Kornimate/medical-research-clean huggingface dataset:
5e program for preventing venous thromboembolism in patients with spinal cord disorders

Conditions: Venous Thromboembolism; Spinal Cord Diseases; Spinal Cord Injuries; Nurse's Role

Summary: the goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5e" program, on the rates of venous thromboembolism in patients with spinal cord disorders. the main questions it aims to answer are: * will participants receiving the 5e program have lower rates of venous thromboembolism compared to those receiving the usual care? * will participants receiving the 5e program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care? * will the average thigh and calf circumferences of participants before and after receiving the 5e program be different? participants in the intervention group will receive the 5e program, including * education: health education regarding venous thromboembolism prevention * elevation: leg elevation of 10-20 degrees * exercise: ankle exercises * enough fluid: adequate fluid uptake * early application of intermittent pneumatic compression (ipc): ipc use within 48 hours after admission


Eligibility criteria:
inclusion criteria: * caprini scores of 5-8 and \>8 * able to communicate in the thai language * willing to participate in this study exclusion criteria: * alteration of consciousness * experiencing complications, including neurogenic shock and autonomic dysreflexia * being pregnant * having fluid restriction
anesthesia management in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Conditions: Cytoreductive Surgery; Hyperthermic Intraperitoneal Chemotherapy; Anesthesia

Summary: a combined approach of cytoreductive surgery (src) and hyperthermic intraperitoneal chemotherapy (hipec) represents a potential treatment option for patients diagnosed with primary or secondary gastrointestinal or gynaecological malignancies with peritoneal involvement. while the surgical phase of the operation macroscopically addresses the cancerous tissue, the hipec phase targets the microscopic tumour cells that remain after surgery (1). the surgical procedure known as src and hipec is one of the most complex surgical procedures, presenting numerous challenges for both the surgical and anaesthesia teams. the haemodynamic, haematological and metabolic changes that occur before, during and in the early postoperative period are associated with an increased risk of morbidity and mortality. it is therefore crucial for anaesthesia management to maintain normovolemia during surgery, compensate for hypothermia in the surgical phase and hyperthermia in the hipec phase, and maintain metabolic and haemodynamic balance throughout the entire procedure. the objective of this study was to retrospectively examine the anaesthesia management and clinical outcomes in patients who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (hipec) in order to create literature information that can facilitate the early recognition and prevention of haemodynamic, haematological and metabolic problems that occur especially in the intraoperative and postoperative period.


Eligibility criteria:
inclusion criteria: * patients with primary or secondary gastrointestinal or gynecologic malignancies with peritoneal involvement. * over 18 years of age exclusion criteria: * over 80 years of age * those with heart, lung and liver diseases
thyroid hormone replacement for hypothyroidism and acute myocardial infarction(thyroheart-ami)

Conditions: Myocardial Infarction; Hypothyroidism

Summary: based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (ami) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with ami and hypothyroidism. this is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.

the primary hypothesis is that reversing the hypothyroid status with levothyroxine on top of standard therapy for ami is safe and has beneficial effects on cardiac function, myocardial perfusion/metabolism and myocardial fibrosis.

Eligibility criteria:
inclusion criteria: 1. age 18 - 75, male or non-pregnant female; 2. is diagnosed acute myocardial infarction and received primary percutaneous coronary intervention (pci); 3. with presence of hypothyroid status (i.e., tsh \>7.0 miu/l and (or) ft3 \<1.79 pg/ml); 4. is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form. exclusion criteria: 1. those who have participated in other drug or therapeutic equipment clinical trials but do not reach the main study endpoint time limit; 2. symptoms of severe heart failure (killip class iii and above); 3. severely impaired renal function before surgery: serum creatinine \> 2.0mg/dl; 4. impaired liver function before surgery: serum gpt \> 120u/l; 5. those who have prior thyroid diseases and already on levothyroxine or anti-thyroid medicines; 6. those taking medicine which can affect the test of thyroid function; 7. patients who plan to undergo coronary artery bypass grafting or other surgery within 3 months; 8. those having prior myocardial infarction; 9. patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.

Keywords: myocardial infarction hypothyroidism levothyroxine cardiac magnetic resonance imaging myocardial perfusion/metabolism radionuclide imaging myocardial fibrosis myocardial perfusion/metabolism cardiac function
landiolol in postoperative atrial fibrillation

Conditions: Atrial Fibrillation

Summary: postoperative atrial fibrillation is a common complication after cardiac surgery and is associated with an elevation of morbidity and mortality. the recommended treatment includes heart rate control with a beta blocker. landiolol is a new-generation beta-blocker with favourable pharmacologic properties making an interesting drug to treat postoperative atrial fibrillation. however, landiolol micro and macrocirculatory effects in the setting of atrial fibrillation are yet to describe. the aim of this study is to describe microcirculatory effects of incremental doses of landiolol in postoperative atrial fibrillation compared to a placebo. our hypothesis is landiolol will improve microcirculation disorders.


Eligibility criteria:
inclusion criteria: * patient underwent conventional cardiac surgery * age \> 18 years * writing contentment exclusion criteria: * pre-existing chronic atrial fibrillation * contraindication to beta-blockers * circulatory shock (cardiac index\ 4mmol/l) * distributive shock (cardiac index\>2.2 l/min with norepinephrine dose \> 0.3 µg/kg/min to reach mean arterial pressure \> 65mmhg). * acute respiratory distress * major bleeding (\>200ml/h) * patient already included into an interventional clinical study * pregnancy * no social security insurance * patient not able to give consent (curators, patients deprived of public rights)

Keywords: landiolol microcirculation cardiac surgery atrial fibrillation
gnt induction treatment in locally advanced npc

Conditions: Nasopharyngeal Carcinoma

Summary: the goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. it aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to gp induction chemotherapy. participants will be randomly divided into two induction treatment groups.


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years old. 2. pathologically or cytologically confirmed stage iii-ivb nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma. 3. patients suitable for radical radiochemotherapy. 4. ecog ps score of 0-1. 5. according to the recist 1.1 criteria, there is at least one measurable lesion. basic hematological parameters are normal: white blood cell count ≥4×10\^9/l; absolute neutrophil count ≥1.5×10\^9/l; platelets ≥100×10\^9/l; hemoglobin ≥90 g/l. 6. basically normal renal function: serum creatinine ≤1.5×uln or creatinine clearance rate (crcl) \> 60 ml/min (using the cockcroft-gault formula): for females: crcl = (140-age) x weight (kg) x 0.85 / (72 x scr mg/dl) for males: crcl = (140-age) x weight (kg) x 1.00 / (72 x scr mg/dl) 7. basically normal liver function: serum total bilirubin ≤1.5×uln; aspartate aminotransferase (ast) ≤2.5×uln; alanine aminotransferase (alt) ≤2.5×uln. 8. signed written informed consent. exclusion criteria: 1. patients who have previously undergone immunotherapy or targeted therapy. 2. participated in any other interventional clinical trials within 30 days before screening. 3. history of other malignancies (except for cured skin basal cell carcinoma). 4. history of primary immunodeficiency. 5. presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.). 6. known hiv infection, active viral hepatitis, or tuberculosis. 7. major surgery within 90 days before the first dose of the study drug, or planned surgery. 8. allergic to the drugs used in this protocol or their components. 9. pregnant (confirmed by blood or urine hcg tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment. 10. the investigator believes the subject is not suitable for this study. 11. unwilling to participate in this study or unable to sign the informed consent form. 12. live vaccinations within 30 days of dosing.
efficacy, safety and pharmacokinetics of artemether-lumefantrine dispersible tablet in the treatment of malaria in infants < 5 kg

Conditions: Acute Uncomplicated Falciparum Malaria

Summary: the purpose of the study is to obtain efficacy, safety and pharmacokinetic (pk) data following treatment with artemether-lumefantrine dispersible tablet in infants \< 5 kg of body weight (bw) with uncomplicated falciparum malaria.


Eligibility criteria:
inclusion criteria: * neonates / infants * body weight \< 5 kg * in cohort 1, infants aged \> 28 days; in cohort 2, neonates of a term age 0 to ≤ 28 days * microscopically confirmed diagnosis of acute uncomplicated plasmodium falciparum malaria or mixed infections with an asexual plasmodium falciparum parasitaemia of \> 1,000 and \< 100,000 parasites/µl exclusion criteria: * presence of severe malaria (according to world health organization definition) * presence of the following signs of a critical condition: apnea-bradycardia, sustained bradycardia, tachycardia, desaturation, hypotension, hypothermia; or other severely deteriorated general condition (based on imci criteria in sick infants) * presence of any clinically significant neurological condition * presence of clinically significant abnormality of the hepatic and renal systems * patients who sustained a significant blood volume loss (\> 3% of calculated blood volume) in the past 30 days * patients unable to swallow or whose drinking is impaired * family history of congenital prolongation of the qtc interval or sudden death or with any other clinical condition known to be associated with prolongation of the qtc interval such as history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or with severe cardiac disease * disturbances of electrolyte balance (e.g. hypokalaemia or hypomagnesaemia) * presence of any age-adjusted clinically or hematologically relevant laboratory and blood chemistry abnormalities * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: plasmodium p. falciparum malaria infant neonate
patient-reported outcome and patient-reported experience after status epilepticus

Conditions: Patient Reported Outcomes; Patient Satisfaction; Long Term Outcomes; Status Epilepticus; Intensive Care Unit; Burden; Relatives

Summary: status epilepticus (se) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. se remains associated with considerable mortality and morbidity, with little progress over the last three decades. the proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory se. morbidity is more difficult to evaluate, as adverse effects of se are often difficult to differentiate from those attributed to the cause of se. our experience suggests that nearly 50% of patients may experience long-term functional impairments. the precise description of the consequences of these functional impairments and their impact on quality of life after se requiring intensive care management has been little studied. indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (pics), neuronal lesions consecutive to the se itselfor to its cause could be responsible for these different functional alterations. thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress. assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. the poseidon study was a cross-sectional collection of pros and hr-qol components, and associated with patient functional outcomes, in those who required icu management for status epilepticus. we propose here to continue the description of potential alterations after a subsequent me, namely a longitudinal study (poseidon 2) which will also include the evaluation of patient-reported experience (prems) and the measurement of family burden.


Eligibility criteria:
inclusion criteria: * adults 18 years old or older * patients previously included in the ictal registry (status epilepticus cohort nct03457831) * survivors after icu management for status epilepticus more than 3 months and less than 5 years after icu discharge exclusion criteria: * legal guardianship * opposition to participate * unread and unwritten french language * patient not affiliated to a social security system
2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides

Conditions: Diabetes Mellitus

Summary: to compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

one hundred patients with diabetes from srinagarind hospital eye clinic were enrolled and randomized into two groups by block randomization. in group i (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in group ii (50 patients). pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.

Eligibility criteria:
inclusion criteria: * diabetic patients exclusion criteria: * history of intraocular surgery or laser treatment, * any ocular diseases that might affect pupil size such as glaucoma,uveitis,horner's syndrome, adies' pupil, * history of allergy to any drug used, and * hypertension

Keywords: phenylephrine mydriasis diabetes mellitus
thalidomide for the prevention of restenosis after coronary artery stent implantation

Conditions: Coronary Artery Disease

Summary: percutaneous coronary intervention (pci) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases. stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. the sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of pci with stenting.

percutaneous coronary intervention (pci) with the use of bare metal stents is associated with restenosis in approximately 10% to 50% of cases. stenting may induce endothelial damage/dysfunction and inflammatory reactions, which in turn delay healing and endothelialization and may lead to restenosis and atherosclerosis within the stented segments. indeed, experimental studies indicate a marked activation of inflammatory cells at the site of stent struts, which is likely to play a key role in the process of neointimal proliferation and restenosis. indeed, tumor necrosis factor and interleukins 1 and 6 are powerful stimuli for smooth muscle cell proliferation. the sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of pci with stenting. the primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on restenosis rate after successful stent implantation.

Eligibility criteria:
inclusion criteria: * a de novo native coronary artery lesions (reference vessel diameter:2.5-3.75 mm) * class i indication to elective percutaneous coronary intervention * stable conditions and no recent acute coronary syndromes * normal baseline values of markers of myocardial damage (creatine kinase, creatine kinase-mb, myoglobin, and troponin i) * able to understand and willing to sign the informed cf * contraindications to des use (clinical history difficult to obtain, expected poor compliance with dapt, non-elective surgery required, increased risk of bleeding * allergy to asa or clopidogrel/prasugrel/ticagrelor, indication for long-term anticoagulation, large vessels, focal lesions) exclusion criteria: * women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before ct * indications to des use (small vessels, long lesions diabetes, in-stent restenosis, complex lesions)

Keywords: coronary restenosis
aerosolized antibiotics and respiratory tract infection in patients on mechanical ventilation

Conditions: Ventilator Associated Pneumonia; Respiratory Infection; Tracheobronchitis

Summary: the purpose of this study was to determine the effect of aerosolized antibiotics on respiratory infection in mechanically ventilated patients.we hypothesize that aerosolized antibiotics , which achieve high drug concentrations in the airway, would more effectively treat respiratory infection, decrease the need for systemic antibiotics and decrease antibiotic resistance.

in patients requiring mechanical ventilation, signs of respiratory infection often persist despite treatment with powerful antibiotics given through the patient's vein. in this trial, patients with purulent secretions were assigned aerosolized antibiotics or placebo by a randomizing protocol. neither the patients or their doctors knew what the patient was receiving.need for a systemic antibiotic was determined by the clinical physician. comparisons were made between placebo and study drug for their effects on pneumonia, respiratory signs of infection, ability to wean patients from the ventilator, systemic(given in the vein) antibiotic use and the development of organisms that were resistant to antibiotics.

Eligibility criteria:
inclusion criteria: * be on mechanical ventilation greater than 3 days * greater than or equal to 18 years of age survival greater than 14 days * greater than 2 ccs of tracheal secretions/4 hours exclusion criteria: * allergy to drugs, pregnancy

Keywords: aerosolized antibiotics ventilator associated pneumonia clinical pulmonary infection score bacterial resistance
german multicenter trial for treatment of elderly patients with newly diagnosed acute lymphoblastic leukemia

Conditions: Adult Acute Lymphocytic Leukemia

Summary: the study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. in patients with expression of cd20 on leukemic cells the efficacy and tolerability of additional application of rituximab together with chemotherapy is evaluated.


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (pro b, pre b, c-all or t-all), proved by morphology and immunophenotyping * age \> 55 yrs (no upper age limit) * written informed consent exclusion criteria: * severe leukemia associated complications, not controllable before therapy onset e.g. * life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding) * severe comorbidity e.g. * decompensated renal failure if not caused by leukemia with creatinine \> 2x uln * heart failure (nyha ii/iv), instable angina, significant coronary stenosis * hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin \> 1,5 x uln and/or asa, ala, ap \> 2,5 uln * decompensated metabolic disturbances (e.g. not controllable diabetes) * severe obstructive or restrictive pulmonary disease with hypoxaemia * severe psychiatric illness or other circumstances which may compromise cooperation of the patient * active second neoplasia * hiv infection * severely reduced general condition * cytostatic pre-treatment of all * chemotherapy treatment of any other malignancy during the last 5 years * participation in other clinical trials interfering with the study therapy

Keywords: all treatment elderly de novo