Kornimate/medical-research-clean huggingface dataset:
effect of nutri-jelly on quality of life in head and neck cancer patients

Conditions: Head and Neck Cancer; Dysphagia

Summary: the purpose of this study is to determine whether a novel edible nutritious gel for patients with chewing and swallowing difficulties, nutri-jelly, is effective in improving the quality of life of head and neck cancer patients while undergoing conventional radiotherapy.

* independent variable: continuous nutri -jelly intake * dependent variable (outcome): changes in health-related quality of life score

Eligibility criteria:
inclusion criteria: * diagnosed as head and neck cancer * definitive or palliative radiotherapy treatment plan * can communicate well exclusion criteria: * bleeding in the mouth * respiratory distress * psychiatric disorders * radiation field not involve masticatory and swallowing apparatus e.g. certain cases of laryngeal cancer and brain cancer
healthy futures project: a community based obesity prevention program

Conditions: Overweight; Obesity

Summary: the purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management. the problem of obesity is at epidemic proportions and has become the most important public health problem confronting the united states today. of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. childhood obesity is a precursor of adult obesity.

the switch™ program is a unique community and family-based behavior change initiative that helps motivate children to change three critical health behaviors that are risk factors for childhood overweight and obesity. through community education, family-based strategies and partnerships with schools, 3rd, 4th and 5th graders are encouraged to: switch what you do™ switch what you view™ switch what you chew™.

Eligibility criteria:
inclusion criteria: * all children in 3-5 grades who provide parental consent and child assent will be eligible to participate in the project. exclusion criteria: * participants who meet the following exclusion criteria will not be considered for participation. * do not provide consent * unable or unwilling to adhere to project procedures

Keywords: screen time fruits and vegetable consumption physical activity obesity overweight
low-fat vegan diet versus a mediterranean diet on body weight

Conditions: Overweight; Obesity; Insulin Resistance

Summary: this randomized, cross-over trial aims to assess changes in body weight, plasma lipids, insulin sensitivity, and postprandial metabolism with a low-fat, plant-based diet and a mediterranean diet, both followed for 4 months.

in a 36-week cross-over trial, overweight adults will consume a low-fat vegan diet and a mediterranean diet in two separate 16-week phases. changes in body weight will be the primary dependent variable. in addition, plasma lipid concentrations, insulin sensitivity, and postprandial metabolism will also be assessed and changes over time will be compared between the two diets. participants will be randomly assigned to start either a low-fat vegan diet or a mediterranean diet for 16 weeks. both groups will receive weekly classes and support, and will be asked to make no changes to their exercise patterns for the study period. after a 4-week washout period, participants will cross over to the second dietary intervention for another 16 weeks.

Eligibility criteria:
inclusion criteria: * men and women age ≥18 years of age * body mass index 28-40 kg/m2 exclusion criteria: * diabetes mellitus type 1, history of any endocrine condition that would affect body weight, such as thyroid disease, pituitary abnormality, or cushing's syndrome * smoking during the past six months * alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use * use of recreational drugs in the past 6 months * use within the preceding six months of medications that affect appetite or body weight, such as estrogens or other hormones, thyroid medications (unstable dose within the preceding 6 months), systemic steroids, antidepressants (tricyclics, maois, ssris), antipsychotics, lithium, anticonvulsants, appetite suppressants or other weight-loss drugs, herbs for weight loss or mood, st. john's wort, ephedra, beta blockers * pregnancy or intention to become pregnant during the study period, as verified by self--- - unstable medical or psychiatric illness * evidence of an eating disorder * likely to be disruptive in group sessions * already following a low-fat vegan diet or mediterranean diet * lack of english fluency * inability to maintain current medication regimen * inability or unwillingness to participate in all components of the study * intention to follow another weight-loss method during the trial

Keywords: plant-based diet mediterranean diet vegan diet metabolism insulin sensitivity cholesterol advanced glycation end-products
efficacy and safety of sirolimus with or without cyclosporin a in chinese patients with aplastic anemia refractory/intolerant to cyclosporin a

Conditions: Aplastic Anaemia

Summary: this is a single center, randomized, open-label, phase ii study to compare the efficacy of sirolimus combined with cyclosporin a (csa) to sirolimus alone in chinese subjects with aplastic anemia refractory/intolerant to csa. the safety would also be evaluated. patients would be randomized to receive sirolimus alone or sirolimus combined with csa at a 1:3 ratio. treatment with sirolimus will be started at 1-3 mg once daily orally, with a target trough blood concentration of 4-12 ng/ml. csa will be given at 25-150 mg orally every 12 hours, with the dose adjusted based on renal function and trough concentration. for patients with normal renal function, the target trough concentration is approximately 150 ng/ml. for patients with impaired renal function, the cyclosporine a dose is reduced to 25-50 mg every 12 hours, aiming for recovery or stabilization of renal function. the hematological response rate and safety will be recorded and compared at 3 and 6 months after starting the study treatment (week 13 and 25).


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. diagnosed with acquired aplastic anemia (aa), excluding congenital aa; 3. at least one of the following criteria met at enrollment: hemoglobin \< 100 g/l, platelets \< 50 × 10⁹/l, or neutrophils \< 1.0 × 10⁹/l; 4. at enrollment, meeting at least one of the following conditions: ① cyclosporine a (csa) ineffective: (csa) used for at least 3 months without achieving partial response (pr), or disease relapse occurred; ② csa intolerant: unsuitable for standard dose csa treatment due to adverse events or underlying conditions. 5. no active infections; 6. not pregnant or breastfeeding; 7. willing to sign the consent form; 8. eastern cooperative oncology group (ecog) performance status score of 0-2. exclusion criteria: 1. pancytopenia caused by other reasons, such as myelodysplastic syndrome (mds); 2. evidence of clonal hematopoietic system bone marrow diseases (e.g., mds or acute myeloid leukemia, aml); 3. paroxysmal nocturnal hemoglobinuria (pnh) clone ≥ 50%; 4. history of hematopoietic stem cell transplantation (hsct) before enrollment; 5. previous use of sirolimus or allergy to sirolimus; 6. severe adverse events to csa in the past, making it unsuitable for reuse; 7. uncontrolled infection or bleeding with standard treatment; 8. active infections with hiv, hcv, or hbv, liver cirrhosis, portal hypertension; 9. any concurrent malignancy within the past 5 years, except for localized basal cell carcinoma of the skin; 10. history of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid antibody syndrome), or current use of anticoagulants; 11. pregnant or breastfeeding women; 12. participation in other clinical trials within the past 3 months.

Keywords: sirolimus relapsed/refractory aplastic anemia
safety and efficacy of two tetanus-diphtheria vaccines for a donor hyper immunization program

Conditions: Healthy

Summary: many plasma donation centers have tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. the immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease. the tetanus vaccine previously used for these programs is no longer being manufactured. therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. the only other fda approved tetanus vaccines currently available for adults in the us are combination vaccines that also immunize against diphtheria and/or pertussis. in this study, the investigators will evaluate two vaccines that are combinations of tetanus and diphtheria (td). investigators will not evaluate any vaccines containing pertussis antigen. the vaccines to be evaluated are manufactured by massbiologics and sanofi pasteur (tenivac). the package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. however, this study will evaluate whether they are safe and effective for dosing every 90 days. the investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. each vaccine will be evaluated separately.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18\* years of age at visit 1. 2. subject has met all suitability criteria that would allow donation as a normal source plasma donor 3. subject has not been immunized for tetanus within the prior three (3) months 4. subject is not participating in any other immunization program 5. subject possesses a pre-existing antibody for tetanus of at least 0.15 iu/ml exclusion criteria: 1. pregnant. 2. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 3. subject has a hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.) 4. subject has history of a severe reaction to any immunization 5. subject has a history of guillain-barré syndrome 6. subject is unable to read and/or write due to illiteracy or a physical impairment. 7. the investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for adverse event assessment * or legal adult according to local law. participants in ne limited to individuals age 19-69 years due to age of majority laws in ne.

Keywords: plasma plasma donor plasma donation tetanus td immunoglobulin hyper-immunization
the healthymoms trial to promote healthy gestational weight gain

Conditions: Gestational Mothers; Weight Gain

Summary: excessive gestational weight gain is a major public health problem. traditional face-to-face intervention programs has been shown to be succesful in order to promote healthier weight gains, however, they are time-consuming and expensive. the objectives of this study are to assess whether a 6-month smartphone application can promote healthy gestational weight gain, dietary habits and physical activity in pregnant women.

excessive gestational weight gain (gwg) increases risks for pregnancy complications, postpartum weight retention and offspring obesity. traditional intervention programs are time and cost intensive. mobile technology (mhealth) has been successful for weight loss and behavior changes; however, their use in pregnancy need to be further examined. this study aims to evaluate the impact of a smartphone application (app) intervention on gwg, diet, physical activity and glucose homeostasis. healthymoms is a randomized controlled trial recruiting women at the first maternity clinic visit (week 6-10) in the linköping area, sweden. women will be randomized to the control or intervention group (n=150 per group). all women will receive standard care. the intervention group will also receive the healthymoms smartphone app promoting healthy eating, activity and gwg during 6 months. pregnancy outcomes are gwg (primary), food intake (web-based questionnaire), fat mass (bodpod), glucose homeostasis, activity (accelerometer) in week 37. maternal and infant body fatness will be assessed one week post partum.

Eligibility criteria:
inclusion criteria: * a single pregnancy * aged 18 years or above * be able to speak and read swedish sufficiently well. exclusion criteria: * previous diagnosed eating disorder * pre-pregnancy diabetes or medical conditions or pharmacological treatments prior to pregnancy that may affect body weight
food frequency questionnaire (ffq) for coronary heart disease (chd) patients

Conditions: Coronary Heart Disease

Summary: this study aims to evaluate the psychometric properties of a newly developed ffq specified for northern chinese chd and their high risk patients (chd-ffq). the psychometric properties include test-retest reliability, content validity, convergent validity, discriminant validity, concurrent validity and predictive validity. particularly, this study will measure the physiological indicators, including plasma lipid profile (i.e. tg, tc, hdl-c, ldl-c), bg, bp and bmi twice at baseline and the end. the level of these physiological indicators will be compared with the fat intake measured by the chd-ffq, i.e. the baseline intake to test its convergent validity. it is also expected to predict the diet-related progression of chd risks among high-risk individuals, i.e. patients with two or more chd risk factors as following: raised fasting blood glucose (bg) level, increased blood pressure (bp), increased triglycerides (tg), decreased hdl-cholesterol (hdl-c), increased ldl-cholesterol (ldl-c), smoking and central obesity (international diabetes federation, 2015). in addition, this study will provide the ffq's concurrent validity in assessing the intake of energy and nutrients against the cdc-ffq. moreover, whether the ffq could detect the known differences in energy intake between men and women will be established for its discriminant validity.


Eligibility criteria:
inclusion criteria: * 18 years or older; * have no chd at enrollment; * at high risk of chd with at least two of the following risk factors: * current smoking: current smokers are defined as individuals who smoked regularly during the last 12 months * central obesity: for chinese, central obesity is defined as waist circumstance above 90cm for male and 80cm for female, or with bmi above 30kg/m² * raised bp (systolic bp \[sbp\] ≥ 130 mmhg or diastolic bp \[dbp\] ≥85 mmhg or under antihypertensive treatment) * raised fasting bg (fbg) (100mg/dl \[5.6mmol/l\]) or under treatment with insulin or oral hypoglycemic agents * elevated tg (150mg/dl \[1.7mmol/l\]) * elevated tc (≥ 240 mg/dl \[5.18 mmol/l\]) * raised ldl-c (≥ 160 mg/dl \[4.15 mmol/l\]) * decreased hdl-c (\<40 mg/dl \[1.03 mmol/l\] for males, and \<50 mg/dl \[1.29 mmol/l\] for females) * undergoing hyperlipidemia treatment exclusion criteria: * impaired bilateral hearing * impaired mental status (according to their medical record)

Keywords: food frequency questionnaire; psychometric properties
effectiveness of educational poster to primary and secondary teachers regarding emergency management of dental trauma

Conditions: Knowledge Regarding Dental Trauma

Summary: the poster is effective in improving the level of knowledge regarding dental trauma of primary and secondary schools teachers in hong kong. a cluster randomized controlled trial was conducted in mid may 2011,to test the level of knowledge regarding dental trauma with two groups, the intervention group with posters and control group without posters. a questionnaire is used to test the level of knowledge.

a cluster randomized controlled trial was conducted in mid may 2011, hong kong where no educational campaign regarding dental trauma targeting on primary and secondary school teachers was implemented before. lists of primary and secondary schools were requested from the education bereau. schools were invited to join the study from 1.3.2011 and then randomized to the intervention group and the control group in the unit of school using computer generated numbers. all teachers filled in the first questionnaire and send it back to the investigator in 1 week. 3 copies of the same educational poster were given to the intervention schools, these schools were requested to display them in 1. the medical room 2. staff common room and 3 anywhere that information was usually placed for the teachers. no poster was given to the control group. after 2 weeks, the posters were removed by the teacher in charge. the same questionnaire was filled in by all the teachers in both groups and sent back in 1 week. the data were processed to show whether the poster was effective to improve the knowledge of the teachers. the study was complied with declaration of helsinki and ich gcp guidelines primary outcome measures the score of the questionnaire

Eligibility criteria:
inclusion criteria: * the targeted group of this study included teachers working in primary (us grade1-6) and secondary (us grade 7-12 plus 1 year) schools in hong kong, who can read chinese or english. exclusion criteria: * cannot read english or chinese

Keywords: education, knowledge, poster, dental trauma
a methodology study of brain imaging of pain-killers in post-traumatic neuropathic pain patients

Conditions: Pain

Summary: this study is a methodology study designed to discover whether a brain imaging technology is a better way of compare the relative sensitivities of fmri and subjective psychometric assessments of pain to multiple doses of pregabalin and tramadol sr in a cross-over clinical study design.


Eligibility criteria:
inclusion criteria: * diagnosis of neuropathic pain associated with brush allodynia in specific dermatomes. * brush allodynia score of ≥4 and calculated average pain score of ≥3 on an 11-point numerical rating scale by the completion of down-titration of existing medications. * right-handed exclusion criteria: * subjects with trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and/or traumatic spinal cord injuries including spinal surgery). * phantom limb pain, painful diabetic neuropathy. * subjects with any other co-existing pain which he/she or a qualified pain physician cannot differentiate from nep of peripheral origin. * subjects with diabetes mellitus and with an hba1c value of \>10% upon measurement at screening.
retrospective analysis of 2nd-line nab-paclitaxel + gemcitabine after 1st-line folfirinox in pancreatic cancer

Conditions: Pancreatic Cancer; Metastatic Pancreatic Cancer

Summary: in this study, clinical data of patients who received 2nd-line nab-paclitaxel plus gemcitabine (nab-p+gem) after progression on 1st-line folfirinox will be reviewed retrospectively.

folfirinox is one of standard 1 st-line regimens for patients with advanced pdac. however, there is no globally established 2 nd-line regimen after the failure of folfirinox. although gemcitabine-based regimens are recommended by multiple guidelines and widely used in daily practice, further analysis is needed to reveal the magnitude of clinical benefit with these regimens. nab-paclitaxel plus gemcitabine (nab-p+gem) is another standard 1 st-line regimen for pdac, but there are limited data as 2 nd-line therapy in pdac. therefore, the investigators are conducting a multicenter retrospective analysis of 2 nd-line nab-p+gem after progression on folfirinox in patients with advanced pdac.

Eligibility criteria:
inclusion criteria: * pathologically confirmed pancreatic ductal adenocarcinoma * administration of 2nd-line nab-paclitaxel plus gemcitabine * progression on 1st-line folfirinox exclusion criteria: * pathologic diagnosis other than pancreatic ductal adenocarcinoma * administration of nab-paclitaxel plus gemcitabine as 3rd or greater lines of therapy

Keywords: pancreatic cancer folfirinox nab-paclitaxel plus gemcitabine
implant-associated p. aeruginosa bone and joint infections : experience in a regional reference center in france

Conditions: Bone and Joint Infection

Summary: the aim of this study is to describe the bone or joint infection due to pseudomonas aeruginosa in patients having implant.


Eligibility criteria:
inclusion criteria: * patients having bji on implant caused by pseudomonas aeruginosa exclusion criteria: -
study to characterize and identify bacteria causing acute otitis media in young egyptian children

Conditions: Infections, Streptococcal

Summary: the purpose of this epidemiological study is to identify and characterize the bacteria causing acute otitis media episodes in children aged \>= 3 months to \< 5 years in egypt.


Eligibility criteria:
inclusion criteria: * age: \>= 3 months and \< 5 years at the time of enrolment. the subject becomes ineligible on the fifth birthday. * signs, symptoms, and conditions: * one of the functional or general signs of otalgia, conjunctivitis, fever and either * paradise's criteria, or * spontaneous otorrhoea of less than 1 day. * onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. to be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment. * written informed consent obtained from parent(s) or legally acceptable representative prior to study start. exclusion criteria: * hospitalised during the diagnosis of acute otitis media or during treatment, * otitis externa, or otitis media with effusion, * presence of a transtympanic aerator, * systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment, * receiving antimicrobial prophylaxis for recurrent acute otitis media, * provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea, * patients on antibiotics for acute otitis media who are clinically improving. * child in care.
hypertriglyceridemia associated acute pancreatitis in intensive care unit and therapeutic plasmapheresis

Conditions: Pancreatitis; Hypertriglyceridemia

Summary: acute pancreatitis (ap) is a one of the potentially life-threatening complication of severe hypertriglyceridemia (htg), with mortality around to 30%. htg-associated pa and their complications management has to be the same as the other pancreatitis, but they are associated with the worse clinical outcomes. triglycerides levels are correlated with the risk of pancreatitis and severity. therapeutic plasma exchange (tpe) could provide positive effects in reducing triglyceridemia plasma levels during the acute phase of htg-ap, and in prevention of recurrence. there is currently no difference about mortality in studies. some authors have recommended its use only in severe htg-ap and have precised the need of early initiation to have positive results. despite such promising findings from studies, the effects of therapeutic plasma exchange on htg-associated pa have never been specifically assessed and its benefits in critically ill patients with ap remains uncertain.


Eligibility criteria:
inclusion criteria: * age \> 18 years * admission in icu for acute pancreatitis associated with htg exclusion criteria : patient without norepinephrine or missing data. * acute pancreatitis without htg * patient already include in this study * patient opposed to use of his data

Keywords: icu