Kornimate/medical-research-clean huggingface dataset:
interaction in chronic obstructive pulmonary disease experiment

Conditions: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Smoking; Bronchodilation

Summary: the final purpose of this study is to determine whether bronchodilation and cigarette smoking in chronic obstructive pulmonary disease (copd) patients interact, resulting in an increase of cardiovascular disease. the aim of this part of the study is to demonstrate the basic mechanism: does increased respiratory function after administration of a bronchodilator in patients with copd lead to elevated pulmonary retention of the harmful compounds in inhaled cigarette smoke and to short-term biological effects associated with cardiovascular disease?

copd currently is one of the most frequent diseases. in more than 80% of copd patients, the disease is caused by smoking. about half of the copd patients are active smokers, although smoking is also the most important prognostic factor. also, smoking is an important cause as well as an important prognostic factor in cardiovascular disease. the corner stone of medical treatment in copd is bronchodilation; more than half of the patients use a long-acting bronchodilator. an increase of the pathogenic effect of smoking by an increased lung function after bronchodilation is likely though, since more pathogenic particles would penetrate the lung. we hypothesize that bronchodilators increase cardiovascular disease in copd patients who smoke. in order to demonstrate the basic mechanism of our hypothesis, copd patients receive a bronchodilator at one time and a placebo at another time, preceded and followed by cigarette smoking during one hour as by a strict time schedule. smoke retention, lung function and blood biomarkers are repeatedly measured.

Eligibility criteria:
inclusion criteria: * copd gold stage ii-iii (fev1/fvc\<0,70 and fev1 30-80% of predicted value). * current cigarette smoking (at the time of performing the study). * willing to provide written informed consent. * refrain from smoking and bronchodilators \> 8 hours (depends on treatment) before the test. * registered in one of the recruitment institutes. exclusion criteria: * copd gold stage i or iv. * asthmatic component: history of asthma, present asthma by complaints, eosinophilia or reversibility ≥ 10% of predicted. * unable to communicate. * physically unable to perform any of the tests. * non-copd respiratory disorders. * previous lung-volume reduction surgery and/or lung transplantation. * evidence of alcohol, drug or solvent abuse. * known α-1 antitrypsin deficiency.

Keywords: intervention study interaction copd
phase i/ii study of venetoclax or lenalidomide in combination with ublituximab and umbralisib in subjects with relapsed or refractory cll/sll and nhl

Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma

Summary: phase i/ii study of venetoclax or lenalidomide in combination with ublituximab and umbralisib in subjects with relapsed or refractory cll/sll and nhl


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of b-cell chronic lymphocytic leukemia, or non-hodgkin's lymphoma * refractory to or relapsed after at least 1 prior treatment regimen * eastern cooperative oncology group (ecog) score of 0 to 2 exclusion criteria: * any major surgery, chemotherapy or immunotherapy within the last 21 days * known hepatitis b virus, hepatitis c virus or hiv infection * known histological transformation from cll to an aggressive lymphoma (richter's)
lantus versus humalog mix as add-on therapy in type diabetes patients failing sulfonylurea and metformin combination treatment

Conditions: Diabetes Mellitus, Type 2

Summary: study primary objectives: to compare glycemic control, as measured by hemoglobin a1c (a1c), between insulin glargine and 75% insulin lispro protamine suspension/25% insulin lispro as add-on therapies in subjects who failed oral combination therapy with sulfonylurea and metformin. study secondary objectives : to compare the following measures between subjects receiving insulin glargine or 75% insulin lispro protamine suspension/25% insulin lispro: * incidence of hypoglycemia * change in weight * change in serum lipid profile * percentage of subjects achieving a1c levels ≤7%

the planned duration of enrollment is 6 months. the study consists of 2 weeks screening phase and a study period that was planned to be 24 weeks.

Eligibility criteria:
inclusion criteria: * patients must have given their signed informed consent. * males or females between 18 and 79 years of age. * diagnosis of type 2 diabetes mellitus for at least one year. * patients must have had continuous oral hypoglycemic treatment for at least three months using dosing of: at least half maximally labeled dose of sulfonylurea + at least 1000 mg metformin daily. * hba1c ≥ 8 % and ≤11 %, inclusive, as measured at screening (visit 1). * patients must have bmi of \> 25 kg/m2 at baseline * willingness to accept, and demonstrate ability to inject insulin glargine or 75% insulin lispro protamine suspension and 25% insulin lispro injection therapy. * ability and willingness to perform smbg profiles using a plasma glucose meter at least twice a day. * patients must be able to understand and willing to adhere to and be compliant with the study protocol exclusion criteria: * patients, who have had stroke, mi, coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) or angina pectoris within the last 12 months. * patients with congestive heart failure requiring pharmacological treatment. * patients on non-selective beta blockers (including ocular). * patients with impaired renal function, as shown by but not limited to serum creatinine ≥ 1.5 mg/dl (133μmol/l) for males, or ≥ 1.4 mg/dl (124 μmol/l) for females. * patients with acute infections. * patients with diagnosis of dementia. * treatment with systemic steroids or large doses of inhaled steroids. * patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis. * patients with planned radiological examinations requiring administration of contrasting agents. * clinical evidence of active liver disease, or serum alt 2.5 times the upper limit of the normal range. * patients with history of hypoglycemia unawareness. * pregnant or lactating females. * failure to use adequate contraception (women of current reproductive potential only). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
use of a smartphone mobile application (app) to enhance smoking cessation treatment

Conditions: Depression; Tobacco Use Disorder; Current Every Day Smoker

Summary: this trial studies how well smartphone mobile applications work in enhancing smoking cessation treatment in current smokers. smartphone mobile applications may help current smokers quit smoking.

primary objectives: i. to test the acceptability and preliminary efficacy of a smartphone health application (app), kick ash, which will incorporate brief behavioral activation versus (vs.) a relaxation app, breathe2relax in a small randomized controlled trial of smokers with elevated depressive symptoms. outline: participants are randomized to 1 of 2 groups. group i: participants receive kickash smartphone mobile application designed to help the learning of relaxation skills over 8 weeks. group ii: participants receive breathe2relax smartphone mobile application designed to help improve mood and increase level of enjoyable activities over 8 weeks.

Eligibility criteria:
inclusion criteria: * md anderson patient between the ages of 18 to 65 * current smoker (i.e., at least 1 cigarette or e-cigarette per day) * smoking for at least one year * willing to set a quit date in the next 30 days * not engaged in smoking cessation treatment other than the mdacc tobacco treatment program * currently elevated depressive symptoms or a history of elevated depressive symptoms; (phq 2 = or \> 1); current or past * english speaking and ability to read and comprehend english * currently own an ios mobile phone or tablet (iphone; ipad) using ios 9.0 or later and reports regular use (at least weekly) of at least 1 ios app exclusion criteria: * any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator or collaborator * subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study
consolidation therapy for acute myeloid leukemia guided by leukemia stem cell behavior

Conditions: Acute Myeloid Leukemia

Summary: the primary objective of the trial is to compare the two-year relapse-free survival (rfs) of patients with acute myeloid leukemia (aml), presumed to be at high risk for relapse due to the presence of leukemia stem cells (lscs) in their bone marrow at first complete remission (cr1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (sct).


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years 2. able to give informed consent 3. new diagnosis of aml, other than apl or poor-risk aml, as defined in section 3.2 exclusion criteria: 1. has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy 2. any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up 3. pregnancy: women of childbearing potential who are β- hcg+
neurobic exercise program on cognitive abilities

Conditions: Mild Cognitive Impairment

Summary: this research aims to investigate the significance of a neurobic exercise program on cognitive abilities, memory retention, activities of daily living (adl), and quality of life (qol) among older adults with mild cognitive impairment in pakistan. it aims to find the long-term effects of a neurobic exercise program by comparing subjective and objective memory and its effects on quality of life.

mci is a condition marked by a noticeable decline in cognitive functions, it is often considered a precursor to more severe forms of dementia, making early intervention crucial. neurobic exercises are designed to stimulate the brain through multiple senses and to create a novel thinking pattern. these exercises might include activities involving sight, smell, touch, taste, and hearing, structured over six weeks to challenge the brain with non-routine tasks that promote creative thinking and memory retention. neurobic exercise aims to maintain strength, flexibility, and mental health as you age. however, most research has focused on older, healthy individuals or those with chronic conditions. studies on elderly persons with mci are rare, and there are limited studies on the long-term effects of improved memory function. this research aims to investigate the significance of a neurobic exercise program on cognitive abilities in older adults with mild cognitive impairment in pakistan. it aims to find the long-term effects of a neurobic exercise program by comparing subjective and objective memory and its effects on quality of life. the findings will give insight to physiotherapists and multidisciplinary teams to improve memory retention, delay brain deterioration, and promote memory health and quality of life, making the intervention program a valuable guide.

Eligibility criteria:
inclusion criteria: * older adults above 60 * both male and female. * scored \<24 on the montreal cognitive assessment (moca). * scored \>12 on the modified barthel adl index (bai). * ability to write and read as well as communicate well, willingness to participate in the study throughout the program exclusion criteria: * neurological, musculoskeletal, psychiatric conditions, hearing loss and visual impairment. * older adults with a history of allergies to the food or flowers used in the activities.

Keywords: cognitive impairment neurobic exercise memory adl
modeling between plasma concentration and serotonin transporter occupancy induced by escitalopram in obsessive-compulsive disorder(ocd) patients

Conditions: OCD

Summary: to modeling the pharmacokinetic-pharmacodynamic(pk-pd) simulation with the plasma concentration and the transporter occupancy from ocd patients treated with escitalopram. to examine the effect of g2677t/a single nucleotide polymorphism(snp) of abcb1 gene to the pk-pd modeling in ocd patients treated with escitalopram.

to measure plasma concentration of escitalopram in ocd patients treated with escitalopram. to measure serotonin transporter occupancy by escitalopram in ocd patients treated with escitalopram. to genotype g2677t/a snp of abcb1 gene in ocd patients treated with escitalopram.

Eligibility criteria:
inclusion criteria: * diagnosis of ocd based on diagnostic and statistical manual(dsm)-iv criteria * no change of escitalopram dosage in 6 weeks exclusion criteria: * psychiatric comorbidity other than ocd * history of head injury, epilepsy, other general medical disorder
safety, pharmacokinetics and potential activity of he3286 in obese adult subjects

Conditions: Insulin Resistance

Summary: the objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of he3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of he3286 to decrease insulin resistance. an open-label cohort of 6 patients with type ii diabetes mellitus will be treated at 10 mg (5 mg bid).

he3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. in preclinical experiments, he3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. he3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. in these experiments, he3286 lowered blood glucose levels and prevented progression of hyperglycemia and he3286 appeared to enhance insulin sensitivity.

Eligibility criteria:
main inclusion criteria: * males or females between 18 and 65 years of age * body mass index for females between 29 and 35 kg/m2 and no more than 37 kgm2 for males * fasting blood glucose level \< 126 mg/dl at screening * 2 hour postprandial (following 75 grams glucose) blood glucose between 140 to 200 mg/dl * normal thyroid stimulating hormone with or without thyroid replacement therapy * fasting triglycerides \< 350 mg/dl * for females of reproductive potential, agree to avoid pregnancy during the study and for 3 months following study completion, have a negative serum and/or urine pregnancy test, and use an acceptable method of birth control * non-smoker or has not smoked for 6 months prior to the screening visit * no history of alcohol abuse within 2 years * negative drug screen at screening and baseline * stable weight (+/- 5%); no history of weight loss or gain (\> 10% body weight) * must provide voluntary, written, informed consent prior to screening evaluations * must be able to swallow capsules main exclusion criteria: * marked prolongation of qt/qtc interval or history of additional risk factors for torsades de pointes at screening or baseline * positive for hiv, hav, hbv or hcv * history of clinically significant cardiovascular, hepatic, respiratory or renal or endocrine disorders * history of breast and/or prostate cancer * clinically significant neurological or psychiatric condition, uncontrolled hypertension, clinically significant unstable medical abnormality, chronic disease or active, serious clinical infection or condition * personal or family member with breast and/or prostate cancer * malignancy within past 5 years except for successfully treated basal cell carcinoma of the skin * personal and/or family history of venous thromboembolism * history of stroke and/or heart attack * medication prohibited from study

Keywords: phase i safety tolerance insulin resistance obese pharmacokinetics
data collection study of wedge pressure data in patients with crt-d devices

Conditions: Heart Failure

Summary: zwedge is a clinical feasibility ide study. the objective is to characterize the relationship between intra-thoracic impedance measurements obtained from a crt-d device and pulmonary capillary wedge pressure (pcwp) measured via a right heart catheterization (rhc) acutely and over time.

intra-thoracic impedance will be obtained at programmed intervals by using an investigational monitoring feature in the crt-d device. to obtain impedance values, the device delivers a sub-threshold impulse that measures the resistance between 2 electrodes.

Eligibility criteria:
inclusion criteria: * have a sjm promote crt-d (model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per acc/aha/hrs guidelines. * have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation. * have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar lv lead. exclusion criteria: * be less than 18 years of age. * have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia. * have a contraindication for right heart catheterization. * have a contraindication for the delivery of iv nitroglycerin. * be pregnant or planning a pregnancy for the duration of their study participation. * be currently participating in a clinical investigation that includes an active treatment arm. * have a life expectancy of less than 12 months due to any condition. * be unable to perform the valsalva maneuver with airway pressure \> 40 mm hg for ≥10 seconds. * are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.

Keywords: heart failure impedance monitoring wedge pressure
efficacy and safety of lercanidipine and valsartan in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of fixed combination of lercanidipine (10 mg or 20 mg) and valsartan (80 mg or 160 mg), lercanidipine and valsartan alone in reducing blood pressure. the study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility criteria:
inclusion criteria: * patients aged between 20 and 75 * essential hypertension at screening (-3 week) randomization criteria: * essential hypertension at baseline (90mmhg≤sitdbp≤109mmhg, except sitsbp≥180) exclusion criteria: * mean sitdbp≥110mmhg or sitsbp≥180 * secondary hypertension or suspected secondary hypertension * uncontrolled diabetes * severe heart disease or severe cerebrovascular disease * clinically significant hematological test results, renal disease (serum creatinine) or liver disease (alt or ast) * history of malignant disease * autoimmune disease * women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial

Keywords: hypertension lercanidipine valsartan
a study to evaluate intravitreal jnj-81201887 (aavcagscd59) compared to sham procedure for the treatment of geographic atrophy (ga) secondary to age-related macular degeneration (amd)

Conditions: Geographic Atrophy

Summary: the purpose of this study is to evaluate change in geographic atrophy (ga) lesion growth of eyes treated with jnj-81201887 compared to sham control.


Eligibility criteria:
inclusion criteria: * have non-subfoveal (defined as not involving the center point of the fovea) geographic atrophy (ga) secondary to age-related macular degeneration (amd) with an area that can be measured and measures 2.5 millimeter square (mm\^2) to 17.5 mm\^2 (1- and 7- disc areas respectively), determined by the central reading center (crc) from screening images of fundus autofluorescence (faf) and spectral domain optical coherence tomography (sd-oct) * if ga is multifocal, at least one focal lesion must be greater than or equal to (\>=) 1.25 mm\^2 (0.5- disc area), as assessed by the crc * ga can be photographed in its entirety by faf, using a 30- degree image centered on the fovea, as assessed by the crc * fellow eye must be present with a best corrected distance visual acuity (bcva) of counting fingers or better * man or woman (according to their reproductive organs and functions assigned by chromosomal complement) exclusion criteria: * history of transpupillary thermotherapy, photodynamic therapy or external-beam radiation therapy in the region of study eye * any prior thermal laser in the macular region, regardless of indication * history of retinal detachment (with or without repair) * active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis * any sign of diabetic retinopathy or central serous chorioretinopathy

Keywords: macular degeneration
mental practice in parkinson's disease

Conditions: Parkinson Disease

Summary: introduction although drug therapy is the mainstay of treatment for parkinson's disease, the therapy also has its importance by means of exercises which maintains the muscular activity and preserve mobility. one of the techniques that has been used for physical therapy is the mental practice of the mental simulation of movement, aiming at learning or improvement of motor skills through the cortex areas of activation responsible for the movement of preparation before it is executed. in patients with parkinson's disease motor anticipation this system is compromised, culminating in the march changes and increased risk of falls. objective: to evaluate the effects of mental practice on physical therapy on the march and the risk of falls in people with parkinson's disease. method: the study is defined as a randomized clinical trial with systematic recruitment. recruitment will be conducted at the clinic of neurology, hospital das clinics federal university of pernambuco (pro-parkinson project: neurology) and the intervention will be held at the same hospital physiotherapy clinic. both the control group and the trial will be subjected to 15 therapy sessions twice a week, lasting 40 minutes for physical therapy and 15 for mental practice.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of idiopathic parkinson's disease * male and female * stage 1-3 of the hoehn and yahr scale. exclusion criteria: * have other neurological diseases * they have decompensated systemic diseases * musculoskeletal changes that prevent the achievement of movements * with lowering of the cognitive level assessed using the mini-mental state examination with cutoff point according to education * with respiratory impairment * with medical restrictions for performing exercises * do not get hold motor imagination during the application of visual and kinesthetic imagery questionnaire-10 * in physical therapy, occupational therapy service for 3 months or more; * patients with moderate to severe depression assessed by inventory beck depression inventory