Kornimate/medical-research-clean huggingface dataset:
safety of amg 706 plus panitumumab plus chemotherapy in the treatment of subjects with metastatic colorectal cancer

Conditions: Rectal Cancer; Colon Cancer

Summary: the purpose of this study is to characterize the safety and tolerability of amg 706 plus panitumumab when administered with either folfiri or folfox4 chemotherapy regimens. this is a phase 1b clinical study.


Eligibility criteria:
for complete inclusion and exclusion criteria, please refer to the investigator. inclusion criteria 1. competent to comprehend, sign, and date an institutional review board (irb) approved informed consent form 2. diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic crc) 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 4. adequate hematological function 5. adequate renal function 6. adequate hepatic function 7. life expectancy of greater than or equal to 3 months as documented by the investigator exclusion criteria: 1. more than 1 prior chemotherapy regimen for metastatic crc 2. central nervous system (cns) metastases 3. history of venous thrombosis 4. myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment 5. history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (ct) scan 6. average systolic blood pressure \> 150mm hg or average diastolic blood pressure of \> 90mm hg 7. radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions 8. prior amg 706, oral inhibitors of amg706, panitumumab, or another anti-egfr monoclonal antibody (mab) (e.g., cetuximab \[erbitux®\] or emd 72000) 9. systemic chemotherapy within 28 days before study enrollment 10. major surgery within 28 days or minor surgery within 7days of study enrollment 11. history of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia) 12. female and male subjects of childbearing potential not using adequate contraceptive precautions 13. participation in therapeutic clinical trials within 30 days before study enrollment 14. not recovered from all previous therapies 15. clinically significant open would, ulcer or fracture 16. any co-morbid medical condition that would increase the risk of toxicity

Keywords: amg 706 panitumumab
efficacy and safety study of fluticasone/salmeterol administered with elpenhaler

Conditions: Asthma

Summary: the aim of this study is to establish the therapeutic equivalence between the test (fluticasone/salmeterol administered with elpenhaler®db, rolenium®) and the reference formulation (seretide®, administered with diskus®), both containing 250/50μg of the fluticasone/salmeterol combination. in case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence.

a pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of fluticasone/salmeterol with the innovative one. the test and reference fluticasone/salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. forced expiratory volume in 1 second (fev1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both fluticasone/salmeterol formulations in patients with asthma. in terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ecg changes will enable the establishment of the similar safety profile of the test and reference fluticasone/salmeterol combinations. the study will be conducted in a randomized, double-blind, double-dummy, placebo-controlled, 3x3 crossover fashion.

Eligibility criteria:
inclusion criteria: * age 18-65 years, * diagnosis of asthma of 6 months, * fev1 ≥ 50% and ≤ 80% predicted, reversibility of at least 12%, * stable asthma for at least 4 weeks, * inhaled steroids (ics) at a stable dose within the previous 30 days, * pif 30 - 90 lt/min and * informed consent. exclusion criteria: * history of other pulmonary disease, asthma exacerbation or respiratory infection within the previous 4 weeks, * hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase within the previous 30 days, * heavy smokers, * change of asthma medication within the previous 4 weeks, seasonal asthma alone, * history of severe heart disease, * pregnancy or lactation, * use of a β-blocker, of a nsaid or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.

Keywords: respiratory combination treatment elpenhaler diskus
multimodal intervention for patients with non-small cell lung cancer

Conditions: Cachexia; Cancer

Summary: a single-arm intervention study assessing the feasibility of a multimodal intervention of management of cancer cachexia in patients with non-small cell lung cancer during primary anti-neoplastic treatment. the effects of the intervention is compared to a historical control group

in a single arm intervention study, we will provide a multimodal intervention consisting of dietary counselling, physical exercises plan as well as fish oil. the target of the dietary counselling is: * 30 kcal/kg/d (in patients with bmi \ 30) * at least 1.0 g protein/kg/d * three daily meals of at least 20 g of protein * restrict overnight fasting to a maximum of 11 hours the initial dietary counselling is at the first cycle of anti-neoplastic treatment. the patient will be provided an individual plan to meet the dietary targets tailored to the individual preferences and symptoms. at every cycle of anti-neoplastic treatment, the plan will be adjusted if needed. at every week the patients will be prompted by telephone to comply with the dietary plan. the physical exercise consists of two exercises: * strength training: a progressive sit-to-stand exercise which is a lower extremity exercise. * cardio-vascular training: a progressive brisk walking plan. patients are prompted to execute both exercises twice weekly. the individual targets are set at the first cycle of anti-neoplastic treatment and adjusted during the trial. fish oil: the patients are instructed to ingest 10g of liquid fish oil (consisting of 2 g epa/dha) or 8 capsules of fish oil (consisting of 2 g epa/dha)

Eligibility criteria:
inclusion criteria: * histopathologically or cytologically verified with nsclc * inoperable tumour, candidates for, but naïve to or no systemic anti-neoplastic treatment the previous two years * commence first line of chemotherapy (carboplatin/vinorelbin, cisplatin/vinorelbin) with or without radiation therapy or pembrolizumab * performance status ≤2 (eastern cooperative oncology group) * age \>18 and provided oral * written consent exclusion criteria: * excessive alcohol or drug abuse * incapable to follow the intervention (i.e. cognitive problems or unable to walk) were excluded.

Keywords: cachexia cancer multimodal intervention
a safety clinical trial of different doses of medi-507 in the prevention of acute renal allograft rejection

Conditions: Kidney Diseases

Summary: to evaluate the clinical safety of different doses of medi-507 through day 33.

to evaluate the pharmacokinetic characteristics of medi-507 given in dose intervals.

Eligibility criteria:
inclusion criteria: * renal allograft recipients receiving their first or second allograft * age over 18 * maintained on conventional immunosuppression * completed informed consent document exclusion criteria: * known hypersensitivity to medi-507 * more than two renal allografts * moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial * simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert) * any of the following clinical settings or diagnoses posttransplant: pregnancy or nursing mother: ø human immunodeficiency virus infection ø hemodialysis or chronic peritoneal dialysis ø use of a ventilator ø hyperacute rejection * having received okt3, tacrolimus, or antilymphocyte globulin during the current allograft * less than 10 ml/hr average urine output over 4 hours since the end of surgery
impact of interval training on sympathetic hyperactivity and vascular function

Conditions: Heart Failure

Summary: in this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (hiit) than moderate-intensity continuous training (mict) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (hfref).

in this study, the investigators are testing the hypothesis that reductions in sympathetic activity would be greater following high-intensity interval training (hiit) than moderate-intensity continuous training (mict) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (hfref). to test this hypothesis patients with chronic heart failure (30 - 65 years), left ventricular ejection fraction ≤40%, functional classes ii-iii), are being randomized into exercise with hiit, mict or no training (nt) three times/week for 12 weeks. muscle sympathetic nerve activity is assessed by microneurography. brachial artery flow-mediated dilation (fmd), blood flow and vascular conductance were assessed by ultrasonography. blood pressure (bp) and heart rate (hr) by are being measured via finger photoplethysmograph and peak oxygen uptake (v̇o2peak) by a cardiopulmonary exercise test on ergometer cycle for leg. biopsy samples from the lateral vast of the thigh are being collected for analysis of the intracellular mechanisms in the skeletal muscle. exercise training is being conducted under supervision at the heart institute, school of medicine, university of são paulo. both hiit and mict are performed on a cycle ergometer, three times per week for 12 weeks, and training sessions were matched for energy expenditure (i.e., an isocaloric energy expenditure of 200 kcal/session). the intensity of the mict session is established based on the hr and workload levels corresponding to anaerobic threshold and respiratory compensation point (rcp). the intensity of the hiit session is established based on the hr and workload levels corresponding to 5% above the rcp. all exercise sessions were performed under the supervision of an exercise physiologist. the patients in the nt group were instructed to avoid any regular exercise program or any non-supervised exercise protocol during the study. all patients are being assessed before (pre) and after (post) both exercise training modes or control, no training.

Eligibility criteria:
inclusion criteria: * functional class ii to iii of new york heart association * left ventricular ejection fraction ≤40% * peak oxygen uptake (v̇o2) \<20 ml•kg-1•min-1 exclusion criteria: * myocardial infarction within three months * unstable angina * acute heart failure * pacemaker * pulmonary disease * chronic renal disease * peripheral neuropathy * history of stroke * untreated hypo/hyperthyroidism * body mass index (bmi) \>30 kg/m2 * history of smoking
resilience to antibiotic-induced obesogenic microbiota: discovering mechanism of microbiota modulation

Conditions: Healthy Newborn Infants

Summary: the aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. a total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.


Eligibility criteria:
inclusion criteria: pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery. exclusion criteria: * chorioamnionitis * pre-eclampsia and hepatogestosis * suspected malformation or serious condition of the foetus and neonates * serious infection or other conditions not permitting breast milk feeding

Keywords: antibiotics human milk oligosaccharides probiotics newborn microbiome microbiota obesity infectious diseases
descriptors and predictors of burden and information needs

Conditions: Advanced Lung Cancer; Symptoms

Summary: the purpose of this study is to investigate over time patients' symptom burden, caregiving burden, and patients and caregivers' need for information on patient symptom self-management at home during palliative radiotherapy(rt) for lung cancer. repeatedly assessing burden and information needs on symptom self-management at home can help healthcare professionals to design a bespoke service and plan of care for both patients and family caregivers. in addition, i will explore psycho-social and clinical predictors of burden and information needs in patients and caregivers. these predictors can help health professionals to identify patients and caregivers at risk for distress during palliative radiotherapy for lung cancer.

eligible patients will be invited to take part in the study via a patient information sheet. they will also be asked to nominate their primary caregiver, who will also be invited to take part in the study. we will give patients and caregivers 24 hours to decide whether they want to take part or not. if they do decide to take part, all research participants will be involved in the study on four consecutive occasions before, during and after their treatment. these four time points will be the following: * before first fraction of rt * 1st week of rt (1st-5th faction) * 2nd week of rt (6th-10th fraction) * 1 month after the last fraction of rt the principal researcher, i.e. saengrawee thanthong, will endeavour to collect questionnaires in the hospital. if participants cannot come to the hospital to receive radiotherapy or for their follow up appointment and complete the questionnaire, then the principal researcher will call them and offer to complete the questionnaires over the phone so as to minimise missing data due to attrition.

Eligibility criteria:
inclusion criteria:• inclusion criteria for patients: * histological diagnosis of lung cancer with stage iii-iv(tnm) * age: 18 years or over * planning for palliative rt * scheduled to receive up to 10 fractions of palliative radiotherapy (stevens, macbeth, toy, coles, \& lester, 2015) • exclusion criteria for patients: * non-english, non-thai speaking * diagnosis of severe cognitive or mental illness that affects communication patients' family caregivers will also be invited to participate as per below: * inclusion criteria for caregivers: * family member of the care recipient can be spouse, child, parent, friend etc. * age: 18 years or over * only one family member if the patient presents with more than one. * same person in every time point * exclusion criteria for caregivers: * non-english, non-thai speaking

Keywords: symptoms predictor information needs self-management at home palliative radiotherapy
extended physiotherapy after intensive care unit (icu) stay

Conditions: Critical Illness; Physical Disability

Summary: patients in an intensive care unit (icu) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. the objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-icu patients.the study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.

the study design is a before and after study. a control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. an intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). the primary outcome was physical function measured with the chelsea critical care physical assessment tool (cpax), in the icu and the surgical ward.

Eligibility criteria:
inclusion criteria: * age over 18 years * icu stay \>48 hours * understand the swedish language exclusion criteria: • patients palliative care with no intention of rehabilitation

Keywords: physical therapy physical function
left ventricular diastolic function during anesthesia induction

Conditions: Left Ventricular Diastolic Dysfunction

Summary: diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. the impact of different anesthetics on diastolic function is investigated.

in this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. anesthesia is maintained with sevoflurane or propofol. before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. all anesthetic medications, fluids, vasoactive medications and catecholamines are registered.

Eligibility criteria:
inclusion criteria: * patients older than 60 years scheduled for general anesthesia exclusion criteria: * mitral regurgitation or stenosis \> i° * sp. mitral valve repair or replacement * pericardial effusion * atrial fibrillation/flutter * patients with pacemaker * bmi \> 35 kg/m2
study of two marketed ocular anti-allergy medications in subjects with allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * documented history of ocular allergy to cats. * positive skin prick allergen reaction to cat dander. exclusion criteria: * use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, nsaids, or asprin during the two weeks prior to enrollment into the study. * history of severe asthma, reactive airway disease or bronchial obstruction. * ocular surgery or trauma in the last year.
mri versus four dimensional ultrasound in detection of cns fetal congenital anomalies

Conditions: Congenital Anomalies

Summary: congenital central nervous system (cns) anomalies are common and most devastating. they occur in frequency of about 1.4 to 1.6 per 1000 live births but are seen in about 3-6% of still births.they account for 40% of deaths of all infants in the first year of life. in survivors, they cause a variety of neurological disorders, mental retardation or drug resistant epilepsy. cns anomalies are usually compatible with life, prolonged hospitalization, higher health care costs, uncertain future life quality and significant burden to families and society.

early detection of congenital cns anomalies gives time available for the clinician and parents to plan about the outcome of pregnancy. prenatal ultrasound has been well established for decades as the primary technique for evaluating the developing fetus in normal as well as in high risk cases. advantages of us include widespread availability, relatively low cost and quick, lack of harmful effect to fetus or mother and real time imaging. although ultrasound can characterize many anomalies accurately, it has many limitations as operator dependent, small field of view, and relatively poor soft-tissue contrast, beam attenuation by maternal adipose tissue and fetal bone, limited visualization of posterior fossa after 33 weeks gestation because of calvarial calcification. also, ultrasound relies heavily on fetal positioning and presence of sufficient amniotic fluid to provide an adequate acoustic window fetus so, us findings are occasionally incomplete or inconclusive to guide treatment choices. fetal brain mri became embraced as a clinically important imaging technique useful for fetal assessment, which is helpful in formulating prognosis and perinatal management and can detect occult abnormalities in up to 50% of cases for certain indications. it can overcome many of ultrasound limitations as it is not limited by maternal obesity, fetal position, or oligohydramnios. additionally, it has better soft tissue contrast resolution, as well as the ability to distinguish individual fetal structures such as brain, lung, liver, kidney, and bowel. in addition, visualization of the brain is not restricted by the ossified skull. moreover, mri provides multiplanar imaging as well a larger field of view, facilitating examination of fetuses with large or complex anomalies.

Eligibility criteria:
inclusion criteria: 1. all pregnancies with either suspected or detected fetal anomalies on ultrasound excluding first trimester pregnancies (to allow completion of period of organogenesis). 2. pregnant females with past or family history of congenital fetal abnormality. exclusion criteria: 1. pregnancies with normal antenatal us. 2. pregnancies in first trimester 3. claustrophobic patients. 4. contraindication to mri as cochlear implants and pacemakers.