Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in egyptian patients with liver cirrhosis

Conditions: Hepatic Encephalopathy

Summary: this is a pilot study designed to evaluate the efficacy and safety of nifuroxazide in the treatment of hepatic encephalopathy in patients with grade ii-iii hepatic encephalopathy

hepatic encephalopathy (he) is a central nervous system dysfunction caused by liver insufficiency and/or portosystemic shunting, manifesting as a wide spectrum of neurological or psychiatric abnormalities characterized by alteration of cognitive and motor function. the pathogenesis of hepatic encephalopathy is believed to be due to increased nitrogenous substances, primarily ammonia, in the blood. the treatment goal is to reduce nitrogen load from the gi tract and to improve central nervous system (cns) status. treatment options include lactulose administered orally and non-absorbable antibiotics. lactulose is nonabsorbable disaccharides that is currently used as first line agents for the treatment of he. its action is thought to be due to colonic metabolism of lactulose to lactic acid results in acidification of the gut lumen. this favors conversion of ammonium (nh4) to ammonia (nh3) and the passage of ammonia from tissues into the lumen. gut acidification inhibits ammoniagenic coliform bacteria, leading to increased levels of nonammoniagenic lactobacilli. lactulose also works as a cathartic, reducing colonic bacterial load. nifuroxazide is an oral broad-spectrum nitrofuran antibiotic that is commonly used as an intestinal anti-infective agent. it is active against the majority of intestinal bacteria: gram-positive (staphylococcus family) and gram-negative (enterobacteriaceae family: escherichia, citrobacter, enterobacter, klebsiella, salmonella, shigella, yersinia) and is therefore expected to decrease ammonia production and to reverse the symptoms of he.

Eligibility criteria:
inclusion criteria: * patients suffering from liver cirrhosis aging above 18 years who will be admitted to hospital with neuropsychiatric condition suggestive of hepatic encephalopathy (grade ii or iii) confirmed by their known previous hepatic disease by history, clinical examination and laboratory investigations in the form of hyperammonemia with model for end-stage liver disease (meld) score ≤ 25 and patients are able to swallow. exclusion criteria: * patients with neurological or communication problems. * degenerative central nervous system (cns) disease. * any significant psychiatric illness. * patients with previous intake of nifuroxazide and rifaximin within the last month. * presence of underlying renal impairment (serum creatinine ≥ 2 mg/dl). * alcohol consumption within prior 4 weeks. * non-hepatic metabolic encephalopathy. * anemia with hemoglobin level \< 7 g/dl.

Keywords: clinical hepatic encephalopathy staging scale hepatic encephalopathy nifuroxazide
in-patient study in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2

Summary: this study is a placebo-controlled study in both healthy normal subjects and patients with type 2 diabetes mellitus to assess the levels of exenatide in the bloodstream when it is given for 7 days, and to assess the impact this medication has on various substances in the blood. assessments include repeat blood sampling and monitoring of any side effects.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus that has been diagnosed for at least three months * must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea * must be willing to wash-out of these medications for 14 days prior to the start of the study * must have bloodwork that meets certain criteria (for example, total cholesterol \< 240 mg/dl) exclusion criteria: * must not have any other major illness other than diabetes

Keywords: exenatide pharmacokinetics pharmacodynamics
the immersive experience of virtual reality during chemotherapy in patients with early breast and gynecological cancers: the patient's dream study

Conditions: Breast Cancer

Summary: "patient's dream" study is a two-arm randomized controlled trial that will be conducted at regina elena national cancer institute, irccs (rome), from april 2019 to january 2020. before starting the first course of chemotherapy, patients will be randomly divided to receive the vre (vre arm) as "distraction therapy", or to entertain themselves with conventional means such as listening to music, watching a mobile program, reading newspapers, books, magazines or also doing nothing, according to the patient's preferences and for the entire duration of administration of the first ct cycle (control arm). a clinical team composed of three oncologists, three psychologists, one nurse and one expert vr operator will support the patients involved in the study. the primary aims were the assessment of psychological distress, anxiety and quality of life between the two study arms. secondary endpoints were the perceived time during the first course of ct and the acute and late toxicity. the study will conduct in accordance with the ethical standards as laid down in the declaration of helsinki and its later amendments and within the protocol approved by the central ethics committee (trial registration number: rs 1105/18). a written informed consent will obtain from all participants included in the study.


Eligibility criteria:
inclusion criteria * diagnosis of breast or ovarian cancer confirmed histologically, from i to iii stage; * surgery as first therapeutic approach (in case of ovarian cancer, patients with minimal residual disease after surgery will be also included) * first cycle of adjuvant ct, with or without a biological treatment according to the specific cancer (regimens including anthracyclines/taxanes, anthracyclines/cyclophosphamide, carboplatinum/taxane combined or not with trastuzumab for breast cancer, carboplatin/paclitaxel combined or not with bevacizumab for ovarian cancer); * aged ≥ 18 years; * performance status (ecog) 0-2; * life expectancy \> 12 months; * ability to understand and sign the informed consent. exclusion criteria: * presenting prior history of seizures; * disorders of the mood; * previous history of alcohol and/or drug addiction; * disorder of vision and eyes; * history of psychiatric pathologies.

Keywords: breast cancer virtual reality supportive care
gingival augmentation and root coverage with superficial and deep cut acellular dermal matrices

Conditions: Gingival Recession

Summary: this entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. patients needing root coverage for gingival recession will be enrolled.

each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. no risk or benefit is expected from being assigned to either group as both procedures are both standard care. in both groups, a commercially available allograft (adm-d or adm-s) will be used. allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes. grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. when recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. this material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. the study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.

Eligibility criteria:
inclusion criteria: * patients between age 18 and 89 * patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth) * patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report. * female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential. exclusion criteria: * patients who disclose that they will not be able to cooperate with the follow-up schedule. * patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * pregnant women or women intending to become pregnant during study period. * smokers who smoke \> 10 cigarettes per day

Keywords: gingival augmentation graft materials acellular dermal matrix (adm) subepithelial connective tissue graft (sctg)
relationship between gut microbiome, probiotics, and mild cognitive impairment

Conditions: Mild Cognitive Impairment (MCI)

Summary: this study is to evaluate whether the consumption of probiotics can improve the symptoms of patients with mild cognitive impairment; also evaluate the effects of probiotics on patients' blood, oxidation and stress related indicators.

mild cognitive impairment (mci) is the stage between the expected cognitive decline of normal aging and the more serious decline of dementia. it can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. probiotics are regarded as active microorganisms. when consumed in sufficient amounts, participants can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body, and may produce host health, including delaying disease and regulating metabolic disease progression and prevent complications.

Eligibility criteria:
inclusion criteria: 1. patients who is suffering from mild cognitive impairment. 2. clinical dementia rating (cdr) 0.5. 3. age 40-80 and willing to sign the informed consent. 4. education level is above the junior high school level. 5. healthy control who is eligible judged by pi. exclusion criteria: 1. patients on antibiotics within the preceding one month. 2. patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks. 3. have undergone surgery of liver, bladder, or gastrointestinal tract. 4. have current or history of inflammatory bowel disease. 5. have history of cancer. 6. known allergy to probiotics. 7. dementia (mmse ≤ 23). 8. cognitive impairment caused by head injury. 9. history of cerebral apocalypse. 10. other possible diseases may cause cognitive impairment, such as: parkinson's disease, cervical mass, hydrocephalus or epilepsy. 11. severely depressed patients (sick person health questionnaire-9 (phq-9) ≥ 20). 12. severe anxiety patients (generalized anxiety dosorder 7-item (gad-7) ≧ 15). 13. undergoing medication treatment for acute illness, organic psychosis or diagnosed as psychiatric illness within 3 months or poor control of chronic psychiatric illness. 14. undergoing parenteral nutrition. 15. not eligible judged by pi.
thiamine intervention and coronary artery bypass grafting

Conditions: Coronary Heart Disease; Coronary Artery Bypass Grafting

Summary: the purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (chd) patients undergoing coronary artery bypass grafting (cabg) and whether a low-cost thiamine intervention can be used to reduce post-cabg cognitive issues in chd subjects.

using a two-group, double-blind randomized, longitudinal study design, 52 coronary heart disease (chd) patients undergoing coronary artery bypass grafting (cabg) (ages 60-80 years; 26 thiamine treatment and 26 placebo) will participate in cognitive assessment and evaluation of blood thiamine, lactate, and inflammatory marker levels. the investigators propose that thiamine infusion will help in reducing lactate and inflammatory marker levels, as observed in other conditions. the findings from this study might serve as a novel and innovative treatment strategy for protection against declining cognition, and hence better outcomes, and improved quality of life and daily activities. this clinical trial study will provide required data regarding the benefits of a low-cost thiamine intervention that could be implemented on a large-scale clinical trial to reduce post-cabg cognitive deficits in older chd, and thus, decrease early dementia, improve social function, increase quality of life and daily activities, and reduce healthcare costs in this serious older chd patient population.

Eligibility criteria:
inclusion criteria: * patients with coronary heart disease (chd) scheduled for bypass grafting (cabg) * thiamine deficiency before cabg * european system for cardiac operative risk evaluation ii (euroscore ii) \>1.5% * off-pump surgery exclusion criteria: * dementia at baseline \[montreal cognitive assessment (moca) \<21 within 5 days before cabg\] * current in-take of thiamine * known thiamine allergy * uncontrolled blood glucose levels * unable to give consent due to illness * history of hyperlactatemia * recent (within several years and/or up to the judgment of the pi/co-pis) cerebral incidents (seizure or head trauma resulting in loss of consciousness and/or concussion) * stroke * diagnosed psychiatric diseases (clinical depression, schizophrenia, manic-depression) * patients with history of alcohol or substance abuse * acute or chronic infections (tuberculosis, hepatitis, or encephalopathy) * diagnosed neuro-degenerative diseases (alzheimer's or parkinson's disease) * chronic immunodeficiency (including hiv) * congenital brain deficits will also be excluded

Keywords: thiamine intervention
an open-label, comparative study of the efficacy, safety and pharmacodynamics of single dose of anb-002 in patients with hemophilia b

Conditions: Hemophilia B

Summary: the aim of the study is to demonstrate non-inferiority of anb-002 compared with preventive use of coagulation factor ix (fix) in adult subjects with hemophilia b with fix activity ≤2% and without fix inhibitor. the study will have an open-label single-arm design.

after signing the icf and screening examination the subjects are to be included in the non-interventional lead-in period in which the subject will receive standard fix prevention. the lead-in period will last for at least 6 month for every subject. after completiong the lead-in period subjects will enter the main (interventional) period. at the first visit of the main period subjects will recieve investigational product anb-002. the main period ends 18 months after the administration of anb-002, after which subjects will switch to the follow-up period and will be evaluated up to 5 years after the anb-002 infusion.

Eligibility criteria:
inclusion criteria: * men diagnosed with hemophilia b aged 18 or older * fix activity ≤2% * absense of fix inhibitor * ≥150 previous exposure days of treatment with fix concentrates exclusion criteria: * any diseases of blood and hematopoietic organs other than hemophilia b * a history of any gene therapy, including anb-002 * diagnosed hiv-infection, not controlled with anti-viral therapy * active hbv or hcv infection * anti-aav5 antibodies * any active systemic infections or recurrent infections requiring systemic therapy * any other disorders associated with severe immunodeficiency * relevant hepatic disorders or conditions that can be a symptom of existing liver disorder * malignancies with less than 5 years of remission
correlations between lens star and phacoemulsification.

Conditions: Cataract; Lens Diseases; Lens Opacities

Summary: to assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.

to analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.

Eligibility criteria:
inclusion criteria: * patients that will undergone phacoemulsification for their mild to moderate senile cataracts. exclusion criteria: * congenital and developmental cataract. * cases with congenital lens anomalies as ectopia lentis and spheophakia.

Keywords: cataract
phase ii study of lactulose and circadian rhythms in patients with cirrhosis

Conditions: Portal Hypertension; Hepatic Encephalopathy; Cirrhosis

Summary: objectives: i. assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. ii. assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. iii. assess which elements of the neuropsychological test battery show the response to lactulose.

protocol outline: patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks. a dietician advises patients on a 1 g/kg per day protein diet. the lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting --prior/concurrent therapy-- * no concurrent therapy for hepatic encephalopathy --patient characteristics-- * age: under 65 * performance status: not specified * hematopoietic: not specified * hepatic: see disease characteristics * renal: not specified * other: no alcohol intake within 1 month prior to entry no requirement for beta blockers no requirement for corticosteroids not in intercontinental travel

Keywords: cardiovascular and respiratory diseases cirrhosis gastrointestinal disorders hypertensive disorder portal hypertension rare disease
management standard of bone marrow infusion in acute and critical patients

Conditions: Emergency Patients

Summary: as the spike in the number and severity of patients with critical patients, then quickly effective transfusion treatment demand becomes more and more serious, and the pattern of infusion pathways have traditionally used already can not adapt to this change, therefore, an urgent need to establish a set of is in line with international standards and accord with the situation of our country is simple, effective and scientific accuracy of io management solution. in order to ensure the safety of the treatment of acute and critical patients, and in the province and even domestic experts recognized and promoted the application.

1. investigate the current situation of infusion treatment for critical and critical patients in two hospitals in the province, the cognition of medical staff in critical and critical units on io, io training and assessment, and continuous quality improvement, etc. a comprehensive understanding of the needs of medical staff in the acute critical care unit for the refined io management standard, including the analysis of the application of the standard in some hospitals. 2. clarify and refine the contents of relevant indexes of io management standards to form a standardized, scientific, unified and simple way to quickly judge difficult vessels. defining the appropriate infusion access, infusion tool, puncture site, infusion speed, infusion effect, patient outcome, complications, indications, contraindication, infusion risk management, relevant personnel training and assessment, and continuous quality improvement as indexes. 3. on the basis of the standards of existing guidelines, a reasonable observation time range and the number of puncture times consistent with the first infusion puncture were established.

Eligibility criteria:
inclusion criteria: * 1.emergency medical staffmore than two years of critical work experience 2.volunteer to participate in research exclusion criteria: * patients who have neurological disease

Keywords: acute and critically ill patients intraosseous infusion management standards
influence of tonic and burst transcranial magnetic stimulation (tms) characteristics on acute inhibition of subjective tinnitus

Conditions: Tinnitus

Summary: transcranial magnetic stimulation (tms) is already broadly used in different areas of neuroscience research. last year, special attention was drawn to tms in tinnitus. the aim of the researchers' study is to investigate the stimulation characteristics of tms in tinnitus patients, in particularly the effect of tonic and burst stimulation of the superior temporal lobe.


Eligibility criteria:
inclusion criteria: * patients presented to our multidisciplinary tinnitus clinic with tinnitus as a main complaint. exclusion criteria: * patients with known history of epilepsy, pacemakers, cochlear implants, neurostimulators or intracerebral pathology were excluded from the study.
product performance of a toric contact lens

Conditions: Myopia; Astigmatism

Summary: product performance of a bausch \& lomb toric contact lens compared to ciba vision focus daily toric contact lens


Eligibility criteria:
inclusion criteria: * subject is an adapted soft contact lens wearer with astigmatism of 0.50 diopter or greater * visual acuity (va) correctable to 0.3 logmar or better (driving vision) * clear central cornea exclusion criteria: * systemic disease affecting ocular health * using systemic or topical medications * wears monovision or multifocal contact lenses * any grade 2 or greater slit lamp findings * adapted wearer of ciba focus dailies toric lens upon study entry
glycemic holter study (continuous glucose monitoring) -

Conditions: Type 2 Diabetes Mellitus

Summary: the study will assess glycemic variability and optimized glycemic control in t2dm patients treated with a dpp-4 inhibitor as add-on therapy to metformin.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (dm) willing to perform smbg at least 6 times daily to use the minimed cgms for up to 3 consecutive days on 2 occasions. * hba1c: 6.5 to 9% with metformin monotherapy for a least 3 months exclusion criteria: * age \>= 80 years * bmi \ =40 kg/m2 * secondary t2 dm * hepatic failure, asat/alat\>3 uln, and moderate/severe renal failure (ci \< 50 ml/min) chf iii \& iv other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus, vildagliptin, continuous glucose monitoring