Kornimate/medical-research-clean huggingface dataset:
a proposed study of atherosclerotic plaques in leg arteries

Conditions: Vascular Disease; Diabetes

Summary: biofilm has been identified as the major bacterial phenotype contributing to atherosclerosis. it has become very important to evaluate atherosclerosis and the role of biofilm using advanced technologies. it is also important to understand wound biofilm at a genetic and a molecular level.

high throughput pyrosequencing is opening new doors in nucleic acid analysis. 454 roche has developed sequencing instrumentation which has the ability to sequence not only genomic dna (gdna) but also derivatives of messenger rna (mrna) and 16s ribosomal dna (rdna). this technology has the potential to survey the nucleic acids involved within a mixed population of species, such as atherosclerotic biofilm. in addition to transcriptome science; proteome, metabolome, and other -omic sciences are advancing rapidly. examining atherosclerotic plaque using transcriptome, proteome, metabolome, and other -omic approaches may provide valuable insight into the wound's microecology.

Eligibility criteria:
inclusion criteria: 1. the subject with identifying leg or legs that were amputated for vascular disease and/or diabetes. 2. the subject must be 18 years of age or older. exclusion criteria: * the subject will be excluded if they have had a traumatic amputation which did not involve vascular disease and/or diabetes.

Keywords: atherosclerosis
omalizumab with oral food immunotherapy with food allergies open label safety study in a single center

Conditions: Immune System Diseases

Summary: the long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. the investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.


Eligibility criteria:
inclusion criteria: * moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old. * sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific immunocap ige level, with 7 ku/l as a lower limit of eligibility. exclusion criteria: * no absolute contraindications are known. however, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). * subjects with a total ige at screening of \>2,000 ku/l * previous reaction to omalizumab * subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an icu, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.

Keywords: multiple food allergies
ptcy plus uhcg/egf for graft versus host disease prophylaxis

Conditions: Graft Versus Host Disease

Summary: so this a phase i study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhcg/egf) as graft versus host disease prophylaxis in stem cell transplant with mmuds secondary objectives are to determine the incidence acute and chronic gvhd, progression-free survival , and overall survival


Eligibility criteria:
inclusion criteria: 1. patients with hematologic malignancy who have the indication for allogeneic sct and have no mrd or mud. 2. age 18-70 years old 3. performance score of at least 80% by karnofsky 4. adequate kidney and liver function as demonstrated by: 1. creatinine clearance should be \>60 ml/min 2. total bilirubin \<1.5, alt/ast/alk phos \< 2.5 x normal. no evidence of chronic active hepatitis or cirrhosis. 5. negative beta hcg test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. women of childbearing potential must be willing to use an effective contraceptive measure while on study. 6. patient or patient's legal representative, parent(s) or guardian able to sign informed consent. exclusion criteria: 1. positive for hiv, hbsag, hcv or other viral hepatitis or cirrhosis from any cause 2. active or prior cns leukemia, unless in complete remission for at least 2 months. 3. history of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs. 4. uncontrolled infection 5. donor specific antibodies 6. ejection fraction \<40% or history of heart failure or cardiovascular disease 7. history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia. 8. previous history hormone responsive cancer 9. history of seizure 10. history of migraine or severe headache 11. history of asthma 12. history of uterine fibroid
dual-energy ct in detecting bone marrow edema of vertebral compression fractures

Conditions: Compression Fracture of Thoracic Vertebral Body; Spinal Compression Fracture

Summary: the purpose of this study is to 1. assess bone marrow edema within the vcf by use of a de ct virtual noncalcium image compared with mr imaging as standard reference. 2. evaluate parameters related to the bme of the collapsed vertebral body on de ct virtual noncalcium images, such as the morphologic signs, visual qualitative detection, and quantitative values.

patients with multiple compression fractures and in those with chronic fracture, determining which vertebra to treat is frequently difficult. in such patients, the treatment location is commonly determined from findings at imaging, which includes magnetic resonance (mr) imaging, bone scintigraphy, and computed tomography (ct). the bone marrow edema (bme) in acute/subacute vcfs is useful in determining the vertebra that is to be treated. mr imaging provides information on anatomic vertebral collapse and the loss of normal t1 high signal intensity from the marrow space of vertebrae with acute fractures. loss of normal t1 high signal intensity indicates the presence of bme, which is the important sign for the pvp treatment of vcfs. dual-energy (de) ct has been used to create a virtual unenhanced scan by subtracting iodine from contrast agent-enhanced ct examinations.we expect that the same technique can be used to calculate a virtual noncalcium image from an unenhanced image, which makes bone marrow accessible for ct diagnosis.

Eligibility criteria:
inclusion criteria: * compression fractures (thoracic and lumbar vertebrae) exclusion criteria: * age less than 18 years * pregnancy * any contraindications to mr imaging.
postoperative delirium: eeg markers of sleep and wakefulness

Conditions: Postoperative Delirium

Summary: postoperative delirium is a condition in which patients develop temporary difficulties in maintaining attention and thinking clearly. these new problems can appear after surgery and change throughout the day. this confusion can last several days. the overall purpose of this study is to measure brain activity during sleep and wakefulness to learn about their relationships to delirium after surgery. while participants may not feel like their normal self during the study, they are in the best position to help us learn how to improve the recovery of brain function and sleep in others having surgery. the investigators need to learn from those who have and have not become confused after their surgical procedure.

postoperative delirium is a condition that can develop in some older patients after they have surgery and receive general anesthesia. patients that develop delirium have difficulty maintaining attention and thinking clearly. both of these issues can come and go throughout the day. the incidence of postoperative delirium is greater than 25% and is associated with longer hospitalization and increased risk of persistent mental and physical decline. it is thought that this disorder may be preventable, but there is no agreed upon way of identifying which patients are at risk for delirium prior to their surgery. additionally, patients with atypical delirium are often misdiagnosed or undiagnosed postoperatively. based on previous research, the researchers have hypothesized that delirium may be directly related to wakefulness and sleep problems, as shown on electroencephalography \[eeg\]. eeg is a test that records the electrical activity of brain through placement of small wires on a person's scalp. in light of this, the purpose of this study is to evaluate sleep and wakefulness using eeg before, during and after surgery in order to discover any abnormalities of sleep or wakefulness that associate with postoperative delirium onset, severity, and length of recovery. subjects in this study will have preoperative at home sleep testing performed, using a device called the sleep profiler, and questionnaires administered to characterize their mental function and brain function prior to surgery. when they arrive for their scheduled surgery, the subjects will be fitted with the sleep profiler to record brain activity during surgery and after surgery for 5 days. postoperatively, the subjects will be asked to do simple tasks like move toes and fingers and to answer questions that assess their mental state.

Eligibility criteria:
inclusion criteria: 1. english speaking 2. age 60 or older 3. scheduled for cardiac surgery requiring cardiopulmonary bypass for coronary artery bypass grafting and/or heart valve repair/replacement exclusion criteria: 1. pre-existing delirium or dementia 2. legal blindness or severe deafness 3. surgery requiring deep hypothermic circulatory rest
mother matters online postpartum support

Conditions: Depression

Summary: postpartum depression is common, yet only 20% of women seek treatment. online support groups are a potential means of providing accessible mental health care during this time. mother matters is a 10-week online psychotherapy group for women with postpartum depression \& anxiety. the investigators aim to conduct a pilot rct to demonstrate the feasibility of proceeding to a large-scale rct evaluation of the mother matters intervention.

the postpartum period is a particularly vulnerable time for the development of mental health concerns; postpartum depression (i.e. depression with onset between 0-12 months postpartum) affects approximately 13% of mothers in canada. there are serious negative consequences to both mother and child during this period, yet only 20% of women seek treatment, citing significant systematic and personal barriers. online support groups have been identified as a potential means of providing accessible mental health care during this time. mother matters is a 10-week online support group for women with postpartum depression and anxiety, run trained psychotherapists in the reproductive life stages (rls) program at women's college hospital in toronto, ontario. mother matters was designed to address barriers related to accessing postpartum mental health services: it can be accessed anywhere (online group), at any time (available 24/7), and with anonymity (to address the barrier of shame/stigma). the overall objective of the current pilot rct is to determine the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the group, comparing outcomes among those with and without access to the program.

Eligibility criteria:
inclusion criteria the specific inclusion criteria for this group are women who are: 1. mothers of a baby/babies between 0 and 12 months old at enrollment, and 2. over 18 years old, and 3. have an edinburgh postnatal depression scale (epds) score of \>9, and 4. reside in ontario. exclusion criteria women will not be eligible to participate in the study if they are: 1. experiencing active suicidal ideation, or 2. have active substance use, mania or psychosis, or 3. unable to access the internet, or 4. unable to participate in english.

Keywords: pilot rct waitlist-controlled rct postpartum depression
world bleeding disorders registry pilot study

Conditions: Hemophilia A and B

Summary: the world federation of hemophilia (wfh) is conducting the pilot phase of an international, observational, world bleeding disorders registry (wbdr). this pilot phase will assess the feasibility of conducting an expanded wbdr to more centres with a more comprehensive case report form, around the world.

the pilot phase of the wbdr is an observational disease registry of patients with hemophilia. forty hemophilia treatment centres (htcs), of varying levels of economic development (emerging, mid-level and established), that have data entry capabilities and the ability to obtain the required data on patients in english, were invited to participate in the pilot phase. participating htcs will complete a minimal data set (mds) of data on approximately 10 patients each. a series of performance indicators have been identified by the steering committee and will be used to assess the feasibility of expanding the pilot phase to the wbdr. the performance indicators include: proportion of htcs invited that are willing to participate; proportion of participating htcs who successfully obtain necessary regulatory approvals; proportion of patients approached who consent to participate; proportion of enrolled patients on which data collection and database entry is successful.

Eligibility criteria:
inclusion criteria: * patients of participating hemophilia treatment centres with hemophilia a or b. * ability to provide data in english exclusion criteria: * none
study to evaluate safety and pharmacokinetics of ub-421 antibody in hiv-1 infected adults

Conditions: HIV-1 Infection in Adults (Asymptomatic)

Summary: the purpose of this phase i study is to determine whether the antibody (ub-421), targeting the hiv-1 receptor on the cd4 molecule (domain 1) of t-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic hiv-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. the neutralizing activity of ub-421 blocks hiv-1 from binding to its receptor on cd4-positive cells; thus, ub-421 functions as an immunotherapeutic intervention to prevent hiv-1 infection.


Eligibility criteria:
inclusion criteria: * asymptomatic, treatment-naive, hiv-1 seropositive * cd4+ t cell count \>350 cells/cubic millimeter * hiv-1 viral load \>5,000 copies/ml * other inclusion criteria apply exclusion criteria: * active infection requiring immediate therapy (except hiv-1) * prior participation in any hiv vaccine trial * previous exposure to a monoclonal antibody * use of immunomodulating drugs or systemic chemotherapy * other exclusion criteria apply

Keywords: hiv-1, cd4, antibody, immunotherapy
hypnotic intervention for women with chronic pelvic pain

Conditions: Chronic Pain; Pelvic Pain; Psychological; Hypnosis, Animal

Summary: objective: to establish whether the pilot online hypnosis design was well received by women with persistent pelvic pain and worthy of a full randomised control trial to establish whether hypnosis improves mental health outcomes, including anxiety, depression, life impact and catastrophizing, in women with chronic pelvic pain conditions.

design: pilot randomised control trial methods: twenty women with persistent pelvic pain completed assessment questionnaires and were recruited from a variety of social media sites related to persistent pelvic pain and randomly allocated to either control or hypnotic intervention groups. the intervention group completed a seven week online hypnotic intervention. the control group received no intervention. both groups completed assessment and concluding questionnaires related to demographic information and the outcomes of interest. this included measures for anxiety, depression, pain, coping styles, pain related disability, pain catastrophizing and suggestibility. the results of the intervention and waitlist control groups were compared using linear mixed-effects modelling. suggestibility was screened for at baseline using the short suggestibility scale, and included in a secondary set of linear effects modelling.

Eligibility criteria:
inclusion criteria: * meets criteria for persistent pelvic pain. having experienced pain in the pelvic region below the umbilicus for over three months either beyond the healing time of a pathology or injury or without a diagnosed cause. * must be biologically female. * must be over the age of 18 years old. exclusion criteria: * must not have a previously diagnosed or current mental health disorder involving dissociative states. examples include diagnosed or current symptoms of bipolar type 1 or 2, psychotic disorders, untreated post-traumatic stress disorder. * must not reported current plan or intent to commit suicide.
assess the safety of elgn-2112 in preterm infants born under 26 weeks ga and iugr infants born 26-32 weeks ga

Conditions: Intestinal Malabsorption

Summary: to compare the safety of treatment with elgn-2112 to placebo in preterm infants born less than 26 weeks ga and iugr infants\<3rd percentile\* born at 26-32 weeks ga.


Eligibility criteria:
inclusion criteria: * male or female preterm infant born less than 26 weeks ga or intra-uterine growth restricted infants born between 26+0 to 31+6 ga. * birth weight ≥ 450g * singleton or twin birth exclusion criteria: n/a
efficacy and safety study of pitavastatin compared to atorvastatin in type 2 diabetes mellitus with hypercholesterolemia

Conditions: Hypercholesterolemia With Type2DM

Summary: a randomized, open label, dose titration study to evaluate the efficacy and safety of pitavastatin compared to atorvastatin in type 2 diabetes mellitus with hypercholesterolemia

to evaluate the effect of pitavastatin compared to atorvastatin on the change of lipid profiles, apoa1, apob, adiponectin and bapwv as a marker of atherosclerosis in type 2dm .

Eligibility criteria:
inclusion criteria: * age: 25yrs\~75yrs * fasting tg \<400mg/dl, ldl-c ≥130mg/dl * 3months \> diagnosed type2 dm, with oad, hba1c ≤ 10.0% or first diagnosed type2 dm, 6.5%≤hba1c≤10.0% exclusion criteria: * type1 dm, gestational diabetes * patient need to treat with insulin * patient with operational treatment for severe diabetic complication * uncontrolled hypothyroidism * unstable angina, mi, transient ischemic attack(tia), stroke, pci, heart failure within 3 months (nyha class4) * severe hypertension (sbp ≥ 180 or dbp ≥ 110mmhg) * renal disorder (serum creatinine ≥ 2.0mg/dl) * hepatic disorder (ast or alt ≥ 2.5 x unl) * creatinine kinase \> 2.5 x unl * gravida or lactation phase * administration of atorvastatin, rosuvastatin, pitavastatin

Keywords: pitavastatin pwv esprit pitavastatin and atorvastatin adiponectin fasting insulin hs-crp bapwv
treating post traumatic stress disorder in children exposed to domestic violence

Conditions: Stress Disorders, Post-Traumatic; Anxiety; Depression

Summary: this study will determine whether trauma-focused cognitive behavioral therapy (tf-cbt) is more effective than child-centered therapy (cct) in reducing post traumatic stress disorder (ptsd) in children exposed to domestic violence (dv).

up to 10 million children in the united states are exposed to dv directed at their mothers by intimate partners. dv exposure puts these children at an increased risk for developing behavioral problems, depression, anxiety, and ptsd. while studies targeting ptsd in dv-exposed children are limited, data indicates that tf-cbt is effective in improving ptsd as well as depression, anxiety, and behavioral symptoms. this study will determine the effectiveness of tf-cbt in reducing ptsd and other dv-related psychological symptoms in children from a community dv agency in pittsburgh, pennsylvania. this study will last 8 weeks. children and their mothers will be randomly assigned to receive 8 weeks of either tf-cbt or cct. in tf-cbt, patients recall the events of their trauma and try to deal with the emotions that arise. supportive treatment empowers children to deal with their emotions in general. both the children and their mothers will complete questionnaires at study entry and at week 8. children will also complete self-report scales at study entry and at week 8. the questionnaires and self-report scales will be used to assess symptoms of ptsd, depression, anxiety, and behavioral problems. children and their mothers will be contacted 6 and 12 months after study completion for follow-up interviews.

Eligibility criteria:
inclusion criteria: * diagnosis of ptsd related to exposure to dv, defined as their mother having been the victim of intimate partner violence within 1 year prior to study entry * able to read and understand english * parent or guardian able to read and understand english * parent or guardian willing to give informed consent exclusion criteria: * certain psychiatric disorders which preclude participation in cognitive-based treatment

Keywords: posttraumatic stress disorder domestic violence children cognitive behavioral therapy cbt
flexible ureteroscopy versus percutaneous nephrolithotomy as primary treatment in renal stones 2-3 cm

Conditions: Stones, Kidney; Stones Ureter; Urolithiasis

Summary: flexible ureteroscopy versus percutaneous nephrolithotomy as primary treatment in renal stones 2-3 cm


Eligibility criteria:
inclusion criteria: stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones. exclusion criteria: stone burden from 2- 3 cm, single or multiple stones and radio-opaque or radio-lucent stones.
survey and reduction of mortality in peridialysis uremic patients via intervention of risk factors

Conditions: End Stage Renal Disease on Dialysis

Summary: in patients with non-dialysis-dependent end stage kidney disease (eskd) the common transition of care to renal replacement therapy is dialysis. each year over 70 000 chinese transition from non-dialysis-dependent eskd to dialysis. whereas dialysis therapy is intended to be life-sustaining, eskd patients have a 10-fold or higher risk of death compared with the general population. mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. hence, there is an urgent need to examine the emerging field of transition of care in eskd. we suggest the term "peridialysis period" for this transition period for eskd patients, so that the transition of care from non-dialysis-dependent eskd to dialysis eskd can be more pragmatically defined and studied. in the current study, we will investigate the mortality and its risk factors of eskd patients during peridialysis period, and improve the survival rate and quality of life of peridialysis eskd patients by intervening the risk factors.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with end stage kidney disease (egfr\<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in yangzhou, china since january 1, 2016 exclusion criteria: * patients who have had a history of dialysis and have been transferred to yangzhou during this period; * patients who are transferred to a dialysis area outside yangzhou city * patients who give up dialysis treatment * patient whose renal function recover and stop dialysis treatment; * patient who receive kidney transplantation