Kornimate/medical-research-clean huggingface dataset:
a study to compare patient-controlled pain medications delivered either through the skin or intravenously

Conditions: Pain; Analgesia, Patient-Controlled; Pain, Postoperative

Summary: the purpose of this study is to evaluate the effectiveness and safety of a patient-controlled system to deliver fentanyl compared with a patient-controlled intravenous system to deliver morphine in the management of postoperative pain.

this is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention) study to evaluate the clinical use, safety and ease of care of two patient-controlled analgesia (pca) systems to deliver pain medication either through the skin or intravenously. the fentanyl hydrochloride pca system, which delivers the medication through the skin, and morphine intravenous (iv)- pca, which requires injection into a vein, are used for management of moderate to severe acute pain in postoperative patients who have undergone elective major abdominal or orthopedic surgery. these patients, who are expected to require postoperative pain relief with strong opioids for at least 24 hours, will control the delivery of medication for up to 3 days. assessment of effectiveness include: patient's global assessment of pain control (poor, fair, good, excellent); pain intensity, measured on a visual numerical rating scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain; ease-of-care questionnaires including patient ease-of-care questionnaire, nurse ease-of-care questionnaire, and physical therapist ease-of-care questionnaire; and, total number of doses delivered by patients in the fentanyl transdermal pca or morphine iv pca treatment groups. safety evaluations include vital signs (pulse, blood pressure) and oxygen saturation, respiratory function, and the incidence of adverse events. the study hypothesis is that fentanyl transdermal pca is not inferior to morphine iv pca treatment in patient's global assessment of method of pain control during the first 24 hours after surgery. transdermal pca: 40 micrograms fentanyl per on-demand dose, each delivered over 10 minutes for a maximum of 6 doses/hr for 24 hours (maximum of 80 doses, 3.2milligrams). morphine iv pca: morphine doses with a maximum of 20 milligrams per 2 hours for 24 hours (maximum 12 doses, 240 milligrams).

Eligibility criteria:
inclusion criteria: * patients who meet the criteria of american society of anesthesiology (asa) pre-operative physical status i, ii, or iii * patients expected to have moderate or severe pain after a major abdominal or orthopedic procedure * patients expected to remain hospitalized for at least 24 hours postoperatively exclusion criteria: * known allergy or hypersensitivity to fentanyl, morphine, or to skin adhesives * known or suspected to be dependent on strong opioids or to have abused any drug substance or alcohol * severe respiratory symptoms * chronic pain disorder * pregnant or nursing women, or those lacking adequate contraception

Keywords: pain patient-controlled analgesia postoperative pain transdermal fentanyl surgical pain opioid analgesics
non-pharmacological nursing pain management for preterm infants

Conditions: Pain Management

Summary: a randomized controlled trial will be conducted to examine the effect of non-pharmacological nursing pain management strategies in alleviating pain among preterm infants. the study includes a simple random sample of 105 preterm infants with cga 32- \< 37 weeks were randomly assigned into five groups: routine care (n = 21), breast milk (n = 21), oral sucrose (n = 21), kmc (n = 21), nesting position (n = 21). pipp-r will be used to subjectively assess the pain intensity after heel stick, and salivary cortisol measures will be used to objectively assess the pain intensity in nicu at children welfare teaching hospital/ medical city complex in baghdad city.


Eligibility criteria:
inclusion criteria: * preterm infants whose corrected gestational age from (32 - \<37) weeks of pregnancy, * preterm infants who do not experience any painful procedure for last 24 hours. * preterm infants who do not receive any sedation for last 24 hours, and clinically required heel stick. exclusion criteria: * full-term infants whose gestational age (ga) is \>37 weeks * preterm infants who extremely preterm (\< 28 weeks); very preterm (28-\< 32 weeks) * preterm infants who are proven or suspected sepsis, major congenital malformations, heart defect, necrotizing enterocolitis (nec), and neurodevelopmental disability. * preterm infants who receive respiratory support {mechanical ventilation, continuous positive airway pressure (cpap), or high-flow support} * preterm infants who are indicated for surgery * preterm infants who are contraindicated to oral sucrose * twins * preterm infants who had a condition that might influence their physiological and responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

Keywords: non-pharmacological pain management strategies preterm infants nicu
efficacy and safety of modified gegen qinlian decoction for diarrhea-predominant irritable boewl syndrome

Conditions: Diarrhea-predominant Irritable Boewl Syndrome

Summary: diarrhea-predominant irritable boewl syndrome(ibs-d) seriously affect the quality of life in patients. clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. c1orf106/cyth-1/arf6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in ibs-d . based on the clinic, the project is to study the effect and mechanism of chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. with the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, ibs-d patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. furthermore, the experimental study is to clarify the drug targets via c1orf106/ cyth-1/arf6 signal pathway.through the study of association between dampness-heat syndrome in ibs-d and intestinal microbiota, it is of important academic significance to reveal the chinese theory intension of "homotherapy for heteropathy ".


Eligibility criteria:
inclusion criteria: 1. it meets the diagnostic criteria of diarrhea-predominant irritable boewl syndrome and meets the diagnostic criteria for damp-heat syndrome. 2. age between 18 and 70 years old. 3. not taking antibiotics, steroids and other hormones, chinese herbal preparations in the past week (including) probiotics such as oral and intravenous), microecological preparations or yogurt. 4. the subject informed and voluntarily signed the informed consent form. ; 5. have a certain reading ability exclusion criteria: 1. patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness; 2. combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes); 3. those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.); 4. those with a history of allergic reactions to related drugs and a history of severe food allergies.
a study of a novel approach to titrate basal insulin (ly2963016) in participants with type 2 diabetes

Conditions: Type 2 Diabetes; Type 2 Diabetes Treated With Insulin

Summary: the main purpose of this study is to evaluate a novel approach for insulin glargine (ly2963016) titration for insulin-naïve adults with type 2 diabetes (t2d) the study will last about 6 months.


Eligibility criteria:
inclusion criteria: * adults with type 2 diabetes as diagnosed by endocrinologist * no insulin over past 3 months * inadequate glycemic control with a1c ≥8.0% at or within 1 month prior to screening visit * no history of diabetic ketoacidosis (dka) or severe hypoglycemia leading to mental status change in the past 6 months * willingness and ability to follow the protocol including willingness to commence basal insulin, wear cgm, and communicate with healthcare provider. exclusion criteria: * contraindication to use of insulin glargine (e.g., allergy) * impaired recognition of hypoglycemia by the participant (as judged by the investigator)

Keywords: t2d
lactate to treat hypoglycemia

Conditions: Hypoglycemia

Summary: tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. however, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. the bispectral index (bis) is derived from the eeg and measures of brain electrical activity noninvasively. it has already been shown that its value changes according to hypoglycemia and its correction. furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in icu patient. the usual treatment of hypoglycemia is based on parenteral infusion of glucose. btu this can lead to a hyperglycemic rebound that can be deleterious. lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. it has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. the hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the icu in terms of glycemic variation, brain function and hormonal response.


Eligibility criteria:
inclusion criteria: * hypoglycemia under 0.6 g/l exclusion criteria: * hepatic failure * hyperlactatemia above 5 mmol/l

Keywords: hypoglycemia lactate glucose icu
study on the quality of life and pathological state in patients who underwent radical cystectomy

Conditions: Muscle-Invasive Bladder Carcinoma; Muscle Invasive Bladder Urothelial Carcinoma; Bladder Cancer TNM Staging; Bladder Cancer Stage IIa; Bladder Cancer Stage IIb; Bladder Cancer Stage IV; Bladder Leiomyosarcoma; Bladder Cancer; Bladder Cancer Stage II; Bladder Cancer Stage IIIa; Bladder Cancer Stage IIIb; Bladder Cancer Stage IIIc; Bladder Urothelial Carcinoma; Progression, Disease; Urinary Diversion; Neobladder; Radical Cystectomy

Summary: observational study on the quality of life and pathological state of patients underwent radical cystectomy.

each patient will be followed for approximately 10 years starting from the date of surgery. the patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the urology department. the data for each patient will then be transferred to the database itself. the data collected will be handled following the most strict gcps and privacy norms. the data entered will concern: * period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire * hospitalization period with all its related data * questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Eligibility criteria:
inclusion criteria: * subjects underwent radical cystectomy * \> 18 years old * ability to read and sign the informed consent exclusion criteria: * age \<18 years * inability to read and sign the informed consent

Keywords: radical cystectomy
investigating novel strategies in pediatric immune responses and microbiome environment: comprehensive lung disease investigation in children.

Conditions: Lung Diseases

Summary: the inspire child-study is a clinical research project focused on understanding lung diseases in children. the study aims to explore how the presence of certain bacteria, immune responses, and inflammatory markers in the lungs are connected to different lung diseases in pediatric patients. background: lung diseases in children can have long-lasting effects on their health, not only during childhood but also as they grow into adults. however, the specific causes and mechanisms behind these diseases are not yet fully understood. the inspire child-study is designed to investigate whether children with various lung conditions have distinct differences in the types of bacteria, immune system activity, and inflammation in their lungs. hypothesis: different lung diseases in children are hypothesized to be associated with unique patterns of bacteria, immune responses, and inflammation in the lungs by studying these patterns, the investigators hope to gain new insights that could lead to better diagnostic tools and more personalized treatments for children suffering from lung diseases. children already scheduled to undergo bronchoscopy are included in the study. a small sample of fluid from the lungs is collected, and the sample is analyzed for bacteria, immune markers, and signs of inflammation. this research could pave the way for improved care and treatment for young patients with lung conditions.


Eligibility criteria:
inclusion criteria: * age ranging from new-born to 17 years of age. * diagnosed with or being assessed for a lung disease. * possible to sample at least 2 ml of bal-fluid besides the scheduled amount during the bronchoscopy. exclusion criteria: * age older than 17 years. * not undergoing diagnosis at childrens center for pulmonary and allergic diseases. * failure to meet the requirement of being able to sample an additional 2 ml of bal-fluid.

Keywords: pediatric lung disease microbiome cytokine inflammation immune cell bacteria asthma coughing immunophenotype bronchiectasis bronchoscopy bal bronchoalveolar lavage diffuse lung disease interstitial lung disease
diphenhydramine and sweating

Conditions: Diphenhydramine Causing Adverse Effects in Therapeutic Use; Hyperthermia; Allergic Rhinitis; Sweating

Summary: in 2012, it was estimated that nearly 1 in 4 canadians suffer from allergic rhinitis. to add, 78% of individuals working in predisposing environments are predicted to develop occupational rhinitis. currently, the most popular treatment for rhinitis is antihistamine medication such as diphenhydramine, a first-generation antihistamine sold commercially as benadryl®. due it its anticholinergic effects, diphenhydramine has been suggested to impair the whole body sweating response during heat stress, potentially leaving consumers at an increased risk of heat-related illness. this randomized control trial approved by health canada will investigate whether ingesting extra strength diphenhydramine (50mg) will alter whole-body sweat losses during 60 minutes of exercise.


Eligibility criteria:
inclusion criteria: * able to safely perform \~60 minutes of moderate intensity exercise * no known hypersensitivity to diphenhydramine * not on any prescribed medication * body-mass index (bmi) less than 30 exclusion criteria: * outside 18 - 49 years of age * diagnosed with any cardiovascular, respiratory, neurological or metabolic disease * history of any cardiovascular, respiratory, neurological or metabolic disease * unable to exercise for 60 minutes at moderate intensity, or have a musculoskeletal injury * bmi \> or = 30

Keywords: thermoregulation diphenhydramine anticholinergic sweating
a study to evaluate the safety of two influenza vaccines in children and adolescents 3 to <18 years of age at risk for influenza-related complications

Conditions: Influenza

Summary: the study is designed to evaluate the safety of tivc or tiv vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.


Eligibility criteria:
inclusion criteria: * individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection. * further eligibility criteria may be discussed by contacting the site(s) exclusion criteria: * individuals with any fatal prognosis of an underlying medical condition (\<12 month life expectancy). * individuals hospitalized at the time of enrolment. * individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components. * further eligibility criteria may be discussed by contacting the site(s)

Keywords: influenza vaccine flu children adolescents
a1c discordance in diabetes patients

Conditions: Diabetes Mellitus

Summary: hba1c is used as a gold standard to see whether patients have optimal glycemic control. today, many physicians rely solely on hba1c to change medication. however, there is a select group of patients that have low average glucose levels but high hba1c levels. the investigators believe that these patients are fast glycators meaning that they incorporate sugar into their hemoglobin faster than normal. the investigators want to determine whether these patients are fast glycators.


Eligibility criteria:
inclusion criteria: * patient with diabetes * patients who test their sugar levels at least 3 times daily * recorded diary of sugar levels for the past month * willingness to have blood drawn * willingness to allow their blood sugar diary to be photocopied * estimated average glucose as derived from a1c is ≥ 4 mmol from measured glucose from self-monitoring blood glucose testing exclusion criteria: * patient with medical conditions that may affect their study participation or results will be excluded. * patients who are anemic * renal insufficient with a serum creatinine level \> 200 μmol/l

Keywords: diabetes mellitus hba1c glycation rate fructosamine
an investigational drug on clinical outcomes in patients with aortic stenosis (narrowing of the major blood vessel of the heart)(mk-0653a-043 am4)(completed)

Conditions: Aortic Stenosis

Summary: the purpose of this study is to evaluate whether treatment with an investigational drug as compared to placebo will reduce the risk of major cardiovascular events in patients with aortic stenosis.


Eligibility criteria:
inclusion criteria: * patients aged 45 to 85 with mild abnormalities of the aortic valve as confirmed by an echocardiogram. exclusion criteria: * patients previously in a trial using the study drug, or currently taking any medications that are not allowed in this study.
inflammation reduction to prevent cardiovascular injury in renal disease (repair)

Conditions: Chronic Kidney Diseases; Renal Failure

Summary: phase 1 basket trial including 2 open-label single-arm cohorts: repair ckd cohort and repair dialysis cohort. open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

the repair ckd cohort will enroll 100 patients with chronic kidney disease not requiring dialysis. the repair dialysis cohort will enroll 100 patients with chronic kidney disease requiring chronic maintenance dialysis. each participant will be followed for up to 17 weeks, to determine among adults with severe chronic kidney disease not requiring dialysis and (separately) in those requiring dialysis, the proportion who, over 8 weeks of treatment, discontinue colchicine 1) 0.3 mg daily and 2) 0.6 mg daily.

Eligibility criteria:
inclusion criteria: 1. one of either: 1.2 estimated gfr using ckd-epi 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (repair ckd cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (repair dialysis cohort); 2. age ≥18 years 3. provide informed consent to participate. exclusion criteria: 1. currently treated with and cannot withdraw colchicine due to medical necessity; or 2. known allergy/sensitivity to colchicine; or 3. prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or 4. currently pregnant or planning to become pregnant or breastfeed during the study; or 5. of childbearing potential and do not have a negative pregnancy test or do not agree to use two forms of contraception for the duration of the study; or 6. anticipated living donor renal transplant within the next 6 months; or 7. using a strong inhibitor of p-glycoprotein or strong inhibitor of cyp3a4 in the last 14 days; or 8. b12 deficiency not managed with intramuscular supplementation; or 9. uncontrolled chronic diarrhea; or 10. cirrhosis, or chronic active hepatitis; or 11. pre-existent neuromuscular disease or persistent serum ck level \> 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or 12. patient with any of the following within the past 60 days: * white blood cell count \< 3.0 x 109/l; or * platelet count \<110 x 109/l; or * alt or ast \> 3 times the upper limit of normal (uln); or * total bilirubin \> 2 times uln and not due to gilbert syndrome. 13. patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Keywords: tolerance colchicine resistance hematologic markers
pilot study of the treatment of vascular endothelial growth factor(vegf)signaling pathway inhibitor-induced hypertension

Conditions: Treatment Induced Hypertension

Summary: the purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (vegf) inhibitor treatment induced hypertension.


Eligibility criteria:
inclusion criteria: * ongoing treatment for malignancy by at the university of chicago with any agent with recognized, specific inhibition of vegf, vegf-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. these agents include but are not limited to: bevacizumab (avastin™), sorafenib (nexavar™), sunitinib (sutent™), axitinib (ag-013736), and azd 2171. * treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmhg. * stable management of other toxicities from the cancer treatments * expected to continue current cancer treatments for at least 4 weeks * 18 years and older * ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures. exclusion criteria: * concurrent use of hematopoietic supportive treatment with erythropoietin or congeners. * current uncontrolled toxicities due to the cancer treatments. * patients having known contraindications to hydralazine or minoxidil therapy. * any readings of systolic blood pressure \>200 mmhg or diastolic blood pressure \>120 mmhg in the four (4) weeks prior to screening. * use of either minoxidil or hydralazine in the six (6) months prior to screening.