Kornimate/medical-research-clean huggingface dataset:
basal-bolus insulin therapy versus standard therapy for the inpatient management of type 2 diabetes: the ida2 study

Conditions: Type 2 Diabetes Mellitus

Summary: hyperglycemia during admission is associated with increased rate of complications and longer hospital stays, thus insulin treatment is recommended for all diabetes patients with hyperglycemia. inpatient studies of non-critically ill patients show better glycemic control with the use of basal-bolus insulin therapy compared to sliding scale insulin therapy, but increased rates of hypoglycemia. the investigators hypothesize that basal-bolus insulin therapy with a new ultra-long-action basal insulin can treat hyperglycemia more efficiently than sliding scale insulin, with few episodes of hypoglycemia.

the aim of this study is to investigate and compare the efficacy and safety of basal-bolus insulin therapy using the insulin analogue, insulin degludec once daily and insulin aspart before meals versus standard therapy with sliding scale insulin in non-critical ill hospitalized patients with type 2 diabetes. the design of the trial is an open, randomized controlled trial with two parallel arms (treatment arm and control arm). randomization is 1:1.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes for at least 6 months * age 18 - 90 years * pre-meal plasma glucose in the range 10 - 22,2 mmol/l prior to inclusion * expected hospital stay longer than 4 days exclusion criteria: * hyperglycemia without known history of type 2 diabetes * type 1 diabetes mellitus * severely impaired renal function (egfr ≤ 30 ml/min/1,73 m2) * severe hepatic disease * cardiac disease defined as: decompensated heart failure (nyha class iii-iv) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last 6 months * pregnant or lactating women or fertile female patients not using chemical, hormonal or mechanical contraceptives or not in menopause (i.e. must not have had regular menstrual bleeding for at least one year) * planned treatment during hospital stay with intravenous glucose/ insulin for ≥ 12 hours * treatment at admission or planned treatment during hospital stay with parenteral nutrition or enteral nutrition (i.e. gastroenteric tube feeding) * treatment at admission or planned treatment during hospital stay with high dose glucocorticoids (\>40 mg) * history or presence of malignancy (except basal skin cancer) unless a disease-free period exceeding five years * presence of alcohol or drug abuse * inability to understand the written information or incapability to provide informed consent

Keywords: type 2 diabetes, inpatient diabetes management, basal-bolus insulin
peripheral inflammation and brain structural alterations in patients with disorders of consciousness.

Conditions: Disorder of Consciousness

Summary: evidence suggests that inflammatory processes are key elements in the secondary effects of severe traumatic brain injury (tbi). the present study was designed to examine whether the peripheral inflammatory markers and brain structural alterations be associated with clinical measures and primary outcome following severe tbi. we hypothesized that peripheral inflammatory markers might be correlated with voxel-based gm volumes in patients with disorder of consciousness.

background: systemic inflammation, neurocognitive impairments, and morphologic brain changes are associated with outcome in patients with disorder of consciousness. objective: the aim of this study is to assess the value of peripheral inflammatory markers and brain structural alterations in the chronic phase after severe traumatic brain injury. methods: serum levels of interleukin (il)-1β, il-4, il-6, il-10, il-13 and tnf-α were investigated in patients with chronic disorder of consciousness and healthy volunteers. correlations were carried out between gm, wm, and csf volumes and inflammatory cytokines levels. in addition, the coma recovery scale-revised (crs-r) score was used to quantify the severity, and long-term recovery clinical outcome at 12 month was determined according to glasgow outcome scale (gos).

Eligibility criteria:
inclusion criteria: 1. patients ages 14 to 65 years old; 2. patients had a history of stbi; 3. patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state; 4. patients stay unconscious for more than 1 month. exclusion criteria: 1. patients with acute infectious diseases or liver dysfunction; 2. patients with serious diseases such as cardiac or pulmonary problems.

Keywords: inflammatory markers magnetic resonance imaging disorder of consciousness
role of oral tramadol 50 mg in reducing pain during colposcopy-directed cervical biopsy

Conditions: Cervical Biopsy

Summary: the study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.

.colposcopy-directed cervical biopsy (cdb) is a procedure performed in women with abnormal papanicolaou smear or abnormal human papillomavirus (hpv) testing whose cervical lesions are colposcopically identified. generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.the degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (vas). tramadol hydrochloride is an orally active centrally acting synthetic opioid. it is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. it has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents

Eligibility criteria:
inclusion criteria: women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure. exclusion criteria: * patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers. * cervical and vaginal infection * pregnant patients. * patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids * patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, people with uncontrolled epilepsy. * people under the influence of (intoxicated with) alcohol, sleeping tablets, tranquilisers, psychotropic drugs (those affecting mood or emotions) or other opioid painkillers, e.g. morphine, codeine.
asthma control-a "patient follow up programme" maintenance and reliever therapy in a single inhaler

Conditions: Asthma

Summary: to investigate the change in patient's asthma symptom control using acq scores after 4 to 6 weeks of symbicort turbuhaler (budesonide/ formoterol) in smart approach.


Eligibility criteria:
inclusion criteria: * asthma patients from both sexes, age 18 or older * have already been on symbicort smart treatment * willing to give written informed consents to participate in the program. exclusion criteria: * patients who are not willing to give written informed consent * patients in emergency care for asthma at icus or copd patients are excluded from the program.

Keywords: asthma symbicort nis
the optimization of mycoplasm pneumonia antibiotic therapy

Conditions: Mycoplasma Pneumonia

Summary: mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. the study aim is to optimize anti-infection therapy.

mycoplasma pneumoniae was one of important atypical pathogens of community acquired pneumonia. as lack of cell wall, β-lactam medicines were invalid, however, macrolides, tetracyclines and quinolones were effective. but from 2001, many countries reported macrolide- resistant mycoplasma pneumoniae. typically, erythromycin was first-line antibiotic medicine. with the resistance increasing, mycoplasm pneumonia treatment will become more and more difficult. thus, optimization of mycoplasm pneumonia antibiotic therapy is very important.

Eligibility criteria:
inclusion criteria: 1. confirmed community acquired pneumonia 2. 60ys≥age≥18 ys 3. respiratory symptom (cough accompanied by little or no sputum) 4. new infiltration showed by chest radiology(x-ray or ct) 5. lung signs was not obvious 6. white blood cell\<10,000/mm3 7. without underlying diseases or mild exclusion criteria: 1. age\ 60ys 2. pregnancy or breast-feeding 3. over one week after the onset of symptoms 4. hiv infection 5. recent 90-day hospitalized history(length of stay greater than 2 days) 6. live in nursing homes or rehabilitation hospitals 7. taken macrolides or quinolones medicines before enrollment

Keywords: macrolide- resistant mycoplasma pneumoniae, mycoplasm pneumonia antibiotic therapy
the efficacy of removal of animal milk from the diet in functional dyspepsia: a cross-sectional study

Conditions: Dyspepsia; Gastrointestinal System Disease

Summary: the goal of this observational study is to learn about compare the effect of removing animal milk from diets on the symptoms of fd patients in describe participant population. the main question it aims to answer are: • can removing milk and dairy from diets be used to treat fd patients? the participants will be divided into two groups and will do the following; * removing milk and dairy products under the advice of a dietician without medical treatment * receiving medical treatment without restricted diet. researchers will compare two groups to the effect of removing milk from diet on the symptoms of fd patients.

in this cross-sectional cohort study, 120 patients with fd diagnosed by the rome iv criteria were included. patients were divided equally into two groups; those who removed milk and dairy products under the advice of a dietician without medical treatment and those who did not. for determining the severity of symptoms, "the gastrointestinal symptom rating scale (gsrs)" was used at the onset of the study and the end of the one-month follow-up period. between the two groups, there was no statistically significant difference regarding age, body mass index (bmi), frequency and duration of symptoms, weight changes in the last six months, fd subtypes, and upper gi endoscopy results (p\>0.05). female patients outnumbered men in the animal milk removal group (p=0.01). although the patients in the animal milk removal group had higher gsrs scores at the beginning (p=0.01), both groups had similar gsrs scores at the end of the study (p=0.99). after one month follow-up period, gsrs scores have improved in both groups compared to the baseline (p=0.01). however, the decrease in the gsrs total symptom score was significantly higher in the animal milk removal group compared to the free diet group (p=0.01). in the evaluation of gsrs symptom subsets, a statistically higher reduction was observed in 7 of the 15 subsets in the animal milk removal group compared to the free-diet group (p\<0.05). of the 120 fd patients who followed up for one month, 60 who removed milk products had a more significant reduction in gsrs symptom score and 7 of the 15 symptom subset scores than 60 patients receiving an unrestricted diet.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65 * having at least one of the complaints of postprandial fullness, early satiety, epigastric burning and pain * the onset of the complaint is at least 6 months ago and at least one complaint has been going on at least 3 days a week for the last 3 months * no underlying organic pathology is detected in the examinations. exclusion criteria: * being outside the age range of 18-65 * having alarm symptoms such as vomiting, gastrointestinal bleeding, and weight loss of 5% or more in the last 3 months * presence of comorbidities such as dementia, cvd, psychiatric diseases * covid-19 positivity during the research

Keywords: functional dyspepsia milk dairy products
mechanical insufflation-exsufflation and hypertonic saline in nosocomial bacterial respiratory tract infection

Conditions: Nosocomial Infection; Nosocomial Pneumonia; Tracheobronchitis; Mechanical Ventilation Complication; Endotracheal Intubation

Summary: multicenter, randomized open label clinical trial to evaluate iem and hs as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the icu. lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes. current specific treatment consists of intravenous antibiotics. the current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized hs has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.

open label, randomized, multicenter (7 icus at 7 hospitals in spain). the study has 2 main arms, pneumonia and tracheobronchitis. if the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups: 1. iv antibiotic therapy 2. iv antibiotic therapy + mechanical insufflation-exsugglation (mi-e) 3. iv antibiotic therapy + mi-e + nebulized hypertonic saline-hyaluronic acid (hs) if the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups: 1. no specific therapy (recommendation of the infectious diseases society of america) 2. iv antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation) 3. mi-e + hs safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.

Eligibility criteria:
inclusion criteria: * signed informed consent * nosocomial pneumonia (vhap or vap) or nosocomial tracheobronchitis * intubated with a cuffed endotracheal tube or tracheostomy cannula. exclusion criteria: * ominous prognosis * frank hemoptisis * barotrauma (pneumothorax or pneumomediastinum) * bronchospasm (patients on bronchodilators for previous bronchospasm may be included * unstable thoracic cage * suspected unmonitored intracraneal hypertension

Keywords: mechanical insufflation-exsufflation cough assist device hypertonic saline nosocomial respiratory tract infection hospital-acquired pneumonia tracheobronchitis ventilator-associated pneumonia nebulization
best (burn center evaluation of standard therapies) ventilator mode study-

Conditions: Burns

Summary: the purpose of this study is to compare high frequency pressure ventilation (hfpv) to conventional mechanical ventilation. hypothesis: patients placed on hfpv will have significantly higher number of ventilator-free days compared to patients placed on a conventional volume mode.

this is a prospective, randomized, controlled trial comparing hfpv to conventional ventilator modes in the support of burn patients with respiratory failure. burn patients who develop the need for mechanical ventilation present a variety of challenges that call for innovative therapeutic options. even in the absence of smoke inhalation injury,decreased chest wall compliance from full thickness burns as well as massive fluid requirements are just a few variables that make it difficult to achieve gas exchange goals when attempting to apply conventional lung protective strategies recommended by the ards net investigators.

Eligibility criteria:
inclusion criteria: * patients who are deemed to require ventilatory support for more than 24 hours from the time of screening. exclusion criteria: * anticipated extubation within 24 hours of screening * patients who are pregnant patients not expected to survive for more than 24 hours

Keywords: burns
acoustic cardiographic assessment of heart function and the role of phrenic nerve stimulation

Conditions: Heart Failure, Congestive; Cardiac Pacing, Artificial; Transcutaneous Electric Nerve Stimulation

Summary: in this study, the investigators sought to determine whether a stimulation of the phrenic nerve affects heart function. heart function is assessed by acoustic cardiography.

patients who need temporary pacing following open heart surgery and who are willing to participate receive a phrenic nerve electrode during the operation. heart function is postoperatively assessed by acoustic cardiography (audicor, inovise medical inc., portland, usa) during different forms of pacing (right ventricle, left ventricle, biventricular; aai, ddd) and with or without phrenic nerve stimulation. acoustic cardiography simultaneously integrates heart sounds and single-channel electrocardiography input to generate multiple parameters that correlate to established hemodynamic measures. effects of phrenic nerve stimulation on heart function will be analyzed.

Eligibility criteria:
inclusion criteria: * patients following open heart surgery who need temporary pacing exclusion criteria: * patients with permanent pacemakers * patients with fast changing need of vasopressor therapy
the effect of milk powder with fiber and probiotics on digestive habits and general health well-being of selected filipino mothers.

Conditions: Constipation

Summary: in-shape nutritional milk powder is a nutritional milk powder containing fibers, probiotics and other nutrients. this study will focus on the effects of fiber and probiotics on digestive health and health well being in selected filipino mothers


Eligibility criteria:
inclusion criteria: * female between 21 and 35 years of age. * has at least one child under the age of three. * willingness and ability to participate in the study. * suffering from mild to moderate constipation and bowel troubles, and non-specific symptoms including bloating, flatulence, gurgling, feeling heavy after eating, and abdominal pain. * slow transit or irregular bowels movements (stool consistency harder than usual or fewer bowel movements, i.e. every 2-3 days or less than 3 bowel movements per week). * agree to maintain dietetic measures (on their own volition or as previously recommended by health/nutrition professionals), if any, during the study period. * subject, or subject's legally acceptable representative, has voluntarily signed and dated an informed consent form, approved by a local ethics committee/institutional review board authorization prior to any participation in the study. exclusion criteria: * having participated in another trial currently and up to two months prior to this trial date. * known chronic constipation. * treated gastrointestinal symptoms. * regular intake of laxatives or other remedies to promote digestion (herbal teas, peppermint etc.) during the two weeks before the start of the study or during the study. * consuming dairy products or supplements containing probiotics (e.g., yogurt, lactic acid drink, drinkable yogurt, food supplements, extracts), prebiotics (e.g., oligosaccharides), or fiber supplements within 10 days prior to the start of the study or during the study. * currently taking (and during the past 3 months) any dietary fiber supplementation except from food sources. * previous contraindication to fiber supplement (crohn's disease). * recently or currently on antibiotic medication in the past two weeks. * known allergy to milk proteins or intolerance to lactose. * currently pregnant.

Keywords: constipation bowel movement intestinal health
feasibility usability & acceptability study: symptom reporting by children adolescents & young adults w/cancer

Conditions: Adolescent Behavior; Pediatric Cancer; Oncology

Summary: the purpose of this project is to pilot test an electronically delivered symptom assessment tool pediatric patient-reported outcomes version of the common terminology criteria for adverse events (ped-pro-ctcae), completed by children/adolescents and young adults (ayas) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.


Eligibility criteria:
inclusion criteria: 1. first diagnosis of cancer 2. receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation 3. 7-21 years of age 4. completed at least 1 month of cancer chemotherapy treatment and are within 7-28 days of starting a treatment cycle or during ongoing therapy, followed at least every month in clinic 5. if surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study 6. caregiver must be present and 18 years and older. 7. ability to understand and the willingness to personally sign the written irb approved informed consent or assent document as appropriate. exclusion criteria: 1. child must be able to read or listen to and understand english and not have cognitive/memory impairments determined by the child's clinician 2. caregiver must be able to read and understand english.
correlation between 3 phase bone scintigraphy and pressure pain thresholds in patients with complex regional pain syndrome (crps)

Conditions: Complex Regional Pain Syndrome Type I of the Upper Limb; Unilateral Limb Pain of Other Origin; Healthy Subjects

Summary: the aim of the study is to investigate the correlation between increased bone metabolism in the 3 phase bone scintigraphy (tpbs) and decreased pressure pain thresholds in patients with complex regional pain syndrome (crps) of the upper limb and a non-crps-group. the investigators assume that there will be a significant correlation between the investigated values in the crps-group whereas the non-crps-group shows no significant correlation.

pressure pain of the distal hand joints is a predominant symptom of crps. but so far, the diagnostic value of pressure pain in the diagnosis of crps has not been investigated. we compared the pressure pain thresholds of the carpus, metacarpophalangeal and proximal interphalangeal joints to a region of interest-based (roi) analysis of a tbps in patients with crps and patients with limb pain of other origin (non-crps-group).additionally, the ppts were established for a healthy control group to get reference data.

Eligibility criteria:
inclusion criteria: every participant: * aged \> 18 years with written informed consent * adequate understanding of the german language * indication for a tpbs independent of the study patients with crps: * patients with crps type 1 of the upper limb diagnosed on the basis of the budapest criteria (harden, bruehl et al., 2010) * unilateral pain control group: * patients with pain of the upper limbs of other origin than crps who underwent a tpbs * unilateral pain healthy subjects: * checked by the dfns imi questionnaire exclusion criteria: * missing informed consent * inadequate understanding of the german language * disease duration of more than 12 months * other disease of the upper extremity (e.g. polyarthrosis, rheumatoid arthritis) * pregnancy/ lactation period

Keywords: crps tpbs pressure pain thresholds limb pain of other origin