Kornimate/medical-research-clean huggingface dataset:
fructo-oligosaccharides and irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of bifidobacteria. imbalance of the intestinal microbiota such as reduction of bifidobacteria is implicated in irritable bowel syndrome (ibs). thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve ibs score and to explore which modifications of the microbiota are responsible of this improvement.


Eligibility criteria:
inclusion criteria: * ibs subjects according to rome iii criteria * incomfort below or equivalent to 30mmhg during tensostat test * between 18 and 60 years * no antibiotic treatment for the last 2 months * less than 20g of dietary fibres consummed per day * no analgesic treatment * no treatment for intestinal transit exclusion criteria: * subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, hirschprung disease, anorexia * excessive consumption of alcohol or tobacco * participating to another clinical study * pregnant women * antidepressor or anxiolytic treatment
this study looks at the effects of idarucizumab in patients who take dabigatran and need emergency surgery or are bleeding

Conditions: Hemorrhage

Summary: the primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. the secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.


Eligibility criteria:
inclusion criteria: * ≥ 18 years at screening. * male or female patients. women of childbearing potential (wocbp) and men able to father a child must be ready and able to use highly effective methods of birth control per ich m3 (r2) that result in a low failure rate of less than 1% per year when used consistently and correctly. a list of contraception methods meeting these criteria is provided in the patient information. * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial * currently taking dabigatran etexilate * they meet the following criteria: * group a: overt bleeding judged by the physician to require a reversal agent. or * group b: a condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. emergency is defined as within the following 8 hours. exclusion criteria: group a: * patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care. * patients with no clinical signs of bleeding. * contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol). group b: * a surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low. * contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
a dose increase finding study of doxorubicin hydrochloride liposome injection for patients with breast cancer

Conditions: Breast Cancer

Summary: to study the maximum tolerated dose of doxorubicin hydrochloride liposome injection combination with cyclophosphamide and sequential treatment of docetaxel for patients with locally advanced breast cancer


Eligibility criteria:
inclusion criteria: * female patients newly diagnosed breast cancer≥18 and ≤70 years of age; * karnofsky performance status≥70 and measurable or evaluable; * stages ⅲa-ⅲc; * baseline left ventricular ejection fraction (lvef) ≥ 50%; * adequate marrow function (wbc count\> 4.0×10(9)/l, neutrophil\> 2.0×10(9)/l, platelet count \> 100×10(9)/l，hemoglobin \> 90g/l ); * ast and alt ≤1.5× institutional upper limit of normal, alkaline phosphatase * ≤2.5×institutional upper limit of normal，bilirubin ≤institutional upper limit of normal; * serum creatinine ≥ 44µmol/l and ≤ 133 µmol/l; * expected lifetime ≥ 12 months; * pregnancy tests of reproductive age women is negative; * all patients provided written informed consent. exclusion criteria: * distant metastasis; * severe heart failure (nyha grade ii or higher); * active and uncontrolled severe infection; * hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing liposomal doxorubicin and docetaxel; * have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride liposome or doxorubicin; * pregnancy or breast feeding; * other situations that investigators consider as contra-indication for this study
neonatal platelet transfusion threshold trial

Conditions: Thrombocytopenia; Neonatal; Platelet Transfusion; Infant, Newborn, Diseases; Infant, Extremely Low Birth Weight; Infant, Small for Gestational Age; Thrombosis

Summary: the objective of the neoplatt trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (pma).

thrombocytopenia, defined as a platelet count \<150 x 10\^9/l, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. the incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk. the neoplatt trial was designed to address this pressing uncertainty in the highest risk population (\<27 weeks ga). it will test whether a threshold of 20x10\^9/l could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. the results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization. this is a randomized trial with 1:1 allocation to parallel arms. infants, inborn or outborn, who are admitted to participating nicus, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. only consented and enrolled infants meeting the additional platelet count trigger of \< 50 x 10\^9/l (postnatal days 1-7) or \<35 x 10\^9/l (8 or more postnatal days) will be randomized. postnatal day 1 starts at birth. randomization will be allowed to occur up to 36 6/7 weeks' pma; subjects will be monitored through 40 0/7 weeks pma. approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.

Eligibility criteria:
inclusion criteria: * gestational age of 23 0/7 to 26 6/7 weeks * postnatal age of \< 48 hours exclusion criteria: * comfort care or withdrawal of care planned * neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder * receipt of platelet transfusion * no receipt of vitamin k * parents/guardian decline consent

Keywords: platelet transfusion neonatal thrombosis
high sensitive crp in prediabetics and diabetes

Conditions: Assess Level of High Sensitive CRP in Diabetics and Prediabetics

Summary: the aim of this study was to study the level of high-sensitivity crp in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with homa ir and hba1c

this study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. the study individuals will be recruited from the diabetes and internal medicine clinics of fayoum university hospital

Eligibility criteria:
inclusion criteria: * pre-diabetic patients: * a fasting blood glucose level (100 to 125 mg/dl). or * a 2-hour blood glucose level (140 to 199 mg/dl) .or * hb a1c 5.7% to 6.4%. * newly diagnosed type 2 diabetes: (maximum within one month from diagnosis) * a fasting blood glucose level \>126 mg/dl * a 2-hour blood glucose level \> 200 mg/dl * hb a1c \> 6.5% exclusion criteria: * pregnant or lactating females. * patients who have recent infection. * patients with acute inflammatory diseases as autoimmune diseases. * patients with malignancy or on chemotherapy. * patients with acute or chronic liver or renal diseases
influence of sutent on tumor vascularization and necrosis in patients with renal cell carcinoma

Conditions: Renal Cell Cancer

Summary: the purpose of the study is to assess the effect of sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.

sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. very often tumor necrosis is seen after the start of the treatment. it is unknown after how many days this effect starts. in patients with renal cell cancer with metastases, who will be treated with sutent, 3 mris will be made. kep, r2\*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.

Eligibility criteria:
inclusion criteria: * patients with metastatic renal cell cancer for whom treatment with sunitinib is planned * histologically verified stage iv renal cell carcinoma of clear cell type * measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs * karnofsky score \> 70% * age \> 18 year. * written informed consent exclusion criteria: * contra-indications for mri * contra-indications for treatment with sunitinib * previous systemic treatment within the last 30 days

Keywords: sutent tumor necrosis dce-mri (dynamic enhanced magnetic resonance imaging)
turmeric and turmeric-containing tablets and sebum production

Conditions: Skin Inflammation

Summary: a noticeably increasing number of patients are asking for naturally based extracts and ingredients as supplementary dermatologic remedies. patients are seeking natural and cost-effective skin care alternatives in place of prescription medications and procedures. this study will isolate the effects of oral turmeric and assess a combination tablet that includes turmeric on sebum production in healthy subjects.

turmeric (curcuma longa) is a spice that has been shown to exhibit anti-inflammatory, antimicrobial, antioxidant, anti-neoplastic properties, and even potential to improve mental illnesses. in western herbalism, turmeric is primarily used as an anti-inflammatory agent. in india, turmeric is used in ayurvedic medicine for the treatment of acne. it has been used both internally and externally. curcumin is a phytochemical derived from turmeric and believed to be one of the key active components of turmeric. curcumin is reported to have activity as an antibacterial and anti-inflammatory agent and has been used as a paste for skin eruptions and infections. previous basic science work by dr. raja sivamani's lab has shown that both turmeric and curcumin inhibit lipid synthesis in human sebocytes, the cells responsible for the production of sebum the goal of this study is to evaluate how ingestion of turmeric and tablets that have a combination of herbs including turmeric may modulate sebum production.

Eligibility criteria:
inclusion criteria: 1. age 18 to 50 years of age, and 2. subject must be able to read and comprehend study procedures and consent forms. exclusion criteria: 1. subject should be generally healthy and have no smoking history in the past one year, and must have no history of diabetes, metabolic syndrome, known cardiovascular disease, malignancy, kidney disease, or chronic steroid use. 2. subjects who consume more than 6 servings of caffeine per day, such as coffee and energy drinks (example - red bull). 3. subjects with known allergies to herbal ingredients. 4. subjects with known ekg changes. 5. those who used topical medications in the past two weeks or systemic antibiotics within one month of starting the study. 6. subjects who are postmenopausal 7. those who are pregnant or breastfeeding. 8. those that are prisoners or cognitively impaired.
bioequivalence of 2 formulations of tki258 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors; Excluding Breast Cancer

Summary: this is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of tki258, fmi capsule and fmi tablet in patients with advanced solid tumors, excluding breast cancer. the aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. during the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of tki258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. after the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only tki258 fmi capsule formulation until disease progression (assessed by recist 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.


Eligibility criteria:
inclusion criteria: 1. patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists 2. ecog performance status (ps) 0, 1 or 2 3. patients must meet protocol-specified laboratory values exclusion criteria: 1. patients with brain metastases 2. patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study 3. patients who have not recovered from previous anti-cancer therapies 4. patients who are expected to receive any prohibited medications during the bioequivalence phase of the study 5. female patients who are pregnant, breast feeding 6. fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception other protocol-defined inclusion/exclusion criteria may apply

Keywords: cancer tumors phase i crossover bioequivalence
deep brain stimulation in huch region between 2006 and 2014

Conditions: Parkinson's Disease

Summary: this study reviews the outcome of deep brain stimulation treated patients in helsinki and uusimaa university hospital between 2006 and 2014. the aim of the study is to investigate the outcome and possible side effects of deep brain stimulation treatment.

deep brain stimulation is a fda approved method in treating patients with advanced parkinson's disease when the best medical treatment is insufficient. in this study the aim is to investigate the outcome of deep brain stimulation treated patients in helsinki and uusimaa university hospital between 2006 and 2014. this study is a retrospective study based on existing patients' medical records and does not include an intervention in the treatment of an individual patient. deep brain stimulation carries the risks of major surgery. a complication risk for a hemorrhage is 1-2 % and for an infection is 3-10%. the aim of this study is to evaluate the complications that have occurred and the possible benefit of deep brain stimulation in deep brain stimulation treated patients with advanced parkinson's disease. the gathered data will be processed anonymously and an individual patient cannot be identified. the data will be processed with an appropriate statistical program (spss). no data will be given to external parties.

Eligibility criteria:
inclusion criteria: * patient with advanced parkinson's disease and given deep brain stimulation according to the best clinical protocol. this study only observes the outcome of given deep brain stimulation and does not affect on the given treatment. exclusion criteria: * the normal exclusion criteria for deep brain stimulation which are dementia, a significant vascular atrophy seen in brain cat scan or mri, parkinson's disease with non-levodopa response with less than 30 % improvement in levodopa challenge test, disease duration less than 5 years

Keywords: advanced deep brain stimulation
factors associated with complicated pneumonia in paedatrics

Conditions: Complicated Pneumonia in Pediatrics

Summary: detecting factors associated with complicated pneumonia in pediatrics

community acquired pneumonia is the cause of morbidity and mortality in children worldwide ,complication of community acquired pneumonia in paedatrics include para -pneumonic pleural effusion ,empyema, necrotizing pneumonia and lung abscess.( sawicki gs,2008) pediatric para-pneumonic pleural effusion and empyema are considered different stages of the same pathophysiological process in which pleural inflammation causes fluid to accumulate in the pleural cavity, necrotizing pneumonia results from pulmonary necrosis and tissue liquefaction. ( ira erlichman, md,2017) recent reports have characterized the clinical presentation of this complication and have shown favorable outcomes in children.( sawicki gs,2008) complicated pneumonia was defined as clinical pneumonia and the presence of pleural effusion, empyema (emp) or para-pneumonic childhood emp was defined as the presence of pus (purulent fluid and/or wbc count\>5,000 permm3) or bacteria in the pleural fluid. ppe was defined by pleural fluid not fitting criteria of emp and the diagnosis of np was made by the presence of multiple cavity gas-filled spaces within a pulmonary consolidation on chest x-rays or liquefaction of lung tissue according to ct scans as reviewed by a pediatric radiologist .( ira erlichman, md 2017) among patients with pneumonia as many as half may develop pleural effusions (i.e., fluid in the pleural space); of these, 5-10 % may develop empyeman ingeneral , "complicated pneumonia" refers to pneumonia accompanied by pleural effusion.( byington cl,2010) empyema is a serious complicatio characterized by pus and bacteria in the pleural space which may progress to necrosis, cavitation, or fistulas in the thoracic cavity. s. pneumoniae is the most common cause of complicated pneumonia in children (an m. a. fletcher ett 2014) empyema among children age below 19 years in utah (usa) (1994-2007)\] and australia(1998-2010)ranged from 0.9 to 12.5 per 100,000 (byington cl,2010)the incidence was highest in children aged 0-4 and tend to increase over time. (strachan re,2013).

Eligibility criteria:
inclusion criteria: * patient admitted at auch aged 2months up to 16 years old with sign and synptoms suggestive of pneumonia. exclusion criteria: * immunodefiecency * hematological and malignancy. * neonatal peroid.
evaluation of neuronal damage in patients undergoing robot-assisted laparoscopic radical prostatectomy with biomarkers

Conditions: Brain Damage; Postoperative; Surgery-Complications

Summary: robotic assisted laparoscopic surgery has become an alternative to open or laparoscopic technique in various surgical fields. robot assisted laparoscopic surgery is preferred by surgeons and patients due to easy accessibility, lower blood loss and lower transfusion rates. however, robotic assisted laparoscopic surgery can cause significant changes in cardiovascular, respiratory, metabolic and cerebral physiology because it requires a deep trendy position. when long -lasting deep trendelenburg position is applied, the cerebral autoregulation is impaired. in the literature, the presence of cases with brain edema is shown. in recent years, many biomarkers have been used in the evaluation of brain damage. s100 calcium binding protein (s100β), n ron specific enolase (nse), glial fibrils are among the biomarkers used to show acidic protein (gfap) brain damage. the s100β is specific and is mainly produced by astrocytes and enters the bloodstream after neuron damage. glial fibrils is an acidic protein (gfap), a protein encoded by the gfap gene in humans, an intermediate filament protein produced in the central nervous system. neuron specific enolase (nse) is one of the enzymes that increase brain damage encoded by enolase 2 (eno2) gene. mini mental state examination and montreal cognitive assessment will be performed to determine neurological changes developing in patients. the purpose of this study; robotic assisted laparoscopic surgery is to examine the brain damage that may develop in patients due to deep trendelenburg position in patients with the said biomarkers and to evaluate the anesthesia methods applied in these surgery in line with the study results.


Eligibility criteria:
inclusion criteria: * all patients aged 18-75 who were operated on under general anesthesia for ralrp surgery and agreed to participate in the study will be included. exclusion criteria: * participants who did not accept the study, had active intracranial pathology and history of intracranial pathology will not be included in the study.

Keywords: brain damage postoperative robot-assisted laparoscopic radical prostatectomy (ralrp) gfap nse s100b