Kornimate/medical-research-clean huggingface dataset:
mindfully optimizing delivery of end-of-life care

Conditions: Cancer; Coping Skills

Summary: the study evaluates the feasibility, acceptability, and preliminary efficacy of a mindfulness meditation-based intervention designed to provide a synergistic solution to the avoidant coping that often inhibits advance care planning discussions that are crucial to quality end-of-life care.


Eligibility criteria:
inclusion criteria: oncologists: * be a physician specializing in medical oncology * care for oncology patients at the affiliated cancer center * have a patient panel that will allow for ≥6 eligible patients to be enrolled in the study * be willing to attend the 5-session model care program for providers at the specified location, date, and time patients: * adults ≥ 18 years of age * receiving care from a medical oncologist enrolled in the study * diagnosed with an incurable and advanced-stage solid malignancy (late stage iii \[b or c\] or stage iv) * have an attending medical oncologist who would not be surprised if the patient died in the next 12 months * willing and able to travel to the class location for 6 weekly 2-hour sessions * have a family member or friend eligible and interested in participating in the model care study * able and willing to provide informed consent * not have completed a physician orders for scope of treatment (post) form family caregivers: * adults ≥18 years of age * chosen by a family member or friend with cancer to join them in participating in the model care study * willing and able to travel to the class location for 6 weekly 2-hour sessions * able and willing to consent. exclusion criteria: oncologists: * planning to leave current practice setting for other employment in the next 3 months. patients: * eastern cooperative oncology group (ecog) performance status of \>2 or karnofsky performance status \<60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist * currently receiving hospice care.

Keywords: advance care planning coping skills mindfulness meditation cancer adult caregivers oncology providers advance directives anxiety depression quality of life pilot project
remote continues glucose monitoring during the covid-19 pandemic in quarantined hospitalized patients

Conditions: Diabetes; Covid-19; Infection

Summary: this is a randomized controlled trial of isolated patients with diabetes admitted to nordsjællands hospital with or without covid-19-pneumonia. a continuous glucose monitoring (cgm) based system with transmission of glucose data to a central system is used for remote monitoring of glucose levels and compared to standard finger-prick glucose. blinded (to patients) cgm is mounted in the finger-prick group.

epidemics and pandemics are a constant threat to health care systems globally. this stresses the importance of preparedness for a large amount of hospitalized quarantined patients in isolation, with the extra challenges it brings. the covid-19 pandemic challenges the danish health care system in many aspects: an increased number of citizens are expected to be admitted to hospital due to covid-19 infected pneumonia and this will demand extra workforce resources, extra use of protective equipment (gowns, masks, gloves, etc) and extra time used for taking protective equipment on and off. in concert these extra demands will drain the health care system and any initiative to reduce these challenges is needed. in this randomized controlled trial, isolated patients with diabetes will be randomized to either standard care fingerprick glucose + blinded cgm or dexcom g6 only.

Eligibility criteria:
inclusion criteria: 1. hospitalized with confirmed covid-19 infection by real-time pcr or another validated method or hospitalized with a non-covid-19 diagnosis and in isolation at time of inclusion. 2. a documented clinically relevant history of diabetes or newly discovered during hospitalization. 3. written informed consent obtained before any trial related procedures are performed. 4. male or female aged over 18 years of age. 5. must be able to communicate with the study personnel. 6. the subject must be willing and able to comply with trial protocol. exclusion criteria: 1. known hypersensitivity to the band-aid of the dexcom g6 sensors

Keywords: endocrinology diabetes quarentine isolation cgm
hangover and residual zopiclone effect on spatial perception

Conditions: Healthy; Alcohol Drinking

Summary: hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. three recording visits plus screening included.


Eligibility criteria:
inclusion criteria: * weight \>45 kg * likely to experience and predict alcohol hangover within the next five weeks * no childbearing potential of negative pregnancy test at screening * a valid driving license exclusion criteria: * breastfeeding * infection with hcv, hbv or hiv * a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation * suspected or current drug or alcohol abuse
gestational weight gain and postpartum weight loss in active duty women (moms fit 2 fight)

Conditions: Weight Gain; Weight Loss

Summary: the purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping tricare beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.

investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (gwg-only); b) a postpartum weight loss intervention (ppwl-only), or c) a combined gestational weight gain and postpartum weight loss intervention (gwg+ppwl) to determine the efficacy of the interventions on gwg as well as ppwl. procedures: interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. individuals who meet the telephone screening eligibility criteria will be invited to schedule a screening visit, during which written informed consent will be obtained. at this visit, eligibility will be assessed and measures will be administrated. the potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. should she continue to be interested, she will return for a baseline visit and will be randomized. randomized participants will have 5 in person scheduled visits after their screening visit and baseline visit to the wilford hall ambulatory surgical center (whasc) or san antonio military medical center (sammc) obstetrics (ob) clinic. these visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. at these visits, physical measurements will be collected and participants will complete various questionnaires.

Eligibility criteria:
inclusion criteria: * participants will be active duty military, dependents or retired with tricare benefits * participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at whasc and sammc) * participants also must be within the normal, overweight, or obese bmi ranges * are generally in good health * currently not smoking more than 5 cigarettes per day at the time of conception exclusion criteria: * expecting multiple babies (e.g. twins) * diabetic * not interested in participating in a program for 21 months

Keywords: pregnancy postpartum
variation in fluids administered in shock

Conditions: Shock

Summary: to conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years admitted to the participating hospital. * patients in the emergency department, intensive care unit, pacu, or any hospital floor. for patients not in the icu, there must be plans to transfer to an intensive care unit when an icu bed is available for patient. * patients with shock as defined by: * need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep map \> 65 mmhg or * systolic bp \< 90 mmhg exclusion criteria: * patients previously enrolled into this study. * patients who were in the operating room at time of shock and fluid bolus. * patients admitted to an icu after cardiac surgery patients with primarily cardiogenic shock as etiology for their shock * patients transferred from another hospital or emergency room to the study hospital.
nibp validation study

Conditions: Critical Illness

Summary: the purpose of this study is to compare measurements of blood pressure (bp) between the philips non-invasive blood pressure (nibp) system (including nibp cuff and portable patient monitor) and invasive radial arterial line (a-line) in critical care patients.

this is a multicenter, multi-phase, prospective, non-randomized, self-controlled, observational study to evaluate the validity of philips non-invasive blood pressure technology. this study is designed for the purpose of establishing equivalence of the philips nibp system with the gold standard arterial line. main phase will be considered complete when the number of pre-defined subjects and data points are achieved per subject group. * subject group 1: neonates, infant, children \<3 years of age minimum of 24 subjects and 180 data points * subject group 2: children 3-12 years of age minimum of 41 subjects and 205 data points * subject group 3: adolescent/adult \>12 years of age minimum of 124 subjects and 620 data points

Eligibility criteria:
inclusion criteria: * patient admitted into the neonatal intensive care unit (nicu), pediatric intensive care unit (picu), intensive care unit (icu), or operating room (or) * adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent * indication for nibp cuff * indication for radial arterial line exclusion criteria: * inability to place the study device appropriately due to patient's anatomy or condition * known pregnancy or lactating women (self-report) * patients treated with an intra-aortic balloon pump * aortic and mitral regurgitation (\> 2nd degree) * measurements taken in the lateral position * currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s) * if valid sbp reference measurements for lateral difference is \> 15 mmhg * if valid dbp reference measurements for lateral difference is \> 10 mmhg * at the principal investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
a multicentre trial of nerve-spring radical hysterectomy vs. radical hysterectomy for cervical cancer

Conditions: Cervical Cancer

Summary: the investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. patients with figo stage ia2, ib1, iia1 and figo stage ib2, iia2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. the primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. a total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.


Eligibility criteria:
inclusion criteria: 1. figo(2009) stage ia2, ib1, and iia1 untreated cervical cancer or figo(2009) stage ib2 and iia2 cervical cancer that possible to surgery after neoadjuvant chemotherapy 2. possible to radical hysterectomy or nerve-spring radical hysterectomy 3. age: 17 to 60 years 4. no complication during operation 5. written informed consent exclusion criteria: 1. patients who underwent radiotherapy 2. pathologically diagnosed pathologically diagnosed squamous carcinoma, small cell carcinoma, small cell carcinoma 3. patients who have uncontrolled diabetes or uncontrolled hypertension 4. patients with neurogenic bladder dysfunction 5. patients with uterine prolapse 6. patients with psychiatric illness 7. patients who have active infection 8. patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 9. patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
central arterial hemodynamics and resistance training

Conditions: Hypertension; Cardiovascular Risk Factor

Summary: resistance exercise training is one of the popular exercise modes that has been drawn the public's attention. however, existing evidence showed high-intensity resistance exercise training-induced negative adaptation on vascular function and blood pressure responses. upper-body resistance exercise training is more likely to induced arterial stiffening, which has been shown to be gender-dependent. it is still unknown whether age also plays a role. we like to test the hypothesis that high-intensity upper body resistance exercise may lead to a higher increase of arterial stiffness, central blood pressure, and hemodynamic parameters in younger adults than older adults. we also hypothesize high intensity resistance training could contribute to greater central hemodynamic responses and muscle stiffness than the control; the change of muscle stiffness correlates with the change of hemodynamic parameters. collectively, study 1 in this project is aimed to recruit 40 apparently healthy young (20-35yrs) and middle-aged to older adults (50-75yrs) into this study followed by upper-body or lower-body high-intensity exercise (80% 1 repetition maximum, 10 reps, 4 sets) by a randomized order. blood draw, central blood pressure, hemodynamics will be performed and obtained at pre-, immediately-post, 20min, 40mins, and 60 mins post-exercise. study 2 is aimed to investigate the effects of 8-week whole-body resistance exercise training followed by a 4-week detraining on above-measured variables in order to determine the long-term effects on resistance training. we will employee state-of-art ultrafast ultrasound to obtain muscle stiffness and carotid local pulse wave velocity. endothelin-1 and catecholamines will also be measured to discover its underlying mechanisms on such stiffening effects induced by high-intensity resistance exercise.


Eligibility criteria:
inclusion criteria: * healthy middle-aged to older adults exclusion criteria: * (1)bmi≧27, (2) smoking habits for more than six months in the past, (3) hypertension (blood pressure\>140/90 mmhg), (4) personal diabetes history (fasting blood sugar \>126 mg /dl), heart disease, or other cardiovascular diseases, (5) bone damage, (6) regular use of supplements or vitamins

Keywords: exercise ultrafast ultrasound
evaluation of the use of relax glasses on anxiety of patients undergoing dental extraction > 2 teeth, under local anesthesia, compared with those not using glasses

Conditions: Surgery

Summary: the vast majority of tooth extraction surgery is performed under local anaesthetic, and can be a source of anxiety. in their 2015 article, appukuttan et al studied the anxiety felt by 1148 patients prior to tooth extraction, and reported up to 82% of patients anxious before a procedure. in 2020, yamashita et al demonstrated the value of virtual reality in reducing patient anxiety during the extraction of three impacted mandibular molars, with no clear effect on the pain felt by the patient. the use of a virtual reality headset has been shown to reduce anxiety in dental surgery or in hand surgery under local anesthesia with the walant technique. on the other hand, virtual reality and the use of 3d can cause discomfort and side effects such as nausea and dizziness. audiovisual distraction is also known to be effective in reducing pain and anxiety in patients, with fewer side effects. the investigators have therefore chosen to use relax® eyewear. they wish to study its effect on anxiety, pain and overall patient and surgeon satisfaction.


Eligibility criteria:
inclusion criteria: * patient undergoing dental extraction \> 2 teeth under local anesthesia; * over 14 years of age on the day of inclusion; * patient with written consent or additional parental consent for minors; * socially insured patient; * patient willing to comply with all study procedures and duration. exclusion criteria: * medical history contraindicating relax glasses * known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance; * any condition that would render the patient unfit for the study: current presence of cognitive disorders (mms \< 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to dsm-v classification); * major anxiety requiring preoperative anxiolytics; * patient under court protection; * patient participating in another study; * patient's refusal to use glasses; * visually impaired or blind patient.

Keywords: audiovisual sedation anxiety dental extraction local anesthesia
a natural history study of charcot-marie-tooth 4j (cmt4j)

Conditions: Charcot-Marie-Tooth Disease; Hereditary Motor and Sensory Neuropathy IV

Summary: charcot-marie-tooth 4j (cmt4j) is a rare inherited peripheral neuropathy often characterized by rapidly progressive, asymmetrical upper and lower extremity weakness, muscle atrophy leading to loss of ambulation, respiratory compromise and premature death with no available treatment. the purpose of this study is to investigate the clinical characteristics and natural clinical progression of symptoms in individuals with cmt4j. this natural history study is important to better understand disease course to be able to determine clinically meaningful outcome measures for use in future clinical trials.

charcot-marie-tooth (cmt) diseases are the most common inherited motor and sensory neuropathies, composed of a group of pathologically and genetically distinct subtypes ranging from slowly to rapidly progressive disease. cmt4j is a rare subtype of cmt caused by mutations in the fig4 gene. pediatric-onset disease can often be characterized by rapid progression of muscle weakness and atrophy, culminating in loss of ambulation and respiratory compromise and premature death. adult-onset cmt4j can present with a more variable disease course. no prospective natural history study for cmt4j has been reported. this study aims to prospectively investigate the natural history of cmt4j, and concurrently to identify potential outcome measures that could be used in future clinical trials. no investigational product will be provided in the study.

Eligibility criteria:
subjects must have a prior confirmed molecular (genetic) diagnosis of cmt4j by clinical presentation and genetic testing.

Keywords: cmt4j
a study to evaluate the safety and immunogeneicity of multivalent pneumococcal conjugate vaccine in healthy adults

Conditions: Pneumococcal Infection

Summary: phase-1 study pneumococcal conjugate vaccine study in healthy adults

a study to evaluate the safety and immunogeneicity of lbve(multivalent pneumococcal conjugate vaccine) in healthy adults

Eligibility criteria:
inclusion criteria: * healthy adult older than 19 years old and younger than 50 years old * a subject who was informed of the purpose, method, and efficacy of the clinical study and signed the written informed consent form exclusion criteria: * a subject who participated in other clinical studies within 3 months before screening * a subject who was vaccinated with other vaccines within 4 weeks before screening, or who is expected to receive other vaccination during the clinical study period * a subject with medical history of hypersensitive reactions (e.g. anaphylaxis) to the test drug or its ingredients * a subject who received immunoglobulin or blood-derived materials within 3 months before screening * a subject with immunologic function disorders including congenital or acquired immunodeficiency disorders * a subject who is receiving immunosuppressive therapy or drugs that can affect immunological reaction * a subject with pyrexia of over 38 celsius degrees on the day of the vaccination with the investigational products * a subject with medical history of invasive pneumococcal disease (ipd) or pneumonia caused by streptococcus pneumoniae * a subject who was vaccinated with any pneumococcal vaccine before screening * a subject who received the vaccine containing diphtheria toxoid within 6 months before screening (e.g. adult td vaccine)
a trial assessing the long term safety and tolerability of [s,s]-reboxetine in patients with post-shingles pain.

Conditions: Pain

Summary: the purpose of this study is to assess the long-term safety and tolerability of \[s,s\]-reboxetine in patients with chronic pain following shingles. this is the extension study of protocol a6061026.


Eligibility criteria:
inclusion criteria: * patients must have met the patient selection criteria for the preceding double-blind protocol a6061026 and have completed the 16-week trial. * patients at screening must have a score of \>/=40mm on the pain visual analogue scale. exclusion criteria: * serious adverse event during the preceding double-blind protocol a6061026 that was determined to be related to the trial medication by the investigator. * patient treatment compliance was less than 80% in the preceding double-blind protocol a6061026.