Kornimate/medical-research-clean huggingface dataset:
somatostatin in living donor liver transplantation

Conditions: End Stage Liver DIsease; Portal Hypertension

Summary: aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (esld) and clinically significant portal hypertension (csph) undergoing adult-to-adult living donor liver transplantation (a2aldlt).

in liver transplantation (lt) portal hyperperfusion can severely impair graft function and survival, mainly in cases of partial lt. perioperative somatostatin infusion has been shown to be safe, to reduce the hepatic vein to portal vein gradients and to preserve the arterial inflow to the graft in whole liver transplantation. in partial grafts, the pharmacological action of somatostatin could reduce the graft damage due to portal hyperperfusion and arterial hypoperfusion, reducing the incidence of small-for-size syndrome and graft loss and improving the patients survival. objective of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (esld) and clinically significant portal hypertension (csph) undergoing adult-to-adult living donor liver transplantation (a2aldlt). fifty-six patients undergoing a2aldlt for esld and csph will be randomized double-blindly to receive somatostatin or placebo (1:1). the study drug will be administered intraoperatively as 5ml bolus (somatostatin: 500 μg), followed by a 2.5 ml/hour infusion (somatostatin: 250 μg/hour) for 10 days. hepatic and systemic hemodynamic will be measured, along with liver function tests and clinical outcomes. the ischemia-reperfusion injury (iri) will be analysed through histological and protein expression analysis. the primary endpoint of the study will be the portal vein flow reduction measured at the end of liver transplant. secondary end-points will be the reduction in the portal vein pressure, the rate of patients requiring surgical inflow modulation, the incidence of small for size syndrome, the severity of the ischemia reperfusion injury, the need for early re-transplantation (6 months), the incidence of adverse and serious adverse events, the 90-day mortality. this randomized controlled trial could be the first to show the efficacy of somatostatin as modulator of the graft inflow in living-donor liver transplantation and potential improvement in graft and patient survival.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years old) undergoing adult-to-adult living donor liver transplantation (ldlt) (right or left lobe) * indication for ldlt: end stage liver disease with portal hypertension (hvpg ≥ 10mmhg) exclusion criteria: * complete portal vein thrombosis (pre-operative or intraoperative diagnosis) * hepatopulmonary hypertension * adult-to-adult living donor liver transplantation for fulminant hepatic failure * recipients of multiple solid organ transplants * history of cardiac arrhythmias

Keywords: adult-to-adult living donor liver transplantation small-for-size syndrome graft hyperperfusion
sulphate accumulation in prostate

Conditions: Prostate Cancer

Summary: this study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. preliminary data from ongoing intervention trials carried out at the ifr suggest that dietary changes can directly influence the metabolic profile of prostate tissue. the most significant result observed to date is that of sulphate accumulation within the prostate. the additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from atp. a significant rise in levels of both adp and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular atp. interestingly, the data indicate that the extent of adp accumulation is negatively correlated with prostate cancer progression. the investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and adp in prostate tissue. a potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (pten) will also be investigated. furthermore, the investigators aim to determine whether the accumulation of sulphate and adp is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.

Eligibility criteria:
inclusion criteria: * males * scheduled for tpb as part of routine investigation or staging for prostate cancer * aged 18-80 years * bmi between 19.5 and 35 kg/m2 * smokers and non-smokers exclusion criteria: * those regularly taking 5α-reductase inhibitors or testosterone replacement medicines * those on warfarin treatment * those diagnosed with diabetes * those diagnosed with or suspected to be high-risk for human immunodeficiency virus (hiv) and/or hepatitis * those allergic to any of the ingredients of the broccoli soups * those taking dietary supplements or herbal remedies which may affect the study outcome. please note that some supplements may not affect the study and this will be assessed on an individual basis * those that are unable to understand english or give informed consent * parallel participation in another research project that involves dietary intervention * any person related to or living with any member of the study team

Keywords: prostate sulphate atp pten
hyperproteic diet plus lactobacillus reuteri and nitazoxanide in minimal hepatic encephalopathy

Conditions: Hepatic Cirrhosis; Minimal Hepatic Encephalopathy

Summary: hepatic encephalopathy is a serious complication of cirrhosis which relays under the burden of diseases with therapeutical difficulties for its given morbidity and mortality and the high recurrence it poses. its treatment remains a challenge for most of the cases. even more, minimal hepatic encephalopathy is an entity that has an additional morbidity for it being a subclinical entity. as so, the investigators propose an auxiliary treatment for the management of such patients with minimal hepatic encephalopathy, using a specific diet consisting on hyperproteic and fibre-rich foods along with two independent interventions, whether a probiotic, lactobacillus reuteri, or a drug, nitozoxanide, so to diminish the rate of progression to any clinical stage of hepatic encephalopathy and to revert minimal hepatic encephalopathy itself to none hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: * hepatic cirrhosis * minimal hepatic encephalopathy exclusion criteria: * personal history of surgery in the last 4 weeks * use of neuropsychiatric drugs * neuropsychiatric disorders (schizophrenia, bipolar disorder, major depression, dementia and attention-deficit hyperactivity disorder) * thyroid disorders without replacement therapy * hepatic or renal transplant * alcoholism with active ingest of alcohol in the last 6 months * pregnancy * labour turn-overs * spontaneous bacterial peritonitis * personal history of hepatocellular carcinoma * placement of transjugular intrahepatic portosystemic shunt * use of a probiotic in the last 6 months

Keywords: hepatic cirrhosis minimal hepatic encephalopathy hyperproteic and fiber-rich diet lactobacillus reuteri psychometric hepatic encephalopathy score (phes) critical flicker frequency (cff)
study on the safety of risperidone on obese or overweight patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

this is an observational, multicenter, open and prospective study. the primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. it is expected to enroll 1500 patients with schizophrenia or schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a bmi (body mass index) \>25, or for patients that have increased their body weight \>7% in the last year with the previous treatment (even with a bmi\< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. the study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). all data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus i \& ii, hypertension and hypercholesterolemia) and adverse events. observational study: risperidone, 3-6 mg per day, orally, during the study period (6 months).

Eligibility criteria:
inclusion criteria: * patients with schizophrenia or schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a bmi \>25 * patients have increased their body weight \>7% in the last year with the previous treatment even with a bmi\< 25 * patients that have shown intolerance to a previous antipsychotic treatment exclusion criteria: * pregnant or lactating patients * patients with psychiatry pathology other than schizophrenia or schizoaffective disorder * patients with neurology pathology except parkinsonism induced by neuroleptics * patients with other severe concomitant pathology * patients treated with risperidone in the last 30 days.

Keywords: schizophrenia risperidone schizoaffective disorder schizophreniform disorder weight gain
musculoskeletal pathologies of the upper extremity in surgical device mechanics

Conditions: Musculoskeletal Diseases or Conditions

Summary: work-related upper extremity musculoskeletal disorders (wruemsds) have shown to be related to many occupational situations and specific industries. however, there is conflicting information about monotonous and repetitive activities. in this context, the profession of surgical device mechanics has not been analyzed so far. the objective of this study is to examine surgical device mechanics at different workplaces with varying work contents and to compare them with a control group without the repetitive workload exposition as described above. the headquarters and main production site of aesculap are located in tuttlingen/germany. aesculap is the world leading manufacturer of surgical devices. after statistical power analysis, the investigators plan to randomize and include a total of 90 voluntary test persons in 3 groups (30 persons each). the study will include standardized questionnaires and a physical examination as well as an industry test (purdue pegboard test). primary and secondary endpoints were defined to show if significant difference between surgical device mechanics and a control group is present.


Eligibility criteria:
inclusion criteria: * 18-65 years of age * work ability without absence \> 2 weeks within the last 3 months * \>5 years on workplace or similar workplace when in group of surgical device mechanics exclusion criteria: * spinal syndrome in history * chronic shoulder pain in history * congenital malformation of the upper extremity/hand * rheumatoid arthritis or fibromyalgia in history * actual hand therapy as conservative therapy or therapy after operation due to upper extremity musculoskeletal pathology * previous operation(s) due to nerve entrapment syndrome or chronic musculoskeletal pathology of the upper extremity

Keywords: musculoskeletal disorders upper extremity work surgical instruments
assess efficacy and safety of durvalumab alone or combined with bevacizumab in high risk of recurrence hcc patients after curative treatment

Conditions: Hepatocellular Carcinoma

Summary: a global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

this is a phase iii, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. this study will be conducted in patients with hcc who are at high risk of recurrence after curative hepatic resection or ablation.

Eligibility criteria:
inclusion criteria: * histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed hcc and successfully completed curative therapy (resection or ablation) * imaging to confirm disease-free status within 28 days prior to randomization * ecog 0-1 at enrolment * child-pugh score of 5 or 6 * adequate organ and marrow function. exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc or mixed cholangiocarcinoma and hcc * evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging * history of hepatic encephalopathy within 12 months prior to randomization * evidence, by investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging * patients with vp1 to vp4 portal vein thrombosis on baseline imaging are excluded * active co-infection with hbv and hdv. * receipt of prior systemic anticancer therapy for hcc * those on a waiting list for liver transplantation

Keywords: early stage hcc durvalumab bevacizumab liver cancer
mechanisms of obesity and its metabolic complications in youth

Conditions: Obesity, Childhood

Summary: the overarching goal of this project is to determine whether the effect of gut microbiota on human metabolism might be mediated by short chain fatty acids (scfa) and whether the scfa might modulate lipid metabolism.

this would be the first study determining the effect of scfa synthesis on hepatic de novo lipogenesis and to assess whether and how isocaloric dietary changes (namely low carbohydrates) might modify the composition of the gut microbiota and reduce the synthesis of scfa during adolescence, a sensitive period for the development of obesity.

Eligibility criteria:
inclusion criteria: * good general health, * taking no medication on a chronic basis * age 15 to 21 years, * in puberty (girls and boys: tanner stage iii - v) * bmi \>25th and \ 95th for obese cohort * girls who begin menstruating must have a negative pregnancy test during the study. exclusion criteria: * baseline creatinine \>1.0 mg * food allergies * pregnancy * presence of endocrinopathies (e.g. cushing syndrome) * significant chronic illness.
favipiravir combined with tocilizumab in the treatment of corona virus disease 2019

Conditions: COVID-19

Summary: the purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.

in clinical institutions that enroll patients with corona virus disease 2019, three arms, multi-center, randomized and controlled methods are adopted. patients are divided into three groups, favipiravir combined with tocilizumab group, favipiravir group and tocilizumab group. 150 patients are expected to be enrolled and the cases are allocated according to the ratio of 3( favipiravir combined with tocilizumab group): 1(favipiravir group): 1(tocilizumab group).

Eligibility criteria:
inclusion criteria: 1. clinically diagnosed with corona virus disease 2019 2. increased interleukin-6 3. sign the informed consent 4. subjects who can take medicine orally 5. agree to collect clinical samples 6. female subjects of childbearing age are not pregnant and agree to take effective contraception within 7 days of the last oral medication to ensure that they are not pregnant within 3-6 months 7. male patients agree to effective contraception within 7 days of last oral medication. exclusion criteria: 1. cases of severe vomiting that make it difficult to take the drug orally 2. allergic to favipiravir or tocilizumab 3. pregnant and lactating women 4. subjects received specific antiviral drugs such as lopinavir / ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission. 5. cases of respiratory failure and requiring mechanical ventilation 6. cases of shock 7. combined organ failure requires icu monitoring and treatment 8. predicted clinically that there is no hope of survival, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission 9. alanine aminotransferase / aspartate aminotransferase\> 5 times of upper limit of normal 10. neutrophils \<0.5 × 10\^9 / l, platelets less than 50 × 10\^9 / l 11. clear diagnosis of rheumatoid immunity, malignant tumors and other related diseases 12. long-term oral anti-rejection drugs or immunomodulatory drugs 13. allergic reactions to tocilizumab or any excipients 14. patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections 15. organ transplant patients 16. patients with mental disorders

Keywords: novel coronavirus pneumonia favipiravir tocilizumab
a phase 3 trial of mm120 for generalized anxiety disorder (voyage)

Conditions: Generalized Anxiety Disorder

Summary: a phase 3 double-blind, placebo-controlled study (part a) with an open-label extension (part b) evaluating mm120 compared to placebo in generalized anxiety disorder - voyage

the study will enroll up to 200 participants aged 18 to 74 years, inclusive with a diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) confirmed primary diagnosis of gad and a minimum ham-a total score of at least 20 at screening and baseline without clinically relevant medical or psychiatric history. the study consists of a 12-week randomized, double-blind, single-dose administration period evaluating mm120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. during this phase, participants will be monitored and evaluated for potential treatment with mm120 based on pre-specified safety and symptom severity criteria.

Eligibility criteria:
inclusion criteria: 1. diagnosis of gad per dsm-5 2. male or female aged 18 to 74 3. ham-a total score ≥20 exclusion criteria: 1. certain psychiatric disorders (other than generalized anxiety disorder) 2. first degree relative with or lifetime history of a psychotic disorder or bipolar disorder 3. current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) 4. any clinically significant unstable illness
hematological disorders in covid 19 patients

Conditions: Hematological Abnormalities in covid19

Summary: aim of the research is to detect hematological abnormalities in covid 19 patients and its correlation with the severity and outcome of the disease.

covid 19 is an infectious disease caused by a newly discovered coronavirus.most people infected with the covid 19 virus will have mild to moderate respiratory illness and recover without specific treatment.older people and those with underlying medical problems like cardiac diseases,diabetes,any chronic respiratory disease and cancer are more likely to have serious illness.the covid 19 virus spreads primarily through droplets of saliva or discharge from the nose oral cavity when an infected person coughs or sneezes.people with covid19 have had a wide range of symptoms reported _ranging from mild to severe symptoms.symptoms may appear 2_14 days after exposure to the infection .any one can have mild to severe symptoms.people with these symptoms may have covid 19: fever or shivering,cough,shortness of breath,fatigue,body or muscle aches,headache,new loss of smell or taste ,sore thraot,congestion or running nose , nausea or vomiting,diarrhoea. the most common hematological clinical findings include lymphocytopenia,neutrophilia,eosinophilia,mild thrombocytopenia,and less frequently thrombocytosis,the presence of reactive lymphocytes has been reported only occasionally the leucocyte count may be normal,reduced or increased.according to a meta analysis leucocytosis,lymphopenia and thrombocytopenia are associated with greater severity and fatality in covid 19 cases

Eligibility criteria:
inclusion criteria: all covid 19 patients diagnosed by pcr or ct chest - exclusion criteria: * no
effects of a non-nutritive sweetener reduction intervention in pregnancy and lactation on maternal and infant outcomes

Conditions: Gestational Diabetes Mellitus in Pregnancy; Glucose Intolerance During Pregnancy; Non-nutritive Sweeteners Consumption in Pregnancy And/or Lactation

Summary: the effects of consuming non-nutritive sweeteners (nns) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. in this project, pregnant women who frequently consume nns will be randomly assigned to an nns-restriction intervention (nns restriction during pregnancy and lactation or during lactation only) or a control group (no nns restriction) to determine whether nns consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. the results of this study have the potential to shape recommendations around nns consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.


Eligibility criteria:
inclusion criteria: * pregnant * ≤ 16 weeks\&#39; gestation * singleton pregnancy * report frequent nns beverage consumption (≥ 7 servings/week) * 18-45 years of age * able to read english at a 5th grade level; and * intend to breastfeed for at least the first 6 months of life. * for infants: the mother must be enrolled and provide assent for the infant to participate. exclusion criteria: * physical or mental concerns preventing study participation; * medication (e.g., metformin; glp-1 agomists) use that may affect body weight, body composition, insulin resistance, or lipid profiles; * tobacco or drug use during pregnancy; * alcohol consumption (\&gt;1 drink per week) during pregnancy; * pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - crohn\&#39;s disease, ulcerative colitis, inflammatory bowel disease) that may impact nns absorption or gut microbiota; * known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.

Keywords: non-nutritive sweeteners (nns) pregnancy lactation infant fat mass gestational diabetes (gdm) glucose tolerance peapod
impact of a multidisciplinary therapeutic education program being set up for patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2; Patient Education as Topic

Summary: therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease the multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop. at the end of the program, individual and personalized goals are given to the patient. this study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.


Eligibility criteria:
inclusion criteria: * all type 2 diabetic patients who participate in the multidisciplinary program * signature information form and consent by the patient exclusion criteria: * none

Keywords: diabetes mellitus, type 2 + patient education