Kornimate/medical-research-clean huggingface dataset:
prevalence of comorbid spasticity and urinary incontinence in residents of a long-term care facility

Conditions: Spasticity, Muscle; Muscular Diseases; Musculoskeletal Disease; Muscle Hypertonia; Muscle Spasticity; Neuromuscular Manifestations; Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Summary: the purpose of this study is to improve spasticity diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral.

the aim of this study is to improve spasticity (a form of muscle rigidity) diagnosis through exploration of potential new diagnostic markers for spasticity that can assist in diagnosis and referral. this will be done by assessing the relatedness of comorbid conditions in patients with spasticity. emphasis will be placed on urinary incontinence, as previous work has suggested a link between the two conditions. an additional aim of this study is to assess health-related quality of life measures in this population. a medical record review will be performed for all consenting participants residing in tennessee state veterans' homes, which is a long-term care facility in murfreesboro, tn. participants will also be asked to complete a brief questionnaire assessing their perceived health-related quality of life, physical wellbeing, and mental wellbeing.

Eligibility criteria:
inclusion criteria: * male or female subjects of any race, aged 18 and above * resident of the selected long-term care facility * the subject, or if appropriate their medical decision maker, is willing and able to provide written informed consent. exclusion criteria: * subjects for whom participation in the study may cause medical harm
prospective observation for serial changes of acute intracranial artery dissection using high resolution mri

Conditions: Cerebral Arterial Diseases; Dissecting Aneurysm of Cerebral Artery; Intimal Dissection

Summary: intracranial artery disease has been more detected with development of hr-mr. hr-mr can depict vascular wall directly and give us more information beyond the pre-existing imaging modalities such as digital subtraction angiography, magnetic resonance angiography, computed tomography angiography. hence, hr-mr is considered to become promising imaging modality for intracranial artery disease and many studies have been published recently. however, there was not enough to differentiate various intracranial artery disease such as atherosclerosis, dissection, moyamoya disease, vasculitis, reversible vasoconstriction syndrome. in real clinical arena, intracranial artery disease is too difficult to diagnose and distinguish among the disease. of the disease, usefulness of hr-mr has been consistently published in the detection and diagnosis of intracranial artery dissection recently. hr-mr seems to be the most important and reliable imaging method in intracranial artery dissection as of now. therefore, intracranial artery dissection is necessary to study using hr-mr. intracranial artery dissection is dynamic vascular pathology. the geometric change is the most common among intracranial artery disease. however, there was no report about the geometric change in hr-mr. the investigators acquired retrospective data about the natural course of intracranial artery dissection in hr-mr and are preparing for publishing an article. however, the data is not prospective and not intraindividual comparison. therefore, reliability is not enough to convince the natural course. if the investigators got prospective and intraindividual data, definite natural course of intracranial artery dissection could be acquired and would be helpful to diagnose the dissection and differentiate from other vascular pathologies. the prospective longitudinal information from this study could guide us as the important map on the confusing hr-mr findings. the protocols for imaging are as follows: initial (optional), 1 month, 3 month, 6 month (optional), 12 month.


Eligibility criteria:
inclusion criteria: * informed consent * acute intracranial artery dissection exclusion criteria: * angioplasty, or stenting, * contraindication for mr imaging, * hypersensitivity to gadolinium based contrast media, * pregnant or lactating women, * renal condition : egfr \< 60, 6) patients unable and/or unwilling to comply with treatment or study instructions
common canister protocol for inhaler administration in mechanically ventilated patients

Conditions: Ventilator Associated Pneumonia

Summary: many hospitals employ a common canister inhaler protocol in patients that do not require mechanical ventilator support. common canister refers to a single inhaler paired with standardized cleaning methods for use on more than one patient. small reports suggest that this method does not pose an increased infectious risk and is associated with significant cost savings. common canister protocols offer a solution to the discordance between inhaler sizes and average inpatient use of the drugs. metered dose inhaler canisters are contain enough drug for several days to weeks of daily use. however, the average length of stay for most inpatients is only several days. therefore, most inpatients do not use all of the canister contents, an unused resource that is potentially wasted. the common canister approach has not been previously described in mechanically ventilated patients (people requiring intensive care unit admission on breathing machines). this study aims to assess the safety of common canister utilization by assessment and comparison of infection rates in the study and control group.


Eligibility criteria:
inclusion criteria: * mechanically ventilated patients prescribed bronchodilator therapy in a medical intensive care unit exclusion criteria: * lung transplant * neutropenic * contact isolation

Keywords: mechanical ventilation chronic obstructive pulmonary disease asthma common canister mdi ventilator associated pneumonia
efficacy and safety of the acat inhibitor cs-505 (pactimibe) for reducing the progression of carotid artery disease. this study is also known as captivate.

Conditions: Atherosclerosis; Heterozygous Familial Hypercholesterolemia

Summary: the effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of heterozygous familial hypercholesterolemia * ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects * calculated ldl-c level greater than or equal to 100 mg/dl (or 2.5 mmol/l) and triglycerides less than 500 mg/dl (5.65 mmol/l) while on usual and stable lipid-lowering therapy exclusion criteria: * breast feeding or lactating women * previous organ transplantation * high-grade stenosis (\>75%) or the occlusion of any segment of either carotid artery * history of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures
simvastatin and fenofibrate vs simvastatin alone in patients with type 2 diabetes mellitus and acute coronary syndrome

Conditions: Acute Coronary Syndrome; Diabetes Mellitus, Type 2; Hypertriglyceridemia

Summary: to test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (t2dm) and hypertriglyceridemia (htg) who experienced acute coronary syndrome (acs) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (tg) levels as an independent risk factor in the case of htg with diabetes.

the primary objective of this parallel group study is to demonstrate that the combined therapy of simvastatin and fenofibrate is superior compared to monotherapy with simvastatin based on the comparisons of change of tg levels after 12 weeks of treatment compared to baseline. secondary objectives are to compare both treatment alternatives the combination therapy of simvastatin and fenofibrate to simvastatin monotherapy with respect to achievement the european society of cardiology 2011 (esc 2011) non-hdl-c target (less than 2,6 mmol/l), change of apolipoprotein b/apolipoprotein a1 (apob/apoa1) ratio, high-density lipoprotein-cholesterol (hdl-c), low-density lipoprotein-cholesterol (ldl-c) and uric acid (ua) after 12 weeks and 52 weeks (1 year) of treatment compared to baseline.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * fasting triglycerides ≥ 1,7 mmol/l * acute coronary syndrome at least before 5 and maximum 21 days before the inclusion * if previously treated with statin therapy, the dose should be equivalent to 40 mg of simvastatin at inclusion * in case of previous statin therapy, last ldl-c measurement before event should be ≤ 2,6 mmol/l * written informed consent obtained exclusion criteria: * heart failure iv class (nyha) * acute decompensated heart failure * life expectancy no more than 1 year * chronic kidney disease (ckd) with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m2 * severe chronic liver diseases with alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 upper limit of normal (uln) * known gallbladder disease, including cholecystolithiasis * creatinphosphokinase (cpk) \> 5 uln at baseline * chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia * known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, * known allergy to peanut or arachis oil or soya lecithin or related products * hypersensitivity to simvastatin or fenofibrate or to any of the excipients of the investigational drugs * concomitant administration of potent cytochrome p450 isoenzyme 3a4 inhibitors (e.g. itraconazole, ketoconazole, fluconazole, posaconazole, human immunodeficiency virus (hiv) protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone) * pregnancy and lactation

Keywords: acute coronary syndrome diabetes mellitus, type 2 hypertriglyceridemia simvastatin fenofibrate
covid19-convalescent plasma for treating patients with active symptomatic covid 19 infection (falp-covid)

Conditions: COVID-19 Infection; Cancer Patients; General Population

Summary: covid-19 infection has spread worldwide causing several deaths in few months convalescent plasma from covid 19 donors has shown huge activity in small series from chinese patients and currently many centers from usa and the european union are assessing its use looking to avoid mortality and prolonged hospitalizations covid-19-related

this is a collaborative, 4 arms , non randomized clinical trial assessing the use of convalescent plasma from covid-19 recovered donors to be used in oncological and non-oncological patients with current severe covid-19 infection or in patients with risk factors of major complications secondary to covid-19 infection

Eligibility criteria:
inclusion criteria: for all patients: a. patient must sign an informed consent to participate in this trial b. signed consent to participate in this trial must be given not after 14 days from the first day of symptoms covid-19 related 1. patients with severity criteria must have any of the following: dyspnea and or respiratory rate \>=30 per min and or saturation \<= 93% with fraction of inspired oxygen 21% and or ratio of partial pressure arterial oxygen and fraction of inspired oxygen (pafi )\<300 and or lung images showing worsening in 24-48 hours or 2. patients without severity criteria but with 2 or more factor risks: a. 50 years or older b. any of the following comorbidities: diabetes mellitus, hypertension, chronic obstructive pulmonary disease, chronic kidney failure, non-oncological related chronic immunosuppression c. total bilirubin\>1,2 mg/dl or blood urea nitrogen\> 20 mg/dl or lactate dehydrogenase\>245 u/l d. d-dimer \> 1mg/l e. neutrophils 7.3 x 10³ or greater and or lymphocytes lesser than 0,8 x 10³ µl f. c reactive protein \>9,5 mg/dl and ferritin \> 300 ug/ml g. interleukin-6 \>7 pg/ml h. antineoplastic treatment such as radiotherapy- cytotoxic chemotherapy- immunotherapy- molecular therapy- oncological surgery during the last 8 weeks exclusion criteria: * known allergy to plasma * severe multiple organic failure * active intra brain hemorrhage * disseminated intravascular coagulation with blood products requirements * patient with an adult respiratory distress longer than 10 days * patients with active cancer and life expectancy shorter than 12 months according with medical criteria

Keywords: convalescent plasma covid
tezacitabine and oxaliplatin for the treatment of patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. this study will also evaluate tumor response to the combination of anti-cancer drugs.


Eligibility criteria:
* patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy. * patients must have at least one measurable tumor. * patients may not have received prior treatment with oxaliplatin.
pharmacokinetics of tranexamic acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers.

Conditions: Healthy Volunteer Study

Summary: this is a phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. it will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

fifteen healthy volunteers will receive in random order 1 gram of intravenous and intramuscular injections and 2 grams of oral tranexamic acid solution. blood samples will be taken at: * t0+ 5min (only for iv route) * t0+30min * t0+1h * t0+2h * t0+3h * t0+4h * t0+5h * t0+6h * t0+8h (only for im and po routes) * t0+24h

Eligibility criteria:
inclusion criteria: * adult healthy volunteers both men and non-pregnant women * ≥18-≤45-year-old * body mass index between ≥18 and ≤30 kg/m2, and bodyweight between ≥50 and ≤100 kg * coagulation test results of fibrinogen, d-dimers, prothrombin time and a partial thromboplastin time within normal limits at screening * normal renal function based on medical history and laboratory tests * if a woman, must have a negative urine β-human chorionic gonadotropin (βhcg) pregnancy test at screening and inclusion visits * provision of signed informed consent prior to any study specific procedure * people with public healthcare insurance (in france) exclusion criteria: * previous thrombotic event or pre-existing pro-thrombotic disease * any history of seizures * any chronic or active cardiovascular or renal disease * planned general anaesthesia or surgery in the 3 months following inclusion * pregnant and/or breastfeeding * known allergy to the study drugs or any of the excipients of the formulations * use of any prescription or non-prescription medication (other than hormonal contraception) within 7 days before the first dose of the study drug is scheduled * inability to give informed consent * previous participation during the year in clinical studies compensated for an amount incompatible with participation in this study, verified by recording in the national register of subjects participating in human research trials * legal criteria: * people deprived of liberty by judicial or administrative decision * adult protected by law (france)

Keywords: pharmacokinetics, tranexamic acid
hip fracture rehabilitation programme

Conditions: Hip Fractures

Summary: objectives: to evaluate the effect of a hip-rep on the quality and independence in adl ability (performance), measured with the assessment of motor and process skills (amps) and health-related quality of life (qol). hypothesis: the hip-rep will increase the quality and independence in adl performance, measured with amps and health-related qol measure.

little is known about the effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in activities of daily living (adl) ability for elderly with hip fractures. despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and adl ability. after hip fracture, the loss of independence, and further decrease in adl ability often persists beyond three months after surgery. this increases the risk of social isolation, depression and thus a decrease in qol. therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is effective and influences this fragile group of patients. the investigators hope to increase the ability to safely and independently perform adl in elderly with hip fractures, and thereby enhance their health-related qol.

Eligibility criteria:
inclusion criteria: * aged 65 years or older * recent proximal hip fracture (s 72.0 medial femur fracture, s 72.1, pertrochanteric femur fracture, s 72.2 subtrochanteric femur fracture) * living at home prior to hip fracture in herlev, gentofte, furesoe, rudersdal or lyngby-taarbæk municipalities * ability to give informed consent exclusion criteria: * not expected to be discharged to home or rehabilitation centers in the municipality * not able to speak and/or understand danish * have prior severe physical and /or mental disabilities
cardio-cerebrovascular disease and aspirin ulcer relapse evaluation

Conditions: Cardio-cerebrovascular Disease

Summary: the aim of this study is to evaluate the efficacy of proton pump inhibitor (ppi), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.

the events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of ppi (rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (gefarnate 50mg capsule twice a day).

Eligibility criteria:
inclusion criteria: * patients with ischemic heart failure or vascular disease of brain * patients taking low-dose aspirin to prevent relapse of vascular diseases * patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy * patients without active gastric and duodenal ulcers * more than 20 years old * outpatients * patients written an informed consent exclusion criteria: * patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation * patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack * patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator * patients who are treated with steroid hormones * patients who are women of, pregnant and lactating and childbearing * patients who are alcoholism * patients who show the hypersensitivity for test drugs * patients who are enrolled in another clinical study * patients who are judged as unsuitable by investigator

Keywords: the efficacy of ppi patients receiving low-dose aspirin for vascular protection
comparable study of different thoracic radiotherapy regimens for extensive stage small cell lung cancer

Conditions: Carcinoma, Small Cell; Lung Neoplasms

Summary: most patients with extensive stage small-cell lung cancer (es-sclc) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. a dutch study recently proved that thoracic radiotherapy(trt), using 30 gy in 10 fractions of 3 gy, could improve 2-year overall survival(os) of this patient group compared with non-trt group. but intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the trt group. the ideal trt regimen for es-sclc is undefined. maybe higher dose can provide better local control(lc) and overall survival. in this study, the investigators propose to give an increased dose of trt to determine whether higher dose will improve 2-year os, lc and progression-free survival.

this is a multicenter, prospective, randomised phase iii study. for patients with es-sclc who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45gy/15f of thoracic radiotherapy will be used in experimental arm, while 30gy/10f of thoracic radiotherapy will be used in the control arm. both survival and toxicity of the two arms will be observed and compared.

Eligibility criteria:
inclusion criteria: * 18 - 70 years old, ecog 0-2. * patients with histologically or cytologically proved small cell lung cancer. * extensive stage small-cell lung cancer (es-sclc), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. according to 2007 ajcc cancer staging 7th edition, stage i-iiib with lung metastases and stage iv should be defined as ld. * has 1-4 extracranial metastatic lesions. * no brain or central nervous system (cns) metastases. * no prior history of anti-tumor treatment. * response after 4 to 6 cycles of ep-based chemotherapy within the past 4 weeks. * no severe internal diseases and no organ dysfunction. * written informed consent provided. exclusion criteria: * malignant tumors of other sites. non melanoma skin cancer and cervical carcinoma in situ were not included if curable. * active heart disease or acute myocardial infarction happen in six months. * psychiatric history. * pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (hcg). * uncontrolled diabetes or hypertension. * interstitial pneumonia or active pulmonary fibrosis. * acute bacterial or fungal infection. * oral or intravenous use of steroids.

Keywords: extensive stage small cell lung cancer thoracic radiotherapy radiotherapy regimen