Kornimate/medical-research-clean huggingface dataset:
a study to assess s-217622 in participants with renal impairment and healthy participants

Conditions: Renal Impairment

Summary: the objective of this study is to measure the pk, safety, and tolerability of s-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal function.


Eligibility criteria:
inclusion criteria: * body weight ≥ 50 kilograms (kg) and body mass index (bmi) within the range of ≥ 18.5 to \< 38.0 kilogram-meter squared (kg/m\^2) at the screening visit participants with renal impairment * participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their modification of diet in renal disease (mdrd) creatinine clearance estimate (estimated glomerular filtration rate \[egfr\]) calculated at the screening visit: 1. mild renal impairment: 60 to 89 milliliters per minute (ml/min)/1.73 m\^2 2. moderate renal impairment: 30 to 59 ml/min/1.73 m\^2 3. severe renal impairment: no lower limit of egfr, \<30 ml/min * a stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the follow-up/early termination visit. healthy participants * participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. renal function, calculated by mdrd, must be normal (ie, egfr \> 90 ml/min/1.73 m\^2). * matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and bmi (± 10%). exclusion criteria: * participants with life expectancy less than 3 months. * history or presence of/significant history of or current cardiovascular, respiratory, hepatic, gastrointestinal (gi), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). * history of gi surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in gi function. * lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. * breast cancer within the past 10 years. * participant with poor venous access.
the value of follow-up after childhood acute lymphoblastic leukaemia in denmark - family perspectives

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Surveys and Questionnaires

Summary: the aim of the study is to evaluate the family perspective on follow-up programs after treatment for childhood acute lymphoblastic leukaemia. it is relevant when new follow-up programs are to be designed.

more than 90 % of paediatric patients with acute lymphoblastic leukaemia (all), treated on the nordic society of pediatric hematology and oncology (nopho) all-2008 protocol, are alive five years after diagnosis. the main reason for treatment failure being relapse. the risk of relapse after treatment for all is highest within the first two years after cessation of maintenance therapy. therefore, it has been routine in most countries to follow-up patients in the outpatient clinic every one or two months during the first years after end of therapy for all in order to detect recurrence and possible late sequelae at an early stage. in children with all there are only a few studies on the value of routine follow-up, including haematological status after cessation of maintenance therapy. these studies showed that approximately 90% of the relapses were diagnosed in children with symptoms of leukaemia progression and that routine blood tests and clinical follow-ups were of little value. it is well known that there are other issues besides the risk of relapse, which are relevant for families after cessation of all therapy i.e. risk of late effects of treatment, psychosocial problems related to the child's return to "normal" life etc. these issues will also have an impact upon how the follow-up programs are planned. the investigators will study the family perspectives on follow-up during the first 5-years after cessation of maintenance therapy in a danish cohort of children treated according to the nopho all-2008 protocol. the investigators will conduct a cross-sectional study. outcomes are patient-reported as the measurement instrument used is questionnaires. eligible families are families with children diagnosed with acute lymphoblastic leukaemia in denmark and being in the period 0-5 years after cessation of maintenance therapy.

Eligibility criteria:
inclusion criteria: * patients with b-precursor all and t-all enrolled in the nopho all-2008 trial * age group 1.0-14.9 years. * patients treated on one of the four danish paediatric oncology departments * patients in the time period 0-5 years after cessation of maintenance therapy for all exclusion criteria: * a history of recurrence or second malignancies * bone marrow transplantation * down syndrome * if, due to language barriers, the family is unable to complete the questionnaire.

Keywords: aftercare
quadratus lumborum block reduced postpartum uterine pain after virginal childbirth

Conditions: Quadratus Lumborum Nerve Block; Postpartum Cramping; Vaginal Delivery

Summary: with the continuous advancement of ultrasonic technology, nerve block in which drugs are injected into the periphery of the target nerve through ultrasonic guidance has become the mainstream method for postoperative pain control. the quadratus lumborum nerve block has been effectively and safely used in abdominal surgery (such as laparotomy, caesarean section, etc.), effectively reducing postoperative wounds and visceral pain. there is no research on the use of quadratus lumborum nerve block to control the pain of natural postpartum uterine contractions in the current literature, so the purpose of this experiment is to explore whether the quadratus lumborum nerve block can effectively reduce the pain of uterine contractions after vaginal delivery.


Eligibility criteria:
inclusion criteria: * females over twenty years of age * maternal vaginal delivery * postpartum moderate to severe pain with uterine contractions (numerical pain scale (nrs) ≥ 4 points) after delivery. * subject's consent signed by the subject exclusion criteria: * severe coagulation abnormalities (plt\ 1.2、pt\>13) * infection of the epidermis at the anticipated relevant site of injection * allergy to local anesthetics * allergy to or abuse of pain control medications * episiotomy is more painful than uterine contractions * inability to cooperate with associated pain assessment * body mass index (bmi) ≧ 35 kg/m2
evaluation of the bd oneflow acute leukemia panel on the bd facslyric flow cytometer

Conditions: Acute Leukemia

Summary: this study is a multi-site, prospective performance study to determine equivalency between the investigational oneflow acute leukemia panel on the facslyric system versus the final clinical diagnosis.

hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. high speed and broad applicability of flow cytometry allows for the diagnosis. currently, there are no consensus panels being used; consequently, the leukemia \& lymphoma (l\&l) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (ldts) being used to test patient specimens. furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed. enrollment will occur at up to 8 investigational sites . data will be acquired from eligible remnant/leftover specimens on the bd facslyric flow cytometer and evaluated by site personnel and expert analysts . the final diagnosis and the affected cell population will be determined by site standard of care . analysis of data will evaluate identification of 1) normal vs abnormal cell populations and 2) bcp-all, aml, and less certain diseases by the expert \& site analysts as compared to the final diagnosis.

Eligibility criteria:
inclusion criteria: 1. specimen collected/handled prior to enrollment in accordance with site policies and procedures. 2. specimen with adequate volume (1 ml) to complete protocol tests. 3. specimen is leftover pb and bm from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. aml, bcp-all, alal, etc.), myelodysplastic syndrome (mds), other hematological, or non-hematological disorders. 4. specimen from newly diagnosed or relapsed subject. 5. only one specimen type (pb or bm) shall be enrolled per given subject. 6. specimen is stored at room temperature, upon receipt by the site. 7. specimens are collected in edta (k2 or k3) or heparin (sodium or lithium). 8. age of specimen (bcp all t1: time of collection to start of first pre-wash; alot, aml t1-t4: time of collection to start of staining): ≤ 24 hours. 9. specimens are from subjects irrespective of race, gender, and ethnicity exclusion criteria: 1. specimen is from healthy subject. 2. specimen from subject \<3 years of age. 3. specimen is from subject undergoing any treatment for any form of leukemia. 4. specimen is from subject with minimal residual disease (mrd) as determined by the site. 5. specimen is from subject suspected of plasma cell disorders. 6. visibly clotted specimen. 7. visibly hemolyzed specimen. 8. frozen specimen. 9. refrigerated specimen. 10. fixed specimen.
canadian humira post marketing observational epidemiological study: assessing effectiveness in psoriasis

Conditions: Psoriasis

Summary: this was a canadian post-marketing observational study (pmos) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

this was a canadian post-marketing observational study (pmos) utilizing a prospective cohort design. participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. off-label use was not permitted, and these participants were not included in the study. dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Eligibility criteria:
inclusion criteria: * active moderate or severe plaque psoriasis according to the judgment of the treating physician. * the treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference. exclusion criteria: * had currently participated in another prospective study with similar objectives. * participant could not or would not sign informed consent. * presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Keywords: effectiveness psoriasis observational prospective adalimumab traditional systemic agents topical agents comparative
liaison nes influenza (flu) a/b & coronavirus disease 2019 (covid-19) clinical agreement in australia

Conditions: Influenza A; Influenza Type B; Coronavirus Disease 2019

Summary: the diasorin molecular liaison® nes flu a/b \& covid-19 real-time polymerase chain reaction (rt-pcr) assay is intended for use on the diasorin liaison® nes instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza a, influenza b and sars-cov-2 virus from dry nasal swabs (ns) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors. the liaison® nes flu a/b \& covid-19 assay is intended for use as an aid in the differential diagnosis of influenza a, influenza b and sars-cov-2 infection in a professional laboratory setting. negative results do not preclude influenza a, influenza b, or sars-cov-2, infection and should not be used as the sole basis for patient management decisions. the assay is not intended to detect the presence of the influenza c virus.


Eligibility criteria:
inclusion criteria: * human patients with active signs and symptoms of respiratory tract infection at time of collection * specimens collected within 7 days of symptom onset for the initial collection * availability of age, gender, race, ethnicity, collection dates, collection time, routine respiratory testing method, routine respiratory result, signs and symptoms (e.g., fever), date of symptom onset for each symptom, vaccination status (flu and covid-19, as applicable), pre-existing medical conditions (as applicable), medications (e.g., covid-19 antivirals), etc. for each subject exclusion criteria: * incorrect swab type * incorrect transport media * incorrect specimen handling (specimens not stored at recommended temperature) * samples collected \>7 days from symptom onset * subjects not consented
a randomized controlled mindfulness based stress reduction intervention in women with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer


Eligibility criteria:
inclusion criteria: * patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy exclusion criteria: * patients with advanced illness at diagnosis * patients previously used mbsr

Keywords: breast cancer, mindfulness based stress reduction, rct, mood, cooping, health related quality of life
spinal anesthesia versus combined sciatic-femoral nerve block for outpatient knee arthroscopy

Conditions: Knee Arthritis

Summary: the aim of the study is to compare the time of home discharge in day-case patients receiving either a spinal anesthesia or a combined sciatic-femoral nerve block for knee arthroscopy

two groups: the first receive a spinal anesthesia injecting 2% hyperbaric prilocaine 40 mg with the patients in lateral decubitus and the surgical limb declive, the second a combined ultrasound-guided sciatic-femoral nerve block injecting 25 ml of 2% mepivacaine solution. onset time, performance time, duration of the block, time of voiding, as well as the time of home discharge will be evaluated.

Eligibility criteria:
inclusion criteria: * outpatients knee arthroscopy exclusion criteria: * diabetes * allergy to local anesthetic * patient refusal * chronic opiods assumption
efficacy and safety of naft-600 in subjects with tinea pedis

Conditions: Tinea Pedis

Summary: the purpose of this study is to evaluate the efficacy and safety of naft-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.


Eligibility criteria:
inclusion criteria: * males or non-pregnant females, ≥12 years of age, of any race or sex. females of child-bearing potential must have a negative urine pregnancy test. * presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s)). exclusion criteria: * subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,unstable angina or myocardial infarction) within the last 6 months. * subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results. * subjects with a known hypersensitivity to study drugs or their components. * subjects who have a recent history or who are currently known to abuse alcohol or drugs. * uncontrolled diabetes mellitus. * hemodialysis or chronic ambulatory peritoneal dialysis therapy. * current diagnosis of immunocompromising conditions. * foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis. * severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection. * extremely severe tinea pedis (incapacitating). * female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study

Keywords: fungal infection athlete foot
gi tolerance and acceptability of a new thickener

Conditions: Gastro-intestinal Tolerance

Summary: the current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed and dated an icf approved by an irb/iec, and provided applicable privacy authorization prior to any participation in the study. * subject is diagnosed with dysphagia. * subject is under the care of a speech and language therapist and is currently using a thickener. * subject currently has normal gi function. * subject is interested in participating in the study, willing to comply with the study protocol and product. * subject who is able to consent and is able to evaluate the product. exclusion criteria: * subject has a normal swallow. * subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding. * subject has impaired renal function. * subject has liver failure, decompensated chronic liver disease, active hepatitis b or c receiving treatment, or hepatic encephalopathy. * subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures. * participant is known to be allergic or intolerant to any ingredient found in the study product. * participation in another study that has not been approved as a concomitant study. * subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease. * subject has a clinical condition which may interfere with gastrointestinal tolerance. * subject is pregnant.
iatrogenic impairment of urethral coitus owing to midurethral sling procedure in a woman with vaginal agenesis.

Conditions: Stress Urinary Incontinence; Vaginal Agenesis

Summary: to report a case of impairment urethral coitus after the midurethral sling procedure

to report a case of impairment urethral coitus after the midurethral sling procedure.

Eligibility criteria:
inclusion criteria: * midurethral sling procedure for stress urinary incontinence * woman with vaginal agenesis. exclusion criteria: * nil
microarchitecture, bone strength and fracture risk in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Bone Fractures

Summary: this multicenter, prospective, observational cohort study will assess bone differences in women and men with type 2 diabetes mellitus (t2dm) with and without fragility fractures.

cross-sectional evaluation of clinical, biochemical and microstructural measures of bone in patients with type 2 diabetes and age-matched healthy controls. longitudinal assessment of clinical, biochemical and microstructural measures of bone in study participants without prevalent fragility fractures.

Eligibility criteria:
inclusion criteria: - presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes) exclusion criteria: * immobility * coexisting metabolic bone disease or comorbidities affecting bone health * previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment * thiazolidinedione use

Keywords: intra-cortical pore volume hr-pqct dxa bone mineral density bone turnover markers urinary pentosidine
emergency department (ed) drug interaction in emergency department patients

Conditions: Drug Interactions

Summary: this study examines how hepatic cytochrome cyp2d6 drug interactions affects the efficacy of oxycodone, hydrocodone, and ondansetron in emergency department (ed) patients.

patients with pain and/or nausea are enrolled in the emergency department (ed). they are given either oxycodone, hydrocodone, or ondansetron at the discretion of the emergency department (ed) provider or the triage nurse by triage protocol. detailed prescription, over the counter, herbal, supplement, and illicit drug ingestion histories are taken from the patient or their health care proxy. serial visual analogue scales are captured prior to study drug administration then between 30 and 90 minutes following drug administration.

Eligibility criteria:
inclusion criteria: * self-reported pain or nausea identified by the initial nursing assessment exclusion criteria: * unable to speak english, * \< 18 y.o., * previously diagnosed with chronic pain or cyclic vomiting

Keywords: drug interactions cyp2d6 opioid efficacy pain nausea