Kornimate/medical-research-clean huggingface dataset:
pre-operative phentolamine vs intraoperative esmolol efficacy for hypotensive anesthesia in functional endoscopic sinus surgery

Conditions: Preoperative; Phentolamine; Intraoperative; Esmolol; Hypotensive Anesthesia; Functional Endoscopic Sinus Surgery

Summary: the aim of this study is to evaluate the efficacy of intra-operative phentolamine vs intraoperative esmolol for hypotensive anesthesia in functional endoscopic sinus surgery.

functional endoscopic sinus surgery (fess) is becoming a widely performed operation. its introduction associated with enhanced illumination and visualization has dramatically improved surgical dissection. however major complications have been reported for fess under general anesthesia resulting from impaired visibility due to excessive bleeding. esmolol is a selective β1-adrenoreceptor antagonist involved in the control of heart rate (hr), contractility, and atrioventricular conduction. currently, the use of β-blockade for hemodynamic stability and cardiac protection is well accepted among anesthesia providers, but recently, researchers have begun to explore the perioperative use of esmolol as an anesthetic adjunct. esmolol was found to produce desired hypotension without tachycardia and improved surgical condition by reducing operative field bleeding. phentolamine is well known selective α1-blocker which is used to treat hypertensive emergency by producing profound vasodilatation. the reduced blood pressure will induce response in the arterial baroreceptors leading to release of adrenal catecholamine, eventually inducing reflex tachycardia. the reflex tachycardia is less profound in the selective α1-blockers such as phentolamine. phentolamine is a short acting drug with a context sensitive half-life of 15 minutes which makes it ideal for rapid control of blood pressure.

Eligibility criteria:
inclusion criteria: * age from 21 to 50 years. * both sexes. * american society of anesthesiologists (asa) physical status i-ii. exclusion criteria: * patients with a medical condition that contraindicated hypotensive anesthesia, such as peripheral vascular disease, cerebrovascular stroke, carotid artery stenosis, previous myocardial infarction, ischemic heart disease, congestive heart failure, limb ischemia, uncontrolled hypertension and raised intracranial tension * renal disease, liver dysfunction, pregnancy. * patients on hypnotic or narcotic analgesic. * history of alcohol or drug abuse. * history of allergic reaction to any drug used in this study. * bleeding diathesis. * previous nasal surgery. * patients on non-steroidal anti-inflammatory drugs (nsaids). * patients with peripheral vascular disease.
brain training in preterm children at risk for inattention, hyperactivity, and executive function impairment

Conditions: Premature Birth

Summary: the purpose of this study is to determine if different forms of child-friendly, computer-based puzzles and games ("brain training") targeting executive function (ef) skills (i.e., thinking, problem-solving) result in improvements in ef in preschool children at risk for ef problems due to premature birth. the investigators hypothesize that children receiving active "brain training" will show greater improvements in ef and related skills immediately after treatment than children receiving passive "brain training." the investigators are also interested in whether any improvements in ef and related skills occur or are maintained at 3 and 6 months after completion of brain training.

detailed description: * investigators will talk to you by telephone to determine if your child might be eligible for the study. * children complete two baseline testing sessions to evaluate executive function (ef) and related skills * parents complete a packet of information, including questionnaires about the child's behavior, ef, and functional skills. * after completion of the baseline testing, we will inform you of eligibility for the "brain training" phase. * during "brain training" children play online computer games for 25-30 minutes/day (can range from 15-45 minutes/day depending on your child's attention, training version received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete a total of 25 sessions. * children return for 3 more time points, immediately after the completion of "brain training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after completion of "brain training."

Eligibility criteria:
inclusion criteria: * age 4 or 5 years * born prematurely at \<33 weeks gestation * able to comprehend task instructions * ef impairment on standardized questionnaire (t-score of 60 or greater) or ef battery (lower quartile) exclusion criteria: * major neurosensory impairment (i.e., blind, deaf) or technology dependence (i.e., ventilator dependent) that interferes with testing * genetic syndrome * inability to comprehend task instructions

Keywords: premature birth; executive function; preschool
the role of glutamine for preventing oxaliplatin-induced peripheral neuropathy

Conditions: Peripheral Neuropathy

Summary: oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal cancer. the dose limiting side effect of oxaliplatin is neurotoxicity. in this study we aimed to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.

our study population includes the colorectal cancer patient who is going to have mfolfox6 (modified, folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil l 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) regimen. we randomly assigned the patients into two groups. we administered glutamine at dose of 3x10 gr/day to one patient group concomitantly with mfolfox6 regimen and other group had no additional intervention. we performed questionnaire, neurological examination and emg (electromyography) before and after 4th cycle of mfolfox6 regimen in both patient groups. we planned to compare the neurological signs, symptoms and emg action potentials between mfolfox6+glutamine and only mfolfox6 group. we aimed to search the role of glutamine as a prophylactic agent against oxaliplatin induced neuropathy.

Eligibility criteria:
inclusion criteria: * age between 20 - 65 years * operated and non operated colorectal cancer patients * patient administering mfolfox 6 ( folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) exclusion criteria: * patients who had chemotherapy in last 6 months * diabetes mellitus * sensorimotor polyneuropathy * anemia

Keywords: glutamine oxaliplatin peripheral neuropathy
trial of inhaled nitric oxide (ino) on ischemia / reperfusion injury during orthotopic liver transplantation with marginal grafts

Conditions: Liver Transplant

Summary: this study is being done to determine if patients receiving (ino) will have increased liver function and less damage from ir than patients who do not receive (ino).


Eligibility criteria:
inclusion criteria: * liver transplant exclusion criteria: * living donor transplants

Keywords: liver transplant
registry of sarcoidosis associated pulmonary hypertension (resaph)

Conditions: Sarcoidosis; Pulmonary Hypertension

Summary: registry to follow patients with sarcoidosis associated pulmonary hypertension

this is a multi center registry of sarcoidosis associated pulmonary hypertension (saph). with this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the united states. the investigators will also compare these features to non-us sites.

Eligibility criteria:
inclusion criteria: * patients with sarcoidosis as defined by the ats/wasog statement * patients with pulmonary hypertension as confirmed by right heart catheterization * patients willing to provide written informed consent exclusion criteria: * unwillingness to provide assurance that they will complete the follow up visits for the study

Keywords: ambrisentan bosentan iloprost
aspirin dose comparison in elderly pci patients: 30mg vs. 75mg in acute coronary syndrome

Conditions: Myocardial Infarction; Acute Coronary Syndrome

Summary: elderly patients undergoing percutaneous coronary intervention (pci) face a high risk of both ischemic and hemorrhagic complications necessitating antiplatelet therapy. previous data indicate that even at a dose of 20-30 mg/day, aspirin (asa) allows almost complete inhibition of thromboxane (tx) a2 biosynthesis in healthy volunteers. however, asa at a dose of 30 mg/day has not been evaluated in the acute phase of myocardial infarction or among elderly patients, where it may achieve an optimal balance between bleeding risk and ischemic complications. this randomized study will include 40 patients over 65 years undergoing pci for acute coronary syndrome (acs). it compares a new dual antiplatelet therapy (dapt) strategy consisting of a p2y12 antagonist (ticagrelor) and asa at a very low dose of 30 mg/day (n=20) against the current standard treatment (p2y12 antagonist and asa at a dose of 75 mg) (n=20) in the control group.


Eligibility criteria:
inclusion criteria: * age above 65 years * acute coronary syndrome (acs) * positive results for myocardial necrosis markers (troponins) * undergoing successful coronary angioplasty with stent implantation within the last 24-48 hours before enrollment in the study * dual antiplatelet therapy (dapt) containing ticagrelor exclusion criteria: * indications other than acs and pci for dapt use * history of stent thrombosis during the course of dapt * planned subsequent coronary artery revascularization * planned surgery requiring suspension or interruption of dapt * planned discontinuation of asa or p2y12 antagonist during the study * use of doses other than 75 mg asa once daily or non-use of a p2y12 inhibitor - intake of diuretic drugs (e.g., loop diuretics, thiazides, potassium-sparing drugs) * intake or planned intake of oral anticoagulants, parenteral antithrombotic therapy (e.g., unfractionated heparin, low molecular weight heparin, bivalirudin), glycoprotein iib/iiia inhibitors (e.g., abciximab, tirofiban), fibrinolytic agents (e.g., tissue plasminogen activator), or nonsteroidal anti-inflammatory drugs * history of acute or chronic liver disease; severe kidney disease requiring dialysis; pregnancy; comorbidities associated with a predicted life expectancy of less than 1 year * any other condition deemed by the investigator to impact hemostasis, coagulation, bleeding risk, or the ability to adhere to the study protocol; receiving a strong inhibitor of cytochrome p450 3a, simvastatin or lovastatin at doses greater than 40 mg per day, a narrow therapeutic index cytochrome p450 3a substrate (e.g., cyclosporine or quinidine), or a strong inducer of cytochrome p450 3a (e.g., rifampin, rifabutin, phenytoin, carbamazepine, phenobarbital) * hemodynamic instability; clinical condition preventing obtaining informed consent.

Keywords: dual antiplatelet therapy myocardial infarction acute coronary syndrome very-low dose aspirin pci
posteromedial tibiofemoral incongruence (pmtfi) treatment

Conditions: Meniscus Disorder; Meniscus; Degeneration; Meniscus Tear; Meniscus Lesion

Summary: the aim of this study is to assess outcomes of posteromedial tibiofemoral incongruence (pmtfi) treatment

the aim of this study is to assess outcomes of posteromedial tibiofemoral incongruence (pmtfi) treatment by the means of published technique (reference nr 1). a decrease in the posterior curvature of the femoral metaphysis close to the medial femoral condyle is one of the anatomical alterations that can be seen within the knee joint. when the knee is fully flexed, this curve is typically concave enough to accommodate the posterior horn of the medial meniscus (phmm). similar to cam incongruence in the hip joint, a decrease in curvature may cause posteromedial tibiofemoral incongruence, a condition marked by compression of the phmm in complete knee flexion. if deep knee flexion occurs, clinical symptoms may appear, and phmm degeneration may be shown to worsen over time. surgery may be recommended for patients for whom activity modification and conservative therapy have failed. our team proposed an arthroscopic procedure that allows for the least amount of correction that is still necessary while also providing final intraoperative confirmation of the clinical need to repair posteromedial tibiofemoral incongruence.

Eligibility criteria:
inclusion criteria: * pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat * reduced concavity of the femoral metaphysis proximal to the medial femoral condyle confirmed on mri * impingement of posterior horn of medial meniscus with the metaphysis of femur during full knee flexion confirmed arthroscopically exclusion criteria: * active knee inflammation * chondral injuries icrs 3-4 * extraarticular reasons of pain, snapping or discomfort in posterior part of the knee in deep knee flexion during squat * cyst or avascular changes within the femoral metaphysis adjacent to the planned localization of the procedure
gxr rm china be study (darmstadt - jiangsu)

Conditions: Healthy

Summary: the purpose of this study is to assess bioequivalence (be), pharmacokinetics (pk), safety and tolerability following single oral dose administrations between a glucophage extended release, reduced mass (glucophage xr rm) manufactured in merck jiangsu china (test product) and that manufactured in merck darmstadt germany (reference product) administered under fasted and fed conditions.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation, including medical history, ecg recording and physical examination judged by investigator. * participants with a body weight within 50 to 90 kg (kilogram) and bmi (body mass index) within the range 19 to 26 kg/m2 (kilogram per meter square). * participants with all values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the investigator. * other protocol defined inclusion criteria could apply. exclusion criteria: * participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation. * participants with history or presence of relevant liver diseases or hepatic or renal dysfunction. * participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the investigator's opinion. * participation in a clinical study within 90 days prior to first drug administration. * non-acceptance of study high-fat breakfast. * other protocol defined exclusion criteria could apply .

Keywords: bioequivalence glucophage® xr rm
a study evaluating the efficacy and safety of zg005 in combination with donafenib or bevacizumab in patients with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: this is a randomized, open-label study to evaluate the safety and efficacy of zg005 in combination with donafenib or bevacizumab in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age. * fully understand the study and voluntarily sign the informed consent form. * histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (hcc). * life expectancy \>= 3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * fibrolamellar or sarcomatoid hcc, or mixed cholangiocarcinoma and hcc. * patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.
study evaluating treatment of fever in children who have been vaccinated with prevenar and infanrix hexa

Conditions: Vaccines, Pneumococcal; Infant; Fever, Chemically Induced; Drug Therapy, Combination

Summary: the purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with prevenar and a concomitant hexavalent dtpa combination vaccine reduces the rate of febrile reactions.


Eligibility criteria:
inclusion criteria: * healthy infants age 55 to 112 days * subject's parents/legal guardians provide written informed consent exclusion criteria: * prematurely born subjects \< 37 weeks gestation * known or suspected disease of immune system * known or suspected hypersensitivity to any vaccine or vaccine component

Keywords: vaccine infant
study of effects of sacubitril/valsartan vs. enalapril on aortic stiffness in patients with mild to moderate hf with reduced ejection fraction

Conditions: Heart Failure and Reduced Ejection Fraction

Summary: to determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[lvef\] ≤ 40%) after 12 weeks of treatment. the primary endpoint is the change in aortic characteristic impedance (zc = dp/dq in early systole) between baseline and week 12.


Eligibility criteria:
inclusion criteria: * history of htn and one of the following at both screening and pre-randomization: 1. sbp \>105 mm hg on antihypertensive medication. 2. sbp \>/= 140 mm hg and not on antihypertensive medication. * nyha class i-iii heart failure and with reduced ejection fraction \</= 40%, as determined by any local measurement made within the past 12 months using echocardiography, muga, ct scanning, mri, ventricular angiography or single-photon emission computed tomography (spect), provided no subsequent measurement above 40%. patients who have had an intervening medical event (e.g. myocardial infarction) or procedure (e.g. revascularization, cardiac resynchronization), must have a reassessment of ef ≥ 3 months following the event to ensure that eligibility criteria are still met. * on stable doses of treatment with guideline-directed therapy, other than aceis and arbs prior to randomization. 1. if the patient is currently taking an acei, a 36-hour washout is required prior to randomization (visit 2). 2. if the patient is currently taking an arb, they must discontinue the arb before initiation of study treatment however washout is not required. * on an optimal medical regiment of diuretics and background medications to effectively treat co-morbidities such as htn, dm, and coronary artery disease. key exclusion criteria: * history of hypersensitivity to any of the study drigs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to aceis, arbs, or nep inhibitors as well as known or suspected contraindications to the study drugs. * previous history of intolerance to sacubitril and valsartan, acei or arb standard of care doses despite appropriate and gradual up-titration. * history of angioedema, drug-related or otherwise. * requirement of treatment with both ace inhibitor and arb. * current or prior treatment with sacubitril and valsartan.

Keywords: heart failure reduced ejection fraction central aortic stiffness vascular echocardiogram aortic stiffness
sox as adjuvant chemotherapy for resectable gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to assess the safety and efficacy of s-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase i/ii study of this combination in patients with d2 resection of gastric cancer.

this stage i/ii study is designed to evaluate the appropriate dose of s-1 plus fixed-dose of oxaliplatin (sox regimen) for patients with d2 resection of gastric cancer and survival of sox regimen for stage ii-iii patients(ajcc 7th). to assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. to evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.

Eligibility criteria:
inclusion criteria: * 20-70 years * histologically proven adenocarcinoma of the stomach * curative d2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery * stage ii, iii (ajcc 7th edition) * eastern cooperative oncology group (ecog) performance status of 0-1 * no prior chemotherapy or radiotherapy * adequate bone marrow, renal, and liver function exclusion criteria: * any evidence of metastatic disease (including presence of tumor cells in the ascites). * previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer. * major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. * pregnant or lactating women. * history of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix. * lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication. * organ allografts requiring immunosuppressive therapy. * serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (dpd) deficiency) or patients with known dpd deficiency. hypersensitivity to platinum compounds or any of the components of the study medications. * received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.

Keywords: gastric cancer s-1 oxaliplatin adjuvant chemotherapy
low-intensity cognitive-behavioural therapy for insomnia

Conditions: Insomnia

Summary: a randomized controlled trial is proposed to compare the effectiveness of workshop-based and self-help cognitive behavioral therapy for insomnia (cbti), and sleep hygiene education (she) to treat insomnia in hong kong adolescent and adult patients, in terms of alleviation of insomnia severity, reduction in associated insomnia symptoms/ complications, and enhancement in quality of life. insomnia is prevalent in hong kong and can cause severe impacts on patients and society, but there is a dearth of related research in the local population. therefore, it is significant to conduct this study. a total of 210 participants aged \> 18 with insomnia will be recruited and randomized into 3 groups to receive one of the 3 treatments. outcomes will be measured using relevant questionnaires filled in at the baseline, 6 and 12 weeks afterwards. the results obtained will be compared within each group and among the 3 groups using statistical testing to determine the most effective treatment option for insomnia.


Eligibility criteria:
inclusion criteria: * hong kong residents * aged 16 or above * satisfy the dsm-5 criteria for insomnia, i.e. inability to fall or keep asleep, or wake up too early for 3 days or more per week, throughout a minimum period of 1 month (instead of 3 months in the diagnostic criteria d) using the brief insomnia questionnaire. this is to include episodic insomnia which is considered as an 'other specified insomnia disorder' in dsm-5. * score at least 10 points in insomnia severity index * able to read and understand cantonese * have internet access exclusion criteria: * suffer from recently diagnosed and untreated medical, psychiatric or sleep disorders that likely contribute to the onset and maintenance of insomnia, e.g. major depressive disorder, obstructive sleep apnea, restless legs syndrome, chronic pain. * currently receiving cbti or she * work on irregular rotational shift

Keywords: insomnia cognitive behavioural therapy for insomnia sleep hygiene education