Kornimate/medical-research-clean huggingface dataset:
open-label study comparing etanercept to conventional disease modifying antirheumatic drug (dmard) therapy

Conditions: Rheumatoid Arthritis

Summary: the purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional disease modifying antirheumatic drug (dmard) therapy in latin american subjects with moderate to severe rheumatoid arthritis over 128 weeks. phase 1 is a randomized 24 week treatment period; phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase i treatment or the addition, discontinuation or titration of other dmard therapy already being utilized for the study.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) * currently receiving a suboptimal response to a stable dose of methotrexate for treatment of rheumatoid arthritis (ra) * active rheumatoid arthritis (ra) at time of screening and baseline exclusion criteria: * previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents * concurrent treatment with a disease modifying antirheumatic drug (dmard), other than methotrexate, at screening * receipt of any disease modifying antirheumatic drug (dmard), other than methotrexate, within 3 months before screening

Keywords: enbrel moderate arthritis severe arthritis rheumatoid arthritis
a multi-site evaluation of the pain relief, support, fit and comfort from use of a custom knee or ankle brace in persons suffering from chronic ankle or knee pain and instability

Conditions: Joint Instability

Summary: this study will look to examine the overall performance of a custom fit knee or ankle brace as a means of providing ankle or knee joint support in subjects that have determined the need for bracing based upon chronic joint instability and/or joint swelling and pain following daily activity.


Eligibility criteria:
inclusion criteria: * subjects must indicate that they currently have weakened ankles or knees and that they experience chronic discomfort after performing daily activities. * subjects must suffer from pain assessed on a 100 mm (10 cm) visual analog scale (vas) of ≥20 mm to ≤ 90 mm for subjects with either unstable ankle or unstable knee, at visit 1 and 2. * subjects must be able to walk unaided by cane or walker. * subjects must not have a noticeable limp or other permanent ailment that interferes with normal gait. * subjects free of other types of health problems that, in the opinion of the investigator, could influence their ability to participate. * if subjects are taking pain medication (prescription or over-the-counter (otc)) for a chronic condition, they may continue that medication as long as they have been on a stable dose for at least 2 months, and agree to continue their regular dose and regimen for the duration of the study. * subjects must be willing to undergo a 1-week period without a brace and then willing to wear a brace for a 1-week period, that is: 8 ±2 hours a day for a minimum of 5 out of 7 days. exclusion criteria: * subjects with an ankle or knee pain and instability which is due to a recent sprains, strains, or other non-reversible injury to the knee or ankle. * subjects who have diabetes, circulatory problems, open wounds, and lack of sensation in the ankles, knees, or feet or any problems that would make brace wear uncomfortable or inappropriate. * subjects who wear a physician-prescribed orthotic device, prescription shoes or back braces. * subjects who are undergoing traction or manipulative back adjustments or have had a traumatic injury to the lower extremity (deemed of non-overuse nature), which in the opinion of the examining investigator would interfere with the study evaluations. * subjects whose condition requires surgery or other medical intervention or who have undergone foot back or knee surgery within the past 3 months or with any planned surgeries and/or invasive medical procedures during the course of the study. * subjects who are currently taking an opioid based pain medication or have taken such medication within 2 months prior to visit 1. * subjects who are taking any chronic pain medication (prescription or otc) for at least 2 months, who do not agree to continue taking it at the same dose and regimen throughout the study. * subjects who have severely painful bunions, warts, corns and/or calluses, severely overlapping toes or lesions on the bottom of their foot. * subjects who have sensitivities or allergies to plastics or adhesives.

Keywords: pain ankle knee brace
clinical and radiographic outcomes of tlif w/3d printed cellular implant

Conditions: Foraminal Stenosis; Degenerative Disc Disease; Lumbar Spondylolisthesis; Lumbar Spinal Stenosis

Summary: this study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the conduit 3d printed titanium tlif cage.

this prospective, single-center study is being conducted as a post market evaluation of the conduit 3d printed titanium tlif cage. patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.

Eligibility criteria:
inclusion criteria: * skeletally mature adults ages 35 - 80 years of age, inclusive * diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis * subject undergoing one or two level transforaminal lumbar interbody fusion * able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires exclusion criteria: * patients over 80 years of age * patients under 35 years of age * current smokers * bmi\>42 * subject has spondylolisthesis \> 2 * subjects with multilevel \>2 levels of symptomatic disease * subjects with significant spinal deformity * subject is pregnant, plans to become pregnant or is breast feeding

Keywords: transforaminal degenerative disc disease (ddd) lumbar fusion interbody fusion
the impact of chewing food on stroke patients

Conditions: Stroke

Summary: the goal of this clinical trial is to explore the effect of chewing food on quality of life and nutritional status in ischemic stroke patients. patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. on this basis, the interventional group will receive chewing food training before each feeding for 10 min. researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if chewing food can improve the quality of life and nutritional status in ischemic stroke patients.

the study will last 15 days for each participant. the goal of this clinical trial is to explore the effect of chewing food on quality of life and nutritional status in ischemic stroke patients. patients will be randomly divided into an interventional group and a control group, all receiving routine rehabilitation treatment and enteral nutrition feeding. on this basis, the interventional group will receive chewing food training before each feeding for 10 min. researchers will compare changes in quality of life, and nutritional status of two groups of patients before and after the study to see if chewing food can improve the quality of life and nutritional status in ischemic stroke patients.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for ischemic stroke . * dysphagia confirmed by videofluoroscopic swallowing study. * clear consciousness. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.
mri (including spectroscopy and fat-saturations and diffusion-weighted imaging) in cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: to detect differences in mr spectroscopy, diffusion weighted mr, diffusion tensor imaging (dti) or dynamic contrast enhancement (dce) mr imaging between primary cervical tumors and normal cervical tissue.

at our institution, all patients receiving external beam and/or brachytherapy as part of the treatment of primary cervical cancer receive ct, pet, and mri simulation scans as standard of care. brachytherapy patients also receive weekly t1/t2 weighted mr simulation scans as part of their treatment planning. we propose the use of additional mr sequences to the standard t1/t2 weighted mr simulation scans. the data obtained from these additional sequences will be used for improving tumor delineation and obtaining prognostic information.

Eligibility criteria:
inclusion criteria: * patients must have biopsy-proven newly diagnosed squamous cell cervical cancer (figo clinical stages ib2-iva). * patients must be ≥ 18 years of age. * patients must be able to receive standard radiation therapy (external beam radiation and brachytherapy) with or without chemotherapy. * patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least one year. * patients must be scheduled to undergo or have already undergone fdg-pet/ct imaging for clinical staging cervical cancer at barnes-jewish hospital clinical pet facility on the siemens biograph 40 true point tomograph scanner or elsewhere in the wusm nuclear medicine department using the quality controls instituted by nuclear medicine. * patients must be able to give informed consent. exclusion criteria: * patients with another known active malignancy. * patients who have received treatment for any malignancy (with the exception of non-melanoma skin cancer) in the past 5 years. * pregnant or breastfeeding patients. * patients whose tumors are not fdg avid on baseline standard of care fdg-pet/ct imaging. * patients with contraindications to mri scanning.

Keywords: squamous cell cervical cancer
nis-observe treatment efficacy in maintaining symptoms control in moderate/severe asthma with symbicort smart

Conditions: Moderate/Severe Asthma

Summary: the primary objective of this non-interventional study is to evaluate efficacy of symbicort® smart treatment in adult patients with moderate to severe asthma using acq scores during 6 months period


Eligibility criteria:
inclusion criteria: * patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with symbicort smart within the last month, before inclusion in this program * all eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme. exclusion criteria: * all the patients who have a known hypersensitivity to symbicort or any of its excipients will not be included in this study. * as per valid romanian smpc, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

Keywords: asthma
exploration of allograft humoral rejection in chronic histiocytic intervillositis

Conditions: Chronic Histiocytic Intervillositis; Intrauterine Growth Retardation; Fetal Death in Utero; Miscarriage

Summary: chronic histiocytic intervillositis (chi) is a rare condition with an incidence of 5 in 10,000 pregnancies. this rare condition is associated with placental inflammatory lesions leading to severe and recurrent obstetrical complications: intrauterine growth retardation (iugr), fetal death in utero and miscarriage. the pathophysiological mechanisms of chi are poorly understood, while the empirical treatments prescribed to prevent recurrence are cumbersome and of poor efficacy. recent findings suggest that an alloimmune response may play a role. in a recent work, the investigators have demonstrated the role of maternal alloantibodies directed against fetal hla antigens in two patients followed for recurrent iugr associated with chi. their work suggests that a humoral alloimmune response directed against fetal hla antigens mimics an allograft rejection process. the investigators propose to extend the preliminary results obtained in these patients to provide new insights into the pathophysiological mechanisms of chi, and eventually to predict the risks of fetal loss.


Eligibility criteria:
family inclusion criteria: * mother and father ≥ 18 years old * for mothers in the chi group : * history of a normal pregnancy (full term, alive child) or iugr/mfiu or miscarriage(s) or abortion followed by at least 1 obstetrical complication such as iugr, mfiu, miscarriage * diagnosis of chronic histiocytic intervillitis made by placental anatomopathological examination with cd68+ marking * for the mothers of the antiphospholipid syndrom group * history of miscarriage(s) * having an anti-phospholipid syndrome * for mothers in the normal pregnancy group: * third consecutive pregnancy of normal course, at term (≥ 36 weeks of amenorrhea) with eutrophic child for the mother and father: o consent to participate in the study and for the participation in the study of at least one child and/or the use of existing samples (placenta / fetal dna) from at least one previous pregnancy with chi for the chi group or at least one previous miscarriage for the aps group for the father: o father of the last pregnancy and of the child(ren) participating in the study exlusion criteria : * for mothers in the normal pregnancy group: o suspected or confirmed intra-amniotic infection * for all the mothers: * history of blood transfusion * history of allogeneic organ transplantation * for the mother and the father: * person under legal protection (guardianship, curatorship)
effectiveness of supplemental calcium in preventing postpartum depression

Conditions: Depression; Depression, Postpartum

Summary: this study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.

postpartum depression is a combination of physical, emotional, and behavioral changes that occur after childbirth. the rapid drop in estrogen and progesterone levels, as well as the social and psychological changes resulting from the birth of a child, can often trigger depression in women. common symptoms include crying, irritability, fatigue, loss of appetite, and feelings of guilt and anxiety. women who develop postpartum depression often feel unable to care for their baby or themselves. postpartum depression is common; it is estimated that about 10 percent of new mothers experience some symptoms of depression following delivery. risk factors include a personal or family history of depression and a history of suffering from premenstrual dysphoric disorder (pmdd), a severe form of premenstrual syndrome (pms). the purpose of this study is to evaluate the effectiveness of calcium supplements taken during pregnancy in reducing the likelihood of postpartum depression in women at risk for developing this condition. pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant. all recruited women will undergo psychological testing for screening purposes. women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study. all participants will then be randomly assigned to receive either a calcium supplement (2 grams) or placebo on a daily basis. treatments will continue throughout the remainder of each woman's pregnancy and for 12 weeks after she gives birth. outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels. if any participant exhibits significant depressive symptoms, she will be referred for psychiatric treatment. all measurements will be assessed at weeks 26, 32 and 38 of the pregnancy, and 6 and 12 weeks after giving birth.

Eligibility criteria:
inclusion criteria: * less than 26 weeks pregnant * at risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (pmdd) exclusion criteria: * currently depressed * currently taking medications for depression, bipolar disorder, or schizophrenia * history of medication treatment for depression within 3 months of study entry * any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease * currently taking a diuretic or calcium channel blocker * does not speak english

Keywords: calcium pregnancy postpartum depression depression
initial test of the time to talk cardio (creating a real dialogue in the office) program

Conditions: Cardiovascular Disease; Cardiovascular Risk Factors

Summary: this research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. the goal is to help improve communication about heart health issues. this pilot (or beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. the investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals. participants in this research study are being recruited from the people who currently receive care at the richmond family health center of the oregon health \& science university. people who participate in this study will be between 55 and 70 years old, speak english as their preferred language, and have one of several possible diagnoses related to heart health. these could include, for example, hypertension, diabetes, asthma, or obesity. additionally, the investigators are recruiting a small number of health care professionals from the richmond family health center. their participation will be similar to but separate from the participation of patients. all participants will take two web-based surveys. some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients. the surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients. data analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.


Eligibility criteria:
inclusion criteria: * age 55-70 years * english is preferred language * has one or more chronic cardiovascular-related diagnosis or risk factor * has an appointment with primary care provider within 2 weeks of enrollment exclusion criteria: * inadequate vision or hearing to complete on-line assessment

Keywords: health communication health literacy patient health care professional satisfaction
study of medical student use of templates to document outpatient asthma care in electronic medical record

Conditions: Disease

Summary: the purpose of the study is to measure the effectiveness of a social marketing-based medical education intervention on student use of evidence-based templates for documenting outpatient asthma care within an electronic medical record.

the purpose of the study was to measure the effectiveness of a physician-educator led clinical documentation workshop, embedded with 7 persuasive social-marketing based messages, on medical student response using a targeted asthma template. stated differently, whether a physician-educator could "persuade" medical students to use an evidence-based emr asthma template to document an outpatient mild persistent asthma encounter with a patient.

Eligibility criteria:
inclusion criteria: * third year medical student completing family medicine clerkship uniformed services university exclusion criteria: * all students other than those listed above

Keywords: electronic medical records documentation templates clinical encounter notes
anti-vegf in real-world

Conditions: Neovascular Age-related Macular Edema; Diabetic Macular Edema; Choroidal Neovascular Membrane; Non-proliferative Diabetic Retinopathy; Retinal Vein Occlusion; Proliferative Diabetic Retinopathy

Summary: anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. according to fda and china food and drug administration, ranibizumab, aflibercept, and conbercept are major types of anti-vascular endothelial growth factor therapy drugs. in the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. according to fda and china food and drug administration, ranibizumab, aflibercept, and conbercept are major types of anti-vegf drugs. in the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.

Eligibility criteria:
inclusion criteria: * patients with neovascular age-related macular edema (namd), diabetic macula edema (dme)/non-proliferative diabetic retinopathy (npdr)/ proliferative diabetic retinopathy (pdr), retinal vein occlusions related macular edema, and choroidal neovascular (cnv) secondary to multiple retinal diseases. * undergo intravitreal anti-vegf therapy exclusion criteria: * unable to receive oct examination * severe corneal opacity, cataract that affect oct examination