Kornimate/medical-research-clean huggingface dataset:
validity and reliability of perceived exertion rating scale in children with brain damage

Conditions: Traumatic Brain Injury; Cerebral Palsy

Summary: the purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.

walking on a treadmill twice- one weeks interval five intensity level in each session

Eligibility criteria:
inclusion criteria: * children post severe closed head injury (glasgow coma scale \[gcs\] score at admission to emergency room of ≤8, at least one year post trauma * ages 7 to 12 years * (3) independent ambulation (foot orthoses permitted). * children with cerebral palsy, gmfcs 1 or 2, ages 7 to 12 years. typically developed controls. exclusion criteria: * cannot understand simple instructions
estimating peak oxygen uptake in people living with coronary heart disease

Conditions: Coronary Heart Disease

Summary: in people living with coronary heart disease (chd), v̇o2 peak predicts all-cause mortality. v̇o2 peak increases with regular exercise training. thus, in exercise-based cardiovascular rehabilitation programmes, v̇o2 peak is a useful marker of how effective the exercise training has been. maximal cardiopulmonary exercise testing (cpet) is the gold standard method of measuring v̇o2 peak. however, maximal cpet is expensive and requires trained staff to conduct the test and interpret the results. furthermore, cpet is not routinely available in united kingdom (uk) cardiovascular rehabilitation programmes. field exercise tests, such as incremental cycle ergometer tests, are used in conjunction with predictive equations to estimate v̇o2 peak. however, this group has shown that estimating changes in v̇o2 peak in this way is inaccurate. alternative solutions are required. ventriject seismofit® uses a technique called seismocardiography (scg); the measurement of vibrations in the chest wall, caused by each heartbeat, using accelerometers. scg can be used to estimate v̇o2 peak from a scg measurement taken at rest. this study will explore the validity of ventriject seismofit for estimating v̇o2 peak in people with chd.


Eligibility criteria:
inclusion criteria: * stable coronary heart disease * able to lay fully supine for five minutes * capable of performing a maximum effort cpet on a stationary cycle ergometer * currently enrolled in a phase iv cardiac rehabilitation programme * a minimum of 12 weeks after a cardiac event exclusion criteria: * awaiting any significant medical investigations relating to cpet absolute contraindications * hospitalisation within the last 4 weeks relating to cpet absolute contraindications * implantable cardiac devices e.g. pacemaker or implantable cardioverter defibrillator * unstable angina * unstable diabetes * left main coronary stenosis or its equivalent * known third degree heart block * unstable heart failure/new york heart association (nyha) iii or iv heart failure * acute aortic dissection, myocarditis, or pericarditis/endocarditis * suspected or known dissecting aneurysm * symptomatic severe aortic stenosis * acute deep vein thrombosis, pulmonary embolism or pulmonary infection * uncontrolled asthma * pulmonary oedema * respiratory failure * ambient o2 desaturation at rest \<85% * resting tachycardia (\>100bpm) * currently in atrial fibrillation * uncontrolled arrhythmia * resting systolic blood pressure \>180 mmhg * resting diastolic blood pressure \>100 mmhg * other conditions that prevent participants from completing study investigations (e.g. recent (last \~6 months) cardiac arrest)
clinical evaluation of efficacy of shield force plus varnish vs sodium fluoride on dentin hypersensitivity

Conditions: Dentin Hypersensitivity; Dentin Desensitizing Agents

Summary: the aim of the study to compare the clinical effectiveness of shield force plus (sfp) versus sodium fluoride varnish in the management of hypersensitivity of cervical dentin in adult patients for 8weeks.


Eligibility criteria:
inclusion criteria: * patients with good oral hygiene. * the age range of 18-65 years. * patients from both gender. * patients suffering from pain due to dentin hypersensitivity. * patients with sound first upper molars. exclusion criteria: * patients with teeth exhibiting mobility (grade 2 or 3). * patients with constant use of analgesic, carious lesions, fractured teeth, defective restorations or prosthesis. * patients with orthodontics appliance. * patients with allergy sufferers with any of the materials will be used in the study as shield force plus and sodium fluoride. * patients with carious, crowned upper first molars.

Keywords: dentin hypersensitivity dentin sensitivity shield force plus dentin desensitizing agents sodium fluoride varnish
brinzolamide-brimonidine fixed combination for preventing iop elevation after intravitreal anti-vegf injections

Conditions: Eye Diseases; Injection Complication; Intraocular Pressure

Summary: this study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (iop) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-vegf). patients scheduled for treatment with intravitreal injections of anti-vegf will be randomly divided into two groups. in control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. iop will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. in case group, the pre-injection iop will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. the icare (ic200) tonometer will be used for iop measurements at all time points.

the intravitreal anti-vegf (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. intravitreal injections οf anti-vegf agents result in an immediate and transient increase in iop, which returns to normal within a short period of time, typically within thirty minutes. repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of iop, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. a fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.

Eligibility criteria:
inclusion criteria: * patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors exclusion criteria: * history of glaucoma or ocular hypertension * use of topical medications (e.g. iop-lowering medication, corticosteroids) * pseudoexfoliation * pigment dispersion syndrome * corneal diseases * active intraocular inflammation * any intraocular surgery in the last 6 months

Keywords: anti-vascular endothelial growth factor intraocular pressure brinzolamide brimonidine fixed combination
dha brain delivery trial

Conditions: Brain DHA Delivery and Alzheimer's Disease Risk

Summary: carrying the apoe ɛ4 allele is the strongest genetic risk factor for developing alzheimer's disease. the goal of this project is to identify whether carrying the apoe ɛ4 allele is associated with reduced delivery of dha to the brain. this information will help us identify the target population that could benefit from dha supplementation to prevent cognitive decline.

the brain dha delivery trial will examine the effect of apoe genotype on the changes of cerebrospinal fluid (csf) dha to arachidonic acid (aa) ratio in 184 cognitively healthy older individuals in response to dha supplementation. randomized clinical trials have yielded mixed results on the effect dha supplementation on cognitive outcomes. this study asks the critical question of whether dha gets into the brain in sufficient amounts after supplementation, and whether apoe genotype affects brain penetrance. this trial will also test the effect of dha supplementation on changes in brain structural and functional connectivity assessed by mri, and changes in cognition after two years of supplementation in all 368 participants.

Eligibility criteria:
inclusion criteria: * age: ≥ 55 and ≤ 80 * at least one dementia risk factor (obesity, education years, hypertension, hyperlipidemia) * mini-mental state examination (mmse) ≥ 25 * logical memory ii delayed recall score ≥ 6 and ≤ 18 . exclusion criteria: * diagnosis of dementia as assessed by the investigator * use of omega-3 preparations in the last 3 months * \> 200 mg/day of dha consumption using a validated questionnaire * use of donepezil, rivastigmine, galantamine and/or memantine * alcohol or drug abuse * a concomitant serious disease such as active cancer treatment or hiv. * participation in a clinical trial in the last 30 days * use of anticoagulants such as plavix or coumadin or the newer generation blood thinners.

Keywords: alzheimer's disease docosahexaenoic acids apolipoprotein e4
the active by choice today (act) trial to increase physical activity

Conditions: Exercise; Physical Activity; Obesity

Summary: the increasing prevalence of obesity in u.s. children and adolescents is a major health threat to our society, especially among minority and low social economic status (ses) populations. during adolescence physical activity (pa) decreases and is likely an important contributor to the increasing trend in childhood obesity rates. little evidence suggests that school-based curriculum interventions lead to increases in overall pa. thus, this proposal will evaluate the efficacy of an innovative motivational and behavioral skills after-school program for promoting increases pa among underserved adolescents (e.g., minorities, low ses). the motivational plus behavioral skills intervention is consistent with self-determination (motivation) theory and social cognitive theory in that it emphasizes increasing intrinsic motivation and behavioral skills for pa. adolescents in the intervention take part in developing the program, selecting physical activities that generate fun and interest, and generating their own coping strategies for making effective pa changes during a videotaped session. preliminary data from our group demonstrates the feasibility of the motivational plus behavioral skills pa program for increasing moderate-to-vigorous pa (mvpa) in underserved adolescents in south carolina. the proposed project will use a school-based nested cohort design to evaluate efficacy of a 17-week motivational plus behavioral skills program versus typical after-school program (general health education only) on increasing pa in underserved adolescents. twenty-four middle schools (70 6th graders per school; n=1,680), located in south carolina will be randomly assigned to one of two after-school programs. the study employs a nested cohort design, with schools, rather than individuals assigned to condition and will be analyzed using repeated measures analysis of covariance techniques as outlined by murray. we will also examine psychosocial variables (pa self-efficacy, self-concept, motivation, social support, and enjoyment) as potential mediators of the intervention on changes in mvpa using regression and structural equation modeling techniques. this study will address an important public health problem that will have implications for decreasing obesity in underserved adolescents.


Eligibility criteria:
inclusion criteria: * parental consent * agree to random assignment * 6th grade student exclusion criteria: * medical condition that interfered with physical activity * developmentally delayed such that the intervention materials were not cognitively appropriate * currently in treatment for a psychiatric disorder

Keywords: exercise physical activity adolescent minority health
a clinical study to evaluate tv003 in healthy adults in taiwan

Conditions: Dengue

Summary: the goal of this study is to determine the immunogenicity and safety of tv003(tetravax-dv), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in taiwan


Eligibility criteria:
inclusion criteria: * adult male or female between 20 and 70 years of age * good general health as determined by physical examination, laboratory screening, and review of medical history * available for the duration of the study * willingness to sign the informed consent document * female of childbearing potential willing to use effective contraception for the duration of the trial exclusion criteria: * females currently pregnant, as determined by positive β- human choriogonadotropin (hcg) test, and/or breast-feeding. * evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies * behavioral, cognitive, or psychiatric disease * below lower limit of normal for absolute neutrophil count * any significant alcohol or drug abuse in the past 12 months * history of a severe allergic reaction or anaphylaxis * self-reported systemic hypersensitivity to any of the vaccine components * severe asthma * known hiv, hepatitis b or hepatitis c * any known immunodeficiency syndrome * use of anticoagulant medications * receive chronic administration of immunosuppressant drugs within 6 months prior to the administration of the study vaccine * use of any investigational product within 30 days before study vaccination or at any time during the study * asplenia * receive administration of immunoglobulins and/or any blood products within 12 months preceding the administration of the study vaccine or at any time during the study * fever or suspected fever within 72 hours prior to vaccination or tympanic temperature greater than 38°c on the day of vaccination * receive administration of any licensed live attenuated vaccines within 30 days preceding the administration of the study vaccine and ending 30 days after * receive administration of any licensed inactivated vaccines within 14 days preceding the administration of the study vaccine and ending 14 days after * any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol

Keywords: dengue vaccine
evaluation of structural and functional integrity of the rotator cuff after total shoulder arthroplasty

Conditions: Osteoarthritis of Shoulder

Summary: the purpose of this study is to examine the rotator cuff muscles in your shoulder at one and two year post total shoulder replacement surgery.


Eligibility criteria:
inclusion criteria: * age \>45yrs * primary diagnosis of osteoarthritis of the shoulder * total shoulder replacement performed by dr. armstrong * administered a local anesthetic mixture and not regional anesthesia * all genders * fluent in written and spoken english * patients capable of giving informed consent exclusion criteria: * known contraindications to ct/emg * inability to provide informed consent * history of recent trauma to the shoulder * atypical shoulder pain * other suspected shoulder pathology (i.e. tumor, infection) * pregnancy * bilateral total shoulder arthroplasty

Keywords: shoulder surgery arthritis rotator cuff
posttraumatic stress disorder in parents and children after discharge from the pediatric intensive care unit

Conditions: Posttraumatic Stress Disorder; Parents; Children, Only

Summary: background: if disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems. objectives: this study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (ptsd) in both children and parents. methods: the study was a cross-sectional study. a total of 110 children, 98 mothers and 80 fathers were included in the study.

background: if disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems. objectives: this study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (ptsd) in both children and parents. methods: the research was carried out in the intensive care unit of a children's hospital in turkey. children between the ages of 8-12 who had spent time in the picu over the period january 1 - march 1, 2019, who had been discharged from the picu or transferred into another unit during this time, and who met the research criteria were included in the study. between these dates, the total number of children discharged from intensive care or transferred into another unit was 166. of these children, 138 were between the ages of 8-12. during this period, three children who died, two children whose general condition meant they were unable to participate in the study, and 23 children for whom parental consent could not be obtained were excluded from the study. the study was ultimately completed with 110 children. in addition, the parents of the children in the sample group (98 mothers and 80 fathers) who were alive, reachable, and who agreed to participate were included in the study. results: a total of 110 children, 98 mothers and 80 fathers who agreed to participate in the study, met the sample selection criteria, and were available throughout were included in the study.

Eligibility criteria:
inclusion criteria: * the child was between 8-12 years old, * the child had an accompanying adult present, * the child was conscious and/or able to communicate verbally, * the child did not have any intellectual disability, * there were no challenges in communicating with the family and/or the child (i.e., they spoke turkish, were able to communicate), * the child's stay at the picu was no longer than 29 days, * the child and their family volunteered to participate in the study. exclusion criteria: * all participants who do not meet the inclusion criteria

Keywords: child, intensive care, parent, ptsd
renin and aldosterone levels in the preterm neonate at risk for hypertension

Conditions: Hypertension; Diabetes; Infants Small for Gestational Age

Summary: the purpose of this study is to find out if mothers with high blood pressure (hypertension) and/or diabetes have babies with high levels of different substances (that help to regulate blood pressure, called renin and aldosterone) in their blood. the investigators are also trying to determine if these babies have higher blood pressure than those babies born to mothers without high blood pressure or diabetes, during the first year of life. the investigators will measure your baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until your baby is discharged. the investigators will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the neonatal follow-up clinic or at a visit to our outpatient nephrology clinic, both at cheo.

we will compare two groups of babies born between 26+0 and 34+0 weeks gestation.group 1 is the babies born to mothers with diabetes and/or high blood pressure, and babies that are small for dates. group 2 are babies that are 26 to 34 weeks of age, that are born to mothers without these problems. in the study we will measure the baby's blood pressure once a day for the first 4 days, at 1 week of age, and then once per week until the baby is discharged. we will also measure the blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's follow-up appointment in the neonatal follow-up clinic or at a visit to our outpatient nephrology clinic, both at cheo. as blood tests will be done. a small amount of extra blood, 0.75ml - 1.5 ml (about 1/6 -1/3 of a teaspoon, or approximately 1 ml) will be collected for measurement of the blood substances we are studying will be collected when the baby has their regular non-study blood work. this will be done within six hours of birth and then again at 2-3 weeks of life.

Eligibility criteria:
inclusion criteria: 1. infants \< 6 hours of age who require nicu admission 2. infants 26+0 to 34+0 weeks gestation. exclusion criteria: * immediate exclusion from enrollment 1. maternal treatment with drugs known to be teratogenic and cause nephrotoxicity in the fetus (i.e. ace-inhibitor). 2. infants with known congenital anomalies and/or renal anomalies. 3. infants with known chromosomal anomalies. 4. infants with severe asphyxia defined as cord ph \< 7.0, 5 min apgar \< 3, and urine positive for blood. 5. infants with a known or suspected blood loss at birth (ie: uterine rupture, placental abruption, bleeding placenta previa, or post-natal blood loss in the delivery room). 6. infants who will not receive follow-up care in ottawa upon discharge from the nicu (ie: live out of town).

Keywords: renin aldosterone neonate
a phase i/ii study of continuous oral treatment with bibf 1120 added to standard gemcitabine/cisplatin therapy in first line nsclc patients with squamous cell histology.

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the lume-lung3 study is in 2 parts: run-in phase i - open label study to identify the maximum tolerated dose of bibf 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin. phase ii - placebo controlled efficacy study of bibf 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least stable disease after 2 previous courses of the chemotherapy


Eligibility criteria:
inclusion criteria: run-in phase i 1. histologically or cytologically confirmed diagnosis of stage iiib/iv or recurrent non small cell lung cancer (nsclc) with squamous cell histology. 2. measurable disease according to response evaluation criteria in solid tumours ( recist 1.1). 3. patient eastern cooperative oncology group (ecog) score of 0-1. 4. male or female patients age = 18 years. 5. life expectancy of at least three (3) months. 6. written informed consent in accordance with international conference on harmonisation - good clinical practice (ich-gcp) guidelines. phase ii - in addition to the above criteria: 7. radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy. exclusion criteria: 1. prior therapy for advanced or metastatic or recurrent non small cell lung cancer (nsclc). one prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization 2. prior treatment with other vascular endothelial growth factor receptor (vegfr) inhibitors (other than bevacizumab) 3. any contraindications for treatment with gemcitabine and/or cisplatin. 4. use of any investigational drug within 4 weeks of entering the 1199.82 study. 5. history of major thrombotic or clinically relevant bleeding event in the past 6 months. 6. significant cardiovascular diseases (i.e. hypertension not controlled by medication. 7. surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing. 8. active brain metastases 9. radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis \< 4 weeks prior baseline imaging. 10. any other current malignancy or malignancy diagnosed within the past five (5) years.