Kornimate/medical-research-clean huggingface dataset:
the maintenance treatment of apatinib/capecitabine versus observation in advanced gastric cancer

Conditions: Stomach Neoplasms; Gastrointestinal Neoplasms; Stomach Diseases; Digestive System Neoplasms; Capecitabine; Apatinib; Neoplasms; Molecular Mechanisms of Pharmacological Action

Summary: the purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of apatinib/capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. our study is designed to prove whether the maintenance treatment of apatinib or capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic gastric or gastroesophageal junction adenocarcinoma * ecog ps 0-2 * at least one measurable or evaluable lesion in the first-line chemotherapy * the fist line treatment should be 5-fu based regimen (e.g. ecf/eof/eox/folfox/xelox/xp) , and patients should received 6 cycles (3-week regimen) or 12 cycles (2-week regimen) treatment with the efficacy of non-pd * the time from the last cycle treatment to the enrollment cannot exceed 6 weeks * adequate hepatic, renal, heart, and hematologic functions (platelets ≥75×109/l, neutrophil ≥1.5×109/l, hemoglobin ≥80 g/l, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase ≤2.5× the uln) exclusion criteria: * received 2 or more regimens for palliative chemotherapy * pregnant or lactating women * concurrent cancer, or history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * uncontrolled brain, or leptomeningeal involvement, complete intestinal obstruction * clinically significant active bleeding, ob 2+ or higher * patients with locally advanced gastric cancer who are scheduled to receive radiotherapy * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia * uncontrolled significant comorbid conditions

Keywords: capecitabine apatinib maintenance treatment advance gastric cancer
hyponatraemia and mortality in schizophrenic and bipolar patients: protocol for a bayesian causal inference study

Conditions: Hyponatremia; SIADH

Summary: this study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.


Eligibility criteria:
source population: * danish residents * at least one international classification of diseases version 10 (icd-10) f2 or f31 diagnosis from a hospital in region zealand and the capital region (denmark) no exclusion criteria.

Keywords: causality bayesian analysis antipsychotics psychotropics polypharmacy
bivalirudin as a procedural anticoagulant in pediatrics

Conditions: Cardiology

Summary: pharmacokinetics and safety of weight based bivalirudin in children


Eligibility criteria:
inclusion criteria: * male and non-pregnant females, with an age range of birth to 16 years of age. * expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease. * written informed consent from a legal guardian/parent. * life expectancy of at least 15 days at study entry. * assent of the patient if older than 8 years, whenever possible. exclusion criteria: * history of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit. * gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles. * cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. * known congenital or acquired bleeding or clotting disorder. * patients undergoing renal dialysis.\* * weight \< 2.5 kg. * confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential). * known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (angiomax®). * any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements. * participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study. * patients who have been receiving warfarin (coumadin®) therapy and whose inr is \> 1.5. * patients who cannot be discontinued from ufh at least 30 minutes prior to study drug bolus. * patients who have received a dose of lmwh within 8 hours prior to study drug bolus. * patients previously enrolled in the study.

Keywords: pediatrics bivalirudin
changes of the neuronal activity in the subthalamic nucleus under remifentanil sedation during stereotactic electrode implantation

Conditions: Movement Disorders; Effect of Remifentanil

Summary: deep brain stimulation is commonly used for the treatment of movement disorders. electrode positioning is usually performed under local anesthesia in fully awake patients. the procedure is uncomfortable to the patients who has to remain motionless during the whole surgery. previous reports of electrode positioning under general anesthesia was found to be less accurate. this result was probably due to the effect of the anesthetics on the electrical activity of the basal ganglia. the purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to remifentanil sedation. electrical activity of single neurons will be recorded before, during and after sedation.


Eligibility criteria:
inclusion criteria: * patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode. exclusion criteria: * suspected difficult intubation * history of sleep apnea * known allergy for remifentanil

Keywords: deep brain stimulation movement disorders remifentanil sedation basal ganglia electrical activity
efficacy and safety for different regimen of vte pharmacoprophylaxis among severely burn patients

Conditions: Burns

Summary: this study aims to assess the feasibility and safety of vte prophylaxis for 3 modality regimens (unfractionated heparin 5000 u sq q8 hours, enoxaparin 40 mg sq q24 hours or enoxaparin 30 mg sq q12 hours) in adult patients (≥18 y/o) with severely burn injuries (bsa≥20%) by measuring the bleeding incidence and vte events.

this is a pilot , randomized control trial-open label, prospective trial in tertiary academic hospitals for patient admitted to burn icu for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units s.c. tid, enoxaparin 40 mg s.c. od, or enoxaparin 30 mg s.c. bid. vte prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, vte prophylaxis should be started immediately unless contraindicated. all patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of dvt and as clinically indicated for clinical suspicion for vte thereafter until discharge, an urgent spiral cta chest will be requested on clinical suspicion for pe. anti xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. will follow-up patient until discharge from icu, developed vte requiring treatment (switch to treatment dose), developed hit or death.

Eligibility criteria:
inclusion criteria: * burn icu admitted adult patients, age ≥ 18 years old. * body mass index of 18.5 to \< 40 kg/m2. * tbsa of 20% or more. exclusion criteria: * vte history. * death within 24 hours of injury. * burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours. * coagulopathy (inr \> 1.7, ptt\> 2 times upper normal limit, platelet \< 50k mm3) * patient with positive baseline us for vte. * heparin induced thrombocytopenia (hit). * active bleeding. * patients with crcl of 30 ml/min or less. * patients using anticoagulation treatment dose for other indications.

Keywords: severely burn bsa≥20% enoxaparin unfractionated heparin vte bleeding
investigation of spinal health and internet addiction of individuals working remotely

Conditions: Posture; Spine; Internet Addiction; Neck Pain; Low Back Pain

Summary: low back pain and neck pain are common problems that affect people at certain times in their lives. these people constitute a significant part of the disease burden due to their recurrent complaints. people with low back and neck pain often seek medical attention. this situation causes individuals to apply to the hospital frequently and causes a serious cost at the social level. when the risk factors for neck pain are examined, many factors such as genetics, sleep problems, smoking, obesity, sedentary lifestyle, poor posture, previous neck pain, trauma, back pain and poor general health cause neck pain to develop. similarly, conditions such as age, obesity, and poor general health appear to be risk factors for low back pain. in addition to these risk factors, it has been reported that occupational factors such as long and sedentary working hours and unsuitable workplace conditions may also cause low back and neck pain. fixed posture and prolonged sitting are thought to be risk factors for low back and neck pain, but opinions on this subject are not clear. the covid-19 pandemic has created a global crisis since 2019 and caused a change in the lifestyle of all people around the world. the world health organization (who) stated that social distance should be increased and face-to-face contact should be reduced to prevent the spread of the pandemic. for this reason, many institutions have decided to work remotely and trainings have been carried out remotely. the increasing teleworking style with the covid-19 pandemic has led to an increase in the average screen time of individuals. it was reported that time spent on the internet increased by 52% compared to the pre-pandemic period. this study aims to investigate the relationship between increased teleworking hours and internet use during the pandemic period in individuals with low back or neck pain. researchers think that postural changes that may occur with increased distance working time, increased fixed posture and asymmetrical loading may contribute to the uncertain relationship between low back and neck pain and posture.


Eligibility criteria:
inclusion criteria: * working online during the pandemic process, * have a smart phone, * agree to voluntarily participate in the research. exclusion criteria: * have a malignant condition, * loss of function due to neurological or systemic disease, * having had a surgical operation in the last 6 months, * have an unhealed fracture, * withdraw consent at any stage of the study.

Keywords: posture spine neck pain low back pain screen time internet addiction
cyclosporine a plus low-steroid treatment in covid-19 pneumonia

Conditions: COVID 19 Pneumonia

Summary: methods: single-center pilot study included pcr+ sars-cov2-patients, hospitalized from april to may 2020 in puebla, mexico. comparative treatment with steroids plus csa or steroids. mild, moderate or severe pneumonia was measured by clinical, laboratory tests, lung damage score by computed tomography, and score for clinical improvement. death rate was evaluated at 28 days.

this is a pilot study done in a single center (issste regional hospital, puebla, mexico). consecutive patients with suspected or confirmed diagnosis of covid-19 were assigned, in an unblinded and non-randomized fashion, to receive either steroids plus csa (intervention group) or steroids only (standard of treatment in this hospital, control group), as per individual clinical judgment. the primary outcome was the number of days to clinical improvement until hospital discharge or death. the secondary outcome was the improvement of patients, defined by the following parameters: lower oxygen requirements (2 liters per minute, or less), absence of fever by three consecutive days, respiratory rate \<22, a decrease of 50% or more in the c reactive protein on admission, and length of hospital stay. adult patients attending to the hospital between april 15, to may 31, 2020, fulfilling symptoms compatible with covid-19 pneumonia, according to the who guidance, were invited to participate and all the patients gave their written informed consent.

Eligibility criteria:
inclusion criteria: * confirmed covid 19 pneumonia by clinical, lung computed tomography and rt-pcr nasopharyngeal swabs. exclusion criteria: * influenza infection.
clinical trial comparing bl123 versus ketoconazole in patients with tinea pedis

Conditions: Tinea Pedis

Summary: this is a non-inferiority, phase ii, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (dapaconazole cream 2%) versus the active control (ketoconazole cream 2%) in patients with tinea pedis. study schedule comprises enrollment, treatment and follow-up visits. treatment period is 14 days.

the study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple tinea pedis lesion(s). sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (dapaconazole) and the other foot will be allocated to active control (ketoconazole). randomization will determine which foot (right or left) will be treated with dapaconazole or ketoconazole.

Eligibility criteria:
inclusion criteria: * male or female subjects, aged between 18 and 60 years-old; * presence of skin lesion(s) characteristic of tinea pedis, with diagnosis confirmed by direct mycological exam; * absence of previous antifungic treatment for the current lesion(s) under study; * absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests; * ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by informed consent form signature. exclusion criteria: * known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions; * current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected; * use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected; * screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion; * drugs addiction, including alcohol; * use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives; * treatment, within 3 months before this trial, with any drugs known to have a well-established toxic potential to major organs; * participation in any other experimental research or administration of any experimental drug within 6 months before this trial; * positive pregnancy test, labor or miscarriage within 12 weeks before study treatment; * any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.
arrythmia burden in cardiac contractility modulation (ccm)

Conditions: Atrial Fibrillation; Arrythmia

Summary: the impulse dynamics optimizer device is a food and drug administration (fda) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (hfref). many candidates of this device have a previously implanted cardiovascular implantable electronic device (cied)- internal cardioverter defibrillator (icd) or permanent pacemaker (pm). patients with heart failure are at high risk for both atrial and ventricular cardiac arrhythmias. the aim of this study is to evaluate patients for atrial fibrillation (af) burden episode data obtained from interrogation of their cied 8 months or greater after optimizer implant and compare arrhythmia burden 6 months before optimizer cardiac contractility modulation (ccm) device insertion to 8 months or greater after optimizer insertion (after 2 month blanking period).


Eligibility criteria:
inclusion criteria: 1. 1%≤af burden≤99% in the 6 month period prior to optimizer implant as documented the patient's cied 2. 18 years of age or older on day of signing consent 3. any gender 4. functional pacemaker or icd and using remote follow-up for their ceid 5. not scheduled for planned catheter ablation or cardioversion 6. ability to sign consent in english or spanish exclusion criteria: 1. permanent atrial fibrillation 2. pregnancy (in prospective arm only) 3. expected survival \<1 year

Keywords: impulse dynamics optimizer device heart failure cardiovascular implantable electronic device atrial fibrillation reduced ejection fraction internal cardioverter defibrillator permanent pacemaker arrythmia cardiac contractility modulation
probiotic s. salivarius k12 for the prevention of upper respiratory tract infection in nursery-age children

Conditions: Upper Respiratory Tract Infection

Summary: the purpose of this retrospective study is to assess the treatment benefits of probiotic streptococcus salivarius k12 for the prevention of recurrent bacterial and viral infections of the pharynx, tonsils and ears in children under 3 years of age.

recurrent bacterial and viral infections of the pharynx, tonsils and ears are a problem that can affect children of all ages. the persistence of these infections can lead to an overuse of drugs such as antibiotics, antipyretics and anti-inflammatories, with the possible consequent presence of side effects and above all an increase in antibiotic resistance, a global public health issue. in search at reducing the use of antibiotics and antivirals, there is currently a great scientific interest in probiotic therapies for the oral cavity infection. the aim of this retrospective, controlled, multicenter, non-profit study is to evaluate the efficacy and safety of the administration of streptococcus salivarius k12 in pediatric patients attending the 1st or 2nd year of nursery school (\< 3 years of age ), in the prophylaxis of the most common bacterial or viral respiratory infections, assessing the consequent reduction in the use of antibiotics, antivirals or other therapies compared to children.

Eligibility criteria:
inclusion criteria: * healthy children attending the 1st or 2nd year of nursery (under aged 3 years) * treated with probiotic streptococcus salivarius k12 (1 billion cfu) for 90 continuous days * children not treated with probiotic streptococcus salivarius k12 exclusion criteria: * children with underlying health condition
the effect of two different approaches on palatal donor site

Conditions: Wound Heal

Summary: an epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. the donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.

after epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. these outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. patient-reported outcomes will be recorded using the oral health impact profile-14 questionnaire.

Eligibility criteria:
inclusion criteria: age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible; stable periodontium after phase i therapy; full-mouth plaque and bleeding scores \&lt;15% exclusion criteria: * previous palatal harvesting history; unstable endodontic conditions; tooth mobility at the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues

Keywords: coconut oil wound healing palatal graft harvesting
edema and fibrosis cmr imaging in cardiomyopathy

Conditions: Cardiomyopathies

Summary: 7 tesla mri is a new magnetic field strength that has become available at penn for cardiovascular mri. this new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. the purpose of this study is to assess the feasibility of 7 t cmr. secondly, we wish to investigate its use, to improve clinical and research mri. altogether, 7 t may permit better clinical diagnosis of cardiomyopathy.


Eligibility criteria:
inclusion criteria: * subjects between the ages of 20-70 years old exclusion criteria: * advanced renal disease (estimated gfr rate \< 30 ml/min) or hypersensitivity to gadolinium contrast agent. * presence of cardiac pacemaker or implanted cardioverter defibrillator * pregnancy * inability to provide informed consent * other contraindications to mri (such as claustrophobia)
validation of the french version of the lithium knowledge test (lkt)

Conditions: Patient Treated With Lithium, With Bipolar or Schizo-affective Disorder, Hospitalized in a Psychiatric Ward

Summary: lithium is a drug used to treat several psychiatric illnesses. this medication requires particular vigilance because it has a narrow therapeutic margin: the dose necessary to obtain an effective treatment is close to the toxic dose. the blood dosage of the drug and the patient's knowledge of the drug are necessary to optimize and secure the drug intake. the objective of this observational study is to confirm that the score obtained by the lkt lithium knowledge self-questionnaire translated into french is representative of the knowledge of patients treated with lithium. participants will be asked to complete this questionnaire twice, and the scores obtained will be compared to the blood lithium level to see if a good score is associated with an effective blood lithium concentration.


Eligibility criteria:
inclusion criteria: * patient hospitalized in a psychiatric ward or in an epsm for more than 10 consecutive days * patient treated with ir or er lithium li * patient over 18 years of * patient on a fixed dosage of lithium for more than 5 days prior to blood sampling for lithiaemia testing * obtain patient's non-opposition exclusion criteria: * clinically unstable patient or patient with a cognitive disorder that makes it impossible to perform interview and/or completion of the lkt self-questionnaire * patients under guardianship or trusteeship * illiterate patients * patient with a therapeutic target concentration different from general recommendations (e.g. elderly subject) * patient receiving a pharmaceutical interview or any other interview between the completion of the 1 and 2nd questionnaires, likely to modify the lkt score.

Keywords: lithium observance security lithium knowledge test