Kornimate/medical-research-clean huggingface dataset:
modified-release dipyridamole/aspirin (200mg/25mg bd) versus aspirin (75mg) in aspirin-resistant patients

Conditions: Coronary Arteriosclerosis

Summary: the primary objective of this study is to assess whether adding modified-release dipyridamole to aspirin (asasantin retard) has measurable effects on markers of platelet function (for example, platelet aggregation) in patients with cardiovascular disease who are known to be resistant to aspirin alone


Eligibility criteria:
inclusion criteria: * cardiovascular disease (including history of stroke or transient ischaemic attack) * documented evidence of resistance to aspirin * capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent. * willing to give informed consent prior to participation in the trial. exclusion criteria: * any clinically significant condition other than cardiovascular disease. * clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings. * use of dipyridamole, clopidogrel, ticlopidine or any non-steroidal anti-inflammatory agent (nsaid)(including cox-2 inhibitors) during the two weeks before randomisation and during the trial. * active peptic ulceration or history of peptic ulcer disease. * known history of or suspected hypersensitivity to dipyridamole, aspirin, any nsaid or any other component of the test drugs. * history of any bleeding disorder. * history of cerebral haemorrhage. * resting seated blood pressure less than 90/60mmhg. * participation in any drug clinical trial within sixteen weeks prior to the start of the trial. * any indication of current or previous abuse of alcohol, solvents or drugs. * asthma. * pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile). * previous participation in the randomisation phase of this clinical trial.
calcium isotope ratios to assess calcium bone balance in dialysis children receiving cinacalcet

Conditions: Children Over 3 Undergoing Dialysis With Secondary Hyperparathyroidism

Summary: managing bone and mineral disorders associated with chronic kidney disease (ckd-mbd) in children is a complex task. controlling parathyroid hormone (pth) levels involves adjusting calcium intake, managing hyperphosphatemia, intensive dialysis, and considering specific therapies like active vitamin d analogues and cinacalcet. cinacalcet, authorized in europe since 2017 for children over 3 undergoing dialysis with secondary hyperparathyroidism (shpt), has shown efficacy in reducing pth levels. the 2019 guidelines call for its use with caution particularly to avoid hypocalcemia, in children with severe hyperparathyroidism despite optimized conventional treatments. in adults, cinacalcet has been found to reduce serum pth, calcium, and phosphate levels, decrease the risk of vascular calcification, and have a positive effect on bone formation. this suggests that cinacalcet may slow the progression of cardiovascular calcifications. additionally, professor shroff has introduced a non-invasive method for assessing bone calcium status by analyzing stable calcium isotope ratios in blood. this method would allow to determine whether a treatment such as cinacalcet has a positive influence on bone calcium balance, a key element in the management of ckd-mbd.


Eligibility criteria:
inclusion criteria: * children from 3 to 17 years of age * on maintenance dialysis : hemodialysis, hemodiafiltration, peritoneal dialysis * patient who begin treatment with cinacalcet based on the 2019 european guidelines and at the discretion of the treating physician * with normal qtc interval on electrocardiogram * with total serum calcium \>2.40 mmol/l * with heamoglobin \> 8g/dl * non - opposition from parents/legal guardians exclusion criteria: * children \< 12 kg * persons deprived of their liberty by a judicial or administrative decision * persons under psychiatric care * persons admitted to a health or social institution for purposes other than research * persons not affiliated to a social security scheme or beneficiaries of a similar scheme * persons participating in other interventional research with an exclusion period still in progress at pre-inclusion * patients who received cinacalcet with 3 months prior inclusion

Keywords: ckd-mbd children secondary hyperparathyroism cinacalcet dialysis
acute pancreatitis : comparison of various scores in predicting severity and outcome

Conditions: Acute Pancreatitis

Summary: the study will make a comparison between various severity scoring systems that has been designed to assess the severity and predict prognosis in acute pancreatitis

the study will evaluate the relationship between homeostatic model assessment of insulin resistance , bedside index of severity score and the harmless acute pancreatitis score and prognosis of acute pancreatitis ,will compare of these scores in predicting severity of acute pancreatitis and will compare of these scores in predicting outcome of acute pancreatitis.

Eligibility criteria:
inclusion criteria: * any patient with 18 years or above and met criteria for diagnosis of acute pancreatitis will be eligible for the study. exclusion criteria: -
gene expression profiling in pbmcs as a tool for prediction of anakinra responsiveness in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the objective of the study is to identify and validate predictive markers of anakinra responsiveness in ra patients by a transcriptomic approach. patients with active ra (acr criteria) were given subcutaneous anakinra (100mg/d) 3 associated with metotrexate. anakinra efficacy was evaluated at week 12, using the eular response criteria. a blood sample was collected just before the onset of anakinra treatment and total rnas were extracted from the peripheral blood mononuclear cells. the \[33p\] radiolabeled mrnas were hybridized (duplicate or triplicate) over a set of 10.000 human cdna probes spotted at a high density on nylon membranes. data were normalized and filtered to allow the comparison between rna samples. statistical analyses were performed with the r software and hierarchical clustering was performed with the cluster and tree view softwares.


Eligibility criteria:
inclusion criteria: * is age 18 years old or older satisfies the 1987 american college of rheumatology revised criteria for rheumatoid arthritis has active disease at the time of randomization as indicated by a das28\> 5.1 has a disease at least refractory to dmards whose methotrexate or leflunomide is capable of understanding and signing an informed consent form agrees to use a medically accepted form of contraception during the study exclusion criteria: * is pregnant or breast-feeding or without contraception has significant concurrent medical diseases including cancer or a history of cancer within 5 years of entering the study, uncompensated congestive heart failure, significant active infection or any underlying diseases that could predispose subjects to infections (whose tuberculosis) has renal disease (creatinin clearance level \< 30 ml/min) has allergy to anakinra has leukopenia (white blood cells \< 1.5 x 109 /l
a multicenter data registry for outcomes from surgical treatment of atrial arrhythmias

Conditions: Atrial Fibrillation

Summary: minimally invasive surgical treatment of atrial fibrillation is safe and effective at controlling atrial fibrillation. the fundamental goal of star outcomes registry is to improve the understanding of the efficacy of surgical ablation intervention in the treatment of atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. adult patients with paroxysmal (intermittent) or persistent atrial fibrillation 2. \> 18 years of age exclusion criteria: 1. patients unable to give adequate informed consent 2. patients who are known to be pregnant, plan to become pregnant or are lactating 3. inability to return for follow up 4. patients who are prison inmates or institutionalized 5. patients in an emergency state 6. patients under the age of 18

Keywords: afib atrial fibrillation maze mini-maze
evaluate the relationship of bone remodeling markers for skeletal complications in metastatic breast cancer patients

Conditions: Metastatic Breast Cancer

Summary: to evaluate whether bone marker can provide the valuable predictor of skeletal complications and whether regular assessing of ntx(n-telopeptide of type i collagen) and osteocalcin can be useful in advanced breast cancer patients with bone metastasis receiving zoledronic acid.

to evaluate the efficacy and safety of zoledronic acid by measuring changes in bone turnover markers * the incidence of skeletal-related events * time to skeletal-related events * time to bone metastases progression * overall survival * the incidence of each adverse event including osteonecrosis

Eligibility criteria:
inclusion criteria: 1. patients with advanced breast cancer with radiographic confirmation of bone metastases (minimum of one bone scan lesion must be confirmed as metastatic on plain radiographs or ct/mr imaging) 2. men or women aged ≥ 18 years 3. who (ecog) performance status 0-2 4. women of child-bearing potential must be using a reliable and appropriate method of contraception 5. urine sample taken and sent to the central laboratory for baseline ntx analysis 6. written informed consent. exclusion criteria: 1. bisphosphonate treatment within the 4 weeks prior to planned first study treatment 2. abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute 3. poor venous access 4. metabolic bone disease 5. unable to comply with study procedures, especially the reliable collection of urine samples for bone resorption marker measurements 6. estimated life expectancy of \< 6 months 7. treatment with systemic bone seeking radioisotopes within the 3 months prior to study entry 8. wide field (hemi-body) radiotherapy within the 3 months prior to study entry 9. concomitant medication with drugs known to affect bone metabolism 10. pregnancy or breast-feeding 11. current active dental problems including infection of the teeth or jawbone (maxilla or mandibular), or a current or prior diagnosis of osteonecrosis of the jaw (onj) 12. recent (within 4 weeks of study entry\*) or planned dental or jaw surgery

Keywords: metastatic breast cancer bone remodeling markers zoledronic acid
this is a randomized study comparing two doses of int131 ( 3 mg and 1 mg) administered orally (po) daily (qd) versus placebo 1 tablet po qd in subjects with treatment-naïve rrms for ≤ 3 years

Conditions: Multiple Sclerosis, Relapsing Remitting

Summary: this is a randomized, double-blind, parallel group study comparing two doses of int131( 3 mg and 1 mg) administered orally (po) daily (qd) versus placebo 1 tablet po qd in subjects with treatment-naïve rrms for ≤ 3 years.

this is a randomized, double-blind, parallel group study comparing two doses of int131( 3 mg and 1 mg) administered orally (po) daily (qd) versus placebo 1 tablet po qd in subjects with treatment-naïve rrms for ≤ 3 years.. part 2 of the study is open-label, subjects completing 6 months of evaluations and study drug in part 1 without serious study drug-related treatment emergent adverse events (teae) will be switched to int131 1 mg po qd and followed for an additional 6 months.

Eligibility criteria:
inclusion criteria: 1. signed informed consent before any study procedures 2. male and female subjects aged 18-50 3. subjects with a diagnosis of rrms of three (3) years or less based on date of diagnosis 4. at least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart exclusion criteria: 1. subjects with a history or presence of chronic disease of the immune system other than rrms 2. subjects with a diagnosis of primary or secondary progressive multiple sclerosis 3. ten (10) or more active gadolinium ce mri-detected lesions on baseline mri obtained on visit 2
the rhode island prescription and illicit drug study

Conditions: Opioid Overdose; Drug Overdose

Summary: this study will test the efficacy of a novel drug-checking intervention to prevent fatal and non-fatal overdose among people who use drugs (pwud), who are 18-65 years old at the time of enrollment. the investigators will evaluate whether the incorporation of rapid fentanyl testing into a theory-driven overdose education and prevention intervention reduces rates of overdose compared to standard overdose education and naloxone distribution. results from this study will significantly improve public health efforts to address the fentanyl overdose epidemic and reduce harms associated with exposure to drugs contaminated with fentanyl. this is a full clinical trial, building on the previously approved fentanyl-test-strip pilot study (2016-2017), the results of which have recently been published.(krieger et al., 2018)

the investigators will assess the efficacy of the rapids intervention on preventing overdose among pwud. participants will be randomized 1:1 to receive the rapids intervention or the attention-matched control condition. experimental arm participants will receive the rapids intervention, which includes education about the dangers of illicitly manufactured fentanyl (imf), motivational interviewing to increase willingness to use fentanyl test strips and engage in overdose risk reduction behaviors, hands-on training to use the test strips, and opportunities to plan and role- play how to implement overdose risk reduction behaviors upon receipt of a positive or negative test result. in the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (oend) training. all participants will attend additional study visits at months 1,2,3,6, and 12. the primary endpoint will be the rate of self-reported overdose over the follow-up period. secondary endpoints (e.g., overdose death) will be ascertained by data linkage to statewide overdose surveillance databases. the primary aims of this study are to: 1) assess the efficacy of the rapids intervention in reducing rates of overdose among people who use drugs; 2) examine the degree to which reductions in rates of overdose are mediated by increases in information, motivation, behavioral skills, and self-efficacy regarding fentanyl, rapid fentanyl testing, and harm reduction practices; and 3) explore whether there is heterogeneity of treatment effect related to key participant characteristics.

Eligibility criteria:
inclusion criteria: * reside in rhode island * are able to complete interviews in english * are able to provide informed consent * self-report past 30 day heroin, illicit stimulants, counterfeit prescription pills, or injection drugs exclusion criteria: * participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Keywords: drug overdose substance-related disorders chemically-induced disorders fentanyl analgesics, opioids narcotics naloxone central nervous system depressants physiological effects of drugs
phase ii trial of docetaxel and celecoxib in patients with androgen independent prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: a multi-center controlled, non-comparative open phase ii trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by psa response defined as a 50% reduction in psa maintained on two consecutive evaluations at least 4 weeks apart.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed maipc * documented progressive disease in bone, soft tissue or psa despite castrate levels of testosterone * if lhrh agonist were used previously it must be kept * previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida * previous des should be held for at least 4 weeks before partcipating in the trial * chemotherapy naive patients * no prior radioisotope * less than 25% of bone marrow should be irradiated for prior palliative radiotherapy * kps\> 70% * adequate hematologic, hepatic and renal function exclusion criteria: * patients with serious medical illness * history of significant active cardiac disease * history of gastrointestinal ulceration, bleeding or perforation * history of myocardial infarctin within past 12 months * allergy to sulfonamides or to celecoxib or history of urticaria to any nsaid the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: metastatic androgen independent prostate cancer (maipc)
body impedance analysis to detect icuaw

Conditions: Critical Illness

Summary: the aim of the study is to detect a value of muscle and organ mass measured by body impedance analysis and its correlation with the medical research council (mrc) score. an mrc score ≤ 48 is defined as a diagnosis of icu acquired weakness. the correlation of the values detected by bia and their transfer to an mrc score ≤ 48 will be investigated. the knowledge gained will be used for early detection of icuaw in order to reduce the consequences of the same.

intensive care unit acquired weakness (icuaw) describes the clinically diagnosed manifestation of neuromuscular organ dysfunction. it develops in approximately 40% of all icu patients, which corresponds to at least 1.2 million patients annually in germany. all these patients face a wide spectrum of sequelae and increased mortality up to 5 years after icu discharge. a characteristic pathophysiological phenomenon is early severe muscle atrophy, which is as high as 17% in the first days after icu admission. icuaw is currently diagnosed by the mrc score, which is assessed by the sum of manual muscle strength test results in 12 muscle groups (sum score). manual muscle testing (mmt) is not possible during the early phase in critical illness in most patients due to coma, delirium, and/or injury. in addition, there is a possible discrepancy by different observers. as a result, early detection of icuaw may be inadequate in most patients and unreliable during critical illness. measurement by bia is reproducible, so differences in measurement can be attributed to changes in clinical condition. body impedance analysis thus demonstrates a means of objective measurement. thus, the study aims to counteract the long-term consequences of icuaw through early detection of icuaw by allowing countermeasures to be taken earlier.

Eligibility criteria:
inclusion criteria: - patients aged ≥ 18 years with ventilatory support within 36 hours from icu admission. exclusion criteria: * with a language barrier * patients with pacemaker or other electronic implant * expected death or discontinuation of life-sustaining measures. * not walking independently before hospitalization (gait aids allowed) * allergy to electrode gel * bia or ultrasound not technically feasible due to e.g. extensive wounds, skin rash or bandages
treatment of facial flushing with botulinum toxin a injections

Conditions: Facial Flushing

Summary: the purpose of this study is to find out if botulinum toxin a (botox®) can be used to treat facial flushing. this study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria:
inclusion criteria: 1. patients 18-65 years of age with persistent facial flushing 2. willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff. exclusion criteria: 1. unable to understand the protocol or give informed consent 2. younger than 18 or older than 65 years of age 3. females who are pregnant or lactating 4. known hypersensitivity to btx-a 5. subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics) 6. subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma 7. botulinum toxin injections in the past 6 months 8. ablative laser procedure in the past 6 months 9. radiofrequency device treatment in the past 6 months 10. ultrasound device treatment in the past 6 months 11. medium to deep chemical peel in the past 6 months 12. temporary soft tissue augmentation material in the area to be treated in the past year 13. semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years 14. permanent soft tissue augmentation material in the area to be treated 15. is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region. 16. is planning to use tretinoin or retinoic acid in the next 6 months 17. has an active infection in the forehead or glabellar region (excluding mild acne) 18. is allergic to cow's milk protein 19. is allergic to albumin 20. is currently using anticoagulation therapy 21. has a history of bleeding disorders
study to assess the safety and tolerability of a parp inhibitor in combination with topotecan

Conditions: Malignant Solid Tumors

Summary: the purpose of this study is to identify a safe and tolerable dose of the drug ku-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists; * evaluable disease * adequate bone marrow, hepatic and renal function exclusion criteria: * any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study * heavily pre treated patient \> 2 previous chemotherapy regimens for metastatic disease * co-existing active infection

Keywords: malignant solid tumours poly(adp ribose) polymerases
outcome enduro versus link sl rotating hinge knee

Conditions: Knee Arthrosis,

Summary: randomized clinical outcome study of two rotating hinge knee prosthesis in knee surgery. hypothesis: no difference in the clinical outcome for 1 year after the operation. clinical follow-ups at 3, 10, 90 and 360 days after surgery. measurement of clinical parameters


Eligibility criteria:
inclusion criteria: * rotating hinge knee indicated exclusion criteria: * infection, * malignant tumor, * rheumatism

Keywords: knee revision surgery, rotating hinge prosthesis