Kornimate/medical-research-clean huggingface dataset:
safety and performance of agilik in cp

Conditions: Cerebral Palsy

Summary: the purpose of this post market study is to demonstrate the safety and performance of a powered extension assist (ea) knee ankle foot orthosis (kafo), or ea-kafo, in individuals with knee extension deficiency due to cerebral palsy (cp). the ea-kafo tested in this investigation, whose commercial name is agilik™, is registered as a class 1 medical device in the european (eu) medical device regulation (mdr) and with the united states (us) food and drugs administration (fda). the study will take place in astrolab at the istituto scientifico e. medea - la nostra famiglia (irccs medea hereafter). the duration of the investigation will be 36 months. the duration of the study for a single subject will be approximately 10 weeks. the primary purpose of this study is to demonstrate the safety and performance of a powered extension assist knee ankle foot orthosis (agilik) in individuals with knee extension deficiency due to cerebral palsy. the focus is on the improvement of anti-gravity knee extension during stance in patients with cp with crouch gait. therefore, the primary aim is to compare the knee and range of motion (rom) at baseline and after 10 sessions of agilik training while wearing agilik itself. secondary aim is to compare knee rom before and after the training with agilik without wearing agilik. the changes in lower extremity functions, kinematics and muscle activity during walking with agilik compared to baseline conditions will be examined. furthermore, the performance of agilik during uphill and downhill walking over the grail platform will be investigated. hypotheses when using agilik: * improve knee extension during stance and swing gait phases * increase step length, walking distance and speed


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form. * stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination. * age between 5 and 17 * maximum weight of 70 kg * volunteer who have a gait pathology involving the knee joint, from a diagnosis of cp * knee flexion retraction assessed in supine position by less than 10°. hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study. * subjects must not have had a tibio-tarsal arthrodesis. in addition, they must have at least 10° of passive dorsi-flexion of the ankle. * able to walk at least 3 m without stopping with or without a walking aid. * able to understand and follow simple directions based on parent report and physician observation during history and physical examination. * gmfcs level i, ii and iii * mas score ≤ 2 exclusion criteria: * any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy that would affect the ability to walk as directed for short periods of time. * a history of uncontrolled seizure in the past year * severe spasticity
ticagrelor in clopidogrel resistant patients undergoing chronic hemodialysis

Conditions: Platelet Reactivity

Summary: clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. it has also been shown that in patients with chronic kidney disease (creatinine clearance \<60 ml/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. clopidogrel resistant patients as assessed by verifynow p2y12(accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. platelet reactivity will be determined at the end of the treatment period. bleeding events, major adverse cardiac events and any side effects until day 15 will be reported in a descriptive manner.


Eligibility criteria:
inclusion criteria: * age≥18 years * chronic renal failure under haemodialysis * platelet reactivity under clopidogrel 75mgx1 ≥235 pru * informed written consent exclusion criteria: * recent (within 1 month) pci or acs * requirement for oral anticoagulant prior to the day 14 visit * plts\ 52% at randomization * increased risk of bradycardiac events. * severe uncontrolled chronic obstructive pulmonary disease * known severe hepatic impairment * history of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months. * other bleeding diathesis, or considered by investigator to be at high risk for bleeding * concomitant therapy with a strong cytochrome p-450 3a inhibitor or inducer * recent (\<6weeks)major surgery including cabg * recent (\<6weeks)stroke or any prior intracranial bleeding

Keywords: ticagrelor platelet reactivity clopidogrel haemodialysis
clinical evaluation and assesment of ginigivitis patients treated by yarrow natural extract in compare to a contro group

Conditions: Gingivitis

Summary: a double-blind, prospective, randomized, intra-individual comparative, single-center clinical study was conducted. participants were placed in parallel groups, and the study was performed in the department of operative dentistry and periodontology, dental school and hospital, minia university to compare the antibacterial activity of yarrow moringa herbal combinations nanoparticles in compared to chlorhexidine as a potential treatment for gingivitis.


Eligibility criteria:
inclusion criteria: * a minimum of four natural uncrowned teeth in one quadrant present * good general health * can follow instructions exclusion criteria: * were pregnant or breastfeeding * evidence of antibiotic use during the 4 weeks prior to the study * were allergic to personal care/consumer products or their ingredients
comparison of catheterized and clean catch urine specimens for protein/creatinine ratio in preeclampsia evaluation

Conditions: Preeclampsia; Proteinuria; Hypertension; Pregnancy

Summary: the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. the gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. however, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. at our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. however, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. thus, the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Eligibility criteria:
inclusion criteria: * pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia exclusion criteria: * ruptured membranes * any vaginal bleeding or spotting * pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine * patients who have previously been enrolled in the study

Keywords: protein/creatinine ratio clean catch urine catheterized urine
large simple trial (lst) of cardiovascular safety of ziprasidone and olanzapine- (zodiac)

Conditions: Schizophrenia

Summary: the primary objective of the study is to estimate the relative incidence among users of ziprasidone and olanzapine of non-suicide mortality.


Eligibility criteria:
inclusion criteria: * patients newly treated for schizophrenia and those receiving continuing treatment will be eligible if the treating psychiatrist is ready to initiate a new antipsychotic medication, and would consider using either ziprasidone or olanzapine as an appropriate therapy. * male and female patients who meet all criteria listed below are eligible to be enrolled in this study: * diagnosed with schizophrenia * willing to provide information on at least one alternate contact person for study staff to contact regarding patient's whereabouts, should the patient be lost-to-follow-up over the course of the study exclusion criteria: * progressive fatal disease of a life expectancy which prohibits them from participating in a one year research study * previously randomized to study medication and enrolled in this study
a safety study of a monoclonal antibody against a5b1 integrin in solid tumors

Conditions: Advanced Non-Hematologic Malignancies

Summary: dose finding study of the moab pf-04605412 directed against the alpha5beta1 integrin. main objective is to define the mtd (maximum tolerated dose) or mad (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy * eastern cooperative oncology group (ecog) performance status 0 and 1 * life expectancy more than12 weeks * adequate bone marrow, liver and renal function exclusion criteria: * known brain metastasis * chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures * major surgical procedure within 4 weeks of start of screening procedures * active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months

Keywords: neoplasms monoclonal antibody pf-04605412 advanced metastatic solid tumors
evaluation of two strategies for debriefing in the development of skills for neonatal resuscitation

Conditions: Asphyxia Neonatorum; Birth Injuries; Cardiopulmonary Resuscitation

Summary: introduction: training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation. objective: to evaluate two debriefing strategies for the development of neonatal resuscitation skills in professionals specialized in critical newborn care. materials and methods: a simple blind randomized clinical trial was conducted. twenty-four professionals (pediatricians, nurses, and respiratory therapists) were randomly assigned for two interventions; one group received oral debriefing and the other oral debriefing assisted by video. three standardized clinical scenarios that were recorded on video were executed. a checklist was applied for the evaluation, administered by a reviewer blinded to the assignment of the type of debriefing. null hypothesis: the improved in the skills of neonatal resuscitation is the same for both strategies of debriefing. alternative hypothesis: the improved in the skills of neonatal resuscitation is different for both strategies of debriefing


Eligibility criteria:
inclusion criteria: * the specialized health professionals (professional nurses, respiratory therapists, and pediatricians) in charge of newborn care that working in the neonatal unit areas, maternity wards, surgery rooms responsible for the care of caesarean sections, and those of pediatric emergencies of university hospital of la sabana exclusion criteria: * none

Keywords: debriefing
triage of patients with acute ischemic stroke due to large vessel occlusions-1 (track-lvo-1)

Conditions: Stroke, Acute Ischemic; Endovascular Procedures; Large Vessel Occlusion

Summary: the aim of this study is to establish an academic, real-world, single-center, observational registry of consecutive patients hospitalized with acute ischemic stroke (ais) due to large vessel occlusions (lvo), treated with either endovascular therapy (evt) or best medical management (bmm).

stroke is a major threat to public health and is exacerbating socioeconomic development. it is the leading cause of mortality among residents in china. large vessel occlusion (lvo) is a predictor of unfavorable outcomes and can account for up to 52% of patients with acute ischemic stroke (ais). the definition of lvo and its optimal screening imaging modalities remain controversial. in this registry, the investigators defined lvo as an occlusion of the intracranial ica with or without the involvement of the terminal bifurcation, m1 and/or m2 segment of the mca, a1 and/or a2 segment of the aca, va, ba, or p1 and/or p2 segment of the pca. track-lvo is an academic, real-world, single-center, observational registry, in which consecutive patients hospitalized with ais due to lvo will be treated with either evt or bmm. baseline information and clinical follow-up information at 90 days from stroke onset are collected. the key baseline items in this registration for both evt and bmm groups include basic demographic profiles, past medical history, nihss score, treatment with intravenous alteplase, type of stroke onset, time from stroke onset to admission/imaging, imaging characteristics such as the volume of the ischemic core and occlusion site, and treatment-related complications. additional information collected in evt groups includes details of evt procedure and angiographic images. the investigators enrolled patients with lvo screened under different imaging modalities to further reveal the optimal imaging modalities in the detection of lvo. the investigators also tend to compare the prognosis of ais patients with lvo receiving endovascular therapy and the best medical management respectively.

Eligibility criteria:
inclusion criteria: 1. patient admitted from jan. 1st, 2018 to june. 1st, 2021; 2. age ≥ 18; 3. ischemic stroke confirmed by head ct or mri; 4. large vessel occlusion confirmed by head cta or mra: intracranial internal carotid artery (ica), middle cerebral artery (mca m1/m2), anterior cerebral artery (aca a1/a2), basilar artery (ba), vertebral artery (va), and posterior cerebral artery (pca p1/p2); 5. patients receiving either endovascular therapy or best medical treatment; exclusion criteria: -

Keywords: acute ischemic stroke endovascular therapy large vessel occlusion
predictive blood tests for severe radiation reactions in breast cancer patients

Conditions: Abnormalities, Radiation-Induced

Summary: some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. the goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

three tubes of blood will be drawn from each subject. two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. if the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Eligibility criteria:
inclusion criteria: * breast cancer treatment: lumpectomy followed by external beam xrt to breast * age at the time of radiotherapy treatment: 45-65 years old * xrt dose to breast: \>/= 4500 and \</= 5200 cgy, fraction size 180 or 200 cgy * dose distribution: no area receiving \>/= 112% of prescribed dose * follow-ups: patients must be \>/= 2.5 years post-treatment exclusion criteria: * reconstructive surgery to involved breast

Keywords: breast cancer radiation effects
aranesp® monthly preference study - 2

Conditions: Kidney Disease

Summary: the purpose of this study was to evaluate subject preference for aranesp® administered once monthly (i.e., every 4 weeks (q4w)) or procrit® administered once weekly (qw).


Eligibility criteria:
inclusion criteria: - subjects must have signed written informed consent - be on procrit® qw or q2w for a minimum of 8 weeks - must currently be on a stable dose of procrit® (defined as less than 25% change in procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - have hgb 10-12 g/dl for at least 4 weeks prior to study start - have 15 less than gfr less than 89 ml/min/1.73 m2 exclusion criteria: - currently receiving investigational erythropoietic agents - self-injecting at home with procrit® - expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - have less than 1 year life expectancy

Keywords: kidney disease, renal, ckd (chronic kidney disease) cri (chronic renal insufficiency), pre-dialysis, amgen aranesp®, darbepoetin alfa, qw dosing q2w dosing, q4w dosing patient preference, subject preference
the effect of the timing of colloid and crystalloid infusions on postspinal hypotension after spinal anesthesia for caesarian section

Conditions: Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Summary: prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. the comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.

to prevent hypotension fluid replacement is usually used in pregnant patients scheduled for c/s. different types of fluids can be used in order to achieve this. also the timing of fluid replacement is important. in the present study patients were separated into 4 groups. each receiving a one of two fluids in different times. ( colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) the effect of overall hemodynamics and the incidence of hypotension are evaluated. also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.

Eligibility criteria:
inclusion criteria: * pregnant 37-41 weeks * one fetus * scheduled for c/s under spinal anesthesia * accepting to participate exclusion criteria: * emergency surgery * placenta previa * preeclampsia * cardiovascular and cerebrovascular comorbidities * morbid obesity (bmi\>40) * pregnancy weeks \ 41 * the use of vasoconstrictors * severe anemia ( hb \<9 g/dl) * refusal or known contraindication for spinal anesthesia
cognitive and memory function in patients with fibromyalgia

Conditions: Fibromyalgia; Cognitive Impairment

Summary: patients suffering from fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests. their results will be compared to those with active ra associated with pain and with a normal control group.


Eligibility criteria:
inclusion criteria: * patients suffering from fibromyalgia patients suffering from active ra exclusion criteria: * patients with depressive disorders patients treated with ssri

Keywords: memory disturbances
an expanded access study of bemarituzumab (fpa144) for a single patient with recurrent bladder cancer

Conditions: Recurrent Bladder Cancer

Summary: this is an open-label, expanded access protocol to continue administration of bemarituzumab (fpa144) in a single patient with recurrent bladder cancer

this protocol is intended to provide access to bemarituzumab (fpa144 an investigational agent) to a single patient with recurrent bladder cancer who had a response to study drug on fpa144-001. that study is closing and this expanded access protocol allows this single patient to continue receiving this agent.

Eligibility criteria:
inclusion criteria: 1. understand and sign an institutional review board-approved informed consent form prior to receiving bemarituzumab 2. previously enrolled on the fpa144-001 study, received bemarituzumab and obtained clinical benefit from the investigational product (ip) administration exclusion criteria: 1. pregnancy and lactation

Keywords: single patient
phase iii randomized, double-blind, placebo-controlled study of antenatal thyrotropin-releasing hormone in pregnant women with threatened premature delivery

Conditions: Respiratory Distress Syndrome

Summary: objectives: i. evaluate the effect of thyrotropin-releasing hormone (trh) on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery. ii. evaluate possible mechanisms for the effects of trh on the severity and incidence of chronic lung disease. iii. investigate whether a deficiency in endogenous cortisol and/or thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease.

protocol outline: this is a randomized, double-blind study. participants are stratified by participating institution. participants are randomly assigned to 1 of 2 treatment groups. the first group is treated with intravenous thyrotropin-releasing hormone (trh) and intramuscular injections of betamethasone or dexamethasone. the second group receives a placebo in place of trh. postnatal therapy with surfactants, prophylactic steroids, and indomethacin is allowed.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- threatened premature delivery at 24 to 30 weeks gestation, i.e.: premature labor premature rupture of membranes elective premature delivery medically indicated fetal lung maturity immature or unknown --prior/concurrent therapy-- no more than 72 hours since any initial corticosteroids --patient characteristics-- the following complications exclude: fetal distress amnionitis severe maternal bleeding uncontrolled with transfusion or volume replacement fetal or maternal heart disease significant fetal blood loss maternal blood pressure 140/90 mm hg or higher with or without treatment maternal hyperthyroidism maternal hyperprolactinemic condition significant fetal anomaly multiple gestation with demise of 1 or more fetuses nonimmune hydrops no participation in other clinical research projects

Keywords: cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome