Kornimate/medical-research-clean huggingface dataset:
a single dose study of pf-06678552 in healthy subjects

Conditions: Healthy

Summary: pf-06678552 is a new compound proposed for the treatment of hypercholesteremia. the primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of pf-06678552 in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non childbearing potential. * body mass index (bmi) of 18 to 30.5 kg/m2; and a total body weight \>50 kg * low density lipoprotein cholesterol between 115 mg/dl and 190 mg/dl exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Keywords: single ascending dose healthy subjects hypercholesterolemia hyperlipidemias dyslipidemias lipid metabolism disorders metabolic diseases
querying stroke unit nursing interventions in the emergency department

Conditions: Stroke; TIA

Summary: the aim of the study is to monitor if specialized stroke nurses as team partners in the ed can reduce hospital acquired infections. the study is designed as pre- post-intervention study in which specialized su nurses partner with ed nursing staff to asses and screen stroke admissions in the ed.

an intervention study comprised of 1) a primary registry database component and 2) a secondary questionnaire based quantitative evaluation . the intervention study includes a 3-month baseline observational period followed by a 7-month baseline data collection period, a 2-month intervention implementation phase, and a 3-month intervention observational period followed by 7-month intervention data collection period. an intervention, where dedicated stroke nurses handle acute care of stroke and tia patient in the ed prior to admission to a dedicated stroke unit will take place in the timeframe of 11-19:00 hrs, 7 days a week. notably, the intervention is set to be integrated into clinical practice on a permanent basis after end of study. data for all stroke patients admitted to the ed at hgh are collected during the 3-month baseline and intervention observational periods. fulfilment of danish stroke quality program (dap) quality indicators is monitored as follows - use of dysphagia screen (guss), mobilization within day of ed admission and transfer to su. additional nursing interventions monitored in the ed are: use of nasogastric catheter, use of bladder scan and intermittent catheterization, frequency of temperature monitoring and use of anti-pyretics, acute phase monitoring of blood-pressure every 2 hours, use of scandinavian stroke scale (sss) score. outcomes are monitored in hospital and at visits to the out patient clinic, as well as by registry.

Eligibility criteria:
inclusion criteria: * patients referred to the ed at herlev hospital with a diagnosis of stroke or tia from 11 am to 7 pm * patients fulfilling one of the following icd-10 codes at discharge: ich: i61, cerebral infarction; i63, unspecified: i64, tia: g45 and a scheduled follow-up appointment at the outpatient clinic herlev hospital exclusion criteria: * patients transferred from other hospitals or stroke units * patients elegible for thrombolysis or thrombectomy at time of admission
changes in the consumption of psychoactive substances during containment linked to covid-19

Conditions: People Incarcerated; COVID-19

Summary: the sars-cov 2 pandemic started in china in december 2019, then reached france on january 24, 2020. on march 14, france moved into phase 3 of the epidemic threshold with the implementation of containment measures on march 17 measures were put in place by n.belloubet (french minister of justice) from march 17, including suspension of visiting rooms and activities in detention. containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, ptsd, depression, suicide, addictive behavior and violence. however,prisoners have a higher prevalence of substance use disorders than the general population. what will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the villeneuve les maguelone prison. * anonymous questionnaire from the start * collection of socio-demographic data * collection of consumption data before and during containment * collection of monitoring data


Eligibility criteria:
inclusion criteria: * men incarcerated at villeneuve les maguelone prison * on a given date (may 12) * major * french speaking * non illiterate exclusion criteria: * minors * patients refusing * non-french speaking * illiterate
defining a pd-specific breath fingerprint of underlying inflammatory and neurodegenerative processes

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the potential for a parkinson's disease (pd) -specific breath signature as a non-invasive screening tool for identifying pd patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions. the study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood.

the purpose of this study is to determine the potential for a parkinson's disease (pd) -specific breath signature as a non-invasive screening tool for identifying pd patients with inflammation, tracking the progression of disease, and responsiveness to various therapeutic interventions, in particular anti-inflammatory or immunomodulatory therapies. neurological disorders include any disorder involving the brain or the nervous system, for example memory disorders, stroke, movement disorders and many other conditions. the study will lay the foundation for future studies in which breath fingerprinting could be used as a screening technique. investigators will also be looking at how the breath fingerprint correlates with inflammatory proteins in the blood. investigators will determine how molecules in human breath can define a "breath signature" that can be associated with neurological disorders like parkinson's disease. the long-term goal of this study is to use blood inflammatory marker relationships and breath analytical approach to identify individuals at risk for development of neurologic disorders and to monitor the effects of immune interventions on the rate of disease progression. the study team will recruit a total of 100 participants: 50 early stage (defined by a hohn \& yahr stages 1-2), non-smoking parkinson's disease patients from among the emory movement disorders clinic and 50 age and sex-matched healthy controls (hc). investigators will recruit six to eight participants per month over an 18-month time period.

Eligibility criteria:
participants with parkinson's disease (pd) inclusion criteria: * must be capable of providing written informed consent * non-smoking * clinical diagnosis of pd hohn \& yahr stages 1 and 2 exclusion criteria: * cognitively impaired to the degree that they are not able to provide consent healthy controls inclusion criteria: * must be capable of providing written informed consent * age matched and a family member or healthy community control exclusion criteria: * diagnosed with cancer and/or undergoing cancer treatment.
zactima in non small cell lung cancer (nsclc) elderly patients in combination with or versus gemcitabine

Conditions: Non Small Cell Lung Cancer

Summary: the primary objective of this study is to demonstrate an improvement in progression-free survival (pfs) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced nsclc.


Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmation of advanced nsclc (stage iiib with supraclavicular lymph node metastases or pleural effusion or stage iv) on entry into study * one or more measurable lesions at least 10 mm in the longest diameter (ld) by spiral ct scan or 20 mm with conventional techniques according to recist criteria * chemotherapy-naïve (prior chemotherapy in the adjuvant setting completed more than 3 months before the trial entry is accepted). * female or male aged 70 years or above exclusion criteria: * patients must not have received prior anti-cancer therapy except in the adjuvant setting * inadequate end-organ function or evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial * significant cardiovascular event (e.g. myocardial infarction, superior vena cava \[svc\] syndrome, new york heart association \[nyha\] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of * history of arrhythmia or qtc with bazett's correction unmeasurable or ≥ 480 msec on screening ecg

Keywords: zd6474 vandetanib zactima advanced nsclc lung cancer elderly patients gemcitabine phase ii randomized double-blind histologically or cytologically-confirmed advanced (stage iiib with supraclavicular lymph node metastases or pleural effusion or stage iv) nsclc
evaluation of the biop colposcopy system's safety and performance (accuracy of its registration procedure)

Conditions: Cervical Cancer Screening

Summary: this is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the biop digital colposcope and the accuracy of the image registration procedure between the biop digital colposcope unit and the biop micro colposcope probe unit.

this is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the biop digital colposcope and the accuracy of the image registration procedure between the biop digital colposcope unit and the biop micro colposcope probe unit. the biop digital colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. the images from the digital colposcope are to be viewed on a color display. the digital colposcope is intended for use in hospitals, clinics, and doctor's offices. the biop micro colposcope probe unit is an imaging tool intended to be placed in the vagina for acquisition of images of the cervix. it is intended as an adjunct to the biop digital colposcope. it should not be used as a substitute for a thorough colposcopic evaluation. the biop micro colposcope probe unit is not intended for use on the vulva and vagina. it is anticipated that it will take approximately 3 months to complete active enrollment. study duration for each subject is 1-2 days, including screening, enrolment and procedure. the study will be completed when the final study subject has completed the procedure. 1. performance - to confirm that average image registration error is less than or equal to (≤) 2mm. 2. safety - to evaluate the safety of the biop digital colposcope in women undergoing cervical colposcopy procedures.

Eligibility criteria:
inclusion criteria: * females, ages 22 to 65 years old * referred for colposcopy, following abnormal cervical cytology * subject provides signed informed consent exclusion criteria: * currently pregnant or nursing * currently menstruating * currently has intrauterine device (iud) * diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera. * diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system * hiv-positive status * psychological instability, inappropriate attitude or motivation * use of any additional experimental drug or device or participation in another clinical study within the past 30 days
is microlearning the alternative in the age of hyperconnectivity

Conditions: Knowledge Acquisition; Engagements and Motivation

Summary: this quasi-experimental study evaluated whether microlearning a strategy delivering brief, focused learning units enhances knowledge acquisition and retention among fifth-year medical students studying pediatric spinal deformities compared to a traditional block-format module. methods: twenty-four students will be included into two groups. the microlearning group will receive sequential daily learning units over ten days, while the traditional group will engage in a comprehensive two-day self-learning module. pretest, immediate post-test, and one-month post-intervention assessments will be performed using standardized mcq and saq instruments. learner engagement, time investment, and content clarity were additionally evaluated via structured surveys.


Eligibility criteria:
inclusion criteria: * currently enrolled fifth-year medical students registered for the optional module in physical medicine and rehabilitation access to a personal computer, tablet, or smartphone with internet connectivity ability to access the institutional modular object-oriented dynamic learning environment (moodle) learning management system (lms) voluntary oral informed consent commitment to complete both pre-assessment and post-assessment evaluations willingness to participate in either learning modality (microlearning or traditional block-format) as determined by randomization exclusion criteria: failure to complete the pretest assessment non-completion of the pre and post-test assessment withdrawal of consent at any point during the study development of circumstances that would render continued participation burdensome to the participant

Keywords: microlearning medical education digital natives hyperconnectivity spinal deformities
neurofeedback-based digital therapeutics for the diagnosis and treatment of adhd in children.

Conditions: Attention Deficit Disorder With Hyperactivity; Executive Function Disorder

Summary: a multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (dtx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with adhd. this gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with adhd. it is delivered through an engaging ipad game in a home-based treatment format. patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. investigators will reassess symptoms of adhd, executive functions, and objective measures of attention at the end of the treatment. additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. this innovative digital therapeutics approach is expected to improve adhd symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria established by the 5th edition of the diagnostic and statistical manual of mental disorders (dsm-5) for adhd. * digital cancellation test total score\<50 points. * raven's standard progressive matrices score≥85. * 6 years ≤ age\<12 years. * no interventions for adhd received within 4 weeks. * no color blindness. exclusion criteria: * patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions. * patients with comorbid autism spectrum disorder, tourette's syndrome, and other neurodevelopmental disorders. * patients with comorbid conduct disorders. * patients with severe traumatic brain injury or neurological disorders. * patients with a history of severe somatic diseases. * patients with a history of substance or drug dependency.

Keywords: digital therapeutics neurofeedback attention deficit disorders with hyperactivity children executive function disorder
an observational clinical study to evaluate covid-19 symptoms in "long hauler" patients who participated in k031-120 or k032-120

Conditions: COVID-19

Summary: this observational clinical study aims to evaluate the presence of symptoms of covid-19 infection in patients who participated in k031-120 or k032-120 ("long hauler").


Eligibility criteria:
inclusion criteria: * have consented to participate over the telephone * have been randomized in either the k031-120 or k032-120 study exclusion criteria: * have withdrawn consent from k031-120 or k032-120

Keywords: microbiome covid-19 corona virus corona virus disease kaleido kaleido biosciences kb109 oligosaccharide glycan microbiome metabolic therapy mmt supportive self care ssc telemedicine k031-120 k032-120
innovation of audio-visual triage system in combating the spread of covid-19 infection and its efficacy: a novel strategy

Conditions: Audio-Visual Triage System; Anxiety Levels; COVID-19 Spread; GAD-7 Score; Healthcare Professionals; Screening Strategy

Summary: during the novel coronavirus pandemic, also known as sars-cov-2 or covid-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. the protocols to prevent the spread of this disease proved to be less effective than anticipated. in these circumstances, improvement of the existing triage system was felt and an audio-visual triage (avt) system was introduced to enhance confidence as well as increase the safety of frontline healthcare professionals. the current analysis was performed from march 21, 2020, to april 28, 2020, until the completion of sixty response forms, at bahria town international hospital, lahore. thirty participants (group a) deployed on visual triage and other thirty (group b) on audio-visual triage for screening suspected cases of covid-19 infection. anxiety levels were measured by using the gad-7 scoring system and the participants of both groups were periodically tested for covid-19 infection by pcr. independent t-test was used to evaluate the significance of different variables at a confidence level of 95%.

a novel strategy 'audio-visual triage' was introduced to boost up the confidence levels, lower down the anxiety levels and the most important factor is to reduce the risk of covid-19 infection spread. this triage system included audio system to communicate with patients and access the covid-19 infection status at recommended distance of 6 feet. the main disturbing factors that were noted on visual triage system were, 1). close contact of healthcare professionals with patients and attends, 2). fear of transmission of infection lead to higher levels of anxiety. to assess the efficiency of avt anxiety level were analyzed by using spitzer et al., 2006, general anxiety disorder-7 (gad-7) scoring system and outcomes were assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety, 10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.

Eligibility criteria:
inclusion criteria: * participants performing their duty on visual triage. exclusion criteria: * those participants having previous psychological illness, frequently used to use the washroom, had non-serious attitude and poor compliance with the protocols of wearing ppes were excluded from the study.
evaluation of plerixafor plus g-csf to mobilize and collect 5×10^6cd34+ cells/kg in non-hodgkin's lymphoma (nhl) patients for autologous transplantation

Conditions: Non-Hodgkin's Lymphoma

Summary: the study is to determine if nhl patients mobilized with g-csf (10 µg/kg/day \[gran® only\]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10\^6 cd34+ cells/kg in 4 or fewer days of apheresis than nhl patients mobilized with g-csf plus placebo.

eligible patients who are unable to achieve adequate apheresis cell counts may enter an open-label rescue period where they will receive plerixafor, following the same study schedule as during the double-blind treatment period.

Eligibility criteria:
inclusion criteria: * has a biopsy-confirmed diagnosis of nhl * is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy * treatment with an autologous peripheral hsc transplant is planned and the patient is eligible for autologous transplantation * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment. * has an actual body weight \<175% of their ideal body weight (ibw) * the patient agrees to use a highly effective method of contraception from day 1 through ≥3 months following plerixafor treatment. exclusion criteria: * concurrent serious illness and pathological conditions * has undergone previous hsc collections or collection attempt * has had any autologous or allogeneic hsc transplant * has active central nervous system (cns) involvement * bone marrow lymphoma cells involvement \>20%, as assessed by bone marrow biopsy within 4 months before signing the icf * has received radiation therapy to the pelvis * has a diagnosis of all leukemias including any type of cll * active infection * pregnant or nursing * anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm * received any prior radio-immunotherapy * prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (bcnu) within 6 weeks prior to first dose of g-csf * prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of g-csf * prior granulocyte/macrophage-colony stimulating factor (gm-csf) or pegfilgrastim within 3 weeks prior to the first dose of g-csf * prior g-csf within 2 weeks prior to the first dose of g-csf * inadequate organ funtion evidenced by unacceptable laboratory result

Keywords: hematopoietic stem cell transplantation
reliability and diagnostic accuracy of an alternate lachman's test performed in a prone position

Conditions: Anterior Cruciate Ligament Stability

Summary: this study is investigating the reliability and diagnostic accuracy of a lachman's test conducted in a prone position to detect the presence of a torn anterior cruciate ligament.


Eligibility criteria:
inclusion criteria: * current knee pain complaint in subjects between 15 and 60 years old exclusion criteria: * the inability to assume the prone testing position * evidence of a fracture by application of the ottawa fracture rule * previous knee joint arthroplasty * suspicion of posterior cruciate involvement * knee surgery in the previous six months * presence of serious underlying non-mechanical pathology * systemic illness

Keywords: accuracy, anterior cruciate ligament, diagnostic value, examination, knee, lachman test, sensitivity, specificity