Kornimate/medical-research-clean huggingface dataset:
statin monotherapy or statins in combination with ezetimibe in patients for prevention of cvd

Conditions: Lipid Metabolism Disorders; Cardiovascular Diseases

Summary: retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (cvd). the study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of cvd who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (cs), low density lipoproteins (ldl), high density lipoproteins (hdl), triglycerides (tg), data on which will be obtained from primary medical records. demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (mace).


Eligibility criteria:
inclusion criteria: patient can be included in the study only once. 1. age \> 18 years. 2. patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of cvd. 3. receiving statins as monotherapy or statins in combination with ezetimibe in a stable dosing regimen for 3 or more months at the time of enrolment in the study. 4. willingness and ability to sign an informed consent to participate in the study. 5. availability of primary medical documentation, which allows assessment of all parameters necessary for the study from the moment of initiation of statin monotherapy or statins in combination with ezetimibe. 6. initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study. exclusion criteria: 1. age \< 18 years. 2. a diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia. 3. change in lipid-lowering therapy within 3 months prior to study enrolment. 4. concomitant administration of omega-3 pufa with statin monotherapy or combination therapy of statins and ezetimibe, as well as the use of any methods of extracorporeal filtration and/or plasmapheresis. 5. clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results 6. presence of hypothyroidism 7. ezetimibe monotherapy 8. intolerance to statins at any dose

Keywords: ezetimibе statin cardiovascular diseases lipid-lowering therapy
physical activity and gastrointestinal investigations

Conditions: Gastro-oesophageal Reflux Disease

Summary: this is an observational study, which aims to compare the outcomes of ambulatory gastrointestinal investigations with physical activity using accelerometry. an ambulatory study refers to one in which the patient is monitored freely, often outside of the hospital environment. for this the investigators will use a lightweight (7.4g) tri-axial accelerometer worn behind the ear. hypothesis 1 there is no change in the amount or nature of physical activity taken by patients during ambulatory oesophageal ph monitoring or capsule endoscopy. hypothesis 2 there is no correlation between physical activity levels and speed of gastrointestinal transit.

for capsule endoscopy, the investigators are interested in how physical activity affects the speed of capsule transit through the gi tract. capsule endoscopy involves a patient swallowing a pill which contains a camera, in order to image the parts of the bowel that a conventional endoscope cannot reach. a rapid transit may result in insufficient mucosal visualisation, which would reduce the sensitivity of the investigation. for oesophageal ph monitoring, it is essential that the patient behaves as they would normally to produce measurements that represent a standard day. using accelerometry, the investigators can compare the amount, and nature, of physical activity taken throughout the investigation to that of the preceding day, or week. in addition, further analysis of motion data captured will allow us to correlate specific activities and body orientation with ph readings to get a better insight into the pathophysiology of a patient's condition. the studies will be conducted over 6-9 months in imperial college trust's medical outpatient service. all patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will be asked to consider participating. patients will receive the ear sensor up to 2 days before their investigation, and will be asked to wear it until the end of their investigation (not whilst sleeping). capsule endoscopy normally takes less than 12 hours, and ph monitoring takes between 24 and 48 hours. participation makes no difference to the standard or type of care that they will receive, the sensor data is additional.

Eligibility criteria:
inclusion criteria: * planned 24 hour oesophageal ph monitoring study, or capsule endoscopy exclusion criteria: 1. undergone previous capsule endoscopy or ambulatory oesophageal ph test 2. currently a hospital in-patient 3. severe mobility disorder (unable to walk or mobilise independently) 4. age less than 18 or above 65 5. physically unable to wear ear sensor (eg. bilateral hearing aids or particularly small ears)

Keywords: physical activity accelerometry oesophageal ph capsule endoscopy
symptomatic treatment of acute uncomplicated diverticulitis

Conditions: Diverticulitis

Summary: the purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.


Eligibility criteria:
inclusion criteria: * computed tomography-diagnosed acute uncomplicated\* diverticulitis * no abscess, fistula, obstruction and distant intra- or retroperitoneal air. pericolic air allowed. exclusion criteria: * already commenced antimicrobial medication * immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease) * suspicion of generalized peritonitis * organ dysfunction * another infection requiring antimicrobial medication * pregnancy * age \ 90 years * missing written consent
impact of air pollution and climate changes on the epidemiology of cardiovascular disease

Conditions: Pollution; Exposure; Acute Coronary Syndrome; Chronic Coronary Insufficiency; Particulate Matter Inhalation Injury; Cardiovascular Diseases; Cardiovascular Risk Factor

Summary: despite the fact that the topic of air pollution has been in focus of researchers for many years, there are no big studies that take up the matter of its influence on acute coronary, cerebral syndromes and cvd mortality in europe. taking into consideration the scarce number of surveys from europe the investigators decided to analyze the impact of air pollution on cardiovascular diseases and cvd mortality in poland.

air quality and its impact on health was put in the spotlight since the infamous great smog of london. since then, it became clear that adverse effects are serious and can no longer be ignored. according to the world health organization (who) estimations, in last year ambient air pollution caused 4,200,000 deaths worldwide. these statistics included a total of 29,165 deaths that were attributed to air pollution in poland. the vast of studies are conducted in highly polluted areas, in which patients are exposed to extreme concentrations like china oraz indie. taking into consideration the scarce number of surveys from europe the investigators decided to analyze the impact of air pollution and cardiovascular diseases in poland. data on morbidity and mortality were collected from the national statistical office in poland. the data of air pollutions and gases were obtained from voivodeship inspectorate for environmental protection. the daily meteorological data were obtained from the institute of meteorology and water manageme

Eligibility criteria:
inclusion criteria: - residents from analysed area. exclusion criteria - none

Keywords: air pollution particulate matter acute coronary syndromes cardiovascular disease risk factors
improved ability to cope with everyday life through a person-centered training program in elderly patients with rheumatoid arthritis - pep-walk study

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to examine whether person-centered high-intense aerobic / strength training during five months reduces inflammation and disease activity, improve immune cell function, and increases muscle strength, fitness and ability of the individual independence in elderly patients with rheumatoid arthritis.


Eligibility criteria:
inclusion * patients 65 years or older with ra diagnosed according to the acr / eular 1987/2010 criteria, * disease duration 2 years or more, * disease activity as measured by das28 \<5.1 exclusion * comorbidities, such as unstable coronary artery disease, uncontrolled cardiac arrhythmia, or uncontrolled high blood pressure, which prevents moderate to intense exercise. * joint surgery completed within 6 months prior to study entry. * ongoing training at moderate to high level 2 or more times per week
br790 in combination with anlotinib in adult subjects with advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is a phase ⅰ/ⅱa, multi-center, open-label study, aiming to evaluate the safety, tolerability, pharmacokinetic (pk), and efficacy of br790 in combination with anlotinib in adult participants with advanced nsclc.

this study is a phase ⅰ/ⅱa, multi-center, open-label study of br790 in combination with anlotinib with a dose escalation part followed by a dose expansion part in adult subjects with advanced nsclc. participants will be treated until disease progression per recist v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤75 years old. * subjects with histologically or cytologically confirmed locally advanced or relapsed metastatic driver negative (egfr, alk, ros, etc.) advanced nsclc，whose disease progressed after at least 2 previous standard therapies. * eastern cooperative oncology group (ecog) performance status of 0 to 1. * has at least one measurable lesion per response evaluation criteria in solid tumors version 1.1 (recist 1.1) . exclusion criteria: * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. * has uncontrolled moderate to massive effusion. * central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (\>50ml/day). * other kinds of malignancies within 5 years or for now. * has not enough organ functional reserve at baseline, which met at least one of the following criteria： anc\ 1.5×uln, alt or ast\>2.5×uln (without liver metastases) , alt or ast\>5×uln (with liver metastases);cr \>1.5×uln, urine protein≥++，or confirmed 24h urine protein≥1.0g;inr \>1.5×uln, pt\>1.5uln or aptt \>1.5×uln. * previous use of other shp2 inhibitors (such as tno-155, jab-3312, jab-3068, rly-1971, rmc-4630, etc.) * has used anlotinib before * the first assessment of efficacy was pd, or occurred ≥grade 3 adverse reactions with antitumor angiogenesis small-molecule drugs (e.g. apatinib, surufatinib, fruquintinib, etc.), or less than 6 months after the last antitumor vascular therapy. * has got non remissive toxic reactions derived from previous therapies, which is over level 1 in ctc ae (5.0), alopecia and grade 2 peripheral neuropathy are not included.

Keywords: br790 anlotinib nsclc ptpn11 shp2
nva237 bid versus placebo twelve-week efficacy study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study serves to determine whether the treatment of patients with stable, symptomatic chronic obstructive pulmonary disease (copd) with the investigational drug nva237 is efficient and safe. the efficacy and safety of the drug will be tested against a placebo treatment. the primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with nva237 versus those that have received placebo treatment for 12 weeks. a serial lung function measurement (fev1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.


Eligibility criteria:
inclusion criteria: 1. patients with stable, symptomatic chronic obstructive pulmonary disease (copd) with airflow obstruction of level 2 and 3 according to the current global initiative for chronic obstructive lung disease (gold) strategy (2011). 2. patients with forced expiratory volume in one second (fev1) ≥ 30% and \<80 % of the predicted normal, and fev1/fvc \< 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide. 3. current or ex-smokers with at least 10 cigarette pack years smoking history. exclusion criteria: 1. patients with a history of long qt syndrome, with a prolonged qtc measured during screening, or patients who have a clinically significant ecg abnormality at screening. 2. history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 3. pregnant or nursing (lactating) women. women of childbearing potential unless using an effective method of contraception. 4. patients who in the judgment of the investigator, would be at potential risk if enrolled into the study. 5. patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment. 6. patients with a body mass index (bmi) of more than 40 kg/m2. 7. patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines. 8. patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening. other protocol-defnied inclusion/exclusion criteria may apply.

Keywords: anticholinergic antimuscarinic chronic obstructive airway disease chronic obstructive lung disease chronic obstructive pulmonary disease copd lama lung disease lung diseases, obstructive lung function muscarinic receptor antagonist pulmonary disease, chronic obstructive respiratory tract diseases
balance training in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a growing body of evidence suggests that individuals with chronic lung disease have important deficits in balance control that may be associated with an increased risk of falls. the main purpose of this study is to examine the effects of a balance training program on measures of balance and fall risk in people with chronic lung disease.


Eligibility criteria:
inclusion criteria: * diagnosis of copd; a self-report of decline in balance or fall in the last 5 years or a recent near fall; smoking history greater than 10 pack years; and are able to provide written informed consent. exclusion criteria: * inability to communicate because of language skills, hearing or cognitive impairment; and evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced parkinson's disease, amputation).
attention deficit disorder and exposure to lead

Conditions: Attention Deficit Disorder

Summary: we are examining the past exposure to lead in 250 well characterized children with adhd, and a suitable group of controls. our measure of past exposure is bone lead levels obtained by xray fluorescence spectroscopy, a relatively new way of estimating bone lead concentrations, and by inference, body lead burdens. by comparing the lead concentrations in these two groups, controlling for other factors which could confound, we will estimate odds ratios for adhd given elevated bone lead, and estimate the contribution of lead to this disease of childhood.


Eligibility criteria:
case subjects are drawn from adolescents aged 10 to 18 previously seen at western psychiatric institute and clinic for evaluation, and meet the dsm-iiir criteria for diagnosis of adhd based on a structured parent interview and standardized parent and teacher rating scales. cases were also systematically observed and evaluated in the summer treatment program between 1987 and 1996 at wpic. controls are demographically matched non-adhd adolescents, recruited from surrounding communities and pediatric practices.

Keywords: lead exposure bone lead attention deficit
chronic clinical effect of acetazolamide

Conditions: Hypertension, Pulmonary

Summary: the study seeks primarily to determine the chronic clinical effect of aza on exercise capacity (6mwd) compared to placebo.

pulmonary hypertension (ph) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (qol) and survival. treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. unfortunately, ph specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. therefore, novel therapeutic drugs are needed. we have recently demonstrated that sleep related breathing disorders, which are common in ph patients, can be improved by both nocturnal oxygen therapy and acetazolamide (aza). aza is a carbonic anhydrase (ca) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly ph. there are even data suggesting that ca-inhibitors have a direct pulmonary vasodilator effect. however, the potential role of aza in the treatment of ph has not been conclusively studied. therefore, the purpose of the current project is to investigate, the chronic clinical effects of aza in ph patients.

Eligibility criteria:
inclusion criteria: * all patients undergoing right heart catheterisation (rhc) for a clinical indication and who are diagnosed with precapillary ph (mean pulmonary arterial pressure (mpap) ≥25 mmhg, pulmonary wedge pressure (pawp) ≤15mmhg) * patients have to be in a stable condition, on the same medication for \>4 weeks exclusion criteria: * patients in whom a rhc is clinically not indicated * pregnant women * ph in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease

Keywords: treatment outcome acetazolamide
enhancing speech fluency with non-invasive brain stimulation in developmental stuttering

Conditions: Stuttering; Fluency Disorders; Speech Disorders

Summary: this study aims to test whether the addition of transcranial direct current stimulation (tdcs) to speech fluency training results in improvements in speech fluency in adults with developmental stuttering. half of the participants will receive anodal tdcs on five consecutive days, the other half will receive a sham stimulation for the same amount of time.

studies using tdcs have shown improvements in motor performance, and in expressive language skills in clinical and healthy populations. the benefits of single sessions of tdcs are short-lived. however, stimulation over multiple sessions can increase and prolong learning effects that can persist for several weeks after the end of the stimulation period. we aim to target left hemisphere frontal regions involved in speech production with tdcs, and to pair this stimulation with speech fluency training.

Eligibility criteria:
inclusion criteria: * native speaker of english. * right handed. * participant has moderate to severe developmental stuttering (stammering) exclusion criteria: * speech, language or communication disorder other than developmental stuttering. * sensory impairment (hearing loss or visual impairment) * history of drug abuse. * history of seizures * history of a neurological or psychiatric illness. * history of neurosurgical procedure. * currently taking certain prescription medications such as anti-depressants and anti-malarial medication (as these may lower the seizure threshold)

Keywords: stammering brain stimulation
improving clinical trial awareness in nsclc: pilot testing a novel healthcare it platform for incorporating education at the point of care

Conditions: Non-Small Cell Lung Carcinoma (NSCLC)

Summary: the objective of this study is to 1) evaluate the impact of a novel individualized care planning/ educational technology (the on q care planning system or cps) on oncology patient and provider knowledge, attitudes and beliefs about non-small cell lung carcinoma (nsclc) clinical trials, as well as 2) to evaluate the impact of the on q cps on patient referral to and enrollment in nsclc clinical trials.


Eligibility criteria:
inclusion criteria: * all participants must be 18 years of age or older. * patient participants must have stage iii, iv and/or recurrent nsclc. * patient participants must be at a point of treatment initiation/change or evaluation for treatment initiation/change * patients must have working email address and internet access exclusion criteria: * any participant who cannot understand written or spoken english. * any participant who is not competent to provide informed consent for study participation per the investigator. * any participant who cannot be present for the related study visits and/or complete the post-test assessment
electrical stimulation of cutaneous lesions

Conditions: Chronic Ulcer; Burns

Summary: skin lesions, such as chronic ulcers and burns, represent a serious public health problem due to high government costs, and scarce successful conservative treatments.there is a growing scientific literature on the use of electrotherapy in the process of wound healing, but in return there is a dearth of scientific studies on the use of various types of currents and the different parameters in the proposed treatments.

this project proposes the use of polarized currents to increase the speed of healing in chronic ulcers and donor sites in burn patients. will be included 30 patients with chronic ulcers and 30 burn patients undergoing skin graft surgery, will be randomized into control and treated groups. for the ulcer chronic group treatment will be with 50 minutes high voltage and 10 minutes diadynamica current and the burn group only 50 minutes high voltage current.

Eligibility criteria:
inclusion criteria: * all patients admitted to the rehabilitation center of clinical hospital with chronic ulcer, faculty of medicine of ribeirão preto / usp, in the period between january 2010 and december 2011 * all patients admitted to the burns unit of clinical hospital, faculty of medicine of ribeirão preto / usp, in the period between march 2011 and december 2012 exclusion criteria: * infection * weight below 16kg

Keywords: electrical stimulation wound healing polarity current burn chronic ulcer