Kornimate/medical-research-clean huggingface dataset:
intrathecal ketorolac in patients with intrathecal morphine dose escalation

Conditions: Pain

Summary: the purpose of this study is to determine how the drug ketorolac, when given with the spinal morphine, affects pain.

this study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications). to treat persons with chronic pain, doctors sometimes implant a permanent tube in the spinal space in the back to give pain medicines. this tube, also called a spinal pump, is used to administer pain medicine directly to the spinal space. the most commonly used medicine given through the spinal pump is morphine which works well for most people, but sometimes loses tolerance, and larger and larger doses are needed, causing many side effects. the purpose of this study is to find out if another medicine, ketorolac, when given with morphine in the spinal space, can stop or reverse the need for larger and larger doses of morphine. in animals, ketorolac has been shown to slow the need for an increase in morphine dosage and to reduce the morphine dose, while giving good pain control. this study will enroll 30 individuals with chronic pain below the chest, caused by nerve injury, who are receiving morphine through a spinal pump. after learning to estimate pain accurately using thermal heat testing, participants will be randomly assigned to one of two study groups. group one will receive the active study medication, ketorolac, while group two receives an inactive control (placebo). all participants will receive morphine (administered through the spinal pump). afterwards, participants will rate their levels of pain, and provide samples of their spinal fluid (taken from the spinal tube/pump) for study. the above procedure will be repeated over a 4-week period. duration of the study for participants is 4 weeks, and includes ten visits to the research center, each lasting less than one hour.

Eligibility criteria:
inclusion criteria: * implanted spinal pump for at last 9 months * must be receiving and the dose must have been doubled in the past 6 months * currently taking 60-200 mg morphine equivalent as oral rescue per day * men and women, ages 18-70 * weigh no more that 250 pounds * neuropathic pain exclusion criteria: * pregnancy * unstable medical problems (heart lung, liver, kidney, or nervous system) * allergy to morphine, ketorolac, or drugs which may be used to treat side effects

Keywords: pain chronic pain morphine ketorolac
disposition of dietary polyphenols and methylxanthines in mammary tissues from breast cancer patients

Conditions: Breast Cancer

Summary: the aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

the objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients. the patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. the metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using uplc-esi-qtof-ms/ms.

Eligibility criteria:
inclusion criteria: * eligible patients are those over 18 years with a newly biopsy-confirmed breast cancer, programmed surgery at least 3 days after the recruitment and no neoadjuvant treatment. exclusion criteria: * suspected intolerance to any component of fruits or vegetables. * neoadjuvant chemo- or radiotherapy. * urgent surgery (less than 3 days after the recruitment). * patient under 18 years. * patient with breast adenoma.

Keywords: polyphenol methylxanthine metabolism breast tissue disposition uplc-qtof
efficacy, safety, tolerability, and pharmacokinetics of indacaterol salts in patients with asthma

Conditions: Asthma

Summary: this study assessed the efficacy, safety, and pharmacokinetics of indacaterol salts (maleate, xinafoate and acetate) in patients with asthma.


Eligibility criteria:
inclusion criteria: * non-smoker male and female adult patients aged 18-75 years inclusive, who have signed an informed consent form prior to initiation of any study-related procedure, including any adjustments to asthma medication prior to screening. * patients with asthma, receiving daily treatment with inhaled corticosteroid. * patients with a forced expiratory volume in 1 second (fev1) during screening of ≥ 50% of the predicted normal value for the patient. * body mass index (bmi) must be within the range 18-32 kg/m\^2 (inclusive). * able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria: * a urine cotinine level greater than the local laboratory lowest level of quantification (loq of 500 ng/ml or lower). * patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to screening. * patients who have had an emergency room visit for an asthma attack/exacerbation within 6 weeks prior to screening or any time between screening and pre-dose on day 1 of the study. * patients who have had a respiratory tract infection within 4 weeks prior to screening or any time between screening and pre-dose on day 1 of the study. * patients who require the use of ≥ 8 inhalations per day of the short-acting β2-agonist salbutamol/albuterol (100 μg/90 μg salbutamol/albuterol metered dose inhaler \[mdi\] or equivalent dose of a dry-powder inhaler \[dpi\]) on any 2 consecutive days from screening to randomization. * patients diagnosed with chronic obstructive pulmonary disease (copd) as defined by the global initiative for chronic obstructive lung disease (gold) guidelines (2008). * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation. previous participation in a study with either the investigational or comparator drugs does not exclude a patient from participation in this study. * significant illness. * history of being immunocompromised, including a positive human immunodeficiency virus (hiv) test result (elisa and western blot). * a positive hepatitis b surface antigen (hbsag) or hepatitis c test result. * patients who are considered vulnerable as per ich gcp guidelines. * patients with a history of hypersensitivity to indacaterol or to similar drugs including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. * treatments for asthma and allied conditions: * the following treatments should not be used unless they have been stabilized prior to screening: antihistamines, inhaled nasal cromolyn, inhaled nasal corticosteroids, and maintenance immunotherapy. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: qab149 asthma indacaterol salts (acetate, maleate, and xinafoate) orally inhaled indacaterol salts persistent asthma
clinical observation on the treatment of motor and sensory dysfunction after stroke with ruyizhenbao pill

Conditions: Post-stroke Patients With Motor and Sensory Dysfunction

Summary: many years of clinical practice experience has found that ruyi treasure pill can be used to treat nerve meridian injury caused by cerebrovascular disease, but in the end, the clinical efficacy is still lacking systematic clinical evidence-based medical research data. based on this, the clinical observation of ruyi treasure pill in the treatment of post-stroke motor and sensory dysfunction was carried out to verify its clinical location, to provide evidence for the application of clinical subdivision of later products and two development of products, and to publish academic papers on the expected research results.


Eligibility criteria:
inclusion criteria: 1. compliance with stroke diagnostic criteria; 2. the course of the disease is 15 days to 6 months; 3. people who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment; 4. age 20 to 80 years old; 5. sign an informed consent and participate voluntarily in the study. exclusion criteria: 1. diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination; 2. combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.; 3. those who are not aware or concoced due to more severe cognitive impairment and complete aphasia; 4. people who are allergic to the drug or are allergic to multiple medications.

Keywords: ruyizhenbao pill post-stroke motor dysfunction sensory dysfunction
wearable robotic upper body exoskeleton for workers

Conditions: Work-Related Condition; Physical Stress; Mental Fatigue

Summary: the main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. in a first stage of the project, an extensive study involving the end-user companies will be carried out to clearly identify the operator target tasks and typical target task loads for which the exoskeleton will be designed. based on standard ergonomic evaluation scales (rula and niosh, the need for recovery scale and the ovako working posture analysing system), high risk tasks will be identified in the field, based on the evaluated information about the workspace configuration, the performed operations and their physical constraints. these will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front, to the side, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.


Eligibility criteria:
inclusion criteria: industrial employees - exclusion criteria: * non-able bodied individuals

Keywords: industrial work physical effort mental effort questionnaires ergonomic evaluation
measuring hiv quality of care

Conditions: HIV Positive; Facility Level Care; Clinical Reminder

Summary: the va is the largest single provider of hiv care in the united states. the late 1990's have seen a revolution in the quality standards for this disease with the onset of highly active antiretroviral therapy (haart) and other developments.

background: the va is the largest single provider of hiv care in the united states. the late 1990's have seen a revolution in the quality standards for this disease with the onset of highly active antiretroviral therapy (haart) and other developments. objectives: our purpose in this project is to develop a method for assessing quality in two important areas of hiv care - antiretroviral medications and opportunistic infection screening and prophylaxis - and explore the determinants of high quality care in order to suggest quality improvement strategies. methods: the analysis has four parts. first, it will describe the level of adherence to the indicators in va hiv patients nationwide and compare va hiv patients to national benchmarks. second, it will analyze facility and patient level predictors of adherence to indicators of quality of care and compare them with the predictors in the non va population using staged logistic regressions. third, it will seek to validate certain indicators (e.g. haart therapy) against clinical outcomes like hospitalization and immune status. we will also model the clinical "price" that the va pays in suboptimal clinical outcomes as a result of current performance levels. fourth, we will compare the performance of the facilities after one year of an intensive targeted indicator-specific feedback group versus those receiving aggregate data only. status: data analysis.

Eligibility criteria:
inclusion criteria: facilities with hiv clinics exclusion criteria:
ketorolac plus tobramycin/dexamethasone versus tobramycin/dexamethasone after uneventful phacoemulsification surgery

Conditions: Cataract

Summary: this randomized controlled trial compares two regimens of topical therapy: * tobramycin 0.3% - dexamethasone 0.1% (tobradex®, alcon), one drop four times/day * combination of tobramycin 0.3% - dexamethasone 0.1% (tobradex®, alcon), one drop four times/day, plus ketorolac tromethamine 0.5% (acular®, allergan), one drop three times/day. patients are independently assessed by two ophthalmologists. on days 7,14,21,28 patients are evaluated for * corneal edema * conjunctival hyperemia * anterior chamber (tyndall) reaction. the investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (td group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus ketorolac tromethamine 0.5%, one drop tid (td-k group, n=73, 28 days). patients undergoing vitrectomy due to posterior capsule rupture were excluded. on days 7, 14, 21, 28, the frequency of inflammation-related signs \[corneal edema, conjunctival hyperemia, anterior chamber (tyndall) reaction\], as well as the best corrected visual acuity (bcva) were measured. on day 21, logistic regression was performed to evaluate risk factors for inflammation.

Eligibility criteria:
inclusion criteria: * phacoemulsification (due to cataract) * uneventful phacoemulsification surgery exclusion criteria: * history of intraocular surgery in the operated eye, * any previous episode of uveitis in the operated eye, * severe systemic disease (heart failure nyha stage iii of iv, end-stage renal failure, pulmonary failure, patients receiving chemotherapy), * regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months * disruption of the anterior lens capsule
comparison of therapeutic effect between speech rehabilitation program and speech therapy in stroke patients with aphasia

Conditions: Stroke; Aphasia; Speech Therapy

Summary: our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group. clinical evaluation tools will be performed before and after the treatment for all patients * k-western aphasia battery for aphasia assessment tools * cerebral blood flow changes with near-infrared spectroscopy

during the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. in addition, the k-western aphasia battery for aphasia assessment tools(k-wab) and cerebral blood flow changes with near-infrared spectroscopy will be performed. all participants will be assigned to a test group or control group. in addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment. after treatment is completed, the k-wab test and near-infrared spectroscopy will be performed again.

Eligibility criteria:
inclusion criteria: * adults over 19 years old * those with speech disorders that occurred after a stroke was diagnosed * those who can follow the clinical study procedures * those who voluntarily signed the consent form exclusion criteria: * patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline
association of two desensitizing protocols to control dentinal hypersensitivity in non-carious lesions

Conditions: Dental Hypersensitivity

Summary: this randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.


Eligibility criteria:
inclusion criteria: * age between 18 to 50 years * good general health * dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (eva) * presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe) * exposed root surface caused by abrasion, erosion or gum recession exclusion criteria: * volunteers using analgesic medication * presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease * patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months * patient with fixed orthodontic appliances * drug users or pregnant women were also excluded.
protocol to validate the performance of the mellitus glycated cd59 elisa for gestational diabetes screening

Conditions: Gestational Diabetes

Summary: demonstrate effective performance of the mellitus gcd59 test (an elisa) in screening for gestational diabetes mellitus (gdm)

validate the performance of the mellitus gcd59 elisa as a screening test for gdm by evaluating its negative predictive value (npv) and positive predictive value (ppv) to identify pregnant women at risk for gdm. sensitivity and specificity of the mellitus gcd59 elisa will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. women 18 years of age or older at enrollment 2. has an established viable singleton pregnancy 3. is recommended for routine gdm screening between 24-28 weeks gestation 4. has confirmed gestational age of 24-28 weeks at the screening visit 5. is willing and able to provide documentation of informed consent exclusion criteria: 1. has diabetes before pregnancy or has already been diagnosed with gdm 2. has contraindications for drinking oral glucose solution up to 100 g of sugar 3. is taking metformin for any reason 4. has any concomitant illness, disease or condition that, in the clinical judgment of the investigator, is likely to prevent the subject from complying with any aspect of the protocol, or that may put the subject at unacceptable risk

Keywords: in vitro diagnostic gdm gestational diabetes mellitus screening pregnancy prenatal care women's health
reducing the risk of metabolic decompensation in diabetic adolescents by supervised school administration of insulin

Conditions: Type 1 Diabetes Mellitus

Summary: this is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (t1d) from development of ketones.

this study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/l at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of i-deg or i-glar. hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving i-deg than in subjects receiving i-glar, since the long half-life of i-deg will compensate for missed insulin doses over the weekend/holidays. to remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t1d, diagnosed at least 12 months prior to enrollment * hba1c ≥8.5%9 and \<14% on enrollment * taking no medications known to affect blood glucose levels other than insulin. * ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is \< age 18 before any trial-related activities * current regimen includes insulin detemir or i-glar, as long acting insulin * willingness to use either i-glar or i-deg pens as basal insulin, and have school personnel supervise administration * willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week * willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check exclusion criteria: * female participants who are pregnant, breast-feeding or planning on becoming pregnant * participant (and parent if age \<18) unable to read, write, and speak english. * adolescents who are home schooled or no longer attending secondary school * participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels * known or suspected allergy to trial medication(s), excipients, or related products. * contraindications to study medications, including hypersensitivity to i-deg or one of its excipients, hypersensitivity to i-glar or one of its excipients, and administration of either during episodes of hypoglycaemia
goal direct therapy to prevent acute kidney injury

Conditions: Acute Kidney Injury

Summary: this is an randomised controlled trial to investigate an strategy based in a protocol in prevention of acute kidney injury after cardiac surgery.

this is a prospective, randomized controlled trial to assess the influence of use of angiotensin-converting enzyme inhibitors (acei) and angiotensin receptor blockers (arb) in the development of the acute kidney injury in the postoperative period of cardiac surgery. patients undergoing cardiac surgery at the heart institute (incor) - brazil, will be randomized and in accordance with a list of random numbers, generated by a computer program, will be allocated in one of the groups (gdt or standard).

Eligibility criteria:
inclusion criteria: * cardiac surgery with cardiopulmonary bypass (cpb); age greater than 18 years; chronic kidney disease stages 3 and 4 (gfr less than 60 ml/min and greater than 15 ml/min); sign the informed consent form. exclusion criteria: * chronic renal insufficiency (gfr less than 15 ml/min); heart surgery without cpb; aortic procedures; heart transplant or congenital heart disease; prior use of intra-aortic balloon pump; decompensated heart failure; participation in other research protocol.

Keywords: early goal direct therapy preventive strategies cardiac surgery