Kornimate/medical-research-clean huggingface dataset:
postoperative pain management in hospital and following discharge from hospital.

Conditions: Arthropathy of Knee Joint

Summary: to investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.

we hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. a total of 200 patients undergoing total knee surgery will be enrolled in this observational study. they will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing total knee arthroplasty exclusion criteria: * patients attending rehabilitation facilities after discharge * unwilling or unable to provide consent

Keywords: total knee arthroplasty
mars: magnetic resonance study: a novel assessment of placental function

Conditions: Placenta Diseases

Summary: the objective of this study is to evaluate functional mri as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). the investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.

in this study, we propose to utilize two novel and innovative non-invasive tools to measure placental oxygenation and lipid and nutrient transport in vivo in women who are obese (ob), have pregestational diabetes (dm) or have neither (controls). to evaluate differences in placental oxygenation, we propose to use blood oxygen level depending (bold) imaging, a method of functional magnetic resonance imaging, to measure tissue oxygenation in the placenta during the third trimester of pregnancy. to evaluate placental lipid and nutrient content, we propose to utilize magnetic resonance spectroscopy (mrs), a novel and powerful tool to compare lipid and nutrient transport across the placenta among ob, dm and controls. to confirm in vivo bold and mrs findings, we will extensively evaluate the placental lipid content and lipid transport capability. fatty acid transport protein-4 (fatp-4), one of 6 fatp proteins, is important for placental lipid accumulation, especially lc-pufa21-24. docosahexaenoic acid (dha) is a crucial lc-pufa for neurogenesis in early development18. major facilitator super family domain containing mfsd2a is a lysophospholipid transporter required for dha uptake in the brain and has been linked to placental dha transfer. lipid content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the most abundant structural protein on the surface of lipid droplets of adipocytes. we hypothesize that altered placental function including diminished placental oxygenation and abnormal placental transport of lipids and other metabolites will be seen in ob and dm women as compared to controls. we further hypothesize that ex vivo placental pathologic, histologic and immunohistochemistry characteristics will be associated with in vivo findings. our findings from this pilot study have the potential to serve as the basis of a larger study to further evaluate the potential impact of bold and mrs technology on our understanding of placental lipid and oxygen transport among women with obesity and pregestational diabetes as compared to women without these conditions.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * planned cesarean section exclusion criteria: * non-english speaking * fetal anomalies * gestational diabetes mellitus
a survey to evaluate diabetes management, control, chronic complications, psychosocial aspects of diabetic subjects in bangladesh

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this observational study is to evaluate current status of diabetes management, control, complications in diabetic subjects in asia.


Eligibility criteria:
inclusion criteria: * diabetic patients registered in the particular centre for more than 12 months. * patients should have visited the centre at least once in the last 3-6 months apart from the initial visit. * patients willing to sign informed consent form. exclusion criteria: * repetition of any patient as patients should not be included twice for any reason. * unwilling to participate or unable to comply with protocol requirements.
is there an ideal dose of intravenous fentanyl in the prehospital setting

Conditions: Acute Pain

Summary: in a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (ci 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain \[numeric rating scale (nrs, 0-10) \> 3\] at hospital arrival. the number of patients with possible fentanyl-related side effects was low. therefore, the aim of the present study is to explore the efficacy and safety of a liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport). the investigators hypothesize that: * a higher proportion of patients will experience sufficient pain relief at hospital admission (nrs \< 4) using the liberalized protocol and * there will be no differences in the proportion of potential fentanyl related side-effects are observed.

a prospective cluster-randomized trial observing proportional differences in sufficient pain relief at hospital admission (nrs \< 4) and potential fentanyl related side-effects between patients treated by ambulance personnel applying either: * a more liberal treatment approach (a total of 3 μg/kg per transport) or * existing treatment approach (a total of 2 μg/kg per transport). the ambulance stations and their affiliated ambulance personnel are stratified into 5 clusters according to size/average transports per month and randomized to either liberal or existing treatment approach within each cluster. as patients are not randomized on an individual level baseline differences between the two groups and its patients are adjusted statistically with relevant confounders on 3 overall levels: 1. patients: charlson comorbidity index score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality). 2. ambulance personnel: years of experience and preinterventional cumulative fentanyl administration and 3. ambulance stations and geographical factors: prehospital time measures and geographical distance from site of emergency to hospital. these covariates are obtained from the danish national patient registry, the danish civil registration system and the electronic prehospital patient journal.

Eligibility criteria:
inclusion criteria: * patients with acute pain treated with intravenous fentanyl by ambulance personnel exclusion criteria: * reduced conscious level (gcs \< 15) before initiation of fentanyl treatment * reduced respiratory rate (\< 10/minute) before initiation of fentanyl treatment * patient weight \< 30 kg * known opioid allergy * women in labour * chronic pain conditions

Keywords: emergency medical services analgesics
admixture mapping of ethnic and racial insulin complex outcomes

Conditions: Healthy

Summary: the main objective of this study is to investigate the effect of genetic and environmental parameters on racial/ethnic differences in aspects of insulin secretion and action. the genetic component will be modeled by estimating the degree of european genetic admixture (adm) obtained from approximately 50 ancestry informative markers (aims). the environmental components will be modeled by measuring energy intake (food intake), energy expenditure (physical activity) and socioeconomic status.


Eligibility criteria:
inclusion criteria: * african american, european american, or hispanic american, aged 7-12, healthy, weight is equal to or greater than 25 kg exclusion criteria: * type 1 or 2 diabetes, polycystic ovary disease, disturbances in glucose or lipid metabolism disturbances * use of medication known to affect body composition or physical activity, diagnosis of genetic disorders known to affect body composition or fat distribution * use of tobacco, alcohol consumption in excess of 400 g per week * menstruated for more than a year prior to the recruitment; or * a medical history that counter-indicates inclusion of the study

Keywords: race/ethnicity insulin senistivity genetic admixture type 2 diabetes obesity body composition insulin dynamics racial/ethnic differences
maternal anxiety related to how the pediatrician provided prenatal information about preterm birth

Conditions: Preterm Birth

Summary: women hospitalized for preterm labor require clear information about prematurity. this study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. this was a prospective, single-center observational study.women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information + a booklet about prematurity given to the women at admission. the primary endpoint was the change in anxiety-state (before and after the information procedure) evaluated by the state trait anxiety inventory-y (stai-y).

women hospitalized for preterm labor require clear information about prematurity. this study assessed whether or not specific written information about prematurity delivered at admission to the unit combined with an oral explanation from a pediatrician would decrease women's anxiety compared to an oral explanation alone. material and methods.this was a prospective, single-center observational study.women were included in the high-risk pregnancies department and distributed into two groups: receiving ''only oral'' information for a prenatal clinical consultation with a senior pediatrician or receiving ''combined'' oral information + a booklet about prematurity given to the women at admission.

Eligibility criteria:
inclusion criteria: * patients hospitalized in the service of pregnancies and having a risk of premature delivery. * term \<34 sa exclusion criteria: * term ≥ 34 sa * no understanding of the questionnaire * foetus presenting a pathology or malformation that is life-threatening * patient presenting a risk of delivery before passing the pediatrician or presenting a risk of imminent delivery * patient hospitalized without risk of premature delivery.

Keywords: maternal anxiety
nutritional screening in older individuals

Conditions: Malnourished

Summary: hospital-based case management programs and home hospitalization services following the risk stratification model of kaiser permanente and kings fund select an estimated 5% of older individuals living in the community who are at high risk of hospitalization and adverse outcomes. the objective of these services is to avoid deterioration and hospital admissions or visits to the emergency services by regular follow-up, proactive home visits and support of self-care . the prevalence of malnutrition in patients selected using this model of care is unknown.

the aim of this study was to estimate the prevalence of malnutrition, using the mna, in this high-risk community living population, and to explore risk factors that could identify subgroups of individuals at higher risk. this study was performed in individuals included in a case management (cm) program lead by the telemedicine unit of a tertiary university hospital in valencia. patients admitted to the hospital with two or more hospital admissions for medical reasons in the previous year are detected by a computerized system and included in the program, an integrated care intervention developed for patients with complex multimorbidity using patient-centred education activities and integrated care interventions, with the support of a hospital at home unit (hhu). telephone follow-ups by case manager nurses are focused on identifying problems and detecting disease exacerbations. the main aim of this program is to avoid hospital admissions and reduce the number of visits to emergency services

Eligibility criteria:
inclusion criteria: * patients included at case management program for complex chronic condition * must be able to answer questions on the telephone exclusion criteria: * subjects with no telephone, * subjects unable to determine their usual weight * end-of-life clinical situation

Keywords: nutritional screening mna-sf malnutrition case management
safety and tolerability of regeneron anti-sars-cov-2 monoclonal antibody/ies in adult healthy volunteers as related to covid-19

Conditions: Healthy

Summary: the primary objective of the study is to evaluate the safety and tolerability of regn15160 in healthy participants, as measured by all treatment-emergent adverse events (teaes) and treatment-emergent serious adverse events (saes). the secondary objectives of the study are: * to assess the concentration-time profile of regn15160 in serum * to assess the immunogenicity of regn15160


Eligibility criteria:
key inclusion criteria: 1. has a sars-cov-2 negative test result from a sample collected ≤72 hours prior to randomization using a local reverse transcription polymerase chain reaction (rt-pcr) test or other molecular diagnostic assay and sample collection following assay standards 2. has received complete primary series of standard-of-care covid-19 vaccination per local guidance, completed at least 2 weeks prior to screening 3. has a body mass index (bmi) between 18 and 31 kg/m2 (inclusive) at the screening visit 4. is judged by the investigator to be in good health based on medical history, as defined in the protocol 5. is in good health based on laboratory safety testing obtained at the screening visit key exclusion criteria: 1. history of clinically significant disease and any concern, as defined in the protocol and as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation 2. was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit 3. has history of alcohol or drug abuse as determined by the investigator 4. has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food 5. use of any prescription and non-prescription medications or nutritional supplements within approximately 5 half-lives or 2 weeks, whichever is longer, prior to first administration of the study drug through the end of the study, except for the permitted medications listed 6. participated in any clinical research study evaluating another investigational drug including biologics or therapy, including specific immunotherapy, within at least 5 half-lives or 90 days (whichever is longer) of an investigational biologic drug, or at least 4 weeks for small molecules or other investigational drugs, prior to the screening visit 7. is a pregnant or breastfeeding woman 8. is a woman of childbearing potential (wocbp)1 who is unwilling to practice highly effective contraception (as defined in the protocol) prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after study drug administration note: other protocol defined inclusion / exclusion criteria apply

Keywords: vaccinated negative sars-cov2 test result
person-centered assessment and monitoring systems

Conditions: Autism Spectrum Disorder

Summary: the proposed study will include an analysis of data for residents of pennsylvania who are age 21 and older, have a diagnosis of autism spectrum disorder (asd), and are enrolled in the commonwealth's adult community autism program (acap). the individuals enrolled in the program will be administered a standardized assessment battery quarterly for two years. the proposed study will analyze the data gathered during each of the assessment periods in order to aid in service/treatment planning, assess for individual improvements, and ultimately measure treatment outcomes.

the proposed study seeks to more closely monitor the changing needs and challenges of adults with asd, which will be facilitated through a battery of assessments given over quarterly time points in a two year time period. investigators seek to address whether increased frequency of behaviorally driven assessments will inform treatment. more specifically, investigators are interested in knowing if the assessment data influences treatment planning with providers or if it is guiding any decisions about treatment once data is returned to participants in a meaningful way which is easily understood. if data prompts treatment changes, the study will examine whether improvements are being shown months or even years later. an "elected reporter", a family member, is asked to take part in the research study with the participant. an elected reporter is asked to complete several questionnaires quarterly, both reporting on themself and the participant.

Eligibility criteria:
inclusion criteria: * enrolled in pennsylvania's adult community autism program (acap), \> 18 years of age * english as primary language spoken * ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) * have an elected reporter exclusion criteria: -inability to provide consent
addition of anlotinib hydrochloride to the stupp regimen versus the stupp regimen alone for newly diagnosed glioblastoma

Conditions: Glioblastoma

Summary: for patients with glioblastoma,postoperative radiotherapy combined with concurrent and adjuvant temozolomide (stupp regimen) has long been considered a standard treatment approach.the treatment outcomes, however, are still dismal, with a median overall survival time of 8-12 months. as a novel small molecule multi-target tyrosine kinase inhibitor, anlotinib hydrochloride has been found to be able to inhibit both tumor angiogenesis and cell growth.previous studies on recurrent glioblastoma have demonstrated its effectiveness in tumor control with manageable toxicities. the current study is designed to evaluate the efficacy and feasibility of the additional anlotinib hydrochloride to the stupp regimen for newly diagnosed glioblastoma.


Eligibility criteria:
inclusion criteria: * newly diagnosed and histological proven glioblastoma * complete gross resection or subtotal resection * eastern cooperative oncology group (ecog) performance status of 0-2 * adequate bone marrow, liver and renal function * written informed consent exclusion criteria: * meningeal carcinomatosis or spinal compression * patients who have previously received chemotherapy, targeted therapy, or anti-angiogenesis * active, known, or suspected autoimmune disease * severe allergy to anlotinib or temozolomide * patient having acute hepatitis virus infection, active tuberculosis, or other acute infectious diseases * uncontrolled mental disorders * high risk of bleeding * severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade ii, poorly controlled arrhythmias (including men with qtc interval ≥ 450 ms, women ≥ 470 ms), according to nyha criteria; grades iii to iv insufficient function, or cardiac color doppler ultrasound examination indicates left ventricular ejection fraction (lvef) \<50% * contraindicated for mri examination * recipient of live vaccine prior to the first dose of anlotinib * ready for or previously received organ transplantation

Keywords: glioblastoma anlotinib hydrochloride stupp regimen temozolomide radiation therapy tyrosine kinase inhibitor
asian study on cilostazol effectivity in neuropathies of diabetes mellitus type 2-a pilot study in the philippines

Conditions: Polyneuropathy

Summary: to describe if there are differences in the subjective, objective and electrophysiologic parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and twelve (12) weeks after cilostazol therapy.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. male and female ages 18 to 70 years old. to be able to eliminate type i diabetes mellitus among the younger subjects, we will only recruit patients who are stable on oral hypoglycemic agent. 3. established diagnosis of diabetes mellitus type 2 (national diabetes data group) who are currently on good control of the diabetic state. 4. presence of predominantly distal symmetrical sensory polyneuropathy of the lower limbs as assessed by nss, nis and ncs. exclusion criteria: 1. current use of potentially neuropathic agents (isoniazid, phenytoin, dapsone, metronidazole, vinca alkaloids, etc.) within the past 1 month; 2. presence of severe metabolic disease (renal failure, hepatic failure, etc.), alcoholism and malignancy; 3. presence of hemorrhagic tendencies; 4. patients who are diagnosed to be of type 1 diabetes mellitus; 5. pregnant and lactating patients, including those who plan to have pregnancy within the study period. 6. concomitant intake of agents currently used to treat neuropathic pain like gabapentin, carbamazepine/ oxcarbazepine, anti-depressants (tricyclic anti-depressants and ssris) and topical capsaicin. 7. concomitant intake of other anti-platelet agents, rheologic agents and anticoagulants. 8. have received cilostazol therapy within the past three (3) months

Keywords: symmetric diabetic polyneuropathy