Kornimate/medical-research-clean huggingface dataset:
mitral valve replacement with mvalve dock and lotus

Conditions: Mitral Valve Regurgitation

Summary: this study evaluates the mvalve mitral prosthesis in conjunction with a lotus transcatheter heart valve (thv) for mitral valve replacement in subjects at high risk for conventional mitral valve replacement or repair surgery.

this study is a prospective first in man feasibility study intended to evaluate preliminary safety and effectiveness of the mvalve mitral dock with lotus transcatheter heart valve for mitral valve replacement in subjects who are at high risk for surgical valve repair or replacement. the surgical technique adapts the valve-in-valve approach for mitral replacement in degenerated mitral prostheses to failing native mitral valves. the mvalve dock is designed to provide a structural platform within the mitral annulus so that the lotus thv can be implanted in a secure fashion in the mitral annulus. the investigational device anchors to the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus. this study is designed to treat subjects with moderate-to-severe mr who are not deemed candidates for mitral valve surgery.

Eligibility criteria:
inclusion criteria: * symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure. * new york heart association (nyha) functional class iii or iv. * high risk for conventional open mitral valve repair or replacement surgery in the consideration of the site heart team. * left ventricular ejection fraction (lvef) is ≥30% within 30 days prior to the procedure. * mitral valve annular commissure to commissure (c/c) dimension between 30-35 mm by echocardiography. * left atrial diameter \<5.5 cm by echocardiography exclusion criteria: * prior mitral valve replacement or repair surgery. * prior transapical surgery. * severe aortic or tricuspid valve disease. - severe symptomatic carotid stenosis (\>70% by ultrasound). * acc/aha stage d heart failure. * hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology. * infiltrative cardiomyopathies (amyloidosis, hemochromatosis, sarcoidosis). * physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction. * severe mitral annular calcification. * glomerular filtration rate (gfr) \< 30. * hemodynamic instability defined as systolic pressure \< 90 mm hg with or without afterload reduction, cardiogenic shock, or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance.
developing an intervention to prevent visceral adipose tissue accumulation

Conditions: Menopause; Visceral Adipose Tissue Accumulation; Abdominal Obesity; Obesity; Overweight

Summary: the aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.


Eligibility criteria:
inclusion criteria: * resident of the beverly or morgan park neighborhood of chicago or contiguous neighborhoods * female * african american or caucasian * age 42 years or older * intact uterus, at least one functioning ovary, at least one menstrual period in the last 12 months prior to screening. * sufficient motivation level to make lifestyle changes, as determined by wishfit staff. exclusion criteria: * hysterectomy * physical activity \> 90 min per week * metabolic conditions or use of medications that affect weight of visceral adipose tissue (diabetes, acquired immune deficiency syndrome, weight \> 300 lbs) * presence or history of major psychiatric comorbidity (i.e. dementia, schizophrenia, bipolar disorder, alcohol/drug addiction) in the last 6 months * history of inpatient mental health treatment * currently prescribed antipsychotic medication * history of hallucinations or bizarre thoughts * current pregnancy * has been told by a physician that it is unsafe to engage in physical activity * an illness expected to limit functional status or life expectancy, including: heart failure, recent heart attack, liver cirrhosis, kidney failure, oncologic conditions, history or heart surgery, angioplasty or artery stenting.

Keywords: multi-level intervention menopause body composition abdominal adipose tissue visceral adipose tissue perceived stress computed tomography dual energy x-ray absorptiometry
neuropathic pain and quality of life in icu survivors

Conditions: Critical Illness

Summary: previous research on intensive care unit (icu) survivors shows that rehabilitation is challenging, because of patients experiences of disease related problems both under and after treatment. approximately 20 % of patients die within hospital, up to 80% suffer from hallucinations and nightmares, deal with paranoiac experiences, chronic pain and other symptoms and disability (angus et al 2004; de letter et al 2001; ely et al 2001; nelson et al 2006; van den berghe et al 2001; van den berghe et al 2003) . a recent study shows that 28% of intensive care survivors have chronic pain that reduce their health related quality of life (boyle et al 2004). the aim of this study is to perform a survey about prevalence of pain type, and which consequences this causes when it comes to function and quality of life up to 12 months after the icu stay. 1. what type of pain has icu survivors and how do pain change over time, related to treatment/rehabilitation and the illness' development? 2. what is the relationship between different pain characteristic, quality of life, anxiety, depression, fatigue, sleep and ptsd in these patients? 3. what is these patients largest obstacle for good qol after discharge from hospital?

a prospective and longitudinal survey 3 time points for data collection: 1. icu - background data about the patients icu stay (days on ventilator, medication, treatment, saps ii, sofa etc). 2. 3 months after icu discharge - survey about pain, qol, sleep, fatigue, post traumatic stress disorder (ptsd), anxiety and depression. 3. one year after icu discharge - the same as 3 months. survey instruments: pain - brief pain inventory, neuropathic pain syndrome inventory, pain diary qol - sf 12, sleep - general sleep disorder scale fatigue - lee fatigue scale anxiety and depression - hospital anxiety and depression scale ptsd - ptss 10 social provision - revised social provision scale

Eligibility criteria:
inclusion criteria: * icu stay longer than 48 h * 18 years old or older * patients must write and understand norwegian well. exclusion criteria: * dying patients * no acceptance form next of kind * no concent from the patients * other that the researcher thinks should be excluded f. ex patients with very bad prognosis * patients with low probability for self report after icu stay

Keywords: critical illness pain quality of life
peripheral defocus profile of multifocal minus contact lenses

Conditions: Myopia; Refractive Errors; Contact Lens

Summary: purpose: numerous studies have proven that emmetropization in young animals including humans is regulated by visual input. it has long been hypothesized that peripheral myopic defocus may act as a stop signal to reduce myopia progression and axial elongation. as such, multifocal soft contact lenses (mfcls) have been utilized for myopia control in school-aged children, with variable efficacies. one potential explanation is that the actual peripheral myopic defocus an eye experiences during mfcl wear may not be identical to the add power and not sufficient to reduce myopia progression. our study investigated and compared the peripheral power profiles of myopic eyes when they were uncorrected and wore single vision contact lenses (svcls) and mfcls of different add powers. methods: subjects with -1.00 d to -10.00 d of myopia (se, determined with manifest refraction) were custom fit with both single vision (sv) and mfcls (+2.00 and +4.00 d add; provided by specialeyes) in both eyes. these specialeyes mfcls had an aspheric design with a standard total optical zone of 8.0mm. cycloplegic central autorefraction was conducted with both grand seiko wam-5500 open-field auto-refractor (grand seiko co ltd) and opd opd-scan iii wavefront aberrometer (marco) on the subjects in the following conditions: (1) no cls, (2) svcls, (3) mfcls (+2.00d add), and (4) mfcls (+4.00d add). relative peripheral power profiles were measured using the opd under the same 4 conditions after cycloplegia. data in the right eye was used for analysis.


Eligibility criteria:
inclusion criteria: * 18-30 years of age * spherical equivalent (determined with subjective refraction) between -1.00 and -10.00 d in each eye, spherical power between -0.75 and -10.00 d and cylindrical power ≤ 1.50 d * monocular best corrected visual acuity 20/25 or better * no previous contact lens experience required * no history of ocular pathology, binocular vision anomalies, or refractive surgery. exclusion criteria: -
the prediction of extent and risk profile of coronary atherosclerosis and their changes during lipid-lowering therapy based on non-invasive techniques

Conditions: Coronary Artery Disease

Summary: * the prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques. * detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (wss) changes during lipid lowering therapy (rosuvastatin 40mg) from 3d vessel reconstruction. * prediction of changes in coronary arteries based on changes in non-invasive examinations. * examination of wss influence on atherosclerosis development and changes of wss during lipid lowering therapy.

the fundamental aim of this project is development of reliable algorithm for detection of extent and risk profile of coronary atherosclerosis based on non-invasive examinations (carotid ultrasound, examination of retinal vessel, diagnosis of endothelial dysfunction, pro-inflammatory markers including new markers of atherosclerosis and gene polymorphisms) with maximal effort on diagnosis of vulnerable plaques. the second part of the study is prediction of coronary atherosclerosis changes during high-dose lipid-lowering therapy (rosuvastatin 40 mg daily). coronary artery impairment will be examined by up-to date technology using the fusion of angiography, intravascular ultrasound and virtual histology for 3d coronary artery reconstruction together with information about mechanical properties of arteries like a vessel shear stress. this algorithm for non-invasive assessment of coronary impairment and its changes during will be used for detection of high risk patients (in terms of acute coronary syndrome development) and of patients with low response to statin therapy. further target is detailed assessment of atherosclerosis development and its changes during lipid-lowering therapy.

Eligibility criteria:
inclusion criteria: * stable angina pectoris exclusion criteria: * age less than 18 or more than 80 * renal insufficiency * liver insufficiency * pregnancy or , child potential without contraception * intolerance of statins * rhabdomyolysis or other myopathy in patient´s history * acute coronary syndrome in last 6 weeks * coronary anatomy unsuitable for intravascular ultrasound * active cancer

Keywords: intravascular ultrasound virtual histology optical coherence tomography coronary atherosclerosis statins retinal imaging
a study of nivolumab and ipilimumab in untreated participants with stage 3 non-small cell lung cancer (nsclc) that is unable or not planned to be removed by surgery

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: the primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (ccrt) followed by nivolumab plus ipilimumab vs ccrt followed by durvalumab in participants with untreated locally advanced non-small cell lung cancer (la nsclc).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status ≤1 * locally advanced stage iiia, iiib, or iiic (t1-2 n2-3 m0, t3 n1-3 m0, or t4 n0-3 m0) pathologically-confirmed nsclc, according to 8th tnm classification. participants who are not planned for potential curative surgical resection are eligible. * newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease exclusion criteria: * any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation * active infection requiring systemic therapy within 14 days prior to randomization * history of organ or tissue transplant that requires systemic use of immune suppressive agents * prior thoracic radiotherapy other protocol-defined inclusion/exclusion criteria apply
proliferation of endometrial stromal cells in adenomyosis

Conditions: Endometriosis

Summary: adenomyosis refers to the presence of endometrial glands and stroma that is haphazardly deep within the myometrium. however, the etiology and pathologic mechanism responsible for adenomyosis are not yet very well known. our previous results revealed that the expression of killer inhibitory receptors on natural killer cells was decreased in eutopic endometrium in women with adenomyosis. it implies that the formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. our further investigation revealed that in vitro coculture of macrophages and endometrial stromal cells (escs) increase the expression of il-6 mrna in esc, which might further enhance the proliferation of esc and subsequently result in the formation of ectopic endometrial implants in adenomyosis. abnormal cell proliferation has been generally found in the tumorigenesis, including the formation of endometriosis. adenomyosis is considered to have a similar pathophysiology with endometriosis, and it must be interesting to examine whether there is abnormal cell proliferation in the eutopic endometrium of adenomyosis. lipopolysaccharide (lps) was found to promote proliferation of escs via induction of tnf-a and il-8 expression, whereas ifn-g significantly inhibited escs proliferation. therefore, whether abnormal cell proliferation occurs under the effects of lps and ifn-g in the eutopic endometrium of adenomyosis needs further clarification. adenomyosis preferentially affects women between the ages of 35 and 50 years, and the symptoms subside gradually after menopause. it is well known that there is a close conjunction between estrogen and adenomyosis. estradiol (e2) was demonstrated to induce endometrial cell proliferation, whereas medroxyprogesterone (mpa) inhibited endometrial cell proliferation via antagonizing estrogenic effects. experiments to investigate these steroid effects on esc proliferation in vitro in the eutopic endometrium of adenomyosis are of clinical relevance. in this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify escs from endometrium. escs are cultured for 2 days with the supplement of lps, ifn-gamma, estradiol, mpa and estradiol+mpa. quantification of cell proliferation was done with cell proliferation assay kit and immunocytochemical detection of ki-67, in an attempt to examine the cell proliferation of escs in women with adenomyosis.

eutopic endometrium was obtained and separated into single endometrial stromal cell (esc) in women with adenomyosis (study group) and without adenomyosis (control group). escs are cultured for 2 days with the supplement of lps, ifn-gamma, estradiol, mpa and estradiol+mpa. quantification of cell proliferation was done with cell proliferation assay kit and immunocytochemical detection of ki-67.

Eligibility criteria:
inclusion criteria: * women with adenomyosis * at early- to mid-secretory phases exclusion criteria: * postmenopausal * malignancy

Keywords: adenomyosis cell proliferation immunocytochemistry
open-label study of diclofenac capsules to treat osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the safety of diclofenac \[test\] capsules for the treatment of osteoarthritis pain of the knee or hip.


Eligibility criteria:
inclusion criteria: * male or female ≥ \[greater than or equal to\] 40 years of age * if a participant in the previous dic3-08-05 study, completed the study and did not discontinue for lack of efficacy or safety * has a diagnosis of oa of the hip or knee with ongoing knee and/or articular hip pain * is a current chronic user of nonsteroidal anti-inflammatory drugs (nsaids) and/or acetaminophen for his/her oa pain and is anticipated to benefit from continuous treatment with therapeutic doses of nsaids. a current chronic user is defined as a subject who has used these treatments for ≥ \[greater than or equal to\] 20 days of the last 30 days before screening exclusion criteria: * has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any nonsteroid anti-inflammatory drugs (nsaids), including diclofenac * requires chronic use of opioid or opioid combination products to control oa pain of the knee or hip * has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease * has significant difficulties swallowing capsules or is unable to tolerate oral medication
once-daily simultaneous modulated accelerated thoracic radiotherapy in limited small-cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this phase ii randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (rt) resulted in better survival than twice-daily rt for patients with limited-stage small-cell lung cancer (ld-sclc).

this phase ii randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) rt for patients with limited-stage small-cell lung cancer (ld-sclc). all patients receive four to six cycles of etoposide and cisplatin (ep) every 3 weeks. thoracic rt is initiated with cycle 1-3 of chemotherapy. qd rt includes the delivery of 65 gy in 26 fractions delivered on weekdays for a total of 33 days. bid rt includes the delivery of 45 gy in 30 fractions delivered on weekdays for a total of 19 days. after the chest rt and the last cycle of ep, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.

Eligibility criteria:
inclusion criteria: * pathologic confirmation of sclc. imaging studies' confirmation of limited stage. * no previous chest radiotherapy, chemotherapy or biotherapy. * patients have measurable or evaluable lesions based on the response evaluation criteria in solid tumors (recist) criteria. * white blood cell count ≥4×109 /l, platelet count≥100×109 /l, hemoglobin ≥100 g /l; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (uln), aspartate aminotransferase two times or less the uln. * eastern cooperative oncology group (ecog) performance status 0-1. * weight loss ≤10% within the past 3 months. * forced expiratory volume in 1 s \>1 l. exclusion criteria: * previous or recent another malignancy. * a myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia. * malignant pleural or pericardial effusion. * pregnant or lactating. * weight loss \>10% within the past 3 months. * drug addiction, long-term alcohol abuse and aids patients.

Keywords: small cell lung cancer radiotherapy dose fractionation
safety and efficacy of arni after lvad implant (seal-it) study

Conditions: Stage D Heart Failure

Summary: the purpose of the study is to evaluate how well tolerated and effective an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) is in patients with contemporary durable continuous flow left ventricular assist device (cf-lvad) implantation compared to usual care oral vasodilator therapy.

the aim of this pilot study is to prospectively determine the short-term (at 3 months) and long-term (at 6 and 12 months) safety and efficacy of an angiotensin receptor-neprilysin inhibitor (sacubitril-valsartan) in patients with contemporary durable continuous flow left ventricular assist device (cf-lvad) implantation compared to standard-of-care (usual care) oral vasodilator therapy.

Eligibility criteria:
inclusion criteria: 1. adults (age ≥ 18 years) 2. durable cf-lvad for any indication 3. nyha ii to iv classification 4. lvef \< 40% 5. written informed consent exclusion criteria: 1. inability to comply with the conditions of the protocol 2. any patient with durable cf-lvad who has any one of the following: i. symptomatic hypotension or map \< 60 mm hg at randomization, ii. egfr \< 30 ml/min/1.73 m2 at randomization, iii. potassium \> 5.4 mm at randomization, iv. history of angioedema at randomization, v. history of unacceptable side effects with ace inhibitor, arb, or sacubitril-valsartan therapy at randomization, vi. use of vasoactive agents (e.g., dobutamine, dopamine, epinephrine, norepinephrine, phenylephrine, vasopressin, nitroglycerin, nitroprusside, epoprostenol) or parenteral diuretics in 24 hours preceding randomization.

Keywords: continuous flow left ventricular assist device sacubitril-valsartan oral vasodilator heart failure
detection of minimal residual disease based on hpv ctdna in cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: in this study, a large-scale cohort of cervical cancer patients was established in multiple centers. minimal residual disease(mrd) was assessed by ddpcr detection of hpv e7 gene ctdna to assess tumor burden and predict the risk of disease recurrence, so as to provide new biomarkers for precise treatment of cervical cancer patients. the study continued until 36 months after the end of treatment.

the purpose of this study is to assess mrd by detecting hpv e7 gene ctdna to assess tumor burden and predict the risk of disease recurrence. according to the treatment methods, the patients were divided into two groups :(1) initial surgical treatment group (2) initial concurrent chemoradiotherapy group. after the patients were enrolled in the study according to the criteria, they were given standard treatment. the patients were followed up every 3\~6 months within 2 years after treatment and every 6\~12 months from 3 to 5 years after treatment, including general and gynecological physical examination, cervical or vaginal cytology test, hpv typing test, scc, ca125, and imaging examination such as ct or mri if necessary. peripheral blood samples were collected to detect hpv e7 ctdna before treatment, after treatment, and at 6, 12, 18, 24, 30, and 36 months of follow-up. the primary endpoint is disease-free survival (dfs, time from the treatment initiation to disease progression). secondary endpoints include hpv ctdna state before treatment, dynamic change trend of hpv ctdna after treatment and overall survival (os, time from the treatment initiation to death).

Eligibility criteria:
inclusion criteria: * pathological diagnosis: cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma * figo stage: ia2-iva * hpv typing: type 16 or 18 * ecog 2-0 * the initial treatment was surgery (cohort a) / concurrent chemoradiotherapy (cohort b) exclusion criteria: * the diagnosis of cervical cancer was made within 3 years of other malignancies * pregnant or lactating women * refused to sign a consent form