Kornimate/medical-research-clean huggingface dataset:
prognostic perspective of invasive hyperemic and non-hyperemic physiologic indices measured after percutaneous coronary intervention

Conditions: Ischemic Heart Disease

Summary: coronary physiologic assessments by the pressure-derived fractional flow reserve (ffr) have become standard methods for identifying hemodynamic deprivation in coronary arterial stenosis for evidence-based percutaneous coronary intervention (pci). invasive physiologic indices-guidance enables on-site real time assessment for functional significance of epicardial coronary stenosis and the use of those indices has shown to be effective to guide treatment decision. several studies further support the role of post-pci ffr measurement as a functional marker of residual disease after pci and prognostic indicator of patients. although optimal cut-off values of post-pci ffr varied across studies, an inverse relationship between post-pci ffr and the risk of future clinical events have been reported consistently. recently, non-hyperemic pressure ratios (nhprs) have been introduced in clinical practice. although there are several different nhprs, previous studies consistently indicated that those nhprs shares similar diagnostic performance and prognostic implications. nevertheless, few reports were available for clinical relevance of nhprs in evaluation of post-pci status. in this context, we will evaluate the physiologic characteristics and prognostic implication of post-pci nhprs and compare with those of post-pci ffr in patients who underwent angiographically successful pci with 2nd generation drug-eluting stent implantation (des).

patients who diagnosed significant coronary artery disease and treated by 2nd generation des with post-pci physiologic evaluation would be enrolled. invasive physiologic assessment including recording of resting pressure trecing would be required at the baseline and at the end of index pci procedure. pci procedure would be performed upon local routine. any available 2nd generation des could be used. web-based electronic-case record form (crf) system will be used for collecting data. all data will be handled and analyzed by blind fashion at independent core lab. 2-year clinical outcome after index procedure will be analyzed.

Eligibility criteria:
inclusion criteria: * any patient meets eligible criteria who underwent pci with des followed by invasive physiologic assessment at the index procedure * available both post-pci resting pressure tracing and ffr exclusion criteria: * culprit vessel of acute coronary syndrome * failed achieving timi 3 flow at the end of pci * left ventricular ejection fraction \<30% * graft vessel * collateral feeder * in-stent restenosis * primary myocardial or valvular heart disease * in patient whose life expectancy less than 2 years * visible thrombus of target vessel segment * unmeasured post-pci resting pressure tracings

Keywords: fractional flow reserve non-hyperemic pressure ratio percutaneous coronary intervention prognosis myocardial ischemia
atorvastatin for prevention of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery

Conditions: Coronary Artery Bypass

Summary: the purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

atrial fibrillation after cardiac surgery is the most common arrhythmic complication that may increase incidence of congestive heart failure, renal insufficiency, and stroke, which increase the length of hospital stay, the rates of re-hospitalization, and cost of care. its pathogenesis is multifactorial, and its prevention and management remain suboptimal. recently, observational evidence has suggested that patients who have undergone previous statin therapy have a lower incidence of postoperative atrial fibrillation. the purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Eligibility criteria:
inclusion criteria: * consecutive patients scheduled for the elective off-pump cabg surgery exclusion criteria: * prior statin use * previous episodes of atrial fibrillation * impaired renal function with serum creatinine \>2mg/dl * serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal * a malignancy or inflammatory disease

Keywords: off-pump coronary artery bypass graft atorvastatin postoperative atrial fibrillation
immunogenicity and safety of an acellular dpt vaccine during pregnancy

Conditions: Pregnancy

Summary: that is a double-blind randomized trial with parallel control to demonstrate the safety and immunogenicity of acellular tdap vaccine in pregnant mexican women. the general objective is to determine the safety and immunogenicity of acellular tdap vaccine. the experimental group will receive acellular tdap vaccine and the control group will receive a placebo consisting of saline 0.9% sodium chloride solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine.

type of study: clinical, randomized, double-blind, parallel control study. study subjects: pregnant women of 19-38years of age, gestational age of 12-24 weeks, low risk of obstetric complications (according to the obstetric risk assessment form), normal anatomic ultrasound performed in the second quarter of pregnancy and residence in guadalupe, and juarez cities in nuevo leon state. the experimental group will receive acellular tdap vaccine and the control group will receive a placebo consisting of saline (0.9% sodium chloride) solution, randomly assigned, which will be administered by the same route (intramuscular) and at the same dose (0.5 ml) that the vaccine by trained personnel. for both groups, 6 blood samples will be taken. women: before and at least 4 weeks after the vaccine or placebo were administered, at hospital admission for delivery. infant: collected at delivery (cord), 2, 4 and 6 months of age. immunogenicity will be compared in both groups by measuring the increase of three of the following antigen-specific antibodies: pertussis toxin (pt), pertactin (prn),and fimbriae 2 fim 2). safety assessment: each pregnant will be observed at 30 minutes, 24 and 48 hours and one month after the application of the vaccine for side effects.

Eligibility criteria:
inclusion criteria: * 18 to 38 years * pregnancy between 22 and 32 weeks of gestation * covered by ministry of health medical security * definitive residency in guadalupe and benito juarez cities * pregnancy termination in the study's hospital. * at low risk for complication as determined by the obstetrical risk assessment form (oraf) * second trimester or later ultrasound with no significant abnormalities * intend to be available for follow up visits and phone calls access through 6 months following delivery * willing to give written informed consent exclusion criteria: * serious mental illness. (schizophrenia, psychosis, major depression). * serious underlying medical condition (e.g degenerative diseases: diabetes mellitus,hypertension and so on. * current smoking or use of drugs. * receipt of tetanus-diphtheria toxoid immunization within the past 2 years. * be considered as a high risk pregnancy for serious obstetrical complication according to the local obstetrical risk assessment form.

Keywords: tdap vaccine pregnant woman pertussis
a study to evaluate the safety, effectiveness and tolerable dose of bms-986393 in novel combinations in participants with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to establish a safe and tolerable dose of bms-986393 in combinations with alnuctamab, mezigdomide, and iberdomide in participants with relapsed and/or refractory multiple myeloma (rrmm).


Eligibility criteria:
inclusion criteria: * history of relapsed and/or refractory multiple myeloma (rrmm) treated with at least 3 (part 1 and part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (part 2) * measurable multiple myeloma (mm) * eastern cooperative oncology group performance status of 0-1 exclusion criteria: * condition that confounds the ability to interpret data from the study * known active or history of central nervous system (cns) involvement of mm note: other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-986393 relapsed multiple myeloma refractory multiple myeloma first-in-human alnuctamab mezigdomide iberdomide cc-95266 gprc5d gprc5d car t cell therapy car t cell therapy combination therapy
safety and efficacy of valsartan and amlodipine combined and alone in hypertensive patients

Conditions: Hypertension

Summary: this trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension


Eligibility criteria:
inclusion criteria: * outpatients 18 years and older. * male or female patients are eligible. female patients must be either post-menopausal for one year or surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. hormonal contraceptive use is disallowed. * patients with essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. patients must have a msdbp \> 90 mmhg and \ 95 mmhg and \< 110 mmhg at visit 2 (week 0). * patients must have an absolute difference of \> 10 mmhg in their average sitting diastolic blood pressure between visits 1 and 2. * patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). exclusion criteria: * severe hypertension (msdbp 110 mmhg and/or mssbp 180 mmhg) at anytime. * inability to discontinue all prior antihypertensive medications safely for a period of 14 weeks. * known keith-wagener grade iii or iv hypertensive retinopathy. * history of hypertensive encephalopathy or cerebrovascular accident at anytime prior to visit 0 (week -6 to -4). * transient ischemic cerebral attack during the last 12 months prior to visit 0 (week -6 to -4). * evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing disease, pheochromocytoma, polycystic kidney disease etc. * type 1 diabetes mellitus. * type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated hemoglobin (hba1c) \>8% at visit 1 (week -4 to -2). * administration of any agent indicated for the treatment of hypertension within a minimum 4 weeks prior to randomization into the study (visit 2, week 0), with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at visit 0 (week -6 to -4). * known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, valsartan, amlodipine, high blood pressure
a comparative study to determine if motivating asthma education (compliance enhancement) has an effect on asthma control

Conditions: Asthma

Summary: this study will investigate whether study subjects with previously uncontrolled asthma treated with seretide diskus 50/250 cci18781+gr33343 mcg twice a day can attain a level of total control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.


Eligibility criteria:
inclusion criteria: * diagnosed with persistent asthma. * not treated with the combination of a ics (inhaled corticosteroid)and a laba (long-acting beta-agonist). * female subjects must not be fertile or must use effective contraception. * subject must be able to comply with the use of the questionnaires in the local language. exclusion criteria: * known or suspected chronic obstructive pulmonary disease. * pregnant or lactating. * participating investigator, employee of an investigator, or family member of any of the aforementioned. * smoking history: pack-years \> 10 years. * have known clinical or laboratory evidence of a serious uncontrolled systemic disease. * known hypersensitivity to any substance contained in investigational product or as-needed medication. * treatment with oral corticosteroid within 2 months prior to the screening visit. * upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit. * acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.

Keywords: qol asthma asthma compliance enhancement salmeterol/fluticasone total control seretide fev1
hypertonic saline for mac

Conditions: Nontuberculous Mycobacterial Lung Disease; Nontuberculous Mycobacterium Infection

Summary: the mac-hs study is a testing whether hypertonic saline helps improve symptoms and clearance of mycobacteria in patients with m. avium complex lung infections.

the mac-hs study is an open label, randomized control trial of hypertonic saline in pulmonary m. avium complex patients. eligible patients who consent to participate will be randomized 1:1 to hypertonic saline or standard of care for 12 weeks. all patients in the treatment group will take inhaled hypertonic saline twice daily for 12 weeks. patients may continue with other airway clearance methods (i.e. flutter, acapella valve, aerobika, postural drainage, huff cough, percussion). patients may also be treated with antibiotics targeted at other pathogens if an exacerbation occurs. patients may also be actively treated with inhaled corticosteroid at the time of enrollment, with dosing adjustments during the trial discouraged. patients with disease progression at any time can be discontinued from the study treatment and treated according to ats/idsa guidelines at the discretion of the primary investigator. however, such patients will still complete the 12 week final visit, sputum collection and ae assessment.

Eligibility criteria:
inclusion criteria: * at least 2 positive mac sputum cultures in the last 12 months with at least one afb positive sputum obtained within 12 weeks prior to randomization * meet american thoracic society (ats)/ infectious disease society of america (idsa) 2007 pulmonary clinical disease criteria\[1\] * age 18 and older * diagnosis of bronchiectasis and/or bronchiectatic findings evident on chest ct report * ability to provide informed consent exclusion criteria: * any patient who is unwilling or unable to provide consent or to comply with this protocol * cavitary ntm disease * patients who are currently taking or within the prior 6 months received any of the following: bedaquiline, or any component of ats/idsa multi-drug recommended therapy (macrolide, ethambutol, rifampin) for mac treatment * diagnosis of hiv * diagnosis of cystic fibrosis * active pulmonary tuberculosis, fungal, or nocardial disease requiring treatment at screening * current use of chronic systemic corticosteroids at doses of 15 mg/day for more than 3 months * prior lung or other solid organ transplant
patient satisfaction and safety of miradry treatment for axillary hyperhidrosis

Conditions: Axillary Hyperhidrosis

Summary: primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat production without an underlying cause. the disease usually affects the axillae but can also involve palms, soles of the feet or face and causes major problems in many social situations with a negative impact on quality of life and mental health. in this study, the investigators want to investigate the effect of microwave therapy (miradry®) on self-rated sweating, quality of life and anxiety in participants with severe axillary hyperhidrosis. the study also aims to evaluate the safety (side effects) of the method and long term effects over 1 year of follow upp.

the study is conducted during several visits or telephone follow-ups at the clinic over a period of 12 months and each patient receives a maximum of two treatments with miradry® (at 3-month intervals). 100 participants are planned to participate in the study. the primary objective is to evaluate the effectiveness of the miradry ® treatment measured by hyperhidrosis disease severity scale(hdss). secondary objectives are to evaluate the side effects and the quality of life by assessment of the dermatology life quality index, the hyperhidrosis quality of life index, and hospital anxiety and depression scale.

Eligibility criteria:
inclusion criteria: * this study will recruit participants diagnosed with primarily axillary hyperhidrosis * informed consent is required. * hdss 3 or 4 (the criteria used in sweden to allow hospital-based intervention). exclusion criteria: participants * who are unable to provide informed consent, * have known allergies to lidocaine, chlorhexidine, and/or epinephrine, * are pregnant, * are unable to take oral antibiotics or antiseptic washes, * have heart pacemakers or other electronic device implants, * who need supplemental oxygen, * have had axillary surgery procedures for hyperhidrosis, * with previous hidradenitis suppurativa or other local infections * had previous cancer in the treated area are not eligible to participate in this study

Keywords: hyperhidrosis hyperhidrosis disease severity scale (hdss) hospital anxiety and depression scale (hads) dlqi hyperhidrosis quality of life index (hidroqol) microwave
intradialytic progressive resistance training for maintenance haemodialysis patients

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis. it is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.

muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life. in other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. it is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. however, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients. therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.

Eligibility criteria:
inclusion criteria: * chronic kidney diseases stage five requiring maintenance hemodialysis. exclusion criteria: * patients who have been receiving dialysis for less than 3 months; * are under the age of 18years; * have medical contradictions to participate in the exercise programs; * any uncontrolled medical condition which does not allow participation in exercise; * have known neuro-muscular disorders; * have any other uncontrolled medical condition, including pregnancy; * are not independently ambulant for 50 m; * have received anabolic intervention, or had catabolic conditions within the last 3 months; * have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance; * are vulnerable to heat stress; * or are unable to give consent.

Keywords: progressive resistance training/exercise muscle wasting chronic kidney disease
interaction between ngf and acute exercise-induced ischemia

Conditions: Hyperalgesia; Pain Response; Healthy Subjects

Summary: the purpose of this study is to investigate pain evoked responses and facilitation of ngf-induced mechanical muscle hyperalgesia over time following an acute exercised-induced ischemic condition in a ngf-sensitized muscle.

assessing evoked pain responses and muscle hyperalgesia following contractions during acute ischemia in a ngf-sensitized muscle may clarify whether an interaction between ngf sensitization and acidic stimulation exist. it is hypothesized that acute ischemic exercise with the ngf-sensitized ta muscle, in contrast to ischemic exercise in a non-sensitized would: 1) potentiate pain-evoked responses, and 2) facilitate ngf-induced muscle hyperalgesia.

Eligibility criteria:
inclusion criteria: * healthy and pain free volunteers exclusion criteria: * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, mental illnesses, or psychiatric diseases. * past history of chronic pain in the musculoskeletal system (muscle, joint, cartilage, connective tissue) * participation in other pain trials throughout the study period * lack of ability to cooperate * taking any analgesic 24 hours before the injections * performing any strenuous leg exercise through out the study period causing sore muscles

Keywords: ngf-induced pain ischemia-induced pain hyperalgesia ngf pain model
study of children's well-being after the covid-19 pandemic in belgian french-speaking primary schools

Conditions: Well-being

Summary: in order to limit the transmission of severe acute respiratory syndrome coronavirus 2 (sars-cov-2), a significant numbers of measures were taken worldwide. it has been shown that the pandemic and its consequences, such as lockdown and isolation, can have a significant long-term impact on the well-being of children. this study follows the initial dynatracs study on sars-cov-2 transmission in primary schools. in belgium, 2488 children and 444 school attenders in 11 primary schools of the federation wallonia brussels are invited. every participant will be invited to answer a well-being questionnaire. this study aimed to document the children and workers well-being in the primary schools of belgium after the covid-19 pandemic. the results of the study should contribute to improved decision making regarding measures for schools and children well-being in the context of current and future pandemics. the objective of this study is to document the well-being of children and workers after the covid 19 pandemic in primary schools of the federation wallonia-brussels.


Eligibility criteria:
inclusion criteria: * all children between the ages of 6 and 12 years and all school attenders from selected primary schools were invited to participate. exclusion criteria: * refusal or absence of written informed consent before enrolment

Keywords: primary schools