Kornimate/medical-research-clean huggingface dataset:
effects of nsk-sd (nattokinase) on blood pressure

Conditions: Hypertension

Summary: this is a randomized double-blinded placebo-controlled study to evaluate the effects of nsk-sd consumption in subjects with stage i hypertension. the study population will be randomized into two groups, where both groups will receive dietary and lifestyle recommendations to help reduce hypertension. one group will receive placebo and the other group nsk-sd for 8 weeks. the endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of treatment in the two subject groups.

previous randomized double blinded placebo-controlled studies on the consumption of the fibrinolytic enzyme nattokinase and nsk-sd is transported across the gut, and has shown multiple effects on vascular health, including fibrinolytic effects and regulation of blood pressure. a previous study on effects on blood pressure was conducted in an asian population involving 86 people, where 73 people completed the study requirements (39 in the nsk-sd group, 34 in the placebo group). the data showed statistically significant reduction in both systolic and diastolic blood pressure after consumption of nattokinase, whereas the changes after consuming placebo were not significantly different from baseline. the objective of this study is to evaluate the effects of consumption of nattokinase on hypertension in a north american hypertensive population with associated genetic, dietary, and lifestyle factors. this is in extension of, and contrast to, previous studies in asian populations.

Eligibility criteria:
inclusion criteria: * healthy adults of both genders; * age 18-85 years; * elevated blood pressure as identified by: * systolic blood pressure 130mmhg or higher, or diastolic blood pressure 90mmhg or higher; * confirmed on three separate occasions. exclusion criteria: * use of nattokinase-containing supplements within 60 days prior to enrollment; * currently on blood pressure medication; * history of cancer chemotherapy within the last 12 months; * significant active uncontrolled disease (such as lymphoma, cirrhosis, nephritis, uncompensated heart failure); * consumption of more than an average of 2 standard alcoholic drinks/day (14 drinks per week) * currently experiencing intense stressful events/ life changes that would negatively affect compliance; * pregnant, nursing, or trying to become pregnant; * women not using effective contraception; * food allergies related to ingredients in test product.
swiss itch registry

Conditions: Pruritus

Summary: this project is to develop a national registry for cp patients. patients admitted to this registry will be examined and documented with pros, physician-based assessments, blood tests, 3d photodocumentation and, if indicated, by skin biopsies, neurophysiological testing and radiological imaging at defined timepoints. the data collection will allow deepened insights into patient needs, different mechanisms and courses of pruritic conditions, treatment outcomes and treatment-related safety issues. in addition, the collection of clinical, biological and image-based data may be used for retrospective analyses.

pruritus (synonymous "itch") is the commonest skin-related symptom caused by numerous dermatological and non-dermatological conditions. chronic pruritus (cp) defined by a duration of \> 6 weeks is associated with significantly impaired quality of life and high socio-economic burden. at present, a data registry to monitor and compare clinical presentation, treatment outcomes and safety issues of these patients is lacking in switzerland. the implementation of the switchr could help to i.) improve medical care of cp patients, ii.) allow standardised comparison of different pruritic conditions as well as national data with international cp populations and iii.) raise the awareness for cp in general practitioners, health care institutions, national public health authorities and pharmaceutical companies within switzerland.

Eligibility criteria:
inclusion criteria: * age ≥ 14 years. * written informed consent of the patient. * diagnosis of cp irrespective of the international forum for the study of itch (ifsi) group (i-iii) and/or underlying cause (according to the judgment of the investigator). * a numerical rating scale (nrs) score of min. ≥ 4 within the last 7 days. * sufficient language skills (in the languages which the patient information and the consent form is available) to provide informed consent. exclusion criteria: * any medical or psychological condition in the treating physician's opinion, which may prevent the patient in registry participation * lack of informed consent for registry participation. * refusal to complete patient reported outcomes (pros)

Keywords: itch chronic pruritus (cp)
ambulatory electrocardiographic monitoring for the detection of high-degree atrio-ventricular block in patients with new-onset persistent left bundle branch block after transcatheter aortic valve implantation. the "mare" study

Conditions: Aortic Valve Disease; Conduction Disturbances

Summary: the purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (avb) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (nop-lbbb) following transcatheter aortic valve implantation (tavi) and to evaluate the usefulness of the reveal linq® insertable cardiac monitor (icm) (medtronic, inc., minneapolis, usa) for the detection of significant arrhythmias in patients with nop-lbbb following tavi.

this is a prospective observational study including patients undergoing tavi with either self- or balloon-expandable valves. after the procedure, patients will be on ecg monitoring during the hospitalization period (or at least 72 hours), and an ecg will be performed daily until hospital discharge in all patients. patients with new-onset persistent lbbb at hospital discharge (new-onset lbbb of a duration of at least 48 h which persists at hospital discharge, at least 3 days and up to 15 days after the procedure) will receive an implantable loop recorder reveal icm linq®, which will be implanted subcutaneously to record adequate qrs complexes and p waves. the patients will be followed in outpatient clinic visits at 1, 12, 24 and 36 months after tavr, or if symptoms suggestive of cardiac origin or relevant arrhythmic events occur. the device will be manually interrogated in each visit. phone contacts will be also carried out every three months.

Eligibility criteria:
inclusion criteria: -patients undergoing tavi with either balloon or self-expandable valves who develop new-onset lbbb persistent at hospital discharge, at least 3 days after the procedure exclusion criteria: * failure to provide informed consent * baseline pacemaker/defibrillator or pacemaker/defibrillator implanted during the hospitalization period following the tavi procedure * pre-existing complete lbbb * patients with a life-expectancy of less than 2 years
the efficacy of acupuncture in the management of postoperative pain in the pediatric intensive care unit

Conditions: Pain, Postoperative; Pediatric Disorder; Acupuncture; Acupuncture, Ear; Pediatric Intensive Care Unit

Summary: pain is an unpleasant sensory and emotional experience resulting from tissue damage. pain management is typically conducted according to the world health organization (who) pain management ladder. analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. the acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use. the study was conducted using a randomized controlled trial (rct) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the pediatric intensive care unit at cipto mangunkusumo hospital. subjects were divided into two groups: a control group and an experimental group. the control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the pediatric intensive care unit for 24 hours. pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the face, legs, activity, cry, and consolability (flacc) scale for children aged 1-8 years, and the numeric rating scale (nrs) for children over 8 years old. this study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.


Eligibility criteria:
inclusion criteria: * pediatric postoperative patients admitted to the pediatric intensive care unit at cipto mangunkusumo hospital * aged between 1 and 18 years * patients with a platelet count greater than 20,000/ml * patients undergoing elective surgery * willingness to participate in the study exclusion criteria: * patients with a local infection at the puncture site * patients with anatomical abnormalities of the outer ear * failure to complete the acupuncture therapy * patients with chronic illnesses who have previously received analgesic therapy

Keywords: acupuncture postoperative pain pediatric intensive care unit press needle pain therapy
timing personalized feedback after alcohol health education

Conditions: College Student Drinking

Summary: heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment. in a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (braitman \& henson, 2016). a second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline (braitman \& lau-barraco, 2018). although promising, the booster incorporated in the study needs further empirical refinement. the current project seeks to build on past progress by further developing and refining the booster. in particular, to identify the most efficacious timing for sending the feedback. the content will be similar across conditions, but will be disseminated at different times to identify the most impactful timeline. there will be 6 study conditions: those who receive the emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at all (control). thus, the aim of the current study is to identify optimal timing for sending the tailored booster feedback via booster email.


Eligibility criteria:
inclusion criteria: * current college students at the sponsor institution at the time of enrollment * between the ages of 18 and 24 * consumed at least standard drink of alcohol in the past 2 weeks exclusion criteria: * under age of 18 * over age of 24 * not a college student * did not drink alcohol in the past 2 weeks
directional preference exercises in comparison to motor control exercises in mechanical low back pain

Conditions: Low Back Pain, Mechanical

Summary: the purpose of this study is to determine the effects of directional preference exercises in comparison to motor control exercises in patients with mechanical low back pain


Eligibility criteria:
inclusion criteria: * both male \& female patients * age group 20-60 years * diagnosed with mechanical low back pain having pain aggravation in flexion bias exclusion criteria: * lumbar stenosis * cauda equina * spondylolisthesis * ankylosing spondylitis * scoliosis * leg length discrepancy * muscular dystrophy * low back pain from non-musculoskeletal causes * fracture or traumatic low back pain * any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded
impact of sodium glucose co-transporter 2-inhibitors on clinical outcome and left ventricular function in patients presented by acute myocardial infarction

Conditions: Sodium-glucose Cotransporter 2; Inhibitors; Clinical Outcome; Left Ventricule; Acute Myocardial Infarction

Summary: this study aimed to assess the effect of adding sodium glucose co-transporter two inhibitors on clinical outcome and left ventricular function in patients with acute myocardial infarction.

sodium-glucose co-transporter-2 (sglt-2) inhibitors are a class of anti-hyperglycemic agents that act on the sglt-2 proteins expressed in the renal proximal convoluted tubules. they exert their effect by preventing the reabsorption of filtered glucose from the tubular lumen. early initiation and continuation of sglt2 inhibition for acute myocardial infarction is appealing with many proposed mechanistic effects that may alter the natural history, predisposition to ventricular remodeling, and progression to chronic heart failure and end-stage heart disease

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * recent myocardial infarction. evidence of significant myocardial necrosis defined as a rise in troponin level \> 99th percentile uln (upper limit of normal). in addition, at least one of the following criteria must be met: * symptoms of ischemia. * ecg changes indicative of new ischemia (new st-t changes or new left bundle branch block (lbbb)) * imaging evidence of new regional wall motion abnormality. * estimated glomerular filtration rate (egfr)\> 30 ml/min/1.73 m2. * blood pressure before first drug dosing \>110/70 mmhg. exclusion criteria: * known allergy to sodium/glucose cotransporter 2 (sglt2) inhibitors. * patients with poor echocardiographic views. * hemodynamic instability as defined by intravenous administration of catecholamine. * \>1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea. * pregnant women or females of childbearing age without adequate contraceptive methods. * acute symptomatic urinary tract infection (uti) or genital infection * patients currently being treated with any sglt-2 inhibitor or having received treatment with any sglt-2 inhibitor within the 4 weeks before the screening visit. * patient with a previous myocardial ischemic event or previous heart failure. * patients with significant valvular dysfunction.
equivalence of calcium acetate oral solution and sevelamer carbonate tablets in hemodialysis patients

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels this is a phase iv, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, cos, to sevelamer carbonate tablets, in hemodialysis dependent chronic kidney disease subjects (ckd). the aim of the study is to maintain serum phosphorus level and establish equivalence between cos and sevelamer carbonate tablets.

total 40 subjects will be randomized for participation into the study the subjects are hemo-dialysis dependent chronic kidney disease (ckd) stage 5d patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥18 years of age able to give written informed consent to the study * hemodialysis dependent chronic kidney disease stage 5d patients * taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy * taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day exclusion criteria: * estimated life expectancy of less than 6 months and for cancer patients, an eastern cooperative oncology group (ecog) performance status \>1 * active malignancy within the past 5 years. basal or squamous cell skin cancer is not exclusionary. history of malignancy is not an exclusion * known hypersensitivity reaction to calcium-based phosphate binders * anticipated renal transplantation during the study * pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Keywords: serum phosphorus levels
zurich multiple endpoint vitamin d trial in knee oa patients

Conditions: Knee Osteoarthritis

Summary: this is a 2-year double-blind randomized controlled trial in 287 community-dwelling individuals age 60 years or older undergoing uni-lateral total knee replacement due to severe oa of the knee.we compare an oral dose of 2000 iu vitamin d3 per day to 800 iu. the primary endpoints are pain and disability related to rehabilitation of the operated knee,and related to the expected high prevalence of oa in the contra-lateral knee. secondary endpoints are change in 25(oh)d levels, muscle strength, balance, lower extremity function, the rate of falls, bone density and bone quality, bone metabolism, general pain, fall-related fractures, body composition, blood-pressure, major cardiovascular events, blood glucose-insulin levels, executive cognitive function, rate of upper respiratory tract infections / all infections, tooth loss, dental health, health care utilization, number and size of facial skin keratosis, and radiographic progression of the non-operated knee. pain and disability will be assessed by the pain and function subscales of the western ontario- mcmaster universities osteoarthritis index (womac). randomization will be stratified by womac function prior to surgery, radiological evidence for oa in the contra-lateral knee, and hospital. clinical visits will take place at baseline (6-8 weeks after tkr), at 6, 12, 18 and 24 months of treatment. in addition, all individuals will receive a phone call every 2 month to assess adverse outcomes and compliance to treatment, supported by a hotline for immediate report of adverse events. statistical power: we expect more than 80% power with 200 participants completing their 24 month follow-up, and 260 participants completing their 12 month follow-up. this is a trial with medicinal product.


Eligibility criteria:
inclusion criteria: * unilateral knee replacement due to knee osteoarthritis * age 60+ years * german language skills * community dwelling exclusion criteria: * bi-lateral knee replacement or hip replacement planned in the trial period, or in the previous 6 months * chronic steroid intake * serum calcium corrected for serum albumin \> 2.6 mmol/l * gfr \< 30 ml/min * severe visual or hearing impairment * inflammatory arthritis * malabsorption * high alcohol intake * sarcoidosis, primary hyperparathyroidism * history of kidney stones, lymphoma * chemotherapy for cancer in the previous 12 months * hemiplegia * morbus parkinson * unable to walk 3 meters prior to surgery * bisphosphonate, parathyroid hormone , fluoride or calcitonine therapy in the last 6 months * zolendronate in the last year * m. paget (ostitis deformans) * vitamin d3 intake more than 800iu/d over more than 1 month * stay on a sunny location for more than 6 weeks per year * heart failure
a mediterranean intervention on prediabetic children

Conditions: Prediabetic State

Summary: prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (dm2) diagnosis. until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. recently, it has begun to be detected in children, with family eating habits becoming more critical. therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a mediterranean diet, through the evaluation of the mediterranean diet quality index (kidmed).


Eligibility criteria:
inclusion criteria: * presence of hba1c levels between 5.7 and 6.4% in the blood tests * signed informed consent by the minor * signed informed consent by the minor's parents or guardians. exclusion criteria: * presence of hba1c levels below 5.7% * presence of hba1c levels above 6.4% * presence of pathological metabolic diseases, such as diabetes or metabolic syndrome * lack of the signed informed consent by the minor and legal guardian

Keywords: nutritional intervention prediabetes children mediterranean diet
a phase 1/2a, single- and multiple-dose escalation study of krro-110

Conditions: Alpha-1 Anti-trypsin Deficiency; AATD

Summary: the purpose of this first-in human (fih) study is to assess the safety, tolerability, and pharmacokinetics (pk) of single and multiple doses of krro-110 in both healthy adult participants and in clinically stable patients with alpha-1 antitrypsin deficiency (aatd).


Eligibility criteria:
inclusion criteria: part a sad cohort inclusion criteria (healthy volunteers) * adult male or female participants, 18 to 65 years of age * documented pimm genotype * participants who are willing to and able to provide signed written informed consent pizz genotype (part a sad and part b mad cohorts) inclusion criteria (pizz genotype) * adult male or female participants 18 to 70 years of age (inclusive) * documented pizz genotype * baseline blood total aat level \< 11 µm/l exclusion criteria: exclusion criteria (healthy volunteers) * female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception * body mass index (bmi) \> 32 or \< 18.5 kg/m2 * history or current clinical evidence of hepatic disease * evidence of active infection * history of medical condition(s), eg, advance cardiac disease, current or recent malignancy, organ transplantation, or other illness * serology result indicative of any exposure (past or active) to hepatitis c, hepatitis b, or human immunodeficiency virus (hiv) * respiratory or other acute illness within 8 weeks * tobacco use of any kind within 6 months exclusion criteria (pizz genotype) * female participant of childbearing potential or male participant that is unable or unwilling to use an approved, reliable means of contraception * bmi \> 32 or \ 90 kg * history of fev1 \< 50% * history or current clinical evidence of advanced hepatic disease and/or pulmonary disease * use of an experimental therapy except krro-110 within 6 months or 5 half-lives for the experimental therapy, whichever is greater * tobacco use of any kind within 6 months * use of conventionally dosed aat augmentation therapy within 5 half-lives * serology result consistent with exposure to hiv, or serology consistent with active hepatitis b or hepatitis c infection