Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics, safety and tolerability of dabigatran etexilate solution in children 1 to < 2 years of age

Conditions: Venous Thromboembolism

Summary: study will assess pk/pd parameters and safety and tolerability of the study medication in this age group


Eligibility criteria:
inclusion criteria: 1. males or females 1 to less than 2 years of age 2. objective diagnosis of primary venous thromboembolism 3. completion of planned treatment course with low molecular weight heparin or oral anticoagulant for primary venous thromboembolism 4. written informed consent by parent (legal guardian) and patient assent (if applicable) exclusion criteria: 1. weight less than 9 kg 2. conditions associated with increased risk of bleeding 3. patients who have any condition that would not allow safe participation in study note: further exclusion criteria apply
tdf and ldt in immune-tolerant chb patients awaiting assisted reproduction

Conditions: Hepatitis B, Chronic

Summary: immune-tolerant patients with chronic hepatitis b (chb) awaiting assisted reproduction (ar) are required to initiate antiviral therapy due to laboratory safety. additionally, rapid virus elimination is suggested to faciliate timely performance of ar. however, no consensus is reached regarding the antiviral therapy in this group. this study aimed to explore the efficacy and safety of tenofovir (tdf) and telbivudine (ldt) in this population.


Eligibility criteria:
inclusion criteria: * aged 18-45 years old with artificial reproductive needs * liver function (alt) \<40u/l for male and \<30 for female * hbv-dna\> 10e+5 * hbveag + * history\> 0.5 years exclusion criteria: * cirrhosis * combined with other liver diseases such as autoimmune liver disease, alcoholic liver disease, fatty liver * liver or other parts of malignancies * bilirubin\> 17.1 * ggt\> 2uln * liver transplant patients * combined hcv, hdv, hiv infection * a history of anti-hbv drug resistance * history of habitual abortion * previous fetal malformation history * crp\> 3.0ng / ml * uncontrolled hypertension * proteinuria or calculated creatinine clearance \< 70 ml/min * heart failure or acute coronary syndrome * coagulopathy * drug or alcohol addiction * hyperlipidemia ldl\> 4.6 or tg\> 2.0 * alphafetoprotein \> 50 ng/ml * received interferon (pegylated or not) therapy within 6 months of the screening visit * evidence of hepatocellular carcinoma * received solid organ or bone marrow transplantation * was currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents * known hypersensitivity to the study drugs, the metabolites, or formulation excipients
apricity care to improve ici outcomes of ethnic/racial minority nsclc patients

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this trial is to study the effectiveness of the aprictyrxtm care service to improve treatment outcomes of ethnic/racial minority n.s.c.l.c. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.

immune checkpoint inhibitors (i.c.i.) targeting the pd-1/pd-l1 axis have changed the treatment landscape of non-small cell lung cancer (n.s.c.l.c.). after demonstrating improved efficacy and tolerability compared to standard chemotherapy in several large clinical trials, these novel drugs are now f.d.a. approved in multiple treatment settings. with the increase in i.c.i. use, the incidence of immune-related adverse effects (iraes) has also risen, occurring in up to 16% of ici-treated patients. prompt recognition and timely management are necessary to avert potential poor outcomes from direct toxicity and/or early treatment discontinuation. however, rapid adoption of i.c.i.s may limit healthcare providers' experience and comfort with managing important iraes. additionally, existing barriers to access care that disproportionately impact racial and ethnic minority patients may amplify the inability to manage patients on i.c.i.s effectively. using technologically-enabled health interventions in a culturally competent manner can improve access to health care resources and reduce health disparities. these platforms need to be optimized at the literacy level of underserved minority communities and can be adapted to meet the community's needs. recently, technology-enabled services focused on patient-reported outcomes have garnered growing interest in oncology.

Eligibility criteria:
inclusion criteria: * age≥ 18 years * confirmed nsclc diagnosis * prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy * ability to understand and the willingness to sign a written informed consent document * self-identification as a member of an ethnic minority or underserved population. exclusion criteria: * an individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study. * patients enrolled in other interventional clinical trials at the time of screening will be excluded.

Keywords: non small cell lung cancer immune-checkpoint inhibitor
physiologic ocular changes during pregnancy in women with high myopia.

Conditions: High Myopia; Pregnancy Related

Summary: the prevalence of myopia is seemingly increasing, and it is one of the major causes of blindness. high myopia is defined as a refractive error with spherical equivalent exceeding -6 diopters and/or the axial length longer than 26.5 mm. the global prevalence of high myopia is estimated to rise from 2.7% of the world population in 2010 to 9.8% of the world population in 2050. high myopia is characterized by axial length elongation, and consequent stretching of the posterior eye wall (thin retina and choroid). there are many complications of high myopia such as posterior staphyloma, lacquer cracks and myopic choroidal neovascularization. normal labour may cause the ocular complication in pregnant women with high myopia, such as macular hemorrhage. therefore, the caesarean section with epidural anesthesia is recommended. moreover, there is no standard screening guideline for pregnant women with high myopia.

there are few studies of posterior ocular changes during pregnancy. a recent meta-analysis showed that the choroidal thickness and retinal vascular density were increased during pregnancy especially in the 3rd trimester. from the literature review, there is only one publication of physiologic ocular changes during pregnancy in high myopia. chen et al demonstrated that the choroidal thickness was increased significantly in the 3rd trimester. however, the changes of retinal vascular density in pregnant women with high myopia have never been studied before.

Eligibility criteria:
inclusion criteria: * age \> 18 years * high myopia: spherical equivalent \> 6 diopters and/or axial length \> 26.5 mm * singleton pregnancy * clear ocular media * written inform consent exclusion criteria: * high risk pregnancy such as pre-eclampsia, gestational diabetes mellitus, hyperthyroidism and asthma. * history of retinal diseases such as macular edema and retinal vascular occlusion * history of intraocular inflammation or endophthalmitis * history of intraocular laser treatment * history of intraocular surgery withdrawal criteria * childbirth before 34 weeks' gestation * multifetal pregnancy was detected by ultrasound * high risk pregnancy which could not follow the research protocol such as severe pre-eclampsia * retinal diseases occur during the follow-up period such as central serous chorioretinopathy, retinal detachment and choroidal neovascularization * significant ocular trauma during the follow-up period * severe peripartum or postpartum complications such as thromboembolic disease and postpartum hemorrhage

Keywords: high myopia pregnancy choroidal thickness retinal vascular density retinal nerve fiber layer thickness corneal curvature
non-interventional open label prospective comparative observational study of evaluation of compliance in the empiric treatment with azithromycin sr versus amoxiclav 1000 mg in adult patients with of acute bacterial maxillary sinusitis

Conditions: Maxillary Sinusitis

Summary: the purpose of this study is to compare compliance between patients with acute bacterial sinusitis (abs) treated with azithromycin sr 2.0 g single dose orally and those treated with amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of abs in outpatient clinic practice.


Eligibility criteria:
inclusion criteria: * male or nor pregnant or lactating female outpatients, 18 years of age or older. * a clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days: 1. facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and 2. presence of one or more of the following signs: i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice * a sinus x-ray (water's view) confirming the clinical diagnosis of maxillary sinusitis. at least one of the following must be documented in one or both maxillary sinuses on radiologic examination: 1. complete or partial opacification 2. an air/fluid level two or more of the following: 1. fever, as defined by temperature: \>38ºc 2. leukocytosis \[white blood cell (wbc) \>10,000/mm3 or \>15% band forms\], ecr; 3. headache, 4. nasal congestion and post nasal drainage. exclusion criteria: * known or suspected hypersensitivity or intolerance or contraindications to azithromycin, amoxiclav according to lpds, pregnant or lactating women.

Keywords: azithromycin sr amoxiclav 1000 mg maxillary sinusitis
a phase ii clinical study of shr-1826 for injection in patients with nsclc

Conditions: NSCLC

Summary: this study is an open-label, multicenter phase ii clinical trial to evaluate the safety, tolerability and efficacy of shr-1826 for injection in patients with nsclc.


Eligibility criteria:
inclusion criteria: 1. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. ecog performance score of 0-1. 3. life expectancy ≥ 3 months. 4. have at least one measurable tumor lesion per recist v1.1. 5. subjects with histologically confirmed locally advanced or metastatic nsclc. 6. good level of organ function. 7. provide archived or fresh tumor tissue for vendor test. exclusion criteria: 1. subjects with active central nervous system metastases or meningeal metastases; 2. history of serious cardiovascular and cerebrovascular diseases; 3. subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. severe infection within 4 weeks prior to the first dose; 5. ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 6. subjects with uncontrolled tumor-related pain; 7. received \>30 gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug; 8. concomitant other malignancies ≤ 5 years prior to first dose of study drug; 9. unresolved toxicities from previous anti-tumor therapy to ≤ grade 1 (based on nci ctcae v5.0); 10. history of immunodeficiency, including a positive hiv test; 11. per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
the effectiveness of different risk scales in predicting vte in respiratory inpatients

Conditions: Venous Thromboembolism

Summary: to compare the predictive effectiveness of the caprini risk assessment model, the padua risk assessment model and the vte risk assessment in medical patients mentioned in the 2018 edition of the guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism on the risk of concomitant vte in respiratory inpatients to provide a basis for clinical vte assessment and treatment.

a case-control study was used to collect patients who developed vte during hospitalization in the department of respiratory medicine at peking university third hospital hospital from january 2015 to december 2020 as the case group, and 2-fold patients who did not develop vte matched to the case group (age, sex, adl score, diagnosis, and length of hospitalization) as the control group. the general status of the patients was also assessed using the padua risk model, the caprini risk model, and the vte risk assessment scale for medical patients mentioned in the 2018 edition of the guidelines for the diagnosis, treatment, and prevention of pulmonary thromboembolism, and the relevant items involved in the assessment form were obtained by reviewing the cases.

Eligibility criteria:
inclusion criteria: * age more than 18y respiratory inpatient exclusion criteria: * patients with deep vein thrombosis or pulmonary thromboembolism, sequelae of deep vein thrombosis, and thrombosis in other parts of lower limbs were diagnosed; patients with severe coagulation dysfunction or other hematological diseases

Keywords: vte
national varicose vein study - portugal

Conditions: Chronic Venous Insufficiency

Summary: the national varicose vein study is a cross-sectional, multicenter, observational study. the primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

chronic venous disease is one of the most prevalent pathologies in the world population. it presents a spectrum of variable manifestations, culminating in the most severe form, active venous ulcer. the clinical evaluation, the study of venous anatomy by echo- doppler and the indications for surgical treatment are standardized in guidelines. the same applies to the techniques for surgical treatment that, in the long term, present equally satisfactory results. thus, currently, in the portuguese national health system, the surgical technique most frequently used is conventional surgery. as for postoperative care, namely thromboprophylaxis regimens, analgesia regimens, there is greater variability in its application between clinics and institutions, which may result in significant differences in postoperative recovery. in this way, we intend to develop an observational, cross-sectional and multicenter study, comparing postoperative care protocols and patient compliance and impact on quality of life, as well as absence from work. the primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

Eligibility criteria:
inclusion criteria: * patients treated at chup, chusj and chuc * male and female; * age over 18 years; * all clinical presentations (c) included in the ceap classification system; * period from november 2022 onwards; * conventional surgical treatment of at least one great saphenous vein; * patients treated using the following techniques: arch ligation +/- trunk stripping. exclusion criteria: * exclusive or concomitant treatment with endovenous surgery (thermal ablation by laser or radiofrequency...); * treatment by conservative conventional surgery of the great saphenous vein (chiva, asval); * varicose surgery not involving the great saphenous vein; * age under 18 years; * patients treated in hospital units not covered by the study.

Keywords: venous insufficiency conventional great vein surgery
imatinib (qti571) in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: a multinational, multicenter, double blind, placebo-controlled study evaluating the efficacy and safety of imatinib as an add-on therapy in the treatment of patients with severe pulmonary arterial hypertension (pah).


Eligibility criteria:
key inclusion criteria * male or female patients ≥18 years of age with a current diagnosis of pulmonary arterial hypertension (pah) according to the dana point 2008 meeting: world health organization (who) diagnostic group i, idiopathic or heritable (familial or sporadic) pah, pah associated with collagen vascular disease including systemic sclerosis, rheumatoid arthritis, mixed connective tissue diseases, and overlap syndrome. pah following one year repair of congenital heart defect \[atrial septal defect (asd), ventricular septal defect (vsd) or posterior descending artery (pda)\], or pah associated with diet therapies or other drugs * a pulmonary vascular resistance (pvr) ≥ 800 dynes.sec.cm-5 (as assessed by right heart catheterization (rhc) at screening or in the 3 months preceding the screening visit) despite treatment with two or more specific pah therapies, including endothelin receptor antagonists (eras), phosphodiesterase 5 inhibitors (pde5), or subcutaneous, inhaled, intravenous or oral prostacyclin analogues for ≥ 3 months. background therapy doses were to be stable for ≥ 30 days except for warfarin and prostacyclin analogues ( ≥ 30 days but doses could vary even within the month before enrollment). * world health organization functional class ii-iv. for who functional class iv, one of the 2 or more specific pah therapies were to be an inhaled, subcutaneous, intravenous or oral prostacyclin analogue, unless the subject showed intolerance of prostacyclin analogues. * 6mwd ≥ 150 meters and ≤ 450 meters at screening. distances of two consecutive 6mwts were to be within 15% of one another. key exclusion criteria * with a pulmonary capillary wedge pressure \> 15 mm hg to rule out pah secondary to left ventricular dysfunction. * with a diagnosis of pulmonary artery or vein stenosis * left ventricular ejection fraction (lvef) \< 45% * with disseminated intravascular coagulation (dic) * with evidence of major bleeding or intracranial hemorrhage * with a history of elevated intracranial pressure * with a history of latent bleeding risk such as diabetic retinopathy, gastrointestinal bleeding due to gastric or duodenal ulcers, or colitis ulcerosa * with a qtcf \> 450 msec for males and \> 470 msec for females at screening and baseline in the absence of right bundle branch block. * with a history of ventricular tachycardia, ventricular fibrillation or ventricular flutter * with a history of torsades de pointes * with a history of long qt syndrome * having undergone atrial septostomy in the 3 months prior to the screening visit

Keywords: pulmonary arterial hypertension imatinib 6mwd borg scale pulmonary hypertension
influence of airway clearance techniques on gor in infants

Conditions: Gastro-oesophageal Reflux

Summary: the purpose of this study is to determine whether assisted autogenic drainage (aad) or bouncing combined with assisted autogenic drainage (baad), induces or aggravates acid and non-acid gastro-oesophageal reflux in infants under the age of one year. infants, referred to the hospital for impedance-ph monitoring are included in this study.


Eligibility criteria:
inclusion criteria: * each child under the age of 1 year, referred for 24 h impedance monitoring to confirm a clinically suspected diagnosis of pathological gor will be included exclusion criteria: * prematurity (gestational age less than 37 weeks), * the use of anti-reflux medication and reflux surgery (nissen fundoplication)
metformin use in patients undergoing total joint replacement surgery

Conditions: Hyperglycemia

Summary: the goal of this pilot, randomized, single-blind, placebo-controlled trial is to evaluate the feasibility of and provide preliminary information for a multi-center randomized controlled trial that will assess the effects of metformin on blood sugar control in patients after total hip or total knee replacement surgery. the primary objective of this study is to assess the feasibility of conducting a large, randomized trial with regards to timely recruitment, study drug administration, protocol adherence, and overall retention in patients undergoing total joint arthroplasty. secondarily, the investigators aim to obtain preliminary estimates of group-specific outcome means and variances for primary and secondary outcomes of a larger future trial.


Eligibility criteria:
inclusion criteria: * male or female, age 18-99 years * undergoing total hip or total knee arthroplasty, including elective, primary, and revision surgeries * ability to take oral medication and be willing to adhere to the prescribed metformin regimen regardless of current, past, or no metformin use. note: patients with or without type 2 diabetes are considered eligible. (e.g.) * type 2 diabetic on metformin * type 2 diabetic on metformin and other medication, including insulin * type 2 diabetic on medication but not metformin * pre-diabetic * non-diabetic exclusion criteria: * advanced renal insufficiency (glomerular filtration rate (gfr) \< 45, or chronic kidney disease (ckd) stage 3b or higher) * advanced liver cirrhosis or failure (child-pugh class b or c) * congestive heart failure (new york heart association (nyha) class 3 or 4) * current alcohol abuse within 30 days of surgery (\>4 standard servings daily for men, \>3 standard servings daily for women) * type 1 diabetes * received contrast dye within 48 hours of surgery * vulnerable populations: children, pregnant women, neonates, decisionally impaired adults, prisoners

Keywords: arthroplasty hip knee metformin glycemic variability