Kornimate/medical-research-clean huggingface dataset:
impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery

Conditions: Allodynic Symptoms; Localized Neuropathic Pain

Summary: the aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery.

this is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5lp) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5lp compared to placebo. pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.

Eligibility criteria:
inclusion criteria: * aged from 18 to 80 years * male or female, for women of childbearing potential, a negative pregnancy test * patients with ponp following knee surgery * patients with neuropathic pain dn4 ≥ 4 * patients at least 3 months post-surgery * patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (dma) rated as ≥ 5/10 on the numerical scale * patient with no localized neuropathic pain symptoms (dn4\<4) on the contralateral knee * intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied * naive from versatis® treatment * treated with stable systemic analgesic and planned to remain stable all over the duration of the study * insured by french social security * included or agreement to be included in the national register of participants in biomedical research exclusion criteria: -

Keywords: localized neuropathic pain 5% lidocaine medicated plaster knee surgery
effect of intradialytic exercises in chronic kidney disease patients

Conditions: Chronic Kidney Disease stage3

Summary: the purpose of this study is to compare between intradialytic aerobic versus resistive exercises on immunity response in patients with chronic kidney disease.

the patients of this study will randomly assigned into three equal groups (n=20) 1. study group a (20 patients) will receive intradialytic aerobic exercise and medical treatment. 2. study group b (20 patients) will receive intradialytic resistive exercise and medical treatment. 3. control group c (20 patients) will receive medical treatment only (hd session and drugs) each patient will receive the treatment program three times per week for three months.

Eligibility criteria:
inclusion criteria: * sixty men chronic kidney disease (grade iii rf). they received regular hemodialysis sessions at least one year ago, each one for four hours, three times per week. * they had a history of type ii diabetes more than five years. * their age will be ranged from 50-60 years old. * they are fit for exercise by functional assessment using six minute walk test. * their hemoglobin level more than 10 g\\dl. * their body mass index (bmi) will be ranged from "18.5" to "24.9". exclusion criteria: * severe cardiac disorders. * severe orthopedic problems (for example fractures). * hepatic encephalopathy. * preexisting neuromuscular diseases (e.g. myasthenia gravis). •severe chest diseases. * spinal cord injuries involved the phrenic nerve. * uncontrolled diabetes or hypertension * patients receiving inefficient hemodialysis session. * patients with other cause for inflammation e.g. malignancy and autoimmune disease. * active bleeding as alveolar hemorrhage, hemoptysis. * physical limitation that would limit cycling.

Keywords: exercise dialysis kidney failure chronic
effect of preoperative information to parents before ear-nose-throat pediatric surgery

Conditions: Anxiety; Consumer Satisfaction

Summary: children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. a main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. the purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.


Eligibility criteria:
inclusion criteria: * parents with children undergoing ear-nose-throat surgery in the study period exclusion criteria: * parents who do not speak nor read norwegian. * parents who do not want to participate

Keywords: parents patient education as topic preoperative care pamphlets
salt intake, microbiota, immune response and endothelial function in hypertension

Conditions: Hypertension

Summary: hypertension is a significant cardiovascular risk factor which affects 45% of the adult population. salt intake is essential in the development and progression of hypertension. a reduction in salt intake is associated with a reduction in blood pressure and a 25% lower risk of suffering a cardiovascular event. the mechanisms involved in the association between salt intake and blood pressure are a topic of discussion. increased salt intake can modify cardiovascular function, inducing endothelial dysfunction, modyfing the activity of the immune system and increasing inflammation or oxidative stress. in recent years, dietary salt intake has been linked to intestinal depletion of certain genera of bacteria such as lactobacillus. tryptophan metabolites formed by these bacteria have been shown to modulate the activity of pro-inflammatory cells such as th17/cd4+, interleukin 17a producing cells. studies in animal models have demonstrated that interleukin 17a is able to raise blood pressure by hindering endothelium-dependent vasodilation mechanisms. it is also able to cause sodium and water retention, increase albuminuria, induce renal microvascular injury and vasoconstriction and promote vascular stiffening, cardiac hypertrophy and fibrosis. the main objective of this trial is to describe the relationship between salt intake, gut commensal microbiota, th17 activity, endothelial dysfunction and blood pressure evolution in a sample of patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * diagnosis of primary hypertension on treatment for at least 12 months with an acei or arb-ii in monotherapy. * able to understand the study objectives and to provide written informed consent. exclusion criteria: * severe hypertension, defined as a sitting systolic blood pressure ≥200 mmhg, a sitting diastolic blood pressure ≥115 mmhg or a maximum-minimum difference of ≥20 mmhg in systolic blood pressure or ≥10 mmhg in diastolic blood pressure between the right and left arms after three measurements on each arm. * suggestive symptoms of secondary hypertension, such as abrupt onset hypertension, age \<30 years, advanced end organ damage, new-onset diastolic hypertension in the elderly, * treated with antihypertensive drugs other than aceis or arbs. * use of drugs that affect diuresis or natriuresis. * poorly controlled type 1 or 2 diabetes, defined as a fasting blood glucose ≥200 mg/dl or hba1c ≥9%. * history of cardiovascular disease, defined as acute myocardial infarction, ischemic transient attack or stroke, congestive heart failure, peripheral vascular disease or cardiac arrhythmias. * chronic obstructive pulmonary disease. * liver or kidney disease. * pregnant or lactating women. * legal incapacity or impossibility to understand the study objectives.

Keywords: hypertension salt intake
evaluation of the impact of l- carnitine in intradialytic hypotension in pediatric patients on regular hemodialysis

Conditions: Intradialytic Hypotension

Summary: intradialytic hypotension (idh) is defined as less than the 5th percentile of sbp measurements and is associated with clinical symptoms, such as abdominal pain, nausea, vomiting, muscle cramps, restlessness, light-headedness, syncope, and anxiety. in adults there is no consensus definition of idh, however, according to the kidney disease outcomes quality initiative and european best practice guidelines, idh is defined as a decline in systolic blood pressure ≥20 mmhg or a decrease in a mean arterial pressure by 10 mmhg and associated with clinical events like abdominal pain, nausea, vomiting, muscle cramps, dizziness, fatigue, and restlessness. idh occurs in response to the reduction in blood volume (bv) during ultrafiltration (uf) and subsequent poor compensatory mechanisms due to abnormal cardiac function (left ventricular dysfunction, chamber remodeling, congenital heart diseases, and arrhythmias) or autonomic or baroreceptor failure. to maintain volume status, the body shifts fluid from the interstitial space to the intravascular space and increases heart rate, contractility, and vascular tone. plasma refilling, another essential factor in maintaining euvolemia, depends on oncotic, osmotic, and hydraulic gradients across vascular beds. if uf rates surpass plasma refilling rates, intravascular volume falls and hypotension results. hematocrit levels, tissue hydration and arterial vasoconstriction all promote plasma refilling rates. alterations in these factors during dialysis decrease the plasma refilling rate, resulting in hypotension. aim of the work: the aim of this study is to assess and evaluate the efficacy and safety of l carnitine in the prevention of intradialytic hypotension in pediatric patients on regular hemodialysis.


Eligibility criteria:
inclusion criteria: * patients aged 6-18 years * patients on hemodialysis for 3 months or longer * patients on hemodialysis frequency 3 times weekly (with the same dialysate concentration and temperature) * patients who had two or more episodes of intradialytic hypotension during dialysis (less than the 5th percentile of sbp measurements and is associated with clinical symptoms) in the last 3 months. exclusion criteria: * patients with life expectancy \< 3 months * patients with known hypersensitivity to l carnitine * patients received l carnitine in the previous 6 months
less surgery versus conventional multiport laparoscopy in ovarian drilling

Conditions: Successful Surgical Procedure; Operative Time; Cosmetic Outcome; Intra- and Post- Operative Complications

Summary: laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure with less side effects

laparoendoscopic single-site surgery; one of the most recent advances in the field of minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards successful surgical procedure without conversion to laparotomy or use of an additional port in the single site group. in addition to operative time, intra- and post- operative complications and cosmetic outcome.

Eligibility criteria:
inclusion criteria: * pcos according to rotterdam criteria (2 out of 3): * polycystic ovaries (12 or more follicles in each ovary and/or increased ovarian volume \>10 cm3). * oligo- or an-ovulation. * clinical and/or biochemical hyperandrogenisim. after exclusion of other aetiologies for irregular cycles. * indications of laparoscopic ovarian drilling: * clomiphene citrate- resistance or failure: failure to conceive after 6 to 9 cycles. * other indications for laparoscopy. * before gonadotropin administration to decrease risk of ohss and multiple pregnancy. * before art to decrease risk of severe ohss in women who previously had canceled ivf cycles due to ohss risk or who suffered from ohss in a previous treatment. exclusion criteria: * previous 2 or more laparotomies. * chronic pelvic pain, endometriosis or pelvic inflammatory diseases to avoid pelvic adhesions and bias in the quantification of postoperative pain. * high bmi (\>35kg/m2) * do not possess a native umbilicus. * advanced gynaecological surgeries or malignant disorders (tlh, alvh, laparoscopic myomectomy). * contraindication to any laparoscopy like any medical condition worsened by pneumoperitoneum or trendelnburg position.

Keywords: less surgery conventional multi-port laparoscopy sils single-site surgery covidien laparoscopy minimally invasive surgery ovarian drilling pcos diagnostic laparoscopy
reducing malnutrition and helminthic infectious disease among primary school children by the school nurses

Conditions: Malnutrition, Child; Intestinal Worms

Summary: title: reducing malnutrition and helminthic infectious disease among primary school children by the school nurses: school-based non-randomized study in a developing country introduction: globally, malnutrition alone with the infectious disease a widespread problem among primary school (5 to 12 years) children. infectious diseases such as worm infestations are aggravated with nutritional disorders which most often lead to anemia and several complications. the prevalence of malnutrition and intestinal worm infestation/ helminthic infection is still high and the awareness level of those issues is immensely poor. however, there are limited studies that evaluated the impact of increasing health awareness by the development of the health awareness program for primary school children (hapsc) which is conducted by the experimentally placed school nurse in bangladesh. objective: to increase health awareness and knowledge towards reducing malnutrition and intestinal worm infestation by implement and evaluate the impact of the health awareness program for primary school children (hapsc) in bangladesh. methods: design: a prospective, open-label, parallel-group (1:1), cluster non-randomization controlled trial (nrct) site and sample: school children from four primary schools in the rural areas of north matlab at chandpur district at chittagong division in bangladesh. duration: the duration of this study is from august 2021 to march 2024 (32nd months). outcome variables: primary: changes in malnutrition among primary school children. secondary: evaluate and reduce the prevalence of intestinal worm infestation, increase awareness and knowledge regarding malnutritional and intestinal worm infestation, improvement of health behavior (eating and hygiene), frequency of school absent days, and health-related quality of life. conclusion: health education by the health professional in the school setting may be an effective method for improving health behavior, and increasing awareness and knowledge levels about malnutrition and intestinal worm infestation from early childhood.


Eligibility criteria:
inclusion criteria: * the primary school children who are studying in class 1 to class 5 among male, female or others gender. * the children's parents or legal guardians would like to give consent and are willing to participate in the study. * those, who will be agreed to receive health check-ups, answer questionnaires and are willing to give the sample for laboratory investigation. * who will stay in the same school and area till study completion. exclusion criteria: * the child is absent from school during the health checkup periods (at baseline) due to severe illness or without any reason and information. * who does not want to give consent and is not willing to participate. * who does not want to share their information and does not want to give the sample for laboratory investigations.

Keywords: malnutrition intestinal worm infestation school nurse primary school children
lubiprostone effects on visceral pain sensitivity

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this research study is to determine how lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (ibs-c), works to reduce clinical pain. lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. the increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. first, we want to test the idea that lubiprostone works by making a person less sensitive to pain. second, we want to confirm that lubiprostone decreases the time it takes fecal matter to travel through your gi tract, referred to as transit time.

subjects will be enrolled in an 8-week study requiring a total of 7 visits to the unc center for clinical and translational research. the protocol is divided into 4 two-week periods: (1) two-week baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) two-week treatment with either lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. in addition, patients will be tested for whole gut transit time by the radio-opaque marker (sitzmark) technique in the second week. (3) two-week washout period, during which patients will continue the symptom diary. (4) two-week crossover to lubiprostone or placebo, identical to the second two-week period.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ibs-c * meeting rome iii diagnostic criteria for ibs-c * age 18 or older exclusion criteria: * use of laxatives or prokinetics within two weeks prior to the study or during the study * use of ibs-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect * use of analgesics for 48 hours prior to the study * hypothyroid condition * history of bowel resection except appendectomy or cholecystectomy * psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion * renal disease * inflammatory or ischemic disease of the rectum * known to be an unreliable subject * because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded.

Keywords: ibs pain threshold constipation
acotec dcb post market clinical follow-up

Conditions: Peripheral Artery Disease

Summary: all-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (pmcf) cohort 1 - claudicants: rutherford clinical category (rcc) 2-3 cohort 2 - critical limb ischemia: rutherford clinical category (rcc) 4-6

to prospectively collect and assess safety and efficacy data on the acoart drug-coated pta balloon catheters carrying the ce mark per current instructions for use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Eligibility criteria:
inclusion criteria: * 1. patient is ≥ 18 years old at the time of consent. * 2. significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment. * 3. lesion(s) can be treated with available acoart orchid (0.035"), acoart tulip (0.018") and acoart litos (0.014") dcb device per current ifu. * 4. subject has provided written informed consent prior to participation in the pmcf, understands the purpose of this pmcf and agrees to comply with all protocol-specified examinations and follow-up appointments. * 5. rutherford classification category 2-6 subjects with rutherford category 2 have gone through a conservative therapy without success. * 6. inflow lesion treated prior to target lesion treatment exclusion criteria: * 1. rutherford classification category 0, 1 * 2. patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints * 3. inability to tolerate required antithrombotic or antiplatelet therapies. * 4. non-dilatable severely calcified lesion. * 5. known hypersensitivity/allergy to components of the investigational device * 6. un-treated acute or subacute thrombus in the target lesion. * 7. life expectancy \< 1 year. * 8. pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. * 9. other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up. * 10. myocardial infarction or stroke within 30 days prior to index procedure.
urine voc investigation in bladder cancer diagnosis

Conditions: Bladder Cancer

Summary: the goal of this study to investigate the volatile organic compounds (vocs) in the urine samples of both healthy individual and bladder cancer patients, using gas chromatography - mass spectrometry. researchers aim to find a set of certain vocs specific to bladder cancer and use this set to construct a diagnostic model that can help diagnosing bladder cancer. participants will be asked to collect their early morning midstream urine in a predesignated container. researchers will compare urine vocs from bladder cancer patients and healthy individuals to see if there is any voc whose concentration differ significantly among the two groups.

specifically, participants will be asked to collect 35-45 ml of their early morning midstream urine sample in a predesignated polytetrafluoroethylene bottle. researcher will collect participants' health information, including their: 1)smoking history; 2)comorbidity; 3) history of past urological procedure; 4)medication; 5)pathology diagnosis after surgery, if participants have bladder cancer.

Eligibility criteria:
inclusion criteria: * bladder tumor confirmed by cystoscopy and radiology * women of childbearing age with negative urine pregnancy test result * willing to participate in this trial and sign the informed consent form exclusion criteria: * patient with 1) uncontrollable urinary tract infection; 2) severe systemic disease; 3) history of malignancy within the past 5 years; 4) pregnancy or lactation * patient involved in other clinical trials * other situations researcher considered to be ineligible for this trial

Keywords: volatile organic compounds urine bladder cancer gs-ms
treatment of early systemic sclerosis by bosentan

Conditions: Systemic Sclerosis (Scleroderma)

Summary: systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. thirty adult patients with early ssc will be treated with the endothelin-1 antagonist bosentan for 6 months.disease progression will be assessed.

systemic sclerosis (ssc) is characterised by obliterative vasculopathy and extensive fibrosis. the accumulation of extracellular components in the extracellular matrix is mostly due to increased activity og tissue fibroblasts. the proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.the activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.thus, the actions induced by endothelin-1 may be a potensial target for the therapy of ssc. thirty patients with early ssc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.

Eligibility criteria:
inclusion criteria: * early systemic sclerosis exclusion criteria: * age \> 70 or \< 18 * pregnancy * nursing * hiv * hb \< 8.5 g/l * systolic blood pressure \< 85 mmhg * lack of compliance * liver disease * hypersensitivity to bosentan * concurrent us of glibenclamide, ciclosporine a or tacrolimus -

Keywords: scleroderma fibrosis therapy bosentan endothelin-1