Kornimate/medical-research-clean huggingface dataset:
effectiveness of intravenous vs rectal acetaminophen for pain management in post operative neonates

Conditions: Pain Score Reduction; Effectiveness of Acetaminophen; Postoperative Pain Management in Neonates; Rescue Analgesia; Neonatal Patient

Summary: this randomized controlled trial aims to evaluate the effectiveness of intravenous (iv) versus rectal acetaminophen for postoperative pain management in neonates. the study includes postoperative term neonates who require analgesia for at least 12 hours. the main questions the study seeks to answer are: does iv acetaminophen provide better pain relief compared to rectal administration in neonates? what is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? the study compares 32 neonates receiving iv acetaminophen to 32 neonates administered rectal acetaminophen. both routes are administered at equivalent bioavailable doses to ensure a fair comparison.

this randomized controlled trial investigates the comparative effectiveness of intravenous (iv) versus rectal administration of acetaminophen for managing postoperative pain in neonates. neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. however, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief. the study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. preterm and preoperative neonates are excluded. the neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site. key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded. this study will provide valuable insights into the optimal route for administering acetaminophen in neonates.

Eligibility criteria:
inclusion criteria: * all post-operative neonates requiring acetaminiphen as analgesia. exclusion criteria: * all neonates requiring any other kind of pain relief medication (nerve block or local analgesia) * all neonates in neonatal icu * all neonates with central venous line in place * all neonates that are on ventilatory support

Keywords: neonatal analgesia protocols neonatal care pain score reduction neonatal pain management acetaminophen in neonates pediatric surgery pain relief
pharmacokinetic study to determine time to steady-state

Conditions: Male Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism

Summary: the purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dl) males receiving testosterone undecanoate capsules administered twice daily. serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Eligibility criteria:
inclusion criteria: * male, age 18-75 * morning serum testosterone (t) \<300 ng/dl on two occasions * naive to androgen-replacement therapy or willing to wash-out from current t therapy exclusion criteria: * significant intercurrent disease * abnormal prostate digital rectal exam, elevated psa, aua symptom score \>15 or history of prostate cancer. * serum transaminases \>2 times upper limit of normal * serum bilirubin \>2.0 mg/dl * hematocrit \ 50% * bmi \>36 * untreated, obstructive sleep apnea.
the evaluation of functional parenchymal volume and split renal function before and after partial nephrectomy

Conditions: Renal Cell Carcinoma

Summary: the study aims to compare pre- and postoperative 3d renal function results of patients who underwent on-clamp and off-clamp partial nephrectomy.


Eligibility criteria:
inclusion criteria: 1. men and women \>18 years; 2. diagnosis of unilateral renal cell carcinoma (stage t1-t3an0m0); 3. planned surgery: retroperitoneoscopic/laparoscopic/robotic partial nephrectomy; 4. patients with ct of the kidneys with contrast enhancement performed according to the required protocol. - exclusion criteria: 1. age \ 3; 2. solitary kidney; 3. bilateral kidney 4. the presence of concomitant systemic pathology (dm, ah), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma; 5. obstructive nephropathy 6. systemic intake of nephrotoxic drugs; 7. pregnancy. -

Keywords: kidney cancer partial nephrectomy split renal function
osteopathic manipulative medicine to reduce developmental delays

Conditions: Extreme Prematurity; Neurodevelopmental Abnormality

Summary: this randomized clinical trial seeks to determine if osteopathic manipulative medicine (omm) increases the likelihood of improved neurodevelopmental outcomes as estimated by the test of infant motor performance (timp).

hypothesis: high risk preterm infants born \<34 weeks of gestation who receive omm, compared to the standard supportive care, will have improved neuromotor development scores on the timp. specific aims and objectives: primary aim: to determine the difference in timp scores between infants who receive omm and those who receive only standard neonatal intensive care unit (nicu) care. secondary aims: * to compare length of stay between infants who receive omm and those who receive only standard nicu care. * to compare growth parameters including weight, length, and head circumference, (both means and z scores) prior to discharge between infants who receive omm and those who receive only standard nicu care. * to compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive omm and those who receive only standard nicu care.

Eligibility criteria:
inclusion criteria: * 23 0/7- 33 6/7 weeks' gestational age (ga) at birth, ≥28 0/7 weeks' ga at time of consent * stable enough to tolerate gentle manipulation exclusion criteria: * \> 33 6/7 weeks' ga at birth * known congenital and genetic abnormalities affecting neurodevelopment * known conditions requiring surgical intervention * severe intracranial hemorrhage or other severe neurologic complications * parents unable to read and understand english

Keywords: osteopathic manipulative medicine (omm) test of infant motor performance (timp) neurodevelopmental outcomes
measuring the effect of chair massage on stress related symptoms for nurses

Conditions: Stress; Fatigue; Anxiety; Tension

Summary: the purpose of this study was to assess the feasibility and effect of chair massage provided during working hours for nurses in an inpatient psychiatric and an outpatient pain rehabilitation unit and on the nurses stress related symptoms.

nursing staff working in a hospital in-patient psychiatric unit and out-patient pain rehabilitation/ fibromyalgia units each have varying causes of stress as both are intensely demanding environments. the physical and psychosocial demands of these stress-loaded work environments place a significant amount of strain on the physiological well-being of the employee. nurses in these settings are considered healthy employees and able to participate in the workforce, although symptoms such as headaches, shoulder tension, insomnia, fatigue, and muscle and joint pain are often a part of their work day. as these stress related symptoms become more chronic, they lead to days missed and become pre-cursors to physiological illnesses so warrant further search for prevention tactics. massage therapy has been noted to decrease levels of anxiety and fatigue which is essential to maintaining employee's efficient care in a dynamic environment. this study will provide massage in the workplace utilizing chair massage as it is easy to set up, does not need a great deal of space, and can be provided in semi-private areas, as the participant remains clothed. a 2006 report on a small study indicated chair massage can be effective in reducing stress perception in nurses within a hospital setting, at least in the short-term. another study reported some short-term positive effects on stress related symptoms; and came to the conclusion that further studies are indicated to examine the efficacy of workplace-based massage therapy programs.

Eligibility criteria:
inclusion criteria: * men and women age 18-65 able to give informed consent * able to speak and understand english * minimum of 8-hour per day shift schedule with .75 - 1.0 fte. * need to be able to schedule one massage per week in the available massage schedule time slots. exclusion criteria: * individuals being treated for acute musculoskeletal symptoms * individuals currently on work restrictions * undergoing treatments for a malignancy * pregnancy (due to this being chair massage) * recent head, neck, shoulder or back surgeries * pins or joint fusion of the head or neck * current sinus infections, earaches, or vascular migraines * nursing staff that float on to the unit

Keywords: massage chair massage relaxation nurses
pegaptanib sodium on foveal thickening in patients with exudative subfoveal age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: the purpose of this study is to determine if macugen™ reduces foveal thickness and improves vision in patients with wet amd.

this will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. patients will be stratified by clinical center and foveal thickness to be treated either macugen or a sham injection. after 24 weeks, all patients will treated with macugen until the end of the study at 54 weeks.

Eligibility criteria:
inclusion criteria: * best corrected visual acuity in the study eye between 20/40 and 20/320 and better or equal to 20/800 in the fellow eye. * foveal thickness \<= 300 um (measured by oct center point thickness). * subfoveal choroidal neovascularization secondary to age-related macular degeneration, with a total lesion size (including blood, scar/atrophy \& neovascularization) of \<= 12 disc areas, of which at least 50% must be active cnv. exclusion criteria: * previous subfoveal thermal laser therapy. * any subfoveal atrophy or scarring, blood over the fovea, or fibrosis. additionally no more than 25% of the total lesion size may be made up of scarring or atrophy. * previous photodynamic therapy with visudyne (pdt) in the study eye. eyes with predominantly classic lesions (as classified by fluorescein angiographic appearance) may be enrolled in the trial if, in the clinical judgment of the investigator, pdt can be deferred for at least 54 weeks after the first study treatment

Keywords: amd age related macular degeneration exudative subfoveal age related macular degeneration with subfoveal choroidal neovascularization
intermediate-size expanded access protocol (eap) for lp352

Conditions: Dravet Syndrome; Lennox Gastaut Syndrome; Developmental and Epileptic Encephalopathies

Summary: this is an intermediate-size expanded access program (eap) study. the purpose of this eap is to provide continued access to lp352, an investigational drug product being investigated in participants with dees. the eap study will allow continued treatment with lp352 for eligible participants diagnosed with treatment resistant dees who successfully completed an lp352 clinical trial (enrollment by invitation) or an immediate family member who has the exact same gene mutation resulting in the same dee epilepsy syndrome phenotype or a patient who previously participated in the lorcaserin eap.


Eligibility criteria:
inclusion criteria: 1. participant and/or participant's legally authorized representative is willing and able to provide a written informed consent or assent form before participation in this eap. an assent should be obtained from the patient, if possible. assent must be obtained for adolescent eap patients (\<18 years of age) as required by local regulations. 2. participant with dee who has successfully completed an lp352 clinical trial. 3. participant currently has clinical benefit from lp352 treatment, as assessed by their treating physician. 4. participant currently tolerates lp352 treatment and has no safety issue which would prevent continued treatment. exclusion criteria: 1. participant was discontinued from an lp352 clinical trial for any reason. 2. any serious and/or unstable new medical condition, psychiatric disorder, or other conditions at the time of transition to this eap that could interfere with patient's safety, obtaining informed consent, assent, or compliance to this eap protocol, in the opinion of the treating physician.

Keywords: cdkl5 deficiency disorder developmental and epileptic encephalopathy dravet syndrome epilepsy lennox gastaut syndrome treatment resistant epilepsy tuberous sclerosis complex
brain regulation of appetite in twins

Conditions: Obesity; Appetite

Summary: scientists are examining the genetic and environmental influences on appetite and weight gain. the main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.


Eligibility criteria:
inclusion criteria: * ability and willingness to come with their twin to the university of washington (seattle) * additional criteria for aim 1 random sample only: member of randomly selected mz pair or * additional criteria for aim 2 random sample only: one member of mz or same-sex dz pair with bmi of at least 30 kg/m\^2 * additional criteria for aim 3 sample only: member of randomly selected mz pair, and not bmi discordant ≥ 5 kg/m\^2 exclusion criteria: * history of weight loss surgery or active participation in weight loss program * major medical problem (e.g., diabetes, cancer) * current use of weight loss medications or other medications known to alter appetite * pregnancy or menopause * mri contraindication (i.e., implanted metal, claustrophobia) * lifetime eating disorder * current smoking * current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males) * self-reported weight \>330 pounds at time of phone screening. mri cannot accommodate all shapes or weights. inability to have mri does not exclude subject from participating in other study procedures. * bmi \ 45 kg/m\^2 * allergies to study foods or inability to taste * twins were raised apart * co-twin not eligible or not willing to participate

Keywords: twins obesity appetite
investigating public enthusiasm for mammography screening in denmark

Conditions: Breast Neoplasm Female; Mammography Screening; Decision Making; Information Seeking Behavior

Summary: based on an american study by scherer et al., it is hypothesized that some women will make irrational choices regarding their participation in mammography screening. therefore, the aim is to estimate the prevalence of danish women having an irrational preference for mammography screening even when it confers no benefits, but only harms.

the prevalence of women making an irrational decision will be compared to the participation rate in the danish screening program. the study population will consist of a random sample of women aged 44-49. similar to the american study, two types of information will be compared (detailed vs. non-detailed information about the harms of screening). participants will be randomised to one of two information groups. based on the american study, it is assumed that the willingness to participate in the hypothetical screening program will be 40 percent. to achieve the desired precision in this study, a standard error of 2.5 percent is required corresponding to a confidence interval spanning approximately 35-45 percent. this will require 384 women in each group, corresponding to a total study population of 768. the survey will be sent electronically (using "e-boks") with a link to access the online survey trial. the survey will consist of screening and cancer related questions as well as questions on age, education, and health literacy. five questions on appraisal of health information from the health literacy questionnaire will also be included. after the data collection, data will be linked to data on income, residence, civil status, education, breast cancer diagnosis, and information on whether a participant is immigrant, descendent or of danish origin. the original plan for the main analysis was to compare the two groups of women randomized to different information groups (detailed vs. non-detailed information about the harms of screening). however, due to lower participation rate and therefore smaller sample size than expected, information group was disregarded in the main analysis. the two groups will still be compared in a secondary analysis. this decision was made before getting access to data from the questionnaire.

Eligibility criteria:
inclusion criteria: * residence: central denmark region exclusion criteria: -

Keywords: breast cancer mammography screening decision making information seeking behavior
long-term follow-up to determine outcome in liver disease (love study)

Conditions: Steatotic Liver Disease; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis); Steatotic Liver Disease of Mixed Origin (MetALD); ALD - Alcoholic Liver Disease

Summary: the rational to conduct the love study builds on the lack of available data on outcomes in steatotic liver disease in well characterized patients over a time frame of several years. at current limited data on liver-specific and overall outcome in patients with masld, metald and ald are available. liver histology is the only accepted surrogate to reasonably likely predict outcomes in patients with non-cirrhotic liver disease and is currently used in regulatory trials. to overcome the limitations of liver biopsy and use validated non-invasive tests (nits) to predict outcomes, the love study will be conducted based on existing cohort studies in well pheno- and genotyped patients and will inform on the relevant outcomes based on baseline and ongoing biomarker assessment. the overarching goal is to qualify a nit for patient identification and preventive measures in the regulatory context.


Eligibility criteria:
inclusion criteria: * previous informed consent for cohort studies * \> 18 years of age * diagnosis of sld (masld, metald, ald) exclusion criteria: * no consent for previous cohort studies * \< 18 years of age * no diagnosis of sld (masld, metald, ald)

Keywords: mash sld nits masld ald metald metabolism liver
study of whether 15 mg dose of ketorolac iv is as effective as a 30 mg dose.

Conditions: Pain; Pain, Postoperative

Summary: the primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the vas scores 4 hours after an adult spine surgery.

opioids have traditionally been the cornerstone of acute postoperative pain management. problematic side effects such as nausea, vomiting, ileus, urinary retention, excess sedation, and respiratory depression are significant disadvantages with the use of opioids. alternative treatments have been sought. the concept of adding a nonsedating non opioid analgesic agent is appealing and has been validated by previous studies. nonsteroidal anti-inflammatory drugs (nsaid) are nonsedating and combine analgesic and anti-inflammatory properties ideal for pain after surgery. ketorolac is a potent intravenous nonsteroidal anti-inflammatory drug (nsaid), and a non selective cyclooxygenase inhibitor which mediates pain, inflammation and fever. it has been evaluated and used for treatment of moderate to severe pain including postoperative pain. although intravenous route is not approved by health canada, its use is supported in medical literature and clinical practice. previous studies have demonstrated the effectiveness of standard 30 mg intravenous ketorolac as an adjunct to opioids for postoperative pain relief. standard parenteral dose recommended by manufacturer for healthy non elderly population is 30 mg based on a number clinical trials. alberta health services (ahs) pharmacy formulary has approved the intravenous use of ketorolac in the dosage range of 10-30 mg depending the patient's weight and medical comorbidities. nsaids, including ketorolac, have an analgesic ceiling effect in which higher doses do not provide any additional pain relief but may increase the likelihood of side effects. single dose im ketorolac have been studied in the past showing no difference in analgesia with the 30 and 90 mg dose. because of risk of drug toxicity and unwanted side effects, patients should be given the lowest effective ketorolac dose. low dose ketorolac was studied in the adolescents undergoing spine surgery and showed that dose of 0.2mg/kg (11mg) provides supplemental analgesia postoperatively. however, there were no previous studies found on review of the literature using medline search that look at parallel comparison between intraoperative doses of ketorolac in terms of efficacy and safety profile.

Eligibility criteria:
inclusion criteria: * patients booked for 1-2 level spine laminectomies and/or decompression * adult 18 - 65 years * weight of 50 - 110 kg exclusion criteria: * previous lumbar laminectomy * current anticoagulant use with inr \> 1.2 * narcotic use \> 4 weeks * known allergy or sensitivity to nsaid or morphine * renal insufficiency with creatinine \>100 umol/l * known liver disease * history of gastrointestinal bleeding * pregnancy, history of bronchial asthma * nsaid use 2 days before surgery.

Keywords: pain, postoperative ketorolac anti-inflammatory agents, non-steroidal intraoperative care