Kornimate/medical-research-clean huggingface dataset:
debscan-ivl. drug eluting balloon or drug eluting stent to treat calcified nodules after intravascular lithotripsy.

Conditions: Coronary Artery Disease

Summary: international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (cn) were randomized to drug eluting balloon (deb) or drug eluting stents (des).

regardless some observational data of deb performance in calcified lesions, there is a lack of data about the safety and efficacy in the setting of calcified nodules. however, a "leave-nothing-behind" pci strategy is attractive in this scenario in which the probability of non-optimal stent expansion and apposition is higher, hypothesis is, that following optimal plaque modification with ivl, the utilization of a deb is either non-inferior or possibly superior to des in terms of late lumen loss and net luminal gain at 6 months follow up.

Eligibility criteria:
inclusion criteria: patients must meet all inclusion criteria: * patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (pci) and * severe coronary lesion with a calcified nodule (highly recommended confirmation with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and * lesion to treat in a vessel between 2.5 and 4 mm exclusion criteria: patients must not meet any criteria * inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up. * pregnant patients * cardiogenic shock or cardiac arrest at the moment of the index procedure. * impossibility to maintain double antiplatelet treatment during at least 1 month. * life expectancy \<1 year. * index lesion at left main stem. * aorto-ostial lesion. * target lesion previously treated with stents or deb. * high thrombus burden in the target lesion (timi thrombus scale≥3).

Keywords: calcified nodules calcified lesions drug eluting balloon drug eluting stent
transmission electron microscopy images for platelet ultrastructural criteria before and after the onset of an antiplatelet agent

Conditions: Ischemic Stroke

Summary: the aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of ischemic cerebral accident (ica) at 6 months in patients hospitalized for ischemic stroke.

ischaemic stroke is the leading cause of adult disability. thus, a strategy based on an efficient antiplatelet therapy has been developed to prevent platelet activation occurring in the acute phase of non-cardioembolic ischemic stroke. the biological monitoring of the antiplatelet therapy with available platelet function assays do not provide a global integrative approach considering all the mechanisms involved in platelet activation. platelet transmission electron microscopy recently validated for assessing distinct ultrastructural abnormalities is a reliable morphological platelet structural analysis tool. ultrastructural criteria could be identified and be useful for the assessment of the degree of platelet activation and thus the biological efficiency of antiplatelet agents. all the activation transduction signals are integrated and all antiplatelet agents can be assessed. the aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke. investigators expect to identify ultrastructural characteristics that will be correlated with the platelet degree of activation to guide clinicians in decision-making regarding the antiplatelet therapy strategy.

Eligibility criteria:
inclusion criteria: * social security affiliation * signed informed consent * patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations exclusion criteria: contraindications regarding antiplatelet agent(s) and/or at least one excipient according to summary of product characteristics (spc).

Keywords: ischemic stroke ultrastructural characterization transmission electron microscopy platelet dysfunction blood coagulation disorder
the effect of thalidomide in suppression of the systemic inflammatory response syndrome in hemodialysis patients

Conditions: Hypoalbuminemia

Summary: both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. the researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. the researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients. patients who have a serum albumin concentration \< 3.8 g/dl will be asked to sign consent to have blood drawn prior to dialysis for measurement of crp (c-reactive protein). those with crp values ≥ 0.8 mg/dl will have a second measurement of crp performed within 2 weeks. those with two consecutive values of crp ≥ 0.8 mg/dl will be eligible for enrollment

4.1 pre-assignment measurements will include: 1. patient is eligible for enrollment. 2. complete physical examination. 3. blood draw at initiation of hemodialysis session 4. instruction on birth control methods required. 5. subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the s.t.e.p.s.® program will be immediately discontinued from the study 4.2 detailed description of treatment: patients who completed the first 4 weeks will be randomized into treatment group. a total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. subjects randomized to "active" treatment arm will receive placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. weekly, subjects will have blood drawn; will undergo a capsule count to establish a compliance range of \> 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy. if somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules). patients who completed 24 weeks of study will have final evaluation at week 28.

Eligibility criteria:
inclusion criteria: 1. end stage renal disease (esrd) patients on hemodialysis for at least 3 months. 2. serum c reactive protein level of ≥ 0.8 mg/dl. 3. serum albumin \< 3.8 g/dl (bcg). 4. signing a written informed consent form. 5. willingness and ability to comply with the fda-mandated s.t.e.p.s ® program. 6. age \> 18 years. exclusion criteria: 1. pregnant and/ or lactating female. 2. active infection within the previous 8 weeks requiring administration of antibiotics. 3. patients receiving systemic immunosuppressive therapy. 4. patients with hiv.

Keywords: inflammation albumin
a phase ii study of kuc-7483 in patients with overactive bladder

Conditions: Overactive Bladder (OAB)

Summary: to investigate the efficacy and safety of kuc-7483 in overactive bladder patients.


Eligibility criteria:
inclusion criteria: * patients with a symptom of overactive bladder for more than 6 months. * patients who meet the following condition during the 3-day bladder diary period. * the mean number of micturitions per 24 hours is ≥8 times * the mean number of urgency episodes per 24 hours is ≥1 time exclusion criteria: * patients who are diagnosed as stress urinary incontinence are predominant. * patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Keywords: overactive bladder frequency micturition urgency urge urinary incontinence β3-agonist
a study of cd8+ t cell imaging during treatment in people with non-small cell lung cancer

Conditions: Lung Cancer; Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer

Summary: the purpose of this study to learn whether pet/ct (positron emission tomography/computed tomography) scans using an imaging agent (radiotracer) called zirconium zr 89 crefmirlimab berdoxam is a safe and effective way to identify cd8+ t cells


Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older at the time of signing the informed consent. * patient has a histologically confirmed diagnosis of metastatic non-small cell lung cancer * patient is enrolled in the engineered til cell therapy protocol obx115-23-01, but has not received the treatment yet. * men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product. * patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. * patient or legally authorized representative provided written authorization for use and disclosure of protected health information. exclusion criteria: * pregnant or breastfeeding women * patients with a history of splenectomy or significant splenic dysfunction (e.g., as evidenced by splenomegaly or a history of recurrent infections due to impaired immune function)

Keywords: lung cancer non small cell lung cancer metastatic non small cell lung cancer memorial sloan kettering cancer center 24-369
complex āyurvedic treatment in osteoarthritis of the knee compared to standard care.

Conditions: Osteoarthritis

Summary: the aim of this study is to evaluate the effectiveness of a complex āyurvedic diagnosis and treatment compared to conventional standard care in patients with oa of the knee.


Eligibility criteria:
inclusion criteria: * male and female patients, * age 40-70 years, * prediagnosed, confirmed and documented diagnosis of oa of the knee. diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the american college of rheumatology criteria, * documented radiologic changes of the knee-joint kellgren-lawrence criteria \> or = grade 2 in conventional x-ray or mri-scan, * mean average pain intensity of 40 or more on two 100 mm visual analogue scales in the 7 days before baseline assessment, * written informed consent. exclusion criteria: * pain in the knee caused by ocongenital dysplasia of the affected knee orheumatoid arthritis oautoimmune diseases omalignancies ostatus post knee surgery ostatus post arthroscopy * administration of chondroprotective drugs in the preceding 3 months, * intra-articular injection into the affected knee-joint during the preceding 3 months, * beginning of a systemic medication with corticosteroids within the preceding three months, * beginning of any new treatment for oa during the previous 4 weeks (with the exception of analgesic treatment with paracetamol or nsaids), * pregnancy or breastfeeding, * acute mental disorders, * serious acute organic diseases, * serious chronic co-morbidity, * obesity who-grade ii/iii * blood coagulation disorders, * coagulation-inhibiting medication other than aspirin and clopidogrel, * invasive measures performed at the affected joint during the previous 12 weeks or planned within the following 12 month, * in the process of applying for pension or disability benefits, * simultaneous participation in any other clinical trial, * participation in a clinical trial during the 6 month before inclusion into this trial, * missing of the written informed consent form.

Keywords: osteoarthritis, osteoarthrosis, arthritis, arthrosis
the optimal treatment duration for inspiratory muscle strengthening exercises in stroke patients

Conditions: Stroke, Complication; Respiratory Complication

Summary: the first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory muscle training ( imt ) exercises groups and control groups in stroke survivors. the secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th, 24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6 months) in these aforementioned groups

stroke is one of the leading causes of death and disability. it is not only because of loss of extremity motions but also loss of inspiratory muscle strength. in this study we aimed to determine the optimum duration for inspiratory muscle training exercises for stroke survivors since there is not enough data about it in the literature. the study will include at least 54 patients in total and 18 in each groups ( two intervention and one control) . the patients will be evaluated for angina, chronic obstructive pulmonary disease, congestive heart disease; in these conditions the patients will be excluded from the study. also in first examinations we will evaluate the maximal inspiratory pressure (mip) of patients, of them the ones with mip measurements above 80 mmh2o will also be excluded since it is the expected value in normal people. after admission and randomizing the patients, baseline measurements of mip, 6-minutes walking test will be done. in intervention groups the patients will get 30 minutes of inspiratory muscle training exercises ( 15 minutes of two session each day) with threshold imt device every weekday. and in control group, the patients will get sham intervention for 8 weeks. the mip and 6-minutes walking test will be done in 8th,12th and 24th weeks. and also in 24th week we will record the pneumonia incidence if occured.

Eligibility criteria:
inclusion criteria: * ischemic/ hemorrhagic stroke * stroke duration\> 3 months * age\> 18 years old * baseline maximal inspiratory pressure below 80 cmh2o exclusion criteria: * cognitive deficiency * facial paralysis * chronic obstructive pulmonary disease * congestive heart disease * myocardial infarction in last three months * angina pectoris

Keywords: breathing exercises cerebrovascular disease muscle strength rehabilitation stroke
high-dose vitamin d3 in pancreas cancer

Conditions: Pancreas Cancer; Vitamin D Deficiency; Quality of Life

Summary: different studies have shown that a deficiency in vitamin d (≤20ng/ml) results in higher rates in morbidity and mortality rates in cancer patients. clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. but there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. we want to examine the effect of a high dose vitamin d3 therapy vs. a standard base dose vitamin d3 therapy in pancreas cancer patients with a vitamin d deficiency. in case of benefit in our results we could implement vitamin d3 as a supportive standard therapy in pancreatic cancer patients.


Eligibility criteria:
inclusion criteria: both sexes * vitamin d deficiency(≤20ng/ml) * patients\>18 years of age * pancreatic cancer * surgical intervention/non-surgical intervention * signed written informed consent exclusion criteria: * patients\<18 years of age * pregnancy * contraindication for oral vitamin d intake * hypercalcemia (\> 2.65 mmol/l total calcium and/or \> 1.35 mmol/l ionized calcium at screening) * other ongoing vitamin d conducted trial * known kidney stones, active tuberculosis or sarcoidosis (in the last 12 months) * metastasized pancreatic cancer * normal vitamin d serum levels * missing written informed consent

Keywords: v
contrast-enhanced vs. b-mode ultrasound-guided percutaneous biopsy of retroperitoneal tumors

Conditions: Retroperitoneal Neoplasms

Summary: background: retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate). rationale: real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area. aims: to compare contrast-enhanced ultrasound (ceus) guidance and conventional (b-mode) ultrasound (us) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events. methods: a consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice b-mode us-guided biopsy or ceus-guided biopsy. the diagnostic accuracy, need for repeat biopsy, and adverse events were noted.


Eligibility criteria:
inclusion criteria: * all patients with retroperitoneal tumors with indication for percutaneous biopsy exclusion criteria: * tumors inaccessible for ultrasound guided biopsy * standard contraindications for biopsy (altered coagulation tests, poor performance status) * lack of written informed consent

Keywords: percutaneous biopsy contrast-enhanced ultrasonography ceus retroperitoneal neoplasms
glucose metabolism effects of vitamin d supplementation in prediabetes

Conditions: Prediabetic State; Overweight; Obese

Summary: vitamin d deficiency is widespread throughout the world, and the deficiency has been associated with several chronic diseases, such as cardiovascular diseases and diabetes. in nordic countries, like in finland, there is a particular variation in vitamin d status, and during wintertime, when there is no exposure to ultraviolet-b light from the sun, serum concentrations of vitamin d decrease substantially. in finland, some 40% of middle-aged men and one third of women also have some degree of impairment of glucose metabolism. the purpose of this trial is to investigate the effects of two different daily doses of vitamin d on glucose metabolism in men 60 years of age or older and who are vitamin d deficient, have a high body mass index and at least two characteristics of cardio-metabolic syndrome. altogether 102 subjects with low serum calcidiol (\<60 nmol/l) will be recruited and randomized to one of the three groups: 1) 40 µg/d vitamin d3, 2) 80 µg/d vitamin d3 or 3) placebo. the supplementation period will last for 6 months from september 2011 to march 2012. the main hypotheses of the trial are: (1.) vitamin d supplementation will improve glucose and insulin metabolism in people with a low baseline vitamin d status, in a dose-dependent manner. (2.) vitamin d supplementation will have an effect on the expression of genes involved in glucose and insulin metabolism and inflammation. (3.) vitamin d supplementation will have an effect on epigenetic changes in key genes participating in vitamin d metabolism.


Eligibility criteria:
inclusion criteria: * age 60 years or older * serum calcidiol \<75 nmol/l * body mass index 25-35 kg/m2 * impaired fasting glucose or impaired glucose tolerance (fasting glucose 5.6-7.0 mmol/l or 2h oral glucose tolerance test glucose 7.8-11.0 mmol/l) exclusion criteria: * any chronic disease and condition, which may hamper to follow the intervention protocol (such as alcohol abuse) * any chronic disease or therapy which may mask or interact with the investigated effects (such as diabetes or systemic corticosteroid therapy) * any disease or state that raises a vitamin d related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or wegener's granulomatosis) * use of supplements yielding vitamin d over 20 µg/d and unwillingness to discontinue the use.

Keywords: vitamin d cholecalciferol supplementation prediabetic state obesity glucose metabolism gene expression transcriptomics epigenomics immunological function insulin sensitivity peripheral mononuclear cells
nurse-provided care or standard care in treating patients with pancreatic cancer

Conditions: Fatigue; Nausea and Vomiting; Pain; Pancreatic Cancer

Summary: rationale: meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with pancreatic cancer. purpose: this clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with pancreatic cancer.

objectives: * to test the effects of an advanced practice nurse (apn) standardized nursing-intervention protocol (snip) model vs usual care on overall quality of life (qol) and psychological distress from initial treatment to 6 months post diagnosis for patients with pancreatic cancer. * to compare symptom control in these patients. * to compare geriatric assessment outcomes in these patients. * to test the effects of the snip intervention as compared to the usual care group on resource use by these patients. * to test the effects of snip on patients' and clinicians' satisfaction with care. * to describe the effects of snip on patients' management of transitions from one phase of chronic illness to another. * to identify subgroups of these patients who benefit most from the snip in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors. * to obtain feedback from clinicians regarding interpretation of findings and application to the routine care of pancreatic cancer patients. outline: patients are sequentially enrolled to 1 of 2 groups. group 1 is enrolled during months 4-21 and group 2 during months 25-54. * group 1 (usual care): patient questionnaires are administered at baseline and at 3 and 6 months. the clinicians' satisfaction with care is also evaluated. * group 2 (advanced practice nurse \[apn\] intervention): patients are accrued by an apn. patients meet with the apn periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. questionnaires are administered at baseline and at 3 and 6 months. in both groups, questionnaires include the fact-hep, memorial symptom assessment scale, psychological distress thermometer, comprehensive geriatric assessment, and patient satisfaction with intervention. clinicians also complete questionnaires. patients' medical charts are also reviewed.

Eligibility criteria:
disease characteristics: * diagnosis of pancreatic cancer (all stages) patient characteristics: * admitted to city of hope national medical center * resides within a 30-mile radius of the medical center * no prior cancer prior concurrent therapy: * no prior therapy

Keywords: pain fatigue nausea and vomiting recurrent pancreatic cancer stage i pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer