Kornimate/medical-research-clean huggingface dataset:
recombinant influenza vaccination in u.s. nursing homes

Conditions: Influenza; Influenza -Like Illness; Influenza, Human

Summary: based on recent evidence on the mutation of the a/h3n2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (riv4, flublok) compared to the standard dose quadrivalent vaccine (iv4) in a cohort of long-stay nh residents with a primary endpoint of all-cause hospitalization.

a study sample goal of 1000 u.s. nhs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay nh residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. participating facilities will be randomly allocated in a 1:1 ratio to riv4 or iv4 vaccine for their residents. also, all staff must be offered the same vaccine in both allocation groups, in order to eliminate differences in transmission of influenza through staff to residents related to differences in vaccine-related protection of staff and will reduce heterogeneity between clusters. the minimum data set from the nh resident assessment instrument will be evaluated from all evaluable facilities meeting inclusion criteria and will be cross-referenced to medicare claims and drug use data.

Eligibility criteria:
inclusion criteria: * medicare-certified nhs with at least 50 long-stay residents ≥ 18 years of age * facilities with at least 80% of their long-stay population ≥ 65 years of age or at least 70 long stay residents ≥ 65 years of age that make up ≥ 45% of their total number of beds exclusion criteria: * hospital-based facilities * facilities where fluzone high-dose or fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season * facilities not submitting mds data * facilities not in one of the 50 u.s. states

Keywords: influenza vaccine vaccination nursing home respiratory-related hospitalizations cluster randomized trial mace (major adverse cardiovascular event) cardiorespiratory-related hospitalizations all-cause hospitalization
efficacy and safety study of seroquel sr in the treatment of generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the primary purpose of this study is to evaluate the efficacy of (seroquel sr™ ) quetiapine fumarate sustained-release (sr) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (gad). please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * male or female aged 18 to 65 years; * a diagnosis of generalized anxiety disorder; * absence of current episode of major depression. exclusion criteria: * the presence or history of schizophrenia and other psychotic disorders; * hypertension; * a current diagnosis of cancer, unless in remission for at least 5 years

Keywords: anxiety gad
adult pilot study for reference ranges and optimal cut-offs for the sucrose challenge test and sucrose breath test

Conditions: Congenital Sucrase-Isomaltase Deficiency

Summary: an adult pilot study to establish the normal reference range and optimal cutoffs for the oral 50g sucrose challenge test (sct) and the 50g 13c-sucrose breath test (cbt) for patients with csid and healthy controls. this study will enroll 120 healthy controls and 50 csid patients. no study drug will be administered during this study.

in an effort to mimic the real-world diagnostic setting for these tests, this study will be conducted virtually using a central site with telemedicine capabilities and electronic data capture software to collect data in real time via a mobile app. subject will complete 3 visits within 21 days. eligible subjects will undergo the following tests: 1. 50g 13c-sucrose breath test (cbt) 2. sucrose intolerance hydrogen methane breath test (hbt) 3. sucrose challenge test (sct) 4. buccal swab for csid genetic testing (gt) the primary aim is to establish the reference/normal ranges and optimal cutoff values for the sct and cbt.

Eligibility criteria:
inclusion criteria: * subject must provide informed consent prior to any study procedures being performed. * subject is a u.s. resident, and speaks and understands english * subject is male or female, ≥ 18 years old. * csid cases must have been on sucraid for at the last 12 months. * healthy volunteers do not have a csid diagnosis or other chronic gastrointestinal conditions. * subject must have their own android or apple device to access the mobile patient app. exclusion criteria: * females who are lactating or pregnant. * subjects with allergy to sucrose. * subjects with causes of abdominal pain or altered bowel habits other than symptoms -related to csid (in csid group) such as sibo, ibd, celiac disease, pancreatitis, or -gastrointestinal bleeding. * diabetes mellitus. * use of systemic antibiotics, had a barium study, colonoscopy, unexplained runny diarrhea, or similar within 14 days prior to informed consent. potential subjects can be re-screened once they meet this criterion. * recent febrile illness. * subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.

Keywords: csid
the effect of bmi on hand grip force in healthy adults

Conditions: Motor Activity; Overweight and Obesity; Hand Injuries

Summary: this study will be conducted to investigate the effect of bmi on hand grip force in healthy subjects. the participants in this study will be 90 healthy subjects with right dominant lower limb (49 females and 49 males) they will be recruited from college of applied medical sciences, jazan university.

subjects will be categorized according to bmi into three groups: group i (normal subjects): 30 individuals (15 male, and 15 female students) with (bmi\<25 kg/m2) group ii (overweight subjects): 30 individuals (15 male, and 15 female students) with (bmi, 25-30 kg/m2). group iii (obese subjects): 30 individuals (15 male, and 15 female students) (bmi\>30 kg/m2). baseline hydraulic hand dynamometer: (fabrication enterprises incorporated, white plains,new york, usa) will be used to measure the hand grip strength and pinch strength

Eligibility criteria:
inclusion criteria: 1. subjects would not have any diseases of the central nervous system. 2. subjects would not have any orthopedic disorders either of the trunk or the lower limbs in the previous year. 3. none of the subjects has history of balance training ( erkmen et al., 2010, li li, 2012) . exclusion criteria: 1. sign of foot pain, reduced tactile and thermal foot sensibility. 2. peripheral neuropathy. 3. a history of previous back or abdominal surgery/injury 4. a history of patellofemoral pain syndrome, plantar fasciitis, and back pain . 5. limb-length discrepancy, and anterior or posterior tibialis dysfunction. 6. evidence of a systemic or musculoskeletal disease within the past six months (alabdulwahab \& kachanathu, 2016).

Keywords: bmi, hand grip, healthy adults
effects of treatment of sleep apnea on metabolic syndrome

Conditions: Impaired Glucose Tolerance; Obstructive Sleep Apnea

Summary: the investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of continuous positive airway pressure (cpap) to 8 weeks of sham-cpap in patients with moderate to severe sleep disordered breathing (sdb) and impaired glucose tolerance. a rigorous assessment of metabolic responses to sdb treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. the paradigm shift of cpap as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.

there are few controlled studies that address whether treatment of sleep apnea improves glucose tolerance. this is a randomized, double-blind cross-over study of subjects with sleep apnea (apnea hypopnea index \> 15) and impaired glucose tolerance. subjects will be randomized to 8 weeks of continuous positive airway pressure (cpap) or sham-cpap, followed by the alternate therapy after a one month wash-out. after each treatment, subjects will undergo 2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of indices of glucose control. the investigators intend to analyze the changes in glucose metabolism and insulin sensitivity in patients with sleep apnea with cpap intervention.

Eligibility criteria:
inclusion criteria: * moderate to severe sleep disordered breathing (sdb) defined by an apnea hypopnea index (ahi) \> 15 * had evidence of impaired glucose tolerance (igt) defined by the mean 2-hour oral glucose tolerance test (ogtt) glucose of \> 140 mg/dl calculated from the two 2-hour ogtts performed within 3 days of each other
the effect of recruitment maneuver with protective ventilation during thoracic surgery

Conditions: Mechanical Ventilation Complication; Thoracic Surgery; Inflammation

Summary: the purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.


Eligibility criteria:
inclusion criteria: * 20 years and older * patients undergoing thoracic surgery exclusion criteria: * emergency surgery * heart failure * pulmonary hypertension * forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values * coagulation disorder * pulmonary or extrapulmonary infections * history of treatment with steroid in 3 months before surgery * history of recurrent pneumothorax * history of lung resection surgery
a study to provide real-world evidence on the treatment goal achievement rate, adherence to and utilization patterns of adalimumab in patients with moderate to severe plaque psoriasis in greece

Conditions: Moderate to Severe Plaque Psoriasis

Summary: this study estimates the treatment goal achievement rate, depicts the implementation of the progressive psoriasis initiative (ppi) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in greece.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as body surface area (bsa) \>10 or pasi \>10 and dlqi \>10 * patients for whom the decision to prescribe therapy with adalimumab (humira®) according to the locally approved summary of product characteristics (smpc) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study * patients with an available psoriasis area severity index (pasi) and dermatology life quality index (dlqi) scores at the start of adalimumab treatment * patients able and willing to provide written informed consent and to comply with the requirements of this study protocol * patients with a signed informed consent document exclusion criteria: * patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular) * patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study * patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved smpc * patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed * patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.

Keywords: moderate plaque psoriasis severe plaque psoriasis plaque psoriasis
the regulation of human skeletal muscle mass by contractile perturbation

Conditions: Muscle Atrophy; Disuse Atrophy (Muscle) of Lower Leg

Summary: it is well known that periods of weight training lead to increases in skeletal muscle size and strength. in contrast, periods of inactivity such as bed rest or immobilization result in losses of skeletal muscle size and strength. however, individuals experience variable magnitudes of muscle size change in response to changes in mechanical tension, such that certain individuals experience large changes in muscle mass whereas others do not. what is not currently known, and will be the primary goal of the present investigation, is to determine whether individuals who gain the most muscle mass with exercise training also lose the most muscle when they are immobilized. the investigators hypothesize that individuals who gain the most muscle with training will also lose the most with immobilization.

resistance exercise, paired with protein ingestion, leads to the accretion of muscle proteins that over time results in the augmentation of muscle size and muscle strength. by virtue of its ability to stimulate increases in muscle size and strength, resistance exercise is an effective method that can be used by healthcare practitioners to promote the recovery of lost muscle mass resulting from a period of immobilization (resulting from broken bones, elective surgery, etc.). however, while exercise in general is an effective therapeutic strategy to combat muscle loss and frailty, the extent to which individuals respond to resistance exercise is highly variable. some individuals exhibit large changes in muscle size (high responders) whereas other exhibit little to no change (low responders). thus, where as one resistance exercise program might be an appropriate treatment for one individual following disuse, another individual might require a greater stimulus and/or pharmaceutical assistance in order to fully recover. what is currently unknown is whether individuals who experience the most profound increases in skeletal muscle mass following resistance exercise also lose the most muscle upon limb immobilization. answering this gap in our knowledge will be the primary goal of this study. the procurement of this knowledge will hopefully permit the development of individualized exercise programs that can be used to influence the recovery of skeletal muscle that is lost with inactivity and immobilization.

Eligibility criteria:
inclusion criteria: * healthy * non-smoker * do not heavily consume alcohol exclusion criteria: * female * younger than 18, or older than 30 years * use of anti-inflammatory or analgesic medication * history of neuromuscular disorders * family history of deep vein thrombosis * regularly take part in structured physical exercise (greater than 2 days per week) * take any medications known to influence protein metabolism

Keywords: muscle hypertrophy muscle atrophy resistance training immobilization
dielectric tissue imaging in cavotricuspid isthmus ablation

Conditions: Atrial Fibrillation and Flutter

Summary: this is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the kodex - epd functions for assessing tissue pressure, tissue thickness, lesion transmurality.

this is a prospective, single center, non-randomized, open-label, single arm study in which we will gather data and physician input for the assessment and further development of the kodex - epd functions for assessing tissue pressure, tissue thickness, lesion transmurality. the study will include up to 30 subjects. we will enroll patients with atrial flutter and patients with atrial fibrillation who are scheduled to undergo rf ablation of the cavotricuspid isthmus (cti). both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study. we will be assessing the feasibility of the kodex-epd tissue pressure (tp), tissue thickness and lesion transmurality applications.

Eligibility criteria:
inclusion criteria: 1. subject must be aged \>18 years. 2. subject must have signed a written informed consent form to participate in the study, prior to any study related procedures. 3. subject must be willing to comply with the protocol requirements. 4. a female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. 5. subject is deemed amenable to therapeutic ablation for atrial flutter or atrial fibrillation. exclusion criteria: 1. any planned surgical or endovascular intervention within 30 days before or after the index procedure. 2. subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. 3. patient had experienced previous stroke (tia or cva). 4. thrombi detected in the heart. 5. known marked valvular insufficiency (moderate-severe and severe) 6. life expectancy less than 12 months. 7. known severe renal insufficiency (stages g4 and g5, characterized by severe reduction in gfr \[15-29 ml/min/1.73 m2\] and gfr \[\<15 ml/min/1.73 m2\], respectively). 8. subjects that according to the clinical judgment of the caring physician do not fit for the study. 9. previous right atrial ablation procedure or cardiac ablation procedure performed within 90 days prior to enrollment.
effectiveness of a vap prevention bundle in the picu

Conditions: Ventilator Associated Pneumonia

Summary: this observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (vap) management in the pediatric population in the pediatric intensive care unit (picu) of fondazione policlinico agostino gemelli of 8 beds. the investigators will compare the incidence of vap in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. vap bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.


Eligibility criteria:
inclusion criteria: * age \< 18 years * patients receiving mechanical ventilation for more than 48 hours exclusion criteria: * no informed consent * pregnancy * previous endotracheal antibiotic therapy

Keywords: pediatric intensive care unit oral hygiene care chlorhexidine broncho-alveolar lavage pharyngeal swab
acupoint stimulation for pain reduction and the associated benefits in head and neck cancer patients receiving concurrent chemoradiotherapy

Conditions: Head and Neck Cancer

Summary: this study was designed to investigate the effect of acupoint stimulation on pain reduction, and fatigue, anxiety and depression and quality of life in head neck cancer receiving concurrent chemoradiotherapy.

data were collected from 92 participants in northern taiwan medical center radiation outpatient.they are randomly assigned to the experimental group (n=46) with acupoint stimulation and control group(n=46). outcomes were assessed according to the pain, brief fatigue inventory, hospital anxiety and depression scale, quality of life, five repeated measures was conducted.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of head and neck cancer with initial concurrent chemoradiotherapy * must be able to communicate clearly * must be above age 20 exclusion criteria: * previous radiotherapy * history of arrhythmia or use of a pacemaker * local swelling or infection over the acupoint area
association between left ventricular deformation and aerobic exercise capacity in untreated arterial hypertension

Conditions: Arterial Hypertension

Summary: impaired myocardial deformation may determine cardiac diastolic dysfunction. the investigators will investigate the vascular determinants of myocardial deformation and twisting-untwisting and their interrelation with exercise capacity in patients with untreated arterial hypertension

the investigators plan to examine 320 untreated hypertensives and 160 controls. they will measure: 1. the carotid to femoral pulse wave velocity (pwvc) using the complior apparatus 2. the coronary flow reserve (cfr) at baseline and after adenosine infusion (140 μg x kg-1 x min-1) by doppler echocardiography 3. the global longitudinal strain and strain rate, peak twisting, the percentage changes between peak twisting and untwisting at mitral valve opening (utwmvo), at peak (utwpef) and end of early lv diastolic filling (utwedf) by speckle tracking imaging 4. the perfusion boundary region (pbr-micrometers) of the sublingual arterial microvessels (ranged from 5-25 micrometers) using sideview darkfield imaging (microscan, glycocheck). increased pbr is considered an accurate non invasive index of reduced endothelial glycocalyx thickness 5. transforming growth factor (tgfb-1), metalloproteinase-9 (mmp-9), markers of collagen synthesis (n-terminal procollagen type-iii propeptide , carboxy-terminal propeptide and telopeptide of procollagen type-1, representing cardiac extracellular matrix turnover) and n-terminal pro-brain natriuretic peptide (nt-probnp) and soluble angiotensin-converting enzyme (sace). 6. twenty-four hour daytime and night-time average systolic blood pressure (sbp), diastolic blood pressure (dbp) and heart rates as well as 24h-pulse pressure (pp) by means of 24h ambulatory blood pressure monitoring (abpm) monitoring will be carried out on the non-dominant arm using the valid recorder tonoport v (general electric, health care, berlin, germany) after validation of readings against a mercury sphygmomanometer by means of a y tube. the abpm device will set to obtain bp readings at 15 min intervals during the day (07.00-23.00) and at 20 min intervals during the night (23.00-07.00). the patients will be instructed to attend their usual day-to-day activities but to keep still at the times of measurements. recordings will be analysed to obtain 7. oxygen consumption as an absolute value and in relation to body weight (vo2/kg) and maximum work load (mets) by means of a physician-supervised maximal, symptom-limited cardiopulmonary exercise test (cpet) on a bicycle ergometer using a standard ramping protocol (oxycon pro system, jaeger, germany).

Eligibility criteria:
inclusion criteria: * untreated patients with newly diagnosed essential hypertension * normotensive subjects exclusion criteria: * history of diabetes * familiar hyperlipidemia * coronary cad * cardiomyopathy * chronic pulmonary disease

Keywords: lv deformation endothelial glycocalyx coronary flow reserve
horse therapy for children, adolescents and young adults in remission from medulloblastoma

Conditions: Neuroblastoma

Summary: on average, each year in the former region, 60 new patients under the age of 18 are treated for a brain tumor, with an active post-treatment follow-up file of 350 patients. because of the significant sequelae induced by the disease or the treatments, these patients will very often require rehabilitative care. the interest of involving the horse in the population of patients cured of a medulloblastoma but with important physical and psychological after-effects is to be able to combine a therapy using animal mediation (equitherapy) and a rehabilitation therapy based on the three-dimensional movement of the horse (hippotherapy).


Eligibility criteria:
inclusion criteria: * complete remission of medulloblastoma and after 5 years of the end of treatment * living within 30 km away the riding center and/or less than 1 hour of transport * informed consent exclusion criteria: * landsky score below 50% for minors until 16 years old and karnofsky score below 50% for patients over 16 years * major under juridical protection

Keywords: hippotherapy equitherapy