Kornimate/medical-research-clean huggingface dataset:
neoadjuvant chemotherapy plus surgery versus surgery first for elderly gastric cancer patients

Conditions: Gastric Cancer; Chemotherapy Effect; Elderly Patients; Surgery

Summary: the main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified sox) for elderly patients with locally advanced gastric cancer.

dragon senile research, neoadjuvant chemotherapy plus surgery versus surgery first for elderly gastric cancer patients, is an investigator-initiated; phase ii/iii, open-label, randomized controlled study. the main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified sox) for elderly patients with locally advanced gastric cancer.

Eligibility criteria:
inclusion criteria: * histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction. * clinical stage: ctnm: stage iii * performance status: eastern cooperative oncology group ecog ≤ 2 (normal to symptomatic but in bed less than half the day) * clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function. * written informed consent exclusion criteria: * clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia * distant metastases (including retroperitoneal lymph node) * locally advanced inoperable disease (clinical assessment) * relapse of gastric cancer * malignant secondary disease * prior chemo or radiotherapy * inclusion in another clinical trial * known contraindications or hypersensitivity for planned chemotherapy
trial comparing perioperative care for breast cancer patients at a patient hotel vs a general surgical ward

Conditions: Breast Cancer

Summary: to explore the possible benefit of a patient hotel, a study was undertaken to test the hypothesis that perioperative care at a patient hotel would be valued better than care in a general ward. the study focuses solely on the patients' perspective and satisfaction of the care provided.

the study was designed as a prospective randomised controlled trial, carried out at a single centre (danderyds university hospital). the protocol was approved by the ethical committee for human studies. with a primary outcome that perioperative care at the hotel would be valued 15-20% higher than care in a general ward, a power analysis, two-sided with α = 0.05, indicated that a sample size of 150 was needed to attain a power of 80%. the patients were randomised to receive pre- and postoperative care either in a general surgical ward or at a patient hotel by using a sealed envelope method. to evaluate the patients' experiences of the care provided at the ward and the hotel, respectively, the swedish validated version of the adult inpatient survey of 2005 (in2005-e) was used. adjacent to the discharge from the ward or hotel, the patient was provided with the in2005-e questionnaire, which was filled out before the patient left the facility. the filled out form was sealed in an envelope by the patient herself and thereafter sent to a separate institute (indikator) for further analysis. indikator is responsible for the majority of the statistical analysis of patient surveys in sweden. patient characteristics were compared using a confidence interval of 95%. the sf-36 was analyzed with a two-sample t-test. the in2005e was analyzed by a cross-tabulation of the data using the χ² test in spss 17.0. the significance level was set to \< 0.05.

Eligibility criteria:
inclusion criteria: women with a breast tumour, who were to undergo surgical treatment in order to remove a known cancer or to exclude cancerous changes in a diagnosed tumour exclusion criteria: * insulin dependent diabetes * severe impairment of mobility * a known coagulopathy * cancer surgery with a coherent primary reconstruction * severe cardiac illness * an inability to understand swedish * mental incapacity.

Keywords: patient hotel patient satisfaction perioperative care in2005e
evaluation of the relationship between vaginal and lower urinary tract microbiomes and infection after hysterectomy

Conditions: Pelvic Organ Prolapse; Hysterectomy; Urinary Tract Infection

Summary: the purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. the investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair. the investigators expect lactobacillus and gardnerella will be the dominant organisms for most women. non-lactobacillus dominant microbiome communities will be more common in women who ultimately develop postoperative urinary tract infection.

the goal of this pilot study is to characterize the presence and stability of the microbial community in the vagina and lower urinary tract in a cohort of 20 postmenopausal women undergoing transvaginal hysterectomy with pelvic reconstruction for pelvic organ prolapse. the investigators intend to collect longitudinal samples in the preoperative, intraoperative, and postoperative time period in order to understand the pervasiveness of the microbes in the vagina and lower urinary tract, and to identify, in a very preliminary way, particular microbes that may be associated with postoperative urinary tract infection.

Eligibility criteria:
inclusion criteria: * postmenopausal females (defined by cessation of menses for one full year) * planned surgical correction of pelvic organ prolapse with transvaginal hysterectomy and concomitant pelvic reconstruction for uterovaginal prolapse * scheduled surgery date within 4 weeks of study consent * physically able to self-collect vaginal swabs and clean-catch urine samples exclusion criteria: * women who are premenopausal, pregnant or nursing * currently taking or have taken antibiotics in the past 2 weeks * history of recurrent urinary tract infections * history of mesh complications, including erosion/extrusion * non-vaginal approach to hysterectomy or prolapse repair

Keywords: microbiota proteome
evaluation of the efficacy of polybutester suture on postoperative complications in lower impacted third molar surgery

Conditions: Impacted Third Molar Tooth

Summary: this study aimed to evaluate the efficacy of polybutester sutures on postoperative complications in lower impacted third molar surgery.

after extraction of the bilateral lower third molars (35 patients), two different types of sutures were used on each side. group 1( polybutester suture) , group 2 (polypropylene suture). measurements to evaluate edema, trismus, and pain (using the vas scale) had been taken pre-procedure and post-procedure( 2nd and 7th day )

Eligibility criteria:
inclusion criteria: * any medication until 2 weeks before the operations, * impacted teeth in mesial and horizontal positions and in class 2 and class b according to pell \& gregory classification, * asymptomatic impacted teeth. * coming to control and fill in the given and requested forms, * regularly use the given drugs exclusion criteria: * systemic disease, * smoking, * pregnancy or breastfeeding, * allergy to the drugs to be used in the study, * using any additional medication that may affect the outcome of the study, * post-operative alveolitis.

Keywords: polybutester polypropylene pain edema trismus
prognostic impact of frailty assessed by edmondon in elderly patient undergoing cardiac surgery

Conditions: Elective Cardiac Surgery

Summary: the score on the edmonton frail scale will be recorded in 250 consecutive patient aged of 75 years or more and undergoing elective cardiac surgery. in those patients the investigators will also record the itu length of stay, the hospital length of stay, the incidence of complications, the ability to be discharged home and to live independently at postoperative day 30. the ability of the edmonton score to predict complication, prolonged hospital and itu length of stay as well as loss of autonomy at discharge and day 30 will be assessed.


Eligibility criteria:
inclusion criteria: * 75 yo and older * elective cardiac surgery exclusion criteria: * refuse or inability to give consent * emergency surgery

Keywords: aged of 75 years or more
nutritional assessment tool and nutritional intervention in childhood chronic liver disease

Conditions: Chronic Liver Disease

Summary: children (exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3 yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/ml, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician (group a). the control group (group b) in comparison will receive standard nutritional counseling from a trained dietician but will not receive any additional nutritional supplement. all the children will be followed up at 1 month, 3 months, 6 months, 9 months and 1 year after inclusion. clinical, nutritional assessment and laboratory data will be collected at each visit. additionally il-6 levels will be done at each visit in children of both arms of the intervention group. the outcomes of interest will be growth and improvement of nutritional status parameters, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {sbp (spontaneous bacterial peritonitis), hrs (hepatorenal syndrome), etc and outcome (improvement, death or liver transplantation}. all children will receive individualized standard treatment for infantile cholestasis syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for sbp (spontaneous bacterial peritonitis)/cholangitis (to at risk children) and drug therapy wherever indicated (steroids/ copper chelation/ udca).


Eligibility criteria:
inclusion criteria: 1. nutritional intervention in children with moderate and severe malnutrition as pr standard anthropometric measures children (exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed : 3mo to 3 yrs) with infantile cholestasis syndrome) 2. hindi/english speaking family exclusion criteria: 1. any metabolic or endocrinal diseases independently affecting nutritional status 2. refusal to give written informed consent to participate in the study
comparison of dexamethasone oral preparations to assess taste and acceptance in children with asthma and croup

Conditions: Asthma; Croup

Summary: study of the palatability and acceptability of dexamethasone oral tablets crushed and placed in apple sauce or pudding in comparison with the iv solution mixed with sugar syrup and given orally. it is hypothesized that dexamethasone tablets crushed and administered in apple sauce or pudding will be more palatable and acceptable for pediatric patients receiving dexamethasone for an acute asthma exacerbation or croup.


Eligibility criteria:
inclusion criteria: * diagnosis of acute asthma exacerbation or croup (laryngotracheitis) in the vanderbilt children's hospital emergency department * age 1 to 7 years * dexamethasone treatment indicated * no other acute or chronic process accounting for signs and symptoms (e.g., foreign body aspiration, pneumonia, cystic fibrosis) * have not received systemic corticosteroid for current episode prior to enrollment exclusion criteria: * allergy to dexamethasone or apple sauce and pudding * unable to take medication orally
high-dose chemotherapy and stem cell transplantation for central nervous system (cns) relapse of aggressive lymphomas

Conditions: Lymphoma, Non-Hodgkin

Summary: central nervous system (cns) relapses of aggressive lymphomas are a rare but devastating complication. there is no therapy standard, conventional approaches are palliative. this study investigates an intensive chemotherapy with cns penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.


Eligibility criteria:
inclusion criteria: * highly-malignant non-hodgkins-lymphoma, mantle-cell lymphoma or follicular lymphoma 3° * cns relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations * ecog performance score ≤2 * no active infection * negative hiv-serology * adequate renal function (creatinine clearance \> 50 ml/min) * adequate bone marrow function (granulocytes \>1500/μl, platelets \> 80000/μl) * normal bilirubin, ast \< 3 x unl * negative pregnancy test exclusion criteria: * newly diagnosed nhl with primary cns involvement * indolent nhl, lymphoblastic nhl or burkitt lymphoma * preceding cns irradiation * pretreatment of cns relapse other than corticosteroids * immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation * second cancer other than basalioma or cervical carcinoma in situ within the last 5 years * unfit to receive an intensive chemotherapy * pregnancy or breastfeeding * known intolerance to mtx, ifosfamide, depocyte, cytarabine, thiotepa, carmustine or etoposide

Keywords: cns relapse aggressive lymphoma hd-asct
treatment of high risk myelodysplastic syndromes (mds) not candidates for allogeneic transplantation of hematopoietic progenitors (alo-hsct)

Conditions: Myelodysplastic Syndromes

Summary: an observational, non-interventional, prospective and multicenter study of azacitidine in newly diagnosed high risk myelodysplastic syndromes. primary objectives are to asses mutational status of target genes by next generation sequencing, to evaluate prognostic value of geriatric assessment scales and to evaluate overall survival. the main hypothesis is that mutation status of target genes and geriatric scales have statistical significant impact on overall survival. study time points will be at diagnosis, 6, 12, 18 and 24 months, always taking into account the routine clinical practice, when sample to assess mutational status will be collected. geriatric assessment will only be performed at diagnosis. upon the signature of informed consent and the checking of inclusion criteria, patients will receive treatment with azacitidine 75 mg/sqm on a 28 days based cycles (both 7-0-0 and 5-0-2 regimens are allowed) until disease progression, unacceptable toxicity or investigator decision. 150 patients are expected to be recruited at study sites.


Eligibility criteria:
inclusion criteria: * patients diagnosed with myelodysplastic syndrome (mds) according to who criteria, including non-proliferative chronic myelomonocytic leukemia (cmml) that is considered high risk, and not candidates for transplantation. * high-risk mds: (following the grupo español síndrome mielodisplásico, gesdm mds guides) and the recommendations of valcárcel, d. et al). median expected os less than 30 months. intermediate-2 or high risk ipss and / or high or very high risk wpss and / or high or very high risk ipsss-r. ipss of intermediate risk and / or wpss of intermediate risk and / or ipss-r of intermediate risk that present at least one of the following characteristics: cytogenetic abnormality of the ipss-r high or very high cytogenetic risk group platelet count \<30 x10e9/l neutrophil count \<0.5 x 10e9 / l presence of dense and diffuse myelofibrosis, with or without collagen formation (grades 2-3 of the european consensus) category 3 of the lrss score (md anderson low risk score system) * patient diagnosed with lam de novo according to who criteria, with 20-30% blasts count in bone marrow, trilineal dysplasia and more than 70 years and not candidate for intensive chemotherapy. * willing to provide voluntary written informed consent exclusion criteria: * serious active medical condition, not related to mds, that could limit patient compliance and follow-up or that, in the investigator's opinion,could compromise the patient's safety. * presence of other active malignant disease * organic function parameters: (except when the alteration is due to mds) hepatic: bilirubin\> 2 x upper limit of normal (uln) renal: creatinine\> 2 x upper limit of normal (uln) * ejection fraction (\<40%) and / or symptomatic heart failure. * leukaemia secondary to myeloproliferative syndrome. * serious psychiatric or neurological disease. * positive serology for hiv. * proliferative cmml
effects of berberine ursodeoxycholate (htd1801) versus dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (htd1801) compared to dapagliflozin in patients with type 2 diabetes inadequately controlled with metformin alone.

this phase 3 randomized, double-blind, active-controlled, parallel-group study will evaluate the efficacy and safety of htd1801 compared to dapagliflozin after 24 weeks of treatment. all patients will remain on a stable dose of metformin throughout the study. to ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. following this period, patient eligibility will be reassessed. eligible patients will then be randomized 1:1 to receive htd1801 1000 mg bid or dapagliflozin 10 mg qd.

Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes * have received a stable dose of metformin monotherapy for at least 8 weeks prior to screening * if used any glucose-lowering drugs other than metformin within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening * have hba1c ≥7.5% to ≤11.0% (screening) and hba1c ≥7.0% to ≤10.5% (pre-randomization) * have fasting plasma glucose ≤13.9 mmol/l (screening and pre-randomization) * have a body mass index ≥19.0 kg/m\^2 and ≤35.0 kg/m\^2 exclusion criteria: * have type 1 diabetes * have had any acute diabetic complications within 12 months prior to screening * have had any grade 3 hypoglycemic event within 12 months prior to screening * have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot * have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening * have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * have used any hypoglycemic drug other than metformin during the 4-week run-in period prior to randomization * have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization * have a history of refractory or recurrent urinary tract infections or genital infections
the impact of high intensity exercise upon epc number and function in young women

Conditions: Exercise Anaphylaxis

Summary: the purpose of the study is to examine the effects of different exercise intensity training programs upon blood vessel function and circulating blood cells involved in blood vessel repair in young women. the long term effects of exercise may be beneficial to cardiovascular health and it is important to understand the training methods that are the most beneficial. in particular we aim to determine if brief maximal exercise improves the function and stiffness of blood vessels and enhance blood vessel repair. two methods of exercising are being compared, exercise bouts involving intermittent exercise and exercise completed all at once, but at a very high intensity.


Eligibility criteria:
inclusion criteria: * young healthy females * between 18-25 years old * no on medication (this includes contraceptives) exclusion criteria: * medication use (including oral contraceptives) * amenorrhoea * high blood pressure * very active (\>3 hours per week of organized physical activity)

Keywords: high intensity exercise training vascular health endothelial function circulating angiogenic cells endothelial progenitor cells aerobic capacity arterial stiffness traditional and emerging cardiovascular disease risk factors
registry study of id & ida in korean patients with heart failure

Conditions: Iron Deficiency Anemia

Summary: the prevalence of iron deficiency and iron deficiency anemia in korean hf patient

epidemiological study to assess the prevalence of id (iron deficiency) \& ida (iron deficiency anemia) in korean patients with heart failure

Eligibility criteria:
inclusion criteria: * more than 19 years old * informed consent form * hear failure criteria as belows * heart failure sign(more than 1 sx such as fatigue, dyspnea, ankle swelling) * heart failure symptom(more than 1 among jugular venous pressure (jvp) elevation, pulmonary crackle, peripheral edema) ③ lung congestion or edema at chest x-ray ④ objective findings of structural or functional cardiac abnormality(more than abnormality level of bnp or nt-probnp, abnormality of echocardiography ) exclusion criteria: * not applicable
robotic-assisted versus laparoscopic sigmoid resection

Conditions: Sigmoid Diseases

Summary: retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease

the goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.

Eligibility criteria:
inclusion criteria: * all patients that have undergone sigmoid resection for benign or malignant disease exclusion criteria: * emergency procedures
myocardial infarction and past oral contraceptive use

Conditions: Cardiovascular Diseases; Coronary Disease; Myocardial Infarction; Heart Diseases; Menopause; Postmenopause

Summary: to evaluate whether the long-term use of oral contraceptives, after discontinuation, was associated with an increased incidence of first nonfatal myocardial infarction among women above the age of 50.

background: in the mid 1980s, it was known that current oral contraceptive use (in the preceding month) increased the risk of myocardial infarction three to four-fold. evidence seemed to indicate that past use lasting a total of five or more years was associated with a residual two-fold increase in myocardial infarction risk among women 40 to 49 years old. since the incidence of the disease started to become appreciable beyond age 49, it was of public health importance to reexamine the evidence in a data base which included women aged 50 or older to determine how long the increased risk persisted and whether it varied according to the formulation of the preparation used. an increase in risk that persisted after discontinuation of oral contraceptive use would have major public health implications since millions of women have used or will use oral contraceptives for long periods. design narrative: the design was that of a case-control study. cases were identified by weekly telephone calls to the coronary care units of 78 hospitals in greater boston, southern connecticut, and westchester county. nurse-interviewers administered standard interviews to cases convalescing on medical wards after discharge from coronary care units and to controls identified in the same hospitals. histories of oral contraceptive use, including the timing and duration of use and the name of the preparations, were recorded along with information on other drug use and myocardial infarction risk factors such as cigarette smoking. data were collected for three years. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria