Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab (amg 162) in japanese postmenopausal women

Conditions: Osteoporosis

Summary: the primary objective was to evaluate the safety and tolerability of denosumab (amg 162) after a single subcutaneous administration in japanese postmenopausal women.


Eligibility criteria:
inclusion criteria: * ambulatory women between the ages of 40 and 64 years, inclusive * postmenopausal, defined as amenorrheic for at least 24 months * clinically acceptable physical exam * clinical laboratory tests (complete blood count \[cbc\], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (ast) and alkaline phosphatase (alt), which must be \< 1.25 times the upper limit of normal, or gamma-glutamyl transpeptidase (ggt), which must be \< 1.5 times the upper limit of normal * normal or clinically acceptable electrocardiogram (ecg) (12-lead reporting ventricular rate and pr, qrs, qt, and qtc intervals) * body mass index between 17 and 27 * willing to sign an approved informed consent form before any study-specific assessments and oral consultations are performed exclusion criteria: * administration of medications within 6 months before investigational product administration that are known to effect bone metabolism, including but not limited to the following: calcitonin, parathyroid hormone (or any derivative), supplemental vitamin d (\> 1000 iu/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics * administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis * diagnosed with any condition that affects bone metabolism * greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities * routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of investigational product administration * known sensitivity to any drugs * positive test results for hepatitis b surface antigen, hepatitis c virus, human immunodeficiency virus antigen/antibody, syphilis * receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product * donated any amount of blood within 16 weeks, or over 400 ml (note: not 400 ml but 200 ml, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening * subject had previously entered this study * any other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent

Keywords: postmenopausal denosumab
bassini inguinal hernia repair: obsolete or still a viable surgical option?

Conditions: Inguinal Hernia; Surgery--Complications; Surgical Complication

Summary: retrospective review of hernia surgery patients at hhmcguire vamc focusing on repair type and postoperative complications.


Eligibility criteria:
inclusion criteria: inguinal hernia repair without mesh - exclusion criteria: mesh repair -
incidence of metabolic disorders in neonatal convulsions

Conditions: Neonatal Convulsions

Summary: describe the incidence of metabolic disorders in neonatal convulsions affecting neonates at nicu describe types of metabolic disorders causing neonatal convulsions

neonates are susceptible to seizures due to several physiologic factors and combination of risks that are uniquely associated with gestation, delivery,and the immediate postnatal period. neonatal seizures can be challenging to identify therefore itis imperative that clinicians have ahigh degree of suspicion for seizures based on the clinical history or the presence of encephalopathy with or without paroxysmal abnormal movements. acute symptomatic neonatal seizures are due to an acute brain injury, whereas neonatal onset_epilepsy may be due to underlying structural, metabolic ,or genetic disorders.early identification and treatment are likely important for long term outcomes in acute symptomatic seizures though additional studies are needed to understand optimal seizure control metrics and the ideal duration of treatment. seizures may be the first and the major presenting feature of an inborn error of metabolism. seizures may be preceded by other major symptoms by areduced level of consciousness in achild with an organic acidemia or urea cycle defect or by loss of skills ,progressive weakness ,ataxia ,and upper motor signs in achild with lysosomal storage disorder or peroxisomal leukodystrophy.the metabolic causes of seizure vary according to age at presentation.

Eligibility criteria:
inclusion criteria: * neonatal convulsions associated with vomiting,acidotic breathing,dcl,change of body tone or change in hair color * abnormal metabolic investigations (elevated serum ammonia and lactate ,persistent metabolic acidosis,abnormal metabolic screening and hypoglycemia * persistent neonatal convulsions not respond to antiepileptic drugs exclusion criteria: * history of neonatal asphyxia * history of birth trauma * signs of sepsis and cns infection * neonate with electrolyte disturbance
evaluation of patellar dimension and bristol index in asian population

Conditions: Patello Femoral Syndrome

Summary: restoration of patellar thickness is pivotal during a total knee arthroplasty (tka). several studies showed there are differences in the knee measurements between asian and western population. this study aims to evaluate the patellar dimension and bristol index of patellar width to thickness (bipwit) using magnetic resonance imaging (mri) in asian population.


Eligibility criteria:
inclusion criteria: * knee pain exclusion criteria: * degenerative joint disease * patellofemoral pathology
prevention of type 2 diabetes in children with a family-based healthy lifestyle program

Conditions: Impaired Glucose Tolerance

Summary: the purpose of this study is to determine if the bright bodies (bb) healthy lifestyle program can help reverse early abnormalities in glucose metabolism and prevent the progression to type 2 diabetes (t2dm) in high-risk, obese youth with newly-diagnosed impaired glucose tolerance (igt).

primary aim: (1) to determine whether youth randomized to the bright bodies (bb) healthy lifestyle program have lower 2-hr plasma glucose levels than those randomized to standard lifestyle counseling (control) after 6 months. secondary aims: (2) to determine if greater conversions from igt to normal glucose tolerance (ngt) and less development of t2dm occurs for those in the bb vs control group; (3)to determine if there is improvement in anthropometric/metabolic parameters in bb vs control group; and (4) to determine if there is an improvement in psychosocial and family dynamic outcomes of the child in bb vs control group.

Eligibility criteria:
inclusion criteria: * diagnosis of igt (glucose 140-199 at 2 hrs during ogtt) * age 11 to 16 * an interest in being enrolled in a healthy lifestyle program * a parent/caregiver willing to participate with child in program exclusion criteria: * psychiatric disorder or serious medical condition that would preclude participation in program * currently taking medication that potentially effects insulin sensitivity (eg metformin) or causes weight gain (example: risperidone) or weight loss (eg xenical) * involvement in co-existing weight management/healthy lifestyle program * plans of moving out of the greater new haven area within six months

Keywords: impaired glucose tolerance prediabetes diabetes prevention
effects of exercise oncology intervention in fitness capacity and body composition in breast cancer survivals

Conditions: Breast Cancer; Cancer Survivors

Summary: the goal of this interventional study is to analyze the impact of a supervised oncological exercise intervention in surviving breast cancer patients. the main questions it aims to answer are: * evaluate the efectivity of a supervised individualized and adapted oncological physical exercise program in the cardiovascular fitness of the participants. * analyze the impact of this intervention in the body composition, functionality and quality of life of the parcitipants participants will perform a controlled and adapted program, supervised by an especialized professional during 16 weeks. researchers will compare this intervention group, where the supervised program will take place, with a control group, where the patients will perform regular physical activity (non-supervised) to see the changes in the efectivity and impact in cardiovascular fitness, body composition and quality of life.


Eligibility criteria:
inclusion criteria: * women diagnosed with primary, type i to iii a/b cancer, with hormonal positive (er+ and pg+), triple positive (er+, pg+ y her2+) or triple negative subtype. * women with chemotherapy and radiotherapy phase complete. * women with post-surgery phase complete. * women that are within 5 years from diagnostic. * ecog score above or equal to 0 or 1. exclusion criteria: * submit medical contraindications to physical exercise by their reference doctor. * women in state iv o methastasis. * pregnant women. * meet any of the criteria of the american thoracic society (ats) to perfrom a cardiovascular fitness test.

Keywords: breast cancer exercise oncology cancer survivors fitness capacity quality of life
the effect of consumption of bread types made from various flours on blood glucose fluctuations

Conditions: Obesity; Glycemic Index; Blood Glucose; Bread

Summary: the obesities were aimed at the effect of whole wheat (wwb), buckwheat (bwb), and cornbread (cb) on blood glucose by comparing the glycemic index values with reference bread (rb). overall, wwb consumption had a positive effect on blood glucose in individuals with obesity, while bwb consumption caused an increase in blood glucose levels.


Eligibility criteria:
inclusion criteria: * the study group consisted of volunteer individuals aged between 18 and 35 years. * the first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption. * all measurements were taken between 09.00-13.00. * during the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise. exclusion criteria: * pregnant, * lactating women * patients with physician-diagnosed chronic diseases * medication use

Keywords: obesity glycemic index blood glucose cornbread buckwheat bread
effect of subcutaneous tissue closure on wound complications

Conditions: Cesarean Section

Summary: only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. in a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth \>2 cm.

postoperative wound complications are one of the great issues in cesarean section (cs) with an incidence ranging from 3% to 30%.1 obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections. evaluating the various techniques for closure of the subcutaneous layer.

Eligibility criteria:
inclusion criteria: * all patients included in this research bmi ≥ 30, first cesarean section performed, no medical disorders with pregnancy e.g dm, htn. all patients were subjected to full history taking, examination. depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation exclusion criteria: * the following patients were excluded bmi \<30, previous cs, dm with pregnancy, htn with pregnancy

Keywords: cesarean section wound infection gapping
improved detection of neonatal sepsis using a targeted biomarker assay

Conditions: Neonatal Sepsis

Summary: the purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in nicu patients \>3 days of age.

all infants in the newborn intensive care unit greater than three days old that had blood cultures sent were eligible for this study. left-over blood from the time at blood culture was collected for research purposes. study personnel separated the serum and stored samples at -80 degrees until analysis. samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. clinical information collected included symptoms prompting the blood culture, cbc and culture results, and antibiotic therapy.

Eligibility criteria:
inclusion criteria: * nicu patients \> 3 days of age exclusion criteria: * less than 3 days old or no waste blood available

Keywords: cytokines neonatal sepsis diagnosis of sepsis bacteremia blood culture clinical sepsis
assessing chart's effectiveness and barriers and facilitators of its implementation

Conditions: Extreme Heat; Heat Health; Extreme Heat Waves; Heat; Emergency Preparedness; Disaster Management; Disaster Planning; Disasters

Summary: the goal of this clinical trial is to learn if an innovative online decision support tool (chart) that provides localized health risk assessment for extreme heat at the census tract level helps local health departments plan and prepare for extreme heat by identifying risk drivers in their jurisdictions, highlighting interventions that are effective for their jurisdiction's risk profile, and providing information regarding intervention implementation. this trial will evaluate barriers and facilitators of the tool's implementation. the main questions it aims to answer are: 1. does a health department using the tool have better reach, effectiveness, adoption, implementation, and maintenance of heat-health activities compared with an information-only control? 2. what are the barriers and facilitators of chart's implementation? researchers will compare health departments using chart to health departments using provided heat-health information only.


Eligibility criteria:
inclusion criteria: * local (city or county) health department * local (i.e., city or county) health department with at least partial autonomy to pursue the development and implementation of heat-health activities (i.e., not a state where all public health activities are administered at a state level) * availability of a staff member to participate in all elements of the trial. local health department staff responsible for planning and implementing programming to protect constituents from extreme heat. * adults whose demographics and health status will mirror those of the general population. * current employees of included health departments aged 18 or greater exclusion criteria: * being in a state where public health activities are exclusively managed at a state level and not having staff availability to participate * children and prisoners

Keywords: heat extreme heat event climate risk reduction
comprehensive magnetic resonance of peripheral arterial disease

Conditions: Peripheral Artery Disease

Summary: the purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.


Eligibility criteria:
inclusion criteria: patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4\<abi\<0.9) 96 normal healthy subjects ages 30-85 exclusion criteria: age\ 85 gfr less than 45ml/min based on a serum creatinine drawn within 90 days of the mri: pregnancy contraindications to a magnetic resonance examination * intracranial clips * implantable pacemaker and defibrillator * cochlear or intraocular implants * claustrophobia * any metallic implant not listed as magnetic resonance compatible in shellock f.g ---pocket guide to magnetic resonance procedures and metallic objects, update 2000. lippincott, williams and wilkins

Keywords: pad
adjusting wheelchair set-up to minimize shoulder joint forces during propulsion

Conditions: Paraplegia; Upper Limb Pain

Summary: individuals who use a manual wheelchair depend upon their upper limbs to provide a means of locomotion during completion of their activities of daily living. as a result of greater than normal usage of the upper limbs, shoulder pain and pathology is common among manual wheelchair users. accordingly, proper wheelchair set-up may be paramount to preventing injuries and maintaining comfort during locomotion. the purpose of this research study is to create a subject-specific computer model of wheelchair propulsion to provide information on wheelchair set-up (in particular, axle placement). the primary objective of this study is to investigate the effect of wheelchair set-up on shoulder joint forces during wheelchair propulsion; the secondary objective is to develop a predictive model to identify differences in shoulder joint forces that result from altering the axle position and seating set-up in user's wheelchairs. the hypothesis of the study is that outputs from a patient-specific model will reveal that the current axle position for each subject results in peak shoulder joint forces that are greater than those predicted from an altered axle position (determined by the model). the overall goal is to then adjust each manual wheelchair user's axle placement to one that minimizes the magnitude of shoulder joint forces throughout propulsion. it is intended that in doing so, the repetitive strain injuries associated with manual wheelchair propulsion may be reduced, prolonging a pain-free way of life for this population.


Eligibility criteria:
experienced wheelchair users: inclusion criteria: * have a neurological impairment secondary to a spinal cord injury which occurred over 1 year prior to the start of the study; * sci at or below t1 (complete or incomplete); * use a manual wheelchair as a primary means of mobility (at least 40 hrs. per week but not necessarily always in motion); * sci after age 18 * have 24 inch diameter wheels with quick-release axles. exclusion criteria: * history of fractures or dislocations in the arms including the shoulder, elbow, and wrist; * upper limb dysthetic pain as a result of a syrinx or reflex sympathetic dystrophy; * pregnant women; * shoulder pain that a mwu describes as limiting their ability to propel a manual wheelchair; * history of neurologic disorder other than spinal cord injury (e.g. brain injury). inexperienced manual wheelchair users: inclusion criteria: * be between the ages of 18 and 65 years of age. exclusion criteria: * history of fractures or dislocations in the arms including the shoulder, elbow, and wrist; * have a musculoskeletal disorder; * pregnant women; * shoulder pain that limits their ability to propel a manual wheelchair.

Keywords: wheelchair set-up shoulder joint forces manual wheelchair users paraplegia upper limb pain secondary injury to spinal cord injury biomechanics
comparison of pulse hemoglobin and pleth variability index

Conditions: Anemia; Fluid Management

Summary: the purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and pleth variability index (pvi)\] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. the hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. our current method of checking this is by getting a blood sample for analysis. the investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.


Eligibility criteria:
inclusion criteria: * subjects must be \>18 years old; * must be having a major surgical procedure; * the pre-operative estimation of blood loss must be at least 15% of the total blood volume exclusion criteria: * does subject have hemoglobinopathy; * cardiac arrhythmias producing irregular rhythms; * severe pulmonary disease; * procedures where loss of more that 10 to 15% of total blood volume is unlikely; * subject refusal
cerebellar rtms and physical therapy for cerebellar ataxia

Conditions: Multiple System Atrophy, Cerebellar Variant (Disorder); Spinocerebellar Ataxias

Summary: the present study investigated the efficacy and safety of combination treatment of repetitive transcranial magnetic stimulation (rtms) and physical therapy (pt) in patients with cerebellar variant of multiple system atrophy (msa-c) and spinocerebellar ataxia.


Eligibility criteria:
inclusion criteria: 1. the patients with probable msa-c and spinocerebellar ataxia (sca) 2. cerebellar ataxia as main clinical presenting feature and able to walk independently without walking devices 3. aged over 20 4. presence of cerebellar atrophy proven by brain mri. exclusion criteria: 1. secondary cerebellar ataxia 2. peripheral neuropathy, radiculopathy, or decreased visual acuity that can cause peripheral ataxia 3. musculoskeletal disease affecting gait or balance 4. other neurologic symptoms, including symptomatic parkinsonism (two or more rigidity and/or bradykinesia scores in one limb by unified parkinson's disease rating scale part 3) or spasticity (20) 5. psychiatric symptoms requiring medication or with cognitive decline (mini-mental state examination \[mmse\] \< 20) 6. taking any sedative medications or anti-parkinsonian medications such as benzodiazepine, levodopa or dopamine agonist 7. history of seizure or metallic brain implants; (8) cardiopulmonary diseases causing dyspnea during exercise.
physical activity level and sleep quality in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM); Sleep; Biomarkers / Blood; Physical Activity Level

Summary: in this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (tas), total oxidant level (tos), malondialdehyde (mda) and superoxide dismutase (sod) which are markers of oxidative stress, irisin, fibronectin type iii-protein 5 (fndc5).


Eligibility criteria:
inclusion criteria: * being between 30-65 years old * volunteering to participate in the study * being literate * being diagnosed with type 2 diabetes exclusion criteria: * having a physical or mental illness that prevents communication * malignant disease, * infectious disease, * chronic obstructive pulmonary disease, * liver disease, * patients with kidney disease and joint or muscle disease will not be included