Kornimate/medical-research-clean huggingface dataset:
interdisciplinary home rehabilitation of patients with stroke. a randomised controlled intervention trial.

Conditions: Acute Stroke

Summary: objective: to evaluate the effect of interdisciplinary home rehabilitation of patients with acute stroke. the trial seeks to evaluate: 1. can early home rehabilitation affect the degree of independence (motor capacity, activities of daily living and cognitive status), quality of life and the possibility of discharge to own home? 2. can home rehabilitation influence the length of admission at a rehabilitation centre in the municipality, readmission to hospital, the use of healthcare services and death? 3. to what extend can home rehabilitation be implemented according to finances? materials and methods: patients at the age 18 years or more admitted to the stroke unit at the university hospital of gentofte. the patients were eligible when meeting the following criteria: symptoms of stroke, need of rehabilitation tree days after admission, living in own home in the municipality of gentofte, lyngby-taarbaek or rudersdal and modified rankin score between 0 and 3. the trial was conducted as a randomised controlled trial. the control group patients were rehabilitated according to normal procedure. the intervention group patients were rehabilitated according to normal procedure and were additionally rehabilitated at home during admission and four weeks after discharge.

objectives were to assess the efficacy of home-based stroke rehabilitation compared to standard care in stroke patients using an interventional, randomised, safety/efficacy open-label trial and parallel assignment. the setting was single-center, stroke unit at the university hospital of copenhagen, gentofte, although patients were recruited through a collaboration of several municipalities. participants were eligible patients with a clinical diagnosis of stroke and focal neurological deficits hospitalised in a stroke unit for more than three days and in need of rehabilitation. interventions patients were randomised to home-based rehabilitation during hospitalization and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation services. control patients received treatment and rehabilitation following usual guidelines for the treatment of stroke patients. main outcome measures 90 days post-stroke, modified rankin scale, and motor rehabilitation, cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.

Eligibility criteria:
inclusion criteria: * 18 years or more, * symptoms of stroke, * need of rehabilitation tree days after admission, * living in own home, * modified rankin score between 0 and 3 exclusion criteria: * terminal care, * discharged from another department, living in nursery home, * can not understand the danish language, * memory difficulties

Keywords: stroke rehabilitation motor recovery cognition quality of life
prospective cohort study of patients with early alzheimer's disease treated with lecanemab

Conditions: Alzheimer Disease; Mild Cognitive Impairment (MCI)

Summary: as the population increases and aging intensifies, cognitive disorders represented by alzheimer's disease (ad) not only pose a severe threat to public health but also bring significant social and economic burdens. previously, treatment options for alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. lecanemab, an fda-approved clinical treatment drug in 2023, targets the core pathology of ad-abnormal amyloid-beta (aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. the optimal dosage and safety-efficacy profile of lecanemab for treating early ad have been observed in phase 2 and phase 3 clinical trials. however, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (aria), such as microhemorrhages or hemosiderin deposits (aria-h), and aria-e. this study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early ad patients (stages 3-4), and monitor the risk factors for adverse event occurrence.


Eligibility criteria:
inclusion criteria: * mini-mental state examination (mmse) score between 22 and 30, clinical dementia rating scale sum of boxes (cdr-sb) score between 0.5 and 1; * confirmation of positive amyloid pathology by amyloid-pet or cerebrospinal fluid aβ testing; * completion of apoe gene testing. * willingness to use lecanemab. exclusion criteria: * unable to tolerate mri scans; * mri showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations; * use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding; * with unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.

Keywords: alzheimer disease lecanemab cognition amyloid-related imaging abnormalities
preoperative biochemical predictors of outcome in patients with hip fracture

Conditions: Hip Fracture

Summary: the objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. for this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. during the hospital stay medical history, anesthesiological management recorded. in addition, american society of anesthesiology physiological score (asa), revised cardiac risk index (rcri), and possum score is calculated. morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. biochemical predictors of outcome will be evaluated with logistic regression analysis. biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. the predictive value of the potential markers will be compared to that of asa, rcri and possum.


Eligibility criteria:
inclusion criteria: * patients presenting with out of hospital hip fracture at university hospital lund sweden * informed consent * blood sampling within 3 hrs of first contact with healthcare exclusion criteria: * no consent can be obtained * non-operative management * followup through the swedish national quality for hip fracture patients not possible * high energy trauma

Keywords: predictor outcome biochemical
cross-over study to prove bioequivalence between two brands of cefalexin capsules

Conditions: Anti-Infective Agents

Summary: a single dose, two treatments (two cephalexin capsules brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods. treatment groups balanced with the same number of healthy volunteers who were randomly (in two strata: male and female) assigned to the study drug administration sequences.


Eligibility criteria:
inclusion criteria: * healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ecg), blood chemistry, liver function profile and urinalysis exclusion criteria: * history of illnesses or any organic abnormalities that could affect the results of the study * history of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs * subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup
understanding acute dietary changes after glp-1 agonist treatment: the glad feasibility study

Conditions: Obesity; Type 2 Diabetes Mellitus (T2DM)

Summary: an observational study of those who have been prescribed a glp-1 agonist therapy (yet to commence), for either weight or diabetes management, and are willing to complete dietary records and questionnaires of behaviour and psychosocial health.

forty individuals (20 for weight management, 20 for diabetes management) living in australia who have been prescribed a glp-1 agonist (no previous prescription or no use in the previous 6 months) will be recruited to participate over the initial 3 months of their treatment. assessments will occur remotely (online) at baseline, 2 weeks, 1 month and 3 months. optional body composition assessments will be provided at baseline and 3 months for those based in melbourne, australia.

Eligibility criteria:
inclusion criteria: * aged 18+ years old * intending to commence a prescription for a glp-1 agonist (may be dual agonist, i.e. ozempic, trulicity, monjaro, or saxenda) medication, with no use in the previous 6 months * the primary reason for commencing the medication will be for diabetes or weight management * willing to participate in dietary recall and questionnaires exclusion criteria: * aged under 18 years, * used a glp-1 agonist medication in the previous 6 months, * unwilling or unable to provide dietary recalls * non-english speaking.

Keywords: dietary behaviours psychosocial health
family-skills training to prevent tobacco and other substance use in latino youth

Conditions: Tobacco Use Disorder; Alcohol Use Disorder; Drug Use Disorder; Smoking; Alcohol Drinking; Drug Abuse

Summary: the goal of this project is to evaluate the effectiveness of a family-based tobacco use prevention intervention directed at immigrant latino parents of middle school aged youth as delivered in partnership with seven community organizations. the primary outcomes of the study are youth susceptibility to tobacco use, and changes in parenting practices among the parents of the youth. the planning, initiation, and delivery of the intervention will occur in collaboration with community organizations that have identified this project as important to the families they serve. though the collaboratively designed training curriculum has been successfully tested and a study design for the current project established, a substantive development period for this project will allow the research team and collaborating organizations to consider key aspects of design and delivery.

this study design is a randomized (at the level of the family) controlled trial (rct), with a delayed treatment condition for the control group. participants will be enrolled from community agencies known and trusted within the latino community including two clinics, a school, three social service agencies and a university of minnesota extension site that are likely end-users of the intervention programming.

Eligibility criteria:
inclusion criteria: * parent inclusion * either mother or father born in latin american country * speaks spanish * parent willing to give consent for self \& youth * youth inclusion * age 10-14 years * speak english or spanish * youth willing to give assent exclusion criteria: * parent exclusion * not meeting inclusion criteria * past participant padres informados parenting program

Keywords: spanish speaking
urinary and vaginal hpv testing in cervical cancer screening

Conditions: Uterine Cervical Neoplasms

Summary: cervical cancer, caused by high-risk human papillomavirus (hpv) infection, poses a problem worldwide as it is the fourth most common female cancer. fifty percent of all invasive cervical cancers occur among the 25% not attending cervical cancer screening. to reach these women, this project will contribute to the development of a novel and accurate urinary and vaginal screening tool, which allows women to collect the screening samples at home. this project tests the hypotheses: 1) urinary hpv testing is non-inferior to hpv testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer, 2) vaginal hpv testing is non-inferior to hpv testing on clinician-collected cervical samples for detection of high-grade cervical pre-cancer and 3) dna methylation testing is suitable as a colposcopy triage test among women with hpv-positive urine and/or vaginal samples to prevent unnecessary colposcopies and overtreatment of women without clinically meaningful hpv infections. if confirmed, urinary and vaginal hpv testing could revolutionize todays screening programs and keep denmark at the forefront of cervical cancer prevention.

paired urine, vaginal, and clinician-collected cervical samples will be obtained from approximately 330 women aged 23-64 years referred for colposcopy and cervical biopsies due to abnormal screening result or referred for cervical excision due to treatment of cin2+. upon informed consent, the women will collect a first-void urine sample and a vaginal self-sample. before colposcopy or excision, a clinician will collect a cervical sample. among women referred for colposcopy, four cervical punch biopsies will be taken. for women referred for excision, a cone biopsy will be taken using a loop electrosurgical excision procedure. upon arrival in the laboratory, the paired urine, vaginal and cervical samples will be hpv tested using the cobas 4800 hpv dna assay. histological results will served as reference and be grouped as ≤cin1 (normal tissue, cin1) versus cin2+. the performance of the six individual methylation markers and combinations thereof will be evaluated using the histological results as reference. the primary endpoint will be the relative sensitivity and specificity of hpv testing in first-void urine, vaginal self-sample versus clinician-collected cervical samples to detect cin2+. non-inferiority of hpv testing between sample types will be evaluated against a margin of 90% for sensitivity and 98% for specificity. the performance of each methylation marker will be illustrated by roc curves and assessed by the area under the curve.

Eligibility criteria:
inclusion criteria: * females * aged 23-64 years * referred for colposcopy and cervical biopsies or referred for cervical excision exclusion criteria: * younger than 23 years * older than 64 years * not provided informed conte

Keywords: hpv dna tests, self-collection, cervical cancer screening
a nurse cohort study in xiamen, china

Conditions: Hypertension

Summary: the nurse cohort study xiamen (ncsx) is an open-ended prospective cohort study with very broad research aims. the primary objectives of the ncsx is planned to examine genetic, epigenetic, biological, psychological, social, lifestyle and other environmental factors of nurses in relation to incidence and progression of the common chronic diseases, such as hypertension, ischemic heart disease, stroke, diabetes, chronic kidney disease and some cancers, which are emerging with economic development in xiamen, china. specifically, we intend to test whether empirically driven hypothesis and emerging risk factors mainly developed in response to observations in economically developed western societies apply in a population living in a rapid changing lifestyle in china now.

objectives: to establish a cohort of about 10,000 registered nurses (aged 20 or over) in xiamen, china; to describe the baseline major risk factors; to analyze their interrelationships; and to examine the risks of incidence and progression of major chronic diseases, such as hypertension, stroke, ckd and cancers, and all-cause and cause-specific mortality by different levels of the risk factors after about 5 years follow-up. design: a prospective cohort study. setting: 7 public hospitals in xiamen, china. participants: about 10,000 registered nurses (aged 20 or over) who work in public hospitals in xiamen, china. main outcome: incidences of common chronic diseases, such as cvd, diabetes, chronic kidney disease, and cancers; progression of these diseases; all cause and specific-cause mortality. hypothesis: relative risks of major risk factors. results of the study should have strong impact on prevention and control of these diseases and promoting nurses'health in the local population.

Eligibility criteria:
inclusion criteria: * registered nurses of public hospitals in xiamen, china; * aged 20 years or over; * working in the public hospitals for at least 1 year; * signed the informed consent and agreed to participate in the study; * assuming not moved out of xiamen for at least 5 years; exclusion criteria: * who are unambulatory; * who are receiving treatment modalities, which , if omitted, may result in immediate life threatening risk such as chemotherapy or radiotherapy for cancer, or dialysis for renal failure.
clinical application of sensimed triggerfish sensor (ts) with wireless signal transmission for continuous intraocular pressure measurement

Conditions: Glaucoma

Summary: the study objective is to investigate the clinical applicability of continuous iop measurement using ts with radio transmission over 24 hours. * trial with medical device


Eligibility criteria:
inclusion criteria: * clinical diagnosis of glaucoma exclusion criteria: * other opticus neuropathy than glaucoma * corneal abnormalities (e.g. scaring) * dry eye disease
safety, blood levels and effects of aut00201

Conditions: Healthy Volunteer

Summary: the study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. it is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. it is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. current treatments for schizophrenia don't work very well and can cause unpleasant side effects. it is hoped that the study medicine will work better, and have fewer side effects than existing medicines. in this 2 part study (part a: up to 40 healthy male subjects and up to 8 healthy female subjects, part b: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women. this study will be in 2 parts, as follows: part a will assess single doses of aut00201 and part b will assess multiple doses. part a will be divided into 3 sub-parts: part a1 will assess single ascending doses in healthy men, part a2 will assess single ascending doses in healthy women, and part a3 will assess the effect of food on the pk of aut00201 in healthy men. a pharmaceutical company, autifony therapeutics limited, is funding the study. the study will take place at 1 centre in london.


Eligibility criteria:
inclusion criteria: * normotensive male (all groups except part a2) or female (part a2 only) volunteers * must have body mass index (bmi) of 18.0-31.0 kg/m2 * must be healthy based on clinical history, physical examination, ecg, vital signs, and laboratory tests of blood and urine * must be able to give fully informed written consent. exclusion criteria: history or presence of * epilepsy * severe head injury, or any other chronic neurological condition or any psychiatric disorder * abnormal screening eeg (part a1 and part b only) * positive tests for hepatitis b \& c, hiv * severe adverse reaction to any drug * sensitivity to trial medication * drug or alcohol abuse * use of over-the-counter medication within previous 7 days (with the exception of paracetamol \[acetaminophen\]) * prescribed medication during previous 28 days * participation in other clinical trials of unlicensed medicines * loss of more than 400 ml blood, within the previous 3 months * vital signs or qtcf interval outside the acceptable range * clinically relevant abnormal findings at the screening assessment * acute or chronic illness * clinically relevant abnormal medical history or concurrent medical condition * positive result for suicidal ideation or behaviour using the colombia suicide severity rating scale (c-ssrs) * possibility that volunteer will not cooperate * pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception

Keywords: healthy volunteer schizophrenia
the triple a initiative study ("aktionsbündnis akute atemnot")

Conditions: Dyspnea; Heart Failure

Summary: acute dyspnea is a common chief complaint of patients presenting to the emergency department. patients with acute dyspnea display a high mortality rate. in-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. the triple a initiative study is designed to improve the coordination of care for patients with acute dyspnea alerting the emergency medical service (ems). we hypothesize that the coordination of care starting at the ems level including point-of-care testing of the cardiac biomarker ntprobnp will support preclinical and clinical diagnostic clarification. treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.

the aim of this prospective, randomized study is to evaluate the effects of point-of-care testing of nt-probnp in patients presenting with acute dyspnea to the emergency medical service (ems).patients will be enrolled in the emergency medical services of participating german hospitals (klinikum nürnberg, klinikum fürth, universitätsklinikum jena). to be enrolled in the study, each patient must meet all of the following inclusion criteria and none of the exclusion criteria. patients with acute dyspnea randomized to the poct group will get a nt-probnp-poct measurement in the ems. the emergency physician of the ems will decide to apply predefined treatment strategies according to the resulting working hypothesis. patients with acute dyspnea randomized to the standard care group will not get nt-probnp measurement at the scene. the emergency physician of the ed will construct the working hypothesis following current treatment recommendations. the major focus of the study is to initiate treatment of heart failure as early as possible.

Eligibility criteria:
inclusion criteria: * acute dyspnea (nyha ii-iv) * age \>= 18 years * informed consent exclusion criteria: * cardiopulmonary resuscitation \< 7 days * cardiogenic shock, stemi, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty * systolic blood pressure lower than 100 mmhg at first contact/presentation * ventricular tachycardia * severe aortic stenosis * advanced neoplasm (e.g. lung cancer, hematologic neoplasm, etc.) * chronic kidney disease requiring hemodialysis

Keywords: acute dyspnea heart failure diagnostics poct analysis preclinical area