Kornimate/medical-research-clean huggingface dataset:
wedged insoles for management of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: knee osteoarthritis (oa) is commonly treated using laterally wedged insoles. although these insoles typically reduce knee abduction moments (kam) - a variable associated with knee osteoarthritis - and thus are believed to be beneficial for oa management, recent research has indicated that in some cases lateral wedge insoles actually increase knee joint loads. in such cases, a medial wedge may be more appropriate. the purpose of this study is to evaluate the influence of reduced kams on pain over 3-months for patients with knee oa. it is hypothesized that pain reduction will be directly related to kam reduction. forty-six participants with knee oa will be recruited to participate. each will undergo biomechanical gait analysis to determine the wedge type that most greatly reduces knee adduction moments. in addition, each participant will undergo a dual energy x-ray absorptiometry (dxa) scan to quantify adiposity. finally, participants will complete a series of questionnaires to evaluate pain, function, physical activity, footwear comfort and injury history. participants will be randomized into either a wait list control group (no insole) or experimental group (medial or lateral wedged insole), and monitored for 3 months. changes to pain, function, comfort and physical activity from baseline to 3 months will be assessed within the control and experimental groups. regression analyses will be conducted on the experimental group to determine if a relationship exists between reduced kams and reduced pain over 3 months. comparisons will also be made between the control and experimental groups.


Eligibility criteria:
inclusion criteria: * physician-diagnosed knee osteoarthritis (using american college of rheumatology clinical and radiographic criteria) * kellgren-lawrence grade 1, 2, 3 or 4 * primary symptoms and disease location must be attributed to medial tibiofemoral compartment * koos pain of 75 points or lower (where 0 is worst pain and 100 is no pain) exclusion criteria: * x-ray older than 2 years * viscosupplementation within past 6 months * cortisone injection in past 3 months * narcotic pain medication within past 3 months * use of knee unloading brace interventions in past 2 months * recent (past 6 months) knee or neuromuscular injury that could bias pain assessments or gait analysis results * no kam reduction with either lateral or medial wedge insole

Keywords: osteoarthritis cartilage musculoskeletal biomechanics subtype footwear orthotics joint loading
cranial electrotherapy stimulation in burned patients

Conditions: Post Traumatic Stress Disorders; Burns

Summary: to find out if cranial electrotherapy stimulation is a useful treatment for people who have been burned and have post traumatic stress disorder. ces may be helpful in giving relief to some or all of those symptoms.

the purpose of this research study is to systematically determine if ces therapy is effective in managing post traumatic stress disorder (ptsd) in the burn patient. cranial electrotherapy stimulation (ces) is the delivery of low-level electrical stimulation across the head, delivered with ear lobe electrode clips or self-adhesive electrode pads. ces in the current form has been used for the past 30 years to successfully treat anxiety, depression, insomnia and pain in a variety of patient populations. this fda approved medical device is non-invasive and has no reported significant side effects. it will be used on patients undergoing outpatient rehabilitation in our burn center.

Eligibility criteria:
inclusion criteria: * burned patients requiring outpatient physical or occupational therapy in the usaisr burn rehabilitation gym or center for the intrepid * able to read and speak english * between ages of 18-65 years * screen positive (score greater than 44) on the pcl-m/c instruments exclusion criteria: * pregnant patients * patients with implantable pacemakers or electronic stimulators * patients scoring below 44 on the pcl-m/c instrument * patients who previously used ces therapy

Keywords: anxiety insomnia pain alpha stim cranial electrotherapy stimulation
review of molecular profiling-real time polymerase chain reaction (rt-pcr) in unknown primary cancer

Conditions: Unknown Primary Cancer

Summary: this will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available rt-pcr assays performed on biopsied tumors, in order to determine if the assay results are consistent with clinical features and useful for planning initial therapy or changing therapy.


Eligibility criteria:
inclusion criteria: * patients with rt-pcr testing completed since commercialization of the rt-pcr assay in 2007.

Keywords: rt-pcr molecular profiling assay molecular profiling-real time polymerase chain reaction unknown primary upc cup
lactobacillus reuteri dsm 17938 in the prevention of antibiotic-associated diarrhea in children: protocol of a randomized controlled trial

Conditions: Diarrhea; Antibiotic Associated Diarrhea

Summary: the aim of this study is to assess the effect of lactobacillus reuteri dsm 17938 administration for the prevention of diarrhea and aad in children.

introduction: addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (aad). effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. we aim to assess the effect of lactobacillus reuteri dsm 17938 administration for the prevention of diarrhea and aad in children. methods and analysis: a total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive l reuteri dsm 17938 at a dose 2 x 10\^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. the primary outcome measures will be the frequency of diarrhea and aad. diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. aad will be diagnosed in cases of diarrhea, defined clinically as above, caused by c. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).

Eligibility criteria:
inclusion criteria: * age younger than 18 years; * oral or intravenous antibiotic therapy which started within 24 hours of enrollment; * signed informed consent. exclusion criteria: * pre-existing acute or chronic diarrhea, * history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency, * use of probiotics within 2 weeks prior to enrollment, * use of antibiotics within 4 weeks prior to enrollment, * prematurity, and exclusive breastfeeding.
investigating significant health trends in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: idiopathic pulmonary fibrosis (ipf), a manifestation of chronic progressive fibrosing interstitial pneumonia,ia a rare disease. current treatment options are limited, and the mean survival time of the newly diagnosed (mostly elderly) patients is only about 2-3 years. as in europe data are limited on the characteristics and management of such patients, insights-ipf was initiated as a new registry that documents newly diagnosed (incident) and prevalent patients with confirmed ipf diagnosis prospectively.the registry will contribute to the optimization of the management of ipf patients in the long term.

insights-ipf will report current and comprehensive data on idiopathic pulmonary fibrosis (ipf) in the long-term. baseline (cross-sectional part): description of characteristics of ipf patients in terms of * key (socio-) demographic data * ipf risk factors, comorbidities * methods used for ipf diagnosis * ipf disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values, biomarkers) * ipf treatment (detailed information on prescribed drugs and doses; non-pharmacological treatment; listing and score for lung transplantation) * assessment of patient-related outcomes (pro) such as quality of life follow-up (prospectively up to at least 2 years after inclusion): * clinical course of ipf (e.g. in terms of symptoms, lung function, exercise capacity if available) * documentation of treatment pathways (switch/add-on/discontinuation of medication), and of non-pharmacological treatment (e.g. start of long term oxygen therapy; new listing for lung transplantation)outcomes/events (such as acute respiratory worsening, exacerbations, hospitalisation due to any cause and due to ipf, other complications, survival) * patient-related outcomes such as quality of life, assessed once a year(for comparison with baseline) * resource use for pharmacoeconomic analyses.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * written informed consent for participation in the registry * newly diagnosed (incident) or known (prevalent) ipf (based on diagnosis of treating physician) exclusion criteria: * none

Keywords: drug treatment treatment pathways clinical routine registry outcomes survival patient-related outcomes quality of life steroids azathioprine n-acetylcysteine pirfenidone tyrosine kinase inhibitors nintedanib multicenter germany safety adverse event
clinical translation of a novel brain pet insert for simultaneous pet/mr

Conditions: Brain Disease

Summary: the primary goal of this project is to study the feasibility of a brain-dedicated pet insert for an mr scanner for simultaneous acquisition of pet/mr images of human brains. the study will also allow us to compare the imaging performance of the investigator's brain-dedicated pet insert against a commercial whole-body permanently integrated pet/mri system using a common radiopharmaceutical.

this study will enroll up to 40 participants. 1. 20 participants at stanford injected with an fda-approved pet tracer (e.g. amyloid, fdg, etc.), and 2. 20 participants from stanford who have been pre-injected with a radiopharmaceutical for a study on another pet imaging system

Eligibility criteria:
inclusion criteria: 1. whole body radiation dose within the last year of less than 5000 mrem 2. subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mci of either fdg or neuraceq radiotracer. both tracers are fda approved 3. subjects will be at least 21 years of age 4. subject provides written informed consent 5. subject is deemed healthy by the pi by via self-reported questionnaire exclusion criteria: 1. for patients who will be receiving a tracer injection, no known allergy to the imaging agents 2. participant has a history of or current diagnosis of cancer 3. participant is pregnant or nursing 4. metallic implants (contraindicated for mri)
study to evaluate menses induction in women administered proellex

Conditions: Amenorrhea

Summary: the purpose of this study is to determine the oral dose level at which the investigative drug, proellex, is able induce menstruation.

the purpose of this study is to determine the oral dose level at which the investigative drug, proellex, is able to suppress endogenous progesterone in women. it is believed that giving proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally

Eligibility criteria:
inclusion criteria: * clinical laboratory tests within normal ranges * a normal menstrual period of 26-30 days * desiring not to become pregnant * agreeing to use a double barrier method of birth control for the duration of the trial exclusion criteria: * post-menopausal status * aamenorrhea or dysfunctional uterine bleeding * subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile * subjects with a body mass index (bmi) below 18 or over 39

Keywords: menstruation
anemia and surgery: indications for transfusion

Conditions: Blood Disease; Anemia

Summary: to estimate the risk of death for patients with different pre- and post-operative hemoglobin levels who do not receive blood transfusions and to derive a multivariate model using clinical information available pre-operatively that would predict the risk of death post-operatively.

background: the aids epidemic has focused considerable attention on the risks associated with blood transfusions. perhaps of more importance, hemolytic transfusion reactions and post-transfusion non-a non-b hepatitis continue to be significant concerns. however, guidelines for blood transfusions in the surgical patient vary considerably in the medical literature. some recent texts stress the need to consider factors such as patient's age, surgical procedure, co-morbid illness, predicted blood loss, and cause of the anemia, as well as the hemoglobin level. nonetheless, in practice many surgeons still adhere to the 10g/dl threshold for transfusion. the lack of consensus guidelines can probably be attributed to the dearth of studies exploring the indications for transfusion. the few studies which have examined this question are limited because they fail to analyze subsets of patients by age, co-morbid illness, or blood loss. the need to develop peri-operative transfusion guidelines based on multivariate analysis, therefore decreasing the frequency of unnecessary transfusions resulting from the common use of a hemoglobin threshold, is especially important in light of the hazards and costs associated with blood transfusions. jehovah's witnesses were chosen as the study population because they decline blood transfusion for religious reasons. design narrative: the retrospective case-control study explored the possible associations between peri-operative anemia and post-operative mortality status. cases were defined as those who died within 30 days of the operative procedure and controls as all those who survived. there were approximately eight controls per case. participating surgeons who operated on jehovah's witness patients within the preceeding five years provide a list of patients. charts of patients were reviewed to determine if any died within 30 days of surgery. if the patient was discharged prior to 30 days postoperatively, then the national death index was used to assess the patient's status 30 days after surgery. the incidence of post-operative death, with 95 percent confidence levels, was calculated for strata of pre- and post-operative hemoglobin levels and operative blood loss. the death rate was calculated after stratifying the patients based on status with regard to co-morbid diseases or other possible risk factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
evaluation of a fracture liaison service in the osteoporosis care

Conditions: Osteoporotic Fractures

Summary: the st joseph's hospital set up a fracture liaison service for osteopotic fracture. a specific nurse screens eligible patient admitted in emergency yard and call them to propose a bone densitometry and a medical coverage.. the aim of the study is to evaluate this new organisation


Eligibility criteria:
inclusion criteria: * age between 45 and 95 years old. * admitted in emergency yard for law energy trauma exclusion criteria: * feet fracture * fracture on prothesis * patient transferred elsewhere * homeless people * patient with lot of comorbidities
a novel pathway to detect muscle-invasive bladder cancer based on integrated clinical features and vi-rads score on mri

Conditions: Muscle Invasive Bladder Cancer

Summary: this study investigates the clinical, pathological, and radiological features, including the vesical imaging-reporting and data system (vi-rads) score, that correlate with muscle-invasive bladder cancer (mibc). it found that vi-rads scores, along with other factors, were independent predictors of muscle invasiveness.

the purpose of this study was to determine the clinical, pathological, and radiological features, including the vesical imaging-reporting and data system (vi-rads) score, independently correlating with muscle-invasive bladder cancer (bca), in a multicentric national setting. patients with bca suspicion were offered magnetic resonance imaging (mri) before trans-urethral resection of bladder tumor (turbt). according to vi-rads, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (mibc). trans-urethral resection of the tumor (turbt) and/or cystectomy reports will be compared with preoperative vi-rads scores to assess accuracy of mri for discriminating between non-muscle-invasive versus mibc. performance will be assessed by roc curve analysis. two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and vi-rads categories to determine the variables with an independent effect on mibc.

Eligibility criteria:
inclusion criteria: * a primary diagnosis of bladder tumor, * positive urinary cytology, * suspected bladder neoplasm identifed by ultrasound of the urinary tract and/or cystoscopy and/or ct scan of the abdomen-pelvis. exclusion criteria: * history of prior urinary tract neoplasms, * impossibility of achieving appropriate bladder distension, * concomitant diagnosis of carcinoma in situ (cis), * no detectable lesion on mri * any contraindication to mri (low renal function, mr unsafe medical devices etc.) * any contraindication to spinal and general anesthesia.

Keywords: magnetic resonance imaging vi-rads muscle-invasive bladder cancer hematuria pathway
extended venous thromboembolism prophylaxis comparing rivaroxaban to aspirin following total hip and knee arthroplasty

Conditions: Venous Thromboembolism

Summary: in this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.


Eligibility criteria:
inclusion criteria: 1. all patients undergoing elective total hip or knee arthroplasty at the participating institutions will be potentially eligible for this study exclusion criteria: 1. hip or lower limb fracture in the previous three months 2. metastatic cancer 3. life expectancy less than 6 months 4. history of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis 5. history of aspirin allergy, active peptic ulcer disease or gastritis that in judgment of investigator precludes use of aspirin 6. history of significant hepatic disease or any other condition that in the judgement of the investigator precludes the use of rivaroxaban 7. creatinine clearance less than 30 ml per minute 8. platelet count less than 100 x 109 /l 9. need for long-term anticoagulation due to a preexisting co-morbid condition or due to the development of venous thromboembolism following surgery but prior to randomization 10. did not or will not receive rivaroxaban post-operatively for vte prophylaxis 11. bilateral total hip arthroplasty or simultaneous hip and knee arthroplasty 12. major surgical procedure within the previous three months 13. requirement for major surgery post arthroplasty within 90 day period 14. chronic daily aspirin use with dose greater than 100 mg a day 15. women of child bearing potential who are not abstinent or do not use appropriate contraception throughout the study drug period 16. geographical inaccessibility for follow-up 17. unwilling or unable to give consent 18. previous participation in the study 19. concomitant use with drugs that are strong inhibitors or inducers of both p-gp and cyp3a4
umbilical cord blood proteomic analysis and neonatal brain injury

Conditions: Hypoxia-Ischemia, Brain; Periventricular Leukomalacia

Summary: the investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls. after delivery an umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder of the cord blood is discarded. the investigators plan to use this cord blood that would otherwise be discarded to perform our proteomic analysis. the investigators will use up to 20 ml of cord blood per delivery. this will be a 5 year study during which time the investigators hope to analyze 450 infants at johns hopkins hospital and bayview medical center. the investigators will obtain an umbilical venous sample from infants born at \ 34 weeks the investigators will obtain an umbilical venous sample for any infant suspected to be at risk for neurologic injury by having a diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the time of delivery, or a 5 minute apgar \ 34 weeks, each infant later confirmed to have neurologic morbidity will be compared to a gestational age matched noninjured control. the investigators hope to use proteomic analysis to determine if there are measurable differences in protein expression between the 2 groups.

we will draw up to 20 ml of umbilical venous blood at the time of delivery from infants born at \ 34 weeks suspected to be at risk for neurologic morbidity by having intrapartum chorioamnionitis, nonreassuring fetal heart tracing prior to delivery, or a 5 minute apgar \ 34 weeks later confirmed to have neurologic morbidity by head ultrasound or eeg we will draw cord blood from a gestational age matched control without intrapartum infection or nonreassuring fetal heart tracing prior to delivery. at the time of delivery an umbilical arterial gas and umbilical venous sample for a type and screen, rpr and hematocrit are routinely drawn. the remainder of the cord blood is discarded. after the routinely done arterial blood gas and umbilical venous blood sample are obtained the remainder of the umbilical cord blood, which would otherwise be discarded, will be collected using a 23 gauge or larger needle into a heparinized tube. the sample will be centrifuged for 10 minutes and the plasma layer separated. the sample will be placed into 1.5 ml eppendorf tubes in 500 ul aliquots. proteomic techniques including mass spectrometry, 2-dimensional electrophoresis, and chromatography, will be used to analyze the proteome from the brain injured and control groups. specific proteins will be identified, and differences in expression compared between the 2 groups.

Eligibility criteria:
inclusion criteria: * less than 34 weeks gestational age or more than 34 weeks with a risk factor for brain injury such as chorioamnionitis, nonreassuring fetal heart rate tracing, metabolic acidosis, or hypotonia at birth. exclusion criteria: * major congenital or chromosomal abnormalities in fetus

Keywords: neonatal encephalopathy hypoxic-ischemic brain injury umbilical cord blood proteomics