Kornimate/medical-research-clean huggingface dataset:
a post marketing surveillance study of lipo-ab® (amphotericin b) in neutropenic patients with persistent fever

Conditions: Neutropenia, Febrile

Summary: amphotericin b is a polyene antifungal drug used for the treatment of many systemic fungal infections. it is associated with many side effects which in some cases can be very severe and potentially lethal. lipo-ab® is a true single bilayer liposomal drug delivery system, consisting of unilamellar bilayer liposomes with amphotericin b intercalated within the membrane. prior studies showed that the liposomal formulation of amphotericin b greatly reduces the side effects of the parent drug, such as nephrotoxicity. this study is designed to evaluate the safety and efficacy of lipo-ab® in neutropenic patients with persistent fever in routine clinical practice in taiwan. 1. primary objective: • to evaluate the nephrotoxicity of lipo-ab® (amphotericin b) treatment in neutropenic patients with persistent fever in taiwan clinical practice. 2. secondary objectives: (1) to evaluate the safety profile of lipo-ab® (amphotericin b) in neutropenic patients with persistent fever in taiwan clinical practice. (2) to evaluate the treatment efficacy of lipo-ab® (amphotericin b) in neutropenic patients with persistent fever in taiwan clinical practice.


Eligibility criteria:
inclusion criteria: 1. female or male with no age limit 2. patient for whom lipo-ab® is medically recommended due to following conditions: * absolute neutrophil count (anc) \< 500/mm3 for at least 96 hours * received parenteral broad spectrum antibacterial therapy for at least 96 hours * fever of ≥ 38.0°c (tympanic temperature) 3. subject or his/her legally acceptable representative is willing and able to provide a written informed consent exclusion criteria: 1. pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved 2. use of other investigational product 2 weeks before the initiation of lipo-ab® treatment which is considered not suitable for this study by investigator 3. use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response) 4. any condition which is considered not suitable for liposomal amphotericin b therapy by investigator

Keywords: amphotericin b liposome post marketing surveillance
cannabinoids and cerebellar-motor functioning

Conditions: Cannabis; Psychotic Disorders

Summary: the purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-thc) in healthy individuals on cerebellum-dependent motor functions.

the overall aim of the current proposal is to investigate whether acute, iv ∆9-thc administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (ebc). in addition, a battery of motor function tests will also be administered (the cantab motor screening test, grooved pegboard motor task, paced finger tapping).

Eligibility criteria:
inclusion criteria: * must have used cannabis at least once in their lifetime * no cannabis use in the past month * men and women aged 21 to 35 years (extremes included) on the day of the first dosing exclusion criteria: * hearing deficits * psychiatric or mental disorders * hearing deficits

Keywords: cannabinoids eyeblink conditioning ebc
versartis international trial in adults with long-acting growth hormone

Conditions: Adult Growth Hormone Deficiency

Summary: a phase 2, open-label dose-finding safety study of individualized monthly vrs-317 dosing for five months in adults with ghd.

a phase 2, dose finding safety study to evaluate an individualized monthly vrs-317 dosing regimen in adults with ghd. this is an open-label, international, multicenter study with vrs-317 treatment for five months. this treatment period will include monthly dose titrations until a subject's mean igf-i sds value is within a target range for two consecutive months. subjects will be stratified into three cohorts based on sensitivity to rhgh.

Eligibility criteria:
inclusion criteria: * female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods * subjects must have documented ghd during adulthood. * subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months. * subjects with underlying disorders responsible for the subject's ghd must have been clinically stable for at least 6 months. * subjects receiving daily rhgh injections must washout for 14 days. * subjects must provide signed informed consent. * subjects must have a bmi (kg/m2) between 19.0 and 35.0. exclusion criteria: * subjects with diabetes mellitus or inadequate glucose control * subjects with untreated adrenal insufficiency. * subjects with free thyroxine outside the normal reference range. * subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies. * subjects with current significant cardiovascular disease, heart insufficiency of nyha class \> 2. * subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease. * subjects with current papilledema. * subjects with a history of persistent or recurring migraines. * subjects with current edema (≥ ctcae grade 2). * subjects with current drug or alcohol abuse. * subjects with a documented history of hiv, current hbv or hcv infection * subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix. * women who are pregnant or breastfeeding. * subjects with a significant abnormality in screening laboratory results

Keywords: vrs-317 long acting growth hormone versartis somavaratan growth hormone deficiency adult growth hormone deficiency aghd growth hormone replacement growth hormone replacement therapy xten
the effect of large versus small clog size on emergency response time

Conditions: Clothing; Occupational Injuries

Summary: in many hospitals, clogs, usually white, are provided for healthcare workers. in our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. clogs are thought to be of importance for running. although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. interestingly, the primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed. participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. following randomization, participants will wear the clogs of allocated size and complete a standardized running course. the primary endpoint is the time taken to complete the course. the enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation. the ethical committee judged the study protocol exempt from extensive review.


Eligibility criteria:
inclusion criteria: * healthcare workers aged 18 years or older. exclusion criteria: * inability to run on clogs.
artificial intelligence to search for abnormalities in ambulatory cancer patients

Conditions: Solid Tumor

Summary: during treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive. currently, adverse effects and toxicities are well codified in the oncology community, notably via the nci ctcae criteria. unlike objective data such as a blood sample or a ctscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). several studies had already highlighted the discrepancies between medical and patient data collection. self-assessment of symptoms is one way to overcome this bias. moreover, there are now a large number of solutions that allow to perform these self-assessments at home. thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form. these new evaluation methods also allow to take a quality of life approach. patient-reported outcomes (pros) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers. the goal of this study is to go one step further than the previous pros studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.


Eligibility criteria:
inclusion criteria: * follow-up for a solid tumor * chemotherapy treatment (oral and/or injectable) scheduled or in progress * life expectancy \> 3 months * performance status (ps) \< 3 * have an internet connection or assistance to answer questions throughout the study (nurse, family members, etc.) * patient having understood, signed and dated the consent form * patient affiliated to the social security system exclusion criteria: * lack of means to answer the online questionnaires * patient in another therapeutic trial with an experimental molecule * patients and their families who cannot read or speak french * persons deprived of liberty or under guardianship (including curatorship)

Keywords: electronic survey artificial intelligence quality of life patient-reported outcomes (pros) symptom management ehealth machine learning
acute effect of exogenous ketosis on sleep architecture following strenuous exercise

Conditions: Sleep

Summary: the aim of this study is to investigate the effect of oral ketone ester administration on sleep architecture. to investigate this, the investigators use a randomised, placebo-controlled, cross-over research design. the study comprises three experimental sessions, each separated by a one-week washout period. two of the three experimental sessions consist of a 120 minutes cycling endurance training session (et) two hours after breakfast and an evening high-intensity-interval training (hiit) ending one hour before bedtime. after each training session, and 30 minutes before sleeptime, subjects receive a ketone ester or a control drink . to investigate the effects of strenuous exercise on sleep alone, an additional experimental session without exercise is added. before bedtime, a venous blood sample is taken to evaluate hormones playing an important role in sleep regulation. during the experimental sessions, the subjects sleep in a sleep facility to evaluate quality of sleep. time spent in different sleep phases is measured via polysomnography (psg). urine output throughout the day and night will be collected for measurement of urinary excretion of adrenaline and noradrenaline as an index of intrinsic sympathetic activity.


Eligibility criteria:
inclusion criteria: * males between 18 and 35 years old * recreational or competitive cyclists performing regularly cycling training sessions with an average training volume of more than 6 hours per week * good health status confirmed by a medical screening * body mass index (bmi) between 18 and 25 * normal sleep pattern as assessed by the pittsburgh sleep quality index (psqi) * moderate sleep chronotype, assessed by the horne and östberg questionnaire exclusion criteria: * excessive daytime sleepiness as assessed by the epworth scale * depression or anxiety as assessed by the beck depression inventory and beck anxiety inventory * night-shifts or travel across time zones in the month preceding the study * any kind of injury/pathology that is a contra-indication to perform high-intensity exercise * intake of any medication or nutritional supplement that is known to affect exercise performance or sleep * smoking * involvement in elite athletic training at a semi-professional or professional level * current participation in another research trial * any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Keywords: ketone exercise sleep
treatment of high blood pressure using olmesartan with hydrochlorothiazide compared to an ace inhibitor with a calcium channel blocker

Conditions: Hypertension

Summary: a comparison of 2 different combinations of high blood pressure medications to treat hypertension


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * patients with high blood pressure exclusion criteria: * hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months * history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months * type 1 diabetes mellitus

Keywords: hypertension angiotensin receptor blocker calcium channel blocker angiotensin converting enzyme inhibitor hydroclorothiazide
economic and clinical outcomes of attendance in psychosis services using sms.

Conditions: Psychosis

Summary: the aim of this research is to find out if mobile phone text message reminders of appointments can help to address missed appointments in psychosis community services. another aim is to examine if fewer missed appointments result in clinical benefits for service users and in lower costs for psychosis community services over a period of 6 months. 600 users from 2 london psychosis community services will take part in this research. each participant will be put into one of two groups, as s/he joins the study: in the first (experimental) group, each participant will receive appointment reminders for 6 months (7 and 1 day/s before each appointment), starting with the first available opportunity upon joining the study. in the second (control) group, each participant will not receive appointment reminders for 6 months. the choice of group for each individual will be made at random by a computer. clinical information will be collected for 6 months from the time each participant joins the study, using, with his or her consent, their anonymised electronic medical records. the following clinical information will be compared between the experimental and control groups: attendance of appointments, number of inpatient admissions, number of days in inpatient care, number of inpatient admissions under the mental health treatment act, number of referrals to a home treatment team, number of times patient has changed medication, health and social functioning. service use, service costs and the cost-effectiveness of the reminder system will also be examined. towards the end of their participation, service users, as well as mental health professionals, will be invited to express their views, concerns and suggestions in relation to the reminder service by completing a brief anonymised (service users) or anonymous (staff) questionnaire


Eligibility criteria:
inclusion criteria: * be a user of psychosis community services * manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and adequate capacity to consent, as assessed by the university of california, san diego brief assessment of capacity to consent (ubacc) scale. * own a mobile phone. * be willing to receive sms reminders of appointments with the psychosis community service. * provide written informed consent to participate in the study. exclusion criteria: * is not a user of psychosis community services. * cannot manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and/or adequate capacity to consent, as assessed by the university of california, san diego brief assessment of capacity to consent (ubacc) scale. * does not own a mobile phone. * is under 18 years of age.
prospective, non-interventional, multi-center post-authorization safety study of eylea for central retinal vein occlusion (crvo)

Conditions: Retinal Vein Occlusion

Summary: this is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of crvo. the investigator will have made the choice of treatment (eylea) as well as the decision to use eylea according the japanese package insert prior to enrolling the patient in this study. the observation period for each patient starts when therapy with eylea is initiated. the enrollment period is 2 years. patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. for each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice). there will interim analysis of study data: 6 months after last patient first visit and j-psur(japanese-periodic safety update report )


Eligibility criteria:
inclusion criteria: * patients who start eylea treatment for crvo exclusion criteria: * patients who have already received eylea treatment * patients who are contraindicated based on approved label

Keywords: crvo, macular edema, aflibercept, anti-vegf
modulating cortical excitability to improve functional movements in individuals with patellofemoral pain

Conditions: Patellofemoral Pain Syndrome

Summary: this study sought to investigate whether modulation of cortical excitability of the gluteal musculature, via tdcs paired with exercise, will reduce the amount the knee caves in during functional tasks in individuals with pfp. the objective is the explore if having tdcs target the area of the brain controlling hip muscles, when paired with exercise, will be more effective in reducing the amount the knee caves in for individuals with pfp versus those who receive exercise alone as their treatment. the aim is to contribute our findings to the growing knowledge in this area in order to help establish the possibility, and feasibility, of its use in clinical settings to strengthen traditional treatments for this patient population.


Eligibility criteria:
inclusion criteria: 1. are between 18 and 45 years old 2. have had patellofemoral pain (pfp; kneecap pain) on one side for at least 3 months, and 3) the knee does cave in when performing functional movements. exclusion criteria: 1. do not have pain coming from the kneecap during screening; 2. have a history of knee injury or surgery, 3. have a history of seizures and/or taking anti-seizure medication, 4. have an implanted device that interacts with electric current, 5. have a history of balance disorder, 6. currently are pregnant or think they may be pregnant.
combining mechanisms for better outcomes (combo)

Conditions: Chronic Pain; Back Pain

Summary: to evaluate the effectiveness of spinal cord stimulation (scs) with multiple modalities as compared to conventional scs in patients with chronic pain when using the boston scientific spectra wavewriter scs system.

to evaluate the effectiveness of spinal cord stimulation (scs) with multiple modalities as compared to conventional scs in patients with chronic pain when using the boston scientific spectra wavewriter scs system.

Eligibility criteria:
key inclusion criteria: * chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. * 22 years of age or older at time of enrollment * able to independently read and complete all questionnaires and assessments provided in english * signed a valid, irb-approved informed consent form (icf) provided in english key exclusion criteria: * any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes * significant cognitive impairment that, in the opinion of the investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception * participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
video-call assisted assessment of acute stroke in addition to stroke severity scales in a prehospital setting

Conditions: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Stroke; Nervous System Diseases; Vascular Diseases

Summary: this study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical services is feasible.

multiple stroke severity scales have been coined in order to examine patients suspected of stroke in a prehospital setting in order to identify and transfer patients eligible for thrombectomy directly to a comprehensive stroke centre (csc). however, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. some recent studies have shown promising results using telemedicine i.e. video solutions between emergency medical services (ems) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. the investigators will perform this trial to examine whether a cluster randomised trial with video call assisted assessment of patients suspected of stroke in a prehospital setting is an appropriate trial design and feasible with regard to recruitment and retention, acceptability among stakeholders (ems and neurologists) as well as patients and lastly with regard to stakeholders' adherence to protocol.

Eligibility criteria:
inclusion criteria: * suspected stroke within 24 hours from onset (confirmed with pre-hospital stroke score 1 ≥1) * catchment area of hospital sønderjylland * deferred informed consent obtained from patient or patient surrogate exclusion criteria: * in-hospital stroke or private transport to hospital * unconsciousness defined as glascow coma score (gcs) ≤ 8 (as they cannot be rated)