Kornimate/medical-research-clean huggingface dataset:
syringes replacement for insulin application for pens device in a population of elderly patients with type 2 diabetes: multifactorial intervention to improve glycemic control

Conditions: Diabetes

Summary: this is a prospective, intervention, randomized, phase iv study. patients will be included with 60 years or older, both sexes, with hba1c \>8.5% using oral antidiabetics agents and insulin and then we will be randomized by use syringe or pens device to use insulin nph and regular. all patients will receive a blood glucose monitor, lancet tapes, capillary blood glucose tests (3 tests/day). hba1c will be measured at baseline, 3 and 6 months. patients will see monthly.


Eligibility criteria:
inclusion criteria: * sixty years or older * diabetes type 2 with glycated hemoglobin higher than 8.5% * using or necessity to use insulin * using syringe to insulin * using at least one oral antidiabetic * accept to participate exclusion criteria: * glomerular filtration rate lower than 30 * considering unfit for self administration of insulin
study assessing single and multiple doses of idx21459 in healthy and hcv-infected subjects

Conditions: Chronic Hepatitis C

Summary: a multi-part study to evaluate the safety and pk of single ascending doses of idx21549 in healthy and hcv-infected subjects. the effect of food on the pk of idx21549 will also be evaluated. antiviral activity will also be assessed in hcv-infected subjects.


Eligibility criteria:
inclusion criteria: all subjects * subjects are in good general health. * subjects have provided written informed consent form. * all subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from screening through at least 90 days after the last dose of the study drug. hcv subjects * documented clinical history compatible with chronic hepatitis c without cirrhosis. * treatment-naïve * hcv genotype 1 exclusion criteria: all subjects * pregnant or breastfeeding * co-infected with hepatitis b virus (hbv) and/or human immunodeficiency virus (hiv). * decompensated liver disease * other clinically significant medical conditions or laboratory abnormalities.

Keywords: hepatitis c virus hcv
randomized controlled trial of biofeedback therapy for dyssynergic defecation

Conditions: Dyssynergia

Summary: constipation is a common disorder and current treatments are unsatisfactory. biofeedback may help patients with constipation and dyssynergic defecation, but its efficacy is unproven and whether this is due to behavioral modification or excessive attention is unknown. methods: in a prospective randomized trial, the investigators investigated the efficacy of biofeedback (manometric- assisted anal relaxation, muscle coordination and simulated defecation training), with either sham feedback therapy (sham) or standard therapy (diet, exercise, laxatives; standard) in 77 subjects (69 women) with dyssynergic defecation. primary outcome measures included presence of dyssynergia, balloon expulsion time, number of complete spontaneous bowel movements (csbm), and global bowel satisfaction. data analyzed per protocol.


Eligibility criteria:
inclusion criteria:patients were included if they fulfilled rome ii criteria for functional constipation, and during attempted defecation demonstrated a dyssynergic pattern of defecation, and either had prolonged difficulty with expelling a simulated stool (\> 1 minute) or prolonged delay (\> 20% marker retention) in colonic transit. exclusion criteria: they were required to have no evidence of structural or metabolic diseases that could cause constipation, as assessed by colonoscopy/barium enema and routine hematological, biochemical and thyroid function tests. patients taking drugs known to be constipating, for example opioids were either excluded or were asked to discontinue the drug prior to enrollment. other exclusion criteria included: severe cardiac or renal disease, previous gastrointestinal, spinal or pelvic surgery except cholecystectomy, hysterectomy or appendectomy, neurologic diseases such as multiple sclerosis, stroke or spinal injury, impaired cognizance (mini-mental score \< 15), legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating constipation and diarrhea.
hiit on overweight middle-aged adults

Conditions: Overweight or Obesity

Summary: 36 middle-aged with overweight adults were divided into three groups: 1. l-hiit group: the long-interval hiit group (4 × 4 min exercise/4 min rest), 2. m-hiit group: the medium-interval hiit group (8 × 2 min exercise/2 min rest), 3. control group: no exercise intervention. all groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different hiit interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.

aging, obesity, have been shown to lead to higher oxidative stress and chronic inflammation. however, high-intensity interval training (hiit) has anti-inflammatory and anti-obesity benefits. different training prescriptions may also affect improvements. therefore, this study will explore the optimal hiit prescription to improve fat, inflammation, metabolism, and exercise performance in overweight middle-aged and older adults. thirty-six middle-aged with overweight adults were divided into three groups: 1. l-hiit group: the long-interval hiit group (4 × 4 min exercise/4 min rest), 2. m-hiit group: the medium-interval hiit group (8 × 2 min exercise/2 min rest), 3. control group: no exercise intervention. all groups carried out the training stage for 8 weeks (three sessions per week), then the detraining stage for 4 weeks in order to investigate the effects induced by different hiit interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.

Eligibility criteria:
inclusion criteria: * recruit people who are overweight or obese (bmi between 24-35) who are 20-65 years old and have no exercise habits in a sitting lifestyle. exclusion criteria: * if there are any of the following circumstances, they are not allowed to participate in this research and are included in the listing conditions of this case: 1. have smoking and drinking habits. 2. people who have stroke, type 1 and type 2 diabetes, neuromuscular disease, so that they cannot participate in physical activities. 3. chronic obstructive lung disease, asthma, interstitial lung disease or alveolar cyst fibrosis. 4. metabolic diseases include thyroid disease, kidney disease (kidney, bladder stones) or liver disease. 5. those with arrhythmia, a rhythm regulator, severe cardiovascular disease, peripheral vascular disease or cerebrovascular disease. 6. people with epilepsy and rheumatoid arthritis. 7. those who have implanted artificial joints in the past six months and have had recent surgery. 8. migraine, acute thrombosis and hernia. 9. those who have engaged in strenuous exercise or have muscle aches within 24 hours before the experiment. 10. people who feel unwell due to other reasons during the experiment. 11. people with severe food allergies. 12. have hospitalization records within three months. 13. people with cognitive impairment. 14. take any drugs that affect the function of the nervous system.
a dose-response study of lidocaine and etomidate

Conditions: Etomidate Overdose of Undetermined Intent

Summary: iv lidocaine administration can reduce the minimal amount of etomidate and time for induction of anesthesia.

the study was carried out in west china hospital of sichuan university, chengdu, china. all the patients were informed in detail about the procedure and the medications they are going to get. patients are well informed about the beneficial and possible hazards of the medicines and procedure. patients are also informed that they can withdraw from the study at any time if they find it uncomfortable or harmful for them. patients' written informed consent was obtained and registered for the permission from the hospital's ethics board.

Eligibility criteria:
inclusion criteria: 1. patients scheduled for elective surgery, 2. age limit within 18-70 years, 3. american society of anaesthesiologists physical status classification i-ii exclusion criteria: 1. adrenal cortex disorder, 2. neurologic disease, 3. psychiatric disorders, 4. allergic to local anesthetic drugs, 5. patients who have received sedatives,analgesics or opioids within the previous 24 hrs.

Keywords: iv lidocaine inducing dose etomidate dose response
10 year follow up of rct comparing different regenerative regenerative procedures

Conditions: Periodontitis

Summary: evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.

this 10-year follow-up of a randomized controlled clinical trial (cortellini \& tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (m-mist, n=15); ii) a second group was treated with m-mist combined with enamel matrix derivative (m-mist emd, n=15, straumann, switzerland); iii) a third group was treated with m-mist+emd plus bone mineral derived xenograph (m-mist+emd+bmdx, n=15, geistlich, switzerland) . the design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (cortellini \& tonetti 2011). clinical outcomes of the three groups were longitudinally followed for 10 years. the 10-year follow-up was approved by the local ethical committee for clinical research of the health service of tuscany (university hospital of firenze protocol atro2019, registration n° 15106_oss). all patients gave informed consent to participate into the clinical trial.

Eligibility criteria:
inclusion criteria: * subjects with periodontitis * presence of one intrabony defect not extending into furcation * good general health * adequate plaque control exclusion criteria: * furcation involvement in the experimental tooth * inadequate control of periodontitis
an observational study to evaluate the efficacy of lodoz in a population of hypertensive patients

Conditions: Hypertension

Summary: this is an observational, prospective, non-interventional, non-randomised, open label multicentric study planned to be conducted in 1000 subjects with mild to moderate primary hypertension in approximately 20 centres in thailand. the purpose of this study is to examine the beneficial effects of combination of bisoprolol with hydrochlorothiazide available as lodoz in treatment of thai subjects with mild to moderate hypertension. the outcome of the study would also provide information on the optimal daily dosage schedule as well as adherence of lodoz.

essential hypertension is a heterogenous multifactorial disease affecting large number of population. monotherapy treatment in hypertension is often unable to achieve the desired blood pressure (bp) goals and subjects even remain at significant risk for developing cardiovascular disease. the use of combination therapy as first line treatment for hypertension provides a solution to the management problems related to hypertension. among combination drugs, low dose combinations are useful tools in treating large segments of hypertensive subjects because of their several advantages, such as simplified dosage regimens, improve compliance and hypertensive control, decrease dose dependent side effects as well as reduce costs. objectives primary objective: * to evaluate the efficacy of lodoz therapy when used in routine clinical practice in subjects with mild to moderate essential hypertension. secondary objective: * to evaluate the discontinuation rate of lodoz therapy.

Eligibility criteria:
inclusion criteria: * signed written informed consent * subjects diagnosed with mild to moderate essential hypertension * subjects foreseen for lodoz treatment for hypertension * age ≥ 18 years exclusion criteria: * subjects treated with lodoz before study initiation * subjects who are pregnant * subjects with any known contraindications to lodoz based on local label

Keywords: hypertension lodoz bisoprolol hydrochlorothiazide
accuracy of the drager dual-sensor temperature measurement system

Conditions: Hypothermia; Anesthesia

Summary: our primary hypothesis is that the draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.

we will include patients undergoing general anesthesia or regional anesthesia. the temperature recorded by draeger dual-sensor monitoring system will be obtained at 5-minute interval.

Eligibility criteria:
inclusion criteria: * patients undergoing trauma surgery with general anesthesia * patients undergoing orthopedic surgery with regional anesthesia exclusion criteria: * younger than 18 or older than 80 years of age * have a pre-existing nasogastric tube * require bispectral index monitoring * upper esophageal disease * forehead rash or infection * oral infection or trauma * ear infection or drainage

Keywords: surgery thermometer non-invasive interoperative core temperature anesthesia
study of the effects of current drug treatments on levels of certain brain chemicals in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer's disease is a medical illness that damages the brain and causes problems with memory, mood and behavior. a substance called acetylcholine (ach), which is naturally produced in the body, plays an important role in the normal functioning of the brain. in subjects with alzheimer's disease, the level of ach is greatly reduced. currently, there are three commonly prescribed drugs used for treating the symptoms of alzheimer's disease by helping to maintain the level of ach in the brain. this study will evaluate how much each of these drugs changes the levels of certain brain chemicals that are known to, or may play an important role in, alzheimer's disease and its symptoms.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate alzheimer's disease * must be able to swallow capsule/tablet * must have a caregiver who is available to attend all study visits exclusion criteria: * digestive problems related to peptic ulcer * experienced a heart attack or stroke in the last 6 months * serious/unstable asthma or severe pulmonary (lung) disease * on current treatment with a blood thinner

Keywords: alzheimer's disease memory loss dementia senility forgetful geriatric behavior mood swings
non-invasive spot hemoglobin measurement in the outpatient obstetric clinic

Conditions: Anemia in Pregnancy

Summary: pregnant patients in the ut medical branch outpatient obstetric clinic are screened for anemia via blood draw at first prenatal visit. those who meet center for disease control (cdc) criteria for anemia during pregnancy (hemoglobin less than 11g/dl in first and third trimesters and hemoglobin less than 10.5g/dl during the second trimester), will be approached for participation in this study. it is the protocol of the ut medical branch outpatient obstetric clinic to repeat a blood draw every 4 weeks in patients with anemia. at the time of their blood draw, patients who participate in our study will have the masimo spot non-invasive hemoglobin monitor placed on our finger. the primary aim of the study is to see how accurate the non-invasive monitor is compared with blood draw. with the potential benefit being earlier diagnosis of anemia and easier method to ensure improvement in the hemoglobin.

pregnant women who are patients in the ut medical branch outpatient obstetric clinic will be screened for anemia using blood draw for cbc during the first prenatal visit. those who are found to have anemia will be prospectively enrolled in this proof-of-concept study. anemia will be defined according to the cdc guidelines (first and third trimesters hemoglobin level less than 11g/dl, and less than 10.5g/dl in the second trimester). patients meeting these criteria will be approached for inclusion. if patients consent to participate, they will have their hemoglobin checked via the non-invasive monitor at the same time as their clinically indicated cbc testing. at the ut medical branch outpatient obstetric clinic, this is usually every 3-4 weeks and determined by the health care provider. the hemoglobin measured by the non-invasive monitor will be compared with the hemoglobin obtained via the complete blood count. other data collected from the patient's medical record will include general characteristics such as demographics, medical history and hemoglobin levels obtained from blood draw.

Eligibility criteria:
inclusion criteria: pregnant women aged 18-50 with anemia (hemoglobin less than 11g/dl during first and third trimester and less than 10.5g/dl during second trimester) exclusion criteria: patients with normal hemoglobin levels patients with hemoglobinopathy (sickle cell disease) patients who are incarcerated patients unwilling or unable to give consent
non invasive evaluation of fluid responsiveness in septic patient

Conditions: Septic Shock

Summary: the study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (ivc) collapsibility for management of critically ill septic patients with hemodynamic instability.

prospective randomized observational comparative single blinded study will be conducted at intensive care unit at benha university hospitals after obtaining approval of the ethical committee and informed written consent from first degree relatives will be issued. the blindness will be performed to the patients. the study will be conducted according to consort 2010 statement. enrolment of eligible patients will occur within 8 h of meeting the criteria for septic shock. all patients will be randomized using the computer-generated software of randomization and sealed closed envelopes to allocate them to one of two groups (30 patients each). routine measurements and investigations will be taken at admission to intensive care unit; history, vital signs, routine laboratory investigation.

Eligibility criteria:
inclusion criteria: 1. asa class i and ii 2. age 18-65 years old of both genders. 3. fulfilment criteria of sepsis as defined according to the standard surviving sepsis campaign criteria using the sequential (sepsis-related) organ failure assessment (sofa) score (sofa score ≥ 2 indicated organ dysfunction). 4. patients within 8 h of meeting the criteria for septic shock. exclusion criteria: 1. lack of consent 2. age below 18 and above 65 years old. 3. acute coronary syndrome 4. major cardiac dysrhythmia, 5. valvular or congenital heart disease 6. massive bilateral pleural effusion 7. severe anaemia 8. end-stage kidney disease (eskd) patients with creatinine clearance (crcl) \<50ml/min. 9. child b and child c hepatic patients 10. impaired systolic function according to the ejection fraction (ef) (ef \< 40% indicated impaired systolic function) 11. severe ards (acute respiratory distress syndrome). 12. tense ascites 13. mechanical ventilation.

Keywords: fluid responsiveness cardiometry ivc collapsibility
cochlear implant with dexamethasone eluting electrode array

Conditions: Sensorineural Hearing Loss; Bilateral Hearing Loss

Summary: an evaluation of cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

the primary objectives of the pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. the secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.

Eligibility criteria:
inclusion criteria: * post-lingual, bilateral, moderate (≥ 40 db hl) to profound sensorineural hearing loss at 250, 500and 1000 hz and profound high-frequency hearing loss, defined by a pure-tone average (pta) threshold, 2000 through 8000 hz, ≥ 90 db hl. * 18 years or older at time of consent. exclusion criteria: * abnormal cochlear and middle ear anatomy * history with cochlear implant surgery * allergy to dexamethasone * women who are pregnant or plan to become pregnant * unable/unwilling to comply to study requirements

Keywords: cochlear implant dexamethasone bilateral hearing loss sensorineural hearing loss
a dose-finding study to evaluate the efficacy and safety of gsk3858279 in adults with knee osteoarthritis (oa) pain

Conditions: Pain; Osteoarthritis, Knee

Summary: this is dose-finding study of gsk3858279 in participants with moderate to severe knee osteoarthritis pain. the purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of gsk3858279.


Eligibility criteria:
inclusion criteria: * participant must be 40 to 80 years of age inclusive * oa of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of oa as per american college of rheumatology (acr) clinical diagnosis criteria. * kellgren and lawrence (kl) score ≥ 2 on x-ray in the index knee * an average of the average daily pain score of ≥4 and less than or equal to (≤) 9 by the 11-point nrs (0-10) * body mass index (bmi) of \< 40 kilogram per meter square (kg/m\^2) (inclusive). * capable of giving signed informed consent. exclusion criteria: * history or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments. * history or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis. * history of significant trauma or surgery to a knee or hip within the last 6 months. * current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency. * current or previous active mycobacterium tuberculosis * history or evidence of clinically significant multiple or severe drug allergies * history of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * alanine transaminase (alt) \>1.5 times upper limit of normal (uln). * bilirubin \>1.5 times uln (isolated bilirubin \>1.5 times uln is acceptable if bilirubin is fractionated and direct bilirubin \< 35 percent (%) * current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) * evidence of renal insufficiency, indicated by estimated creatinine clearance \< 60 milliliter/ minute (ml/min)/1.73 square meter (m\^2) at screening. * sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.

Keywords: osteoarthritis musculoskeletal diseases 209978 gsk3858279 efficacy safety pharmacokinetics