Kornimate/medical-research-clean huggingface dataset:
sucrose practices for pain in neonates part b

Conditions: Pain

Summary: recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. sucrose (sugar water) has been shown to be effective for reducing babies' pain during painful procedures. unfortunately, sucrose is not used as often as it could be to reduce babies' pain. this may be due to lack of certainty about the least effective amount of sucrose to use and concerns about the long-term effects of repeated use of sucrose on infant development. factors within the hospital units where babies receive care may also influence caregivers' decisions to use sucrose. in this research the investigators will conduct two main studies. in the first study the investigators determined the lowest amount of sucrose needed to manage babies' pain effectively. in the second study the investigators will explore (a) if this amount of sucrose can manage pain when it is used repeatedly for all painful procedures while the baby is hospitalized and (b) whether consistent use of sucrose influences the development of babies when they are 18 and 36 months old. during the second study, the investigators will also examine the hospital units where the babies receive care. they will look at staff support for research, time and resources and other factors that promote and prevent sucrose use. the results of these studies will be used to determine the best management of babies' pain during painful procedures in hospitals to achieve the best outcomes.


Eligibility criteria:
inclusion: * less than 32 weeks gestational age at birth * admitted to the neonatal intensive care unit (nicu) * expected to have heel lances for routine blood tests * yet to reach 10 days of life at the time of study enrollment. exclusion: * known hypersensitivity to sucrose, corn, corn products or any component of the formulation * short-bowel syndrome * carbohydrate intolerance * unable to swallow/absent gag reflex (e.g., pharmacologically muscle relaxed, unconscious, or heavily sedated)

Keywords: sucrose effectiveness healthcare delivery neonates nursing
randomized controlled trial of rectal indomethacin versus combined pancreatic stent placement and rectal indomethacin for preventing post-ercp pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: the goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ercp pancreatitis. the main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ercp pancreatitis participants will be patients who give consent to the study and who are required to undergo ercp as part of their standard care. if there is a comparison group: researchers will compare \[rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ercp pancreatitis.\] to see if \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ercp pancreatitis\].


Eligibility criteria:
inclusion criteria: 1. suspected sphincter of oddi dysfunction 2. history of post ercp pancreatitis 3. pancreatic instrumentation or sphincterotomy. 4. precut sphincteroyomy 5. difficult cannulation defined by more than 5 cannulation attempts 6. the use of double wire technique in bile duct access 7. at least 2 of the followings including 1. female age \< 50 year 2. 3 pancreatogram 3. acinarization (contrast injection to tail of pancreas 4. normal serum bilirubin 5. guidewire to the tail of pancreas or secondary branches exclusion criteria: 1. patient planned for pancreatic stenting 2. without informed consent 3. age \< 18 years 4. pregnant women 5. lactating women 6. patient with altered anatomy 7. contraindications to the use of nsaids 8. renal failure 9. ongoing or recent hospitalisation for acute pancreatitis 10. allergy to aspirin or nsaids 11. known chronic calcific pancreatitis -
investigation on the status quo of hyperalgesia in patients after thoracoscopic operation and study on the effect of intraoperative intervention

Conditions: Thoracoscopic Surgery; Hyperalgesia

Summary: to explore the status quo and influencing factors of hyperpain in patients after thoracoscopic surgery, and to explore the effect of earphone sound isolation during combined operation of flurbiprofen axidate and binaural beat music played by earphone during combined operation on the intervention of hyperpain after thoracoscopic surgery.

in this study, patients undergoing thoracoscopy radical lung cancer surgery in union hospital affiliated to fujian medical university were selected for a randomized controlled trial. patients were selected according to the inclusion and exclusion criteria, and the patients were randomly divided into group a of flurbiprofen axidate combined with noise-canceling headset music test, group b of flurbiprofen axidate combined with noise-canceling headset test, and the control group for intraoperative intervention study.

Eligibility criteria:
inclusion criteria: * patients selected by the same group of surgeons to perform thoracoscopic three-hole radical resection of lung cancer * patients ≥18 years old, able to communicate effectively and cooperate with the completion of clinical trials * asa grade i-iii * normal hearing; patients who have not participated in other trials in the last two months exclusion criteria: * previous history of thoracic surgery * history of chronic pain and any intake of analgesics 48 hours before surgery; ● have a history of mental illness, or have taken psychiatric drugs or received psychological treatment in the past six months * deformity of the auricle, inability to wear headphones, and failure to cooperate with this study for any reason * suffering from concurrent severe organ system diseases and hearing impairment * incomplete data collection
adapting and evaluating an ebi to prevent hiv/aids risk among apache youth

Conditions: HIV/AIDS

Summary: the investigators seek to adapt, implement and evaluate a randomized controlled trial of an evidence based intervention delivered by apache interventionists to reduce hiv/aids risk, targeting apache adolescents. specific study objectives include: 1. to perform formative research through focus groups and individual interviews on attitudes, practices and intervention preferences among apache adolescents and community stakeholders. 2. to adapt the focus on youth (foy) evidence-based intervention using findings from the formative research, components of protection motivation theory, and input from a community advisory board. 3. to enroll 304 white mountain apache youth ages 13-19 to participate in a randomized intervention trial measuring behavior change at 6- and 12- months follow-up. 4. to determine the feasibility of gathering biological specimens via self-administered swabs to track sexually transmitted diseases among 18-19 year olds enrolled in this and future studies.

the general format of the study consists of a randomized controlled trial delivered through the medium of an 8-day basketball camp. intervention activities will consist of the daily delivery of a youth hiv/aids prevention curriculum over the course of 8 days.

Eligibility criteria:
inclusion criteria: * american indian ethnicity and primary residence and/or employment within the white mountain apache (fort apache) reservation. participants must be aged 13-19 years and have parent/guardian consent for youth under 18 years old. exclusion criteria: * youth that are unable to fully participate in the evaluation assessments or intervention components will be excluded. in addition, individuals age 16 or older that are listed on either the federal or tribal sexual offender registries will be excluded from participation.

Keywords: hiv/aids prevention american indian substance use cbpr
mantel cell lymphoma efficacy of rituximab maintenance

Conditions: Mantle Cell Lymphoma

Summary: randomized, open-label, phase iii study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

demonstration of the superiority in terms of 4-year event-free survival (efs) of rituximab maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years inclusive, treated with r-dhap then autologous transplantation for mcl as first-line therapy.

Eligibility criteria:
inclusion criteria: * mantle cell lymphoma * initial immunophenotyping with cd20 and cd5. * cd20+. * t (11;14) by karyote, fish, molecular biology or immunohistochemistry (bcl-1) * patient no previous treated. * at least one tumor site accessible for assessment * aged \> 18 years \< 65 * ecog \< or = 2. * no other neoplasms apart from resected basal cell carcinoma or in situ carcinoma. * signed informed consent * fevg 50% exclusion criteria: * other type of lymphoma * ecog \> or = 3 * relapse * serology vih + hepatite + * diabetis

Keywords: mantle cell lymphoma r dhap asct rituximab maintenance
lenticule implantation and autologous serum new approach in treatment of adenoviral keratitis disease

Conditions: Adenoviral Keratoconjunctivitis

Summary: adenoviral keratitis(caused by adenovirus) is one of the most frequently diagnosed eye diseases. most of these infections have symptoms like (ocular itchiness and irritation, chemosis (conjunctival edema),photophobia, epiphora, foreign body sensation, epithelial keratitis etc.adenoviral subepithelial infiltration is one of the most difficult complication to treat. our purpose is to evaluate corneal transparency, recurrence, and visual acuity in patients with adenoviral subepithelial infiltration by first removing the infiltrative stroma with a smile and implanting the same volume of fresh lenticule in the prepared stromal pocket.

our treatment of adenoviral keratitis using lenticule implantation and autologus serum it has been applied to patients who have received medical treatment(antiviral medications, topical corticosteroids ,compresses, artificial tears, and topical cycloplegic) for a long time but have not been successful. in oct, firstly, the thickness of the adenoviral subepithelial infiltration in the cornea is calculated in microns, and extraction is performed accordingly with small incision lenticule extraction( smile )and fresh lenticule implanted stromal in the same volume. as-oct was evaluated using corneal topography and glass-corrected best visual acuity (bscva) measurements and electron microscopy. postoperative complications were recorded during the follow-up period. the patients were followed for one year. no complications were observed in the patients. after the operation, there was an increase in satisfaction and vision. they returned to their daily lives very quickly. postoperatively, uncorrected vision increased to 6 lines in 12 eyes, seven lines in 11 eyes, and eight lines in 3 eyes.

Eligibility criteria:
inclusion criteria: * low transparency of cornea * low visual acuity * recurrence keratitis exclusion criteria: * active anterior segment pathology * previous corneal or anterior segment surgery * any infection
use of allogenic platelet lysate in peripheral arterial disease (pad)

Conditions: Peripheral Arterial Disease

Summary: allogenic platelet lysate will be injected in the gastrocnemius of patients with peripheral arterial disease (pad)

allogenic platelet rich plasma (prp) will be collected from blood group ab donors. this plasma will be tested for the presence of any chronic infectious blood borne disease. platelet lysate will be then prepared from the tested prp to be intramuscularly injected in patients with pad

Eligibility criteria:
inclusion criteria: * competent and willing to give informed consent, and to be available for all baseline treatment and follow up examinations required by the protocol. * gender: male or female. * age group \> 50 years. * established critical limb ischemia (cli), clinically and hemodynamically confirmed as per rutherford 3, 4 and 5 with angiographic evidence of significant infra-inguinal arterial occlusive disease. * history of intermittent claudication for \> eight weeks. * limited exercise due to moderate to severe claudication. * resting abi \< 0.6, toe pressure ≤ 60 mm hg, toe brachial index (tbi) \<0.6, or tcpo2 ≤ 60 mmhg in the foot. * not eligible for surgical or radiological revascularization, and doesn't respond to best standard care delivered as confirmed by a vascular surgeon and/or physician. * fairly controlled diabetes (hemoglobin a1c \<10%). * normal liver enzymes, serum creatinine \< 1.4 * normal platelet count. * on regular medication for hypertension if any. * no evidence of malignancy * body mass index \<30. exclusion criteria: * women with child bearing potential, pregnant and lactating women. * rheumatoid arthritis. * history of neoplasm or malignancy in the past 10 years. * reported unstable cardiovascular disease, heart failure or symptomatic postural hypotension within 6 months before screening. * leg edema * inflammatory or progressive fibrotic disorder * renal insufficiency or failure * history of infectious disorder (human immunodeficiency virus (hiv) and/or hepatitis viruses). * chronic inflammatory disease * history of stroke or myocardial infarction (\< 3 months). * bleeding or clotting disorder, use of oral anticoagulant therapy (heparin, warfarin).

Keywords: peripheral arterial disease platelet lysate
fortified oral rehydration therapy for pediatric diarrhea

Conditions: Acute Gastroenteritis

Summary: the goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ort) to the standard of care ort in pediatric patients with acute gastroenteritis (age). the main questions it aims to answer are: * can amino acid-fortified ort reduce the duration and severity of age compared to standard of care ort? * can amino acid-fortified ort increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ort? participants will be assigned to the experimental treatment (amino acid-fortified ort) or the standard of care ort and their disease severity, duration, and stool antimicrobial peptide content.


Eligibility criteria:
inclusion criteria: * between the ages of 6 months and 5 years. * experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to pediatric emergency department. * diarrhea presumed infectious exclusion criteria: * severe gastroenteritis with moderate to severe dehydration * requiring inpatient care * requiring antibiotics * requiring iv rehydration * history of chronic diarrhea * presenting with diarrhea for greater than 2 days prior to admission * allergy to any of the ingredients in the study products * inborn metabolic disorder of amino acids * receives post-pyloric feedings

Keywords: gastroenteritis intestinal diseases pediatric diseases diarrhea, infantile
a chronic care model based quality improvement (qi) program to improve the care of patients with chronic kidney disease (ckd)

Conditions: Chronic Kidney Disease

Summary: the goal of this study is to evaluate the impact of a chronic care model (ccm) based quality improvement program on 1) outcomes for patients with chronic kidney disease (ckd) and 2) adherence to ckd guidelines. this pilot study will evaluate the feasibility of a ccm based quality improvement program for patients with ckd and assess potential mechanisms for the intervention's effect. hypothesis: implementing a ccm based quality improvement program including system level support in the form of collaborative care, a ckd registry, and provider education will 1) reduce systolic bp in patients with poorly controlled hypertension, 2) increase the percentage of patients appropriately monitored for metabolic complications, and 3) decrease the rate of catheter use in patients initiating dialysis.

research plan: the experimental design is a prospective, randomized controlled trial evaluating the impact of a chronic care model (ccm) based quality improvement program on ckd guideline adherence. the intervention will focus on three main goals: 1) reduction of bp to target levels, 2) appropriate monitoring of patients for metabolic complications of ckd, and 3) reduced use of dialysis catheters in patients initiating dialysis. the ckd ccm qi program will include a lecture on ckd guidelines and hypertension to all cboc providers and a centrally located pharmacist with access to the ckd registry. methodology: veterans receive primary care at community based outpatient centers (cbocs) throughout northeast ohio. patients with ckd who receive their primary care at a northeast ohio cboc will be eligible for the study. the hypothesis was formulated before data collection.

Eligibility criteria:
inclusion criteria: * receipt of primary care at a visn 10 northeast ohio cboc * gfr (calculated according to the 4 variable modification of diet in renal disease study equation) less than 45 ml/min per 1.73m2 with a second gfr less than 60 at least 90 to 730 days prior to the index gfr (26); and * at least one primary care visit in the year prior to study initiation. exclusion criteria: * esrd as defined by chronic renal replacement therapy, * receipt of a renal transplant, * hospice care, and * age greater than 85 years or less than 18 years at the time of study initiation.
a clinical study to evaluate the safety and pharmacokinetics of ckd-344

Conditions: Anticoagulant

Summary: a clinical trial to evaluate the pharmacokinetics and safety of ckd-344

a phase 1 clinical trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of ckd-344.

Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19 years 2. weight ≥60kg, with calculated body mass index(bmi) of 18 to 30 kg/m2 3. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 4. those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening. 5. those who agree to contraception during the participation of clinical trial. 6. those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. exclusion criteria: 1. those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeleto-muscular, immune, etc. 2. those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 3. those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product. 4. those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 5. those who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product. 6. those who exceed an alcohol and cigarette consumption than below criteria. a. alcohol: man- 21 glasses/week, woman - 14 glasses/week b. smoking: 20 cigarettes/day 7. those who exceeds 2 times the upper limit of the reference range of ast(or alt) or 1.5 times the upper limit of the reference range of γ-gtp. 8. those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions. 9. those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.) 10. those who were deemed inappropriate to participate in the study by the investigator. 11. those who have a pregnant or nursing woman.
effects of constipation treatment in chronic kidney disease: a pilot feasibility trial

Conditions: Chronic Kidney Disease; Constipation

Summary: constipation is one of the most prevalent gastrointestinal disorders in patients with chronic kidney disease (ckd) and has been associated with their adverse kidney and cardiovascular outcomes; however, little is known about the effects of constipation treatment on clinical outcomes nor on outcome-related biochemical and microbiological parameters in patients with ckd. the investigators aim to test the feasibility of delivering an intervention with constipation treatment and determine its effects on changes in clinical, biochemical, and microbiological parameters in patients with ckd and constipation.


Eligibility criteria:
inclusion criteria: 1. male or female patients \>18 years old. 2. patients able and willing to provide written informed consent and hipaa authorization. 3. ckd stages g3-g5 without kidney replacement therapy with estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2 calculated using the chronic kidney disease-epidemiology collaboration (ckd-epi) 2021 creatinine equation. 4. functional or opioid-induced constipation based on the rome iv criteria. 5. patients must refrain from taking any laxatives for at least one week prior to screening, although rescue with one bisacodyl 5 mg tablet will be allowed when a patient does not have a bowel movement for ≥3 consecutive days or when symptoms become intolerable. 6. a negative pregnancy test in female patients prior to enrolment, unless the patient is two years postmenopausal or has had a documented tubal ligation or hysterectomy. exclusion criteria: 1. history of drug abuse, anorexia nervosa, or bulimia. 2. history of irritable bowel syndrome, inflammatory bowel disease, or clostridium difficile bacterial infection (ever). 3. liver cirrhosis or chronic active hepatitis (patients with treated hepatitis can be included). 4. galactosemia. 5. allergies to lactulose. 6. history of gastrointestinal surgery except appendectomy. 7. use of antibiotics or immunosuppressants within 30 days prior to the enrollment in the study. 8. use of pre- or probiotics within 30 days prior to enrollment in the study. 9. women who are pregnant, capable of becoming pregnant and not participating in an acceptable form of birth control, or who are breast feeding. 10. patients currently participating in another interventional study. 11. major surgery within one month prior to enrollment in the study or planned surgery while the patient is in the study, other than dialysis vascular access surgery. 12. patients who the investigator determine have a medical status that would preclude the patient's participation. 13. patients on hemodialysis or peritoneal dialysis. 14. patients with a functional kidney transplant. 15. patients with past lactulose use.

Keywords: chronic kidney disease constipation microbiota