Kornimate/medical-research-clean huggingface dataset:
technical feasibility study of a novel wearable capnograph (marie) in an emergency care environment, part 1

Conditions: Technical Feasibility; Ambulances

Summary: you have been assessed by paramedics as needing to go to the emergency department. during transport, the paramedics will monitor you by, for example, measuring your blood pressure and checking your pulse. in healthcare, we are constantly working to improve and optimize the degree of monitoring during ambulance transports and through this also be able to start adequate treatment earlier. in this case, we are working to understand whether exhaled carbon dioxide levels can be used to monitor important processes in the body during ambulance transport. therefore, we offer you to participate in a project that deals with whether we can use a new equipment to measure and monitor exhaled carbon dioxide during the journey to hospital. this clinical trial is being conducted in region uppsala in collaboration with oxlantic medical ab. the main responsible and sponsor for the trial is oxlantic medical ab. the research lead for the trial is region uppsala and uppsala university. this clinical trial has been subject to ethical review and approved by the ethics review authority.


Eligibility criteria:
inclusion criteria: * 20 healthy volunteers 18-84 years * 30 patients between 18-84 years being transported by ambulance exclusion criteria: * priority 1 ambulance transports * patients needing oxygen supply * known pregnancy * patients unable to provide informed consent

Keywords: marie capnograph marie nasal adapter set o2 - adult mainstream respiratory infrared equipment capnograph
safety and effectiveness of the akreos toric intraocular lens.

Conditions: Cataract; Astigmatism

Summary: the purpose of this study is to evaluate the safety and effectiveness of the akreos toric iol following cataract surgery.


Eligibility criteria:
inclusion criteria: * subjects must be willing and able to provide written consent on the ec approved informed consent form. * subjects must require a lens power from 15 to 30 diopters. exclusion criteria: * subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated. * subjects with corneal pathology potentially affecting topography.
the effect of laughter therapy on nursing students

Conditions: Mental Stress; Insomnia; Sleep Disorder; Mental Health Disorder

Summary: the aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.

h1.1: students who receive laughter therapy will have lower mean scores in the general health questionnaire than students who do not receive laughter therapy. h1.2: students who receive laughter therapy will have a lower pittsburgh sleep quality index score than students who do not receive laughter therapy. h1.3: students who receive laughter therapy will have a lower mean stress level than students who do not receive laughter therapy.

Eligibility criteria:
inclusion criteria: * volunteering to participate in research * being a 1st or 2nd-year student in the faculty of health sciences, department of nursing * not have any health problems that may create a communication barrier * being in a quiet environment to participate in the online study due to the pandemic period * have an internet connection to attend online sessions exclusion criteria: * having undergone abdominal surgery in the past three months * having a disability to attend regular sessions

Keywords: sleep quality psychological stress general health nursing students laughter therapy
asia study group of prostate cancer (a-cap study)

Conditions: Prostate Cancer

Summary: this study will target patients who have received a histopathological diagnosis of prostate cancer and who are undergoing treatment in various forms, including active psa surveillance, surgical treatment, radiotherapy, endocrine therapy, and chemotherapy. the study will survey information about the patient at time of diagnosis, clinical staging, details of initial treatment, status of disease progression, and prognosis at the end point of the study. the purpose of the study is to clarify distribution of staging, the actual status of treatment choices and treatment outcomes.

the a-cap will collect information in a linkable anonymized format from all medical institutions in asian countries participating in the study and will engage in data analysis. j-cap which has previous experience of engaging in a similar study in 2010 wll be a sponsor for a-cap study, the aggregated results of which have been reported. the registration period for this study will be three years followed by 7 years of follow-up study, and research will be implemented across a wider range of asian countries, with new institutions participating for the purposes of this study. as this study will be an observational study the acquisition of data will be relatively simple, and as the content of the study will be almost identical to the study conducted by j-cap in 2010, a system for research implementation is already established at j-cap.

Eligibility criteria:
inclusion criteria: * patients who have received a histopathological diagnosis of prostate cancer between january 1,2016,and december 31,2018. * patients who, having received a diagnosis within the abovementioned period, began initial treatment for prostate cancer(including active surveillance). * patients who are either hospitalized as outpatients. exclusion criteria: • patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired.

Keywords: prostate cancer observational study
reclaim study: a phase 2 evaluating the efficacy and safety of pemvidutide in the treatment of alcohol use disorder (aud) in subjects with obesity or overweight

Conditions: Alcohol Use Disorder (AUD)

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of aud in subjects with obesity or overweight. after signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms: * pemvidutide: 2.4 mg sc once weekly * placebo: placebo sc once weekly


Eligibility criteria:
inclusion criteria: 1. written informed consent signed prior to performance of any study procedures 2. male or female ages 18 to 75 years, inclusive 3. diagnosis of current aud of moderate or greater severity according to dsm-5 criteria 4. reported drinking at least 28 drinks per week if male or 21 drinks per week if female in the 28 days prior to signing the informed consent. this should include at least 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4 drinks per day for women) note: baseline heavy drinking days will be determined by the tflb method (28-day recall) drinking pattern collected at the initial screening visit 5. overweight or obesity, defined as bmi ≥ 25 kg/m2 exclusion criteria: 1. presence of clinically significant alcohol withdrawal symptoms, as defined as ciwa-ar score ≥ 10 at screening and/or prior to randomization 2. history of hospitalization for alcohol intoxication or alcohol withdrawal 3. history of alcohol-related disorders including seizures related to alcohol, malloryweiss syndrome, and alcoholic ketoacidosis 4. history and/or current dsm-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the investigator and cleared by the medical monitor 5. c-ssrs score indicative of active suicidal thoughts (answering "yes" to any of questions 2 through 5 on the c-ssrs) in the past 6 months

Keywords: pemvidutide glp-1 receptor agonist alcohol use disorder obesity overweight aud treatment phase 2
altered neural pain empathic reactivity in nssi adolescents

Conditions: Nonsuicidal Self Injury; Pain Empathy

Summary: nonsuicidal self-injury (nssi) is defined as direct, deliberate bodily harm without suicidal intention. in recent years, growing evidence suggests that nssi has become a worldwide public health issue. people with nssi behaviors, especially adolescents, commonly exhibit emotion-related and interpersonal problems. pain empathy represents an essential basal domain of socio-emotional processing and refers to the ability to empathize, connect and share with others' pain. however, altered empathic processing has not been systematically examined in adolescents with nssi. to this end, the current functional magnetic resonance imaging (fmri) study will recruit one group of nssi adolescents (n=40) and one healthy control (hc) group (n=40), to compare their neural activity regarding pain empathy processing, which is measured by blood oxygenation level-dependent (bold) fmri. the investigators included conditions of physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli. the investigators hypothesize that compared to hc, nssi adolescents show increased empathic reactivity to physical pain stimuli in salience and arousal related brain regions but decreased empathic reactivity to affective pain empathic stimuli.


Eligibility criteria:
inclusion criteria: * 15-18 years * right-handed * normal or corrected normal visual acuity * meet the proposed dsm-5 frequency criteria (e.g., ≥5 days of nssi behaviors in the past year) exclusion criteria: * diagnosis of borderline personality disorder, major depressive disorder, other * psychiatric disorders, etc. * high suicidal risk * recent use of medications that can affect neural activity * have received or are receiving dialectical behavior therapy (dbt) other treatment for emotional problems within the past 6 months * have a contraindication to mri scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for mri scanning)
afamelanotide in patients suffering from polymorphic light eruption (ple)

Conditions: Polymorphic Light Eruption

Summary: this study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (ple).


Eligibility criteria:
inclusion criteria: * aged greater than 18 years * male or female patients with a documented history of ple diagnosed or confirmed by a photodermatologist or photobiologist, with a history of ple related pruritus symptoms. * recurrent ple episodes that occur at least once a year (as evidenced by ple related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates) * written informed consent prior to the performance of any study-specific procedure * are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the investigator exclusion criteria: * currently requiring treatment with systemic immunosuppressive agents * documented history of other photosensitivity conditions which may be confused with ple or interfere with the assessment of ple episodes * solarium use in the three months prior to study involvement and throughout the duration of the study * use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the investigator may interfere with this study * documented presence (\> 1 in 320) of anti-nuclear antibody (ana) and/or positive extractable nuclear antibody (ena); historical results from the 3 years prior to randomisation are acceptable if available * in the opinion of the investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters * history of drug or alcohol abuse (in the last 1 year) * female who is pregnant (confirmed by positive serum beta-human chorionic gonadotropin (β-hcg) pregnancy test prior to baseline) or lactating * female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device) * sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months thereafter * participation in a clinical trial with another investigational medicinal product (imp) within 30 days prior to the screening visit or during the study * hypersensitivity to afamelanotide or any of its components
study to define safety and effectiveness of dolutegravir (dtg) use in human immunodeficiency virus (hiv) positive pregnant women

Conditions: HIV Infections

Summary: the purpose of this study is to assess the safety and effectiveness of dtg use in hiv positive pregnant women. this is a 3-year multi-site prospective observational study. approximately, 250 hiv positive pregnant women from potential european aids treatment network (neat id) sites across europe will be enrolled. the enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. the data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.


Eligibility criteria:
inclusion criteria: * hiv positive pregnant women aged 18 years and over on dtg * with no maternal or birth outcomes yet * subjects are able and willing to provide written informed consent and comply with any safety reporting requirements. exclusion criteria: -

Keywords: hiv dolutegravir europe neat id pregnancy safety antiretroviral
inflammatory mediator profiles during heart valve replacement surgery

Conditions: Infective Endocarditis; Valvular Heart Disease

Summary: the study aims at the comparative examination of pre-, intra- and post-operative release profiles of inflammatory and vasoactive mediators in patients undergoing heart valve surgery under cardiopulmonary bypass (cpb) due to either infectious endocarditis or degenerative valvular heart disease. specific attention will focus on the distinction between mediator release associated with infection and that resulting from cpb. concomitantly identification and characterization of infectious pathogens in the circulation and in valvular samples will be carried out, together with the search for resistance-coding transcripts.

exaggerated release of inflammatory mediators and endogenous vasoactive substances resulting from the coincident infection and surgical stress plays a role in post-operative organ failure and altered immune defense, thus contributing to unfavorable post-operative outcome. cardiopulmonary bypass (cpb) itself, even in the absence of ie, has been shown to modify cytokine and vasoactive mediator release and may cause organ failure. tracing of release profiles of inflammatory cytokines and vasoactive mediators and their correlation with postoperative organ dysfunction in cardiac surgery for ie or non-ie patients aims at the assessment of the prognostic validity of these biomarkers and the evaluation of measures for their pro-active clearance during the surgical intervention. induction of inflammatory mediators and their temporal release profile may vary depending on the involved pathogens, which cannot be always identified by conventional techniques (blood culture). since it is conceivable that identification of the involved pathogen could explain differences in cytokine secretory patterns in ie, use of advanced molecular technologies (ngs) will support the clarification of such relations. analysis of transcripts encoding inflammatory and vasoactive mediators in blood cells will enable the surveillance of temporal oscillations in their profiles during the observation time frame. transcriptome analysis of identified putative pathogens can also disclose features of antibiotic resistance.

Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 * confirmed diagnosis of infective endocarditis or valvular heart disease * scheduled surgical intervention with cpb use exclusion criteria: * glucocorticoid dosage above cushing threshold * severe neutropenia (below 1000/mm3) * immunosuppression or immunomodulatory therapy * pregnancy
observational study to assess outcomes during antipsychotic treatment with paliperidone er or other oral antipsychotics

Conditions: Schizophrenia

Summary: the purpose of this non-interventional, observational and international registry study is to document the prescribing patterns in daily clinical practice and to assess long term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting.

pilar is a non-interventional, observational, international registry on the use of oral antipsychotics in a naturalistic setting in patients with schizophrenia. patients initiating a new oral antipsychotic treatment are candidates for documentation in this registry. all patients should be treated according to local labeling specifications. the overall study objective is to document prescribing patterns in daily clinical practice and to assess long-term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting. the primary objective is to prospectively document over one year treatment outcomes and healthcare utilization data that will enable a cost-effectiveness analysis of paliperidone er compared to other oral antipsychotic treatments. additional objectives are to retrospectively collect data over one year, which will allow the evaluation of treatment outcomes before and after treatment initiation with paliperidone er or other oral antipsychotics. evaluation of adverse drug reactions (adr) and serious adverse drug reactions (sadr) for the retrospective period, and adverse events (ae) and serious adverse events (sae) during the prospective period will be performed and reported. dosing and administration of all treatments should be prescribed at the physician's discretion, and should be based on approved local labels. dose adjustments or medication changes should be made by the treating physician based on clinical judgment and usual practice. subjects should receive their medication according to usual care in their treatment setting, and no study drug will be provided. the documentation of the treatment will last one year.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * switch to or start on paliperidone er or another oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago * signed informed consent is available at the beginning of documentation * able and willing to fill-out self-administered questionnaires exclusion criteria: * established treatment-refractory schizophrenia * history of neuroleptic malignant syndrome

Keywords: registry healthcare utilization outcome safety efficacy cost-effectiveness paliperidone er invega® oral antipsychotics
evaluation of regional ventilation distribution using electrical impedance tomography during weaning from mechanical ventilation

Conditions: Acute Respiratory Failure; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury; Weaning Failure

Summary: the goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure. the main question\[s\] it aims to answer are: * to evaluate which weaning trial is associated to a better regional ventilation distribution * to evaluate which weaning trial can be comparable to ventilation distribution after extubation participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 70 years * ready to be weaned from mechanical ventilation according to clinical criteria exclusion criteria: * age \ 70 years * presence of chest drains * presence of pacemaker/impantable cardiac device; * diagnosis of pneumothorax, or pneumomediastinum * diagnois of neuromuscular diseases * use of neuromuscular blockers in the 48 hours before screening; * body mass index \> 35 kg/m2 * refusal to participate of the patient/next of kin

Keywords: electrical impedance tomography weaning trial acute respiratory failure lung monitoring
an alternative dose interval study in participants with hidradenitis suppurativa receiving brodalumab

Conditions: Hidradenitis Suppurativa

Summary: phase 0 study of an alternative dosing interval of brodalumab in patients with moderate to severe hidradenitis suppurativa to identify biomarkers of disease activity and clinical response.

phase 0, open label study of an alternative dosing interval of brodalumab in patients with moderate to severe hidradenitis suppurativa. consisting of n=10 patients receiving 210mg subcutaneously every week for 24 weeks. patients will be followed for a period of 36 weeks (12 weeks after last dose of brodalumab) to assess for safety.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of hidradenitis suppurativa by the pi * age 18 or older * moderate to severe hidradenitis suppurativa as determined by the pi * previously enrolled in jfr-0989 exclusion criteria: * inflammatory bowel disease * hiv positive * active hepatitis b or c infection * pregnant or breastfeeding * no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (require washout period of \>5 half lives) * any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data * high suicide risk as determined by the columbia suicide severity rating scale

Keywords: hidradenitis suppurativa acne inversa brodalumab