Kornimate/medical-research-clean huggingface dataset:
maverick total disc replacement in a 'real world' patient population

Conditions: Degenerative Disc Disease

Summary: the primary purpose of the study is to document the reduction of disability after maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.


Eligibility criteria:
inclusion criteria: * degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies * foraminal stenosis due to loss of disc height * back pain and/or leg pain. exclusion criteria: * spondylolisthesis at the affected or adjacent level * posterior facet joint damage and/or disease at the affected level, including facet osteoarthritis, pars fracture and prior laminectomy * obesity * osteoporosis * metallic allergy to cobalt-chromium-molybdenum alloys * psychosis * infection * spinal canal stenosis * overlying thoracolumbar kyphosis * systemic infection or infection at the site of surgery * osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated * diseases of bone metabolism * pregnancy * signs of local inflammation * fever or leukocytosis * grossly distorted anatomy caused by congenital abnormalities * any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (wbc), or a marked left shift in the wbc differential count (this also includes: spinal active oncology pathology; not healed fracture at treated or adjacent level) * any case where the implants or components selected would be too large or too small to achieve a successful result * any patient in which implant utilization would interfere with anatomical structures or expected physiological performance * any patient unwilling to follow postoperative instructions.
hemodynamic effects of changes in transpulmonary pressure during recruitment maneuver in patients under pressure supported mechanical ventilation

Conditions: ARDS, Human

Summary: according to the anatomical proximity of the heart temporarily elevated intrathoracic pressures may have direct and indirect effects on the cardiovascular system. undesirable hemodynamic effects of a recruitment maneuver primarily arise from the transiently increased airway pressure, manifesting in decreased right heart filling, increased pulmonary vascular resistance, a drop in left ventricular systolic transmural pressure, right and left heart ventricular interactions and subsequent changes in cardiac index. these effects can be more pronounced in patients suffering from ards, a condition commonly accompanied by hemodynamic instability. the complex pathophysiological changes account for why routine intensive care monitoring, such as invasive arterial blood pressure or central venous pressure monitoring is insufficient to follow hemodynamic changes under recruitment maneuver. previous studies by the same research team confirmed that the alveolar recruitment maneuver improves oxygenation in patients with moderate-to-severe hypoxemic respiratory failure under pressure supported ventilation. following recruitment maneuver, arterial oxygenation increased in 74 % of all patients. however, there is lack of information regarding the actual degree of changes in transpulmonary pressure and the consequent hemodynamic alterations. the primary aim of the study is to evaluate precisely the transpulmonary pressure changes during recruitment in patients with severe hypoxemic respiratory failure ventilated in pressure support mode following insertion of a balloon-catheter into the esophagus. in the meantime, hemodynamic changes are monitored by picco and transthoracic echocardiography, and lung field aeration by electric impedance tomography.


Eligibility criteria:
inclusion criteria: * orotracheal intubation * pressure supported ventilation * moderate-to-severe hypoxemic respiratory failure according to ards berlin criteria moderate: 100 hgmm ≤ pao2/fio2 ≤ 200 hgmm, peep ≥ 5 cmh2o severe: pao2/fio2 ≤ 100 hgmm, peep ≥ 5 cmh2o exclusion criteria: * age \< 18 years * pregnancy * previous pulmonary resection, pulmonectomy * clinically verified, end-stage copd * severe hemodynamic instability (i.e. refractory shock to vasopressors) * severe emphysema and/or spontaneous pneumothorax in past medical history * contraindications of a balloon-catheter (e.g. esophageal abscess, esophageal perforation, esophageal diverticulosis, esophagus tumor, esophagus varix, recent esophagus or gastric surgery, severe coagulopathy)
upstate new york infant development screening program

Conditions: Obesity; Blood Pressure; Motor Delay; Developmental Delay; Asthma; Allergies

Summary: the goal of the upstate kids study is to track the growth, development and long-term health of children given the increasing use of infertility treatment, occurrence of maternal obesity and pregnancy complications, and rising maternal age at birth.

the upstate kids study aims to determine if there are differences in health measures between children conceived by infertility treatment and children conceived naturally. in the first phase of the study, the focus was on growth and development through age 3 years. in the second phase of the study, the focus is turning to cardiometabolic factors through age 9 years. infertility treatments include assisted reproductive technologies (art) such as in vitro fertilization (ivf), controlled ovarian hyperstimulation (coh) and ovulation induction (oi). the study was originally designed as a matched exposure cohort. specifically, singletons whose birth certificates indicated the use of infertility treatment were considered 'exposed' singleton infants and subsequently frequency-matched on perinatal region of birth at a ratio of 1:3 to 'unexposed' singletons. twins and higher order multiples were invited to participate regardless of mode of conception. mothers and their newborns were recruited approximately 2-4 months postpartum. the first phase of the study was completed in 2014 and main findings can be found under publications. the second phase objectives are: to determine whether infertility treatment is associated with differences in growth and development from age 6 to 8 years with particular focus on childhood cardio-metabolic outcomes by follow-up of children conceived by art or other infertility treatments and children who were conceived without treatment. secondarily, to assess epigenetic differences as measured by dna methylation using collected biospecimens.

Eligibility criteria:
inclusion criteria: * mothers delivering a live birth in new york state (excluding new york city). exclusion criteria: * refused follow-up
validation and impact of paediatric malnutrition screening tool in hospitalised children

Conditions: Malnutrition

Summary: children hospitalized due to an acute disease may suffer from acute malnutrition or chronic malnutrition caused by chronic diseases. we aimed to evaluate the use of the screening tool for the assessment of malnutrition in pediatrics (stamp) among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

malnutrition prevalence upon admission to paediatric hospitals remains considerably high, ranging from 7.3 to 17.9% in the developed world with higher prevalence rates in infants and toddlers and particularly high rates for specific medical conditions. several studies have reported deterioration of nutritional status during hospitalization. screening children for malnutrition risk is recommended by a number of international organizations such as the american society for parenteral and enteral nutrition (aspen), the european society for parenteral and enteral nutrition (espen) and the european society for paediatric gastroenterology, hepatology and nutrition (espghan). screening tool for the assessment of malnutrition in pediatrics (stamp) was chosen for this study because it is highly applicable, frequently used by nurses and has shown high reproducibility, as well as concurrent and predictive validity. the tool was developed by mccarthy et al11 in england. it collects the following information to assess nutritional risk for a patient: discrepancy between the weight and height percentile weight for the age expected nutritional risk caused by clinical diagnosis, recent changes in the appetite. the assessment results are used to define if there is a need for a referral to a full nutritional assessment. we aimed to evaluate the use of the screening tool for the assessment of malnutrition in pediatrics among children admitted in a pediatric hospital, and assess its effect on medical staff's awareness to nutritional status and health outcomes at discharge.

Eligibility criteria:
inclusion criteria: * patients hospitalized during the study, * patients hospitalized for more than 24 hours. the children will be enrolled from 3 internal medicine and surgical departments, children's parents will give their consent and will be able to understand and sign the consent forms exclusion criteria: * children \< 1 year of age, * children \> 17 years of age, * children hospitalized for less than 24 hours, * children in the intensive care unit or following hospitalization in the intensive care unit. statistical analysis for stamp validation will be performed using kappa (k) test. chi square test will be used in order to calculate the effect of stamp use

Keywords: tool for nutritional evaluation children malnutrition
a randomised controlled trial of face masks and hand hygiene in reducing influenza transmission in households

Conditions: Influenza

Summary: this study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households

randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 hong kong residents who have a household member diagnosed with influenza. influenza in index member and secondary infection will be documented with rapid influenza tests and pcr. minimal risk to participants.

Eligibility criteria:
inclusion criteria: * member of family with influenza infected member exclusion criteria: * age less than 2 yr

Keywords: influenza masks transmission hand hygiene non-pharmacologic interventions
expert patient self-management programme versus usual care in bronchiectasis

Conditions: Bronchiectasis

Summary: the aim of this exploratory randomized controlled trial was to investigate the efficacy of a disease specific expert patient programme compared to usual care in patients with bronchiectasis. hypothesis: disease specific epp will increase self efficacy compared to usual care.


Eligibility criteria:
inclusion criteria: * adult patients (\>18 years) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomography scan were included in the study exclusion criteria: * primary diagnosis of cystic fibrosis * patients with methicillin-resistant staphylococcus aureus infection * patients with any condition that would have an impact on the assessment procedures (e.g. sensory impairment, pregnancy, language barriers) * any factor that would prevent adherence to the self-management programme.
assessment of the disease severity and treatment patterns of rheumatoid arthritis in eastern europe, middle east and north african countries (p08167)

Conditions: Arthritis, Rheumatoid

Summary: the study will assess the disease severity and treatment patterns of rheumatoid arthritis in eastern european, middle eastern, and north african countries.


Eligibility criteria:
inclusion criteria : * confirmed diagnosis of rheumatoid arthritis, preferably based upon criteria established by the american college of rheumatology (acr) 1987 * clinical signs \& symptoms * data obtained from previous laboratory and instrumental examination, which may include but is not limited to: radiography, blood tests * written informed consent, signed before participation in the study. exclusion criteria : * refusal to participate in the study * age under 18 years
effect of carbonated soft drinks on appetite-regulation

Conditions: Obesity; Diet

Summary: compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. however, the mechanisms linking drinks intake to obesity are yet to be clarified. the investigators aim is to investigate the short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. the study is a crossover, intervention trial with 24 overweight, healthy volunteers. the subjects will be tested on four separate days for four hours. each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served. the investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.


Eligibility criteria:
inclusion criteria: * age between 20-50 years; * bmi between 28-36 kg/m2; * weight stabile 3 months prior to the study inclusion; * less than 10 hours of weekly exercise. exclusion criteria: * diabetes * allergic to phenylalanine or milk * smoking * pregnancy or breast-feeding
from innovation to solutions: childhood influenza vaccination planning

Conditions: Influenza

Summary: the purpose of this study is to increase childhood influenza vaccination rates using the fda licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.

the investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 pillars immunization toolkit, in addition to receiving donated vaccine for early season vaccination. control practices will not receive such assistance but will receive the intervention in the second year.

Eligibility criteria:
inclusion criteria: for children: attendance at the selected health care center within the last year and age \>/=6 months thru 18 years. exclusion criteria: for children: severe egg allergy or allergy to influenza vaccine

Keywords: influenza vaccination strategies children/adolescents
preemptive analgesic effects of popliteal sciatic nerve block in patients with bilateral hallux valgus surgery

Conditions: Pain, Postoperative; Preemptive Peripheral Nerve Block; Acute Pain

Summary: the purpose of this study was to investigate the preemptive effect of ultrasound guided popliteal scistic nerve block on postoperative acute pain in patients with bilateral hallux valgus. after induction of general anesthesia, the leg to be operated first is decided randomly. after the operation of one leg is completed, psnb is performed on both legs with 0.2% ropivacaine and surgery is started on the remaining legs. when the surgery is over, check to see which foot pain begins first, how strong the pain is, and whether there are any side effects.


Eligibility criteria:
inclusion criteria: 1. adults between the ages of 20 and 80 2. bilateral hallux valgus surgery on the same day 3. asa class 1 or 2 4. patients who have voluntarily agreed in writing to participate in the trial exclusion criteria: 1. patient with side effects on local anesthetics or steroids 2. patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc. 3. patients with uncontrolled medical or psychiatric problem 4. patient does not agree to participate in the study 5. patients who are pregnant or lactating

Keywords: preemptive analgic effect popliteal sciatic nerve block bilateral hallux valgus
expanded access of onvansertib with folfiri and bevacizumab for the second-line treatment of participants with kras-mutated metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer; KRAS Gene Mutation

Summary: this is an expanded access program for eligible participants designed to provide access to onvansertib in combination with folfiri and bevacizumab.


Eligibility criteria:
inclusion criteria: * participant is not eligible for other clinical trials currently open in the region * participant has failed or progressed on standard of care systemic therapy * folfiri (with or without 5fu bolus and continuous infusion)/bevacizumab plus onvansertib is appropriate for the participant as determined by the treating physician, including participants who have previously been treated with folfiri * histologically confirmed metastatic and unresectable crc with a confirmed kras mutation * age ≥ 18 years * participant was previously enrolled in an existing cardiff clinical trial that is ending and based on investigator judgement has responded to treatment using onvansertib plus folfiri (with or without 5fu bolus) + bevacizumab women of child-bearing potential * women of child-bearing potential (wocbp) must agree to use method(s) of contraception * wocbp must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of onvansertib treatment * if sexually active, the participant must agree to use contraception considered adequate and appropriate by the treating physician during the period of onvansertib administration exclusion criteria: * participant has not recovered from minor or major surgery and less than 6 weeks out from major surgery * participant has active hepatitis b or c infection * participant has a known history of testing positive for human immunodeficiency virus or having been diagnosed with acquired immunodeficiency syndrome * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure class ii or higher according to the new york heart association functional classification, unstable angina pectoris, significant pulmonary disease (shortness of breath at rest or mild exertion), that would limit compliance with study requirements * abnormal glucuronidation of bilirubin, known gilbert's syndrome * participants with any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the treating physician, would substantially increase risk to their well-being * any condition that, in the opinion of the treating physician, would substantially increase risk to their well-being

Keywords: colorectal cancer kras-mutation onvansertib pcm-075 folfiri irinotecan 5-fluoruracil bevacizumab
preoperative panitumumab and radiotherapy in rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy. the main hypothesis of the study is that the association of egfr-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

anti-egfr monoclonal antibodies have radiosensitizing properties. in particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma. similar benefit in rectal cancer is expected. however, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. however, in the past studies, the selection of patients' population was not optimal since kras mutational status was not considered during recruitments. therefore, new trials to investigate egfr-targeting therapies in combination with radiotherapy in wild-type kras patients are required. adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. in our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.

Eligibility criteria:
inclusion criteria: * ecog performance status 0-1 * histologically proven adenocarcinoma of the rectum, t3-t4 and/or n+ m0 * wild-type kras * no prior pelvic irradiation * normal bone marrow, hepatic, renal, cardiac functions * no secondary malignancy * no other active, uncontrolled disease * signed informed consent exclusion criteria: * kras mutation * established or suspected metastasis * prior pelvic irradiation * previous exposure to egfr-targeting therapies * patients under any other investigational agent(s) * concurrent systemic immune therapy, chemotherapy, hormone therapy * drug and/or alcohol abuse * grade 3 to 4 allergic reaction to any of the components of the treatment * history or presence of interstitial lung disease * active, uncontrolled cardiovascular disease

Keywords: rectum colorectal cancer adenocarcinoma anti-egfr monoclonal antibodies neoadjuvant therapy preoperative radiotherapy
personalized nutrition therapy using continuous glucose monitoring to improve outcomes in type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. this diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. continuous glucose monitoring (cgm) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. cgm could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. this study will test the use of cgm to personalize nutrition therapy compared to nutrition therapy alone (without cgm) for participants with type 2 diabetes who are not meeting glycemic treatment goals.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * have a previous diagnosis of type 2 diabetes * hba1c of 7.0 - 9.5% * stable medications for diabetes for at least 3 months prior to enrollment, with no plans to change medications or doses during the intervention period. exclusion criteria: * type 1 diabetes * treatment with insulin, sulfonylurea, or meglitinide * use of a nondiabetic medication affecting blood glucose (e.g. corticosteroid) * bmi \<25 kg/m2 * weight change \&gt;5 pounds in the 3 months prior to enrollment * estimated glomerular filtration rate \&lt;60 ml/minute/1.73 m2 * pregnant or breastfeeding * anemia (which affects hba1c) * presence of any disease that would make adherence to the protocol difficult