Kornimate/medical-research-clean huggingface dataset:
the validate study of valsartan for patients with early stage heart failure

Conditions: Hypertension; Congestive Heart Failure

Summary: this is a study to evaluate the response of patients with hypertension and early stage heart failure to valsartan.


Eligibility criteria:
inclusion criteria: * male or female 25-85 years of age, inclusive * past diagnosis of hypertension for a min 1 year * patients with an established treatment regimen for hypertension with one or more agents for a minimum period of 2 months * bp is considered adequately controlled with dbp \< 90mmhg * elevated bnp levels both in bedside test (62pg/ml) and after validation of a separate blood sample (40pg/ml) in the central laboratory * lv ejection fraction ³ 45% * lvh defined as myocardial mass ³ 116 g /m2 in males and 104 g/m2 in females * at least one of the following parameters of diastolic dysfunction * e/a \< 1 for the patients who are younger than 55 years or \< 0.8 for the patients whose age is ³ 55 years (full year), or * dt \> 220 ms, or * ivrt \> 90 ms exclusion criteria: • present use of ace inhibitor other protocol-defined exclusion criteria may apply. -

Keywords: hypertension heart failure peptide valsartan
incidence of intravascular (iv) injection during trigeminal nerve blocks

Conditions: Trigeminal Neuralgia; Facial Pain; Postherpetic Neuralgia; Cluster Headache

Summary: the purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.

the patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1 ratio to tuohy needle group or quincke needle group after being informed about the study.

Eligibility criteria:
inclusion criteria: * the patients who scheduled to undergo trigeminal nerve block due to the facial pain exclusion criteria: * refusal of the patient * pregnancy * coagulopathy * local or systemic infection * allergy to injectate * anatomical deformation of the skull
directional spread in geographic atrophy

Conditions: Nonexudative Age-related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of irreversible blindness in industrial countries. in the late stages of the disease, neovascular changes or the development of geographic atrophy (ga) may induce severe visual loss. ga is characterized by the development of areas of outer retinal atrophy with continuous spread over time that is corresponded to an visual field defect for the patient. the pathogenesis is still incompletely understood. despite the break-through in the treatment of neovascular amd by intravitreally administrated vascular endothelial growths factor (vegf) inhibitors, there is yet no treatment available to slow down or halt the disease process in ga. we and others have demonstrated that the total ga area progression shows large differences between patients. potential factors influencing differential progression have been intensely studied: while neither systemic nor genetic factors have been shown to influence ga progression, ocular characteristics such as ga baseline size or phenotypic features of fundus autofluorescence (faf) abnormalities have been identified as risk characteristics for increased ga progression. while these previous studies have mainly focused on the characterization of total ga area progression, topographic directional spread has not been analyzed and relevant predictive markers are yet unknown. there may be large differences in the local ga progression. the primary objective of this study is to identify specific characteristics, for the local ga progression. the knowledge of such risk factors may help to better understand the pathogenesis of ga. the identification of predictive markers will allow for better prognostic assessment of the individual disease process. the dsga study is the extension trial of the fam (fundus autofluorescence in age-related macular degeneration) study (nct00393692).


Eligibility criteria:
inclusion criteria: * informed consent * men and women, any race, aged 55 years or older at the baseline visit * if both eyes meet the criteria to be study eye either eye will be included into the analysis. * patient is willing to undergo ocular examinations once every 6 for up to 24 months exclusion criteria: * the presence or history of cnv (choroidal neovascular membrane) in the study eye * ocular disease in the study eye that may confound assessment of the retina, other than non-exudative amd (e.g., diabetic retinopathy, uveitis) * any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease). * any condition that would make adherence to the examination schedule of once every 6 months for up to 24 months difficult or unlikely, e.g., personality disorder, chronic alcoholism, alzheimer's disease or drug abuse * known medical history of allergy or sensitivity to tropicamide or fluorescein dye that is clinically relevant in the investigator's opinion

Keywords: geographic atrophy age-related macular degeneration retina retinal pigment epithelium optical coherence tomography scanning laser ophthalmoscopy
study to evaluate effectiveness of investigational device in the assistance of detection and diagnosis of breast cancer

Conditions: Breast Cancer

Summary: this study aims to evaluate effectiveness of investigational device, lunit insight mmg, in the assistance of detection and diagnosis of breast cancer during screening mammography interpretation.

the lunit insight mmg is developed as a computer-assisted detection/diagnosis device based on deep learning technology. in this pivotal study, effectiveness of the investigational device, lunit insight mmg, was examined by comparing the reading panelist's interpretation ability between cad assisted and unassisted during screening mammography interpretation.

Eligibility criteria:
inclusion criteria: * female * any ethnic origin * acquired with devices from two manufacturers: hologic and ge * 4 views (rmlo, lmlo, rcc, lcc) images of ffdm (full-field digital mammography) exclusion criteria: * previous core needle biopsy in breast for past 2 years * previous vacuum-assisted biopsy, surgical biopsy or surgery in breast * previous breast cancer * lactating when taking screening mammograms * presence of a breast implant in screening mammograms * presence of a pacemaker in screening mammograms * inadequate quality status such as insufficient anatomical coverage of screening mammograms
effectiveness of self-management skills for metabolic syndrome fatty liver disease adults

Conditions: Metabolic Syndrome

Summary: the multidimensional self-management intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome. thus, the purpose of this study was to assess the efficacy of multidimensional self-management intervention program on metabolic syndrome subjects in taiwan.

the study is a 2-parallel groups' randomized controlled trial. participants with metabolic syndrome (three or more risk factors - triglycerides (tg) \>150 mg/dl, systolic blood pressure (sbp) ≥130 mm hg, diastolic blood pressure (dbp) ≥85 mm hg, or fasting blood glucose≥100 mg/dl; high-density lipoprotein cholesterol\<50 mg/dl, or waist circumference ≥80 cm) are enrolled. the four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). the parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (6th months and 18th months). all participants complete a structured questionnaire, including basic information, physical activity, and food-frequency.

Eligibility criteria:
inclusion criteria: * adult women with age ≥ 50 years * low education, defined as having less than 6 years of education or being primary school graduates * presence of metabolic syndrome * community-dwelling * no hearing and visual acuity difficulties exclusion criteria: * unconscious * cognitive impairment or dementia

Keywords: self-management intervention metabolic syndrome women
assesment of new devices for the diagnostic evaluation of diaphragmatic dysfunction

Conditions: Diaphragmatic Paralysis; Healthy Volunteers

Summary: this study aim to evaluate wether new, non-invasive and non-contact devices such as structured light plethysmography (slp) and sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.

the measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using slp and sonar devices. subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. the slp and the sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. data will be collected during 5 minutes of tidal breathing. the same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. during both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (ic) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.

Eligibility criteria:
for healthy volunteers inclusion criteria: * no respiratory disease * no neurologic disease * no thoracic deformation exclusion criteria * respiratory disease * neurologic disease * thoracic deformation for patients inclusion criteria: * patients with a suspicion of diaphragmatic dysfunction exclusion criteria: * pregnant women * contraindications to standard procedure requiring transdiaphragmatic measurement

Keywords: structured light plethysmography sonar transdiaphragmatic pressure
ecmella vs. ecmo on 30-day mortality

Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Extracorporeal Membrane Oxygenation Complication; Cardiogenic Shock; Acute Myocardial Infarction

Summary: this international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (ecpr) during cardiac arrest.

left ventricular unloading with impella® micro-axial pump has been shown to improve survival in patients with cardiogenic shock treated with veno-arterial extracorporeal membrane oxygenation (va-ecmo). this study aims to investigate whether treatment with va-ecmo and impella ® (so called "ecmella") during extracorporeal cardiopulmonary resuscitation is associated with improved outcomes.

Eligibility criteria:
inclusion criteria: * adult patients * cardiac arrest * treatment with veno-arterial extracorporeal membrane oxygenation (va-ecmo) or "ecmella" (that is va-ecmo plus left ventricular impella® micro-axial pump) exclusion criteria: * non-adult patients * no treatment with va-ecmo or "ecmella"
the motor neurological soft signs (mnss) in persons with schizophrenia

Conditions: Psychomotor Status; Schizophrenia; Motor Skills Disorders

Summary: the aim is to contribute to the knowledge of the relationship between motor neurological soft signs (mnss) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia.

the aim is to contribute to the knowledge of the relationship between motor neurological soft signs (mnss) and schizophrenia, as well as to point out the implications and recommendations for clinical and rehabilitative practices, in order to contribute to the identification of these signs as potential facilitators of prevention and a better follow-up in the psychosocial rehabilitation processes of the person with schizophrenia. it is therefore important to answer the following starting questions: * how can mnss be assessed and analysed in the portuguese population with schizophrenia? * how does the manifestation of mnss differ between people with and without schizophrenia? * do the mnss of people with schizophrenia vary according to their functionality level including the following areas of activity (cognition, mobility, self-care, interpersonal relations, daily activities and participation) and their motor experiences? * how can the information obtained by applying a validated assessment tool for this purpose be made operational as a procedure for psychomotor assessment and intervention with this population? the following objectives have been defined to answer these questions, which guide the work: 1. translate, adapt and validate the bms instrument (jahn et al., 2006) for the portuguese population with schizophrenia; 2. explore the relationship of mnss with demographic variables (e.g.: age, gender, education), clinical-therapeutic variables (e.g.: age of diagnosis, number of hospitalizations, medication, type of support) and psychosocial variables (e.g.: functionality, satisfaction and well-being, motor experiences); 3. test a multifactorial model of the relationships between mnss, demographic variables, functional clinical-therapeutic and psychosocial; 4. compare mnss in people with schizophrenia and people from a healthy control group.

Eligibility criteria:
inclusion criteria: * have a schizophrenia diagnoses exclusion criteria: * have a motor disability * drugs consumer
a retrospective non-interventional study of breast cancer patients diagnosed with hr+/her2- locally advanced or metastatic breast cancer treated with palbociclib in denmark

Conditions: Breast Cancer

Summary: the objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (rw) setting of patients with hr+/her2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment


Eligibility criteria:
inclusion criteria: * patients with breast cancer (international statistical classification of diseases and related health problems, 10th revision \[icd-10\]: icd-10 code for patients with breast cancer \[dc50\]) * a diagnosis of hr+/her2- locally advanced or metastatic breast cancer * initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 january 2017 and 31 december 2020 * inclusion date: date of relapse/stage iv disease/progression leading to initiation of palbociclib+ai/progression leading to initiation of palbociclib+fulvestrant exclusion criteria: * there are no exclusion criteria for this study

Keywords: metastatic breast cancer hr+/ her2-
safety and tolerability of vgr-r01 for patients with bietti crystalline dystrophy

Conditions: Bietti Crystalline Dystrophy

Summary: a multicenter, open-label, non-randomized, uncontrolled study of vgr-r01 in patients with bietti crystalline dystrophy.

vgr-r01 is a novel aav vector carrying the human cyp4v2 coding sequence. this study is intended to evaluate the safety and tolerability of a single subretinal administration of vgr-r01. all subjects will undergo at least 52 weeks of safety observation and will be encouraged to enroll in an extension study to evaluate the long-term safety of vgr-r01 for a total of five years.

Eligibility criteria:
key inclusion criteria: 1. able to provide informed consent and comply with requirements of the study; 2. ≥18 years and \<70 years of age; 3. confirmed diagnosis of bietti crystalline dystrophy and molecular diagnosis of cyp4v2 mutations (homozygotes or compound heterozygotes); 4. bcva ≤ 60 etdrs letters in the study eye. key exclusion criteria: 1. have insufficient viable retinal photoreceptor cells based on investigator's decision; 2. have current ocular or periocular infections, or endophthalmitis; 3. have any significant ocular disease/disorder other than bcd, including age-related macular degeneration, diabetic retinopathy, optic neuropathy, significant lens opacity, glaucoma, uveitis, retinal detachment, etc; 4. have intraocular surgery history except cataract surgery in the study eye; 5. have or potentially require of systemic medications that may cause eye injure; 6. have contraindications for corticosteroids or immunosuppressant; 7. unwilling or unable to have the planned follow-up; 8. abnormal coagulation function or other clinically significant abnormal laboratory results; 9. have malignancies or history of malignancies; 10. history of immunodeficiency (acquired or congenital); other protocol defined inclusion/exclusion criteria may apply.
progenitor cells in human esophagus

Conditions: Progenitor Cells; Aging, Cells; Esophagus Disorder

Summary: the purpose of this study is to better understand how esophageal cells change with age.

the researchers will collect information from the patient's medical record and collect esophageal tissue at the time of the patient's surgery in excess of clinical diagnosis (i.e. tissue that would otherwise be discarded). there will be no patient contact after the patient's surgery. the researchers will analyze sections of adult esophagus tissue for the presence of cd34+ sox2+ progenitor cells to determine the number of progenitors present at a particular age. the researchers will also examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others. this study involves testing dna and patients will not be notified of the genetic test results and the results will not be put into their medical record. patients will be asked to give consent to have any remaining esophageal tissue used for future studies of esophageal disease at mayo clinic, learn about, prevent, or treat any other health problems and give their sample and related information to researchers at other institutions.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * esophagus surgery at mayo clinic exclusion criteria: * \<18 years old
breathlessness assessment in adult patients with myotonic dystrophy type 1

Conditions: Myotonic Dystrophy Type 1 (DM1)

Summary: myotonic dystrophy type 1 (dm1) is one of the most common neuromuscular diseases in adults. as respiratory dysfunction is the most common cause of death in patients with dm1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (niv). dyspnea, one of the main respiratory symptoms, has been little studied in patients with dm1. the main objective of this study is to provide the first multidimensional description of dyspnea in patients with dm1. the secondary objectives are: * to compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate niv * to assess associations between dyspnea and respiratory function testing * to assess associations between dyspnea and number of cytosine thymine guanine (ctg) repeats * to assess associations between dyspnea and muscular strength * to assess associations between dyspnea and bmi * to assess associations between dyspnea and anxiety or depression * to assess associations between dyspnea and cognitive impairment * to assess associations between dyspnea and quality of life.


Eligibility criteria:
inclusion criteria: * patient with myotonic dystrophy type 1 confirmed by genetic analysis * with an age older than 18 years exclusion criteria: * an ongoing or recent (i.e. within the last 4 weeks prior to study recruitment) medical condition, including pulmonary exacerbations * patient already under non-invasive mechanical ventilation
statin intolerance in patients with myocardial infarction

Conditions: Statin Adverse Reaction

Summary: patients with acute coronary syndrome (mi, nstemi, usap) will be included. they will be screened for statin intolernace for 6 months.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome exclusion criteria: * being on statin, having statin related side effects
ufur (tegafur/uracil) plus iressa in non-small-cell lung cancer

Conditions: Non-Small-Cell Lung Cancer

Summary: iressa \[epidermal growth factor tyrosine kinase inhibitor (egfr-tki)\] has been reported to activity against non-small-cell lung cancer (nsclc) failed previous chemotherapy. ufur was found to have anti-angiogenesis effect when long term treatment was given. combination of egfr-tki and anti-angiogenesis agents is a novel treatment.

iressa is a selective epidermal growth factor receptor tyrosine kinase inhibitor (egfr-tki). it is an orally active agent for advanced non-small-cell lung cancer (nsclc) in those who have failed a previous platinum-based regimen and taxane treatment. ufur (tegafur/uracil) is effective agent against chemo-naïve nsclc. it has anti-angiogenesis effect when used as long-term low dose treatment. present phase ii randomized clinical trial is designed to answer whether or not adding an oral anti-angiogenesis agent (ufur), that has low toxicity profiles when long term use, to egfr-tki (iressa) could increase patients survival and response rate.

Eligibility criteria:
inclusion criteria: * histologic or cytological diagnosis of nsclc who failed previous platinum-based and taxanes chemotherapy. * no prior radiotherapy on measurable lesion(s). * performance status of 0 to 3 on the zubrod scale. (reference 1) * clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by ct scan, mri, or chest x-ray. * informed consent from patient. * males or females 18 years of age or older. * if female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device \[iud\], birth control pills, or barrier device) during and for three months after trial. exclusion criteria: * active infection (at the discretion of the investigator). * inadequate liver function (total bilirubin \>1.5 times above normal range); alanine transaminase (alt) and aspartate transaminase (ast) greater than 5 times normal. * inadequate renal function (creatinine \>2.0 mg/dl). * breast feeding. * second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) * concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.

Keywords: adenocarcinoma non-small-cell lung cancer gefitinib ufur