Kornimate/medical-research-clean huggingface dataset:
biomarkers based early diagnosis of stroke subtype cohort（bio-east）

Conditions: Stroke

Summary: intracerebral hemorrhage carries high rates of mortality and disability, imposes a significant societal burden. based on findings from our previous multicenter randomized controlled clinical trial (interact4), we revealed that initiating intensive blood pressure reduction therapy within 2 hours of onset in ambulances can markedly enhance the prognosis of patients with intracerebral hemorrhage. nevertheless, the lack of rapid pre-hospital diagnostic technology hinders its clinical application and promotion. given that glial fibrillary acidic protein (gfap), as a biomarker, has been clinically validated for its high specificity in diagnosing intracerebral hemorrhage, this project aims to leverage an industry-academia-research collaborative development model in partnership with shanghai jinguan technology co., ltd. by focusing on the urgent need for rapid diagnosis in stroke emergency care, this project will integrate clinical resources from hospitals with technological advantages in product development from the industry. through resource sharing and complementary strengths, we aim to develop gfap rapid detection technology with single-molecule sensitivity utilizing internationally advanced silicon photonics technology. our objectives further include establishing a chinese cohort to validate the reliability of gfap in diagnosing intracerebral hemorrhage and conducting multicenter randomized controlled clinical trials to ascertain the efficacy and safety of gfap-guided pre-hospital intensive blood pressure reduction for patients with intracerebral hemorrhage. this study also aimed to explore other biomarkers to be combined with gfap in order to improve its sensitivity in detecting ich.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. suspected stroke at emergency department arrival (fast score ≥ 2 points, must include limb weakness); 3. time of stroke symptom onset/last known normal within 3 hours. exclusion criteria: 1. coma - no response to tactile or verbal stimuli; 2. severe comorbidities (such as tumors, severe copd, severe heart failure, requiring assistance with daily living \[unable to walk independently\]); 3. history of epilepsy or onset with seizure; 4. recent history of head trauma (\< 7 days); 5. blood glucose \< 2.8 mmol/l.

Keywords: stroke intracerebral hemorrhage gfap (glial fibrillary acidic protein) pre-hospital diagnosis
wearable monitoring systems for swallowing function and disorders

Conditions: Deglutition Disorders

Summary: wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. the proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). the hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.


Eligibility criteria:
inclusion criteria: inclusion criteria for healthy adults: * age 18-30 or 50-90 years of age * no history of dysphagia * no history of a neurological disorder * a score in the normal/mild range on the montreal cognitive assessment (moca): * a score of \<3 on the eating assessment tool-10 (eat-10, a self-report screening for dysphagia). inclusion criteria for patients with dysphagia: * age 18-90 years of age * diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, parkinson's disease). * a score in the normal/mild range on the montreal cognitive assessment (moca). * a score of ≥3 on the eating assessment tool-10 (eat-10, a self-report screening for dysphagia). exclusion criteria: • significant cognitive impairment (a score in the moderate-severe range on moca):
hypertensive disorders of pregnancy in adolescence and primipaternity

Conditions: Preeclampsia

Summary: hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy, being a serious health problem around the world. previous studies have suggested that there is an association between a short period of exposure to paternal sperm of a new sexual partner and the development of an immunological reaction that could trigger a hypertensive disorder of pregnancy. for this reason we want to study the relationship between the primipaternity concept (exposure to male antigens present in semen over a short period of time previous to the pregnancy) and the development of preeclampsia in adolescents.


Eligibility criteria:
inclusion criteria: * 19 year old or less * pregnancy \> 24 weeks at the moment of delivery exclusion criteria: * 20 years old or more. * pregnancy \< 24 weeks at the moment of delivery

Keywords: preeclampsia in adolescence adolescent primipaternity
analgetic effect of preoperative pregabalin in patients undergoing nephrectomy

Conditions: Postoperative Pain

Summary: pregabalin 300mg or placebo are administered 1 hour preoperatively in patients undergoing elective nephrectomy. postoperatively, patients receive a patient controlled analgesia device for self delivering opioids. morphine consumption in the first 48 hours is documented. hyperalgesia is measured by von-frey-filaments.


Eligibility criteria:
inclusion criteria: * patients undergoing elective nephrectomy exclusion criteria: * contraindication against pregabalin * creatinine \> 2.0 mg/dl * ggt \>165, ast \>105, alt \>135 * peptic ulcus * haemorrhagic diathesis * angina pectoris, myocardial infarction * stroke * bronchial asthma * opioid abuse
study to evaluate satisfaction and usability of duoresp® spiromax® in asthma and copd treatment

Conditions: Patient Satisfaction

Summary: the main aim of the study is to investigate patient satisfaction in the treatment of asthma and copd with the new device of duoresp® spiromax® and patient preference. possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.

the study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or copd.

Eligibility criteria:
inclusion criteria: * male and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease * patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination * patients who recently changed medication to duoresp® spiromax or are about to do so * capacitated person with present declaration of consent exclusion criteria: * diseases contraindicated in accordance with the summary of product characteristic * patients who take part in interventional clinical trials parallel or during the last 4 weeks * patient shows conditions or diseases that might disturb the monitoring according to the physician * patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study * insufficient german language knowledge to understand the patient education and to complete the questionnaires in a correct manner * patients involved in the planning and construction of the study (teva staff and employees of the centres) * patient is incapable of giving consent
brief intervention for justice-involved substance users

Conditions: Substance Use; Violence

Summary: this is a randomized clinical trial to study ways of helping justice-involved people change to more healthy behavior.


Eligibility criteria:
inclusion criteria: * in monroe county pretrial services program exclusion criteria: * none
therapeutic response of patients with soft tissue sarcoma according to choi criteria

Conditions: Soft Tissue Sarcoma

Summary: non-interventional study consisting of a population of patients who had received for soft tissue sarcoma by at least 2 courses of yondelis® at a dose of 1.5 mg / m² / 3 weeks after failure or intolerance to doxorubicin / ifosfamide from 2007 to 2011.

patient selection is based on a database of retrospectively within the gsf / geto. the tumor assessment must be made by scanner at baseline and post-c2 or c3 and should be available and sent to sponsor. the comparative reading of the imaging is centralized and made without the knowledge of the local assessment: * sum of the large diameter for 2 imagery (baseline and 1st evaluation * tumor density on areas of interest for the 2 imaging (baseline and 1st evaluation * rank patients according to two methods (choi and recist): complete response, partial response, stability, progress and non-assessable.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * locally advanced or metastatic soft tissue sarcoma * treated with yondelis after failure or intolerance to doxorubicin/ifosfamide * treated between 2007 and 2011 * have had at least 2 cycles of yondelis * assessment of tumor by ct scan (baseline and after 2 or 3 cycles of yondelis) exclusion criteria: * gastro intestinal stromal tumor gist * primitive bone sarcoma

Keywords: soft tissue sarcoma yondelis intolerance to doxorubicin/ifosfamide choi criteria
a study on the use of the mmf07 foot massager and heat therapy treatments for restless leg syndrome

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to assess whether the mmf07 foot massager and/ or heat therapy may improve symptoms of restless legs syndrome (rls). it will also assess the effect of the mmf07 foot massager and/ or heat on quality of life and sleep in people affected by rls. participants will be randomly assigned to one of four treatment groups; 1. mmf07 foot massager device 2. heat therapy 3. heat therapy and the mmf07 foot massage device 4. neither heat nor mmf07 foot massager device (no treatment group)

few clinical trials have looked into non-pharmacological, non-invasive treatments for restless legs syndrome, despite reports that massage, baths and vibrations can alleviate rls symptoms. we would like to assess whether the mmf007 foot massager device and/or heat therapy is associated with improved severity of rls symptoms. for this study the investigator will enroll 40 participants who have been diagnosed with restless legs syndrome, who will be followed over the course of four weeks and asked to complete two in person study visits. in the study the investigator is comparing the use of the mmf007 foot massager device and/ or heat therapy to a non treatment group to assess if the symptoms of rls improve.

Eligibility criteria:
inclusion criteria: 1. subjects between 18-75 years old diagnosed with rls according to the diagnostic criteria of the international restless legs syndrome study group (11) 2. subjects should have bothersome rls symptoms, despite best medical therapy 3. subjects should be stable on all rls medication for at least 4 weeks prior to enrollment 4. all subjects must have vision and be proficient in english for compliance with testing and surveys 5. all women of childbearing age must be using an acceptable form of birth control, including abstinence, intrauterine device (iud) or intrauterine system in place for at least 3 months prior to screening, subject or partner using barrier method (e.g., condom, diaphragm, or cervical cap) with spermicide from screening through study completion; partner has a documented vasectomy \> 6 months prior to baseline, stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least 3 months prior to screening exclusion criteria: 1. rls secondary associated with end stage renal disease, iron deficiency or pregnancy 2. concomitant sleep disorders 3. any other condition (other than the primary indications), which in the opinion of the investigators might contribute to difficulty complying with the protocol

Keywords: rls
a long-term study of star-0215 in participants with hereditary angioedema

Conditions: Hereditary Angioedema

Summary: the goal of this trial is to enable the collection of information about long-term safety and clinical activity of star-0215 in participants with hereditary angioedema (hae). participants will receive repeat doses of star-0215 for up to 5 years.


Eligibility criteria:
inclusion criteria: * open to participants from star-0215-201 (nct05695248) who have met one of the following conditions: * completed star-0215-201 (follow up through 6 months after their last dose); * eligible for star-0215-201 and entered the run-in period but did not qualify for the treatment period because they did not meet the criterion for the minimum number of hae attacks; * eligible for star-0215-201 and entered the run-in period but did not complete it for reasons other than not meeting the criterion for the minimum number of hae attacks (eligibility requires consultation with the medical monitor); or * discontinued star-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of star-0215 (eligibility requires consultation with the medical monitor). * open to participants who are star-0215 naïve and were not enrolled in star-0215-201 (nct05695248), have a documented diagnosis of hae (type 1 or type 2). exclusion criteria: * any concomitant diagnosis of another form of chronic angioedema, such as acquired c1 inhibitor deficiency, hae with normal c1-esterase inhibitor protein (also known as hae type iii), idiopathic angioedema, or angioedema associated with urticaria. * any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to screening * any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to screening. * use of therapies prescribed for the prevention of hae attacks prior to screening: * lanadelumab within 90 days * berotralstat within 21 days * all other prophylactic therapies, discuss with the medical monitor note: other inclusion and exclusion criteria may apply.

Keywords: hae angioedema long-term safety
preparing children for anesthesia with an educational pop-up book

Conditions: Pediatric Preoperative Anxiety, Pediatric Coping

Summary: the study evaluated an educational pop-up book about general anesthesia induction as an interactive, child-focused preoperative education resource for pediatric patients undergoing outpatient surgery. the study's objectives were to evaluate the book as an educational tool and to understand the book's effects on patient and caregiver perceptions of the surgical experience. the study's hypotheses were that preoperative education from the pop-up book, compared to standard care, would more effectively reduce children's fear and expected pain, facilitate more positive views of the procedure and preoperative explanations, encourage adaptive coping strategies, reduce behavioral anxiety at anesthesia induction, and increase caregiver satisfaction with the surgical experience.


Eligibility criteria:
inclusion criteria: * ages 5-12 (inclusive) * undergoing outpatient medical procedures under general anesthesia with inhalation induction * english-speaking * able to provide electronic consent/assent (legal guardian) exclusion criteria: * patients with severe developmental disabilities * unable to obtain electronic consent/assent from a legal guardian

Keywords: preoperative education patient education preoperative anxiety pediatric outpatient surgery pediatric anesthesia
the effect of allergic rhinitis on educational outcomes

Conditions: Allergic Rhinitis

Summary: the study will assess the the burden of living with allergic rhinitis (ar) and the effect of ar on school performance for children and adolescents in denmark.

the aim of the study is to investigate the effect of ar on school performance and examination test grades for children and adolescents diagnosed with ar early in life, as well as analyse their burden of disease and healthcare resource use using real-world data from the exhaustive danish population registers. this is a retrospective registry analysis that uses danish registers during 1994 and 2021. in denmark, national registers collect data for the entire danish population from birth to death and have done so for decades. this exhaustive data creates a sound foundation for this study of the impact of school performance caused by ar, as subjects can be traced with high certainty and detail over several years.

Eligibility criteria:
inclusion criteria: * the main study population (cases) consists of children who have been diagnosed with ar before turning 13. diagnosis of ar will be identified by dispensations of prescribed ar medications, icd-10 codes of ar-related hospitalisations and reimbursement codes for ar-related healthcare contacts in the primary healthcare sector. at least two dispensed prescriptions of product containing intranasal corticosteroids (incs) or antihistamines during the same calendar year for two consecutive years or at least one visit with the primary healthcare sector with registered ar consultations and at least one dispensed prescriptions of product containing incs or antihistamines or at least one contact with the hospital sector with an icd-10 code for ar (primary or secondary diagnosis). exclusion criteria: * children with their first ar-related healthcare contact or first ar-specific dispensed prescription at the age of 13 or older will be excluded.
clinical study of ixabepilone (bms-247550) by every-3-week dosing regimen in patients with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to determine the response rates for ixabepilone (bms-247550) in subjects with metastatic breast cancer previously treated with an anthracycline and who are taxane resistant.


Eligibility criteria:
inclusion criteria: * women aged 20 years or older * patients with metastatic breast cancer whose primary lesion was definitely diagnosed to be breast by histological or cellular examination exclusion criteria: * patients with an eastern cooperative oncology group (ecog) performance status (ps) of ≥ 2
safety and efficacy study of agn-214868 in patients with idiopathic overactive bladder and urinary incontinence

Conditions: Urinary Bladder, Overactive

Summary: this study will evaluate the safety and efficacy of agn-214868 in patients with idiopathic overactive bladder (ioab) and urinary incontinence.


Eligibility criteria:
inclusion criteria: * if female, must be of nonreproductive potential * if male, must agree to use acceptable contraception * symptoms of overactive bladder with urinary urgency incontinence * inadequate response or limiting side effects with anticholinergics for the treatment of oab exclusion criteria: * overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis) * history of bladder surgery * treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks * previous treatment with botulinum toxin therapy of any serotype for any urological condition
community-engaged research: a tool to advance cookstove interventions

Conditions: Blood Pressure; Inflammation; Glycated Hemoglobin (HbA1c)

Summary: nearly 3 billion people rely on biomass combustion to meet basic domestic energy needs. many households use traditional cookstoves to meet these energy needs, which can result in extremely high indoor air pollution concentrations. indoor air pollution from biomass combustion accounts for an estimated 3.9 million premature deaths per year, representing about 4.8% of the global disease burden. improved stove designs have the potential to substantially reduce indoor air pollution exposures. however, there are few randomized intervention trials, and previous stove intervention studies have been plagued by low improved stove adoption and sustained use, severely limiting interpretations of these studies. this research proposes to conduct community surveys and in-depth interviews among honduran cookstove users to gain insight into the complex pathways surrounding barriers to and predictors of sustained improved cookstove adoption (among the target population for the proposed intervention). this information will be used to conduct and enhance a randomized improved cookstove intervention among 300 honduran families, incorporating qualitative and quantitative measures of cookstove use and measuring pre- to post-intervention changes in pollutant exposures and subclinical indicators of cardiovascular health. the primary goals are twofold: * to incorporate community-engaged approaches throughout all aspects of the research * to maximize sustained stove use (thereby maximizing the health impact of the intervention) to achieve valid exposure-response estimates. both objectives utilize innovative strategies to fill knowledge gaps. the research team will build upon previous studies in latin america that have focused on identifying and validating appropriate field techniques for exposure and health assessments in rural areas of developing countries. in summary, the proposed project will provide insight regarding barriers/predictors of sustained cookstove adoption, an issue impeding research in this field; assess the relationship between stove use and indicators of cardiovascular health, a substantial and quickly growing disease burden in developing countries; and result in a more comprehensive and valid assessment of the impact of a cookstove intervention.


Eligibility criteria:
inclusion criteria: * primary cooks for the household * uses a traditional stove * latina women (representative of the rural honduran population, no exclusions based on race/ethnicity) exclusion criteria: * non-smoking * not pregnant