Kornimate/medical-research-clean huggingface dataset:
prevention of postoperative ventral hernias

Conditions: Gangrenous Postoperative Ventral Hernia (Diagnosis); Dehiscence of Laparotomy Wound

Summary: the research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.

at the first stage, an analysis of the prevalence of postoperative ventral hernias in patients after median laparotomies in urgent surgery will be performed, with the identification of factors contributing to the development of postoperative ventral hernias. at the next stage, the investigators will search for the most reliable methods of suturing the white line of the abdomen, taking into account the risk of hernia formation, with their implementation in patients operated in an emergency through median laparotomic access in comparison with traditionally used methods. in conclusion, an algorithm will be developed for selecting the method of surgical prevention of postoperative ventral hernias, taking into account the risk of their development.

Eligibility criteria:
inclusion criteria: 1. patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis. 2. patients who have signed an informed consent to participate in the study, after the purpose and meaning of the study have been explained to them. 3. patients who follow the doctor's instructions. exclusion criteria: 1. the death of the patient. 2. stage iv cancer 3. hernia repair with hernioplasty, including simultaneous surgery 4. refusal of the patient to cooperate with the researcher.

Keywords: postoperative ventral hernia eventrat defects of the fascia laparotomic wound suture preventive prosthetics of a laparotomic wound
drug-drug interaction study (ckd-501, ketoconazole)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the effect of ketoconazole on the pharmacokinetic characteristics of ckd-501 in healthy subject.

from day 1 to day 5, ketoconazole 200mg is administered twice daily to group 1 patients during period 1. then on day 5,ckd-501 0.5mg is co-administered group 1 patients at period 1. after 28 day-break, period 2 will ckd-501 0.5mg administered on day 5. period 2 will not ketoconazole administered. group 2 is administered in reverse order.

Eligibility criteria:
inclusion criteria: * between 20 aged and 45 years old in healthy males * 18.5 ≤ ibw \< 25 * agreement with written informed consent exclusion criteria: * hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party * medication with drug-mediated induction/inhibition metabolic enzyme such as midazolam within 1 month or with may affect the clinical trial * subject has taken abnormal meals which affects the adme of drug * subject has a history(such as gastric or duodenal ulcer, gastrointestinal surgical histories except for an appendectomy) affects the adme of drug * substance abuse, or a history of drug abuse showed a positive for the party * continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials * previously participated in other trial within 60 days * previously donate whole blood within 60 days or component blood within 30 days * inadequate subject by medical examination(medical history, physical examination, ecg, laboratory test) within 28 days of starting administration of investigational drug * sbp \>140 mmhg, sbp \ 90 mmhg, dbp \ 100 per/min, pulse \< 50 per/min * 12-lead ecg, qtc \> 450 msec * an impossible one who participates in clinical trial by investigator's decision including laboratory test result

Keywords: drug-drug interaction between the ckd-501 and ketoconazole
a therapeutic equivalence study of two metronidazole 1%topical gel treatments for patients with rosacea

Conditions: Rosacea

Summary: the objective of this study is to demonstrate that metronidazole 1% topical gel is effective for the treatment of patients with moderate to severe rosacea.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-lactating female, 18 years of age or older. 2. signed informed consent form, which meets all criteria of current fda regulations. 3. if female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, iud, oral, transdermal, injected or implanted hormonal contraceptives). 4. have moderate to severe facial rosacea. 5. have a baseline investigator global evaluation score of 3 or 4. exclusion criteria: 1. mild facial rosacea (less than 8 inflammatory lesions on the face) or very severe rosacea (more than 50 inflammatory lesions) 2. patients with excessive facial hair (beards, sideburns, moustaches, etc.) that would interfere with the diagnosis or assessment of rosacea. 3. history of hypersensitivity or allergy to metronidazole, or other ingredients of the formulation. 4. use of oral retinoids (e.g. accutane ®) or therapeutic vitamin a supplements of greater than 10,000 units/day (multivitamins are allowed) within the 6 months prior to the baseline visit. 5. use of the following within 1 month prior to the baseline visit: * topical retinoids to the face * systemic antibiotics known to have an impact on the severity of facial rosacea * systemic steroids 6. the use of anticoagulant therapy within 14 days prior to baseline. 7. the use of any antipruritics, including antihistamines within 24 hours of any study visits. 8. history of blood dyscrasia. 9. ocular rosacea (e.g., conjunctivitis, blepharitis, keratitis) of sufficient severity to require topical or systemic antibiotics. 10. any dermatological condition other than rosacea that in the investigator's opinion may interfere with the evaluation of the patient's rosacea (e.g., acne, psoriasis, dermatitis). 11. females who are pregnant, lactating or likely to become pregnant during the study. 12. significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the investigator's opinion would place the study patient at undue risk by participation. 13. any patient (male or female) who has started, or changed hormonal therapy within 3 months of the baseline visit (this includes hormonal contraceptives). 14. use of high strength (20% or above) alpha-hydroxy acid for facial peel or any type of chemical facial skin peel or other significant cosmetic procedures within 2 months of the study start. 15. receipt of any drug as part of a research study within 30 days prior to dosing. 16. employees of the research center or investigator. 17. previous participation in this study.
excimer laser trabeculostomy glaucoma treatment study

Conditions: Glaucoma, Primary Open Angle

Summary: evaluation of the safety and effectiveness of the elios system procedure to reduce intraocular pressure (iop) in adult subjects with mild to moderate primary open-angle glaucoma (poag) undergoing cataract surgery


Eligibility criteria:
inclusion criteria: * diagnosis of mild to moderate poag * operable cataract, eligible for phacoemulsification with a bcva of 20/40 or worse * medicated iop of \<=24 mmhg * unmedicated diurnal iop of \>=22 mmhg and \<=34 mmhg * shaffer angle grade of iii or iv * cd ratio \<=0.8 * at least 45 years old exclusion criteria: * closed-angle and secondary glaucomas * prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * cannot undergo medication washout in the study eye * diagnosis of degenerative visual disorders * non-study eye with bcva worse than 20/80 * known corticosteroid responder * pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
effect of bile acids and bile acid sequstrants on glp-1 secretion after roux-en-y gastric bypass

Conditions: Severe Obesity

Summary: the purpose of this study is to examine the efffects of bile acid and bile acids sequestrants on glp-1 secretion, in patients after roux-en-y gastric bypass.


Eligibility criteria:
inclusion criteria: * uncomplicated rygb performed minimum 3 months prior to the study. * fasting glucose \< 7,0 mm, hba1c \< 48 mmol/mol 3 months after rygb exclusion criteria: * fasting plasma glucose \> 7,0 mm, hba1c \> 48 mmol/mol 3 months after rygb * dysregulated thyroid diseases, use of antithyroid treatment. * late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis. * complications to rygb. documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake) * cholecystectomy.
amiodarone or verapamil in covid-19 hospitalized patients with symptoms

Conditions: COVID-19

Summary: there is an urgent need for effective therapies against the novel covid-19 virus. studies have shown that amiodarone and verapamil can interfere with coronavirus entry and amplification by blocking ion channels. recovery-sirio is a randomized study to investigate amiodarone or verapamil compared with usual care in symptomatic patients hospitalized with confirmed covid-19 infection.


Eligibility criteria:
inclusion criteria: hospitalized patients with confirmed covid-19 infection and symptoms, with an oxygenation index defined as quotient of partial pressure of oxygen in arterial blood (pao2, in mmhg) and fraction of inspired oxygen (fio2) \> 200. exclusion criteria: * acute respiratory distress syndrome (ards) * contraindications for or known hypersensitivity to amiodarone or calcium channel blockers * long qt syndrome * prolonged baseline qtc interval (≥450 ms). * cardiogenic shock or severe hypotension (sbp\< 90 mmhg) * severe left ventricle dysfunction (left ventricular ejection fraction ≤35%) * severe sinus - node dysfunction with marked sinus bradycardia * 2nd/3rd degree heart block * bradycardia without pacemaker that has caused syncope * history of severe dysthyroidism * a-fib/flutter conducted via accessory pathway (ie,wolff -parkinson-white)
natural antioxidant ice-cream, oxidative stress and vascular function

Conditions: Vascular System Injuries

Summary: formation of reactive oxygen species (ros) contributes to pathogenesis and progression of several diseases. polyphenols, have been shown to be beneficial against ros. this study evaluate the effects of a natural antioxidant ice-cream,rich in polyphenols, on oxidative stress, vascular function and physical performance. in this controlled, single-blind cross-over study, 14 healthy subjects were randomized to assume 100 mg of antioxidant ice-cream consisting of dark cocoa powder, extract of hazelnut and green tea, or milk chocolate ice-cream (control ice-cream). subjects were studied at baseline and two hours after the ingestion of the ice-creams. serum polyphenols, antioxidant status (ferric reducing ability of plasma, frap), no bioavailability (nox), markers of oxidative stress (d-roms and h2o2), endothelium function (fmd and rhi) and exercise tolerance (stress test) with measurement of the double product were assessed.

14 healthy, non-smoking, volunteers (7 males ), aged between 20 and 40 years were enrolled. the study was randomized, placebo-controlled. after enrollment, 3 days before entering the study, all subjects performed an exercise stress test. they were then randomly allocated to the treatment sequence with 100 mg of natural anti-oxidant ice cream or milk chocolate ice-cream (control icecream) in a cross-over single-blind design. there was 1 week wash-out between 2 phases of the study. markers of oxidative stress (d-roms and h2o2); serum antioxidant status (frap), no bioavailability (nox), the endothelium flow-mediated vasodilation (fmd and the rhi by endopat 2000) were evaluated in fasting condition at baseline (time 0) and 2 hours after the ingestion of the anti-oxidant or control ice-creams. the exercise stress test was performed before randomization and 2 hours after each ice-cream meal test. in both experiments, the ice-cream was consumed within 10 min. each subject was asked to refrain from any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, such cocoa-containing products, red wine, tea within the previously 2 weeks. all participants gave written informed consent, and the study was approved by the medical ethics committee of la sapienza university of rome (rif: 3727, prot: 2325/15).

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, volunteers exclusion criteria: * assumption of any kind of medication, diet integrators, intensive physical activity and to avoid consumption of polyphenols rich foods, tea within the previously 2 weeks.
evaluate safety, efficacy and pharmacokinetics

Conditions: Metastatic Breast Cancer

Summary: the purpose of the study is to demonstrate equivalent pharmacokinetics (pk)

patients will receive ct-p6 or herceptin.

Eligibility criteria:
inclusion criteria: * are females * have a her 2 over-expression * have eastern cooperative oncology group (ecog) 0 or 1 exclusion criteria: * current clinical or radiographic evidence central nervous system (cns) metastases * current known infection * pregnant or nursing mother

Keywords: herceptin her 2-positive metastatic breast cancer ct-p6
ph metry study to compare the antacid activity of z0063 versus gaviscon double action tablets, in healthy adult subjects

Conditions: Gastroesophageal Reflux Disease

Summary: primary objective: pharmacodynamics: assessment by ph metry of the change in gastric ph (antacid activity) of z0063, in comparison to the effect of gaviscon double action tablets, in healthy adult subjects. secondary objective: safety: assessment of the clinical safety of z0063, and gaviscon double action tablets, in healthy adult subjects.

the maximal total study duration per subject is 5 weeks and 1 day.

Eligibility criteria:
inclusion criteria : * male or female subjects, between 18 and 55 years of age, inclusive. * body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 28.0 kg/m2, inclusive. * certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination). * normal vital signs, electrocardiogram (ecg) and laboratory parameters. * subject has to accept a gastric probe. exclusion criteria: * any history or presence of clinically relevant abnormalities at screening which could interfere with the objectives of the study or the safety of the subject's participation. * blood donation, any volume, within 2 months before inclusion. * history or presence of drug or alcohol abuse. * smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during the study. * if female, pregnancy (defined as positive beta-human chorionic gonadotropin \[β-hcg\] blood test), breast-feeding. * any medication (including st john's wort) within 14 days before inclusion, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. * any subject in the exclusion period of a previous study according to applicable regulations. * any subject who cannot be contacted in case of emergency. * positive result on any of the following tests: hepatitis b surface (hbs ag) antigen, anti-hepatitis c virus (anti-hcv) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti-hiv2 ab). * positive result on urine drug screen. * positive alcohol breath test. * known hypersensitive to alginates, products or formulation excipients, and/or to any component of the standardized meal. * any subject with difficulty in chewing and swallowing. * any subject with strong gag reflex. * any intake of aluminium and magnesium containing antacids or other alginate-containing medicinal products within 14 days before inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluation of alirocumab in addition to lipid-modifying therapy in patients with high cardiovascular risk and hypercholesterolemia in south korea and taiwan

Conditions: Hypercholesterolemia

Summary: primary objective: to demonstrate the reduction of low-density lipoprotein cholesterol (ldl-c) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (lmt) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in south korea and taiwan. secondary objectives: * to evaluate the effect of alirocumab in comparison with placebo on ldl-c after 12 weeks of treatment. * to evaluate the effect of alirocumab on other lipid parameters: apolipoprotein b (apo b), non high-density lipoprotein cholesterol (non-hdl-c), total cholesterol (tc), lipoprotein (a) (lp \[a\]), high-density lipoprotein cholesterol (hdl-c), triglycerides (tgs), and apolipoprotein a-1 (apo a-1). * to evaluate the safety and tolerability of alirocumab. * to evaluate the development of anti-alirocumab antibodies (ada).

the maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks follow-up period.

Eligibility criteria:
inclusion criteria: participants with hypercholesterolemia and established coronary heart disease (chd) or chd risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other lmt, both at stable dose for at least 4 weeks prior to screening visit (week -3). exclusion criteria: * aged \<18 years or legal age of adulthood, whichever was greater. * participants without established chd or chd risk equivalent. * ldl-c \<70 mg/dl (\<1.81 mmol/l) in participants with a history of documented cardiovascular disease. * ldl-c \<100 mg/dl (\<2.59 mmol/l) in participants without a history of documented cardiovascular disease. * not on a stable dose of lmt (including statin) for at least 4 weeks prior to the screening visit (week -3) or between screening to randomization visits. * currently taking a statin other than atorvastatin, rosuvastatin or simvastatin. * atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose. * daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg. * fasting serum triglycerides \>400 mg/dl (\>4.52 mmol/l) at the screening period. the above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
effect of enteral formula (commercial vs. homemade) on muscle mass in trauma brain injury

Conditions: TBI Traumatic Brain Injury; Enteral Nutrition Therapy; Critical Illness

Summary: this randomized controlled clinical trial aims to determine whether there are differences in muscle mass (mm) in patients with traumatic brain injury who receive enteral nutrition based on polymeric formulas (homemade formula with blended natural foods versus commercial formulas).

patients admitted to the intensive care unit (icu) with traumatic brain injury (tbi) lose mm, especially during the first ten days because it's used for organic, immune and tissue repair functions; the patients with moderate or severe tbi are frequently unable to eat food by themselves, so they receive enteral nutrition support (ns) with polymeric formulas. this support has been shown to attenuate muscle loss. polymeric formulas can be industrially formulated or made with natural food, but there is no information available on their effect on mm using indicators such as femoral muscle thickness (femoral thickness, rectus femoris and vastus intermedius) by ultrasound (us) and phase angle (pha) obtained by bioimpedance (bia), as well as gastrointestinal tolerance (git).

Eligibility criteria:
inclusion criteria: * age: ≥ 18 years - 65 years * sex: both sexes * moderate/severe tbi (glasgow \<13 points) admitted to the icu * invasive mechanical ventilation \>48 hours * candidates for enteral nutrition via nasogastric/orogastric tube exclusion criteria: * pregnant women * patients with pacemakers * food allergies: egg, chicken, fish, nuts, or lactose intolerance * brain death * limb amputation or presence of external limb fixators elimination criteria: * withdrawal of consent * transfer to another healthcare institution.

Keywords: trauma brain injury enteral nutrition critically ill muscle loss
panobinostat in combination with carfilzomib and dexamethasone in relapsed or relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to investigate the anti-myeloma effect of panobinostat given at two different doses (10 mg and 20 mg oral) in combination with carfilzomib (20/56 mg/m2 i.v.) and low dose dexamethasone (20 mg oral) vs carfilzomib plus low-dose dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. safety and efficacy will be evaluated. treatment will be administered in 4-week cycles until patients discontinue due to disease progression or unacceptable toxicity or for other reasons. patients who discontinue the study treatment for reasons other than documented disease progression will be followed for disease assessments every 8 weeks until progression. all patients will be followed for survival until 3 years have passed from their entry into the study, or they have discontinued the follow up earlier.


Eligibility criteria:
inclusion criteria: * previous diagnosis of mm based on imwg definitions (rajkumar, 2014) * prior treatment with 1 to 3 prior lines of therapy * relapsed or relapsed and refractory mm * measureable disease at screening based on central laboratory assessment * ecog performance status ≤ 2 * acceptable lab values prior to starting study treatment exclusion criteria: * primary refractory myeloma * prior treatment with dac inhibitors including panobinostat * prior treatment with carfilzomib * allogeneic stem cell transplant recipient with graft versus host disease (either active or requiring immunosuppression) * any concomitant anti-cancer therapy besides the study treatment (bisphosphonates are permitted only if commenced prior to the start of screening period) * intolerance to dexamethasone or contraindication to carfilzomib or dexamethasone * unresolved diarrhea ≥ ctcae grade 2 or a medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple myeloma mm relapsed relapsed and refractory panobinostat lbh589 histone deacetylase inhibitor carfilzomib proteasome inhibitor