Kornimate/medical-research-clean huggingface dataset:
endoscopic variceal ligation in children

Conditions: Esophageal Varices in Cirrhosis of the Liver; Upper Gastrointestinal Bleeding; Endoscopy; Child

Summary: this is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. the study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.

endoscopic variceal ligation group; inclusion criteria from january 2014 to april 2017, a study group was created, including all paediatric patients with a known chronic liver disease with suspicion of portal hypertension and grade 2 or 3 ov or red spots, regardless of the grade of the ov diagnosed by endoscopy. propanolol group patients in the endoscopic variceal ligation study group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices in the upper endoscopy, who received propranolol as primary prophylaxis from january 2009 to december 2013. ligation sessions were performed every 6 weeks until varices eradication. when eradication was achieved, upper endoscopy was performed at 2 and 6 months to assess the efficacy of the treatment. if no varices were observed, upper endoscopies were performed once a year thereafter. eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.

Eligibility criteria:
inclusion criteria for endoscopic variceal ligation cohort * all paediatric patients (\< 18 years) * known chronic liver disease * suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/l), * grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy * from january 2014 to april 2017 exclusion criteria for endoscopic variceal ligation cohort: * patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study. * patients for whom endoscopic variceal ligation was not feasible because of patients' weight/seize were also excluded of the study. inclusion criteria for propranolol cohort * all paediatric patients (\< 18 years) * known chronic liver disease * suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/l), * grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy * that received propranolol as primary prophylaxis * from january 2009 to december 2013. exclusion criteria propranolol cohort: * patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.
bright-sc: blisibimod response in iga nephropathy following at-home treatment by subcutaneous administration

Conditions: IgA Nephropathy

Summary: the purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven iga nephropathy with persistent proteinuria of between 1-6 g/day.


Eligibility criteria:
inclusion criteria: * 18 - 65 years of age, inclusive * biopsy-proven iga nephropathy * receiving stable, clinically-optimized acei and/or arb * proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points exclusion criteria: * clinical or histologic evidence of non-iga-related glomerulonephritis * iga nephropathy with greater than 50% glomerulosclerosis or cortical scarring * meets egfr criteria * history of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months * malignancy within past 5 years * known to be positive for hiv and/or positive at the screening visit for hepatitis b, or hepatitis c * liver disease * neutropenia * active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections * history of active tuberculosis or a history of tuberculosis infection * pregnant or nursing

Keywords: igan iga nephropathy a-623 blisibimod kidney disease persistent proteinuria
a study to evaluate bms-986165 tablet formulation relative to bms-986165 capsule formulation and the effect of a high-fat/ high-calorie meal and increased gastric ph on the bms-986165 tablet formulation

Conditions: Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis; Inflammatory Bowel Diseases

Summary: the purpose of this study is to evaluate bms-986165 tablet formulation versus bms-986165 capsule formulation. this study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric ph on the bms-986165 tablet formulation.


Eligibility criteria:
inclusion criteria: * patients must be willing and able to complete all study-specific procedures and visits * healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive, at screening * normal renal function at screening exclusion criteria: * women of childbearing potential not using an effective contraceptive method or are breastfeeding * any significant acute or chronic medical illness * history of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months * history of headaches related to caffeine withdrawal, including energy drinks * history of syncope, orthostatic instability, or recurrent dizziness * active tb requiring treatment or documented latent tb within the previous 3 years other protocol defined inclusion/exclusion criteria could apply.
study to evaluate and compare the bioequivalence of two abaloparatide-smts treatments in healthy women.

Conditions: Osteoporosis

Summary: a study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-smts treatments 300 μg treatments applied to the thigh for 5 minutes.

this is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-smts 300 μg treatments (patheon sterile abaloparatide-smts and kindeva ultra-low bioburden abaloparatide-smts) applied to the thigh for 5 minutes. the study will also evaluate the effect of small deviations in the wear-time of the patheon abaloparatide-smts worn for 4 minutes or 7 minutes compared to the patheon abaloparatide-smts worn for the prescribed 5 minutes.

Eligibility criteria:
inclusion criteria: * female subjects aged 40 to 65 years old, inclusive, at screening * good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m\^2 inclusive) * laboratory tests within the normal range * serum 25-hydroxyvitamin d values must be \> 20 ng/ml exclusion criteria: * presence or history of any disorder that may prevent the successful completion of the study. * diagnosed with osteoporosis, paget's disease, or other metabolic bone diseases (eg, vitamin d deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening; * history of any cancer within the past 5 years other than squamous or basal cell carcinoma; * history of allergy to abaloparatide or drugs in a similar pharmacological class;

Keywords: osteoporosis transdermal delivery microneedle patch solid microstructured transdermal system abaloparatide tymlos® abaloparatide-sc pk
gabapentin in treatment of muscle cramps in patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: * muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. * quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. however, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

• the aim of the study was to assess the efficacy and safety of gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: * liver cirrhosis patients exclusion criteria: * allergy to gapabentin. * pregnancy and lactation. renal failure.
myopia control: a comparison study between atropine and misight

Conditions: Myopia

Summary: this research project aims to provide additional knowledge of pharmacological and optical methods of myopia control and to gain a better understanding of the biometry of the pediatric eye, which contributes to the onset and progression of myopia. as a result, this study will improving our best practices for myopia control in pediatric patients.


Eligibility criteria:
inclusion criteria: * children age of 5-12 years old at their baseline exam * children with a spherical equivalent refractive error of +0.50d (minimal hyperopia) to -7.50 d (high myopia) * gestational age ≥ 32 weeks. * birth weight \>1500g. exclusion criteria: * current or previous form of myopia control * current or previous use of bifocal, progressive- addition lenses, or multifocal contact lenses * known atropine allergy or contact lens intolerance (allergy to only one can still allow enrollment in the other group) * abnormality of cornea, lens, central retina, iris, or ciliary body * current or prior history of manifest strabismus, amblyopia, or nystagmus * current or previous myopia treatment with atropine, pirenzepine or another anti-muscarinic agent. * current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses. * current or previous use of orthok, rigid gas permeable, or other contact lenses being used to reduce myopia progression. * abnormality of the cornea, lens, central retina, iris, or ciliary body. * prior eyelid, strabismus, intraocular, or refractive surgery. * down syndrome or cerebral palsy. * diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, grave's disease, myasthenia gravis, diabetes mellitus, parkinson's disease) * existing ocular conditions (e.g., retinal disease, cataracts, ptosis) or systemic/neurodevelopmental conditions (e.g., down syndrome) which may influence refractive development * any condition that in the judgement of the investigator could potentially influence refractive development. * existing conditions that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., jia, glaucoma, diabetes mellitus, pre-diabetes) * inability to comprehend and/or perform any study-related clinical tests
returning to work. efficacy of "tailored physical activity or" "chronic pain self-management program" in sicklisted citizens with chronic musculoskeletal pain

Conditions: Musculoskeletal Pain

Summary: test the effect of "tailored physical activity" or "chronic pain self-management program" on returning to work in sicklisted citizens with chronic pain related to the spine or upper body

pain affects quality of life and it's important for the individual who experience chronic pain to find strategies to prevent or reduce pain. in some situations pain can't be reduced and the individual has to master pain by learning to live with it. pain can lead to a loss of functions which may change one's roles both in relation to the family as to colleagues, for example sick leave from work. limited evidence is available on the effects of interventions to sick-listed citizens with chronic musculoskeletal pain. this study test the effect of either "tailored physical activity or "chronic pain self-management program" on returning to work and the parameters pain, function and quality of life respectively on the body function and participation level of sick-listed people with chronic musculoskeletal pain related to columna and the upper body. citizens in dk-sønderborg municipality sick-listed for a maximum of 9 weeks will be invited. participants will be randomized for either tailored physical activity, "chronic pain self-management program" or reference group. primary endpoint is 3 months and 12 months follow-up.

Eligibility criteria:
inclusion criteria: * sick-listed with musculoskeletal pain related to columna or the upper body for a maximum period of 9 weeks in dk-sønderborg municipality

Keywords: sick-listed tailored physical activity patient education returning to work dk-sønderborg municipality columna upper body
investigation of novel and established therapies in a human intravenous lipopolysaccharide model of sepsis

Conditions: Sepsis; Fluid Overload; Endothelial Dysfunction; Microcirculation

Summary: sepsis is a common and life-threatening condition caused by a dysregulated host immune response to infection. given the prominent role of endothelial breakdown and dysfunction in sepsis, therefore, there is an urgent need to establish strategies to protect the endothelium and preserve microcirculatory function. this study is a randomised clinical study investigating intravenous fluid therapy and oral imatinib therapy in healthy human volunteers exposed to intravenous lipopolysaccharide (lps). the objective of the study is to investigate the biological effects of fluid and imatinib therapy on lps-induced microcirculatory dysfunction.

the benefits of intravenous fluid administration in sepsis remain uncertain. a growing body of evidence suggests that excessive fluid administration is harmful. an association between a more positive fluid balance and mortality in critically ill patients has been repeatedly demonstrated. moreover, emerging evidence suggests that intravenous fluid administration induces glycocalyx injury, thought to be mediated by shear stress. in sepsis the rapid administration of intravenous fluids is hypothesised to exacerbate glycocalyx injury, capillary leak and tissue oedema formation. recent work has highlighted the protective effects of imatinib, a tyrosine kinase inhibitor, on endothelial barrier function in animal models of microcirculatory dysfunction as well as in patients with endothelial barrier dysfunction. moreover, imatinib has also been demonstrated to attenuate markers of systemic inflammation in animals with a lps-induced lung injury model of acute respiratory distress syndrome. there is, therefore, a growing body of evidence to support a potential therapeutic role for imatinib in disease states involving inflammatory vascular leak. the hypothesis being tested is that: 1. intravenous fluid therapy will exacerbate the degree of vascular dysfunction and systemic inflammation observed in this model. 2. imatinib pre-treatment will attenuate the degree of vascular dysfunction and systemic inflammation observed in this model.

Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged between 18 and 40 years of age 2. informed consent to participate exclusion criteria: 1. current participation in a clinical trial 2. pregnant or breastfeeding 3. current history of smoking 4. alcohol intake \> 21 units per week 5. regular intake of any relevant prescription or over-the-counter medication. any regular medication use will be reviewed on a case-by-case basis as to (a) risk and (b) potential confounding effect. 6. oxygen saturation \<95% breathing room air 7. abnormal findings on history, examination or laboratory tests suggestive of underlying illness (in the opinion of the clinician undertaking screening) 8. history of recurrent vaso-vagal episodes 9. allergy to imatinib 10. positive or equivocal hepatitis b or c serology result

Keywords: intravenous fluid therapy imatinib
monocentric registry to investigate the role of platelet function, platelet genetics, proteomics and metabonomics in heart disease

Conditions: Cardiovascular Disease

Summary: molecular targets on platelets are pivotal for the development of new pharmacological substrates for platelet inhibition and to better understand the impact of platelet-mediated inflammatory processes for the progression of heart disease, such as coronary heart disease and chronic heart failure. previous investigations on the thienopyridine clopidogrel have underlined the importance of combined risk factor analysis. thus, clopidogrel´s prognostic efficacy relies on the combination of genetic factors (mainly polymorphisms of cyp2c19 encoding genes) and non-genetic factors, such as age, diabetes mellitus or concomitant drugs. therefore, a prospective patient cohort with exact phenotypic characterisation according to standardized protocols is necessary to enable the examination of the clinical relevance of potential molecular targets. a supplementary provision of high quality bio-material enables the systematic examination of new promising platelet-biomarkers in cardiovascular disease, which already have produced significant results on experimental animal and/or cell biologic models. primary objective of the central project is to establish a prospective cardiological cohort in the setting of a cardiovascular clinical research unit (ccru) with an affiliated biobank and thus to review the clinical significance of potential targets deriving from individual subprojects within the research group (german research council kfo 274/1-1) to safeguard a translational approach.


Eligibility criteria:
inclusion criteria: 1. patients with ischemic and non-ischemic heart disease 2. informed consent by patients or relatives in case of missing capacity to consent due to health status exclusion criteria: 1. patients \<18 years 2. missing informed consent

Keywords: molecular cardiology molecular epidemiology platelets cardiovascular disease
e3810-a001-313: efficacy and safety of 10 mg rabeprazole for treating heartburn in frequent sufferers

Conditions: Heartburn

Summary: the purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

this is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. the study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.

Eligibility criteria:
inclusion criteria: 1. male or female patients \> 18 years of age. 2. if female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. females of childbearing potential must have a negative serum pregnancy test before starting the study. 3. patients must report a history of heartburn at least two days per week over the past month. exclusion criteria: 1. history of erosive esophagitis verified by endoscopy. 2. history of gastroesophageal reflux disease (gerd) diagnosed by a physician. 3. patients who have a history of barrett's esophagus or esophageal stricture. 4. evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study. 5. patients who require continuous use of proton pump inhibitors, histamine receptor (h2) blockers, or prokinetics. prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. the h2 blocker, cimetidine (tagamet®), must be discontinued for at least seven days before the study drug is administered.
local anesthesia with lidocaine or articaine for molars affected by mih

Conditions: Molar Incisor Hypomineralisation

Summary: aims: comparison of injection pain with lidocaine and articaine in children with mih . comparison of the efficacy of lidocaine and articaine during treatment of mih molars. design: a randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old

background and aims: effectively achieving anesthesia is one of the difficulties a dentist faces when treating mih molar there are no studies comparing the effectiveness of lidocaine and articaine in mih molar design: a randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old each child will receive either lidocaine or articaine at their ﬁrst or second visit.

Eligibility criteria:
inclusion criteria: * absolute positive or positive behavior according to the frankel scale. * healthy, both physically and mentally. * do not take medications that interfere with the assessment of pain within 24 hours prior to treatment. * a child with a mih-affected mandibular permanent first molar on the right and left sides . exclusion criteria: * teeth with non-response pulpitis inflammation at the injection site. * allergy to the substances used in anesthesia. * presence of general or developmental medical conditions.

Keywords: the local anesthesia lidocaine 2% articaine 4% children mih molars.
nomogram for predicting difficult transoral and submental thyroidectomy

Conditions: Differentiated Thyroid Cancer

Summary: no prior studies have stratified the difficulty of transoral and submental thyroidectomy (toast). the investigators aimed to investigate preoperative factors as indicators of difficult toasts and to develop a predictive model accordingly.

thyroid cancer is the most common endocrine malignancy, with a female predominance. thyroidectomy is the main treatment for thyroid cancer, and considering the good prognosis of thyroid cancer, endoscopic thyroid surgery, which avoids neck incision, is being widely used in the clinic in order to improve the life treatment of patients. among them, endoscopic thyroidectomy with transoral approach has a shorter learning curve because of the short surgical path. however, due to the complex structure of the neck, small space, and rich blood supply of the thyroid gland, surrounded by parathyroid glands and important nerves, endoscopic thyroid is difficult and has a long learning curve. in addition, a series of complications such as haemorrhage, hypoparathyroidism and laryngeal reentrant nerve injury can seriously affect the quality of patient survival. difficult thyroidectomy is usually characterized by a long operative time, high intraoperative bleeding and a high incidence of postoperative complications. according to the literature, in open thyroid surgery, the degree of difficulty is associated with factors such as goiter, inflammation, and hyperthyroidism. however, the degree of difficulty of thyroidectomy due to various factors varies and is difficult to predict. surgical difficulty is closely related to the outcome and safety of thyroidectomy, which is an urgent concern for surgeons. and there is no study on the degree of difficulty of transoral and submental endoscopic thyroidectomy, therefore, there is an urgent need for an effective and objective method to determine the preoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in other hospitals.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of differentiated thyroid cancer with a maximum diameter not exceeding 4 cm * absence of suspicious lateral lymph nodes or distant metastases * participants with high cosmetic expectations * participants who underwent total thyroidectomy and central lymph node dissection. exclusion criteria: * participants with fusion or fixation of lymph nodes in the neck * participants with history of neck surgery or radiation * participants with vocal fold fixation by preoperative fibrolaryngoscope * participants with preoperative examination suggestive of extrathyroidal invasion * participants with a significantly restricted neck

Keywords: differentiated thyroid cancer transoral and submental thyroidectomy surgical difficulty