Kornimate/medical-research-clean huggingface dataset:
trial of xeliri/folfiri + simvastatin followed by simvastatin maintenance in metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to compare 2nd line xeliri/folfiri + simvastatin vs xeliri/folfiri + placebo.

to compare progression free survival of the standard second line chemotherapy (folfiri, xeliri) plus simvastatin in metastatic colorectal cancer patients. this trial is a placebo-controlled study.

Eligibility criteria:
inclusion criteria: 1. histologically documented colorectal adenocarcinoma (previously failed to oxaliplatin) 2. age over 19 years old 3. performance status (ecog scale): 0-2 4. measurable or evaluable disease 5. adequate organ functions 6. life expectancy ≥ 3 months 7. no history of statin treatment within the last 12 months 8. patients should sign a written informed consent before study entry. exclusion criteria: 1. tumor type other than adenocarcinoma 2. second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence) 3. adjuvant or neo-adjuvant treatment for non-metastatic (m0) disease is allowed if completed at least 6 months prior to initiation of study treatment. 4. prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.

Keywords: colorectal cancer simvastatin second-line chemotherapy
effects of dietary supplements on sarcopenic elders

Conditions: Sarcopenia

Summary: sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and strength or an alteration in physical function. although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, the results were inconsistent and remain controversial. the objective of this study was to evaluate if a sufficient protein diet including supplements with leucine-enriched whey protein and vitamin d can lead to better improvement than sufficient dietary protein alone in maintaining muscle mass and strength among sarcopenic elders.


Eligibility criteria:
inclusion criteria: * older adults (≥ 65 years) * subject has lower appendicular muscle mass index (ammi) (\<7 kg/m\^2 in men; \<5.7 kg/m\^2 in women) using bioelectrical impedance analysis (bia, tanita bc-418®, tokyo, japan) * subject has lower handgrip strength (\<26 kg in men; \<18 kg in women) using dynamometer (camry®, zhongshan, guangdong) or slowly gait speed (\<1 m/s) exclusion criteria: * subject's life expectancy was shorter than 6 months * nursing home resident * subject has the history of kidney failure * subject has the history of liver failure * subject has the history of diabetes mellitus * subject has resistance exercise habit.
postnatal steroids effects on cardiac function in extremely preterm

Conditions: Left Ventricular Hypertrophy

Summary: hypothesis/study question in infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content? study objectives to measure effects before and after dexamethasone administration on cardiac structure/performance will be evaluated by using the m-mode technique (devereux method (25-27) and lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the pre specified time points. methodology / study design single center, prospective observational cohort study planning to enroll eligible patients over a period of 12 months

this study investigates the effects of dexamethasone on cardiac structure/performance and lung water content in the extremely preterm population undergoing treatment for significant lung disease. for that, the specific aims are to determine the occurrence, evolution over time and possible hemodynamic impact of left ventricular hypertrophy and occurrence and degree of water retention in premature lungs, after dexamethasone administration. as secondary outcomes, this study also investigates the effects of dexamethasone on the ductus arteriosus, body growth, and autonomic regulation heart rate variability, as well as other important outcomes outlined in this protocol. this study hypothesize that in some infants dexamethasone will be associated with the occurrence of early and/or prolonged left ventricular hypertrophy, which may be associated with changes in cardiac performance. it also hypothesize that the anti-inflammatory effects of dexamethasone would improve inflammation of immature lungs, leading to a decrease in interstitial fluid.

Eligibility criteria:
inclusion criteria: * \< 29 weeks of gestational age at birth admitted at the mcgill university children hospital's neonatal intensive care unit * to be initiated on dexamethasone therapy for treatment of significant lung disease as per medical team decision. exclusion criteria: * congenital heart disease (except: atrial septum defect (asd), ventricular septum defect (vsd) * major congenital anomalies/genetic disorder (trisomy 13, 18, 21) * congenital severe lung or airway malformation (trachea-esophageal fistula, congenital pulmonary airway malformation, congenital diaphragmatic hernia) * twin-twin transfusion syndrome

Keywords: lung ultrasound echocardiography heart rate variability left ventricular hypertrophy ductus arteriosus dexamethasone
nac phase iib: a multi-center, phase iib, randomized, placebo-controlled, double-blind study of the effects of n-acetylcysteine on redox changes and lung inflammation in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: this phase iib proof-of-concept study would examine the effects of an investigational product called n-acetylcysteine (nac) on the basic processes that cause inflammation in cf lung disease. we hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have cf.


Eligibility criteria:
inclusion criteria: 1. male or female 7 years of age or older 2. diagnosis of cf based upon the following criteria: 1. one or more clinical features characteristic of cf and (b or c) 2. positive sweat test \> 60 meq/l by quantitative pilocarpine iontophoresis 3. a genotype with two identifiable mutations consistent with cf 3. written informed consent (and assent when applicable) obtained from subject or subject's legal representative 4. clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment 5. stable mild or moderately severe lung disease defined by an fev1 \> or = 40% and \ or = 18 years, females \> or = 16 years) standardized equations 6. able to tolerate sputum induction with 3% hypertonic saline and to expectorate 7. able to perform repeatable, consistent efforts in pulmonary function testing 8. weight \> or = 25 kg at time of enrollment 9. females of child bearing potential must be willing to use birth control (iud, oral, transdermal, or parenteral contraceptives; abstinence) exclusion criteria: 1. clinically significant liver enzymes (ast, alt or ggt) \> 2.5 times the upper limit of normal at screening 2. history of abpa, unless have evidence of a stable ige (\< 5% increase compared to previous test) for 6 months prior to enrollment 3. current or history of rheumatic or collagen vascular disorders 4. use of nsaids other than for chronic therapy within 1 week prior to enrollment 5. initiation of chronic therapy with ibuprofen, azithromycin, tobi® or aztreonam within 6 weeks prior to enrollment 6. consumption or inhalation of antioxidants (including nac, gsh, immunocal, nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment 7. use of oral or iv corticosteroids within 4 weeks prior to enrollment 8. use of acetaminophen within 3 days prior to enrollment 9. unable to forego during the study: * vitamin e: more than 400 iu/day for subjects \ 12 years of age * vitamin c: more than 0.5 gm/day * more than two alcoholic drinks per day 10. known hypersensitivity to oral pharmanac® 11. current cigarette consumption 12. pregnant or breastfeeding 13. subject unlikely to complete the study as determined by the investigator 14. any condition that the investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject 15. participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment
effect of cervical paraesophageal lymph node metastasis versus supraclavicular lymph node metastasis on the overall survival of patients with thoracic esophageal squamous cell carcinoma: an observational study

Conditions: Esophageal Cancer

Summary: the goal of this observational study is to learn about in health conditions of escc. the main question\[s\] it aims to answer are: •lymph node metastasis(lnm) in cervical paraesophageal or supraclavicular which influence os more. participants will describe the main status quo after surgery researchers will compare lymph node metastasis(lnm) in cervical paraesophageal and supraclavicular to see if dead.

demographic and pathologic data, including gender, age, pathological t stage, pathological n stage, 8th tumor-node-metastasis (tnm) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, lnm, cervical paraesophageal lnm, supraclavicular lnm, and radical resection, were collected from the sichuan cancer hospital and institute esophageal cancer case management (sch-eccm) database.

Eligibility criteria:
the inclusion criteria were as follows: * patients who had undergone esophagectomy and * patients who exhibited lnm in the supraclavicular region. the exclusion criteria: * tumor location outside the thoracic region, * pathological examination results confirming the presence of non-squamous cell carcinoma, - patients with both cervical paraesophageal lnm and supraclavicular lnm, or * those with missing required data

Keywords: oesophageal squamous cell carcinoma; cervical paraesophageal lymph node metastasis; supraclavicular lymph node metastasis; lymphadenectomy; esophagectomy
the influence of type of anesthesia on postoperative pain

Conditions: Colo-rectal Cancer; Anesthesia

Summary: the investigators designed a multi-center prospective randomized controlled trial to study the influence of the type of anesthesia on postoperative pain after laparoscopic colorectal cancer surgery. half of the participants will be anesthetized with propofol and remifentanil, while the other half will be anesthetized with sevoflurane and remifentanil during the surgery. the investigators will measure opioid consumption and pain score in the acute postoperative phase.

previous studies showed that patients receiving total intravenous anesthesia (tiva) with propofol are associated with less postoperative pain and less opioid consumption compared with inhalation anesthesia. however, some studies showed conflicting results. in colorectal surgery, there are only retrospective studies that showed the analgesic effect of tiva and inhalation anesthesia. the investigators designed a multi-center prospective randomized controlled trial and hypothesized that tiva with propofol would be associated with reduced postoperative opioid consumption and less postoperative pain compared with sevoflurane in laparoscopic colorectal cancer surgery.

Eligibility criteria:
inclusion criteria: * adult patient scheduled for elective laparoscopic colorectal cancer surgery exclusion criteria: * pregnant * conversion from laparoscopic to open surgery * allergy to anesthetics and analgesics * previous abdominal surgery * chronic pain * chronic analgesic usage

Keywords: postoperative pain opioid consumption intraoperative anesthesia
comparative study for the validity of various severity scoring system

Conditions: Head Trauma; Polytrauma; Pre-Eclampsia; Sepsis; Septic Shock

Summary: scoring systems for use in intensive care unit (icu) patients have been introduced and developed over the last 30 years. they allow an assessment of the severity of disease and provide an estimate of in-hospital mortality

severity scoring systems that are commonly used in critical care settings include acute physiology and chronic health evaluation (apache), which was developed in the 1980s for predicting mortality, simplified acute physiology score (saps), and mortality probability model (mpm). although these scoring systems use different variables and weights for the classification of disease severity, they commonly monitor parameters such as heart rate, blood pressure, neurological state, and clinical data as these factors significantly deviate from physiological normality in the progression of critical disease. old age and chronic disease are also captured by the scoring systems. sequential organ failure assessment (sofa) score, which is based on organ failure over time to evaluate morbidity and multiple organ dysfunction is also used.

Eligibility criteria:
inclusion criteria: * newly admitted patients to the surgical intensive care unit with head trauma multiple trauma craniotomy sepsis preeclampsia - eclampsia postop. for vascular surgery exclusion criteria: less than 16 years old, readmitted to the icu during the study period as only the first admission will be considered, icu length of stay (los) less than 24 h

Keywords: apach iv; saps iii , sofa score
assessment of the effectiveness of ta versus leep for cervical cancer risk reduction in wlhiv in mozambique

Conditions: HIV Infections; HPV Infection; CIN 2/3

Summary: given that wlwh are more likely to develop persistent hpv infection and cc, effective screening and the management and treatment of pre-cancerous cervical abnormalities is critical to decrease the global burden of cervical cancer. the vast majority of wlwh live in ssa, where resources are more constrained. therefore, simple, affordable, and effective tools are needed for the prevention of cervical cancer in ssa. in this setting, the best method for treatment of screen-positive wlwh has not been determined. the proposed study will compare the effectiveness of ta vs. leep, for treating precursor lesions (cin 2/3) and hpv infection in wlwh, identify the determinants of treatment failure, and develop a strategy to predict patients in whom treatment is likely to fail so that alternative treatments can be provided. moreover, local evidence of the optimal method of treatments is necessary to inform health policy and promote adherence.

a. general purpose: the goal of this study is to compare ta, an ablative cervical treatment modality, and leep, an excisional cervical treatment modality, in screen-positive wlwh patients, for eradication of hrhpv and effectiveness of treating biopsy-confirmed cin 2/3. b. specific purposes primary objectives: 1. compare the effectiveness of treating biopsy-confirmed cin 2/3 by ta versus leep 2. compare the effectiveness of treating hrhpv infection by ta versus leep 3. assess pain and side effects/adverse events due to ta versus leep secondary objectives: 1. identify the determinants of treatment failures 2. develop a deep learning-based automated visual evaluation tool that predicts treatment failure

Eligibility criteria:
inclusion criteria: * ages 25-49 years; * confirmed hiv infection; * physically and mentally willing and able to participate in the study, and provide informed consent. exclusion criteria: * currently pregnant or \<6 weeks post-partum; * had a hysterectomy and no longer have a cervix; * a history of cervical cancer or treatment for cervical abnormalities; and * any medical, psychiatric, or other condition that would interfere with protocol adherence, assessment of safety, and/or ability/competence to provide informed consent.
analysis of the mechanisms of protective humoral immunity in response to the pneumococcal vaccine

Conditions: Healthy

Summary: the lack of clear guidelines and studies addressing the proper response to the pneumococcal vaccine (pneumovax ®) has hampered our ability to diagnosis and care for our immunodeficiency patients. should an age matched normal response range to the pneumovax ® be established, it would have a profound impact in the diagnosis, safety and care of immunodeficiency patients. moreover, characterizing the b cell compartments response to the pneumovax ® may better delineate the mechanism of protective immunity from pneumovax ® and provide an additional tool for the diagnosis and care for immunodeficiency patients.

the ability to respond to a polysaccharide vaccine antigen is an integral part of evaluating a patient with immunodeficiency. the pneumococcal vaccine (pneumovax ®) remains the only readily available and the most widely used unconjugated polysaccharide vaccine. although the pneumococcal vaccine is widely used test the immune systems response to a polysaccharide antigen, no clear guidelines or studies exist to what is considered a proper response to the pneumovax ®. immunoglobulin m (igm) memory b cells are thought to play an important role in protection against pneumococcal disease. it is not known to what extent the ability of b cells to be activated in response to pneumococcal vaccination contributes to protective immunity. to address these issues, the following two specific aims are proposed: specific aim 1. assess immunoglobulin g (igg) antibodies to pneumococcus pre- and post-pneumococcal immunization in healthy controls specific aim 2. analysis of b cell subsets in blood of healthy controls pre-and post-pneumococcal immunization to identify changes in memory b cell, class switched and activated b cells.

Eligibility criteria:
inclusion criteria: * patients from 20 to 70 years of age exclusion criteria: * previous or current diagnosis of an immunodeficiency (primary and secondary) * previous or current diagnosis of a rheumatological disorders (rheumatoid arthritis, lupus, sjögren, vasculitis), cancer, diabetes, active infection and/or other chronic diseases (multiple sclerosis, etc) * current or previous use (within that last 6 months) of systemic/inhaled corticosteroids, sulfasalazine, and other immunosuppressive agents (cyclosporin, methotrexate, cellcept) anti-convulsants (phenytoin, carbamazepine), gold, d-penicillamine, and anti-malarials (quinine, chloroquine, hydroxychloroquine) * pregnancy

Keywords: pneumococcal vaccine normal response immunodeficiency healthy patients healthy volunteers
a clinical trial of anakinra for steroid-resistant autoimmune inner ear disease

Conditions: Sensorineural Hearing Loss; Autoimmune Inner Ear Disease

Summary: the purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with autoimmune inner ear disease (aied) that did not respond to oral steroid therapy for a sudden decline in hearing. the patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. of those treated, approximately 60% respond, however, that response may be lost over time. other therapies use to date have proven largely ineffectual in improving hearing. this study proposes a phase i open label clinical trial of anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.

Eligibility criteria:
inclusion criteria: * bilateral sensorineural hearing loss with an active decline in hearing in one ear * no audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days * enrollment within 14 days of completion of corticosteroid therapy * age 13 years and older * no evidence of neutropenia (low white blood cell count) * no evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma) * may have concurrent, systemic autoimmune disease exclusion criteria: * age over 75, or less than 13 * neutropenia * renal insufficiency * pregnant females * unilateral hearing loss * patients with any immunodeficiency syndrome * patients receiving methotrexate or any tnf (tumor necrosis factor) antagonist therapy * patients with chronic infections * patients treated for a malignancy within the past 3 years * patients with a latex allergy * patients with an inner ear anomaly * patients with retrocochlear pathology

Keywords: steroid steroid-resistant autoimmune inner ear disease immune mediated hearing loss sudden sensorineural hearing loss meniere's disease autoimmune hearing
anxiety in relation to nausea and vomiting in pregnancy

Conditions: Nausea Gravidarum; Anxiety

Summary: the goal of this observational study is to learn more about the relation between anxiety (assessed by gad-7 questionnaire) and the nausea and vomiting in pregnancy (objectively measured by puqe score). participants will answer 2 questionnaires: (gad-7) for anxiety; and (puqe score) for nausea and vomiting.

study procedures: * protocol approval will be sought from the ethical committee of the department of obstetrics \& gynecology, faculty of medicine, ain shams university. * recruitment of pregnant women complaining of nausea and vomiting in pregnancy (nvp) in first trimester will be done from the outpatient clinic and antenatal ward in ain shams university maternity hospital. * an informed written consent will be taken from all participants before enrollment in the study. * history taking, examination, and investigations (cbc, ultrasound, acetone in urine, serum sodium, potassium, alanine transaminase (alt), aspartate transaminase (ast), serum creatinine) will be done to identify eligible patients according to the inclusion and exclusion criteria. * puqe score will be calculated for each patient. patients will be classified into 3 groups (mild, moderate, severe) accordingly. * gad-7 questionnaire will be calculated for each patient. degree of anxiety will be classified into 4 groups (minimal, mild, moderate, severe) accordingly. * data will be recorded in a case report form. * statistical analysis will be done accordingly.

Eligibility criteria:
inclusion criteria: * pregnant women in first trimester complaining of nvp * age (18-40) years exclusion criteria: * history of known medical problem (e.g., endocrine abnormalities, gastrointestinal disease). * known current or past psychiatric disorder (e.g., depression, anxiety, bipolar disorder, delirium, eating disorders, and psychotic disorder) * multiple pregnancy * known obstetric complications (non-viable pregnancy; either ectopic pregnancy; gestational trophoblastic disease, or miscarriage). * medications (including antidepressant, anti-psychotic or other psychiatric drugs during the last 6 months) or illegal drug or narcotic use that would affect the test results * current or past history of cognitive incompetence which can make it difficult to understand how to score gad-7 questionnaire.

Keywords: puqe score gad-7 questionnaire