Kornimate/medical-research-clean huggingface dataset:
early stoppage versus continuation of antimicrobial therapy in low risk pediatric cancer patients with febrile neutropenia, before recovery of counts: -dalfen study

Conditions: Neutropenia, Febrile; Pediatric Cancer

Summary: pediatric patients with febrile neutropenia coming to department of medical oncology with low risk features (culture awaited), will be started on intravenous antibiotics (inj cefoperazone+ sulbactam ± amikacin) on outpatient basis. those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. antibiotics will be stopped in arm-a and oral antibiotics, in place of intravenous antibiotics, will be started in arm-b. the patients will be followed-up till anc≥ 500, or reappearance of fever within follow-up of ≤ 10 days.


Eligibility criteria:
inclusion criteria: * all pediatric febrile neutropenia patients treated on outpatient basis * age 3 years - 18 years * fulfilling low risk criteria ( hematological malignancies in remission, no identifiable focus of infection, no pneumonia/ mucositis / gi sepsis / nausea-vomiting/ neurologic-mental status changes/ central venous catheter (cvc) related infection, anticipated absolute neutrophil count (anc) recovery ≤ 10 days, no organ dysfunction, hemodynamically stable, culture negative ) * afebrile for at least 24 hours, on intra-venous antibiotics exclusion criteria: * bone marrow involvement in solid tumor * already enrolled once, in previous episode * on antibiotics prophylaxis * retroviral positive patients * patient undergone stem cell transplant
therapeutic individualization for patients with locally advanced gastric and gastroesophageal cancer

Conditions: Gastric Cancer; Effects of Chemotherapy; Surgery

Summary: the purpose of this study is to evaluate whether the r0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

patients with locally advanced gastroesophageal junction and gastric cancer with t3-4 and/or n+ are included. initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. the neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group a) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group b). chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 gy). surgery is scheduled 4 to 6 weeks after the end of crt. pathological response is graded according to the becker criteria. statistical analysis is performed ibm spss v20. nonlinear mixed effects (nlme) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (nlr) and platelet lymphocyte ratio (plr) on the clinical outcome of these patients.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer * age ≥18 years old * performance status- eastern cooperative oncology group (ecog) 0-1 * body mass index ≥ 18 * no prior chemotherapy or chemoradiotherapy * tnm stage of t3-t4 and/or positive regional lymph nodes (n+) by endoscopic ultrasound or computed tomography (ct) * no evidence of metastasis (m0) * adequate hematological, liver and renal functions (alt and ast≤2.5 unl, total bilirubin ≤1.5 unl, and serum creatinine ≤1.5 unl) exclusion criteria: * patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated * patients with evidence of severe or uncontrolled systemic disease * medically unfit for chemotherapy

Keywords: radiotherapy neoadjuvant therapy pharmacodynamics pharmacokinetics nonlinear dynamics
the role of hypertonic dextrose spray as endoscopic topical hemostatic agent for acute non-variceal upper gi bleeding

Conditions: Gastro Intestinal Bleeding

Summary: this study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper gi bleeding.


Eligibility criteria:
inclusion criteria: * patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy * patients consented to study participation exclusion criteria: * patients with thrombocytopenia (thrombocyte count \<100.000 cells/ul) and other forms of coagulopathy
comparison of popular weight loss diets

Conditions: Obesity

Summary: this study will compare the safety and effectiveness of three popular weight loss plans. these plans will be compared with the usda dietary guidelines.

obesity is the single most significant, nutrition-related health issue of the new millennium. several "medical experts" have designed and promoted weight loss diets that dramatically differ from one another and from the usda dietary guidelines. these diets have gained surprisingly widespread and persistent popularity among americans despite the lack of evidence supporting their claims. this clinical trial will provide preliminary feasibility data for a full-scale study that will examine health outcomes (e.g., benefits, risks, success) of three popular weight loss diets. the study will investigate behavioral and physiological factors that influence adherence and retention to these diet plans. overweight women will be randomly assigned to one of four diets for 1 year: atkins (extremely low carbohydrate), zone (low carbohydrate, high protein), ornish (very low fat), or usda/food pyramid (high carbohydrate/moderate-low fat). behavioral and physiological data will be collected. participants attend study visits at baseline, 8 weeks, 6 months, and 1 year. at these visits, measurements will include that will include weight and blood pressure measurements and blood tests. participants will be asked to complete ten questionnaires over the course of the study to assess behavior and appetite. participants will also undergo a dexa scan to assess body composition.

Eligibility criteria:
inclusion criteria * body mass index (bmi) between 27 and 40 kg/m2 * weight stable for last 2 months * not actively on a weight loss plan * no plans to move from the area over the next 2 years * willing to accept random assignment exclusion criteria * pregnant or breastfeeding * within 6 months of giving birth or planning to become pregnant in the next 2 years * diabetes (type 1 or 2) or history of gestational diabetes * renal or liver disease, active neoplasms, or recent myocardial infarction * hyper- or hypothyroidism * lipid lowering medications or medications known to affect weight/energy expenditure * excessive alcohol intake (self-reported, \> 3 drinks/day) * postmenopausal, including surgical menopause * currently under psychiatric care or severely clinically depressed (\> 17 on beck inventory)

Keywords: weight loss obesity overweight premenopausal women diet
effects of 6-month of treatment with trpv1 and trpa1 agonists in older patients with od

Conditions: Oropharyngeal Dysphagia; Swallowing Disorder

Summary: in recent years, the investigators have characterized the impairments in pharyngeal sensory function associated with swallowing disorders in older patients with oropharyngeal dysphagia (od). the investigators have demonstrated the acute and sub-acute therapeutic effect of trp agonists on mechanical and neural swallow responses in patients with od. the present hypothesis is that 6-months treatment with trpv1 (capsaicin) or trpa1 (piperine) agonists will improve the biomechanics and neurophysiology of the swallow response without inducing desensitization. the aim of this study is to evaluate the effect on biomechanics assessed by videofluoroscopy (vfs), neurophysiology (pharyngeal evoked sensory potentials -psep- and motor evoked potentials -pmep-), and clinical outcomes during a 6-month treatment with trp agonists added to the alimentary bolus 3 times a day in older patients with od. design: 150 older patients (\>70y) with od will be included in a randomized clinical trial with three treatment arms, in which the effect of oral administration of 1) capsaicin 10µm (trpv1 agonist), 2) piperine 150µm (trpa1), and 3) placebo (control), will be evaluated. measurements: 1) vfs signs of swallowing safety and efficacy and timing of swallow response ; 2) spontaneous swallowing frequency; 3) latency, amplitude and cortical representation of psep and pmep; 4) concentration of substance p and cgrp in saliva, 5) clinical outcomes (respiratory and nutritional complications). the results of this study will increase evidence for a new generation of pharmacological treatments for older patients with od, moving from compensation to rehabilitation of the swallowing function.


Eligibility criteria:
inclusion criteria: * ≥70 years * with a positive volume-viscosity swallow test for oropharyngeal dysphagia * penetration-aspiration scale \>1 in videofluoroscopy * able to follow the protocol and to give written informed consent. exclusion criteria: * life expectancy \< 3m or palliative care * allergy to iodinated contrast or to the components of the treatment solutions * cancer or active infection * implanted electronic device * epilepsy * metal in the head * participation in another clinical trial (previous month).

Keywords: trp agonists sensory stimulation rehabilitation
evaluation and validation of new biomarkers by mass spectrometry

Conditions: Diabetes Mellitus

Summary: the investigators will perform biochemical and metabolic evaluations on cord blood, venous blood of the mother and urine of the foetus and mother using time-of-flight and tandem mass spectrometry. the investigators could evaluate, dose and validate gestational diabetes mellitus biomarkers of the fetus and mother.


Eligibility criteria:
inclusion criteria: for women: * aged 18 or more * 24 weeks of gestation or more * type 1, type 2 or gestational diabetes mellitus for group 1 * without diabetes for group 2. for newborn: * 37 weeks of gestation or more * birth weight 2500 g or more exclusion criteria: * multiple birth
assess the use of rebus with a guide sheath to increase transbronchial lung biopsy yield rate

Conditions: Diagnoses Disease; Lung Tumor

Summary: whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound

for lung nodules, there are several ways to acquire tissue for pathology study, including computed tomography (ct)-guided core needle biopsy, radial probe endobronchial ultrasound (rebus)-guided transbronchial lung biopsy (tblb), convex probe ebus transbronchial needle aspiration (tbna), and echo-guided core needle biopsy. rebus-guided tblb has relatively low limitation of lesion position, comparing to echo-guided core needle biopsy and ebus-tbna, and doesn't need to deal with the risk of radiation exposure.1 for peripheral pulmonary lesions (ppl), it has good yield rate and the operation is easy.2 however, when bleeding occurs, the procedure time is prolonged for hemostasis. nonetheless, using a guide sheath can help with the problem. according to the literatures, biopsy yield rates vary but on average it is higher with a guide sheath (62\~90% vs. 41\~73%), while the complication rates are about the same (1.3\~4.4% 1.5\~5.0%). the investigators would like to know whether the diagnostic rate is higher with a guide sheath and so do the procedure time and the complication rate. whether the lesion character affect the yield rate will also be studied.

Eligibility criteria:
inclusion criteria: age ≥ 20 years old. radiographic evidence of peripheral pulmonary lesions. the lesion can be located by radial probe ebus. exclusion criteria: b1 bronchus. thrombocytopenia with platelet count \ 1.3. high oxygen demand (o2 mask \> 28%, 5l). currently using anti-platelet drug or anti-coagulant.

Keywords: guide sheath, bronchoscopic biopsy
stereotactic body radiotherapy (rt) for non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: nsclc is the leading cause of cancer mortality in north america, accounting for nearly 30% of all cancer deaths. the standard treatment for patients with early-stage non-small-cell lung cancer (nsclc) is surgical resection of the involved lobe/lung. however, many patients are unable to undergo such a major surgery due to medical illness, and an emerging standard-of-care for these patients stereotactic-body radiation therapy (sbrt). sbrt involves highly precise delivery of very high dose radiotherapy (rt) over a very few fractions (hypofractionation) to accurately describe, size-restricted malignant targets in which motion has been accounted for during the delivery process. sbrt administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.


Eligibility criteria:
inclusion criteria: * must have been treated at university of health network with sbrt for an early-stage nsclc (t1n0m0; t2n0m0; or t3n0m0 chest wall primary tumours only). * on follow-up thoracic ct scans, patients must have changes in the previously targeted lung parenchyma that fit into one of the following three patterns: - changes that on ct and clinical grounds are felt to be related to fibrosis * changes that on ct and clinical grounds are suspicious for recurrence * equivocal changes (uncertain whether the changes represent fibrosis or recurrence) * must be greater than 18 years in age * must be able to attend regular follow-up including radiologic investigations and clinical visits * written informed consent exclusion criteria: * standard contraindications to mri study (e.g. ferromagnetic prosthesis, pacemaker/implanted defibrillator, metallic implant in eye, severe claustrophobia, etc...) * contraindications to gadolinium contrast-agent. may include a history of allergic reaction to following previous administration of gadolinium or poor renal function (calculated creatinine clearance \< 30 ml/min). * patients with surgical resection of the treated portion of lung following their sbrt, although surgical resection of other parts of the lung is allowed.
covid-19 phobia in patients with bronchiectasis during covid-19 pandemic

Conditions: Covid19; Bronchiectasis

Summary: in the literature, there are no studies evaluating covid-19 phobia, quality of life, health anxiety, physical activity level and quality of sleep in patients with bronchiectasis during covid-19 pandemic. the investigators will evaluate these parameters in patients with bronchiectasis and compare the findings of healthy individuals during covid-19 pandemic


Eligibility criteria:
inclusion criteria: * having been diagnosed with non-cystic fibrosis bronchiectasis * no acute bronchiectasis exacerbation or infection in the past 2 weeks * volunteering to participate in the research exclusion criteria: * having a cognitive problem * not being literate

Keywords: phobia quality of life health anxiety
addressing root causes for gun violence prevention (arc-gvp)

Conditions: Violence; Adolescent; Firearm Injury; Aggression

Summary: the goal of this study is to help build the evidence base for a locally-relevant youth firearm violence prevention program in washington d.c., a city experiencing disparities in youth firearm violence outcomes. the main question it aims to answer is: how is youth participation in the summer youth employment program, the true reasons i grabbed the gun evolved from risk (the t.r.i.g.g.e.r project), which is designed to address root causes of gun violence, associated with individual youth behavioral outcomes, including pro-social involvement, aggression, and firearm-related attitudes and behaviors?

the goal of this study is to help build the evidence base for a locally-relevant youth firearm violence prevention program in a city experiencing disparities in youth firearm violence outcomes. the main question it aims to answer is: how is youth participation in a summer youth employment program that is designed to address root causes of gun violence (the t.r.i.g.g.e.r project), associated with individual youth behavioral outcomes, including pro-social involvement, retaliatory attitudes, aggression, and firearm behaviors? to examine this question, participants will be invited to complete four surveys over the course of one year to assess attitudinal and behavioral change: * a pre-test at the start of the program * a first post-test 2-4 weeks following the conclusion of the program * a second post-test 6 months following the conclusion of the program * a third and final post-test 12 months following the conclusion of the program

Eligibility criteria:
inclusion criteria: * youth in washington d.c. who are participating in the t.r.i.g.g.e.r project, a grassroots youth firearm violence prevention program exclusion criteria: * emancipated minors

Keywords: youth violence prevention gun violence prevention positive youth development
detection rate of prostate cancer in men undergoing mri

Conditions: Prostatic Neoplasm

Summary: to assess prostate cancer (pca) detection rate in men undergoing magnetic resonance imaging (mri) before planning prostate biopsy. results will be stratified considering men with/without previous negative prostate biopsy. secondary objective will be to compute the negative predictive value of mri in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.

the trial is a retrospective observational study, with the aim to compare two cohorts of patients with suspicion of pca who will undergo mri. group a is composed by patients with previous negative biopsy, while group b is composed by men with no previous negative prostate biopsy. to reach primary aim, men with positive mri (clinically significant lesions with pi-rads score \>= 3) and biopsy data will be considered. in men with negative mri (clinically insignificant lesions or regions classified as pi-rads 2 at mri), follow-up with psa data and repeated mri and/or biopsy will be considered.

Eligibility criteria:
inclusion criteria: * age 50 and life expectancy greater than 10 years * psa values persistently greater than 4 ng/ml * multiparametric mri of the prostate between nov-2014 and nov-2016 * mri with endorectal coil exclusion criteria: * previous history of pca

Keywords: magnetic resonance imaging prostate biopsy
monitoring of helsingborg acute knee injuries (mohak)

Conditions: Knee Injury; Knee Osteoarthritis

Summary: using magnetic resonance imaging (mri), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.


Eligibility criteria:
inclusion criteria: 1. age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval) 2. a history of knee injury not more than 4 weeks prior to inclusion 3. agreement and informed consent to participate in the study exclusion criteria: 1. any mri contra-indications (such as extreme obesity, metal implants, claustrophobia etc.) 2. pregnancy 3. a history of deep vein thrombosis (dvt) or a disorder of the coagulative system 4. general disease that effects physical function or systemic medication/abuse of steroids 5. any other condition or treatment interfering with the completion or assessment of the trial.

Keywords: knee injury osteoarthritis anterior cruciate ligament injury patellar dislocation
effect of iv nalbuphine on nausea and vomiting following intrathecal morphine

Conditions: Inguinal Hernia

Summary: the study aimed to investigate the effect of iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.

bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (ponv) and pruritus, these side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of it morphine. nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 when added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. so, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive. the addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)

Eligibility criteria:
inclusion criteria: * patients of aged 15-70years old * males * scheduled patients for inguinal hernia repair surgery with under spinal anesthesia. * asa grade 1,2 * normal cardiac and renal function exclusion criteria: * patient refusal * allergy to the studied drugs. * patients with contraindications to spinal anesthesia * asa grade 3,4

Keywords: nalbuphine morphine iv intrathecal
msc for treatment of interstitial lung disease after allo-hsct

Conditions: Lung Diseases, Interstitial; Hematopoietic Stem Cell Transplantation; Bronchiolitis Obliterans

Summary: interstitial lung disease (ild） is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-hsct) leading to high morbidity and mortality. at present, the treatment for ild after allo-hsct remains in discussion. in this study, the efficacy of mesenchymal stem cells (mscs) combined azithromycin as well as glucocorticoid as the treatment of ild will be evaluated in the recipients of allo-hsct.

ild is a group of diseases involving pulmonary interstitial, alveolar and (or) bronchioles. in the patients receiving allo-hsct, ild mainly present as bronchiolitis obliterans syndrome (bos). ild after hsct is characterized by non-responsiveness to treatment, leading to high morbidity and mortality. msc has been considered as an effective treatment for refractory acute graft-versus-host disease (agvhd), but the response to treat chronic gvhd (cgvhd), especially refractory bos, is rarely reported.

Eligibility criteria:
inclusion criteria: * receiving allo-hsct * diagnosed with ild after allo-hsct exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)