Kornimate/medical-research-clean huggingface dataset:
healthy moms alcohol intervention

Conditions: Fetal Alcohol Syndrome; Pregnancy; Alcoholism

Summary: the study proposes to test the efficacy of a primary care-based brief intervention with women who resumed heavy drinking during the post-partum period and who used alcohol during a previous pregnancy. the trial will also examine the effects of tobacco use, illicit drug use, depression and domestic violence on alcohol use.


Eligibility criteria:
inclusion criteria: * women of childbearing age (18-40) who drank alcohol during their previous pregnancy and who report drinking above recommended limits in the post partum period. exclusion criteria: * n/a
evaluating nine-year sustainability after implementing evidence-based practices to prevent urinary tract infections and overfilling of the bladder in patients with hip fracture

Conditions: Urinary Catheters; Urinary Retention; Adherence; Documentation Skill; Sustainability of Innovations; Hip Fracture; UTI - Urinary Tract Infection

Summary: this study focuses on evaluating the long-term sustainability of a urinary catheter care bundle designed to prevent urinary tract infections and bladder distension in patients undergoing surgery for hip fractures. the intervention, which included two key innovations-a urinary catheter certificate and a nurse-driven urinary catheter protocol, was implemented between 2015 and 2020 and successfully reduced urinary tract infections and bladder distension, previously published. however, due to the pandemic, the initiative was paused and had to be reintroduced in 2022. now, the study aims to assess the effectiveness of these preventive measures 9 years after their initial implementation. the research will analyze changes in the incidence of urinary tract infections, bladder distension, catheterisation methods, and documentation practices in patients aged 65 and older. the findings will help inform healthcare policies and may have broader implications for preventing adverse events in other surgical patient groups


Eligibility criteria:
inclusion criteria: -hip fracture surgery at the study site, age 65 years and older and cared for in the ortho-geriatric wards. exclusion criteria: -no catheterisation during hospital stay

Keywords: sustainability of innovations hip fracture urinary retention catheter associated urinary tract infection
extrapulmonary presentations of covid-19 patients

Conditions: COVID-19

Summary: an observational study about the extrapulmonary presentations of covid-19 patients during the second wave of the pandemic.

a prospective observational study that aimed at 1. provide an overview about the prevalence of extra-pulmonary presentation of covid-19 during the second wave of the pandemic and 2. detection of the most frequent affected systems with comparison between the pulmonary and extrapulmonary presentation of covid 19 as regard patient demographics, comorbidity and level of care needed.

Eligibility criteria:
inclusion criteria: * all patient with confirmed covid 19 disease presented to our health facility during the second wave of the pandemic exclusion criteria: * other diagnosis than covid 19 as a primary cause of presentation of the patient

Keywords: extrapulmonary presentation pulmonary
rotating frame relaxation and diffusion weighted imaging of human gliomas

Conditions: Low Grade Glioma; Malignant Glioma

Summary: grading of gliomas is of significant clinical importance since the prognosis as well as the treatment of choice are distinct in low-grade and high-grade gliomas. with standard mri modalities, however, a reliable distinction is often impossible. moreover, the gold standard for glioma grading by histopathology may also have limitations due to unrepresentative tumor samples. therefore, more advanced mri techniques are urgently needed that would have higher sensitivity and specificity in the definition of tumor type, grade and extent. assessment of radiologic response for high-grade gliomas utilizes the updated rano criteria 12 weeks after completion of chemoradiotherapy. however, there is an urgent need to identify nonresponding patients earlier, preferentially midtreatment in order to consider alternative treatment strategies. imaging biomarkers, such as diffusion weighted mr imaging (dwi), have provided promising results in assessing early treatment response. furthermore, a serum biomarker with diagnostic value could improve tumor follow-up and clinical management of gliomas. the aim of our study is to develop novel imaging protocols suitable for the magnetic resonance imaging (mri) of glioma using advanced mri techniques such as rotating frame imaging, novel dwi acquisition and post-processing methods we also study the correlation between advanced mri parameters and histopathology of the tumor specimen. in addition, early treatment response is assessed with advanced mri parameters at 3 week and 10 week after initiation of radiotherapy. finally, our objective is to study the association between serum biomarkers and corresponding mri with potential tumor progression.


Eligibility criteria:
inclusion criteria: * age: 18 to 80 years old * language spoken: finnish or swedish * performance status: karnofsky score 70 or better or who performance status 2 or better * supratentorial primary malignant glioma (the diagnosis is based on radiological and clinical grounds) * supratentorial recurrent glioma based on mri and/or \[11c\]methionine pet imaging * patient is scheduled to either surgery or stereotactic biopsy * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * prior medical history: patient must have no history of serious cardiovascular, liver or kidney disease * any psychiatric condition that compromises the subject's ability to participate in the study * infections: patient must not have an uncontrolled serious infection * no contraindications for mri (cardiac pacemaker, intracranial clips etc) * patient must not have claustrophobia with serious symptoms * pregnant or lactating women

Keywords: glioma mri rotating frame relaxation dwi treatment response
a relation of morphine-induced itch and pain processing

Conditions: Morphine; Itch

Summary: in this experiment, the investigators would like to test the two following hypotheses regarding the mechanisms by which opioids cause itch: 1. opioids cause itch by a spinal disinhibition mechanism (central nervous system (cns) effect). 2. opioids cause itch through a mast cell-destabilizing effect leading to release of histamine and tryptase in the skin where itch is evoked (peripheral mechanism).

intrathecal and orally administered opioids are heavily used for the treatment of several acute pain conditions. however, while opioids are effective analgesics for acute pain, they are well-known to frequently cause itch (pruritus) as a side effect according with the two hypotheses stated above. so far, these two hypotheses have never been tested in humans.the present study describes a proposed study design for the purpose of confirming these two hypotheses in parallel in human subjects. primary endpoints of the study: to evaluate changes itch and pain perception, and superficial perfusion after each itch provocations. secondary endpoints of the study: to evaluate the existence of a correlation between itch sensitization and analgesic efficacy.

Eligibility criteria:
inclusion criteria: * healthy men and women in the age of 20-65 years * the participants must be able to speak and understand english exclusion criteria: * participants with any clinically significant abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results. * pregnant or lactating female persons * drug addiction defined as the use of cannabis, opioids or other drugs * previous or present neurologic, musculoskeletal or mental illnesses * current pain and itch causing diseases or psychiatric disorders * participants unable to understand or follow the instructions * participating in another study where investigational drug is used * participants had known allergy/discomfort to morphine * lack of ability to cooperate
health-ebrain study

Conditions: Depression and Burden in Caregivers

Summary: the purposes of this study are to (1) track dementia caregiver health indicators over 12 weeks, both with and without the mindoula plus dana intervention (case manager and mobile messaging and assessment applications) to determine if the intervention improves caregiver health and (2) obtain feedback from caregivers to inform on the design of future interventions.

this study will track the mental status and cognition of caregivers with and without the mindoula and dana intervention and use subject feedback to aid in designing future interventions for caregivers. this is a remotely administered, virtual study targeting dementia caregivers who are mild to moderately depressed. screening calls for online administration of four surveys to determine inclusion in the study arms. these surveys will be taken on the health-ebrain website, both at baseline/screening and throughout participation. all other participation will be completed on the participant's mobile phone, and all psychological and cognitive tests will be self-administered. this study has a between-group design. participants will be screened for eligibility and then randomized into each arm. the intervention arm will receive the mindoula plus dana intervention. the wait list control arm will take the psychological surveys at regular intervals then, after 12 weeks, be enrolled in the dana-only observation group. the dana-only group will take dana and a usability questionnaire.

Eligibility criteria:
inclusion criteria: * females and males who regularly provide care for a person with alzheimer's disease * between the ages of 45-75 * self-reported ability to speak and read english * providing care for at least a year participants in the intervention and waitlist control arms must meet the following additional inclusion criteria: * zarit burden inventory (zbi) score of 9+ * overall m3 score of 33+ * m3 depression score of 7+ * female only * minimum hours of caregiving a week must be equal to or greater than 20 hours exclusion criteria: * anyone with a known cognitive diagnosis * anyone with color blindness * overall score of high risk on the m3 and/or high risk on the ptsd or bipolar subsection of the m3 * failure to meet all inclusion criteria per arm

Keywords: caregivers case management alzheimer's disease cognition caregiver burden depression
an open-label rollover study of entecavir (bms-200475) in adults with chronic hepatitis b infection

Conditions: Chronic Hepatitis B

Summary: to provide open-label entecavir to subjects who have completed previous blinded entecavir trials in japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis b therapy


Eligibility criteria:
inclusion criteria: * subjects who completed a previous entecavir phase ii studies (ai463047, 052 or 053); * alt ≤ 10 x upper limit of normal; * subjects must have well-compensated liver disease according to all of the following criteria; 1. prothrombin time ≤ 3 seconds prolonged compared to control value or inr ≤ 1.5 2. serum albumin ≥ 3 g/dl (≥ 30 g/l) 3. serum bilirubin ≤ 2.5 mg/dl (≤ 42.75 μmol/l) exclusion criteria: * sex and reproductive status exceptions * target disease exceptions * medical history and concurrent diseases
practice of oxygenation and respiratory support during fiberoptic bronchoscopy

Conditions: Acute Respiratory Failure; Pneumonia; Lung Cancer; Fibrosis Lung; Interstitial Lung Disease

Summary: the current practice of oxygenation and/or ventilation supports in patients undergoing fiberoptic bronchoscopy is very heterogeneous among studies published in the literature; in addition, clear outcomes advantages of one strategy over another currently lack. the goal of this observational study is to describe the current practice of oxygenation and/or ventilation supports in patients undergoing fiberoptic bronchoscopy (fob), stratified by baseline respiratory condition, co-morbidities, type of procedure and hospital settings. investigators will enroll all adult patients undergoing any fiberoptic bronchoscopy in any clinical settings (from outpatients to critically ill patients). no specific exclusion criteria are indicated for enrollment in this study. investigators will record the following data: * patient's baseline data. * type of fob procedure: toilet bronchoscopy (for secretions, blood, mucus plugs removal), broncho-aspirate (bas), bronchoalveolar lavage (bal), brushing for cytology, biopsy, endobronchial ultrasound (ebus). the type and size of bronchoscope (with or without an internal/external camera) and the time of the procedure will be also recorded. * type of supportive strategy: no support, standard oxygen therapy, high flow nasal cannula, continuous positive airway pressure and or non invasive ventilation trough mask or helmet, invasive mechanical ventilation. * sedation * intra-procedural vital parameters * occurrence of adverse events: desaturation (i.e. spo2\ 140 mmhg) events, new onset of cardiac arrhythmias (specify the rhythm) or myocardial ischemia or electrocardiographic st-alterations, neurological events (i.e. severe sensorium depression, psychomotor agitation). * post-procedural vital parameters (15 minutes after the procedure). * clinical outcomes: need for support escalation, need for admission to ward (for outpatient) or icu (for outpatients and ward-admitted patient).


Eligibility criteria:
inclusion criteria: * need for any procedure with flexible fob * either outpatients in dedicated ambulatories, and admitted to any hospital ward or intensive care unit (icu) exclusion criteria: * none

Keywords: bronchoscopy
the use of medical devices to monitor chronic obstructive pulmonary disease patients study breath-tracher 2

Conditions: COPD Exacerbation Acute

Summary: the proposed study will explore whether remote monitoring of a copd patient can be undertaken using a wearable medical device.

this study will assess the sensitivity of a wearable device to measure the physiological signals in copd patients, who have previously experienced hospitalization due to exacerbation of their copd. the monitoring device will also assess the effectiveness of medication prescribed before, during, and after the copd exacerbation to see if it has a role in directing day-to-day therapy.

Eligibility criteria:
inclusion criteria: * any person aged 18 years or over. * current diagnosis of copd. * be willing and able to comply with study procedures and be available for study visits. • be able to use a 'smartphone or computer'. * be able to give written consent. * able to understand written and spoken english. exclusion criteria: * inability to give written informed consent. * known respiratory disorders are other than copd which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ilds), tuberculosis, lung fibrosis, cystic fibrosis, and non-copd related bronchiectasis). * known history of significant systemic and other organ-related diseases, other than copd, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and lupus, kidney, liver, endocrine, psychological disorders). * known to be severely alpha-1-antitrypsin deficient (pi, sz or zz). * based on their medical record if there is any social violence/substance misuse. * having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months. * have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. * taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months. * pregnancy * patients already involved in an ongoing research study. * participation in an interventional clinical study within 3 months of visit 1 or participation in a study using an investigational medicinal product (imp) either in the previous 3 months or in the interval from last using the imp to 5 times its half-life. * patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons. * known allergy to strap. * on long-term oxygen therapy. * acute exacerbation of copd within 6 weeks prior to inclusion.

Keywords: medical device remote monitoring technologies respiratory signal heart rate ecg
a twelve week, open label extension study in patients with schizophrenia

Conditions: Schizophrenia

Summary: this is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

this is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia who have participated in study d1050238, a double-blind, placebo-controlled, randomized withdrawal study of lurasidone for the maintenance treatment of subjects with schizophrenia. subjects who have completed the 28-week double-blind phase or who have experienced a protocol-defined relapse event during the double-blind phase of study d1050238 will have the option to participate in this study. in addition, if/when the study is discontinued by the sponsor, all subjects participating in the open-label phase and the double-blind phase of study d1050238 will have the option to participate in this extension study

Eligibility criteria:
inclusion criteria: * subject has agreed to participate by providing written informed consent. * subject will be eligible to participate if one of the following criteria is met: * subject has completed the 28-week double-blind phase of study d1050238 * subject has experienced a protocol-defined relapse event during the double- blind phase in study d1050238 * subject is participating in the open-label or double-blind phase of study d1050238 if/when study d1050238 is terminated by the sponsor. * subject has completed all required assessments on the final study visit (study visit number 42) in study d1050238. * subject is judged by the investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the investigator. exclusion criteria: * subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. * subject answers "yes" to "suicidal ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the c-ssrs at the extension baseline visit (study visit number 42 in study d1050238). subjects who answer "yes" to this question must be referred by the investigator for appropriate follow-up evaluation and treatment. * subject tests positive for drugs of abuse or is suspected of current alcohol abuse at the extension baseline visit (study visit number 42 in study d1050238). in the event a subject tests positive for cannabinoids, the investigator will evaluate the subject's ability to abstain from cannabis during the study.

Keywords: lurasidone latuda schizophrenia
bioequivalence trial of alprazolam 0.5 mg tablets

Conditions: Anxiety Disorders

Summary: the objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. test product was zamoprax® 0.5 mg (glaxosmithkline) and reference product tafil® 0.5 mg (pharmacia \& upjohn). one tablet was the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 28 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 50 years. body mass index between 18 and 27.5 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. positive pregnancy test or antidoping test special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study. breast-feeding. females on contraceptive hormonal treatment. - - -

Keywords: alprazolam anxiety disorders bioequivalence mexico