Kornimate/medical-research-clean huggingface dataset:
pharmacodynamic effects of atorvastatin vs. rosuvastatin on platelet reactivity

Conditions: Coronary Artery Disease

Summary: patients with coronary artery disease (cad) are often treated with dual antiplatelet therapy (dat), including aspirin and clopidogrel, to prevent from recurrent atherothrombotic events. levels of platelet reactivity in patients on dat can be influenced by concomitant treatment with medications that inhibit the cyp3a4 system involved in the activation of clopidogrel. atorvastatin and simvastatin are metabolized by cyp3a4 \[clin pharmacokinetic 2002; 41: 343-70\], whereas the cytochrome p450 mediated metabolism of rosuvastatin appears to be minimal and principally mediated by the 2c9 isoenzyme, with little involvement of cyp3a4 \[clin ther 2003; 25: 2822-5.\]. previous studies comparing atorvastatin versus rosuvastatin by means of ex vivo platelet function tests have yielded conflicting results.

at least 1 month after starting dat (clopidogrel 75 mg and aspirin 100 mg), patients will receive randomly atorvastatin (20 mg day, n=50) or rosuvastatin (10 mg bid, n=50) for 30 days (until t-1). at this time-point, there will be a wash-out period of 15 days after the first treatment with atorvastatin or rosuvastatin in order to avoid any carry-over effect. afterwards, a cross-over will be performed, and patients will be switched to the other drug which will be continued for further 30 days (until t-2).

Eligibility criteria:
inclusion criteria: * angiographically-proven coronary artery disease * class i indication to dat because of recent (\<12 months) percutaneous coronary intervention and/or recent acute coronary syndrome (\<12 months) * stable clinical conditions * able to understand and willing to sign the informed cf exclusion criteria: * use of other drug interfering with cyp activity such as proton pump inhibitors * women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before ct

Keywords: coronary artery disease dual antiplatelet therapy atorvastatin rosuvastatin
assessment of novel sound changing principles in hearing instruments to determine their application

Conditions: Hearing Loss

Summary: a methodical evaluation of novel sound changing principles in ce-labelled sonova brand hearing instruments (e.g. phonak hearing instruments) is intended to be conducted on hearing impaired. these sound changing principles are enabled by respective hearing instrument algorithms. the aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (phase of development). both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. this will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at sonova ag headquarter based in staefa.


Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * known central hearing disorders
the effect of dexmedetomidine in the management of pain after uterine artery embolization

Conditions: Pain Control

Summary: the investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.

leiomyoma are the most common female reproductive tract tumors. uterine artery embolization(uae) is a minimally invasive treatment alternative to hysterectomy and myomectomy. however, post-procedural pain control after uae remains a major problem. therefore, the aim of study is to evaluate the efficacy of dexmedetomidine in pain control after uae.

Eligibility criteria:
inclusion criteria: * age ≥ 20, * asa class i and ii exclusion criteria: * bradycardia (\< 45 bpm) * heart block * liver failure * renal failure * uncontrolled hypertension * body mass index ≥ 30 kg/m2
safety and efficacy of nonacog beta pegol (n9-gp) in previously untreated patients with haemophilia b

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted globally. the aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (n9-gp) in previously untreated patients with haemophilia b.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * male, age below 6 years at the time of signing informed consent * patients with the diagnosis of haemophilia b (fix (coagulation factor ix) activity level below or equal to 2%) based on medical records or central laboratory results * previously untreated or exposed to fix containing products less than or equal to 3 exposure days (5 previous exposures to blood components is acceptable) exclusion criteria: * any history of fix inhibitors (defined by medical records) * known or suspected hypersensitivity to trial product or related products * previous participation in this trial. participation is defined as first dose administered of trial product * receipt of any investigational medicinal product within 30 days before screening * congenital or acquired coagulation disorder other than haemophilia b * any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise the patient's safety or compliance with the protocol * patient's parent(s)/lar(s) (legally acceptable representative) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
retrospective observational study about evolution of patients with breast cancer in hospitals from geicam group

Conditions: Invasive Breast Cancer Between 2002 and 2005

Summary: this study is a non-interventional (nis), multicenter, retrospective cohort study, which will obtain data from patients diagnosed with invasive breast cancer between 2002 and 2005 in the medical oncology departments of hospitals that are members of geicam (using information obtained from patient medical histories).

there is no specific treatment regimen for this study. this is an observational retrospective study in which the clinical decisions concerning the optimal strategy in the treatment of the disease for each patient have been taken independently and prior to the physician's decision to include patient data in this registry, in keeping with the drug information, local treatment guidelines and/or standard clinical practice. the study target population are all patients (men and women) who have been newly diagnosed with invasive breast cancer between january 1, 2002 and december 31, 2005 and treated in the medical oncology departments of participating sites, ensuring an approximate follow-up of 10 years.

Eligibility criteria:
inclusion criteria: * patients whose first primary breast invasive tumor diagnosis occurred between january 1, 2002 and december 31, 2005 and who have received treatment in the medical oncology departments of participating sites. * patients who were diagnosed at the participating site; otherwise the site where the initial diagnosis was made should be contacted with in order to confirm that the patient has not already been enrolled in the study or pending inclusion. the objective is to avoid duplicate records for displaced patients. exclusion criteria: * patients with a single diagnosis of in situ carcinoma (without infiltrating component).
the effect of expressive touch and music applied after lumbar disc hernia surgery.

Conditions: Lumbar Disc Herniation

Summary: patients undergoing lumbar hernia surgery will be divided into expressive touch, music and control groups. pre-test and post-test pain levels, vital signs, and nirs values of the patients will be measured.


Eligibility criteria:
inclusion criteria: * agreeing to participate in the research, * general anesthesia applied, * patients with the same type of treatment protocol, * verbal pain score with at least 4, * patients with a ramsay sedation scale score of 3 and below, * without a chronic disease, * without a disease (avm, blockage of brain vessels, etc.) that will affect brain oxygenation, * who has not been diagnosed with any psychiatric illness * no hearing and perception problems, * no loss of sensation in upper extremity according to light touch test, * any complications after surgery are undeveloped exclusion criteria: * do not meet the inclusion criteria, * interrupting the research, * patients with incomplete answers to questions

Keywords: nursing touch music pain near-i̇nfrared spectroscopy
stress-busting program for caregivers of patients with neruological diseases

Conditions: Psychological Adaptation; Parkinson's Disease; Neurological Disorders

Summary: although family caregivers perform an incredibly valuable service for their relatives and the formal health care system, they do so at a considerable cost to themselves both emotionally and physically. effective stress management techniques can: 1) help to decrease the caregivers' feelings of burden and stress; 2) improve the emotional and physical health of caregivers; and 3) empower caregivers to gain control of their lives.

the overall goal of this randomized clinical trial is to determine the effectiveness of a stress-busting program (sbp) for caregivers of patients with chronic neurological diseases including stroke, alzheimer's disease, multiple sclerosis, and parkinson's disease. specific research objectives include: 1) prospectively determine the effects of a sbp compared to a standard support group (ssg) on quality of life and immune response in caregivers of patients with chronic neurological diseases. subjects will be tested at baseline, at completion of 4 and 8 weeks of sbp or ssg, and at 2- and 4-month follow up sessions. 2) determine subjects' relaxation response as well as their response to acute laboratory stressors using bioinstrumentation. muscle tension, electrodermal response, skin temperature, blood volume pulse, and heart rate will be measured. subjects will be tested at baseline, at completion of 4 and 8 weeks of a sbp or ssg, and at 2- and 4-month follow up sessions. 3) compare the effectiveness of sbp or ssg for adult children caregivers as compared to spousal caregivers based on quality of life measurements, immune parameters, and relaxation response. the proposed multimodal sbp will focus on a variety of approaches based on cognitive behavioral and relaxation response theories. sbp will consist of a 8-week program with 1�-hour sessions per week. the setting will be an educational support group with topics related to stress, stress and challenges of caregiving, depression, coping strategies, positive thinking, and taking time for oneself. in addition, subjects will be taught simple relaxation strategies that they can practice at home. outcomes will be measured using psychosocial instruments as well as state-of-the science technology including bioinstrumentation and immune parameters to measure biological responses. follow up testing will be done 2 and 4 months after the end of the sbp or ssg to determine the long-term effectiveness of the intervention.

Eligibility criteria:
inclusion criteria: the primary caregiver of an individual with a neurological disease. able to read and converse in english. exclusion criteria: presently participating in an ongoing support group related to the neruological disease.

Keywords: caregivers stress coping immune relaxation biofeedback bioinstrumentation homecare
liver and fat regulation in overweight adolescent girls

Conditions: Hepatic Steatosis; Polycystic Ovarian Syndrome; Obesity

Summary: women with polycystic ovarian syndrome (pcos) have increased rates of hepatic steatosis compared to weight similar women with regular menses. it is unclear if this is related to high testosterone or insulin resistance. the investigators will assess hepatic glucose release, rates of lipolysis and hepatic de novo lipogenesis in the fasted and postprandial state to determine if alterations in the processes contribute to hepatic steatosis. participants will be overweight, sedentary girls with or without pcos. those with pcos will either be medication naive, or must be taking metformin or combined oral contraceptives (cocps) for a period of at least 6 months prior to study procedures.

hepatic glucose release will be assessed with a stable isotope glycerol tracer, lipolysis with a glycerol tracer, and hepatic de novo lipogenesis with an acetate tracer. data will be collected fasting and after a glucose challenge. the degree of hepatic steatosis and abdominal fat partitioning will be assessed with magnetic resonance imaging (mri), and total body composition with dual-energy x-ray absorptiometry (dexa).

Eligibility criteria:
inclusion criteria: * females * 2 years post-menarche * bmi percentile \>90% exclusion criteria: * type 2 diabetes * anemia * liver disease * medications known to effect insulin sensitivity * cause of oligomenorrhea or hirsutism other than pcos, * \>3 hours a week of moderate exercise.
peep and spontaneous breathing during ards

Conditions: Acute Respiratory Distress Syndrome

Summary: prospective, physiological study to systematically assess the effects of high positive end-expiratory pressure (peep) with and without inspiratory synchronization in patients with moderate to severe acute respiratory distress syndrome (ards) exhibiting intense inspiratory effort while on assisted ventilation.

this prospective, physiological, randomized, cross-over study will be conducted in the 20-bed general icu of the fondazione policlinico universitario a. gemelli irccs, roma, italy. patients with ards will be screened for eligibility. ards will be defined according to the berlin definition. intubated patients fulfilling ards criteria, undergoing assisted ventilation as per clinical decision and exhibiting intense inspiratory effort (occlusion pressure equal or greater than 13 cmh2o) will be enrolled. patients will be placed in a 30°-45° head up position during all study phases. according to our institution protocol, pressure support setting will be selected by the attending physician to target a predefined tidal volume range of 6-8 ml/kg of predicted body weight (pbw) (female pbw \[kg\] = 45.5 + 0.91 \[cm of height - 152.4\]; male pbw \[kg\] = 50 + 0.91 \[cm of height - 152.4\]).the lowest pressure support level allowed will be 7 cmh2o, even if vt \<8 ml/kg pbw is not achieved. in each patient, four different ventilator settings will be applied in a random order. each step will last 45 minutes.

Eligibility criteria:
inclusion criteria: * (a) ards according to the berlin definition (ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) ≤ 300 mmhg); * (b) assisted ventilation, as prescribed by the attending physician * (c) intense inspiratory effort, defined as a negative deflection in the airway pressure equal or greater than 13 cmh2o in the first breath recorded during an end-expiratory occlusion exclusion criteria: pregnancy, clinically documented barotrauma, contraindication to electrical impedance tomography (eit) use (e.g., presence of pacemaker or automatic implantable cardioverter defibrillator), impossibility to place the eit belt in the right position (e.g., presence of surgical wounds dressing), and any contraindication to the insertion of a nasogastric tube (eg, recent upper-gastrointestinal surgery, esophageal varices), chest tubes with active air leaks, fever.
comparison of who treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in children

Conditions: Acute Watery Diarrhea

Summary: this study aimed to compare who treatment of acute watery diarrhea with or without probiotic (bacillus clausii) in term of mean duration of diarrhea in children

available literature regarding the use of probiotics is not conclusive and contains controversy, and local data is also scarce. therefore, this study was planned to further explore the use of probiotics to furnish the local data. if significantly less mean duration of diarrhea is noted in the probiotic group, it will help to add probiotic bacillus clausii in routine treatment regimen recommended by who and to decrease costs associated with prolonged treatment. however, if otherwise results will be noted it will help to rule out use of probiotic bacillus clausii in children with acute diarrhea to avoid its unnecessary use.

Eligibility criteria:
inclusion criteria: * both genders * aged 6 to 59 months * suffering from acute watery diarrhea for ≤ 7 days exclusion criteria: * children with blood in stool * with prior antibiotics use * children under study with duration of stay more than 5 days * clinical signs of a coexisting acute systemic illness like pneumonia, sepsis, meningitis, severely malnourished * immunocompromised children * hypersensitivity to probiotics * with prior probiotic administration
covid-19 vaccine induced adaptive immune responses

Conditions: SARS-CoV-2; Vaccine; COVID-19

Summary: the coronavirus disease 2019 (covid-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (sars-cov-2)，resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 january 2021. the ongoing pandemic still poses unprecedented global threat to public health system worldwide. on december 31, 2020, the joint prevention and control agency of china council announced that sinopharm sars-cov-2 inactivated vaccine had been conditionally approved by national medical products administration, and the protection rate was 79.34%. so far, more than 198 vaccines were currently in preclinical or clinical development. the investigators aimed to initiate an observational cohort of healthy individuals injected with sars-cov-2 vaccine, which will perform a longitudinal, comprehensive analysis of the sars-cov-2 vaccine induced adaptive immune responses.


Eligibility criteria:
inclusion criteria: * healthy and aged between 18 to 59 years exclusion criteria: * high-risk epidemiology history within 14 days before enrollment * sars-cov-2 specific igg or igm positive in serum * positive pcr test for sars-cov-2 from pharyngeal or anal swab samples * axillary temperature of more than 37·0°c * known allergy to any vaccine component * thyroid disease
association between human immunodeficiency virus (hiv) infection and male hypogonadism

Conditions: Hypogonadism; Ovarian

Summary: cross-sectional study investigating the prevalence of hypogonadism in hiv-infected msm population

in this study, we conduct a cross-sectional study investigating the prevalence of hypogonadism in hiv-infected msm population. age-matched non-hiv infected msm group will be used as comparison group. we will also determine the risk factors associated with male hypogonadism (age, duration of hiv infection, comorbidities, bmi, art use). correlation will be made between serum testosterone levels and sexual function, vitality, exercise capacity, mood, and bone mineral density.

Eligibility criteria:
inclusion criteria: * hiv-infected men who have sex with men * hiv non-infected men exclusion criteria: * use of testosterone supplement, anabolic steroid in the past one year. * history of pituitary , adrenal or gonad diseases * history of pituitary surgery or radiation therapy * history of systemic chemotherapy * active opportunistic infection under treatment * cancer * severe hepatic, renal or cardiac impairment
jcp study of investigation of patient background characteristics

Conditions: Spasticity, Post-Stroke

Summary: to collect the background characteristics of juvenile cerebral palsy patients aged 2-year or older prescribed botox for the treatment of equines foot due to lower limb spasticity, compare them with those of patients whose deaths or adverse drug reactions (adrs) related to the possible spread of toxin are reported through the spontaneous adr reporting system, and discuss potential risk factors for such adrs.

1. in each of prospective medical institutions (where botox is expected to be prescribed annually to at least 10 juvenile cerebral palsy patients aged 2-year or older), the medical representative will explain the objectives, subjects and methods of the investigation to the prospective investigator (i.e., a physician who will prescribe botox and can comply with the protocol of the investigation) and ask for his/her participation in the investigation. 2. when the physician agrees to participate in the investigation, a written agreement will be concluded between gsk and the head (e.g. director) of the medical institution prior to the start of the investigation. 3. after the completion of the investigation period, the physician will complete the case report form (crf) for the patients prescribed botox by him/her during the investigation period. the information of the patients who developed adrs will be collected separately through the spontaneous adr reporting system on a daily basis.

Eligibility criteria:
inclusion criteria: * background factors: the following background characteristics will be compared between the patients collected during the investigation and the patients whose deaths or adrs related to the possible spread of toxin are reported through the spontaneous adr reporting system, to discuss the potential risk factors for death or spread of toxin: 1. severity of indication (cerebral palsy) prior to use of botox 2. medical history/concurrent medical conditions (e.g., dysphagia, seizure, pulmonary disorder, neuromuscular disorder, and cardiac disorder, and others) ; yes/no, and if yes, specify the diseases 3. use of concomitant drugs and non-drug therapies 4. dose per kg body weight 5. dose per injection site (e.g., gastrocnemius muscle, soleus muscle, tibialis posterior muscle) exclusion criteria: * patients whose adverse drug reactions (adrs)

Keywords: botox jcp