Kornimate/medical-research-clean huggingface dataset:
virtual reality experiences on acute pain and distress

Conditions: Virtual Reality; Acute Pain; Anxiety

Summary: the aim of this study is to evaluate the efficacy of virtual reality experiences on acute pain and distress caused by fluoroscopic pain intervention in chronic pain patient.

the investigators perform lots of interventions for patients. but unfortunately, patients cannot help being exposed to the acute pain and fear during the interventions. "virtual reality(vr)" is a state-of-art advanced technology, which is now being extended to various medical fields such as pain management, dental treatment, body rehabilitation and cancer pain. there is no study that have conjugated the virtual reality experience for patients' acute pain and anxiety which occurs during the pain interventions. so the investigators like to evaluate the effects of virtual reality experience on acute pain and anxiety precipitated by the pain interventions.

Eligibility criteria:
inclusion criteria: if all of the following conditions are met : * patient who has chronic pain lasting more than 3 months and whose pain doctor determined that he or she needs following fluoroscopic pain intervention : lumbar sympathetic ganglion block (lsgb), fluoroscopic-guided pulsed radiofrequency ablation (prf), fluoroscopic-guided radiofrequency thermocoagulation (hrf) * adults who are at least 20 years of age * patients whose american society of anesthesiologists(asa) physical status is classified as 1 or 2. * a person who voluntarily agrees to participate in this clinical trial and has agreed in informed consent. exclusion criteria: if the subject falls under any of the following conditions : * patients who cannot have virtual reality experience due to hearing or visual impairment * if the patient has difficulty communicating due to lack of cognitive ability * patients that examiners deemed unsuitable for this trial

Keywords: virtual reality acute pain anxiety
treatment of intracranial hypertension of severe tramatic brain injured patients. physiopathologic effects of neuromuscular blocking agents

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Summary: severely brain injured patients are at high risk of intracranial hypertension. among medical treatments (sedatives), neuromuscular blocking agents (nmba) are recommended by french but not english speaking societies. effects of nmba are unknown. the present study is designed to compare the effects of nmba versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.

in case of intracranial hypertension, french neurocritical care society argue for the use of neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and craniectomy. english speaking societies don't sustain this approach. since then, the use of nmba remains controversial in case of intracranial hypertension and no study is available. we propose to study severely brain injured patients presenting with intracranial hypertension and treat them with cisatracurium besilate or placebo. our hypothesis is that neuromuscular blockade might act on several parameters: * hemodynamics * respiratory parameters, mechanical ventilation and blood gaz analysis * cerebral velocities * diminished o2 peripheral consumption * cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine we wish to assess changes in icp according to the above parameters in a controlled randomized non blinded fashion against placebo (nacl 0,9%).

Eligibility criteria:
inclusion criteria: * - age over 18 * mechanical ventilation and deep sedation * severe traumatic brain injury * intracranial hypertension (icp \> 20 mmhg during \> 15 minutes) * intracranial pressure monitoring * hemodynamically stable exclusion criteria: * - history of anaphylaxia with neuromuscular agents * hemodynamic instability * pregnant and/or breast feeding women

Keywords: icu deep sedation mechanical ventilation traumatic brain injury intracranial hypertension cisatracurium neuromuscular blocking agent randomization versus placebo
gait control in parkinson disease

Conditions: Parkinson Disease

Summary: previous work has shown that a statistical property of gait characterised by long-range autocorrelation functions is altered in parkinson disease (pd). on the other hand it has been suggested that the same property is linked to the ability in healthy humans to co-regulate the amplitude and cadence of strides towards maintaining a constant speed. here the investigators want to better understand why it is altered in pd by measuring the transitions between gait instructed by a metronome, and gait without metronome. the experimental conditions will allow the comparisons between these transitions across pd and healthy groups of volunteers, and assess differences based on statistical and computational modelling. the link with potential freezing episodes will also be studied to assess whether the statistical determinants of gait control in this population can be used as a proxy or predictor of the occurence of freezing episodes.


Eligibility criteria:
inclusion criteria: * patients and volunteers able to walk for 20mins and without other neurological disorders. exclusion criteria: * patients or volunteers unable to walk for 20mins and with other neurological disorders.
aspirin discontinuation in high-risk pregnant women of preeclampsia

Conditions: Preeclampsia; Perinatal Haemorrhage

Summary: low-dose aspirin (lda) is considered to be the most effective agent to prevent preeclampsia (pe). at present, there is little exploration about the timing of aspirin discontinuation. most international guidelines default until 36 weeks of gestation or delivery. china guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. according to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing pe, the significance of aspirin use after 28 weeks of gestation is debatable. if aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm pe, it will not only reduce the risk of perinatal haemorrhage but also save medical expenses.

this study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm pe is not inferior to 36 weeks of gestation. we will include pregnant women with normal nt scan who meet at least one high-risk factor or at least two medium-risk factors. during 12-16 weeks of gestation, the mean arterial pressure (map) and placental growth factor (plgf) are measured, then initiating aspirin 100mg qn. at 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sflt-1 and plgf were detected at the same time. the experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. the incidence of preterm pe in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.

Eligibility criteria:
inclusion criteria: 1. at \<16 weeks of gestation, normal nt scan 2. at least 1 high risk factor or at least 2 moderate risk factors 3. intend to receive prenatal examination and deliver in this institution 4. signed a written informed consent for participation in the study exclusion criteria: 1. aspirin initiated after 16 week 2. intolerant or allergic to aspirin 3. aspirin adherence was \<80% 4. miscarriage or termination of pregnancy before randomization 5. drop out (do not return to the hospital for delivery). 6. lost to follow-up

Keywords: low dose aspirin prevention preeclampsia pregnancy outcomes randomized controlled trial aspirin discontinuation
an expanded access study of pegasys (peginterferon alfa-2a) in patients with hbeag-negative chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this is an expanded access programme to make pegasys (peginterferon alfa-2a) available to patients with hbeag-negative chronic hepatitis b in morocco. patients will receive pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 and \</= 70 years of age * hbeag-negative chronic hepatitis b * hbsag-positive for at least 6 months, anti- hepatitis b (hbs) negative * serum alanine transaminase (alt) \> 2 uln (upper limit of normal) but \</= 10 x upper limit of normal (uln) * hepatitis b virus (hbv) dna \> 10'000 copies/ml (roche monitor or taqman) * no previous treatment with interferon (standard or pegylated) or with a nucleoside analogue * women of childbearing potential must agree to use reliable contraception during the study and for 3 months after treatment completion exclusion criteria: * previous antiviral interferon-based therapy for chronic hepatitis b * pregnant and lactating women * evidence of decompensated liver disease * co-infection with active hepatitis a, hepatitis c, hepatitis d and/or human immunodeficiency virus (hiv) * history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis * previous or current hepatocellular carcinoma * history or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease * inadequate hematologic or renal function * serum bilirubin level \> 2 times the upper limit of normal * severe psychiatric disease * history of severe seizure disorder or current anticonvulsant use * history of evidence of any disease or condition which would make the patient, in the opinion of the investigator, unsuitable for the study * evidence of drug abuse within one year of study entry * alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks per day for women (1 standard drink contains 10 g of alcohol) * participation in another trial or receipt of an investigational drug within 12 weeks prior to screening
a study of mk0431 in patients with type 2 diabetes (0431-010)

Conditions: Diabetes Mellitus, Type II

Summary: a dose-ranging study of mk0431 in patients with type 2 diabetes who have inadequate control of their blood sugar.


Eligibility criteria:
inclusion criteria: * age 21 to 70, you are a man or non-pregnant woman exclusion criteria: * have a history of type i diabetes * you are on a weight loss program with ongoing weight loss or taking weight loss medications * you have a history of minor surgery * you have received investigational drugs within 8 weeks of study start * you have hepatitis b or c
effects of music and conversation in prostate biopsy

Conditions: Prostate Neoplasms; Prostate Biopsy

Summary: the goal of this observational study is to learn about the effects of music and conversation on pain and anxiety levels during transrectal ultrasound-guided prostate biopsy. the main question it aims to answer is: does music or conversation reduces the pain and anxiety levels of patients

the patients who were scheduled to undergo trus-pbx were randomly assigned to one of three groups (n=30) via sealed envelope randomization method: the control group, the music group, and the conversation group. patients' sociodemographic data such as age, height, weight and body mass index were documented. the international prostate symptom score (ipss), psa level and prostate volume of all patients was recorded before the procedure. blood pressure and heart rate were checked before and after the procedure. patients completed the state-trait anxiety inventory (stai) test, which consists of 40 questions, with 20 questions each in the state and trait subscales, both before and after the procedure. low scores indicated low anxiety levels, while high scores reflected higher anxiety levels. also, anxiety and pain levels were assessed using a visual analog scale (vas). the procedure room was designed to minimize external disturbances (e.g., sound or noise). prior to the biopsy, patients received detailed information according to their assigned group. in the music group, patient-selected music was played throughout the procedure. in the conversation group, discussions based on the patients' interests were initiated and continued during the procedure. in the control group, no additional interaction beyond the informational briefing was provided. post-procedure, patients were asked whether they would be willing to undergo the procedure again if necessary. responses were categorized as "positive," "negative," or "abstained."

Eligibility criteria:
inclusion criteria: * pathological findings on digital rectal examination * psa value greater than 2.5 ng/ml exclusion criteria: * psychiatric disorders, * those who declined to participate, * hearing or perceptual impairments, * continuous analgesic use, * history of prior prostate biopsy, * prilocaine allergy were excluded.

Keywords: prostate biopsy music conversation anxiety pain
grip&health: behavioural intervention to reduce smoking, stress and improve financial health in low-ses in rotterdam

Conditions: Smoking Cessation; Smoking, Cigarette; Smoking; Stress; Stress, Psychological; Health Behavior; Smoking, Tobacco

Summary: grip\&health: randomised trial which will examine the effect of theory-based multicomponent behavioural intervention for reducing stress, smoking and improving financial health and perceived health of low-ses residents in rotterdam. between january 2018 and july 2018, a total of 300 participants will be recruited and randomised either to a stress management program (sm), stress management with a buddy program (sm-b) or a control condition. the investigators hypothesise that compared to participants in the control condition, participants in the intervention arms will demonstrate reduced stress, reduced smoking and improved financial health and perceived health.


Eligibility criteria:
inclusion criteria: * perceive stress * smoke * poor financial health exclusion criteria: * follow other stress management course * follow smoking cessation course * receive help from debt services for their financial problems * have health problems which hamper their ability to take part in the study

Keywords: stress management stress intervention smoking intervention lower ses lower income
comparison of high-flow oxygen vs. bipap in type ii (hypercapnic) respiratory failure

Conditions: Respiratory Failure; Respiratory Insufficiency; Respiratory Tract Diseases; COPD; COPD Exacerbation; Pneumonia; Chronic Obstructive Pulmonary Disease

Summary: a retrospective cohort study of all patients treated for type ii (hypercapnic) respiratory failure with either high-flow oxygen therapy or non-invasive ventilation in a general adult hospital.

we will compare various clinically relevant outcomes in patients treated for type ii (hypercapnic) acute respiratory failure (arf) with either high-flow nasal cannula (hfnc) or non-invasive ventilation (niv) in a general adult hospital. all patients treated with hfnc were treated with an optiflow device (fisher\&paykel). various bilevel positive airway pressure (bipap) devices were used during the study period. all ventilatory parameters were set according to the treating physicians' preferences.

Eligibility criteria:
inclusion criteria: * all patients treated with respiratory failure not responding to conventional supplemental oxygen therapy * blood venous gas showing partial pressure of carbon dioxide\>50 mmhg before beginning therapy with either niv or hfnc exclusion criteria: * lack of records of the primary outcome * end-of-life care * lack of gas before the beginning of niv or hfnc

Keywords: non invasive ventilation bipap high-flow oxygen therapy high-flow nasal cannula copd hypercapnia hypercapnic respiratory failure chronic obstructive pulmonary disease
microarray analysis of ifn-induced gene expression in obese and non-obese patients with chronic hepatitis c

Conditions: Chronic Hepatitis C; Obesity

Summary: the response rate to interferon-based anti-viral therapy for chronic hepatitis c is lower in patients who are obese. however, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. alterated immune response had been reported in obese patients. the goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis c in an tissue culture system.

to examine our hypothesis, we will incubate pbmc samples from obese and nonobese patients with ifn, followed by microarray analysis to compare the ifn response patterns in both groups of patients and to identify genes differentially regulated between these two groups. identification of such genes will provide important insight to the mechanism of the antiviral effect of hcv. the identified genes will have the potential of serving as targets for pharmaceutical intervention aiming at enhancing the efficacy of ifn therapy for obese patients. this is an open-label study. ten obese and 10 nonobese patients with chronic hepatitis c will be recruited. for the purpose of this study, obese is defined as body weight \>85 kg and bmi \>30, and nonobese as body weight \<75 kg and bmi\<25.

Eligibility criteria:
inclusion criteria: * obese (weight \> 85kg and bmi\>30) or non-obese patients (\<75kg and bmi \<25) with chronic hepatitis c * chronic hepatitis c infection with documented hcv rna * body habitat either as obese or non-obese as defined above * currently not under ifn therapy * non-african american exclusion criteria: * body habitat neither obese or non-obese as defined for the purpose of this study * unable to give consent * on immunomodulatory agents such as prednisone * active infection other than hepatitis c * co-infection with hbv or hiv * active or excessive alcohol use * other cause of chronic hepatitis

Keywords: microarray analysis obesity chronic hepatitis c
peripheral optics in myopia and orthokeratology

Conditions: Myopia

Summary: the primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. the central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. the aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Eligibility criteria:
inclusion criteria: * myopia (refractive sphere): \> 0.50d and ≤ 6.00d * astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50d; astigmatism of other axes ≤ 0.50d * spherical equivalent (se): \> 0.50d and ≤ 6.75d (myopia) * best corrected monocular visual acuity: equal to or better than 6/7.5 in snellen scale * willingness to wear contact lenses or spectacles on a daily basis * availability for follow-up for at least 2 years exclusion criteria: * strabismus at distance or near * contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex) * prior experience with the use of rigid lenses (including orthokeratology) * prior experience with myopic control treatment (e.g. refractive therapy or progressive spectacles) * systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication) * systemic or ocular conditions which may affect refractive development (e.g. down syndrome, ptosis)

Keywords: children peripheral refraction aberration eyeball length myopic control myopia corneal reshaping orthokeratology
zenith alpha for aneurysm repair

Conditions: Aneurysm

Summary: to prospectively collect 'real world' performance data on the zenith alphatm abdominal endovascular graft for endovascular aneurysm repair, inside and outside instructions for use. to assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (aaa), to assess the use of the new delivery and deployment system of the zenith alphatm abdominal endovascular graft. primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

the zephyr registry has two major objectives: 1. to prospectively collect 'real world' safety, durability and clinical performance data on the zenith alphatm abdominal endovascular graft in subjects with infrarenal abdominal aortic or aorto-iliac aneurysms. 2. to increase the clinical evidence about the safety and effectiveness of the zenith alphatm abdominal endovascular graft by creating a database that can be pooled and/or compared with databases available on this and other stent graft systems. the zephyr registry is a multi-center, post-market, non-randomized, single-arm prospective study. the study has no controls, as it is descriptive in nature. it will recruit approximately 450 subjects from high-volume sites across germany and the benelux. study is open to consecutively enrolled subjects (20-50 per site) whou in the opinion of the investigator are candidates for endovascular aaa repair. the sites are recommended to schedule the subject's post-operative follow-up visits based on the current standard care in endovascular aneurysm repair (evar) therapy, which is generally at 1 month, 1 year and annually thereafter.

Eligibility criteria:
inclusion criteria: * age ≥18 years or minimum age as required by local regulations * non-ruptured aaa with maximum diameter ≥50mm or enlargement \>5mm over 6 months and neck length ≥10mm (site-reported) * elective evar * intention to electively implant the zenith alphatm aaa endovascular graft * signed informed consent form exclusion criteria: * intolerance to contrast media * high probability of non-adherence to physician's follow-up requirements * current participation in a concurrent trial which may confound study results
study of acamprosate to prevent alcohol relapse in criminal justice supervisees

Conditions: Alcohol Dependence

Summary: the purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

acamprosate has been an available treatment for alcohol dependence outside the united states and has recently been approved by the u.s. food and drug administration as an effective therapy for alcohol dependence. in the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. these programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. however, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole. comparison: alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Eligibility criteria:
inclusion criteria: * history of alcohol dependence in the year before entering criminal justice supervision * currently under criminal justice supervision (drug court, probation, or parole) in central virginia exclusion criteria: * pregnant or nursing a baby * known sensitivity to acamprosate * elevated serum creatinine level or other evidence of kidney problems * symptoms of severe depression or suicidal ideation * non-english speaking such that they cannot provide informed consent * cognitive impairment such that they cannot provide informed consent

Keywords: alcohol dependence acamprosate(drug) drug court probation parole criminal justice