Kornimate/medical-research-clean huggingface dataset:
in-vivo regulatory t cell enhancement with cyclophosphamide and sirolimus

Conditions: Graft Versus Host Disease

Summary: in this study the investigators are proposing to treat patients with steroid-refractory graft-versus-host disease (gvhd) stabilization using il-2 and azacitidine

high-dose cyclophosphamide and sirolimus have been successfully used for the prevention of graft-versus-host disease (gvhd) and have shown to enhance the tregs subpopulation. the addition of low dose il-2 and a demethylating agent such as azacitidine will also be studied in an attempt to promote and stabilize the foxp3 expression of tregs.

Eligibility criteria:
inclusion criteria: * patients must have a documented clinical diagnosis of grade ii-iv acute graft-versus- host disease defined as graft versus host disease (gvhd) occurring within the first 100 days of transplantation * patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy. * progression is defined as up-grading * no response is defined as no down-grading * progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent. * no response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent. * patients with exacerbation of gvhd during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria * age 18-70 * patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment. * serum creatinine \< 2 mg/dl exclusion criteria: * patients cannot have active central nervous system (cns) disease. * patients must not have received cyclophosphamide for gvhd prophylaxis * patients must not have pneumonia requiring oxygen supplementation * unable or unwilling to sign informed consent.
hyperpolarized 129-xenon imaging in adult hematopoietic cell transplant recipients with pulmonary impairment

Conditions: Pulmonary; Pneumonia; Hematopoietic System--Cancer

Summary: this study is designed to measure the correlation of hyperpolarized 129-xe magnetic resonance imaging (129-xemri) in allogeneic hematopoietic cell transplant (allo-hct) recipients at md anderson cancer center (mdacc) who develop bronchiolitis obliterans syndrome (bos) or bos stage 0p (pulmonary impairment not meeting the definition for bos, defined below) and controls with chronic graft-versus-host disease (cgvhd). the primary objective of the study is to correlate 129-xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative ct measurements. a secondary objective is to determine whether measurement of 129-xe mri characteristics in patients with bos stage 0p can predict bos progression 6 months after enrollment.

the primary objective of the study is to correlate 129-xenon measures of ventilation, gas exchange, and pulmonary circulation with spirometric and quantitative ct measurements. a secondary objective is to assess the differences in 129-xe mri characteristics between patients with and without os progression at 6 months after enrollment. other secondary objectives include the assessment of the relationship of vdp, barrier defects (continuous variable), and circulation defects (continuous variable) with pulmonary function, quantitative ct measurements, sgrq, and sf-6d.

Eligibility criteria:
inclusion criteria: - allo-hct recipients who are at least 18 years of age and have bos (n=10 patients), bos 0p (n = 10 patients), or cgvhd of a non-lung organ without evidence of pulmonary impairment (n = 5 patients). healthy cohort - inclusion criteria: we will perform only xemri imaging on 10 healthy adult (18 years and older) volunteers with no medical issues for technical calibration of the xemri technology. members of the study team may serve as healthy volunteers if they have no prior history of lung disease. these data will not be included as part of the analysis. exclusion criteria: 1. participants unable to follow up at md anderson for routine clinical care 2. inability or unwillingness to give informed consent 3. relapsed disease or life expectancy less than 6 months at time of enrollment 4. severe claustrophobia precluding mri imaging 5. active pulmonary infection 6. pregnant women
efficacy and safety of foscarnet sodium and sodium chloride injection in patients with herpes zoster

Conditions: Herpes Zoster

Summary: the purpose of this study is to evaluate the efficacy and safety of foscarnet sodium and sodium chloride injection in patients with herpes zoster, and observe incidence of postherpetic neuralgia


Eligibility criteria:
inclusion criteria: 1.patients with clinical diagnosis of herpes zoster, and able to be enrolled into the study ≤ 72 hours from appearance of rash; 2.18-65 years old, men and women; 3.vas score≥4; 4.patients haven't receive any antiviral medication before enrollment; 5.patients able to understand the study procedures, agree to participate and give written consent. exclusion criteria: 1. patients with history of allergy to foscarnet sodium or acyclovir; 2. other combined infection (bacteria, fungi) 3. severe decline in immune function, or long-term use of corticosteroid and immunosuppressor 4. serious liver or renal function abnormalities (aspartate transaminase(ast) or alanine transaminase(alt) ≥ 2.5x upper limits of normal(uln), creatinine(cr) or blood urea nitrogen(bun)≥ 1x uln) 5. women who are pregnant or lactating, and women of childbearing potential failed to use an adequate method of contraception to avoid pregnancy; 6. patients using other antiviral drugs; 7. long-term use of non-steroid anti-inflammatory drug, tricyclic antidepressant, anti-epileptic drugs or analgesic 8. current malignant tumor; 9. patients investigators consider as inappropriate to participate in the study

Keywords: herpes zoster, foscarnet sodium, acyclovir, postherpetic neuralgia
s-condom uterine tamponade in controlling atraumatic postpartum haemorrhage (pph) - rct

Conditions: Post Partum Hemorrhage

Summary: a randomized controlled non inferiority trial will be conducted to see the feasibility, acceptability and efficacy of s-condom uterine tamponade in women with atraumatic pph and not responding to first line of treatment.

a randomized controlled non inferiority trial will be conducted to see the feasibility, acceptability and efficacy of s-condom uterine tamponade in women with atraumatic pph and not responding to first line of treatment. the women will be divided randomly into two groups, in both groups two condom tied on a catheter will be introduced inside the uterus. in one group (control group), condom will be inflated with saline and in another group(study group) it will be inflated with air. time required to stop bleeding will be measured for comparison. data collected will be analyzed using a quantitative approach and the results will be presented in tables and graphs. if air media proved feasible, acceptable and effective the pph management will be easier, cost-effective can make a great impact in reaching the target for reduction of maternal mortality in bangladesh and other resource poor settings.

Eligibility criteria:
inclusion criteria: * all women who presented with atraumatic postpartum hemorrhage, refractory to first-line treatment (uterine massage and oxytocin) and who will give their consent will be included in the study and will be randomized exclusion criteria: * women known to have allergy to latex, or presenting with clinical chorioamnionitis or primary hemorrhage caused by cervical-vaginal lacerations, a uterine rupture, or a placenta accreta will be excluded.

Keywords: randomised controlled trial, s-condom, postpartum haemorrhage
a long term safety study of bcx7353 in hereditary angioedema

Conditions: Hereditary Angioedema; HAE; Prophylaxis

Summary: this is an open-label study to evaluate the long term safety and effectiveness of oral treatment with bcx7353 in preventing acute angioedema attacks in patients with type i and type ii hereditary angioedema (hae).


Eligibility criteria:
key inclusion criteria: * subjects with hae type i or ii who either have participated in a previous bcx7353 study or, in selected countries, in the opinion of the investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks. * access to appropriate medication for treatment of acute attacks * acceptable effective contraception * written informed consent key exclusion criteria: * pregnancy or breast-feeding * any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's safety or ability to participate in the study * any laboratory parameter abnormality that, in the opinion of the investigator, is clinically significant and relevant for this study * discontinuation of study drug due to a hypersensitivity reaction bcx7353 in a prior study * severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology * unacceptable noncompliance in a previous bcx7353 study (if applicable) as assessed by the sponsor or investigator * investigational drug exposure, other than bcx7353, within 30 days prior to the screening visit (or baseline if no screening visit)

Keywords: bcx7353 hereditary angioedema hae
diaphragmatic breathing exercises and pelvic floor retraining in children with dysfunctional voiding

Conditions: Dysfunctional Voiding

Summary: according to the 2016 international children's continence society standardization of terminology of lower urinary tract function in children, dysfunctional voiding (dv) is a "urodynamic entity characterized by an intermittent and/or fluctuating uroflow rate due to involuntary intermittent contractions of the striated muscle of the external urethral sphincter or pelvic floor during voiding in neurologically normal individuals" . symptoms vary from mild daytime frequency and urgency to daytime and nighttime wetting, pelvic holding maneuvers, voiding difficulties, urinary tract infections and vesicoureteral reflux (vur). there are several ways of treating dv, including urotherapy, pharmacotherapy, surgery in the most severe cases, and even botulinum toxin type a application in certain children. ''urotherapy'' stands for non-surgical, non-pharmacologic treatment of lower urinary tract function and can be defined as a bladder re-education or rehabilitation program aiming at correction of filling and voiding difficulties. it involves the change of habits that a child has acquired during the period of toilet training and the development of motor control of the micturition reflex. urotherapy starts with both parental and child education about the importance of regular hydratation and voiding, constipation treatment and genital hygiene. together with this standard treatment, the pelvic floor muscle (pfm) retraining is initiated, and it includes pelvic floor exercises and various forms of biofeedback (visual, tactile, auditory, electromyography) with the same aim in mind - to help the child establish pelvic floor awareness and control, and relearn pelvic floor muscle relaxation. during the past decade, it has been shown that the pfms are not an isolated unit, but a part of the abdominal capsule, which they form together with the diaphragm, superficial and deep abdominal muscles. as lower abdominal and pfm act synergistically, it is important that both be relaxed during voiding. diaphragmatic breathing exercises are easy to learn and serve to teach the children abdominal relaxation.


Eligibility criteria:
inclusion criteria: 1. proven dysfunctional voiding according to the iccs criteria 2. signed informed consent by parents motivated to participate in the study 3. previous treatment by pediatricians in primary care with timed voiding, hydratation and constipation management for three months with no significant success exclusion criteria: 1. neurological disorders 2. monosymptomatic nocturnal enuresis 3. mental retardation 4. structural abnormalities of the lower urinary tract -

Keywords: dysfunctional voiding diaphragmatic breathing urotherapy pelvic floor exercises the dysfunctional voiding and incontinence scoring system
effects of curcumin supplementation on gut barrier function in patients with metabolic syndrome

Conditions: Obesity; High Blood Pressure; High Cholesterol; Type2 Diabetes; Heart Diseases

Summary: this study will investigate the effects of curcumin on the structure/function of the body by investigating whether targeted improvement of intestinal barrier function by supplementation with oral curcumin will result in attenuation of lipopolysaccharide (lps) translocation and/or intestinal inflammation.

a typical diet in the united states, also known as western diet, is very high in sugars and saturated fat, and poor in food such as fruits, vegetables, fish and whole grains. this type of diet is associated with higher risk to develop obesity and other health problems such as high blood pressure, high cholesterol, type 2 diabetes, and heart disease. western diet can also cause changes in the gut that allow bacteria that are typically only present in the gut to leak out into the bloodstream. it is thought that having gut bacteria in the bloodstream may play a role in the development of diseases like type 2 diabetes and heart disease. curcumin is a dietary supplement that comes from the root of the turmeric plant, and it may have an effect on the function of the gut and the leakage of gut bacteria into the bloodstream. the purpose of this research study is to evaluate the effects of daily curcumin dietary supplements on the function of the gut in subjects who are at risk for cardiovascular and metabolic diseases, for example they have increased blood pressure, increase waist circumference and high triglycerides (fat in the blood).

Eligibility criteria:
inclusion criteria: 1. based on national institutes of health (nih) definition of metabolic syndrome, the subject must meet at least 3 of the following criteria: a. waist circumference: female ≥ 88 cm, male ≥ 102 cm b. blood pressure: ≥ 130/85 mm/hg and/or treatment with blood pressure lowering medication c. impaired fasting glucose or hba1c (fasting glucose ≥ 100 mg/dl or hga1c ≥ 5.7 d. hdl-c: females\< 50 mg/dl, males \< 40 mg/dl e. triglycerides ≥ 150 mg/dl 2. willing and able to comply with the study protocol exclusion criteria: 1. diabetes 2. established cardiovascular disease 3. pre-existing liver disease other than nafld 4. chronic kidney disease (stage 4 and 5) 5. rheumatological disease 6. active malignancy 7. alcohol consumption greater than 7 drinks per week for females and greater than 14 drinks per week for males 8. current use of metformin and/or steroids 9. curcumin supplementation 10. females of child-bearing potential (not of child-bearing potential is defined as s/p hysterectomy or post-menopausal.) 11. prisoners/wards of the state and individuals with limited english proficiency

Keywords: curcumin microbiome dietary supplements gut bacteria
safety and efficacy of house dust mite allergoid in the treatment of bronchial asthma

Conditions: Respiratory Hypersensitivity

Summary: the trial is performed to assess efficacy and safety of the allergopharma house dust mite allergoid in bronchial asthma.

the rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase iii clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. this condition is present in paediatric and adult patients with a shorter history of gina ii and iii asthma, who were investigated in this study.

Eligibility criteria:
inclusion criteria: * bronchial asthma * requirements for inhaled corticosteroid * positive skin prick test to house dust mite * positive radioallergosorbent test (rast) to house dust mite * positive provocation test result to house dust mite exclusion criteria: * serious chronic diseases * other perennial allergies

Keywords: house dust mite bronchial asthma allergy house dust mite allergy
thin strut sirolimus-eluting stent in all comers population vs everolimus-eluting stent

Conditions: Coronary Stenosis

Summary: the primary objective of this study is to compare the performance of supraflex to that of xience in an all-comers patient population with symptomatic ischemic heart disease. the patients will be followed through 3 years for major clinical events.

this is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between supraflex and xience in a "real world, all comers" patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). the objective is to compare the supraflex ses with the xience ees with respect to target lesion failure (tlf) at 12 months in a non-inferiority trial in a "real world" patient population. all patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. the 30 day and 12 month will be a clinic visit. all patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.

Eligibility criteria:
inclusion criteria: all comers" patients: * male or female patients 18 years or older; * presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. * the vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); all lesions of the patient must comply with the angiographic inclusion criteria. * the patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. patient is willing to comply with all protocol-required evaluations. exclusion criteria: * known pregnancy or breastfeeding at time of randomization; * known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; * any pci treatment within 6 months (\<6 months) prior to the index procedure. * concurrent medical condition with a life expectancy of less than 12 months. * the patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up. * currently participating in another trial and not yet at its primary endpoint.

Keywords: cad acs all comers pci
metformin in patients with pcos and predictors of poor ovarian response ongoing in-vitro fertilization

Conditions: Infertility; PCOS; Prognosis for Poor Response

Summary: metformin should be administered with caution and could be potentially dangerous in infertile patients with pcos who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. however, data that address this point are totally lacking. on the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with pcos who have a potentially poor ovarian response and who undergo gonadotropin stimulation for ivf cycles.

primary infertile patients with pcos older than 35 years and/or with a basal follicle-stimulating hormone (fsh) level higher than 10 iu/l who were scheduled for ivf cycles were enrolled in the study protocol.

Eligibility criteria:
inclusion criteria: * pcos * prognosis for poor response * infertility exclusion criteria: * male factor infertility * tubal infertility

Keywords: gonadotropins infertility ivf metformin pcos poor prognosis poor responder
immune suppression of infants treated with steroids

Conditions: Hemangioma

Summary: the goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.

infants with large or complicated hemangiomas are often treated systemically with oral steroids. the side effects of the drug on young infants has not been studied. the goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas. prednisone will be started according to established standard of care. visits will occur every four weeks for follow-up. there will be six blood draws from baseline to completion of study. approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infant's immune system. participation in this study will last up to 14 months or until stabilization of the hemangioma. evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system.

Eligibility criteria:
inclusion criteria: * infants \< 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids * infant must be enrolled prior to initiation of steroid therapy exclusion criteria: * infants \> 6 months of age * infants already receiving oral corticosteroid treatment prior to the start of this study * infants with know immunodeficiencies * infants receiving other oral medications for the treatment of hemangiomas

Keywords: hemangioma corticosteroid prednisone