Kornimate/medical-research-clean huggingface dataset:
effect of inflammasome inhibitor on hscrp in patients after pci

Conditions: NLRP3; hsCRP; Percutaneous Coronary Intervention

Summary: coronary artery disease (cad) comprises the major contributor to a global epidemic of cardiovascular disease. patients with cad undergoing percutaneous coronary intervention (pci) have a high-risk for adverse clinical outcomes. residual inflammatory risk (rir) in patients with cad after standardized treatment is the main cause of adverse events such as recurrent myocardial infarction, stroke, and death, which has gained much interest in recent years. inflammation plays an important role in the development of cad. however, several randomized controlled clinical studies (rct) of anti-inflammatory treatments ended in failure previously. since 2017, the success of three large-scale rcts (cantos, colcot and lodoco2) points to targeting the nlrp3 - il-1 β- il-6 pathway for anti-inflammatory treatment of cad. the inhibition of this pathway eventually leads to the decrease of high-sensitivity c-reactive protein (hscrp), consistent with an anti-inflammatory effect. therefore, the change of hscrp may serve as a biomarker to screen anti-inflammatory drugs in this pathway. targeting the nlrp3 - il-1 β- il-6 pathway with monoclonal antibodies is limited by high prices of the biological agents. thus, researchers focused on the upstream molecule nlrp3. currently, nlrp3 inhibitors that are clinically available include colchicine , tranilast and oridonin. although several studies have indicated the effective effects of colchicine in cad, the other two nlrp3 inhibitors lack sufficient data on anti-inflammatory treatment of cad. therefore, we intend to use nlrp3 inhibitors (colchicine, tranilast and oridonin) to treat patients after pci for 4 weeks, compare the changes of hscrp, and explore the effectiveness and safety of these different drugs, and screen the optimal anti-inflammatory drugs for coronary heart disease.


Eligibility criteria:
inclusion criteria: 1. voluntarily participate, and sign the informed consent form; 2. age ≥ 18 and ≤ 80 years, regardless of sex; 3. patients after completion of planned percutaneous coronary intervention for 4 weeks. exclusion criteria: 1. allergic to colchicine, tranilast or oridonin; 2. taking colchicine, tranilast or oridonin before the screening period (10 days); 3. abnormal liver function (alt \> 3 times the upper limit of normal value); 4. abnormal renal function (creatinine clearance \< 45 ml / min); 5. thrombocytopenia (plt \< 100g / l); 6. uncontrolled infectious diseases; 7. complicated with immune diseases or immune related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc. 8. nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs been taken; 9. history of surgery within 6 months before the screening period; 10. pregnant women, lactating women or women of childbearing age who do not use effective contraceptives; 11. other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.
study of btk inhibitor, ibrutinib in combination with carfilzomib in subjects with relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: a multicenter phase 1/2b study of the bruton's tyrosine kinase inhibitor, ibrutinib (pci-32765), in combination with carfilzomib (kyprolis™) in subjects with relapsed or relapsed and refractory multiple myeloma

bruton's tyrosine kinase (btk) is an enzyme that is present in hematopoietic cells other than t cells and is necessary for downstream signal transduction from various hematopoietic receptors including the b cell receptor as well as some fc, chemokine, and adhesion receptors, and is crucial for both b cell development and osteoclastogenesis. although down-regulated in normal plasma cells, btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. pci-32765 is a potent and specific inhibitor of btk currently in phase 2 and 3 clinical trials. the current study is designed and intended to determine the safety and efficacy of pci-32765 in combination with carfilzomib (kyprolis™) with and without dexamethasone in subjects with relapsed or relapsed and refractory multiple myeloma (mm).

Eligibility criteria:
inclusion criteria: * measurable disease of mm as defined by at least one of the following: 1. serum monoclonal protein (spep) ≥1 g/dl 2. urine m-protein ≥200 mg/24 hrs 3. serum free light chain (sflc): involved flc ≥10 mg/dl (≥100 mg/l) and abnormal kappa to lambda serum free light chain ratio * relapsed or relapsed and refractory mm after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to imwg criteria) to the most recent treatment regimen * adequate hematologic, hepatic, and renal function * ecog performance status of 0-2 inclusion criteria for phase 2 sub-study cohort: * must meet all inclusion criteria defined in main study and in addition the following criteria must be met: * subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have: 1. achieved less than a partial response (\<pr) following at least 4 cycles and are without evidence of progression disease (pd). or 2. disease progression following an initial confirmed response of mr or better to the combination (according to imwg response criteria). exclusion criteria: * subject must not have primary refractory disease * plasma cell leukemia, primary amyloidosis or poems syndrome * unable to swallow capsules or disease significantly affecting gastrointestinal function * requires anti-coagulation with warfarin or a vitamin k antagonist * requires treatment with strong cyp3a inhibitors exclusion criteria for phase 2 sub-study cohort: * must not meet any exclusion criteria defined in main study except for exclusion criteria "subject must not have primary refractory disease" which is related to prior carfilzomib

Keywords: pci-32765 multiple myeloma relapsed refractory multiple myeloma bruton's tyrosine kinase carfilzomib dexamethasone ibrutinib
a prospective interventional study assessing the clinical and operational effectiveness of transitioning from mircera to daprodustat for the treatment of anemia in end stage kidney disease

Conditions: Anemia; Renal Insufficiency, Chronic; Renal Anemia

Summary: investigator-initiated, interventional, prospective study to assess the clinical and operational effectiveness of daprodustat in adult patients receiving in center hemodialysis or peritoneal home dialysis who are transitioning from mircera to daprodustat.

investigator-initiated, multicenter, prospective, interventional study to determine the clinical and operational effectiveness of transitioning from intravenous or subcutaneous mircera to oral daily daprodustat as assessed by change in hemoglobin. this trial will be conducted at up to 40 united states renal care sites in the united states and will enroll approximately 200 patients (\~150 in-center hemodialysis and \~50 home dialysis patients). participants who are prescribed daprodustat by their treating physician and have taken at least a single dose of daprodustat will be considered enrolled into the clinical trial. after the prescription of daprodustat by the treating physician, each subject will be followed prospectively for a treatment period of approximately 120 days. subjects taking daprodustat will not have any in-person study related visits and will follow their usual schedule with regard to standard of care. standard of care laboratory assessments as ordered by the primary nephrologist will be utilized. twice monthly hemoglobin collection and monitoring will be required as part of the standard of care laboratory assessments.

Eligibility criteria:
inclusion criteria: 1. adult patients ≥18 years old. 2. diagnosis of end stage kidney disease and receiving maintenance dialysis (in-center hemodialysis or peritoneal dialysis) for ≥ 4 months. 3. has received at least a single dose of mircera within 45 days prior to prescription of daprodustat by treating physician. 4. understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure. exclusion criteria: 1. a known allergy or intolerance to daprodustat or any of its constituents. 2. uncontrolled hypertension. 3. active malignancy as documented in electronic medical record. 4. concomitant use of a strong cyp2c8 inhibitor such as gemfibrozil. 5. severe hepatic impairment as documented in the electronic medical record.

Keywords: daprodustat mircera
biometrical evaluation of the efficacy of a food supplement versus placebo

Conditions: Skin Aging; Hair Condition; Skin Condition

Summary: the purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. this is a national, single-center, double-blind, randomized pilot study. the study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor. participants will: * take a food supplement or a placebo once daily for 2 months * visit the study center at beginning, after 28 days and after 56 days of supplementation. * keep a diary of their skin status and tolerability the secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.


Eligibility criteria:
inclusion criteria: * phototype: i to iv; * subjects with normal to dry skin; * subjects with healthy skin on the study area; * non-smokers; * has normal nutritional habits (not vegetarian/vegan); * is not pregnant or lactating; * has a bmi of 18 - 33 kg/m2; * is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start); * willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study; * no history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism; * uses no medication, which may interact with the study product exclusion criteria: * for women: pregnant or nursing woman or woman planning to get pregnant during the study; * cutaneous pathology on the study zone (eczema, etc.); * subject with make-up on the day of the visit at the laboratory; * use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product: * change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones, * non-invasive procedures within previous month on the studied zones, * intake of food supplement acting on skin within the three previous months, * invasive procedures: * deep chemical peeling within previous 3 months on the studied zones, * mesotherapy, dermapen, laser within previous 6 months on the studied zones, * botox and/or hyaluronic acid injections within previous 12 months on the studied zones; * intake of vitamin substances and diets comprising a change of normal eating habits; * known allergy to one or several investigational product´s ingredients; * participation in a nutritional study within the last 30 days; * surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>140/90 mm hg in three repeated measurements).

Keywords: improvements of skin physiological parameters
anti-xa activity of enoxaparin for prevention of venous thromboembolism in severe nephrotic syndrome.

Conditions: Nephrotic Syndrome

Summary: the primary objective is to test the hypothesis that enoxaparin efficacy is reduced in severe nephrotic syndrome. another purpose is to compare two dosing regimens.

nephrotic syndrome (ns) is a rare clinical condition characterized by proteinuria exceeding \>3.5 g/24h, hypoalbuminemia, dyslipidemia and edema and is associated with hypercoagulable state. in severe cases, with serum albumin ≤2.5 g/dl, the risk of venous thromboembolic events (vte) is particularly high, and pharmacological prophylaxis is recommended. however, there is a limited evidence of its efficacy and optimal dosing. the study is designed as 3 arms clinical trial, with 2 study groups and a single control group. the study groups will include patients with severe ns parallelly, alternately assigned (1:1) into two enoxaparin dosing regimens. the control group will consisted of individuals without proteinuria and edema, similar in terms of age, anthropometric features and renal function to ns patients, who will be administered a standard enoxaparin dose. a peak anti-xa activity at the steady state will be measured to determine the plasma concentration of enoxaparin. additional laboratory tests for markers of ns severity, renal function and coagulation system proteins will be performed. the overhydration and body water compartments will be assessed using bioimpedance spectroscopy technique. nephrotic patients will be followed up by 12 months to assess overt vte and adverse events associated with enoxaparin use.

Eligibility criteria:
inclusion criteria: * severe ns, defined as proteinuria exceeding 3.5 g/24h or 50 mg/kg/24h and serum albumin ≤2.5 g/dl; * egfr ≥30 ml/min/1.73 m2. exclusion criteria: * body mass index (bmi) ≥40 kg/m2; * low body mass (\<45 kg for female, \<57 kg for male); * acute vte; * previously introduced anticoagulation (due to comorbidities); * contraindications for enoxaparin; * pregnancy.

Keywords: nephrotic syndrome enoxaparin low molecular weight heparin anti-xa activity antifactor xa venous thromboembolism
very early rehabilitation in acute ischemic stroke

Conditions: Stroke

Summary: the purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in acute vascular unit and in general ward of hospital de clínicas de porto alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by cct or mri admitted to the acute vascular unit of hcpa between the first 48 hours of onset of symptoms. * patients older than 18 years. * patients clinically and hemodynamically stable (sbp 120-220 mmhg, sato2 up to 92% with or without supplementation, hr between 60 and 100 bmp, body temperature below 38 and rr below 25 bpm). * patients are able to react to verbal commands even without being fully alert (glasgow scale above 8). * prior rankin until 3 * motor deficit and / or coordination measured by the nihss exclusion criteria: * patients with clinical and / or hemodynamic instability * patients with hemorrhagic stroke or tia (transient ischemic attack). * patients with progressive neurological disease and acute coronary disease and / or unstable.

Keywords: stroke early ambulation rehabilitation physical therapy randomized controlled trial
comparison of nasal fentanyl and oral transmucosal fentanyl (actiq) in cancer breakthrough pain (ft-019-im)

Conditions: Pain

Summary: primary: • to compare the efficacy of nasal fentanyl (nf) to oral transmucosal fentanyl (actiq®) (hereafter actiq) in the management of breakthrough pain in cancer patients. secondary: * to compare patients' general impression and preference of nf and actiq * to explore the relationship between nf doses and dose of current opioid for breakthrough pain (btp) and the relationship between dose of nf and of background opioid * to assess safety and tolerability of nf


Eligibility criteria:
inclusion criteria: * adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain. * minimum three btp episodes per week and maximum four per day. life expectancy of at least three months. * chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed. * randomisation in previous studies with nf, i.e. ft-016-im, ft-017-im or ft-018-im, is not allowed. * previous use of actiq is accepted.

Keywords: breakthrough pain in patients with cancer
factors associated with perioperative outcomes in non-emergency surgery

Conditions: Stroke; Acute Coronary Syndrome; Pneumonia

Summary: this epidemiological study investigates the association of recent stroke, acute coronary syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and cardiac surgery using routinely collected uk primary and secondary care patient data.

previous studies have identified prior stroke, heart attack or current diabetes mellitus and anaemia as important risk factors for adverse outcomes following surgery. recent heart attacks are associated with greater risks than older ones. while recent data suggests that newer strokes impart significantly greater risk than older strokes, there is a lack of concordance on the literature on this, despite the plausibility of the finding. despite knowledge that prior pneumonia has long-term health risks, there is a lack of data on whether prior pneumonia influences perioperative risk or whether the time interval from pneumonia to surgery affects this relationship. furthermore while diabetes mellitus and anaemia are known to be important perioperative risk factors, the relationship between haemoglobin concentration or hba1c levels and perioperative outcomes is unclear. the aim of this epidemiological study is to explore these associations with perioperative risk in the united kingdom clinical practice research datalink (with linkage to hospital episode statistics data and office of national statistics mortality data). the research aims are: 1. to investigate the association between three recent acute medical events (stroke, pneumonia and mi) and adverse perioperative outcomes following non-cardiac and cardiac surgery. 2. to investigate the association between time-elapsed between acute medical events (stroke, pneumonia and mi) and adverse perioperative outcomes following non-cardiac and cardiac surgery. 3. to investigate numerical risk thresholds for haemoglobin and hba1c that could predict adverse perioperative outcomes following non-cardiac and cardiac surgery.

Eligibility criteria:
inclusion criteria: * undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013 exclusion criteria: * none

Keywords: mortality perioperative period elective surgical procedures
development and accuracy evaluation of gram staining analysis ai

Conditions: Bacterial Infections

Summary: the investigators use gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of gram staining analysis ai


Eligibility criteria:
inclusion criteria: * patients in whom a gram stain test was ordered exclusion criteria: * no exclusion criteria
supermicrosurgical lymphaticovenous anastomosis for prevention of upper limb lymphedema

Conditions: Breast Cancer-Related Lymphedema; Lymphedema; Breast Cancer Invasive

Summary: breast cancer-related lymphedema (bcrl) is one of the most common chronic complications following breast cancer treatment. this study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (id-lva) following axillary lymph node dissection (experimental group) or not (control group). the study aims to evaluate the safety and efficacy of id-lva in preventing breast cancer-related upper limb lymphedema.


Eligibility criteria:
inclusion criteria: 1. age \>=18 years; 2. female; 3. pathologically confirmed invasive breast cancer; 4. unilateral breast cancer; 5. clinical stage t1-4 and n1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment); 6. no clinical or radiographic evidence of distant metastasis; 7. scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy; 8. willing and able to provide written informed consent. exclusion criteria: 1. currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage. 2. no definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy. 3. pregnant or lactating women. 4. patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair. 5. upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage. 6. pre-existing upper limb lymphedema at baseline.

Keywords: supermicrosurgical lymphaticovenous anastomosis lymphedema breast cancer prevention immediate distal lymphaticovenous anastomosis
centralized pan-asian survey on the under treatment of hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the survey will try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the ldl-c goals according to the third ncep atp guidelines, overall and by country.


Eligibility criteria:
inclusion criteria: * 2 or more risk factors (according to ncep atp iii guideline) * receiving lipid-lowering drug treatment for at least 3 months without dosage change for a minimum of 6 weeks. exclusion criteria: * involvement in the planning and conduct of the study (applies to both astrazeneca staff or staff at the study site). * previous enrolment or randomisation of treatment in the present study. * participation in a clinical study during the last 90 days.

Keywords: hypercholesterolemia ncep atp iii guidelines survey
treatment of hyperglycaemia and insulin resistance in hiv infected patients

Conditions: Insulin Resistance

Summary: the purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus on stable highly active antiretroviral therapy including a protease inhibitor after the period of 48 weeks.


Eligibility criteria:
inclusion criteria: * documented hiv infection * stable protease inhibitor containing haart regimen for at least 12 months * impaired glucose tolerance * elevated insulin levels (above 20 miu/l) exclusion criteria: * patients already taking oral hypoglycaemic treatment or insulin * heart failure nyha i-iv * liver disease or kidney disease * elevated ast or alt above 2 times upper normal range * elevated creatinine (above 150 mmol/l)

Keywords: insulin rosiglitazone metformin hiv protease inhibitors