Kornimate/medical-research-clean huggingface dataset:
assessment of quizartinib pharmacokinetic in subjects with severe hepatic impairment

Conditions: Hepatic Impairment

Summary: this study will evaluate and compare the pk in subjects with severe hi to that of matched healthy control subjects with normal hepatic function.

this is a clinical pharmacology study with 2 cohorts (subjects with severe hi by child-pugh criteria and matched healthy control subjects) to evaluate the pk, safety, and tolerability of a single oral dose of 30 mg quizartinib in otherwise healthy subjects with severe hi (as defined by child-pugh criteria). this study is planned to be conducted at up to 3 sites in the us, which use child-pugh criteria.

Eligibility criteria:
key inclusion criteria: 1. voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. 2. male and female subjects 18 to 75 years of age (inclusive), with a body mass index (bmi) of 18 kg/m2 to 37 kg/m2 (inclusive) with a minimum body weight of 40 kg at screening. 3. in females, documented surgical sterilization (ie, documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[fsh\] \> 40 miu/ml serum and estradiol \<40 pg/ml \[\<147 pmol/l\] at screening), or agreement to have a sterile male partner, or agreement to use 1 of the means of contraception from screening until 7 months after the dose of quizartinib 4. in females, agreement to not retrieve eggs/ova via assisted reproductive technology (art) either for their own use or donation while on the study or for 7 months after the last dose of study drug, whichever is later. 5. in males, documented surgical sterilization, sexual abstinence, or agreement to use 1 of the means of contraception from screening until 4 months after the dose of quizartinib 6. in males, agreement to avoid sperm donation for 4 months after the dose of quizartinib key exclusion: 1. any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality except hepatic impairment) that could interfere with safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results. 2. in the opinion of the investigator, history of a clinically significant illness within 4 weeks prior to administration of quizartinib. 3. subjects with primary biliary cirrhosis or primary sclerosing cholangitis. 4. subjects with history of gilbert's syndrome. 5. presence or history of clinically severe adverse reaction to any drug or known hypersensitivity to any of the ingredients (including inactive ingredients) of quizartinib. 6. history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy).

Keywords: quizartinib
real-world evaluation of eko murmur analysis software in a point of care setting

Conditions: Murmur, Heart; Innocent Murmurs; Heart Murmurs; Pathologic Murmur

Summary: the purpose of this research is to evaluate the impact of eko ai plus emas (eko murmur analysis software) on a clinician's referral decision in a real-world primary care setting. there is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.

eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. in june 2022, the us food and drug administration (fda) granted eko a 510(k) clearance for the marketing of "eko murmur analysis software" (emas), a set of machine learning algorithms that are able to screen signal quality and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent murmurs, and provide a structural murmur's timing in the cardiac cycle. this study sets out to evaluate the impact of emas on a clinician's referral decision in a real-world primary care setting, with the additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. providers will receive access to the emas screening tool, called the sensora™ disease detection platform, which features the fda cleared 3m™ littmann® core stethoscope paired with the fda cleared sensora™ enterprise application and emas ai running on an ipad, which is mounted on a tryten stand. sensora™ will be used by medical assistants or equivalent as part of the initial patient intake process (e.g., during vitals acquisition). emas influence on individual providers will be assessed by reviewing each provider's number of referrals to cardiology and number of echocardiogram orders for the 6 months preceding study start. these values will be compared to cardiac referral and order rates at the end of the study. patient outcomes data (e.g., cardiology appointment notes, echocardiogram findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by their primary care provider. secondary objectives include the continued assessment of algorithm performance on a point-of-care population.

Eligibility criteria:
inclusion criteria: * patient verbally consents to participation * patient is willing to have heart sounds recorded with an electronic stethoscope * patient is age 50 years or older exclusion criteria: * patient is unwilling or unable to give verbal informed consent * patients experiencing a known or suspected acute cardiac event * patient is under the age of 50 years old

Keywords: artificial intelligence machine learning
evaluation of new diagnostic tool using fluorescence to detect high-grade vulvar intraepithelial neoplasia

Conditions: Vulvar Intraepithelial Neoplasia; Vulvar High Grade Squamous Intraepithelial Lesion; Differentiated Vulvar Intraepithelial Neoplasia

Summary: this study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours metvixia application.


Eligibility criteria:
inclusion criteria: * patient aged 18 and over, * with isolated high-grade vulvar intraepithelial neoplasia or associated with invasive cancer proven histologically by biopsy * naive of any vulvovaginal treatment (surgery or radiotherapy) * no metastases * who \<or equal to 3 * contraception method for women of childbearing potential * patient affiliated to the social security scheme * patient who understood, signed and dated the information note and the * consent form, * patient able and willing to follow all study procedures in accordance with the protocol. exclusion criteria: * history of hypersensitivity to the active substance methyl aminolevulinate or to any of the components of the drug (including peanut oil and refined almond oil), soybean or peanut * ulceration or hyperpigmented lesions of the vulva * patient with porphyria * any previous vulvovaginal treatment (surgery or radiotherapy) * metastatic disease * patient undergoing treatment for any other invasive cancer * pregnant, likely to be or breastfeeding patient * patient deprived of liberty or under guardianship (including guardianship) * inability to undergo medical monitoring of the trial for geographic, social or psychological reasons. * patient already included in another therapeutic trial with an experimental molecule, * associated pathology that may prevent the patient from receiving metvixia application and light exposure.

Keywords: vulvar intraepithelial neoplasia vulvar high grade squamous intraepithelial lesion photodynamic diagnosis metvixia differentiated vulvar intraepithelial neoplasia
culturally appropriate strategies for chinese americans with diabetes (cascade)

Conditions: Type 2 Diabetes

Summary: the project aimed to evaluate the implementation process and efficacy of a culturally tailored diabetes self-management and education (dsme) program with mobile health (mhealth) technology integration, entitled culturally appropriate strategies for chinese americans with diabetes (cascade), among chinese american adults with type 2 diabetes.

the cascade program includes 1) a home visit for training of monitoring devices use, wechat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) wechat follow-up on education tips, monitoring data summary, and group discussion. the monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. wechat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication. a single group pre-post-test design was adopted to evaluate changes of primary (hba1c) and secondary (self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention. engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.

Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes * having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both * confirmed hba1c level \>=6.5% and \<10% * 21-75 years old * residents of san gabriel valley * speak and understand of mandarin * willing to use the smartphone-based monitoring devices provided by the project. exclusion criteria: * unable or unwilling to give informed consent * plan to move out of the area within the 1-year participation study period * are or plan to be pregnant or breastfeeding in the next 12 months * have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping) * have major physical disability or condition that prevents them from participating in person.

Keywords: chinese americans type 2 diabetes mhealth diabetes self-management and education
a study of regn5093 in adult patients with mesenchymal epithelial transition factor (met)-altered advanced non-small cell lung cancer

Conditions: NSCLC

Summary: this study will evaluate regn5093 for the treatment of non-small cell lung cancer (nsclc) with met alteration. the main purpose of this study is to determine the safety, tolerability, and effectiveness of regn5093. the study has two phases. the main goal of phase 1 is to determine a safe dose(s) of regn5093. the main goal of phase 2 of the study is to use the regn5093 drug dose(s) found in phase 1 to see how well regn5093 works to shrink tumors. the study is looking at several other research questions, including: * side effects that may be experienced by people taking regn5093 * how regn5093 works in the body * how much regn5093 is present in the blood * to see if regn5093 works to reduce or delay the progression of cancer * how long it takes regn5093 to work in the body


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed advanced nsclc that is unresectable or metastatic as described in the protocol 2. willing to provide tumor tissue as described in the protocol 3. documented presence of met alteration as described in the protocol. 4. eastern cooperative oncology group (ecog) performance status of 0 or 1 5. adequate organ and bone marrow function as described in the protocol key exclusion criteria: 1. has received treatment with an approved systemic therapy or has participated in any study of an investigational agent or investigational device within 2 weeks as described in the protocol 2. has not yet recovered from any acute toxicities resulting from prior therapy with certain exceptions as described in the protocol 3. has received radiation therapy or major surgery within 14 days as described in the protocol 4. untreated or active primary brain tumor, central nervous system (cns) metastases, leptomeningeal disease or spinal cord compression as defined in the protocol 5. uncontrolled infection as described in the protocol note: other protocol defined inclusion/exclusion criteria apply

Keywords: met (mesenchymal-epithelial transition factor) hgf (hepatocyte growth factor) nsclc (non-small cell lung cancer) met-altered advanced unresectable metastatic disease
effect of placental drainage of fetal blood at cesarean section on the incidence of feto-maternal transfusion

Conditions: Fetomaternal Transfusion

Summary: study hypothesis: umbilical cord drainage of fetal blood after delivery of the infant would reduce the incidence of feto-maternal transfusion. patients were randomized to placental drainage or no drainage at the time of cesarean section. the incidence of fetal to maternal transfusion was noted postoperatively.

86 patients were randomized to placental drainage vs. no drainage of fetal blood at the time of cesarean section. kleihauer-betke testing was performed within 12 hours postoperatively to assess the incidence of feto-maternal transfusion. a significant difference was found between the two groups.

Eligibility criteria:
inclusion criteria: * all women undergoing cesarean section exclusion criteria: * preoperative kleihauer-betke, known antepartum erythrocyte sensitization, overt vaginal bleeding, history of a previous delivery by low vertical cesarean section, prolonged rupture of membranes, twin gestation, failure to obtain both preoperative and postoperative kleihauer-betke tests.

Keywords: feto-maternal transfusion kleihauer-betke
efficacy of lactobacillus paracasei ps23 for patients with post-covid-19 syndrome

Conditions: Post-COVID-19 Syndrome

Summary: to evaluate whether probiotics ps23 can improve the symptoms of patients with long covid-19 ; also to evaluate the effects on blood cortisol and inflammation-related indicators in patients.

it is expected that a total of 120 subjects will be recruited within 3 years after irb approval, divided into two groups of 60 subjects, respectively consuming ps23 heat-treated bacteria or placebo, and completing the 6-week period.

Eligibility criteria:
inclusion criteria: 1. aged above 20 years old and below 65 years old. 2. those who consciously have long covid-19 symptoms or actively respond to website advertisements to express interest in participating in this clinical researcher. 3. those who received the confirmation sms or the covid-19 rapid test positive 4 weeks ago. exclusion criteria: 1. have taken antibiotics within one month or are receiving antibiotic treatment. 2. have taken probiotic products have been used within two weeks (excluding yogurt, yogurt, yakult and other related foods). 3. cancer or immunocompromised patients undergoing treatment. 4. those who are allergic to lactic acid bacteria products. 5. diagnosed with dementia before being diagnosed with covid-19. 6. prior to or currently taking medication for acute or psychiatric illness prior to the diagnosis of covid-19. 7. the investigator judges that it is not suitable to participate in the researcher.
training in fever case management with rapid diagnostic tests (rdts) for malaria in uganda

Conditions: Malaria; Fever

Summary: malaria remains one of the most devastating infectious diseases in the world. despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. new diagnostic methods that are practical for limited health-care settings are urgently needed. immunochromatographic rapid diagnostic tests (rdts) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. a major challenge now is to implement rdts effectively in typical african clinical settings. we plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating rdt use in peripheral government health centers in uganda. results from this study will provide evidence for scale-up of rdt implementation in uganda, as planned by the uganda ministry of health from mid-2008, as well as in other sub-saharan african countries. the aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating rdts, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in uganda. our hypothesis is that training in fever case management and rdt use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.


Eligibility criteria:
inclusion criteria: * all outpatients at participating health centers exclusion criteria: * patient refusal

Keywords: malaria diagnosis rapid diagnostic test rapid diagnostic tests fever case management training fever case management in malaria-endemic areas
the risk of falling in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Fall; Balance; Distorted; Activity, Motor

Summary: this cross-sectional study aims to investigate what daily activities increase the risk of falling in chronic obstructive pulmonary disease patients (copd).

to investigate the what daily activities increase the risk of falling in patients with copd, twenty-eight voluntary patients with copd, aged between 35-80 years will be divided into two groups: group-1 have at least one fall (fallers) and group-2 have no history of falls (non-fallers). fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. assessments will be performed at baseline. fear of falling will be assessed with activities-specific balance confidence (abc) scale. balance will be evaluated by berg balance scale (bbs). the level of dyspnea during daily activities will be assessed with london chest activity of daily living (lcadl) scale. the global impacts of copd symptoms on overall health status will be evaluated by the copd assessment test (cat). the modified medical research council dyspnea (mmrc) scale and six-minute walking test (6mwt) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. pulmonary function data will be retrieved from the last 1-month clinical records of the copd patients. statistical analysis will be performed using the statistical package for social sciences (spss) version 21.0. among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. the significance level will be set as p\<0.05.

Eligibility criteria:
inclusion criteria: 1. stable disease (no severe exacerbations in the prior 3 months) 2. ability to walk independently 3. ability to read and write in turkish 4. able to follow simple instructions 5. no pathology in visual ability and hearing exclusion criteria: 1. a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder) 2. severe musculoskeletal, neurological or cardiovascular disorders that limit mobility 3. use of medication(s) that may increase the risk of falls 4. participate in pulmonary rehabilitation in the lasts six months
development, implementation and evaluation of a complex regional intervention for type 2 diabetes: diabetes project aalst

Conditions: Diabetes Type 2

Summary: the purpose of this study is to determine whether regional implementation of shared care with respect to type 2 diabetes is feasible, effective and cost-effective.

background diabetes is an important chronic condition with significant associated morbidity and mortality, which can be reduced by effective care. an interdisciplinary approach, sharing responsibility and involvement and education of patients are of major importance in diabetes care. in belgium a research project aimed at creating regional diabetes shared care was set up. research questions * is regional implementation of shared care feasible? * does it increases quality of care (evidence based care) and patient satisfaction with care? * does it have a positive effect on health status (emotional distress, overall quality of life, hba1c)? methods controlled trial (july 2004 - june 2006) with a regional complex intervention comprising introduction of a care-manager and 2 community based diabetes educators, development and implementation of a shared care protocol (with a central role for the gp), regional feedback on the quality of diabetes care and patient education. practitioners and patients participate on a voluntary basis. in the control region usual care continues. biophysical, psychosocial and process outcomes were collected thru gp registration of patients records and self-administered patient questionnaires (paid, quote).

Eligibility criteria:
inclusion criteria: * all type 2 diabetes patients living in the defined intervention region * all caregivers involved in type 2 diabetes care in the defined intervention region exclusion criteria: * none
effect of different acupuncture schemes for postoperative urinary retention in cervical cancer patients

Conditions: Postoperative Urinary Retention (POUR)

Summary: this is a retrospective cohort study using a paired control design. we will review the patients of pur after cervical cancer surgery who went to the acupuncture department and the urinary retention department in zhejiang cancer hospital from october 2020 to august 2024, and 73 patients met the screening criteria. all patients provided written informed consent. the purpose of the study is to compare the effect of acupuncture at different combinations of acupoints for postoperative urinary retention (pur) after radical hysterectomy of cervical cancer. all outcome-measures data were obtained from past medical records. it is an observational study rather than an intervention study. 73 patients met the screening criteria. they will be assigned into two groups according to the treatment scheme of acupoints combination for acupuncture: group a (37 cases) and group b (36 cases).


Eligibility criteria:
inclusion criteria: * 18-70 years old * karnofsky performance scale (kps) score \> 70 * met the diagnostic criteria of pur * no history of serious urinary system diseases or urinary retention before the operation * had clear cognition and no severe mental diseases * had complete medical records and records of residual urine volume data. exclusion criteria: * presence of other serious systemic diseases or advanced cachexia * obstructive urinary retention caused by urethral stricture, stones, or other diseases * receiving other treatments or self-change treatment * poor compliance or failure to complete the acupuncture treatments * incomplete clinical data.