Kornimate/medical-research-clean huggingface dataset:
sleep and circadian mechanisms in hypertension

Conditions: Hypertension; Cardiovascular Diseases; Cardiovascular Risk Factors; Circadian Rhythms; Sleep

Summary: this study is a mechanistic clinical trial designed to investigate the effects of the circadian system and sleep on non-dipping blood pressure (bp) in people with hypertension (htn).

this study is a mechanistic clinical trial designed to study the effects of the circadian system and sleep on non-dipping blood pressure (bp) in people with hypertension (htn). investigators will study participants with dipping and non-dipping hypertension. all participants will partake in all experiments. first, investigators will assess sleep in the participants' home environment using unattended polysomnography. participants will then complete a 5-day overnight forced desynchrony laboratory protocol to uncover circadian rhythms (constant routine). the second experiment is a randomized crossover protocol. two trials (overnight sleep and rested wakefulness) will be completed in randomized order to separate the effects of sleep on non-dipping blood pressure while assessing nighttime cardiovascular mechanisms. finally, investigators will pilot test if 2 weeks of sleep regularization impacts 24-hour bp.

Eligibility criteria:
inclusion criteria: * ages 25-64 * bmi 18.5-42kg/m2 * hypertension (average resting blood pressure between 130/80 mmhg and 160/100 mmhg) exclusion criteria: * over 5 pack-years of smoking; * prior shift work within 12 months prior to the study; * travel greater than three time zones for at least 3 months; * history of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction; * acute or chronic diseases (except hypertension) that may affect outcome measures; * history of psychological conditions; * sleep disorders, like severe sleep apnea, insomnia, etc.; * prescription medications (contraceptives and anti-hypertensive medications are permissible); * history of illicit drug use and alcohol dependency; * 30 days free of cannabis use prior to the study; * pregnancy; * upper cut-off of 160/100 mmhg for bp

Keywords: cardiovascular circadian rhythms sleep blood pressure constant routine microneurography hypertension sleep regularization
lowlands saves lives: a randomized trial comparing cpr-quality between face-to-face vs. lifesaver vr training

Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Out-Of-Hospital Cardiac Arrest

Summary: the objective of the lowlands saves lives trial is to compare the quality of cardiopulmonary resuscitation (cpr) between face-to-face versus lifesaver virtual reality smartphone application trained participants using a randomized controlled trial.

in order to optimize survival after out-of-hospital cardiac arrest, basic life support (bls) training of lay-person volunteers is essential. face-to-face training has long been considered the standard, but new training-methods have emerged, of which the lifesaver vr (developed by the uk resuscitation council) app seems promising. it is unknown which training method results in the highest quality of cardiopulmonary resuscitation (cpr). therefore, we conduct this randomized controlled trial in which subjects will be randomized to either one of the two training methods. following the training, all participants will undergo cpr-quality testing using certified manikins and blinded assessors. the present study will be conducted during lowlands science, a section of the lowlands music festival exclusively dedicated to science. lowlands will be held on august 16-18 of 2019 and over 50.000 attendees are expected.

Eligibility criteria:
inclusion criteria: * adult (≥18 years). * provide informed consent. exclusion criteria: * alcohol level \>0.5‰ and not able to perform tandem gait test. * for any reason not being able to partake in the face-to-face or vr-app training (e.g. clear alcohol or drugs intoxication). * for any reason not being able to perform the cpr test on the cpr-manikin (e.g. clear alcohol or drugs intoxication).

Keywords: cardiopulmonary resuscitation (cpr) basic life support (bls) virtual reality (vr) education lay-person training
inhibitory rtms in dystonic wilson patients

Conditions: Wilson Disease; Movement Disorders; Repetitive Transcranial Magnetic Stimulation

Summary: wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and eye. the neurologic complications include dystonic syndrome, which is a prolonged and excessive muscle activation responsible for abnormal postures. hand dystonia prevents daily life activities such as writing, which is particularly disabling, since writing is the only mean of communication in these patients with significant slurred speech. treatment is limited and only partially effective. low frequency (\<or=1hz) repetitive transcranial magnetic stimulation (rtms) has shown inhibiting properties when applied over the cortex. since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (ssc), we hypothesize that one single 20-minute session of 1 hz rtms applied on left ssc will improve writing of the right dystonic hand, assessed immediately at the end of the session.

this study investigates the handwriting performance of an homogeneous cohort of patients with wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial magnetic stimulation (rtms). fifteen patients with focal right hand dystonia will receive randomly either active or sham rtms (1 hz) to the left somatosensory cortex (ssc) in one single 20 minutes session. handwriting performance will be measured immediately after this unique session (visual analogic scale of subjective discomfort in writing, dpre and wcrs scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24 hours before the session. three days later, the patient will receive the other session (sham rtms or active rtms) and the same parameters will be evaluated. this is a single-center, randomized, crossover, prospective, clinical and double-blind study (the rtms session is performed by the neurophysiologist, but the patient and the neurologist who will perform the handwriting evaluation are blind to the session).

Eligibility criteria:
inclusion criteria: * wilson disease with focal right hand dystonia * no modification of medical treatment for 6 months * no botulinum toxin administration within the past four months * right handed * focal right hand dystonia * cerebral magnetic resonance performed the last 6 months with no other lesion than met in wilson disease * over 18 * insurance policy holder * informed consent exclusion criteria: * pregnant woman * guardianship procedure * seizure history * other cerebral lesions on cerebral mri than met in wilson disease * unable to stay quiet for 30 minutes * handwriting impossible * contra-indications to repetitive transcranial magnetic stimulation

Keywords: wilson disease dystonia movement disorders handwriting repetitive transcranial magnetic stimulation
impact of heart rate characteristics monitoring in neonates

Conditions: Sepsis

Summary: hypothesis: fewer neonates managed using information from heart rate characteristics (hrc) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness. infants will be randomly assigned to one of two groups. one group of infants will have the hrc index known to the physicians caring for them, and physicians will use the hrc index as they desire to aid in clinical management. infants in the other group will have the hrc index recorded, but this information will not be displayed to the physicians caring for the infants.

following randomization, infants will be managed as usual practice. the treating physicians of the hrc-display group will be able to utilize the hrc score to assist in the care of the infant. the physicians of the no-display group will provide care as per standard. clinical symptoms will be treated according to the medical discretion of each physician. cultures will be obtained and antibiotics administered as per the medical discretion of the physicians. clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their hrc score calculated by the hero heart rate characteristics monitor.

Eligibility criteria:
inclusion criteria: * infants admitted to nicu * birth weight \< 1500 grams * gestational age \< or = 32 weeks * informed consent obtained from parent exclusion criteria: * evidence of sustained cardiac arrhythmia * use of an electronic pacemaker

Keywords: very low birth weight infants heart rate characteristics
shandong cancer hospital affiliated to shandong university

Conditions: Early-stage Breast Cancer; Breast Conserving Surgery

Summary: in this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (wbi 2.5gy x18 and sib 2.88gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(wbi 1.8gy x28 and sib 2.15gy x28). all radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. the outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.


Eligibility criteria:
inclusion criteria: 1. female patients has had breast conserving surgery 2. age ≥ 18 and ≤ 65 years 3. with a histological diagnosis of invasive carcinoma of the breast 4. with pathological stage of t1-2n0-1m0 5. multidisciplinary decision of adjuvant wbi with a boost to the tumor bed 6. informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: 1. patients treated with mastectomy 2. need for lymph node irradiation 3. positive or close(≤ 1 mm) surgical margin 4. treated with neoadjuvant chemotherapy before surgery 5. bilateral malignancy of the breast (synchronous or metachronous) 6. pregnant or breastfeeding 7. mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 8. patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
a safety and efficacy study of drm02 in subjects with plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to determine whether drm02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.

this is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis and designed to assess the safety, tolerability, and preliminary efficacy of drm02. safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs. preliminary efficacy will be assessed through the physician's lesion assessment (pla) and the severity of psoriasis area severity index (pasi) from only the two plaques identified at the baseline visit.

Eligibility criteria:
inclusion criteria: * male or female 18 to 70 years of age. * plaque-type psoriasis with two lesions of similar size and have an identical score of at least 6 but no more than 8 on the sum of the individual components of the severity of psoriasis area severity index (pasi) at the target lesion scale. * male or non-pregnant, non-lactating females. * signed informed consent. exclusion criteria: * subjects who have extensive, and/or 'inverse', and/or exfoliative psoriasis. * subjects who have taken any systemic treatment for psoriasis within the 4 weeks prior to baseline. * prior or concomitant use of topical treatments for psoriasis to within 10 cm of the target lesion within the 4 weeks prior to baseline. * use of enbrel within the 4 weeks prior to baseline. * psoralen \& ultraviolet a therapy (puva) or the use of ultraviolet b (uvb) therapy and/or excessive or prolonged exposure to ultraviolet light within the 4 weeks prior to baseline. * use of humira or remicade within the 3 months prior to baseline. * use of stelara within the 6 months prior to baseline. * subjects who have taken oral retinoids for psoriasis within the 6 months prior to baseline. * subjects who have poor skin condition within 5 cm of the target lesion. * subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease or are a poor medical risk because of other systemic diseases or active uncontrolled infections. * subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy. * subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days * subjects who have a clinically significant laboratory value at screening.
effects of a pufa-rich diet on acute metabolic and inflammatory high-fat meal responses

Conditions: Inflammation; Obesity

Summary: this study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50% carbohydrate, 35% fat, and 15% protein. only, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.) for 7 days.

eating more saturated fats has been shown to decrease how many calories an individual burns and increase chronic disease risk by increasing inflammation, coagulation (blood clotting) potential, blood pressure, and cholesterol. conversely, eating more poly-unsaturated fats has been linked to decreased risk of chronic diseases. the goal of this study is to determine whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the damaging effects of eating occasional high-fat meals that are high in saturated fats. those damaging effects we are interested in studying include how much fat and calories a person's body burns, and measuring some markers of chronic disease risk in the blood (inflammation markers and blood clotting markers).

Eligibility criteria:
inclusion criteria: * apparently healthy men and women between the ages of 18 and 45y with a normal weight based on body mass index (bmi=18-24.9kg/m2), must be sedentary (perform less than 3 hours per week of structured exercise) and , if participant has fasting total cholesterol \>200 gm/dl, high-density lipoprotein \ 100 mg/dl, and/or triglycerides \>150 mg/dl (based on fasting blood lipids). exclusion criteria: * weight loss or gain exceeding 5% of body weight in the past 3 months * current participation in a weight loss program * any current exercisers (greater than 3h per week) * any person who is on a medically prescribed diet * any person who is vegan, or any type of vegetarian other than pesco-vegetarian * any chronic or metabolic disease, hyperlipidemia, gastrointestinal disorder, or history of medical or surgical events that could affect digestion and absorption of nutrients * any current supplement use other than a daily multivitamin (this includes fish oil supplements) * any current medication use other than birth control (this includes anti-inflammatory nsaid use). * anyone who is pregnant, lactating, or planning a pregnancy * anyone who has donated blood or plasma in the last 20 days * any tobacco users * anyone who has allergies to the most common food allergens (milk, eggs, peanuts, almonds, cashews, walnuts, fish, shellfish, soy and wheat) or to any of the food that will provided during the study * anyone who has allergies to any of the components of the liquid meals
cardiac stunning after electrical cardioversion

Conditions: Atrial Fibrillation (AF)

Summary: the goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ecg conducted immediately following electrical cardioversion. the main question it aims to answer is: do echocardiographic and electrocardiographic parameters relating to cardiac stunning predict atrial fibrillation (af) recurrence rates after electrical cardioversion? participants will undergo echocardiography and a 24-hour holter monitoring immediately after electrical cardioversion.


Eligibility criteria:
inclusion criteria: * patients with atrial fibrillation * patients with persistent or symptomatic atrial fibrillation who are candidates for electrical cardioversion * patients eligible for anticoagulation therapy for thromboembolism prevention before and after the procedure * patients who can understand and provide written informed consent exclusion criteria: * patients under 18 years of age or over 80 years of age * patients who do not consent to participate in the study * patients with severe coronary artery stenosis * patients with severe hepatic dysfunction * patients with severe renal dysfunction * patients with severe valvular heart disease * patients with a high risk of severe bleeding * patients with a history of atrial fibrillation-related catheter ablation or cardiac surgery * patients with an expected life expectancy of less than 1 year * potentially pregnant individuals * patients deemed unsuitable for the study by the investigator
pro-calcitonin for early detection of septic arthritis

Conditions: Arthritis, Infectious

Summary: background: children presenting with non-traumatic joint pain require different treatment depending on the cause of pain. septic arthritis, which results from a bacterial infection in the joint, often requires a surgical procedure as well as a long course of antibiotics. in contrast, non-septic arthritis is typically treated by management of symptoms and observation. current diagnostic standards involve microbiologic examination of fluid taken from the affected joint. this procedure can require the patient to be sedated, and the fluid culture analysis can take up to 72 hours. a single laboratory measure that could be easily obtained and quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the diagnostic work-up for this condition. recent research on septic arthritis has identified procalcitonin as a potential septic arthritis diagnostic indicator. procalcitonin (pct) is secreted by cells in the thyroid at higher levels when the body is facing infection. procalcitonin levels rise slowly over the first two hours and peak at 24 hours. levels rise 100-fold in the peripheral blood stream during this time frame. several studies have indicated pct is promising potential diagnostic indicator for septic arthritis. unfortunately, many of these studies have relatively small sample sizes and very few involve pediatric populations. additional study of pct and septic arthritis in children will help evaluate the viability of pct as a diagnostic indicator. research question: can serum procalcitonin assist in clinical differentiation between bacterial (septic) and non-bacterial arthritis? methods: patients presenting with possible septic arthritis in the emergency department will be recruited for this study. patients who consent to participate will receive the current standard for care, including iv placement, laboratory tests for erythrocyte sedimentation rate (esr),white blood cell count (wbc), and c-reactive protein (crp), x-rays and consultation with pediatric orthopedics. patients participating in the study will have a portion of the serum collected for typical diagnostic tests analyzed for pct. research assistants will collect data from medical records of participants, including lab and imaging results. patients who do not undergo surgery will be contacted by phone within 7 days of their ed visit to confirm diagnosis.


Eligibility criteria:
inclusion criteria: 1. are 0 - 16 years of age (inclusive) 2. have a painful, swollen, monoarticular joint 3. are suspected of having a septic joint 4. are able to provide assent and parents provide informed consent exclusion criteria: 1. have reached anatomical maturity indicated by a closed physis in the joint of interest 2. have neuromuscular and/or metabolic disease 3. have a chromosomal disorder affecting chromosome 11 in the region of the calc-1 gene 4. have received antibiotics within 7 days of the ed visit 5. are immune deficient 6. have had surgery in within the last 7 days

Keywords: arthritis, septic
a comparison of mnt-bbavf and bcavf in hemodialysis patients

Conditions: Vascular Fistula

Summary: a well-functioning vascular access is essential for effective hemodialysis. the native arteriovenous fistula (avf) is the preferred vascular access because of the lower thrombosis and infection risks compared to either synthetic arteriovenous grafts or central venous catheters. brachiocephalic arteriovenous fistula (bcavf) and transposed brachiobasilic arteriovenous fistula (t-bbavf) are recommended when there is either a primary failure or no suitable vessels for the forearm fistula. however, bcavf is frequently cannulated at the antecubital fossa, the risks of stenosis and thrombosis are high, which will compromise proper bcavf function and survival. t-bbavf is not only technically challenging, but also associates with severe arm swelling and pain. thus, the investigators introduced a novel modified non-transposed brachiobasilic arteriovenous fistula (mnt-bbavf) for long-term hemodialysis patients. to confirm its efficacy, a prospective clinical study would be carried out.

the study aims to compare the outcomes of a novel modified non-transposed brachiobasilic arteriovenous fistula (mnt-bbavf) and the standard brachiocephalic arteriovenous fistula (bcavf) for long-term hemodialysis patients. briefly, in mnt-bbavf, a side-to-side anastomosis between the brachial artery and non-transposed proximal basilic vein is disposed, followed by the ligation of the vein above anastomosis. all the perforating in the surgical field should be ligated. all patients will be followed up for 12 months after surgeries. the outcomes includes: hemodynamic parameters (vessels's diameters, blood flow velocities and blood volumes) detected by ultrasound in 12 months, complications in 1-month and 12-month, primary patency and secondary patency (cumulative patency).

Eligibility criteria:
inclusion criteria: * age from 18 to 75 years; * radial artery diameter \<2.0 mm or cephalic vein diameter in the forearm \<2.5 mm; * brachial artery diameter ≥ 2 mm exclusion criteria: * stenosis or thrombosis present in the draining vein; * a history of peripheral ischemia in upper extremities; * active local or systemic infections; * inability to consent for the procedure; * patients with previous dysfunctional forearm fistula.

Keywords: hemodialysis vascular access