Kornimate/medical-research-clean huggingface dataset:
testing educational materials in a paediatric setting

Conditions: Immunization

Summary: immunization procedures are a common source of iatrogenic pain for infants. a recently developed clinical practice guideline, led by taddio et al., created evidence-based strategies for management of immunization pain. user-friendly educational tools outlining these strategies were made. the goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.

immunization procedures are a common source of iatrogenic pain for infants. a recently developed clinical practice guideline led by taddio et al. provides evidence-based recommendations for the management of immunization pain in children. user-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. the primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). the study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.

Eligibility criteria:
inclusion criteria: * parents of 2 or 4-month old healthy infants during routine immunization appointments * parent accompanies infant at immunization appointments exclusion criteria: * parents of infants \<30 weeks gestational age (ga) * parents delaying infant immunization for \>2 months * parents who are unable to read and understand english * infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions

Keywords: parent education pain management immunization infant
prognostic model of tac in the treatment of mn

Conditions: Idiopathic Membranous Nephropathy

Summary: the goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (imn) under the treatment of tacrolimus. the main questions it aims to answer are: * to explore the factors that can predict the prognosis difference in patients with imn under the treatment of tacrolimus * to establish a clinical prediction model and verify it to provide a reference for the early participants will receive standard the treatment of tacrolimus treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy. researchers will compare \[remission group and non-remission group\] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase a2 receptor (pla2r) antibody positive by renal puncture biopsy, and the clinical data were complete; 2. according to the kidney disease: improving global outcomes (kdigo) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss. 3. in general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others; 4. volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form. exclusion criteria: 1. there are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins; 2. at the same time, immunoglobulin a nephropathy (igan), interstitial nephritis, acute nephritis and other renal pathological types were combined; 3. the medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases; 4. during follow-up, the patient cannot actively cooperate or accurately understand and express.
bone and body comp: a sub study of the second-line study

Conditions: HIV

Summary: the use of anti hiv drugs (art), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (n(t)rti), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. low bone mineral density and osteoporosis are also common in hiv-infected patients. there appears to be some association between art and bone loss, but this is poorly understood and requires further research. the second-line study provides an opportunity to examine if a new anti-hiv drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing n(t)rti, which is currently standard of care. this study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-hiv drugs and whether non-n(t)rti regimens of art used in second line therapy result in more or less bone loss than use of other classes of anti-hiv drugs such as protease inhibitors or n(t)rti combinations. it is hypothesized that subjects randomised into raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (lpv/r + 2-3n(t)rtis).


Eligibility criteria:
second-line main study identifier: nct00931463 inclusion criteria: 1. hiv-1 positive by licensed diagnostic test 2. aged 16 years or older (or minimum age as determined by local regulations or as legal requirements dictate) 3. have received first antiretroviral regimen consisting of an nnrti plus 2n(t)rtis for ≥ 24 weeks 4. no change in antiretroviral therapy within 12 weeks prior to screening 5. failed first-line nnrti + 2n(t)rti combination therapy according to virological criteria defined by two consecutive (≥7 days apart) hiv rna results of \> 500 copies/ml 6. no prior or current exposure to hiv protease inhibitors and/or hiv integrase inhibitors 7. able to provide written informed consent exclusion criteria: 1. the following laboratory variables: * absolute neutrophil count (anc) \< 500 cells/µl * hemoglobin \< 7.0 g/dl * platelet count \< 50,000 cells/µl * alt \> 5 x uln 2. pregnant or nursing mothers 3. participants with active viral hepatitis b infection defined by the presence in serum of hepatitis b surface antigen 4. use of immunomodulators within 30 days prior to screening 5. use of any prohibited medications (rifampicin, midazolam, triazolam, cisapride, pimozide, amiodarone, dihydroergotamine, ergotamine, ergonovine, methylergonovine, astemizole, terfenadine, vardenafil, and st. john's wort) 6. intercurrent illness requiring hospitalisation 7. active opportunistic disease not under adequate control in the opinion of the site principal investigator 8. participants with current alcohol or illicit substance abuse that in the opinion of the site principal investigator might adversely affect participation in the study 9. participants deemed by the site principal investigator unlikely to be able to remain in follow-up for the protocol-defined period
post-incision antimicrobial wash vs c. acnes in shoulder arthroplasty

Conditions: Shoulder Arthroplasty; Positive C. Acnes Culture

Summary: the purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive c. acnes cultures collected from adults undergoing primary shoulder replacement surgery. subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments: * post-incision application of xperience antimicrobial wash (nextscience, jacksonville, fl) * post-incision application of 3% hydrogen peroxide * post-incision application of 10% povidone-iodine (betadine) * no post-incision treatment (control) the investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive c. acnes cultures. the investigators also hypothesize that post-incision application of xperience antimicrobial wash and betadine will have an equal reduction in the incidence of c. acnes as hydrogen peroxide.

cultures will be collected from the following sites: * the surgical site prior to the initial incision * the incision site after the initial incision * the shoulder joint * the room air cultures will be monitored daily for the presence of c. acnes up to 18 days post-surgery. at postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. a password-secured database and data points will be pulled from electronic medical records. data will be analyzed and will be utilized to come to the conclusion of the study.

Eligibility criteria:
inclusion criteria: * indicated and scheduled for primary shoulder arthroplasty. * chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy, * ability to read and understand english * age ≥18 years * patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (nsaids) exclusion criteria: * patient with history of prior native shoulder septic arthritis or infection * prior surgery of affected shoulder * proximal humerus fracture * active infection * cancer * autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus * history of allergic reaction to citric acid-derived products

Keywords: shoulder arthroplasty antimicrobial post-incision wash c. acnes
effect of retatrutide compared with semaglutide in adult participants with type 2 diabetes and inadequate glycemic control with metformin with or without sglt2 inhibitor (transcend-t2d-2)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with type 2 diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (sglt2i). the study will last about 26 months and may include up to 24 visits.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (t2d) * have hba1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without sglt2i during 90 days prior to screening * are of stable weight for at least 90 days prior to screening * have a body mass index (bmi) ≥ 25.0 kilograms per meter squared (kg/m\^2) exclusion criteria: * have type 1 diabetes (t1d) * have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * have an estimated glomerular filtration rate (egfr) \<45 milliliters/minute/1.73 meter squared (ml/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * have a prior or planned surgical treatment for obesity * have new york heart association functional classification iv congestive heart failure * have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * have a known clinically significant gastric emptying abnormality * have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * have any lifetime history of a suicide attempt * had chronic or acute pancreatitis * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (men) syndrome type 2 * have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Keywords: glucose metabolism disorders metabolic diseases endocrine system diseases incretins
a phase 2 study of the safety and efficacy of brepocitinib in adults with cutaneous sarcoidosis (beacon)

Conditions: Cutaneous Sarcoidosis

Summary: this study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.


Eligibility criteria:
inclusion criteria: 1. adults subjects (18-74) 2. cutaneous sarcoidosis with characteristic skin biopsy histology 3. a csami activity score ≥ 10 4. weight \> 40 kg to \< 130 kg with bmi \< 40 kg/m2 . exclusion criteria 1. history of * lymphoproliferative disorder * active malignancy; * history of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix). 2. high risk of thrombosis or cardiovascular disease 3. high risk of herpes zoster 4. active or recent infection

Keywords: sarcoidosis cutaneous sarcoidosis brepocitinib
chemotherapy treatment in re-occurring non small cell lung cancer (nsclc) after previous chemotherapy and surgical removal of the nsclc tumor

Conditions: Lung Neoplasms

Summary: the purpose of this study is to help answer: * whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last * whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer


Eligibility criteria:
inclusion criteria: * you have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy. * you have good kidney, liver, and bone marrow organ function. * you are fully active or able to carry out light work such as housework or office work. exclusion criteria: * you have received pemetrexed or gemcitabine in the past for lung cancer * you are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past * you are unable to take corticosteroid drugs like dexamethasone * you are unable or unwilling to take the folic acid pills or vitamin b12 injections that are required for the study * you are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study * you have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication
circulating tumor dna as liquid biopsy in patients with stage iv solid tumors, a feasibility study at musc hcc

Conditions: Solid Tumor, Adult

Summary: 1. to demonstrate the ability to detect specific cancer mutations in ctdna isolated from plasma of stage iv cancer patients at hcc. 2. to compare, in each patient, ctdna longitudinal samples through treatment, and when available, with those of primary tumor and metastasis.

the overall goal of this study is to study circulating tumor dna (ctdna) in the blood to determine how cancer cells in patients react to treatment. dna is short for deoxyribonucleic acid. dna contains information that determines in part the traits, such as eye color, height, or disease risk, that are passed on from parent to child. this reaction will be measured by studying patient blood that will be collected before and during treatment until there is disease progression.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stage iv malignancy, including any advanced solid tumors (including lymphoma) * eastern cooperative oncology group (ecog) performance status (ps) 0-3 * life expectancy ≥ 3 months * patients must be able to provide consent * patients can be enrolled in other interventional clinical trials exclusion criteria: - age \< 18-year-old

Keywords: stage iv solid tumor
multicenter study to evaluate the efficacy and safety of metoclopramide nasal spray in women with diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: the purpose of this study is provide confirmation of the safety and efficacy of metoclopramide nasal spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.

diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to metoclopramide nasal spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Eligibility criteria:
inclusion criteria: * non pregnant, non lactating female subjects between the ages of 18 and 75 years * willingness and ability to give written informed consent * the ability to read, understand and speak english * prior diagnosis of type 1 or type 2 diabetes * diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying * a mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization * subjects of childbearing potential must agree to use contraception * willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study exclusion criteria: * gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility * a history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product * a history of, or physical findings suggestive of, tardive dyskinesia * a history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening * a history of allergy to any of the ingredients in the study drug formulation * a history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (ibd), or symptomatic irritable bowel syndrome (ibs) * malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening * renal dysfunction calculated as creatinine clearance (crcl) \<40 ml/min at screening * hemoglobin a1c \>11.5% at screening * subjects who are trying to conceive, are pregnant, or are lactating

Keywords: gastroparesis diabetic delayed gastric emptying gastric stasis nausea vomiting bloating abdominal pain early satiety gastropathy
renal denervation in patients with resistant hypertension and obstructive sleep apnea

Conditions: Hypertension; Obstructive Sleep Apnea

Summary: the purpose of this study is to investigate the clinical utility of renal denervation for the treatment of resistant hypertension coexisting with obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: * \>= 18 and =\< 70 years of age. * systolic blood pressure \>=140mmhg (office); * on 3 or more antihypertensive medications (including diuretic) * mean daytime systolic abpm \>= 135 mmhg * obstructive sleep apnea (ahi \>=15 event/hour, indications for cpap treatment) exclusion criteria: * renal artery abnormalities * egfr \< 60ml/min * previous tia, stroke, heart failure * type 1 diabetes * icd or pacemaker * others

Keywords: hypertension, resistant obstructive sleep apnea renal denervation continuous positive airway pressure therapy
musical neglect training for patients with visual neglect

Conditions: Hemispatial Neglect

Summary: music neglect training has been developed for patients with hemispatial neglect to improve their attention on the left side. the purpose of this study was to examine the immediate and carry-over effect of musical neglect training on unilateral visual neglect. standardized assessments (albert's test and line bisection test) were used to measure a range of visual field. a total of 6 musical exercises with tone bars which are aligned horizontally helped to improve attention and perception of the visual field on the left side.

unilateral visual neglect from right hemisphere stroke is a condition that reduces a person's ability to attend to and process stimuli in one half, mostly left side, of their environment. this perceptual processing deficit can negatively affect individuals' daily living which in turn reduces functional independence. music has been used as a therapeutic tool in a variety of settings to promote cognitive functions. in particular, music has been used to improve attention in the left sides for patients with visual neglect. musical neglect training (mnt) has been developed for patients with visual neglect to improve attention in the left side. the purpose of this study was to examine the immediate and longer-lasting effect of musical neglect training (mnt) on unilateral visual neglect. a single-subject design was used, as participants served as their own control. two individuals participated in this study. participants underwent six individual mnt sessions. mnt uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field. two standardized assessments (albert's and line bisection test) were used. the assessments were administered immediately before and after each of the 6 mnt sessions to assess the immediate effect of mnt. moreover, follow-up testing was done one week after their 6th session to examine the longer-lasting effects of mnt. paired t-test was used to examine the immediate effect, and both participants showed significant improvement with albert's test in immediate effect.

Eligibility criteria:
inclusion criteria: * patients with visual neglect after stroke * right-handed * medically stable * no previous music therapy experiences * no hearing impairments * no cognitive deficits exclusion criteria: * hemianopia * previous music therapy treatment experiences

Keywords: musical neglect training neurologic music therapy unilateral visual neglect hemispatial neglect stroke spatial perception and attention music therapy