Kornimate/medical-research-clean huggingface dataset:
postoperative pain in scheduled craniotomy

Conditions: Pain, Postoperative; Craniotomy; Adverse Effect; Anxiety

Summary: postoperative pain after craniotomy is frequent, with moderate-severe intensity. the fear to the side effects of opioids (nausea and vomiting and sedation), and nsaids (bleeding) makes it difficult to obtain adequate analgesic control in these patients. preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. in this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.

postoperative pain after craniotomy is frequent, with moderate-severe intensity. the fear to the side effects of opioids (nausea and vomiting and sedation), and nsaids (bleeding) makes it difficult to obtain adequate analgesic control in these patients. on the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. the main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain

Eligibility criteria:
inclusion criteria: * patients over 18 years old undergoing scheduled form for supratentorial craniotomy. * signed informed consent. exclusion criteria: * mini mental state examination with a score less than or equal to 24 points. * patients suffering from disabilities. * patients who can not collaborate in the postoperative clinical assessment. * patients who can not be assessed during the postoperative period by the acute pain unit.

Keywords: postoperative pain neurosurgery craniotomy anxiety
reaching rural cancer survivors who smoke using text-based program

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this phase iii trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

primary objectives: i. to evaluate the efficacy of an eight-week text-based scheduled gradual reduction (sgr) intervention (a personalized eight-week reduction schedule paired with national cancer institute's \[nci's\] smokefree.txt) compared to a control intervention (nci clearing the air cessation booklet) on biochemically-validated smoking cessation six-month post-quit date in rural cancer survivors. secondary objective: i. compare the efficacy of the eight-week text-based sgr intervention and a control intervention on linear analog self-assessment (lasa)-6 overall quality of life (qol) at 30-days post-quit date and six-months post-quit date. outline: patients are randomized to 1 of 2 groups. group i: patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. patients also receive cessation support messages via text messages for 12 weeks. group ii: patients receive nci's clearing the air booklet to help plan to gradually quit smoking. after completion of study, patients are followed up at 6 months.

Eligibility criteria:
inclusion criteria: * have a cancer diagnosis within the past 10 years, and can currently be receiving curative treatment * not currently on hospice * currently smokes \>= 5 cigarettes daily * lives in a nonmetro/rural county (defined as having a rural urban continuum code \[rucc\] code of 4-9) * patient interested in participating in a smoking cessation program, and not currently participating in a smoking cessation clinical trial * not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program * patient has a cell phone or smart phone device with texting ability * in order to complete the mandatory patient-completed measures, participants must be able to speak and read english * age \>= 18 years * participant must be willing to provide a urine sample. exclusion criteria: * psychiatric illness which would prevent the patient from giving informed consent * patients with impaired decision-making capacity are not eligible for this study.
feasibility of unattended home polysomnography and comparison to in-laboratory polysomnography in pediatric patients

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of the study is: 1) to assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (ahi), average spo2, and spo2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.

the purpose of the study proposed is twofold. first investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the clevemed sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. second, investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the st. louis children's hospital pediatric sleep center. these comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the washington university pediatric otolaryngology department. investigators will obtain the medical history and medications and results of the sleep study done at slch sleep lab from the medical record for research purposes.

Eligibility criteria:
inclusion criteria: * 5- to 12-years-old * parental informed consent * suspected sleep disordered breathing exclusion criteria: * developmental delay * use of home oxygen * history of parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) * history of tracheal surgery * history of tracheal stenosis * history of nocturnal hypoventilation * history of central sleep apnea * use of a ventilatory assist device (e.g. non-invasive positive pressure ventilation)

Keywords: childhood osa
retrospective data collection study in patients receiving two or more ozurdex® injections for macular oedema secondary to retinal vein occlusion

Conditions: Retinal Vein Occlusion; Macular Oedema

Summary: the purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of ozurdex® in the treatment of macular oedema due to retinal vein occlusion (rvo) in patients who received ozurdex® as part of the belgium medical needs program.


Eligibility criteria:
inclusion criteria: * macular oedema in at least one eye due to branch retinal vein occlusion (brvo) or central retinal vein occlusion (crvo) * received at least two ozurdex® injections in the study eye as part of the belgium medical needs program exclusion criteria: * none
infants with protein sensitive colitis

Conditions: Protein Sensitive Colitis

Summary: infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.


Eligibility criteria:
inclusion criteria: * less than or equal to 6 months of age * 36-42 weeks gestational age at birth * singleton or twin birth * diagnosed with protein sensitive colitis * negative stool culture at time of study entry * no previous history of consuming free amino acid-based medical food * not receiving cisapride or steroids * no vitamin mineral supplement administration during the study period with the exception of iron or fluoride * no milk or soy products for the duration of the study
exercise intensity and video games: persons post-stroke

Conditions: Stroke

Summary: persons post stroke executed stepping activities under four conditions: standard of care, interacting with: an off-the-shelf microsoft-kinect game, with a self-paced repeated custom video game and a game-paced random custom video game. exercise intensity (neuromuscular and cardiovascular), enjoyment and perceived effort were measured during and after each condition.

persons post stroke were first familiarized with the four exercise conditions and then instrumented with a metabolic system and heart rate sensor. they played the games in two counter balanced blocks: repeated (standard of care and self-paced repeated custom) and random (microsoft-kinect game and game-paced random custom). games were played for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. during exercise they reported exertion and at the end of teach exercise trial they completed an enjoyment questionnaire. at the end of the first block, participants removed the metabolic system's mask and were assessed for motor recovery. performances were video taped. at the end of data collection preferences for the activities were ranked and participants answered open ended questions. data for neuromuscular and cardiovascular intensity, enjoyment and perceived effort were reduced and analyzed using a repeated measures analysis of variance (rmanova) with the appropriate post-hoc corrections. where possible clinically meaningful changes were calculated.

Eligibility criteria:
inclusion criteria: * men and women post-stroke at least six months t * able to ambulate 100 feet without physical assistance but allowed to use assistive devices and orthotics, * able to stand for 3 minutes. * cleared for exercise with the parq. exclusion criteria: 1. history of severe heart disease, heart attack, valve replacement or coronary artery bypass surgery, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than stroke 2. are unable to follow directions. 3. do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids 4. are unable to sign a consent form. 5. unstable medical condition or musculoskeletal disorder such as severe arthritis, knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to perform the required stepping for the games presented. 6. any other medical condition contraindications to exercise.

Keywords: active video games virtual reality exercise intensity parkinson disease
a study of the efficacy and safety of enclitide chloride (mk-0616 oral pcsk9 inhibitor) in adults with hypercholesterolemia (mk-0616-008)

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Summary: the purpose of this study is to evaluate the efficacy and safety of enclitide chloride, an oral pcsk9 inhibitor, in lowering low-density lipoprotein cholesterol (ldl-c) in participants with hypercholesterolemia. the primary hypothesis is that at least one of the four doses of enclitide chloride tested in this study is superior to placebo on percent change from baseline in ldl-c at week 8.


Eligibility criteria:
inclusion criteria: * history of clinical atherosclerotic cardiovascular disease (ascvd), or has an ascvd risk equivalent and/or a 10-year risk of having an ascvd event ≥5.0%, and has a corresponding ldl-c that falls within the protocol-specified range at screening. * treatment with a stable dose of one or more lipid-lowering therapies for ≥30 days before screening, or has not received treatment with any lipid-lowering therapy for ≥30 days before screening. * a female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (wocbp) or is a wocbp and agrees to follow contraceptive guidance during the intervention period and for at least 8 weeks after the last dose of study intervention. exclusion criteria: * history of homozygous familial hypercholesterolemia (fh) based on genetic or clinical criteria. * history of nephrotic syndrome. * history of unstable angina, a myocardial infarction, percutaneous transluminal coronary angioplasty, transient ischemic attack, or stroke within 3 months before screening. * has poorly controlled diabetes mellitus, defined as hemoglobin a1c (a1c) ≥9.0% at screening. * history of malignancy ≤3 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, which have no timeframe limitations relative to screening. * currently participating in or has previously participated in an interventional clinical study within 3 months before screening. * has moderate or greater renal insufficiency.
early response to interferon combined short-term nucleoside analogue therapy in hbeag(+) chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: for hbeag(+) patients, interferon is used for 12 weeks. on 12th week of treatment, if hbv dna is undetectable (\<1000 copies/ml), interferon is continued alone for one year. if hbv dna is still positive, nucleoside analogue is added for 3 months. after nucleoside analogue is added for 3 months, hbv dna is tested again. if negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. if hbv dna is still positive, change to another nucleoside analogue or add another nucleoside analogue.


Eligibility criteria:
inclusion criteria: * hbsag posive for 6 months * hbeag positive, and hbeab negative * hbv dna\>1.0×e5 copies/ml * alt\>80 u/l within 3 months exclusion criteria: * pregnant women * conbination infection of hcv, hav, or hev * conbination infection of hiv * any contraindication of interferon α
preservative-free tafluprost eye drops in newly diagnosed patients with glaucoma

Conditions: Glaucoma

Summary: glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss

saflutan® is the first preservative-free prostaglandin analog introduced to the egyptian market. it contains the pg analog tafluprost. better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.

Eligibility criteria:
inclusion criteria: * adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the ocular surface disease index (osdi) questionnaire, and able to provide informed consent form. exclusion criteria: * unable to provide informed consent form
hyper-synchronicity in hypertrophic cardiomyopathy (hcm) : description, mechanism and origin with a multi-imaging approach to predict dual chamber pacing response

Conditions: Hypertrophic Cardiomyopathy; Mechanical Hyper-synchronicity

Summary: hypertrophic cardiomyopathy (hcm) is a common genetic cardiovascular disease. outflow-tract gradient of 30 mmhg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death. the investigators hypothesize that the electrical approach by dual chamber pacing could improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected patients with a mechanical hyper-synchronicity. the aim of the study is to identify and describe this phenomenon in hcm with (o-hcm) and without (no-hcm) outflow-tract obstruction thanks to innovative multi-imaging approach.

the concept of physiological ventricular desynchrony was described recently with technics of myocardial deformation analysis applied in animal models. authors confirmed the existence of a time delay in the contraction of the apical walls before basal walls. in o-hcm, the outflow-tract obstruction could be explained by a mechanical hyper-synchronicity between apical and basal walls. this study aims to describe the possible hyper-synchronized contraction in o-hcm and no-hcm patients unlike the physiological desynchrony observed in healthy volunteers (hv) for this purpose, three imaging tests will be used at baseline: echocardiography (tee), magnetic resonance imaging (mri) with gadolinium enhancement only in hcm, and 3-dimensional electrocardiographic mapping (ecm) combined with computed tomography-scan. no follow-up is planned for this study.

Eligibility criteria:
inclusion criteria: * hcm: adults aged more than 18 years with sarcomeric hypertrophic cardiomyopathy under optimal medical therapy, isolated septal hypertrophy, sinus rhythm, exploitable acoustic window. for women of childbearing age, effective contraception and required negative pregnancy test. * o-hcm : outflow-tract gradient more than 30 mmhg at rest and during exercise * no-hcm : outflow-tract gradient less than 30 mmhg at rest and during exercise * hv: adults aged more than 18 years, without cardiovascular disease. for women of childbearing age, effective contraception and required negative pregnancy test. exclusion criteria: - hv: unusable acoustic window

Keywords: hypertrophic cardiomyopathy, hyper-synchronicity, outflow-tract obstruction, dual chamber pacing
assessments of dietary restrictions in young and elderly obese men : metabolism obesity nutrition age

Conditions: Obesity

Summary: the prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue. the major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. the mona study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.

primary endpoint : study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men. secondary endpoints : study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. all those endpoints are studied comparing elderly obese subjects versus young obese subjects.

Eligibility criteria:
inclusion criteria: * 30 \< years old \< 40 or 60 \< years old \< 70 * obesity : 30 \< bmi \< 40 * stable blood pressure (diastolic \<90mmhg, systolic \< 140mmhg) * glycemia \< 1,26g/l, ldl cholest \<1,9-1,6g/l, triglycerides \<2,5g/l * risk factors concerning high blood pressure, diabetes and dyslipidemia under control exclusion criteria: * insulin dependent diabetes, non-insulin dependent diabetes * high blood pressure * dyslipidemia * history of cardiovascular diseases or bariatric surgery * undernutrition * hba1c \>7% * non authorized treatments : glucagon-like peptide-1 agonists, * incapacity to do physical activity

Keywords: obesity dietary restrictions metabolism nutrition elderly
harmony study (hypertension analysis of stress reduction using mindfulness meditation and yoga)

Conditions: Hypertension

Summary: the purpose of this study is to determine if mindfulness based stress reduction (mbsr) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.


Eligibility criteria:
inclusion criteria: 1. age 20 to 75 years 2. hypertension by abpm at baseline (daytime \> 135/85 mmhg or 24-hour abpm \> 130/80 mmhg) exclusion criteria: 1. use of antihypertensive within 6 months of the screening abpm. 2. screening office bp \> 180/100 and abpm \> 160/100 mmhg. 3. diabetes 4. secondary hypertension 5. renal disease (gfr \< 60 ml/min or overt nephropathy) 6. history of heart attack 7. stroke or tia or 8. re-vascularization procedure. 9. active malignant disease (except non-melanoma skin cancer) 10. epileptic seizure 6 months before the screening visit. 11. congestive heart failure 12. severe liver disease 13. pregnancy or lactation period 14. participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit. 15. planned elective surgery during the study period except for cataract surgery

Keywords: mindfulness based stress reduction (mbsr) stress reduction hypertension high blood pressure ambulatory blood pressure monitoring
development and validation of microbiota and metabolite-based prediction model for recurrence of high-risk colorectal polyps after polypectomy

Conditions: Colorectal Polyp; Colorectal Cancer Recurrent; Colorectal Adenoma

Summary: the characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.


Eligibility criteria:
inclusion criteria: * patients aged 40-75 years who undergo the colonoscopy with at least 1 high-risk colorectal polyp exclusion criteria: * patient with severe physical diseases that prevented them from adhering to the examination requirements, * patient with coagulopathy or other contraindications for biopsy or polypectomy, * patient with previous surgical procedures on the gastrointestinal tract, * presence of colorectal cancer or other malignant tumor at baseline * presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or lynch syndrome) * within 1 month before enrollment, oral antibiotics and probiotics were taken; * inability to provide informed consent or refusal to participate in the study.