagulants such as vitamin k antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs; * women of childbearing age without contraception * pregnancy * deprivation of liberty * no consent

Keywords: beta thalassemia major; hypercoagulability; thrombin generation test
single rising dose (srd), multiple rising dose (mrd) study of bi 671800 in healthy asian volunteers

Conditions: Asthma; Rhinitis, Allergic, Perennial

Summary: the primary objective of the current study is to investigate the safety and tolerability of bi 671800 hea in healthy chinese male volunteers following single oral administration, and healthy japanese male volunteers following single oral administration and multiple administrations.


Eligibility criteria:
inclusion criteria: 1. healthy 2. chinese ethnicity for single rising dose (srd) part, japanese ethnicity for multiple rising dose (mrd) part. 3. age \>= 20 and age =\< 50 4. body mass index (bmi) \>=18.5 and bmi =\< 25 kg/m2 5. signed and dated written informed consent prior to admission to the study in accordance with gcp and the local legislation exclusion criteria: 1. any finding of the medical examination (including blood pressure (bp), pulse rate (pr) and electrocardiogram (ecg)) deviating from normal and of clinical relevance according to the investigators medical judgement 2. any evidence of a clinically relevant concomitant disease 3. intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
enoxaparin as treatment for vulvodynia

Conditions: Vulvodynia

Summary: the investigators hypothesize that injections of low molecular weight heparin (lmwh) \[enoxaparin\] will reduce pain in women with vulvodynia.


Eligibility criteria:
inclusion criteria: * women with vulvodynia exclusion criteria: * women without vulvodynia
cemented vs. cementless unicompartmental knee arthroplasty

Conditions: Partial Knee Replacement

Summary: the primary study objective is to evaluate a cementless partial knee system that has a modular 3-d printed porous metal tibial component and a cemented partial knee system. the hypothesis is that at minimum 2-year follow-up, fixed bearing medial partial knee replacements using cementless and cemented fixation will demonstrate no differences in clinical outcome.

this is a prospective, randomized, unblinded clinical trial of 100 patients will be enrolled by invitation of the principal investigator. inclusion criteria include patients 18-85 years old, patients receiving a medial fixed bearing partial knee replacement and patients deemed suitable for both cemented and cementless fixation after review of the preoperative radiographs. minimum two-year outcome will be analyzed, and long-term follow-up will continue to 5 years.

Eligibility criteria:
inclusion criteria: * age18-85 years old * medial fixed bearing partial knee replacement * bone suitable for both cemented and cementless fixation after review of the preoperative radiographs. exclusion criteria: * non-english speakers * current smokers * grossly porotic bone * advanced other compartment arthritis at the time of surgery necessitating a total knee arthroplasty (tka) * previous high tibial osteotomy with prior hardware * patients who are randomized but are deemed unsuitable to receive the assigned implant by the surgeon due to bone quality or bone cuts

Keywords: osteoarthritis partial knee replacement cementless
biomarkers study in pancreatic cancer

Conditions: Biomarkers Study in Pancreatic Cancer

Summary: study design: patients are eligible if (1) enrolled to tcog 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent. the pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.

we expect to collect tissue samples from 270 pancreatic cancer patients of any stages. since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. the patient enrollment will be completed in 4 years. clinical follow-up will be completed in another one year. data analysis and correlation study may be finished in the end of 5th year of this study.

Eligibility criteria:
inclusion criteria: 1. patients enrolled to tcog 3207 study: a randomized phase iii study of adjuvant gemcitabine versus gemcitabine plus concurrent chemoradiation in pancreatic cancer underwent curative intent (r0 / r1) resection. 2. patients who were not eligible for tcog 3207 study but received surgery or biopsy for pancreatic cancer. 3. patients have to sign informed consent for tissue specimen collection, according to the regulation of doh.

Keywords: biomarkers study
are personal smartphones hurting work-life balance for nurse managers?

Conditions: Burnout

Summary: for leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. but for nms with upwards of 100 direct reports, this can make for a never-ending stream of contact points. this study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout.

the study will be conducted over a six-month period using a quasi-experimental pre-test/post-test design using stamm's (2009) proqol scale. this study is being done as a pilot study with a small sample size. nms will be recruited as volunteers for participation in the study with an anticipated six-month time commitment. upon receipt of informed consent, participants will be divided into two groups. group 1 will receive a list of suggested tools used to decrease the amount of smartphone interruptions after business hours (appendix b) and group 2 will receive a work-issued smartphone with instructions for use (appendix c). both groups will use a pre-post test format designed to compare the outcomes between the two groups. post-study analysis will compare pre- and post-tests within each group and will compare group 1 and group 2 post-intervention outcomes.

Eligibility criteria:
inclusion criteria: * participant must hold the title of nurse manager or interim nurse manager at methodist mansfield medical center * participant must have greater than 50 direct reports exclusion criteria: * participant expects to separate employment with methodist health system prior to the conclusion of the study * participant does not use their personal smartphone to communicate with direct reports
safety and efficacy of turoctocog alfa during long-term treatment of severe and moderately severe haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this study is conducted in europe, and north and south america. the aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor viii agent (fviii).


Eligibility criteria:
inclusion criteria: * informed consent obtained before any study-related activities. study-related activities are any procedure related to recording of data according to the protocol * previously fviii treated (150 exposure days at the time of first dosing with turoctocog alfa) male patients with the diagnosis of severe and moderately severe haemophilia a (fviii below or equal to 2%) * the decision to initiate treatment with commercially available turoctocog alfa has been made by the patient/parent and the patient's treating physician before and independently from the decision to include the patient in this study * a negative fviii inhibitor test obtained not more than four weeks prior to first dosing with turoctocog alfa exclusion criteria: * contraindications for use according to the approved product information text (us package insert (pi), european summary of product characteristics (smpc), or corresponding local prescribing information) * treatment with any investigational drug within 30 days prior to enrolment into the study * previous participation in any clinical trial with turoctocog alfa * treatment with other fviii products after initiation of treatment with turoctocog alfa
homemade yogurt supplementation to prevent stunting

Conditions: Child Malnutrition

Summary: stunting contributes substantially to child mortality and disease burden in low-income countries. in bangladesh the prevalence of stunting among children \<5-years of age is high (36%) reaching 50% in slum areas. the pathogenesis of stunting is multifaceted, yet nutritional inadequacy and repeated infections are established risk factors of stunting. a three-arm randomized controlled trial in dhaka's slum area is proposed. the children will be recruited from vaccination clinics. infants at risk of stunting (-1 sd length-for-age z-score, laz) aged around 5 months are eligible for the study. eligible children will be randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. the investigators will recruit 120 children (40 per arm). intervention will be initiated a month before starting of complementary feeding with an educational session and will last 7 months during which a monthly educational session will be delivered at participant's household. the homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. the yogurt will be supplied to the mothers every day at time of feeding. feeding behaviors will be self-monitored using a pictorial calendar. primary outcome (laz) and secondary outcomes (fecal bio-markers, waz, head circumference, and food diversity scores), will be measured at baseline (6 months), 9 months and 12 months of child age. supplementation with homemade yogurt is a novel approach with the potential to improve infant gut environment, improve food absorption and thus potentially prevent stunting.

hypothesis: the investigators hypothesize that, continued breastfeeding, adequate complimentary feeding and supplementation with homemade yogurt have the potential to reduce stunting. primary objective: the present study is aimed to assess the impact of low-cost nutritional strategies to prevent childhood malnutrition in bangladesh. specific objectives: 1. to compare differences in growth pattern (length-for-age z-score, weight-for age z-score, head circumference) of children at risk of stunting age 6-months between infants receiving educational program only, infants receiving education plus homemade yogurt supplementation and those receiving the "usual-care" (control). 2. to evaluate whether amount of gut microbiota necessary to improve gut health was associated with weight gain and growth in these children to support the casual mechanism behind this approach.

Eligibility criteria:
inclusion criteria: 1. infants at risk of developing stunting aged 5 months (-1sd laz) 2. all gender, religion, language and ethnicity 3. infants born through normal delivery or cesarean section 4. breastfeeding or non-breastfeeding exclusion criteria: 1. stunting or wasting (\<-2sd laz) 2. infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)
adjustment of mask pressure, for bilevel positive airways pressure therapy, by automated algorithm

Conditions: Respiratory Insufficiency; Sleep Disordered Breathing

Summary: the aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. for this purpose, the investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.

persisting ventilatory failure associated with chronic obstructive pulmonary disease (copd), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (nippv). optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. the development of systems lead to automated analysis and development of algorithms to adjust ventilators. however, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (epap), because upper airway obstruction is relatively common in this group of patients. we hypothesise that an automated end-expiratory airway pressure (autoeep) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an autoeep algorithm, comparing it against usual care.

Eligibility criteria:
inclusion criteria: * subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure. * previously stabilised on bilevel noninvasive pressure support ventilation. * both genders, age \<75years. * previously shown to have a requirement for an eep above cm h2o in order to maintain upper airway patency, or those in whom such a raised eep would be expected, e.g. obese patients. * patients also known to have adequate airway patency at an eep of 4 to 5 cm h2o will be included to ensure specificity of the algorithm. exclusion criteria: * acute critical illness (e.g. acute coronary syndrome, stroke) * serious anatomical variations of nose, sinuses, pharynx or oesophagus. * any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.) * age \>75 years * pregnancy * epilepsy * psychiatric disorders that could possibly influence the study * any kind of addiction * insufficient knowledge of the language * noninvasive ventilation otherwise contraindicated

Keywords: breathing pattern gas exchange sleep quality