Kornimate/medical-research-clean huggingface dataset:
cardio-vascular protective effects of wolfberry in middle-aged and older adults

Conditions: Cardiovascular Diseases; Aging

Summary: this purpose of this study is to assess the impact of consuming wolfberry on cardiovascular risk in singapore's middle-aged and older adults. the investigators hypothesize that consuming wolfberry with a healthy eating pattern diet will contribute to improvements in cardiovascular health when compared to a similar diet without wolfberry.

this is a 16-week parallel, single-blind (investigator), prospective randomized controlled trial. the study was designed based on previous research which showed that consuming 15 g/day of wolfberry for 4 weeks and 14 g/day of wolfberry with meal for 6 weeks increased plasma zeaxanthin concentrations and antioxidant status. also, other studies reported observable changes in the endothelial progenitor cells and flow mediated dilation after just two weeks of fruit and vegetables or healthy diet interventions. thus collectively, 16-weeks may be a sufficient period to detect the changes in endothelial function, whole body carotenoids, and anti-oxidant status, which are the outcomes of interest in this research project.

Eligibility criteria:
inclusion criteria: 1. ability to give an informed consent 2. age 50 to 75 years 3. willing to follow the study procedures exclusion criteria: 1. significant change in weight (± 5% body weight) during the past 3 months 2. allergy to wolfberry 3. acute illness at the study baseline 4. exercising vigorously over the past 3 months 5. consistently following healthy eating pattern diet in the past 3 months 6. smoking 7. have an average weekly alcohol intake that above 21 units per week (males) and 14 units per week (females): 1 unit = 360 ml of beer; 150 ml of wine; 45 ml of distilled spirits) 8. pregnant, lactating, or planning pregnancy in the next 6 months 9. taking dietary supplements which may impact the outcome of interests (e.g. vitamin supplements, antioxidant supplement etc.) 10. prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication which started less than 5 years prior to the intervention participation 11. insufficient venous access to allow the blood collection

Keywords: wolfberry (goji berry) healthy diet cardiovascular diseases endothelial function lipidomics middle-aged and older adults oxidative stress inflammation
a multicenter research on the effects of substitution of hospital ward care from medical doctors to physician assistants

Conditions: Substitution of Care

Summary: reallocation of healthcare is one solution to the problems healthcare is facing. in the netherlands reallocation of care to physician assistants (pas) hasn't adequately been studied. given the growing number of pas, it is essential to evaluate the effectiveness and efficacy of (dutch) pa services. this multicenter matched-controlled study aims to evaluate the (cost) effectiveness of substitution of hospital ward care from medical doctors (mds) to pas. the traditional model in which the role of house officer is taken by medical doctors md model) will be compared with a mixed model in which a pa functions as house officer together with a medical doctor (pa/md model). hospital wards will be matched on medical specialism and hospital type (i.e. academic;non-academic). on the basis of usa studies, it is hypothesized that the mixed pa/md model compared to the md model reduces the costs of healthcare, while improving or maintaining the clinical outcomes, patients and provider satisfaction, and continuity and quality of care. primary research question: • what is the effect of 'mixed pa/md model' compared with 'md model' on efficiency of care? secondary research questions: * what is the effect of 'mixed pa/md model' compared with 'md model' on clinical and patients outcomes? * what is the effect of 'mixed pa/md model' compared with 'md model' on continuity of care? * what is the effect of 'mixed pa/md model' compared with 'md model' on nurses and (specialist) medicals doctor experiences? * what are the barriers and facilitating factors considering the implementation of pas as house officer?


Eligibility criteria:
inclusion criteria: • wards using a mixed pa/physician model (with pa ward coverage of at least 50% of the available ward hours per week, during dayshifts on weekdays) or a physician model (daily coverage by a (specialized medical doctor) exclusion criteria on ward level: * wards from specialty hospitals * wards with only pas in training * wards with a nurse practitioner (np) in the role of house officer (np, np/md or pa/np/md model) * pediatric and psychiatric wards, intensive care units exclusion criteria on patient level: * terminal patients * not fluent in dutch language * age \< 18 years * patients in daycare

Keywords: physician assistant substitution hospital ward care secondary health care
conservative treatment of proximal humeral fractures

Conditions: Shoulder Fractures

Summary: optimal treatment of proximal humeral fractures is yet to be defined. many of them can be treated non-operatively. the question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

there is still controversy on best treatment of proximal humeral fractures. while some authors propose surgical treatment other advocate for conservative treatment. traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. nevertheless, there is little evidence to support a 3-week immobilization period. the purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Eligibility criteria:
inclusion criteria: * patients ≥ 60 yo and \< 85 yo * acute fractures less than 1 week evolution * conservative treatment decided by orthopedic surgeon * contact between humeral head and humeral shaft. * no gleno-humeral dislocation * no previous surgery exclusion criteria: * cognitive impairment
effect of physical activity intervention children with spastic diplegia after resistance training

Conditions: Cerebral Palsy; Spastic Diplegia

Summary: the purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. the primary outcomes are gross motor function, participation, and physical activity behavior.


Eligibility criteria:
inclusion criteria: * children with spastic diplegia, aged 6 to 12 year-old, and gross motor function classification system (gmfcs) level between i to iii * able to stand up from a chair independently and maintain standing for more than 2 seconds without falling * able to answer questionnaire designed for school-age children * able to follow verbal instructions exclusion criteria: * have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months * have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious le joint contractures, uncontrolled epilepsy, or cardiopulmonary problems * hearing loss or using hearing aid
role of nepafenac in reducing macular volume after epiretinal membrane surgery

Conditions: Epiretinal Membrane

Summary: the purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.


Eligibility criteria:
inclusion criteria: * 18 year of age or older, of any race and either sex. * able to understand and sign an informed consent that has been approved by an institutional review board. * must agree to comply with study visit schedule and other study requirements. * must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema. * must have pre-operative central foveal thickness greater than 300 microns. * prior cataract surgery must be at least 6 months postoperative. * other protocol-defined inclusion criteria may apply. exclusion criteria: * vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis). * dry macular degeneration (drusen) with central geographic atrophy. * concomitant cataract surgery performed at the time of study vitrectomy. * prior vitrectomy surgery in the study eye(s). * prior macula laser treatment in the study eye(s). * prior periocular steroid injections in the study eye(s) within preceding 6 months. * prior cataract surgery in the study eye(s) within the last 6 months. * any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study. * use of topical ocular medications during the study period. * antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study. * women of childbearing potential not using reliable means of birth control. * women who are pregnant or lactating. * enrollment of more than one person per household at the same time. * enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals. * participation in any investigational drug or device study within 30 days of entering this study. note: patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. second eye will receive the same study treatment as first eye. * other protocol-defined exclusion criteria may apply.

Keywords: nepafenac vitrectomy surgery epiretinal membrane surgery
an observational study in differentiated thyroid cancer which is radioactive iodine (rai) refractory to assess the use of multikinase inhibitors

Conditions: Thyroid Neoplasms

Summary: the purpose of the study was to assess the use of multikinase inhibitors (mkis) in the treatment of patients with a progressive differentiated thyroid carcinoma (dtc) refractory to radioactive iodine (rai) who do not have any symptoms.

the primary objective of this study was to compare time to symptomatic progression (ttsp) from study entry in asymptomatic patients with rai-refractory progressive dtc for whom there is a decision to initiate mkis at study entry with that of asymptomatic patients with rai-refractory progressive dtc for whom there is a decision to not initiate mkis at study entry.

Eligibility criteria:
inclusion criteria: * histologically/cytologically documented dtc (papillary, follicular, hurthle cell, and poorly differentiated carcinoma) * dtc refractory to rai * radiological progression and preferably according to response evaluation criteria in solid tumors (recist) 1.1 * no symptoms due to dtc * \>/=1cm diameter of lesion confirmed by radiological exam * life expectancy of at least 6 months exclusion criteria: * plan to be treated according to a clinical trial protocol for intervention including a locoregional therapy or systemic therapy * previous treatment with mkis for advanced disease * hospice patients

Keywords: progressive radioactive iodine refractory differentiated thyroid carcinoma
study of the anti-tumoral immune response

Conditions: Breast Cancer; Glioma

Summary: this study evaluates the frequency of the spontaneous t cells specific cd4 answers of tumoral antigens breast cancer and glioma.


Eligibility criteria:
inclusion criteria: * performance status 0,1 or 2 * breast cancer or glioma * arm glioma: patients without anti-tumoral treatment * arm breast cancer: inclusion before treatment * arm breast cancer her2: patients with current therapy exclusion criteria: * psychiatric disease compromising the understanding of the information or the realization of the study * vulnerable people according to the law (minors, adults under protection, private persons of freedom ...) * unaffiliated people to the social security * people being for the period of exclusion from another study * life expectancy estimated unless 3 months. * for patients in arm glioma: patients having already begun a systematic treatment. * for patients with a breast cancer: patient already under current therapy
education in therapy of parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) has considerable impact on motor, psychological and social activities and significantly affects the quality of life of patients and their families. to improve the medical care of pd patients, the investigator have developed an educational program specific to pd. the principal aim of this study is to evaluate the therapeutic education program, comparing the quality of life of pd patients with or without the educational program after six month and one year follow-up. the secondary aims are to evaluate the evolution of motor and psychological states in these 2 groups of patients and to compare the medical costs. this is a monocentric, comparative, prospective randomised study. the investigators will evaluate 120 pd patients, 60 patients benefiting of the educational program and 60 patients with a traditional medical care. quality of life of pd patients is evaluated using a specific scale (pdq39) and a generalist scale (sf36) at 6 and 12 months. motor and psychological states were assessed with updrs and had scales. the educational program consisted of both individual and collective educational consultations. the investigators supposed that the therapeutic education program will improve the quality of life of pd patients. the supposition that this improvement will correlate with the motor and psychological states.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of parkinson's disease according to the criteria of the ukpdsbb * parkinson's disease patients with a score ≤4 on the hoehn and year scale * patient without cognitive disorders * patients treated with dopaminergic antiparkisonian drugs (l-dopa, dopamine agonists,icomt...) or dbs stimulation (since at least 3 month) * patients able to fulfil self-administered questionnaire * patients affiliated to a social protection program exclusion criteria: * - patients suffering from an other pathology causing chronic pain (rheumatic disease, traumatic or orthopaedic pathologies...) * parkinson's disease patients with a score\>5 on the hoehn and yahr scale * patients suffering of parkinsonism induce by drugs * patients with important tremors during a off conditions * patients ever included in another study * patients with severe psychiatric disease * patients under tutelage, curatelle or law protection * patients included in an other clinical study * patients unable to fulfil scales of the study

Keywords: therapeutic education parkinson's disease quality of life
expanded access protocol for [123i]mibg for patients with known or suspected neuroblastoma

Conditions: Neuroblastoma

Summary: ge healthcare has recently submitted a new drug application (nda) for iobenguane i 123 injection (\[123i\]mibg (adreview)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. the present protocol establishes an expanded access program to provide adreview to pediatric medical centers and hospitals that treat neuroblastoma patients. adreview will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for \[123i\]mibg imaging.

the sponsor will provide \[123i\]mibg as a single dose in a ready-to-use vial. all patients greater than or equal to 18 years of age and children with a weight of greater than or equal to 70 kg will receive an intravenous injection of 370 ±10% mbq (333 to 407 mbq \[9.0 to 11 mci\]) of \[123i\]mibg. children \<16 years of age (with a weight of 8-70 kg) will receive an activity of \[123i\]mibg calculated on the basis of a reference activity for an adult scaled to body weight. each investigator is responsible for obtaining the appropriate thyroid blockade agent and for its administration in accordance with national and local regulations and guidelines. approximately 24 (± 6) hours following administration of \[123i\]mibg all patients will return to the clinic for scintigraphic imaging. imaging will be performed as per the standard procedures of the investigational site. this should include at a minimum total body planar scintigraphy. single photon emission computed tomography (spect) may be performed following planar scintigraphy, as appropriate.

Eligibility criteria:
inclusion criteria: * the patient has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mibg scintigraphic examination is clinically appropriate). * the patient is able and willing to comply with study procedures and a signed and dated informed consent is obtained from the patient (or their legal guardian. exclusion criteria: * the patient uses medications that are known to interfere with \[123i\]mibg uptake and these medications cannot be safely withheld for a least 24 hours before study procedures.

Keywords: neuroblastoma nuclear medicine diagnostic scintigraphy known and suspected neuroblastoma
project fluido: fluid watchers

Conditions: Congestive Heart Failure

Summary: the long-term goal of this research is to determine whether a psychoeducational intervention will support self-care behaviors in hispanic patients with heart failure. the specific goal of this study is to determine whether a culturally-appropriate psychoeducational intervention in hispanic patients with heart failure, compared to a control group, will improve heart failure knowledge and self-care behaviors. we hypothesize that patients who receive the intervention will have improved heart failure self-care behaviors and depression scores as measured by the self-care heart failure index and patient health questionnaire.

a randomized clinical trial research design is planned. investigators will obtain baseline and final measures on the intervention and control groups. a sample of 60 adult hispanic heart failure patients will be recruited. each patient will either participate in the psychoeducational intervention or usual care. a repeated measures (longitudinal) analysis will be used to examine these aims by employing a linear mixed models approach. the basic analysis has one between subjects (fixed) factor, group, with 2 levels (education and control) and one repeated factor, time, with 2 levels (baseline and 12 months). this analysis allows for testing the main effect of group, main effect of time, and the group by time interaction. the potential benefit of improving heart failure knowledge and self-care in hispanic heart failure patients is that these patients may better understand how to care for themselves. this study will provide data to examine the longer-term outcomes of emergency department visits and hospitalization events in hispanic patients.

Eligibility criteria:
inclusion criteria: * have been hospitalized for heart failure within the previous 24 months * identify themselves as hispanic in origin * speak and write in spanish or english exclusion criteria: * live in a nursing home or institution, * age less than 18 * cognitive deficits * serious life-limiting co-morbidity such as active cancer

Keywords: congestive heart failure self-care spanish
a long term effect of collaborative care on depression treatment in a community dwelling elderly

Conditions: Depression

Summary: suicide is a significant cause of death in korea. according to the report compiled by the korea national statistical office, 24.8 victims of every 100,000 in 2007 (korea national statistical office, 2008), which is higher compared with 10.1 in the united states, 6.0 in the united kingdom, and 19.1 in japan (organisation for economic co-operation and development, 2008). especially, suicide rate is incredibly higher in elderly. most persons who commit suicide have a diagnosed psychiatric disorder. among them, 60% had depression when they committed suicide. therefore, this study aimed the impact of a care management intervention on depression treatment and reducing suicidal ideation in elderly patients with depression.


Eligibility criteria:
inclusion criteria: * 60 and older * current major or minor depression exclusion criteria: * severe cognitive dysfunction * severe auditory dysfunction * history of psychosis

Keywords: care management depression elderly korea
pectoralis major pedicle bone graft for 4-part proximal humerus fractures

Conditions: Patients With Closed Neer Type 4 Proximal Humerus Fractures

Summary: the investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.

the risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.bone impaction grafts are an important treatment option when osteosynthesis with lcp plate is desired especially for osteoporotic patients. fibular strut grafts (fsgs) and autologous iliac bone impaction grafts (aibigs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture. bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.

Eligibility criteria:
inclusion criteria: * patients aged 50-75 years with closed neer type 4 proximal humerus fractures exclusion criteria: * patients under 50 and over 75 years of age, * patients with pathological fractures, * patients with neurological deficits such as brachial plexus injury * patients with previous shoulder surgery

Keywords: proximal humerus closed fracture bone pedicled graft