Kornimate/medical-research-clean huggingface dataset:
apg-1387 plus chemotherapy in advanced pancreatic adenocarcinoma

Conditions: Advanced Pancreatic Cancer

Summary: this study is a two stage study consisting of a dose escalation phase ib and a phase ii study which include subjects with previously-treated, advanced pancreatic adenocarcinoma. dose limiting toxicities (dlts) and maximum tolerated dose (mtd) of apg1387 in combination with nab-paclitaxel and gemcitabine will be evaluated in the dose escalation phase ib. safety and efficacy of apg1387 plus gemcitabine and nab-paclitaxel will be evaluated in phase ii.

the ability of tumor cells to evade apoptosis is currently a major problem in anti-tumor therapy. iaps are an important class of apoptosis-regulating proteins. apg-1387, a potent bivalent smac mimetic, small molecule of iap inhibitor, which could inhibit pancreatic cancer proliferation as monotherapy and in combination with chemotherapy through apoptosis pathway. it's an open label, multiple centers phase ib/ii study. safety and tolerability of apg1387 combined with nab-paclitaxel and gemcitabine will be evaluated in phase ib in previously-treated, advanced pancreatic adenocarcinoma patients. efficacy and tolerability will be evaluated in phase ii study in first line standard treatment failed metastatic pancreatic adenocarcinoma patients.

Eligibility criteria:
inclusion criteria: 1. subjects must be ≥18 years of age at time of informed consent 2. able to comply with the study protocol, in the investigator's judgment 3. expected survival ≥ 3 months 4. histology or cytology confirmed as advanced pancreatic adenocarcinoma, and: * standard treatment failed or intolerant to standard treatment(phase ib); * first line standard treatment failed (phase ii). 5. ecog 0-1; 6. adequate organ function. 7. subjects must have at least one measurable lesion evaluated by computed tomography (ct) scan on recist ver.1.1 at pre-treatment exclusion criteria: 1. has had chemotherapy, radiation, target or other antitumor therapy within 14 days prior to the first dose of study drug. 2. has received an investigational agent or used an investigational device within 28 days of the first dose of study drug. 3. has received a therapy with tnfα within 28 days of the first dose of study drug. 4. known active central nervous system involvement. 5. has received iap-inhibitor before. 6. has had major surgery within 28 days of dosing of investigational agent, or minor surgery within 14 days. 7. patients with clinically evident hepatitis b surface antigen (hbs) positive, hepatitis c virus (hcv) antibody positive, human immunodeficiency virus (hiv) antibody positive. 8. pregnant or breastfeeding (lactating) women. 9. other situations that investigator think not suit for study.

Keywords: iap inhibitor apg-1387 pancreatic cancer inhibitor of apoptosis
a prospective epidemiologic study of alk-positive nsclc in china

Conditions: Non-small-cell Lung Cancer

Summary: this is a post-marketing, observational, non-interventional, multi-central study of patients with non-small cell lung cancer (nsclc), with data collected prospectively from medical records at inclusion. the primary objective is to obtain the epidemiologic data of anaplastic lymphoma kinase (alk)-positive in unselected chinese patients with nsclc.

archived paraffin-embedded and fresh frozen nsclc tumor tissue will be obtained via the department of pathology. alk positive status will be detected by ventana immunohistochemistry (ihc) (ventana medical systems, inc. and roche diagnostics international, inc). when alk positive patients are detected, crizotinib will be administrated by various solutions based on physician's desecration and patients' willingness. the secondary objectives include: 1.to obtain the epidemiologic data of alk positive in unselected chinese patients with nsclc.2.to describe demographic, socioeconomic \[such as age, gender, race/ethnicity, geographic location (including rural/urban area), pathologic parameters, education, family income, national reimbursement drug list (nrdl) or provincial reimbursement list (prdl)\], and clinical characteristics of nsclc patients with alk positive. the exploratory objective is to describe prognosis patterns associated with crizotinib treated patients when efficacy data are available non-interventionally.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years), both sex. * histologically or cytologically proven diagnosis of primary nsclc, including squamous cell carcinoma and adenocarcinoma. * written informed consent. exclusion criteria: * those lung cancers without pathological diagnosis should not be included in case of other types of cancer, including small cell lung cancer (sclc) or metastatic disease from other organs.

Keywords: non-small-cell lung cancer anaplastic lymphoma kinase immunohistochemistry
high intensity interval training (hit) in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the effect of high intensity interval training (hit) on insulin sensitivity in skeletal muscle in patients with type 2 diabetes.

physical exercise increases insulin sensitivity in skeletal muscle in healthy as well as in individuals with type 2 diabetes, but implies a considerable time commitment. high intensity interval training (hit) is time-efficient exercise consisting of repeated bouts of short duration high intensive workloads. the aim of this study is to determine the effect of hit in patients with type 2 diabetes, and to clarify the mechanisms of a possible positive effect of hit. exercise is performed as 2 weeks one-legged training on an ergometer bicycle. thus one leg serves as a control leg. insulin sensitivity in trained and non-trained muscle will be measured after completion of the overall training program by euglycemic hyperinsulinemic clamp method and a-v catheterization of both legs. muscle biopsies will be obtained during training period for measuring of muscle glycogen content, and muscle biopsies for further analysis obtained during the experimental day.

Eligibility criteria:
inclusion criteria: * 10 subjects with type 2 diabetes. 10 healthy control subjects. * bmi 28-35 * diet or tablet treatment for diabetes exclusion criteria: * regular physical activity * diseases other than type 2 diabetes * insulin treatment

Keywords: type 2 diabetes insulin sensitivity high intensity interval training
modification of cue reactivity by neurofeedback in human addiction

Conditions: Alcohol Use Disorder (AUD)

Summary: the project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

project c04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fmri neurofeedback. firstly, the investigators will test whether a prior mindfulness-based intervention (wp1) is able to enhance the effect of rtfmri nfb (wp2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.

Eligibility criteria:
inclusion criteria: * alcohol use disorder according to dsm-5 * ability to provide fully informed consent and to use self-rating scales * abstinent after detoxification for at least 5 days * sufficient understanding of the german language exclusion criteria: * lifetime history of dsm-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence * current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test * current threshold dsm-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, ptsd, borderline personality disorder, or obsessive compulsive disorder * history of severe head trauma or other severe central neurological disorders (dementia, parkinson's disease, multiple sclerosis) * pregnancy or nursing infants * use of medications or drugs known to interact with the cns within the last 10 days, with testing at least four half-lives post last intake

Keywords: alcohol use disorder mindfulness-based intervention neurofeedback ventral striatum
clinician ability to predict the presence of nosocomial pneumonia based on bronchoscopic findings

Conditions: Pneumonia

Summary: this study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients.

this study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients. bronchoscopies will be videotaped. the clinician doing the procedure will make prediction as to whether the patient, in fact, has pneumonia. in addition, at least one other physician will view the videotape and predict whether the patient has pneumonia. once laboratory results are available, the physician predictions will be compared against the definitive laboratory determination

Eligibility criteria:
inclusion criteria: * critical care staff and fellows of the departments of anesthesia and surgery exclusion criteria: * refusal of consent

Keywords: pneumonia
vitamin supplementation after bariatric surgery

Conditions: Complications of Bariatric Procedures; Avitaminosis

Summary: the objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, hba1c and fasting plasma glucose outcomes for patients after bariatric surgery.


Eligibility criteria:
inclusion criteria: * patients currently approved for vertical sleeve or gastric bypass bariatric surgery * female patients should not be pregnant or plan to become pregnant exclusion criteria: * metal objects in the body * current weight greater than 600lbs * previous bariatric (revision) surgery
a placebo controlled trial of the dopamine d-2 receptor agonist ropinirole in treatment of 60 patients with refractory bipolar depression.

Conditions: Bipolar Disorder; Major Depressive Disorder

Summary: we hypothesize that depressed patients who have not responded to their current antidepressant medication will respond to the addition of ropinirole to their current regimen at a rate better than placebo.

most pharmacologic treatments of depression rely on serotonergic and/or noradrenergic mechanisms. yet, evidence both from animal studies and from human trials suggests a role for dopaminergic pathways and particularly for dopamine d2-like receptors in the treatment of depression. in recent years, two new selective agonists of dopamine d2-like receptors have come into clinical use for the treatment of parkinsonism. preliminary evidence suggests that these drugs might be useful as antidepressants. we are testing whether one of these agonists, ropinirole, is an effective augmentation strategy in depressed patients in a double-blind, randomized, controlled trial. we are recruiting unipolar and bipolar patients who remained depressed (modified hamilton depression rating scale score greater than 16) despite at least 4 weeks of treatment with an adequate dose of antidepressant medication. patients receive either 2mg of oral ropinirole or placebo twice daily added on to their current medication and are evaluated weekly over 7 weeks and are assessed weekly using two depression rating scales.

Eligibility criteria:
inclusion criteria: * dsm-iv major depression or bipolar i or ii disorder - currently depressed * one month of a stable, adequate dose of antidepressant medication * bipolar patients must have a mood stabilizer * at least 18 years old * modified hdrs-21 more than 16 (scores reverse vegetative symptoms.) * informed consent exclusion criteria: * cva * antipsychotic medication * drug or alcohol abuse * active suicidality * rapid cycling bipolar disorder * neurologic or dementing illness * psychosis * parkinsonism * pregnancy

Keywords: ropinirole dopamine d2 depression bipolar
magnesium sulphate and rocuronium in patients over 60

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the effects of mgso4 administration on the pharmacodynamics of rocuronium in patients with 60 or more years of age.


Eligibility criteria:
inclusion criteria: * 60 years or older * asa physical status i-iii * scheduled for elective oncologic head and neck surgery exclusion criteria: * severe renal insufficiency (calculated creatinine clearance \< 30 ml/min) * pre-operatory serum magnesium values \> 2.5 meq/l * patients receiving medications known to affect neuromuscular function (furosemide, aminoglycoside, anticonvulsivants, calcio channel blocker, litium, azatioprine, cyclofosfamide)

Keywords: magnesium sulfate rocuronium neuromuscular block onset time elderly
effectiveness and safety of cnep in ethnic japanese with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the aim of this study is to evaluate the effectiveness and safety of cnep (continuous negative external pressure) for the treatment of obstructive sleep apnea during two weeks of home use in subjects of japanese ethnicity.


Eligibility criteria:
inclusion criteria: * both parents ethnically japanese, or one parent japanese and the other east-asian * psg (polysomnogram) done within the previous 12 months that shows an ahi of 10-50/hr and \<80% of apneas and hypopneas are obstructive * cnep collar fits and is well-tolerated key exclusion criteria: * bmi \>34 * abnormalities in neck structure * sleep disturbance other than obstructive sleep apnea * serious medical illness * pregnancy

Keywords: ethnic japanese
standardized management of pregnancy weight of twin pregnancy

Conditions: Pregnancy Weight of Twin Pregnancy

Summary: there are few studies on the optimal value of pregnancy weight gain for twin pregnancy in china.at present, china has not put forward guidelines for the appropriate value of weight gain in twin pregnancy, and the lack of standards for weight gain during pregnancy in clinical application or disease prevention and control seriously restricts the health management of pregnant women.in order to effectively control a series of adverse consequences caused by improper weight gain of women during twin pregnancy, it is urgent to establish the appropriate value of weight gain during twin pregnancy, which will also fill the gap in this field in china.


Eligibility criteria:
inclusion criteria: * 18-45 years * twin pregnancy * pregnancy weeks ≤ 6 weeks exclusion criteria: * adverse pregnancy history * kidney disease
topotecan in treating children with refractory leukemia

Conditions: Leukemia

Summary: phase i trial to study the effectiveness of topotecan in treating children with refractory leukemia. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

objectives: i. describe the qualitative and quantitative toxic effects, including acute and chronic dose-limiting toxicity, cumulative toxicity, and time to recovery, in pediatric patients with refractory leukemia who are treated with a 30-minute daily infusion of topotecan (topo) for up to 12 consecutive days every 3 weeks. ii. estimate the maximum tolerated dose of topo that results in tolerable, predictable, and reversible toxicity. iii. determine the precautions and supportive therapy that should be used and the clinical and laboratory studies needed to monitor or alter therapy to prevent unacceptable toxicity in these patients. iv. observe any antileukemic effects that may occur during this phase i study in which duration of treatment is increased from 7 to 9 and then 12 days and topo doses are escalated. v. determine the recommended phase ii pediatric dose of topo. vi. characterize the pharmacokinetic parameters of topo and evaluate changes in these parameters with the first and last doses to determine whether there is drug accumulation. vii. correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity. outline: single-agent chemotherapy. topotecan, topo, nsc-609699.

Eligibility criteria:
disease characteristics: -histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists patient characteristics: * age: under 21 * performance status: ecog 0-2 * life expectancy: at least 8 weeks * adequate platelet count and hemoglobin required (transfusion allowed) * bilirubin no greater than 1.5 mg/dl * ast or alt no greater than 2 times normal * creatinine less than 1.5 mg/dl * adequate nutritional status, e.g. higher than third percentile weight for height * albumin at least 3 g/dl * no severe uncontrolled infection * no pregnant women * effective contraception required of fertile women prior concurrent therapy: * at least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas) * recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation) * no concurrent anticancer therapy * no concurrent treatment studies

Keywords: recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia relapsing chronic myelogenous leukemia
inhaled corticosteroid withdrawal in chronic obstructive pulmonary disease (copd)

Conditions: COPD; Inhaled Corticosteroid

Summary: according to the wisdom study, withdraw of inhaled steroids has no effect on the acute exacerbation of chronic obstructive pulmonary disease (copd), but the lung function of patients with copd is significantly reclined. in the subgroup analysis of this study, patients with copd were found to have continued to use inhaled steroids in patients with eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of exacerbation per year. however, in sunset study, it was pointed out that withdraw of inhaled steroids had no effect on lung function in patients with copd, but it was also found that in patients with copd, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have a better therapeutic response in steroid inhalation. in addition, some studies have shown that in patients with copd, a decline in lung function after discontinuation of inhaled steroids can make the patient's clinical symptoms worse and increase the risk of acute exacerbations. however, in other comprehensive analytical studies, there are different outcomes. there is no statistically significant difference in the risk of acute exacerbation in patients with copd after discontinuation of inhaled steroids. in past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in patients with copd. however, in these studies, the diagnosis of pneumonia was only from the clinician's suspicion without clear symptom assessment, laboratory examination, microbiological evidence or imaging assessment. therefore, further research is needed to assess whether patients are suitable for the reduction of inhaled steroids and the impact of copd in clinical treatment.


Eligibility criteria:
inclusion criteria: * confirmed patients with copd (at least one lung function test post bronchodilator fev1/fvc \<70% before the start of the study) * age ≥ 40 years old * no acute attack record within half a year * triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months. * eosinophil count in blood \<300 cells/ul * clinical symptom assessment cat score \<20 exclusion criteria: * suspected or diagnosed with asthma * age \<40 years * within half a year, there is a record of moderate to severe acute attacks * eosinophil count in blood ≥300 cells/ul * clinical symptom assessment cat score ≥20
efficiency of diode laser activated irrigation on healing of periapical tissues

Conditions: Periapical Diseases

Summary: study is a randomized clinical trial conducted at endodontic department- ain shams university cairo. egypt. 24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using cbct

sample size is 24 , 24 patients were randomly distributed in 2 groups , one group of patients received laser activated irrigation lai during root canal treatment and the other group received no treatment just conventional rct. • patients were equally divided into 2 groups (n=12 in each group ) the study in a single blinded rct , numbers for patients will be generated and distributed randomly in a table on an excel sheet, and in front of each number either a letter (c) for control or (i) for intervention will be typed after patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not receive a laser activated irrigation group a lai :disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute. irrigation will be performed with a 30-gauge needle side vented the irrigation needles were introduced passively up to 2 mm away the working length. after irrigation laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of 0.2 ms. the laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part group b : received mock laser intervention , conventional root canal treatment with 2.5% sodium hypochlorite cbct was taken pre-operative and another one was taken after 12 month , both volumetric and linear measurements were calculated

Eligibility criteria:
inclusion criteria: * adult patients age between 18-50 years * medically free patients. * patients suffering from acute or chronic infection with symptomatic apical periodontitis with necrotic pulp * preoperative pain * sensitivity to percussion * periapical radiographic x-ray showing periapical lesion with no gutta percha in canal * occlusal contact with opposing teeth exclusion criteria: * pregnant females. * patients having a significant systemic disorder or history of drug abuse * patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively. * patients having bruxism or clenching * teeth having: * no occlusal contact * no sensitivity to percussion * greater than grade i mobility. * pocket depth greater than 5mm. * no possible restorability * procedural errors * previous root canal treatment * open apex

Keywords: diode laser cbct low level laser therapy