Kornimate/medical-research-clean huggingface dataset:
effect of oral magnesium on vascular calcification in chronic kidney disease

Conditions: Chronic Kidney Disease; Vascular Calcification; Uremic Osteodystrophy

Summary: randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. we hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.

chronic kidney disease (ckd) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in ckd by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (vsmc), by inhibiting intracellular pro-calcification enzymes in vsmc and by increasing activity of intracellular anti-calcification enzymes in vsmc. however, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in ckd. we wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with ckd while not decreasing bone mineral density.

Eligibility criteria:
inclusion criteria: * estimated glomerular filtration rate between 45 and 15 ml/min for \> 3 months (i.e. ckd stage 3b-4). * serum total magnesium \ 1,15 mmol/l on average of previous measurements. or serum total magnesium \ 1,30 mmol/l on average of previous measurements. * life expectancy \> 1 year. * expected time until initiation of dialysis or transplantation \> 1 year. * women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test. * written informed consent. exclusion criteria: * current hemodialysis or peritoneal dialysis treatment. * kidney donor recipient. * previous coronary artery bypass graft (cabg). * parathyroid hormone \> 600 ρmol/l. * previous parathyroidectomy. * current treatment with magnesium containing medication or supplements. * any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis). * active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this). * other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial. * pregnancy or breastfeeding. * allergy towards contents of interventional medication. * participation in other interventional trials.
therapeutic adherence in patients with chronic diseases

Conditions: Chronic Disease

Summary: objectives of the study are: * the validation of the gmas questionnaire in patients with chronic disease. * measurement of the level of therapeutic adherence in patients with chronic illness. * measurement of the level of therapeutic adherence in patients with chronic disease undergoing an experimental trial.

the research is multicentre and will be conducted at the fondazione policlinico gemelli irccs in rome as reference centre together with the other participating centres. patients will be enrolled at the centres involved, either during visits or during their hospital stay.

Eligibility criteria:
inclusion criteria: * chronically ill; * age 18 years or older; * willingness to participate in the study; * chronic illness diagnosed at least 3 months before the start of the study; * reading and signing the informed consent. exclusion criteria: * reduced command of the italian language; * subjects suffering from severe psychiatric disorders; * serious clinical conditions that do not permit completion of the questionnaire; * refusal to sign the informed consent to participate in the study.
frc guided therapy in acute respiratory failure

Conditions: Mechanical Ventilation; Acute Respiratory Failure; Cardiac Surgery

Summary: in ventilated patients with acute respiratory failure endotracheal suctioning may lead to alveolar derecruitment, which can be monitored by means of functional residual capacity (frc) measurements. regional distribution of ventilation can be followed at bedside using electrical impedance tomography. the investigators hypothesize that a frc guided recruitment strategy, aimed at restoring a baseline frc value after open endotracheal suctioning, improves oxygenation and regional distribution of ventilation. in addition the investigators research the impact of such a strategy on the inflammatory response to mechanical ventilation.


Eligibility criteria:
inclusion criteria: * need for mechanical ventilation due to respiratory failure after cardiac surgery exclusion criteria: * circulatory failure, eg. need for high doses of inotropes or extracorporal cardiac support

Keywords: functional residual capacity electrical impedance tomography inflammatory parameters
intergroup contact intervention for nursing undergraduates to improve aging stereotype

Conditions: Aging; Ageism

Summary: this study aimed to investigate the effects of intergroup contact training on the levels of aging stereotypes, intergroup anxiety, and willingness to engage in geriatric nursing work among undergraduate nursing students.

this research was designed as a pre-test-post-test randomized controlled experimental study. nursing students from a university in hangzhou, china served as the research subjects, who were randomly assigned to the experimental or control group. the control group received training in the regular course and was given compensatory intervention after the experiment, while the experimental group received intergroup contact training (the regular course combined with intergroup contact content). such training was carried out in the forms of both individual and group interventions for a duration of 12 weeks. the levels of aging stereotypes, intergroup anxiety, and the willingness to engage in geriatric nursing among the nursing students were investigated before and after the training. number, percentage, mean, standard deviation, shapiro-wilk, t-test, wilcoxon signed ranks tests, and mann-whitney u tests were used to analyze the data.

Eligibility criteria:
inclusion criteria: * full-time undergraduate students enrolled in the nursing program * not yet enrolled in a geriatric nursing course * agreed to participate in this study and signed an informed consent form exclusion criteria: * students in the nursing program pursuing a bachelor degree through a vocational-to-degree pathway * students who have taken a break from their studies
validation of the german version of the injustice experience questionnaire

Conditions: Validation Studies

Summary: purpose of the study is the validation of the german version of the injustice experience questionnaire. pretest: participants were informed about the aims of the study and fill in a consent form. they filled in a paper version of the german translation of the injustice experience questionnaire. in a structured interview patients were asked if there were any items difficult to understand, unacceptable or offending them. subsequently they had to answer questions about the content and meaning of the ieq-items. validation study: participants were informed about the aims of the study and filled in a consent form. by e-mail they received an access link to the online survey. the questionnaires of the survey could be filled in at home. the survey could be interrupted and terminated later. about 20 minutes were needed to answer the 80 questions of the survey. all data was saved anonymously during the survey.

pretest: participants were informed about the aims of the study and filled in a consent form. a paper version of the german translation of the injustice experience questionnaire was completed in presence of the interviewer. the structure of the standardized interview followed the recommendations for pretesting transcultural translations of questionnaires. patients were asked if there were any items difficult to understand, unacceptable or offending them. subsequently they had to answer questions about the content and meaning of the ieq-items. the interviewer asked all questions and entered the responses. all data were directly stored in a mysql database at a swiss commercial web-server (www.scientific-affairs.ch). validation study: participants are informed about the aims of the study and fill in a consent sheet. by e-mail they receive an access link to the online survey which can be completed at home. the survey includes the following questionnaires: injustice experience questionnaire (ieq), depression subscale of the depression, anxiety and stress scale (dass), tampa scale for kinesiophobia (tsk), mcgill pain questionnaire (mpq), pain catastrophizing scale (pcs), pain disability index (pdi) and part concerning causes of pain of the german pain questionnaire (dsf). about 20 minutes is needed to answer the 80 questions of the survey. after completing the survey participant can choose if they would like to be informed about the results of the filled in questionnaires. all data is saved anonymously during the survey and stored in a mysql database at a swiss commercial web-server (www.scientific-affairs.ch).

Eligibility criteria:
inclusion criteria: * pain (face, head or rest of the body) * good competence of german language * internet access * being able to fill in a web-based survey * adults exclusion criteria: * disuse / dependency on medication / drugs

Keywords: injustice experience questionnaire validation german translation
modified tomox-haic in combination with sintilimab and bevacizumab biosimilar for first-line treatment of advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a single-center, single-arm, phase ii clinical study, to explore the efficacy and safety of modified tomox-haic combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

hepatocellular carcinoma (hcc) is one of the most common malignant tumors worldwide.the imbrave150 study and the orient-32 study demonstrated that pd-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. in addition, haic combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. oxaliplatin-based folfox regimen is currently the mainstream haic chemotherapy regimen (folfox haic) in china. the results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. also, tomox-haic regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy. in this clinical trial, patients will receive tomox-haic combined with sintilimab and bevacizumab biosimilar. the primary endpoint is overall response rate. the secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety

Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent/assent for the trial. * males or unpregnant females who age ≥ 18 years, ≤75 years. * the investigator believes the patient is capable of complying with the study protocol. * histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma. * is not a candidate for radical surgery * not received previous systemic treatment * patients must have at least one measurable lesion (recist 1.1) * ecog ps：0-1, 14 days before enrollment * child-pugh a or child-pugh b ≤ 7, 14 days before enrollment exclusion criteria: * prior history of other malignant tumors * current or prior immunodeficiency disorders or autoimmune diseases * subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding * subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study * conditions considered unsuitable for inclusion by researchers
transcranial magnetic stimulation (tms) for upper limb dysfunction in spinal cord injury: a feasibility study

Conditions: Spinal Cord Injuries

Summary: this study will investigate how repetitive transcranial magnetic stimulation (tms) using intermittent theta-burst stimulation (itbs) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. tms is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. the purpose of this study will be to assess the feasibility of using tms with itbs paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.


Eligibility criteria:
inclusion criteria: * aged 18-70 years old inclusive * traumatic and non-traumatic tetraplegic patient following chronic incomplete (ais c or d) sci injury (sustained at least three months ago) * referred to the sheffield spinal injuries centre * be able to provide written informed consent or verbal consent in the presence of an independent witness * spasticity affecting upper limbs with a modified ashworth scale (mas) 2 or above * stable medical treatment for at least 1 week before and 1 week after tms application * stable medical condition exclusion criteria: * aged less than 18 years old * lack the mental capacity to consent * ventilated patients with sedation * very acute (\<3 months) sci patients * implanted electrical devices such as pacemakers, concomitant neurological conditions, including any history of epilepsy * significant joint-related limitation of passive range of movement * unable to attend all tms sessions * pregnancy * inability to tolerate tbs * significant upper limb contractures

Keywords: transcranial magnetic stimulation spinal cord injuries muscle spasticity pain spinal cord spinal cord diseases
x-ray study investigating the safety and efficacy of sd-6010 in subjects with osteoarthritis of the knee

Conditions: Knee Osteoarthritis

Summary: the objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of sd 6010, an inhibitor of inducible nitric oxide synthase (inos). the efficacy of sd-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility criteria:
inclusion criteria: subjects aged \>= 40 years diagnosed with knee oa (acr definition of oa) radiographic evidence of oa in the study knee exclusion criteria: a diagnosis of any other rheumatic disease current conditions in the study knee that would confound efficacy selected, traditional clinical safety and laboratory parameters

Keywords: knee osteoarthritis x-ray joint space narrowing
the risk of bleeding after removal of large colorectal polyps in patients taking aspirin

Conditions: Gastrointestinal Hemorrhage

Summary: the risk of bleeding after polypectomy of large colorectal polyps in patients taking aspirin is uncertain. this is a randomized, multi-center, placebo-controlled, double-blind study to compare the risk of significant bleeding after endoscopic polypectomy of large (\>=10mm) colorectal polyps in patients continuing or discontinuing on daily acetylsalicylic acid (asa) use. eligible patients will be randomly assigned in a 1:1 ratio to a group taking 75mg daily asa or placebo 7 days before and 14 days following polypectomy. the primary endpoint of the study is bleeding within 30 days from colorectal polypectomy. the secondary endpoints are composite cardiovascular events occurring between the date of randomization and 30 days after polypectomy.

patients chronically taking aspirin (in prophylaxis doses 75-325 mg), with a diagnosis of colorectal polyps ≥ 10 mm in diameter will be enrolled on a routine polypectomy under hospitalization. meeting the inclusion criteria, after informed consent and a cardiologist consent the patient will receive aspirin/placebo, and the patient diary to fill (visit 1). the patient will be admitted to the study center in 6-7 days taking on the aspirin/placebo and prepared for the study (visit 2). patient will be under the care of a physician after polypectomy by a minimum of 6 hours. 14 days after polypectomy will be the first control visit, during which the physician will take back patient diary and pack treatment (visit 3). 30 days after polypectomy will be the second control visit by phone (visit 4). patients will be monitored by looking at the end points.

Eligibility criteria:
inclusion criteria: 1. age 40 years or older 2. daily aspirin for primary or secondary prophylaxis 3. candidate for endoscopic polypectomy of at least one colorectal polyp 10mm or larger 4. signed written informed consent 5. written opinion from a cardiologist that the patient can cease taking aspirin for a period of 21 days in the peri-polypectomy period exclusion criteria: 1. lifelong anticoagulant therapy with warfarin, acenocumarol 2. concurrent antiplatelet treatment with clopidogrel or ticlopidin 3. coagulation disorders inr \> 1,5, aptt 2xnorm 4. known hemorrhagic disorder

Keywords: gastrointestinal bleeding lower gastrointestinal bleeding (lgib) polypectomy large colorectal polyps asa aspirin acetylsalicylic acid colorectal neoplasms intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms digestive system diseases gastrointestinal diseases colonic diseases intestinal diseases rectal diseases
incentives for daily tooth brushing to reduce gingivitis

Conditions: Gingivitis

Summary: in this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. under cognitive incentives subjects are paid to correctly answer health-related quizzes. under behavioral incentives subjects earn money for making healthy choices. the investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among us adults.


Eligibility criteria:
inclusion criteria: * male or female older than 18 years, with at least 10 teeth present. exclusion criteria: * pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.
the effect of gi biome #7 on gut microbiome and health of the elderly

Conditions: Muscle Weakness

Summary: this study aims to investigate the effects of probiotics named gi biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.

this study is a double-blind, randomized controlled trial. a total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. the intervention group will be given gi biome #7 pills, and the control group will be given the placebo pills for four weeks. the participants will visit the research laboratory four times as follows: a day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked.

Eligibility criteria:
inclusion criteria: * 60 years old or older * those who have no difficulties in daily living * willing to commit throughout the study exclusion criteria: * antibiotics medication in the last month. * probiotics used in the last months. * those who are in the treatment of the following diseases: liver disease, neurological disease, respiratory disease, tumors, psychiatric disorders, angina, myocardial infarction, and stroke

Keywords: gut microbiome probiotics muscle strength intervention
thromboaspiration in patients with high thrombotic burden undergoing primary percutaneous coronary intervention (pci)

Conditions: Primary PCI for STEMI

Summary: 200 consecutive patients presenting with stemi within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. the main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. primary end points: (1) rate of complete st-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (de-mri) at 3 months after the index procedure. secondary endpoints: post-procedural timi flow grade; post-procedural mbg; infarct transmurality at 3 months; mvo at 3 months; 1-year actuarial freedom from maces.


Eligibility criteria:
inclusion criteria: 1. prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and st elevation ≥ 2mm in ≥2 contiguous ecg leads, or new left bundle branch block (lbbb) 2. presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter) 3. written informed consent exclusion criteria: * low-risk (st elevation in ≤2 leads) inferior ami * previous infarction in the same area (assessed by ecg) * pci in the 2 weeks prior to ami * active internal bleeding * history of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit * head or spine surgery or trauma in the previous 2 months * recent (within six weeks) gastrointestinal (gi) or genitourinary (gu) bleeding of clinical significance * administration of oral anticoagulants within seven days unless prothrombin time is \<1.2 times control * bleeding diathesis or severe uncontrolled arterial hypertension * thrombocytopenia (\<100 000 cells/ml) * recent (within six weeks) major surgery or trauma * intracranial neoplasm, arteriovenous malformation, or aneurysm * severe renal or liver failure * allergy to aspirin * contraindication to mri examination * pregnancy and lactation