Kornimate/medical-research-clean huggingface dataset:
hemodialysis reliable outflow (hero) vascular access patency study

Conditions: Renal Failure Chronic Requiring Hemodialysis

Summary: compare the hero vascular access device to a conventional eptfe graft.

the purpose of this study is to compare the hero vascular access device to a conventional eptfe graft. it is hypothesized that hero patency will be comparable to the conventional eptfe graft control.

Eligibility criteria:
inclusion criteria: 1. 22 years of age or older. 2. male or non-pregnant female. 3. life expectancy 2 years. 4. end-stage renal disease requiring an arm vascular prosthesis for dialysis access. 5. ability to understand and provide written informed consent. 6. willing and able to cooperate with follow-up examinations. 7. subject's upper arm can be used for implant (note: the gvas device must be implanted in the upper arm only, but the control group graft can be implanted in the upper or lower arm location.). 8. able to follow a daily aspirin and/or other oral anticoagulation/antiplatelet regimen. exclusion criteria: 1. potential graft target artery less than 3 mm in diameter determined by any suitable preoperative measure. 2. documented history of drug abuse within six months. 3. "planned" concomitant surgical procedure or previous major surgery within 30 days, excluding vascular access related procedures. 4. currently being treated with another investigational device or drug. 5. known bleeding diathesis or hypercoagulable state. 6. peripheral white blood cell count 1500/mm3 (1.5 k/mm3) or platelet counts 50,000/mm3 (50 k/mm3). 7. degenerative connective tissue disease, e.g., marfan's and ehlers danlos syndrome. subjects with lupus erythematosus may be included. 8. subjects with known or suspected concomitant bacterial, fungal, viral, or parasitic infection. subjects with hepatitis b may be included. subjects who are hiv + with cd4 count of \<200 are excluded. 9. severe underlying co-morbidity or immediate life-threatening condition. 10. subjects with any condition which, in the opinion of the investigator, could preclude evaluation of response or completion of follow-up or affect subject safety. 11. subjects who are candidates for autologous fistulas. 12. subjects with scheduled renal transplant within the next 12 months.

Keywords: vascular access hemodialysis eptfe graft graft-eligible long-term vascular access for hemodialysis
mobilaser study to help with people who are having problems with their gait

Conditions: Parkinson's Disease; Parkinsonism

Summary: does use of the mobilaser reduce freezing of gait (fog) and stride reduction in patients with parkinson's disease and parkinsonism.

can patients walk faster and have less freezing when using the mobilaser then when not using it

Eligibility criteria:
inclusion criteria: * parkinsonian patients with freezing of gait or gait hesitation. * must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing) * must have a constant caregiver exclusion criteria: * no cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris; * severe arthritis; * cerebellar or sensory ataxia; * recent knee or hip surgery

Keywords: parkinson's disease parkinsonism gait problems freezing gait
investigation of correlation between interstitial and arterial blood glucose concentrations in septic patients

Conditions: Severe Sepsis

Summary: this is a mono-centre trial performed at the medical icu at the medical university graz. there will be a study visit (v1) and a follow-up assessment (v2). in the study visit (v1) arterial blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (isf) with microdialysis for glucose determination and with microperfusion for cytokine-measurement will be performed. the study visit will last for 26 hours starting with the insertion of two catheters in the abdominal subcutaneous tissue (one microdialysis- and one microperfusion catheter). the primary hypothesis of the study is: interstitial fluid glucose concentration profiles correlates to the arterial blood glucose concentration profile in patients with severe sepsis in the medical icu.


Eligibility criteria:
inclusion criteria: * patients in the medical icu fulfilling criteria for severe sepsis * mechanical ventilation * increased blood glucose levels ( \> 120 mg/dl; \> 6.7 mm), or requiring insulin treatment. * age of patients in the range from 18 to 90 years. exclusion criteria: * any disease or condition which the investigator or the treating physician feels would interfere with the trial or the safety of the patient
aerosol liposomal cyclosporine for chronic rejection in lung transplant recipients

Conditions: Disorder Related to Lung Transplantation; Bronchiolitis Obliterans; Decreased Immunologic Activity; Chronic Rejection of Lung Transplant

Summary: this is a single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine a in the treatment of chronic rejection in lung transplant recipients with bronchiolitis obliterans syndrome (bos). the primary objective is to evaluate the efficacy of liposomal cyclosporine a in the treatment of chronic rejection. pulmonary function and changes in bos grade are the primary end points.

this is a randomized single-center pilot study to investigate the efficacy and safety of aerosolized liposomal cyclosporine a (l-csa) in the treatment of chronic rejection in lung transplant recipients with grade 1 or 2 bos. the primary endpoints will include: * improvement or stabilization of pulmonary function test (fev1) from baseline * stabilization of histology (no deterioration from baseline) * safety of the preparation the secondary endpoints will include: * pharmacokinetics and distribution of csa in blood - * change in cytokine levels from bal specimens.

Eligibility criteria:
inclusion criteria: chronic rejection 1. bronchiolitis obliterans diagnosed by bronchiolitis obliterans syndrome and \> 20% decline from the individual patient's best fev1 is observed 2. recipient of a double or single lung transplant 3. receiving immunosuppressive treatment according to institutional standards exclusion criteria: 1. active invasive bacterial, viral or fungal infection 2. current mechanical ventilation 3. pregnant or breast-feeding woman 4. known hypersensitivity to cyclosporine a 5. serum creatinine value of more than 265 μmol/l (3 mg/dl) or chronic dialysis 6. receipt of an investigational drug as part of a clinical trial

Keywords: case-control study aerosolized liposomal cyclosporine a bronchiolitis obliterans syndrome lung transplantation lung function
comparison of istalol™ 0.5% qd (timolol maleate/sorbitol complex, ista pharmaceutical) to brimonidine tartrate 0.1% bid as adjunctive therapy to latanoprost 0.005% in adults with ocular hypertension (oht) or open-angle glaucoma (oag)

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: to assess the additional benefit of common adjunctive classes on the diurnal iop curve in patients assessed as needing additional treatment to reach target intraocular pressure (iop). to demonstrate superiority of iop control with istalol 0.5% qd compared to brimonidine tartrate 0.2% bid as adjunctive therapy in adults with uncontrolled iop's (determined by p.i. based on target pressures) currently treated with latanoprost 0.05% in the study eye(s).


Eligibility criteria:
inclusion criteria: 1. patients, male or female of any race or ethnicity, 18 years of age or older, diagnosed with ocular hypertension or open-angle glaucoma (with or without pseudoexfoliative or pigmentary dispersion component). 2. stable use of latanoprost 0.005% for a minimum of 30 days prior to screening visit. 3. va of 20/200 or better in either eye 4. pachymetry of 600 microns or less 5. visual field within 6 months of screening visit 6. patients who use contact lenses are allowed to participate provided that they will remove lenses 15 minutes before dosing 7. patients who satisfy all informed consent requirements may be included in the study. exclusion criteria: 1. females of childbearing potential (those who are not surgically sterile, postmenopausal or using a reliable birth control method) will be excluded from the study. 2. any allergic component or contraindication to the study medications 3. pachymetry of 600 microns or greater 4. systemic corticosteroids not on a stable regimen within 30 days of screening visit. 5. any concurrent topical agents that can not be discontinued during the course of the trial (natural tears are acceptable) 6. significant ocular surface abnormalities 7. patients with any form of glaucoma other than ocular hypertension or open-angle glaucoma 8. patients who have been on an investigational therapy within 30 days prior to screening visit 9. history of ocular trauma within the past 3 months 10. intraocular surgery within the past 3 months 11. ocular laser surgery within the past 3 months 12. any abnormality preventing reliable applanation tonometry of either eye 13. va of 20/200 or greater in either eye 14. history or evidence of clinically significant illness or conditions which would make the patient, in the opinion of the investigator, not suitable for the study
extension study of v72p13 to evaluate the safety, tolerability and immunogenicity of novartis meningococcal b recombinant vaccine when administered as a booster or as a two-dose catch-up to healthy toddlers

Conditions: Meningococcal Disease

Summary: the proposed study is an extension study of v72p13 to evaluate the safety, tolerability and immunogenicity of novartis meningococcal b recombinant vaccine when administered as a booster at 12 months of age or as a two-dose catch-up to healthy toddlers


Eligibility criteria:
inclusion criteria: * healthy 12-month-old toddlers (0/ +29 days) who completed study v72p13 exclusion criteria: * previous ascertained or suspected disease caused by n. meningitidis; * history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * any serious chronic or progressive disease * known or suspected impairment/ alteration of the immune system, * receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.

Keywords: toddler meningococcal disease prevention vaccination
outcome following use of different concentrations of naocl as wound lavage and hemostatic agent in partial pulpotomy

Conditions: Irreversible Pulpitis; Extremely Deep Caries; Partial Pulpotomy

Summary: the aim of this randomised control trial is to compare the effect of different concentrations of naocl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. the main question it aims to answer are: 1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% naocl in mature permanent teeth with clinical signs indicative of irreversible pulpitis. 2. ohrqol and pain experience after use of 5% and 3% naocl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

title :- outcome following use of different concentrations of naocl as wound lavage and hemostatic agent in partial pulpotomy: a randomised control trial. question it aims to answer: does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? p (population) -mature permanent mandibular molars with signs of irreversible pulpitis. i (intervention) - 5% naocl c (comparison) - 3% naocl o (outcome) - 1. assessment of clinical and radiographic success at 12 months of follow up. 2. assessment of ohrqol and pain experience at baseline, post-operatively every 24 hours for 1 week and ohrqol at 6 and 12 months. in literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. however, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. the previous studies indicate that the use of naocl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of naocl.so, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.

Eligibility criteria:
inclusion criteria: 1. mature permanent mandibular molars. 2. teeth with clinical diagnosis of symptomatic irreversible pulpitis 3. patients having normal periapical status with periapical index (pai) score ≤ 2 4. periodontally healthy teeth 5. patients having physical status of class 1 or 2 according to asa classification 6. pulpal bleeding can be controlled within 6 minutes. 7. presence of extremely deep carious lesion on radiograph - exclusion criteria: 1) non restorable teeth 2) necrotic pulp evident upon exposure 3) negative response to vitality test 4) presence of sinus tract 5) presence of soft tissue swelling 6) radiographic signs of internal or external root resorption 7) pregnant women -

Keywords: partial pulpotomy sodium hypochlorite mature permanent mandibular molars hemostatic agent
uptake to colorectal cancer screening in familial-risk population

Conditions: Colorectal Cancer; Screening Uptake of Colonoscopy and FIT

Summary: this is a multicenter, controlled, randomized phase iii study to compare participation rate with two screening rounds of fecal occult blood test (fit) versus one-time screening colonoscopy in first degree relatives (fdr) of patients diagnosed of colorectal cancer (crc). the hypothesis of the study is that annual fit uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. assuming an uptake of 0.50 for colonoscopy and 0.60 for fit, a type i error (alpha) of 5% and a power of 90%, 538 fdrs will be necessary to include in each group.

this is a multicenter, controlled, randomized phase iii study to compare participation rate with two screening rounds of fit versus one-time screening colonoscopy in fdr of patients diagnosed of crc. the recruitment process will be programmed through the index case, that will be interviewed to obtain their crc family history. fdr will be contacted in order to make an appointment in the high-risk crc clinic of the participant centers. randomization will be performed before signing the informed consent to avoid selection bias. a researcher will be responsible to provide detailed information about the study and getting the informed consent. in case of willingness to participate in the study, the fdr will be randomized to one of the following arms: a) one-time colonoscopy; b) annual fit for two screening rounds and a colonoscopy in case of a positive fit (cut-off = 10 μg hemoglobin/g feces). screening uptake will be defined as the percentage of fdr who participate at least in one of the two fit screening round in the fit group or who undergo colonoscopy in the other group. screening uptake will be calculated under the assumption of intention to screen analysis. the hypothesis of the study is that annual fit uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. assuming an uptake of 0.50 for colonoscopy and 0.60 for fit, a type i error (alpha) of 5% and a power of 90%, 538 fdrs will be necessary to include in each group.

Eligibility criteria:
inclusion criteria: 1. fdr with a case index meeting the following conditions: at least one case index \< 60 years at diagnosis of the ccr; 2. having ≥ 2 fdrs with crc regardless the age of the case index at diagnosis; 3. having a sibling with crc; 4. age \<75 years. exclusion criteria: 1. past crc screening; 2. inflammatory bowel disease or past history of colorectal neoplasia; 3. family history of hereditary crc; 4. abdominal symptoms; 5. colectomy; 6. severe comorbidity leading to a poor prognosis (life expectancy \< 5 years); 7. refusal to participate in the study.

Keywords: immunochemical fecal occult blood test colonoscopy screening uptake screening participation familiar risk colorectal cancer
airway involvement in inflammatory bowel disease

Conditions: IBD

Summary: to estimate prevalence of subclinical airway injuries among ibd patients. to investigate relationship between activity of ibd and airways

airway diseases are the most commonly described lung manifestations of inflammatory bowel disease (ibd). however, the similarities in disease pathogenesis and the sharing of important environmental risk factors and genetic susceptibility suggest that there is a complex interplay between ibd and airway diseases.extraintestinal manifestations (eim) commonly occur in inflammatory bowel diseases (ibd), with a prevalence rate between 21%-41% reported in various series. crohn's disease (cd) presents with eim more frequently than ulcerative colitis (uc). pulmonary involvement complicating ibd was originally considered rare (with a frequency rate \< 1%), but the first case series published in 1976 assisted in better recognition, evaluation and description of ibd related respiratory disease. pulmonary involvement is often asymptomatic and may be detected solely on the basis of abnormal screening tests. this review will focus on the involvement of the airways in the context of ibd. although ibd related pm were originally considered rare, certain population-based studies have revealed significant interrelationships between the lungs and ibd. bernstein and colleagues in a large population-based study in north america in 2005 reported that airway disorders in general (including asthma and bronchitis) were the most common extraintestinal manifestation in subjects with cd and the second most common in subjects with uc, with the prevalence of asthma in this population between 7%-8%. in another retrospective study from the opposite view, birring reported that ibd was 4 times more prevalent among patients with airway diseases, particularly non-asthmatic patients with productive cough, than in the general population.

Eligibility criteria:
inclusion criteria: * patients attended to ibd clinic at tropical department exclusion criteria: 1. age: less than 18 years 2. unstable patients or need for icu admission
is the decrease in the bispectral index correlated with a decrease in cardiac output during the induction of anaesthesia?

Conditions: Thoracic Surgery

Summary: monitoring the bispectral index (bis) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which bis monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. the current controversy concerning the "triple low" state reinforces the need for an accurate study in this field. furthermore, the recent review by bidd argues in this sense.


Eligibility criteria:
inclusion criteria: * adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth * good echogenicity * social security coverage exclusion criteria: * pregnancy * subjects with black skin (a known technical limitation of plethysmography) * cardiac arrhythmia * sepsis * poor echogenicity * legal guardianship or incarceration * complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Keywords: anaesthesia
comparison of once daily 40 mg torsemide with twice-daily 40 mg furosemide

Conditions: Body Weight Changes

Summary: to compare the effects of 40 mg once-daily torsemide er to 40 mg twice daily furosemide on 24-hour sodium excretion.

to compare the effects of 40 mg once-daily torsemide er to 40 mg twice-daily furosemide on changes in body weight after two weeks of treatment. to compare the frequency and volume of urine passed in 24 hours. to compare the patients' quality of life and levels of natriuretic peptide between the two sets of patients.

Eligibility criteria:
inclusion criteria: * patients of either gender over 18 years of age with clinical diagnosis of chf and on a stable dose of 40 mg furosemide. exclusion criteria: * requirement for any other diuretic, history of cardiac dysrhythmia, other concurrent cardiovascular illness.

Keywords: natriuresis
experimental biomarker study for pain thresholds

Conditions: Pain

Summary: the purpose of this study is to characterize the heat pain tolerance threshold (hptoltr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by uvb (ultraviolet b) irradiation and topical capsaicin.


Eligibility criteria:
inclusion criteria include: 1. signed informed consent obtained. 2. males aged 18 to 45, inclusive. 3. body weight ranging from 50 to 100 kg and bmi ranging from 18 to 32 (kg/m2), inclusive. 4. healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ecg. exclusion criteria include: 1. current or recent (within 5 years) history of drug or alcohol abuse. 2. history or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion. 3. any history of frequent nausea or emesis regardless of etiology. 4. any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other nsaids. 5. subjects who do not develop erythema at the maximum dose of the uvb source (med determination for uvb model) will be excluded from the study. other protocol-specific inclusion/exclusion criteria may apply.
myo-inositol, alpha-lactalbumin and folic acid treatment in pcos

Conditions: Polycystic Ovary Syndrome

Summary: the main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on homa-index improvement in two different groups of women, belonging to the mexican and italian population, both affected by polycystic ovary syndrome.

this is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on homa-index improvement in two different groups of pcos patients from the mexican and italian population. the addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. the scientific evidence so far available shows that these two groups of pcos women have a different genetic, nutritional, and behavioural profile. important factors are body mass index and insulin resistance, both increased in the mexican women, although among them pcos prevalence is not higher compared to many other populations. therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.

Eligibility criteria:
inclusion criteria: * pcos diagnosis based on the rotterdam eshre-asrm consensus workshop group1. * presence of insulin resistance diagnosed by homa-index * patients belonging to the mexican population * patients belonging to the italian population exclusion criteria: * bmi ≥ 30 * other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and cushing syndrome * hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation * drastic changes in diet and physical activity * treatment with products containing inositols in the previous 3 months

Keywords: myo-inositol alpha-lactalbumin homa-index ovulation hyperandrogenism