Kornimate/medical-research-clean huggingface dataset:
colchicine protective effect in patients undergoing percutaneous coronary intervention (colchicine-protect)

Conditions: Coronary Artery Disease

Summary: the goal of this clinical trial is to evaluate the colchicine protective effect in patients undergoing percutaneous coronary intervention (pci). the main question it aims to answer is: does initiating colchicine before planned pci will reduce post-procedural myocardial injury? half of the participants will receive colchicine, while the other half will receive a placebo.

inflammation in the setting of pci is associated with endothelial dysfunction and microvascular obstruction and remains an independent predictor of subsequent major adverse cardiovascular events (mace) even in the contemporary era of second-generation drug-eluting stents (des). inflammation also increases the risk of pci-related myocardial injury, which is associated with long-term all-cause mortality. colchicine is an inexpensive, orally administered, potent anti-inflammatory medication. recent major trials showed that using low-dose colchicine on top of gdmt reduces cardiovascular events in patients with either chronic coronary syndrome (ccs) or acute myocardial infarction (mi). a recent meta-analysis showed that using colchicine in the setting of pci also reduces cardiovascular events, however, the optimal regimen to subside pci-associated inflammation is still not clear. our aims are 1. evaluation of colchicine efficacy in protecting against pci myocardial injury. our hypothesis is that initiating colchicine 0.5 mg twice daily 72 to 48 hours before planned pci in ccs patients will decrease pci-related myocardial injury. 2. evaluation of colchicine efficacy in preventing pci-associated inflammation. our hypothesis is that colchicine will subside post-pci rise in high sensitive c-reactive-protein (hs-crp). 3. evaluation of colchicine efficacy in preventing no-reflow phenomenon. our hypothesis is that colchicine will decrease no reflow phenomenon in ccs patients undergoing pci. 4. evaluation of colchicine efficacy in preventing pci-related (type 4a) mi per the 4th universal definition. our hypothesis is that colchicine will decrease pci-related (type 4a) mi in ccs patients undergoing pci.

Eligibility criteria:
inclusion criteria: * chronic coronary syndrome (ccs) participants referred for pci. * acute coronary syndrome (acs) participants who are medically treated or undergoing revascularization for non-culprit lesions will be included if their troponin i and hs-crp returned back to normal baseline exclusion criteria: * acute coronary syndrome (acs) participants. * chronic kidney disease (glomerular filltration rate \<30 ml/ min). * participants with history of cirrhosis. * participants on systemic immunosuppressive or corticosteroid therapy. * active malignancy or infection. * elevated troponin i.

Keywords: coronary artery disease acute coronary syndrome percutaneous coronary intervention colchicine myocardial injury inflammation myocardial infarction no reflow
effect of a patient education in pain coping for patients scheduled for total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before total knee arthroplasty. resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after tka. furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.

in denmark, are approximately 8000 patients operated annually with knee arthroplasty. most of these patients will have less pain and higher functional ability after the surgery. however, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (tka). research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation. this study consists of two parts. the first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before tka are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). in the second part the patients in control group 1 will be matched on age, bmi and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).

Eligibility criteria:
inclusion criteria: * age above 18 years * inability to understand and communicate with the investigators * scheduled for an elective unilateral total knee arthroplasty * primary diagnosis of osteoarthritis * score greater than 22 or lower than 12 on the pain catastrophizing scale (pcs) exclusion criteria: * planned to undergo another elective joint replacement procedure during the 12 months period of participation * scheduled for revision arthroplasty surgery * tka surgery scheduled because of fracture, malignancy or infection * scheduled for unicompartmental knee arthroplasty * major depression diagnosed with the major depression index (mdi)
phamacokinetic and pharmacodynamic study of ramosetron in chemotherapy induced nasea and vomiting

Conditions: Colon Cancer

Summary: this study is designted to know optimal dose of ramosteron to control for chemotherapy induced nasea and vomoting (cinv)based on its pharmacokinetics, pharmacodynamic study and clinilcal parameters using rhodes index.

nausea and vomiting is a common adverse event during chemotherapy treatment. even if preventive medicines such as dopamine receptor antagonist, corticosteroid, serotonin receptor antagonist, has been developed and used, there is residual nausea and/or vomiting in a significant percentage of patients treated for cancer. serotonin receptor antagonist is the most potent antiemetic agent and has been used widely. however, the optimal dose of serotonin antagnosit based on individual symptoms is not defined. therefore, this study was conducted to design standardization model for optiomal serotonin antagonist concentration using pharmacodynamic study and rhodes index as a suggogate marker for cinv.

Eligibility criteria:
inclusion criteria: * patients who recevied moderate emetogenic chemotherapy * age between 18-75 * ecog ps 0-2 * adequate organ fuction including bone marrow, liver and kidney exclusion criteria: * gastrointestinal obstruction or carcinomatosis peritonei * cns metastasis or disability in cns * intractable medical illness * pregnancy or inadequate contraception

Keywords: chemotherapy induced nausea vomiting
the effect of losartan versus amlodipine-based therapy in ischemic stroke (0954-338)(completed)

Conditions: Ischemic Stroke

Summary: to compare the effect of losartan vs amlodipine-based antihypertensive therapy on atherosclerotic inflammatory markers and cerebrovascular regulation in ischemic stroke patients.


Eligibility criteria:
inclusion criteria: * patient with tia or ischemic stroke (event has occurred more thaan 4 weeks but less than 24 weeks, and modified rankin's scale, mrs\<=3) with mild to moderate hypertension * patient has no other active medical problem, which might of itself or by this treatment significantly affect the patient's blood pressure * the blood level of hscrp\>0.2 ng/dl by two measurements performed respectively one-week apart exclusion criteria: * patients with cardiac arrhythmia * diabetes mellitus * patient with other active inflammatory diseases such as rheumatoid disease, fever and systemic infection which will confound the level of serum crp * patients with known intolerance, contraindication or hypersensitivity to losartan, amlodipine and hydrochlorothiazide * patient with myocardial infarction within the recent three months * anatomy abnormality which results in poor bilateral temporal acoustic windows which prevent tcd procedure * patient who requires continuous medication with alpha blocking agents * concurrent usage of acei * poor mental function or any other reason to expect difficulty in meeting the requirements of the study * concurrent treatment with other lipid-lowering drug * childbearing potential women not undergoing adequate contraceptive control
haploinsufficiency of the rbm22 and slu7 genes in del(5q) myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes; Myelodysplastic Syndrome With Isolated Del(5Q); Myelodysplastic Syndrome With Del(5Q)

Summary: myelodysplastic syndromes (mds) are malignant hematopathies of the elderly characterized by persistent cytopenias and the presence of deregulated clonal hematopoiesis. the risk of progression to acute myeloid leukemia (aml) is variable. acquired cytogenetic abnormalities are found in less than 50% of de novo cases and up to 80% in secondary mds. the deletion of the long arm of chromosome 5 (written del(5q)) is the most common abnormality in mds (15%). del(5q) mds has a good prognosis, with a median survival of 6 years and a 15% risk of progression to aml. however, their life expectancy is shorter than the general population, and the quality of life of patients is diminished. these treatments are not that effective over a long period of time or not well tolerated, and the majority of patients die from causes related to their mds, such as infections (38%), progression to aml (15%), or bleeding (13%). two genes, rbm22 and slu7, coding for proteins of the same complex involved in splicing pre-messenger rna are carried on the long arm of chromosome 5. we investigate the pronostic impact and the predictive value of the double haploinsufficiency of the rbm22 and slu7 genes in del(5q) myelodysplastic syndromes isolated or not compared to the single haploinsufficiency of rbm22 and normal karyotype myelodysplastic syndromes.


Eligibility criteria:
inclusion criteria: * patients diagnosed with del5q mds isolated or not * the clinical and biological data are known at the time of diagnosis. * the clinical and biological data are known 1 year after the diagnosis * consent for the collection of samples for research purposes * non-opposition obtained exclusion criteria: * patients under judicial protection (guardianship, ...) * refusal to participate

Keywords: rbm22 slu7 transformation to acute myeloid leukemia anemia
the effects of different ventilation modes on patients with pulmonary lobe resection

Conditions: Lung Injury; Lung Inflammation

Summary: the objective of this study was to discuss the effects of different ventilation modes on patients with plasma inflammatory factor and respiratory function in patients with pulmonary removal.

patients who meet the inclusion criteria will be numbered in the order of admission, and a dedicated person will prepare codes and opaque envelopes for random allocation. this study was divided into 3 groups, one groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side, the other groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side; the other groups was ventilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side.

Eligibility criteria:
inclusion criteria: comprehensive examination and analysis of imaging, laboratory examination and other comprehensive examinations, the diagnosis is clear, which is in line with lobe resection surgical indications age 18-75 years old, the gender is not limited; asa grading ⅰ \~ iii level; it is expected that the single lung ventilation time is ≥1 hours, and ≤3 hours exclusion criteria: emergency surgery; there is a taboos on the existence of systemic anesthesia; there is a history of acute chronic upper respiratory infections in the past january; previous bronchial asthma, chronic obstructive pulmonary disease, bronchial dilatation, phthisis ,aspergillosis , acute respiratory distress syndrome or history of respiratory failure; merge the function of important organs such as heart, liver, and kidney; there was a history of chest surgery and the history of trauma; preoperative lung function test obvious abnormal abnormal abnormalities (1 second of exhalation (fev1) \<60%); patients refuse to participate in the clinical trial
a study of tanezumab as add-on therapy to opioid medication in patients with pain due to cancer that has spread to bone

Conditions: Neoplasm Metastasis; Palliative Care

Summary: the purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.


Eligibility criteria:
inclusion criteria: * prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain. * requires daily opioid medication exclusion criteria: * patients who do not have bone pain caused by cancer are not eligible for the study. * patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible. * known history or evidence of osteoarthritis. history of significant trauma to a major joint within 1 year prior to screening. * known history of rheumatoid arthritis.
treatment of non alcoholic fatty liver disease with lifestyle modification and acupuncture

Conditions: NAFLD; Accupuncture

Summary: nonalcoholic fatty liver disease (nafld) is the most common cause of liver dysfunction worldwide. nafld may progress to nonalcoholic steatohepatitis (nash) and in turn to cirrhosis. to date, the detailed pathogenic mechanism of nafld including steatosis and nash is not fully characterized, although it is regarded as a hepatic manifestation of the metabolic syndrome, sometimes it occurs in the absence of a metabolic syndrome. based on conventional models of "two-hit" and "multi- hit" hypothesis of nafld, the dysregulated lipid metabolism and insulin resistance are considered as the "first hit" of the liver and the following "second hit" or "multi-hit" likely involves oxidative stress, lipid peroxidation, increased inflammatory responses, induced hepatic fibrosis and apoptosis. this emphasizes the multi-factorial pathogenesis of nafld and the necessity to treat nafld with diabetes-like and multimodal strategy. several changes in dietary intake have occurred in the past few years, including increased energy intake (24%), and increases in added sugars, flour and cereal products, fruit, added fats and total fat intake. the increasing prevalence of nafld is probably directly affected by the contemporary epidemics of obesity, unhealthy dietary pattern, and sedentary lifestyle. currently, there are two major categories of nafld therapy: lifestyle interventions and pharmaceutical therapies, lifestyle interventions in terms of diet and physical activity are regarded as safe and effective, while pharmaceutical interventions showed limited efficacy with unknown safety in the long term ,therefore, the first line of treatment is lifestyle modification. although lifestyle intervention dose positively affects nafld, it has limitations. patients adherence to dietary intervention is 50%, while those who do adhere, find it difficult to maintain after 12 months. ). mediterranean diet has been shown to be effective in reducing nafld, liver steatosis and improve insulin sensitivity. acupuncture has been found as an effective treatment for improving quality of life in various medical conditions , including hepatitis . acupuncture combined with life style intervention has been found effective in the treatment of obesity, metabolic syndrome in terms of weight, lipid regulation, glucose levels and various markers of inflammation. acupuncture's effect on nafld has yet to be studied. we suggest that acupuncture combined with life style intervention can be an effective treatment for nafld.


Eligibility criteria:
inclusion criteria: above 18 years old no known metabolic pathology nafld diagnosis exclusion criteria: known metabolic pathology psychiatric diagnosis auto immune disease known diabetes hypertension
pharmacokinetic study for pca derivate formulations

Conditions: Healthy

Summary: a comparative bioavailability study of pca slow release versus immediate release formulations, after a single dose to fasting healthy subjects.


Eligibility criteria:
inclusion criteria: * subjects who have completed the informed consent process culminating with written informed consent by the subject. * males * age 18-45 years * abstinence from alcohol for 1 week prior to the study * non smoking * bmi \> 19 and \< 30 * no history or evidence of significant * cardiovascular, * hepatic, * renal, * hematopoietic, * gastrointestinal disease, * endocrine, * metabolic, * psychiatric * psychological disorders * normal physical examination * within +/- 10% of normal values in laboratory examinations exclusion criteria: * subjects who suffer from a current medical condition. * subjects who smoke. * subjects who drink \> 20 grams of alcohol per day. * subjects who take prescription medication. * subjects with an abnormality in screening blood tests * known sensitivity to any ingredients in the study drug

Keywords: comparative bioavailability of pca formulations
lipid-poor adrenal masses: evaluation with chemical shift mri

Conditions: Adrenal Gland Disease

Summary: the purpose of this study is to determine if certain mri sequences can accurately diagnose adrenal masses of unknown origin.


Eligibility criteria:
inclusion criteria: * patients can participate in this study if they are 18 years of age or older and if they have had a cat scan (ct scan) performed with and without contrast media (medication given intravenously to enhance the ct images) or if patients are scheduled to have a ct scan performed and if the reason their physician ordered the ct is because they have an adrenal mass of an unknown type. exclusion criteria: * patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator. * pregnant patients or patients who are lactating. * a patient who is claustrophobic and would require sedation to complete the mri exam.

Keywords: adrenal glands, adrenal masses
group exercise in cancer patients under active treatment: feasibility pilot study.

Conditions: Neoplastic Disease

Summary: the aim of this study to investigate the feasibility in hospital reality, of a group exercise program for oncology patients under active treatment and evaluate its impact on some outcomes considered relevant from both clinical and subjective point of view.

the intervention will consist of efg sessions lasting 45 minutes each, twice a week for 12 weeks to be carried out in the gym of the rehabilitation day hospital. each 45-minute session includes an initial relaxation/stretching phase, simple aerobic exercises, muscle strengthening exercises, balance exercises, and will be led by a physiotherapist. the exercises proposed to the group with ecog 2 will be less intense and of less difficulty with the aim of adapting the activity to patients with a lower performance status (see appendix 4.5, v2, 07/10/2024). the groups will consist of a minimum of five patients and a maximum of ten. patients will also be stimulated to perform physical activity at home to a total of 150 minutes per week. patients will be assessed at baseline (t0), at the end of the intervention (t1,12 weeks) and 6 months after the start of the intervention (t2).

Eligibility criteria:
inclusion criteria: * neoplastic tumor * age\>= 18 * prognosis\> 12 months * ecog \<=2 * walking with/ without aids * clinically stable * signed informed consent * patients with bone metastases with ecog from 0-1 suitable results exclusion criteria: * sensory deficits who cannot perform physical exercise * cognitive impairment that compromises collaboration and questionnaire filling * patients with pathologies (e.g. neurological, psychiatric) that do not allow the obtaining of valid informed consent
study of pregnyl as adjunct therapy for high-risk or refractory acute gvhd

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (arm 1) or refractory/dependent (arm 2) agvhd.


Eligibility criteria:
inclusion criteria: * acute graft versus host disease (gvhd) fitting one of the following categories: * high-risk agvhd (arm 1): pediatric or adult (ages 12-76 years) hct recipients with high-risk acute gvhd, as determined by the refined mn acute gvhd risk score: http://z.umn.edu/mnacutegvhdriskscore or high risk on the basis of blood biomarkers (ann arbor score 3 or amphiregulin ≥ 33 pg/ml) or * steroid-refractory agvhd (arm 2): pediatric or adult (ages 12-76 years) hct recipient with grade ii-iv steroid refractory or steroid-dependent acute gvhd, defined as any one of the following: * no response of acute gvhd after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent * progression of acute gvhd within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent * failure to improve to at least grade ii acute gvhd after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent * flare of acute gvhd of at least grade ii/iv severity despite tapering dose of steroids being \> 0.5 mg/kg/day. * adequate organ function at study enrollment defined as: * renal: 1.73m2serum creatinine ≤2.5x upper limit of normal (uln) * cardiac: left ventricular ejection fraction (lvef) ≥ 35% * voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds) exclusion criteria: * progressive malignancy * diagnosis of a hormone responsive malignancy * uncontrolled infection at initiation of protocol treatment * current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible * active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status * pregnancy as assessed on baseline blood hcg level * unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations) * women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment screening inclusion criteria: * pediatric or adult (ages 0-76 years) hct recipients * suspected high risk gvhd * voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)

Keywords: gvhd