Kornimate/medical-research-clean huggingface dataset:
pathological changes in the cardiovascular system in valvular heart disease

Conditions: Valvular Heart Disease

Summary: an observational cohort study of patients recruited presenting with valvular heart disease. the specialized investigations will focus on myocardial remodelling and scar formation/regression and extracardiac micro- and macro-vascular sequelae of valvular heart disease (vhd). the aim is to investigate the natural history of vhd and its ensuing cardiac and extracardiac end organ effects, the impact of existing interventions and the long-term outcome. we hope to establish the underlying causative aetiology of known associated conditions (e.g. vascular dementia) and to determine if extracardiac changes may serve as early biomarkers of prognosis in vhd. participants will attend for two visits at barts heart centre or chenies mews imaging centre and will undergo a panel of tests including cross-sectional cardiac imaging, point-of-care microvascular assessment and blood tests. patient outcome will be assessed by data linkage to hospital episode statistic (hes) data and ons data (via nhs spine). we aim to identify determinants that will help to improve patient selection and timing of valve intervention based on advanced clinical, blood and/or imaging biomarkers.


Eligibility criteria:
inclusion criteria: * age \> 18 years * able to provide written informed consent * mild, moderate or severe valvular heart disease (natural history cohort), or severe valvular heart disease planned for surgical/transcatheter intervention (intervention/heart-brain axis cohort). exclusion criteria: * participants unwilling to consent. * needle phobic patients that would preclude blood taking * diagnosis of dilated or hypertrophic cardiomyopathy * pregnancy/breast feeding * inability to complete the protocol, other conditions that would prevent participation in the study. * in severe vhd, no more than moderate valve disease other than primary lesion (as / mr / ar) exclusion for the heart-brain-axis study: • participants that have more than moderate epicardial coronary disease (by ct or invasive coronary angiography) will be excluded.
circulating tumor cells spillage after pulmonary biopsy

Conditions: Lung Cancer

Summary: the aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.

introduction: lung cancer (nsclc) is a common malignancy with a high recurrence rate even when diagnosed at early stages. biopsy is currently the procedure of choice for the investigation of pulmonary lesions, yet it is unclear whether the biopsy itself releases tumor cells into the circulation and attributes to the late distal recurrence. studies of various malignancies show the ability to identify circulating tumor cells (ctcs) even in early stage cancer. the number of ctcs correlates with disease outcome. dynamics of ctcs after ct or bronchoscopy guided biopsy has not been evaluated so far. in the metastatic setting, the number of ctcs correlates to tumor response to chemotherapy in both small and non-small lung cancer (sclc and nsclc, respectively). the aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer. patients with suspected pulmonary lesions undergoing ct or bronchoscopy guided biopsy will be enrolled into the study. the cellcollectortm will be used for ctcs detection before and after the procedure. these patients will be their own controls. in this study the investigators will use the cellcollectortm (gilupi, germany) needle that isolates ctcs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (epcam). this technology enables high quality immunohistochemical and molecular testing of the acquired cells as needed for treatment planning, and even allows cell culture growth from the live ctcs. this device is certified for use throughout europe, with no adverse events noted with its usage .

Eligibility criteria:
inclusion criteria: * a diagnosis of lung cancer * patients are designated to undertake biopsy * able and willing to participate in this study * availability of a signed informed consent exclusion criteria: * any recent non-lung cancer in the recent 2 years.

Keywords: lung cancer biomarkers early detection circulating tumor cell
ultrasound imaging in finding prostate cancer in patients undergoing surgery

Conditions: Prostate Cancer

Summary: this pilot clinical trial studies ultrasound imaging in finding prostate cancer in patients undergoing surgery. diagnostic procedures, such as ultrasound imaging, may help find and diagnose prostate cancer. this study will serve as an analysis of the histo-scanning technology for the purpose of determining its ability to identify sites of prostate cancer at the time of prostate ultrasound.


Eligibility criteria:
inclusion criteria: * patients who have completed a staging multiparametric mri at new york university (nyu) * patients who plan to undergo radical prostatectomy by open or robotic approach exclusion criteria: * previous history of prostate cancer radiation treatment * focal ablation of the prostate for cancer treatment * men receiving hormonal ablation within 6 months prior to undergoing radical prostatectomy

Keywords: prostate cancer radical prostatectomy ultrasound imaging
study to find out how symptoms severity changes during the standard course of treatment with the cream relief pro and suppositories relief pro (active ingredients are fluocortolone + lidocaine) in patients suffering from twisted and bulging veins in the rectal area (acute hemorrhoids)

Conditions: Acute Hemorrhoids

Summary: in this study researcher wanted to learn more about the changes of biggest twisted and bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment period with the cream relief pro and suppositories relief pro. the study collected information on the treatment satisfaction of patients and their physicians with the prescribed treatment by using questionnaires. there were 3 visits at the physician's clinic for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.


Eligibility criteria:
inclusion criteria: * male \& female patients 18 to 65 years old; * patients with acute hemorrhoids 1 and 2 stage (with thrombosis (external, internal, mixed), including cases with bleeding); * prescription of fluocortolone + lidocaine as a part of routine clinical practice. exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice; * hemorrhoid with stage ˃ ii; * contraindications for use of relief pro in the approved product label; * anemia and/or severe/profuse hemorrhoid bleeding; * surgery in perianal region in anamnesis; * concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic and/or immunosuppressant; * inflammatory bowel disease; * hepatic diseases in severe and acute stages; * colorectal cancer; * purulent-inflammatory diseases of the perianal region and anal canal; * chronic pulmonary diseases in severe and acute stages.
evaluation of food additive contributions to obesity - feasibility study 2

Conditions: Obesity

Summary: the effects of food additives on body weight in humans are largely unknown. this is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. eligible participants with meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. participants will also be asked to limit eating out to a maximum of 2 days per week. primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility criteria:
inclusion criteria: * bmi\>/=30 kg/m2 * routine consumption/use of (i) \>/=250 ml of artificially-sweetened beverages per day and/or (ii) \>/=1 gum per day * willingness and ability to follow the proposed dietary intervention * informed consent exclusion criteria: * previous or planned bariatric surgery in the next 1 year * current or planned participation in any structured weight-loss programs in the next 6 months * current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids * bipolar disorder or attention deficit hyperactivity disorder * current use of anti-depressant or anti-psychotic medications * eating disorder or any other active disorder that may lead to significant weight changes * working night shifts * pregnancy or planned pregnancy in the next 1 year * uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin

Keywords: dietary modification
evolutionary aspects of polydistrict atherosclerosis

Conditions: Atherosclerosis

Summary: atherosclerosis is a systemic, multifocal disease that represents the leading cause of death in western countries. the risk factors contributing to its distribution, extent and progression in different organs (i.e., the heart, brain or limbs) and different segments (large and small vessels) are not identical. the present study analyses data the evolutionary aspects of polydistrict atherosclerosis by analysing the possible role of morphological factors, biomolecular and genetic in the progression of atherosclerotic lesions and the development of major and/or minor acute cardiovascular events. for this purpose, will be recalled to follow-up all 320 patients already enrolled in the previous protocol of research in the period between 1 march 2014 and 28 february 2015 at the department of internal medicine, catholic university of rome. the subjects will undergo a new clinical evaluation, with particular interest to the onset of major cardiovascular events (myocardial infarction, stroke, death for all causes) and major adverse events to the lower limbs (critical ischemia of the lower limbs requiring revascularization or amputation) in the follow-up period, and a ultrasonographic examination of carotid arteries and arteries of lower limb districts at the service of angiology, catholic university of rome. the study employed a new semiquantitative ultrasonographic score (ultrasonographic lower limb atherosclerosis (ulla) score), that enables a complete evaluation of the entire lower limb atherosclerotic burden and has already been shown to be associated with major cardiovascular risk factors. therefore, the aims of this study are: * to assess the association between functional, morphological, biomolecular and genetic factors of atherosclerotic disease and the risk of major cardiovascular events (mace) and major adverse events to the lower limbs (male); * to analyse the morphological progression of atherosclerotic disease in its different localizations and the possible determining factors in such progression with a 10-year follow-up ultrasound study.


Eligibility criteria:
inclusion criteria: * follow-up of n.320 subjects previously enrolled in the period between 1 march 2014 and 28 february 2015 in the previous research protocol at the department of internal medicine, catholic university of rome. exclusion criteria: * acute diseases; * age \< 18 years; * inclusion in another clinical trial; * impossibility of follow-up (homeless, residence abroad)
the effect of 4 weeks of l-citrulline supplementation on macro- and microvascular function in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to examine the effect of 4 weeks of citrulline supplementation on macro- and microvascular function during acute hyperglycemia in middle-aged and older adults with type 2 diabetes.

using a double-blind, randomized, placebo-controlled, and cross-over design, middle-aged and older adults with type 2 diabetes will be randomized to receive either cit supplementation (6g/day) or placebo (microcrystalline cellulose, 6g/day) for 4 weeks. there will be a total of 5 laboratory visits. visit 1 (screening visit) will take approximately 1 hour and 30 minutes, visit 2 will take approximately 2 hours and 30 minutes, and visits 3-5 will be approximately 3 hours each. visit 1 will measure blood pressure, blood glucose and lipid levels, anthropometry, body composition, and muscle strengths. visits 2-5 will assess vascular function and glucose control during fasted and acute hyperglycemia conditions induced by 75g of glucose ingestion.

Eligibility criteria:
inclusion criteria: * middle-aged and older women and men between 40-75 years old * a physician diagnosed type 2 diabetes at least 3 months ago * treated with an oral hypoglycemic medication * body mass index \< 40 kg/m2 * systolic blood pressure \< 160 mmhg * sedentary (defined as \< 120 min/week of exercise) * not currently participating in exercise or dietary interventions for at least 2 months prior the present study and willing to abstain from participating in those strategies during the duration of this study. exclusion criteria: * \ 65 years of age * use of medications and/or any supplements that may affect outcome variables (such as arginine- or citrulline-containing supplements, nitrates, and nitroglycerin) * body mass index ≥ 40 kg/m2 * systolic blood pressure ≥ 160 mmhg * recent changes in medications within 3 months * current smoking any tobacco use * type 1 diabetes, severe cardiovascular/renal/pulmonary diseases * more than 7 alcoholic drinks/week of consumption * premenopausal women with an irregular menstrual cycle (oligomenorrhea) or pregnancy

Keywords: endothelial function arterial stiffness hyperglycemia oral glucose tolerance test aortic blood pressure blood glucose lean mass
a dose escalation study evaluating cpi-818 in relapsed/refractory t-cell lymphoma

Conditions: T-cell Lymphoma

Summary: this is a phase 1/1b, open-label, first in human study of cpi-818, an oral interleukin-2-inducible tyrosine kinase (itk) inhibitor for the treatment of relapsed/refractory (r/r) t-cell lymphoma.. this trial will study the safety, tolerability, and anti-tumor activity of cpi-818 as a single drug.

this is a phase 1/1b, open-label, first in human study of cpi-818, an oral interleukin-2-inducible tyrosine kinase (itk) inhibitor for the treatment of relapsed/refractory (r/r) t-cell lymphoma.. this trial will study the safety, tolerability, and anti-tumor activity of cpi-818 as a single drug. this trial is composed of dose escalation and dose expansion cohorts.

Eligibility criteria:
inclusion criteria: * adult subjects age ≥18 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically confirmed evidence of t-cell lymphoma * measurable disease. * adequate organ function. * at least 2 standard therapies for advanced or recurrent disease or had a disease for which there is no more than one established therapy. exclusion criteria: * treatment with systemic immunosuppressive medication. * history of allogeneic hematopoietic stem cell transplantation. * history of primary immunodeficiency, solid organ transplantation. * history of opportunistic infection within 180 days of starting study drug. * females who are pregnant, lactating, or intend to become pregnant * history of invasive prior malignancy that required systemic therapy within last 3 years. * concomitant use of strong inhibitors or inducers of cyp3a.

Keywords: ctcl ptcl
inpatient alcohol detox & psychotherapy

Conditions: Alcohol Use Disorder

Summary: the aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. the study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in kathmandu. baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.


Eligibility criteria:
inclusion criteria: * diagnosed as ads according to icd 10 exclusion criteria: * major psychiatric or medical comorbidity
celecoxib in preventing non-small cell lung cancer in tobacco smokers

Conditions: Lung Cancer

Summary: rationale: chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. celecoxib may be effective in preventing lung cancer in tobacco smokers. purpose: phase ii trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

objectives: * determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers. * determine the safety and long-term side effects of this drug in this population. outline: patients receive oral celecoxib twice daily for 6 months. patients are followed at 2 weeks and then at 6 months. projected accrual: a total of 20 patients will be accrued for this study within 6 months.

Eligibility criteria:
inclusion criteria: * age \> 45 * smoked \> 20 pack years exclusion criteria: * concurrent use of nsaids * hypersensitivity to celecoxib * documented allergic-type reaction to sulfonamides * history of allergic reaction, urticaria or asthma to aspirin or other nsaids * history of liver dysfunction * hypertension or cardiac conditions aggravated by fluid retention and edema * previous history of gastrointestinal ulceration, bleeding, or perforation * renal dysfunction * end stage respiratory disease * unstable angina * other malignancy * pregnancy * concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2c9 and 2d6 enzymes * patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

Keywords: non-small cell lung cancer
a pilot study evaluating heart and lung metabolism in pulmonary hypertension associated with left heart disease

Conditions: Pulmonary Hypertension

Summary: right ventricular (rv) failure is the leading cause of death in pulmonary arterial hypertension. (pah) right ventricular ejection fraction is one of the most important predictors of prognosis in heart failure patients regardless of cause. it is estimated that 30-50% of patients with heart failure and preserved ejection fraction (hfpef) have right ventricular dysfunction and up to 70% of these patients will have significant pulmonary hypertension (ph), both of which are related to much worse prognosis. right ventricular failure is becoming an increasingly prevalent and significant cause of morbidity in patients with left heart disease. despite the significance of rv function to survival, there are no therapies available that directly or selectively improve rv function. the overall theme of this research project is to evaluate the mechanisms that contribute to the cause of right heart failure. this small study is designed to look at the role of heart and lung metabolism and pulmonary hypertension as they relate to the development of right heart failure in cardiovascular disease.(ph-lhd)

the hemodynamic definition of ph-lhd involves a mean pulmonary artery pressure (mpap) \>25mm hg at rest and pulmonary capillary wedge pressure (pcwp) of ≥15.the coexistence of mitral insufficiency is also a characteristic of ph-lhd. hfpef is a condition caused by impaired relaxation of a stiffened myocardium as a consequence of an increased load to the left ventricle due to elevated systemic pressures. pulmonary hemodynamics can be used to classify ph lhd as either passive or reactive, irrespective of lv function. it has been suggested that diastolic pressure gradient (dpg) may offer added prognostic value as a more accurate indicator of pulmonary vascular remodeling.

Eligibility criteria:
inclusion criteria: * patients must be able to provide their written informed consent to participate in the study after having received adequate previous information and prior to any study specific procedures. * at least 18 years of age at the time of screening. * patients with ph secondary to left heart disease (known as group ii ph) defined as a mean pap\>25 mmhg and a pcwp of ≥15 mmhg. exclusion criteria: * all other types of pulmonary hypertension including dana point classification group 1, 3, 5. * type ii diabetes mellitus requiring medical therapy * previous myocardial infarction within the 3 months prior to screening. * renal insufficiency (glomerular filtration rate \< 30 ml/min. * alt or ast \> 3times uln and/or severe hepatic insufficiency. * contraindication to mri imaging.

Keywords: fdg lung and rv uptake
patient specific guides and surgical planning for periacetabular osteotomy; post marketing evaluation study

Conditions: Pelvic Osteotomy; Acetabular Dysplasia; Periacetabular Osteotomy

Summary: a case series to provide post marketing evaluation of the mypao surgical planning and patient specific guides technology. this will be a single-centre, multi-surgeon evaluation assessing the safety of the use of these guides in periacetabular osteotomy surgery.

after enrolment, baseline data will be collected including age, sex and ethnicity of the participant. the radiographic measures of centre edge angle of wiberg and acetabular inclination will be measured by the surgeon and patient reported outcome measures (proms) will be collected. the proms collected at usual care timepoints in patients undergoing pelvic osteotomy will be collated for use in the dataset. peri-operative data, including clinician opinion on ease of use, intraoperative dose of radiation used and device associated adverse events, will be recorded and reported in the results.

Eligibility criteria:
inclusion criteria: * · age greater than 18 years * patient undergoing pelvic osteotomy exclusion criteria: * · evidence of hip degeneration assessed by the surgeon on x-ray (tonnis grade 1 or greater) * known allergy to polyamide pa12 * unable to provide written informed consent

Keywords: customised surgical guides