Kornimate/medical-research-clean huggingface dataset:
a cross-sectional study on the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer

Conditions: Colorectal Cancer

Summary: the goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (crc). the main question it aims to answer is: are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)

to explore whether peptidoglycan fragments can be used as screening or diagnostic indicators for colorectal cancer

Eligibility criteria:
inclusion criteria: * people who underwent total colonoscopy in gastroenteroscopy room. * people who agree to participate in this study and are willing to sign informed consent. exclusion criteria: * previous diagnosis of malignant tumors other than colorectal cancer. * received any of the following drug treatments within 1 month before sample collection: ① drugs used for the treatment of colorectal diseases; ② antibiotics; ③probiotics; ④ laxatives. * patients with a family history of colorectal cancer.
surgical repercussions in respiratory system in patients with post-traumatic brachial plexus injuries: a prospective cohort study

Conditions: Brachial Plexus Injury; Respiratory Evaluation

Summary: to evaluate the surgical repercussions in patients with traumatic brachial plexus injury in the respiratory and motor systems, trunk biomechanics, functional capacity and quality of life.

type of study will be a prospective cohort. the study will be performed at the laboratory of cardiopulmonary physiotherapy of the federal university of pernambuco (ufpe). the sample will be calculated from a pilot study to be previously performed. the pilot study should have 10 individuals, 5 patients in each of the two groups. a group of patients who has brachial plexus injury and a group of healthy individuals for the pairing by sex and age. eligibility criteria: patients who will undergo surgical intervention (within one year of the trauma), of both sexes, between 20 and 45 years of age, sedentary (oriented and encouraged to perform the activities of daily living at home, however , outside of any rehabilitation program) and encouraged to refrain from using tobacco. patients with pulmonary contusions, severe pneumopathies, patients with congestive heart failure (nyha class iii or iv), diabetes mellitus, coronary artery disease, hemodynamic instability (map \<60 mmhg), multiple thorax fractures, amputation of one limb cognitive changes. physiotherapeutic evaluations will be performed by a single physiotherapist trained in the preoperative one, three and six months after surgery for brachial plexus injury. the instruments of evaluation included are: optoelectronic plethysmography, spirometry, manovacuometry, diaphragmatic ultrasound, g-walk, upper limb dynamometry, pain questionnaires (mcgill and dn4), upper limb functionality questionnaire (dash) minutes and the quality of life questionnaire (whoquol). expected results: the greatest impact should be to assist the patient in the prevention and physiotherapeutic treatment in relation to the possible sequels arising from the surgical process, besides fomenting the literature, expanding the knowledge about the subject and determining the applicability of the existing therapeutic resources, so that these are not used indiscriminately in daily practice.

Eligibility criteria:
inclusion criteria patients who will undergo surgical intervention; male; between 20 and 45 years of age; sedentary. exclusion criteria pulmonary contusions; severe pneumopathies; diabetes mellitus; coronary artery disease; multiple thorax fractures; amputation of one limb; cognitive changes -
safety and efficacy study of rph201 treatment of ischemic optic neuropathy (ion).

Conditions: Non-arteritic Ischemic Optic Neuropathy; Optic Nerve Injuries

Summary: the study objectives are to assess any changes in visual acuity and visual field observed following the administration of rph201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.


Eligibility criteria:
inclusion criteria: 1. participants, either men or women are ≥ 18 years of age. 2. diagnosis of ischemic optic neuropathy unilateral or bilateral: 1. traumatic neuropathy 2. ischemic optic neuropathy - non arteritic ischemic neuropathy (naion) 3. corrected visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both. 4. field of view with a reduction from 10 degrees to one quarter situations functions. 5. participant understands the nature of the procedure and provides written informed consent prior to any study procedure. 6. women of child bearing potential must use adequate birth-control precautions. exclusion criteria: 1. glaucoma 2. neuropathy caused by tumors. 3. neuropathy caused by infections 4. mitochondrial optic neuropathies 5. nutritional, radiation, toxic optic neuropathies 6. retinal diabetic complications 7. hereditary optic neuropathies 8. patients with complete scotoma beyond three quarters. 9. clinical evidence for presence of infection. 10. patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy. 11. patient has a history of alcohol or drug abuse within the last two years. 12. female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception. 13. participation in another clinical trial within 60 days prior to the screening visit or during this study. 14. clinically significant and/or uncontrolled condition or other significant medical disease 15. clinically significant uncontrolled retinal disease (amd)

Keywords: ischemic optic neuropathy traumatic neuropathy non arteritic ischemic neuropathy (naion)
efficacy of an advanced auto-titrating niv in copd

Conditions: Chronic Obstructive Pulmonary Disease Severe

Summary: patients with chronic obstructive pulmonary disease (copd) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. non-invasive ventilation (niv) is a ventilator therapy that is used in copd patients who suffer from respiratory failure. studies have demonstrated that using niv at night regularly can result in improved clinical outcomes. adherence to this therapy is variable, however. this can be due to poor synchrony between the device and the lungs. a novel ventilator has been designed that delivers niv but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath. the investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. the primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator. patients with copd who use ventilation at home will be screened for inclusion in the study. participation will involve a screening visit, and a further two visits to the lane fox respiratory unit. the first will require a two-night admission and the second a single-night admission. they will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. these visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home. patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. this will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.


Eligibility criteria:
patient inclusion criteria: * age ≥ 18 years * bmi \<30 kg/m¬2 * confirmed diagnosis of copd * currently using domiciliary niv with average reported compliance of at least 3hours * ability to provide informed consent * medical stability confirmed by recruiting physician * free of exacerbations for at least 2 weeks prior to enrolment * presence of expiratory flow limitation on forced oscillation technique criteria exclusion criteria: * current acute illness as determined by recruiting physician e.g. upper respiratory tract infection * presence of major medical comorbidity, e.g. severe heart failure (lvef \<30%), active malignancy, end-stage renal failure (ckd 4), and neuromuscular disease * subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. * psychosocial factors that would prevent compliance with study protocol healthy participant inclusion criteria: * age ≥ 18 years * no expiratory flow limitation on forced oscillation testing * no acute illness on study day * ability to provide informed consent
osteotomy of the 1st metatarsal for hallux valgus using pneumatic oscillating saw or piezoelectric scalpel

Conditions: Hallux Valgus

Summary: the main goal of the surgical correction of the hallux valgus is the morphological correction associated with the functional rebalancing of the first ray. the aim of this study was to show the efficacy of piezosurgery in performing distal linear osteotomy of the first metatarsal bone in hallux valgus correction, in terms of clinical and radiological outcomes at 1-year final follow up.

this study was performed collecting pre-operative and post-operative data for all patients. at the time of admission, the patients received and signed an informed consent to adhere to the study protocol. on this occasion, the patients were also given a summary scheme of the clinical and radiographic checks to which they would have undergone in case of adherence to the study protocol. 40 patients were included in the trial and were randomly allocated (1:1) in a piezoelectric group (pg) and in a control group (cg) (that provided for the use of a traditional oscillating saw) utilizing sealed envelopes. the envelopes were prepared and shuffled by the same senior surgeon involved in the surgical procedures and drawn by a researcher not involved in the surgical procedures or the clinical and radiographic assessment. the patients were not aware of the instrument used during surgery. in both groups, patients were treated with the same surgical technique, a distal linear osteotomy of the first metatarsal bone (s.e.r.i. technique). clinical and radiographic assessments were performed during the multiple follow-ups. the final follow-up was at 1 year.

Eligibility criteria:
inclusion criteria: * age 18-80 * mild to moderate hallux valgus (hallux valgus angle \<; 40° and intermetatarsal angle \< 20°), * no osteoarthritis or grade 1 osteoarthritis of the first metatarsophalangeal joint (mtpj) according to regnauld grading exclusion criteria: * stiffness of the first mtpj or osteoarthritis ≥ grade 2 according to regnauld's classification * rheumatoid arthritis or other chronic inflammatory joint diseases * diabetes * neurological disorders * previous hallux valgus surgical corrections * hypermobility of the first mtpj as per congenital laxity syndromes.

Keywords: hallux valgus radiographic consolidation piezoelectric scalpel
no time to pause: physical activity to improve health of midlife hispanic women

Conditions: Elevated Blood Pressure; Perimenopause

Summary: this study will test the effects of a physical activity intervention among midlife hispanic women.

the menopausal transition in midlife is a critical juncture where women experience life transitions and adverse physiological and psychological changes that increase the risk for hypertension and cardiovascular diseases in later life. physical activity improves blood pressure, biomarkers of hypertension, sleep, mood, and well-being; however, hispanic women meet physical activity recommendations at lower levels than non-hispanic white women. the investigator will examine the feasibility of the physical activity intervention among sedentary midlife hispanic women in the menopausal transition with elevated blood pressure, exploring changes in physical activity and health.

Eligibility criteria:
inclusion criteria: 1. female 2. hispanic by self-report 3. able to speak and read english 4. sedentary 5. age 45-50 6. diagnosed with elevated blood pressure or objectively measured systolic blood pressure 120-139 mmhg and/or diastolic blood pressure 80-89 mmhg averaged from ≥ 2 measures on ≥ 2 outpatient visits 7. symptoms consistent with the menopause transition (persistent difference of ≥7 days in the length of consecutive cycles; persistence is defined as recurrence within 10 cycles of the first variable length cycle) 8. apparently healthy 9. self-reported ability to engage in moderate intensity physical activity 10. access to a smart device that is compatible with a fitbit application exclusion criteria: 1. self-reported physical activity of ≥150 minutes per week 2. answered yes to any question on the physical activity readiness (par-q+) questionnaire 3. post-menopausal (12-months without a menstrual cycle) 4. diagnosed hypertension 5. cardiovascular, respiratory, neurological, renal, endocrine, gastrointestinal and/or psychiatric diseases, or any cancers 6. previous hysterectomy, oophorectomy, and/or uterine ablation 7. medication to treat hypertension, elevated glucose, cholesterol, depression, anxiety, and insomnia 8. hormonal medication via any route or implants 9. tamoxifen 10. pregnant, planning to become pregnant, or breastfeeding 11. planning to move out of the galveston/houston area in the next 18 months 12. current participation in another physical activity study or program

Keywords: physical activity women's health minority health behavior change hypertension prevention
renal pk study of lc350189

Conditions: Gout; Hyperuricemia

Summary: this is a phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the pk and pd of lc350189.


Eligibility criteria:
inclusion criteria * the subject has a bmi of 18 to 40 kg/m2, inclusive, at screening. * the subject is able to provide written informed consent. for healthy subjects only : the subject has normal renal function as determined by egfr and calculated using the mdrd formula, or by 24-hour urine creatinine clearance (clcr) corrected for body size. for subjects with renal impairment only : the subject has mild, moderate, or severe renal impairment as determined by egfr and calculated using the mdrd formula. exclusion criteria * the subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator. * the subject has nephrotic syndrome, defined as serum albumin \ 350 mg/mmol (as an estimate of approximate proteinuria of \>3.5 g/day) at screening.
intravenous immunoglobulin (ivig) for parvovirus b19(pvb19) mediated cardiomyopathy

Conditions: Myocardial Diseases; Parvovirus B19, Human

Summary: a prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of ivig on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic icm and a high pvb19 load in the heart.

rationale: parvovirus b19 (pvb19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy. objective: a controlled trial to investigate whether high dose of intravenous immunoglobulin (ivig) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and pvb19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination. study design: all patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (emb)), treatment and follow-up for their heart failure. patients will be randomized to either receive ivig or placebo on top of their standard heart failure regimen.

Eligibility criteria:
inclusion criteria: * idiopathic cardiomyopathy (lvef \ 6months * optimal conventional heart failure medication \>3 months. * pvb19 viral load \>200 copies/mcg dna in endomyocardial biopsies (embs). * signed informed consent * aged between 18 and 75 years exclusion criteria: * other causes for heart failure * significant coronary artery disease (lesions \>70 % stenosis) * significant valvular disease * untreated hypertension (blood pressure \>140mmhg) * substance abuse * chemotherapy induced * significant titer of other cardiotrophic viruses (ev, adv, hhv6, ebv) * pregnancy or lactation * systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases. * treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study * known with allergic reactions against human plasma or plasma products * having an ongoing progressive terminal disease, including hiv infection * having renal insufficiency (plasma creatinin \>115µmol/l or creatinin clearance \<20 ml/min) * having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints * having detectable anti-iga antibodies * active sle

Keywords: immunoglobulins, intravenous cardiomyopathies parvo b19, human
influence of diabetes on tramadol pharmacokinetics

Conditions: Neuropathic Pain; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: this study aimed to investigate the influence of uncontrolled type 1 and type 2 diabetes mellitus (dm) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics of tramadol enantiomers in patients with neuropathic pain. thus, nondiabetic patients (control group, n = 12), patients with type 1 dm (n = 9), and patients with type 2 dm (n = 9), all with neuropathic pain and phenotyped as extensive metabolizers of cytochrome p450 2d6 (cyp2d6) who were treated with a single oral dose of 100 mg racemic tramadol were investigated.

tramadol is a centrally acting analgesic that effectively relieves acute and chronic pain, including neuropathic pain in diabetic patients. the drug is available in clinical practice as a mixture of the (+)-tramadol and (-)-tramadol enantiomers. tramadol is metabolized by cyp2d6 to o-desmethyltramadol (m1) and by cytochrome p450 3a (cyp3a4) and cytochrome p450 2b6 (cyp2b6) to n-desmethyltramadol (m2). both tramadol enantiomers and (+)-m1 contribute to the analgesic activity of the drug: (+)-tramadol and the (+)-m1 metabolite act as -opioid receptor agonists; (+)-tramadol inhibits serotonin reuptake; and (-)-tramadol inhibits the reuptake of norepinephrine. this study investigated the influence of uncontrolled type 1 and type 2 diabetes mellitus (dm) on the kinetic disposition, metabolism and pharmacokinetics-pharmacodynamics of tramadol enantiomers in patients with neuropathic pain. nondiabetic patients (control group, n = 12), patients with type 1 dm (n = 9), and patients with type 2 dm (n = 9), all with neuropathic pain and phenotyped as extensive metabolizers of cyp2d6, received a single oral dose of 100 mg racemic tramadol. serial blood samples were collected up to 24 h after administration of the drug for pharmacokinetic study and for the analysis of noradrenaline in plasma. pain was rated on a visual analog pain scale at the same time as blood sampling. the patients were evaluated for in vivo cyp3a activity using midazolam as a probe drug and genotyped for cyp2b6. total and unbound plasma concentrations of the tramadol, m1 and m2 enantiomers were analyzed by liquid chromatography coupled to tandem mass spectrometry (lc-ms/ms).

Eligibility criteria:
inclusion criteria: * adult patients, both gender * patients with self-reported neuropathic pain (score \>4 in a 0-10 visual analog scale) * patients with normal renal function (creatinine clearance \>60 ml/min) exclusion criteria: * patients with nociceptive somatic pain, visceral or autonomic associated during the study period; * patients with morbid obesity (bmi\> 40), congestive heart failure, severe hypertension * patients who have had acute myocardial infarction or accident stroke less than 6 months of the period of investigation. * patients with chronic obstructive pulmonary disease * patients who were in use of analgesics, cyp2d6 inhibitors or cyp3a4 inducers or inhibitors were excluded. * pregnant and lactating patients were excluded.

Keywords: tramadol pharmacokinetics enantiomers metabolism diabetes
assessing the ability of warfarin treated patients to predict their inr

Conditions: Atrial Fibrillation

Summary: assessing the ability of warfarin treated patients to predict their inr kathleen mcnamara, james hoehns, matthew witry the international normalized ratio (inr) is the accepted lab test used to measure the intensity of warfarin effect. the conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an inr result, whether or not they are therapeutic at any given time. some warfarin treated patients express that they have insight into what their inr result will be. various patient related factors may contribute to these opinions. our objective is to assess how accurately patients can guess their inr result before it is obtained and to describe factors which inform their opinion of what their inr will be.

assessing the ability of warfarin treated patients to predict their inr kathleen mcnamara, james hoehns, matthew witry the international normalized ratio (inr) is the accepted lab test used to measure the intensity of warfarin effect. the conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an inr result, whether or not they are therapeutic at any given time. some warfarin treated patients express that they have insight into what their inr result will be. various patient related factors may contribute to these opinions. our objective is to assess how accurately patients can guess their inr result before it is obtained and to describe factors which inform their opinion of what their inr will be. in this prospective study, the investigators will enroll warfarin treated patients from 7 anticoagulation clinics in iowa. inclusion criteria are: age ≥18 years, warfarin use ≥60 days, inr goal of 2.0-3.0 or 2.5-3.5, expected warfarin use \>6 months, and english speaking. exclusion criteria include: use of self inr-testing, home inr draws, dementia, or residing in a long-term care facility. a data collection form will be completed prior to inr measurement for a 6 month period. information will be collected for subject demographics, warfarin adherence, inr stability, inr prediction, and prediction rationale. inr monitoring represents a significant burden with respect to cost and time. the results of this study may identify patient factors which could help individualize and decrease the frequency of inr monitoring in patients who receive maintenance warfarin therapy.

Eligibility criteria:
inclusion criteria: * age ≥18 years * warfarin use ≥60 days * inr goal of 2.0-3.0 or 2.5-3.5 * expected warfarin use \>6 months * english speaking exclusion criteria: * self inr-testing * home inr draws * dementia * residence of a long-term care facility

Keywords: warfarin