Kornimate/medical-research-clean huggingface dataset:
preserved umbilical vein use as autologous shunt conduits in neonatal cardiac surgery

Conditions: Congenital Heart Defects

Summary: this is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. subjects will be identified here at the advanced fetal care center (afcc) following diagnosis of congenital heart disease (chd) with single ventricle physiology of the fetus via fetal echocardiogram. at time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated stage i palliative procedure between day 3 and 7 of life. subjects will be followed until their stage ii palliative procedure.


Eligibility criteria:
inclusion criteria: * all fetal diagnoses of complex congenital heart disease diagnosed by fetal echocardiogram requiring cardiac repair with blalock-taussig shunt or right ventricle to pulmonary artery conduit will be eligible. * this includes all pre-natal diagnoses of any single ventricle circulation physiology (svp). * subjects being delivered via cesarean section or vaginally at brigham and women's hospital will be considered. exclusion criteria: * meconium at delivery * symptomatic group b streptococcus (gbs) positive mothers * mothers with chorioamnionitis * hepatitis b or c positive mothers * hiv positive mothers. * if unable to collect viable cord on the day of delivery of already enrolled subjects, the subject will be removed from the study on day of birth.
femoral neck system and multiple cannulated screws in femoral neck fracture

Conditions: Femoral Neck Fractures

Summary: investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

clinical outcomes include reoperation, loss of fixation, and change of mobility.

Eligibility criteria:
inclusion criteria: * 18 years and older * non-displaced femoral neck fracture * community ambulator exclusion criteria: * younger than 18 years * displaced femoral neck fracture * intertrochanteric fracture * subtrochanteric fracture

Keywords: femoral neck fractures
cd22/cd19 car-t and blinatumomab combined with auto-hsct sandwich strategy as consolidation therapy for b-all

Conditions: Acute Lymphobkastic Leukemia

Summary: chimeric antigen receptor t-cell (car-t) therapy has achieved remarkable efficacy in b-cell acute lymphoblastic leukemia (b-all). however, relapse after car-t has been a major issue. multi-antigen car t and combination with other regimens may reduce the relapse rate. we conducted cd22/cd19 car t-cells and blinatumoab combined with auto-hsct "sandwich " strategy as consolidation therapy in patients with b-all. the main purpose of this study was to observe the safety and efficacy of this new strategy.


Eligibility criteria:
inclusion criteria: 1. subjects with a primary diagnosis of b-all who have any of the following: (a) no suitable allogeneic hsct donor. (b) refusal of allogeneic hsct; 2. positive expression of cd19 and cd22 in peripheral blood or bone marrow primary cells detected by flow cytometry; 3. cardiac ultrasound left ventricular ejection fraction ≥ 50%; creatinine ≤ 1.6 mg/dl; alanine transaminase (alt) and aspartate aminotransferase (ast) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; pulmonary function ≤ grade 1 dyspnea (ctcae v5.0) with oxygen saturation \> 91% without oxygenation; 4. subjects aged 15-65 years (including 15 and 65 years), regardless of gender; 5. t-cell amplification test pass; 6. expected survival \> 3 months. exclusion criteria: 1. patients with recurrence of only isolated extramedullary lesions; 2. combination of other malignant tumors; 3. previously treated with anti-cd19 or/and cd22 or/and cd3 therapies; 4. immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent; 5. uncontrolled active infections; 6. hiv infection; 7. active hepatitis b or hepatitis c infection; 8. history of severe tachyphylaxis to aminoglycoside antibiotics; 9. history or presence of clinically relevant central nervous system (cns) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
comparison of infection rates among patients using two catheter access devices

Conditions: Catheter-Related Infections; Bacteremia

Summary: intravenous catheters are placed in nearly every hospitalized patient. these catheters, since they are breaks in skin integrity, are potential sources of infection that occur in the bloodstream. bloodstream infections can result in higher rates of death and lengths of hospital stay, as well as increase healthcare costs. blood is drawn or medications delivered through a catheter access device attached to the catheter. in looking at new ways to decrease infections associated with healthcare, the investigators plan to test whether the use of a silver-coated catheter access device (vlink) compared to the standard, non-coated device (clearlink) can reduce infection rates. these devices are identical in design other than the silver coating of the vlink, that imparts a brown color to the device. silver can prevent the growth of bacteria inside the device (biofilm formation) in the laboratory, but this has never been proven in patients. the investigators propose to do a crossover study in two emory-owned hospitals (emory university hospital and emory university hospital at midtown), anticipated to last 10 months. currently, both types of devices, (standard and silver-coated) are fda approved for clinical use and are in use at both hospitals. the investigators plan to have each hospital use only one type of catheter access device for a period of time (approximately 5 months), and then switch ("crossover") to other type of device for the rest of the study. all patients admitted to either hospital (excluding newborns and patients with infections attributed to hemodialysis catheters) will be enrolled since both devices meet the standard of care. during the study, the infection prevention department, as a continuing part of their regular duties will measure infection rates. a small subset of catheters that are removed during routine clinical care (none will be taken out solely for the study) will be sent to cdc to determine the amount of bacteria inside catheters and catheter access devices (look for biofilm). finally, the microbiology lab, again as part of its routine function will determine the rate at which blood cultures are falsely positive. all of these measures will be compared using statistical methods to see if there is a difference between the standard and silver-coated catheter access devices. in undertaking this study, the investigators will be using a type of vascular access device (valve, not positive pressure) already in use in both hospitals and not changing the delivery of care to patients while, in a rigorous, systematic manner, obtaining samples and data for analysis.


Eligibility criteria:
inclusion criteria: * all adult patients admitted to the two participating hospitals. exclusion criteria: * catheter-associated infections attributed to hemodialysis catheters. * neonates and children. * known silver allergy or hypersensitivity.

Keywords: catheters, indwelling biofilms
prehabilitation for aortic aneurysm surgery: proof-of-concept trial

Conditions: Aortic Aneurysm

Summary: this is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the ready for recovery program, a 6-week collaborative care intervention to help prepare individuals for repair of aortic aneurysms.

this is a single-arm, proof-of-concept trial to examine the feasibility, acceptability, and preliminary efficacy of the ready for recovery program. ready for recovery is a 6-week collaborative care program to prepare individuals for surgical procedures to repair an aortic aneurysm. participants will speak with a study trainer on the phone each week and will set goals related to physical activity, a healthy diet, and inspiratory muscle training. they also will be given resources to reduce stress, treat anxiety and depression (if present), and stop smoking, and the study team will make recommendations regarding medication adjustments to reduce complications after surgery. the primary outcome is feasibility (measured by percentage of phone sessions completed). secondary outcomes include acceptability (measured by weekly 0-10 utility ratings) and preliminary impact on functional, psychological, and health behavior outcomes.

Eligibility criteria:
inclusion criteria: * adults undergoing elective aortic aneurysm repair (open or endovascular) exclusion criteria: * cognitive disturbance * current pregnancy or plan to become pregnant prior to surgery * inability to write/speak fluently in english

Keywords: aortic aneurysm prehabilitation collaborative care
single centre, double-blind, single and multiple ascending inhaled doses of azd9819 in healthy subjects

Conditions: Healthy Volunteers; Safety; Tolerability

Summary: the purpose of the study is to assess safety and tolerability of azd9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. * have a body mass index (bmi) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg exclusion criteria: * any clinically significant disease or disorder * any clinically significant abnormalities at screening examination * use of any prescribed or non-prescribed medication

Keywords: safety tolerability healthy inhalation
study of docetaxel and gemcitabine in metastatic esophageal squamous cell cancer

Conditions: Metastatic Carcinoma; Recurrent Esophageal Squamous Cell Carcinoma

Summary: gemcitabine is a novel analog of the nucleoside deoxycytidine that acts via inhibition of dna synthesis.docetaxel is a semisynthetic taxane and promotes microtubule assembly and inhibits microtubule depolymerization. in this study, patients received gemcitabine 900 mg/m2 on days 1 and 8 plus docetaxel 100 mg/m2 on day 8 with g-csf support every 3 week.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic, or recurrent esophageal squamous cell carcinoma * age \> 18 years * ecog performance status 0 - 2 * at least one measurable lesion(s) by recist 1.1 criteria * life expectancy ≥ 3 months * at least one cytotoxic chemotherapy regimen (adjuvant chemotherapy will be considered as one regimen if administered within 6 months from the date of study entry) (upto three prior regimens will be allowed) * prior radiotherapy must be completed 2 weeks before study entry. * adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl) * adequate renal function (≤ serum creatinine 1.5 mg/dl or ccr ≥ 50 ml/min) * adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ ast/alt x 3 upper normal limit) * written informed consent exclusion criteria: * evidence of serious gastrointestinal bleeding * serious pulmonary conditions/illness (e.g. chronic lung disease with hypoxemia) * serious metabolic disease such as severe non-compensated diabetes mellitus * history of significant neurologic or psychiatric disorders * serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease * pregnant or lactating woman
2balance: cognitive-motor dual-tasking in persons with vestibular disorders

Conditions: Vestibular Diseases

Summary: the overall aim of this study is to elucidate the impact of a vestibular dysfunction on the cognitive and motor performance by means of an extensive test protocol, evaluating the vestibular, cognitive and motor function using single as well as dual-task paradigms.

the test protocol consists of five cognitive tasks, all assessing a different cognitive domain: executive function, working memory, processing speed, and visuospatial abilities (mental rotation and visuospatial memory). these cognitive tasks will be performed separately (in single task condition, while seated), as well as while performing different motor tasks (in dual-task condition). these motor tasks will also be performed in single task condition (without performing the cognitive tasks). the study consists of the establishment of normative age-related data for the single as well as dual-task protocol in healthy adults, age ranging from 18 to 65 years old (objective 1). subsequently, the test protocol will be validated in persons with bilateral vestibulopathy (objective 2). finally, a cross-sectional study in persons with unilateral vestibular impairment will take place, and the results on the single as well as dual-task components will be compared to normative data, as well as to persons with bilateral vestibulopathy (objective 3).

Eligibility criteria:
for healthy controls: exclusion criteria: * vestibular disorders or subjective dizziness complains (past or present) * hearing loss * mild cognitive impairment (montreal cognitive assessment, moca) * visual impairment (snellen chart) * motor abnormalities (anamnestic questionnaire) for bilateral vestibulopathy (bv): inclusion criteria: * bilaterally reduced vestibular function, as defined by the bárány criteria for bv(michael strupp 2017): * the horizontal vestibulo-ocular reflex (vor) gain should be \<0.6 bilaterally and/or * the sum of the maximal peak velocities of caloric response for stimulation with warm and cold water should be \<6◦/s bilaterally and/or * the horizontal angular vor gain should be \<0.1 upon sinusoidal stimulation on the rotation test for unilateral vestibulopathy: inclusion criteria: * the horizontal vor gain should be \<0.6 unilaterally and/or * the slow component velocity of the caloric response should be below the age-dependent normative data unilaterally, established by maes et al. (2010)

Keywords: cognition motor performance dual-task
total hip replacement study of gsk576428 (fondaparinux sodium)

Conditions: Thrombosis, Venous

Summary: this study is requested by pmda to confirm the optimal dose for thr (total hip replacement).


Eligibility criteria:
inclusion criteria: * patients undergoing either an elective primary thr (total hip replacement) surgery or a revision of a thr. exclusion criteria: * active, clinically significant bleeding (excluding drainage).

Keywords: fondaparinux hip replacement arthroplasty vte thr mosll pentasaccharide xa factor
toxoplasma gondii seroprevalence among children with some neuropsychiatric disorders

Conditions: Toxoplasmosis in Neuropsychiatric Disorders

Summary: toxoplasma gondii is recognized as being involved in the etiology of various psychotic disorders including epilepsy and adhd (markovitz et al.,2015). there are many explanations for such associations between toxoplasmosis and neurological disorders which include many anatomical and neurotransmitter-related changes. toxoplasmosis may cause alterations in neurotransmitter levels like serotonin, noradrenaline, glutamate, nitric oxide and gamma aminobutyric acid, increase in the levels of proinflammatory cytokines and modulate the dopaminergic signaling (babaie et al., 2017). the behavioral changes produced by the cyst formation in the brain tissue may also related to the localization of the cyst within specific parts of the brain and this is assumed to be one of the main causes of epilepsy in toxoplasmosis. moreover, tachyzoites may invade the brain tissues and excite brain cells especially neurons, microglia and astrocytes. additionally, the presence of toxoplasma in brain evokes inflammatory response and stimulate immune system to produce antibodies with increase in proinflammatory cytokines. interestingly, some studies described that many host genes and proteins could be affected by toxoplasma, signifying its involvement in many genetic disorders including neuropsychiatric diseases.the current study aimed to assess the seroprevalence of anti-toxoplasma igm and igg antibodies among children with some neuropsychiatric disorders (epilepsy and adhd) in sohag governorate, egypt.


Eligibility criteria:
inclusion criteria: children with neuropsychiatric disorders (epilepsy,adhd). exclusion criteria: children with history of neurosurgery, head injury or trauma, neoplastic or autoimmune diseases, or receiving immunosuppressant or systemic corticosteroid, and those with possible neurological infection.
effectiveness of ear acupuncture to improve insomnia in women with breast cancer

Conditions: Breast Neoplasm

Summary: the aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. it will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved. in addition, a proinflammatory cytokine will be meassured.


Eligibility criteria:
inclusion criteria: * histological diagnosed non-metastatic breast cas (tnm stage i-iii) * existing insomnia (difficulty falling asleep or sleeping through on at least 3 days per week for at least 3 months) according to the diagnostic criteria of the diagnostic and statistical manual of mental disorders (dsm 5). * willingness to participate in the study (at least 8 out of 10 treatments) * signed informed consent exclusion criteria: * ongoing or planned chemotherapy, radiation, follow-up treatment or reconstructive plastic surgery during the study period * severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study * pregnancy * participation in other clinical trials with behavioural, psychological or complementary medical interventions during the study period * regular use of barbiturates, antidepressants or other sleep-inducing drugs, drug abusus, alcoholism

Keywords: sleep initiation and maintenance disorders acupuncture, ear cytokines breast neoplasm
identification and assessment of risk factors for the development of osteoporosis in adults and children living in the abay region of the republic of kazakhstan using the method of dual-energy x-ray absorptiometry and clinical and epidemiological research

Conditions: Improving the Early Diagnosis of Osteoporosis in Adults and Children Living in the Abay Region of Kazakhstan

Summary: a survey of people to identify risk factors for osteoporosis, which include age, gender, lifestyle, diet, physical activity, the presence or absence of somatic pathology. diagnosis of osteoporosis by dual-energy x-ray absorptiometry. conducting a correlation analysis of the relationship of the data obtained.

successful diagnosis of osteoporosis is possible with the complex use of clinical, laboratory and radiological methods. in the complex of diagnostic methods, a special place has given to dual-energy x-ray absorptiometry, which is the "gold standard". the research area contains the following tasks: risk factors for the development of osteoporosis will be identified and quantified in the formed study groups of adults; to determine the diagnostic value of the risk factors for the development of osteoporosis obtained during the examination. to assess the state of bmd in adults using x-ray absorptiometry (dxa) to carry out a correlation analysis of the relationship between the obtained data in adults of the abay region of of the republic of kazakhstan

Eligibility criteria:
inclusion criteria: adults and children without a history of pathological fractures and congenital pathology of the musculoskeletal system. - exclusion criteria: adults and children with congenital pathology of the musculoskeletal system -

Keywords: osteoporosis, dual-energy x-ray absorptiometry, bone mineral density, risk factors
risperidone and olanzapine for the schizophrenic patients with neuroleptic-induced tardive dyskinesia

Conditions: Neuroleptic-Induced Tardive Dyskinesia

Summary: we initiate a study with research grant from department of health and taoyuan mental hospital and choose risperidone and olanzapine as study medications. we compare the effects of these 2 drugs in schizophrenic spectrum patients of han ethnics with neuroleptic-induced tardive dyskinesia to test the hypothesis that these two medications have different effects in improving tardive dyskinesia.

objective: first generation antipsychotics would induce tardive dyskinesia in some schizophrenic patients. second generation antipsychotics were the choices for these patients. but which one of second generation antipsychotic was the better choice did not have definitive results. we compared risperidone and olanzapine in schizophrenic patients with neuroleptic-induced tardive dyskinesia to see their effects in improving tardive dyskinesia. we also collected the data of average dose of risperidone and olanzapine to help the dosing strategy guidelines for the schizophrenic patients with neuroleptic-induced tardive dyskinesia. method: this randomized, rater-blind, parallel group, flexible dose study enrolled patients from taoyuan mental hospital from july 2000 to december 2003. schizophrenia, schizophreniform or schizoaffective disorder (dsm-iv) patients who met the research criteria of neuroleptic-induced tardive dyskinesia research criteria of dsm-iv and no less than moderate severity (\> or =4) of global impression of extrapyramidal syndrome rating scale (esrs). 60 patients were random assignment to risperidone or olanzapine for 24 weeks. the primary outcome was to compare the change of total scores of abnormal involuntary movement scale from baseline to study endpoint.

Eligibility criteria:
inclusion criteria: * age of 18-70 y/o * female patients did not have pregnancy plans and must agree to use reliable pregnancy prevention methods if during childbearing age * meet schizophrenia, schizophreniform or schizoaffective disorder criteria of dsm-iv * fulfill dsm-iv neuroleptic-induced tardive dyskinesia research criteria, the severity of tardive dyskinesia was no less than moderate degree (\> or =4) assessed by global impression of extrapyramidal system rating scale (item 42 of esrs) * patients or legal responsible people agree to join study and sign informed consent exclusion criteria: * had other axis i diagnosis of dsm-iv * unstable major systemic diseases * had neurological disorder influenced to eps assessment * substance abuse or dependence other then coffee or tobacco within 6 months before study

Keywords: risperidone olanzapine tardive dyskinesia
falling in patients with copd referred to pulmonary rehabilitation: incidence, risk factors and prediction tools

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary aim of this study is to investigate the incidence of falling in a cohort of patients with chronic obstructive pulmonary disease (copd) referred to a pulmonary rehabilitation program and to verify the risk factors. the secondary aim is to verify whether available balance assessment tools are feasible in clinical practice and which tools and values can best predict falls in people with copd.


Eligibility criteria:
inclusion criteria: * patients with a primary diagnosis of copd according to internationally accepted guidelines * all patients referred to the outpatient pr program of gasthuisberg university hospital (leuven, belgium). exclusion criteria: * none

Keywords: pulmonary rehabilitation balance assessment chronic obstructive pulmonary disease