Kornimate/medical-research-clean huggingface dataset:
cognitive training for older caregivers

Conditions: Life Stress

Summary: the purpose of this study is to test whether certain brain training activities can promote cognitive, emotional, and physical health in caregivers of a loved one with dementia. numerous studies show that family dementia caregiving can be stressful, and can increase mental and physical health risks. this study aims to understand how to reduce those risks.


Eligibility criteria:
inclusion criteria: * english-speaking (consent process and assessments will be conducted in english only) * currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care. * currently experiencing moderate to high levels of perceived stress and caregiver burden. caregivers will be screened for stress levels and caregiving burden using the 10-item perceived stress scale (pss 10) and the modified caregiver strain index (mcsi), respectively. caregivers scoring above the population mean (approx.) on the pss 10 (\> 11), reporting at least moderate caregiver strain (score ≥ 5) on the mcsi will be eligible for participation. exclusion criteria: * cognitive impairment or dementia (identified by the montreal cognitive assessment (moca)). cutoff scores on the moca will be 23 or lower except for subjects who identify as black or african american, in which case cutoffs will be based on scores from the sample population reported in rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded. * current major depression (current major depression diagnosis and/or geriatric depression scale (gds 15) score ≥ 10) * no recent (within 2 months) major surgery * history of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness) * serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from mini international neuropsychiatric exam (mini) modules) * autoimmune disorder (e.g., crohn's disease, lupus, rheumatoid arthritis) * active neoplastic disease or receiving immunosuppressive therapy for cancer (or \< 6 months post-chemo or radiation) or other diseases (\< 3 months prior to enrollment) * no significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis b or c, hiv) * serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months * physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)
peritoneum and anterior rectus sheath suturing and ileostomy

Conditions: Ileostomy - Stoma; Rectal Neoplasms

Summary: in the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.


Eligibility criteria:
inclusion criteria: * preventive ileostomy in laparoscopic rectal surgery exclusion criteria: * ileostomy due to anastomotic leak
impact of a transmission checklist in post anesthesia care unit on immediate respiratory complications

Conditions: Anesthesia; Postoperative Complications; Anesthesia Complication

Summary: this work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted.

communication and information transmission problems are responsible for the majority of serious adverse events. the use of a checklist in the operating theatre has demonstrated its benefit in terms of reducing morbidity and mortality regarding transmissions between caregivers, numerous studies have shown the great difference between the medical data of a patient in their file and the information transmitted. the authors recommend using checklists in order to standardise transmissions. this work highlighted the beneficial role in terms of carers' satisfaction, quantity and quality of information transmitted. on the other hand, no study has looked at the reduction of immediate postoperative complications in post anaesthesia care units (pacu).

Eligibility criteria:
inclusion criteria: * male or female over 18 admitted to pacu * patient having understood the aims and the methods of the research * patient having expressed their consent to the use of their data. * subject registered with or beneficiary of a social security scheme exclusion criteria: * patient participating in another clinical study * acute or chronic respiratory insufficiency preoperatively * protected patient: adult under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant or lactating women

Keywords: checklist postoperative complication anesthesia information transmission care unit
evaluation for nci surgery branch clinical research protocols

Conditions: Synovial Cell Cancer; Melanoma; Colorectal Cancer; Lung Cancer; Bladder Cancer

Summary: background: the national cancer institute surgery branch (nci-sb) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. objective: this study will allow patients to under screening and evaluation for participation in nc-sb protocols. eligibility: patients 18 years or older must meet the minimum eligibility criteria for an nci-sb treatment protocol. design patients will undergo testing and evaluations as required by the appropriate nci-sb treatment protocol.

background: potential research candidates undergo thorough screening including laboratory tests, scans, x-rays, and review of pathology slides to determine initial eligibility for national cancer institute surgery branch (nci-sb) research protocols. objectives: permit evaluation of patients referred to the nci-sb in order to identify individuals who will be suitable candidates for nci-sb clinical research protocols. to assess frequency of hla type, gene specific mutations or expression of neo antigens in malignant tumors across the population of cancer patients undergoing screening for nci-sb protocols. collect results of screening tests for use on subsequent research protocol as baseline (e.g., pretreatment) values. eligibility: age \>= 18 years. patient suspected of having, or with biopsy proven, malignant disease. patient is able to understand and willing to sign a written informed consent document. patient is being evaluated for treatment on an nci-sb protocols.. design: patients enrolled on this protocol will be evaluated by nci-sb physicians to determine the individual's suitability for participation in a clinical research protocol. an accrual ceiling of 7,000 patients has been set to meet the screening needs of the nci-sb.

Eligibility criteria:
* inclusion criteria: age \>= 18 years. patient suspected of having, or with biopsy proven, malignant disease. patient is able to understand and willing to sign a written informed consent document. patient is being evaluated for treatment on an nci-sb protocols. exclusion criteria: women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.

Keywords: cancer gene therapy immunotherapy clinical trial
the effects of breakfast size on hormonal profile in adults with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: studies has found a connection between breakfast consumption and obesity and obesity-related complications, but only few studies examined the effect of breakfast size. the purpose of this study is to examine the effect of breakfast size on several parameters in adults with type 2 diabetes mellitus.

the prevalence of obesity has rapidly increased during recent decades, while the prevalence of skipping breakfast has increased. several studies have reported inverse relationships between the consumption of breakfast and bmi and weight gain. a study that examined the effect of breakfast size, found that an increased percentage of daily energy consumed at breakfast was associated with relatively lower weight gain. preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day. the purpose of this study is to examine the effect of breakfast size on blood glucose balance, and its correlation with hormonal profile (including appetite hormones), adipokines and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with type 2 diabetes. the study will use a randomized-controlled, non-blinded, prospective design, including 48 participants with type 2 diabetes, who are not insulin dependent. the research group will receive instructions to eat a large breakfast compared with the control group that will receive instructions to eat a small breakfast. the estimated duration of the study is about three months.

Eligibility criteria:
inclusion criteria: * men and women ages: 30-70 * type 2 diabetics who are treated on a diet and / or pills * patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research) * obese or overweight (35\> bmi\> 25) * patients who did not participate in another research for at least 30 days * patients who agree to sign a consent form and participate in research * patients with high compliance. exclusion criteria: * patients under the age 30 or over 70 * type 1 i diabetics * patients who are insulin dependent * type 2 diabetics who are treated with injections * bmi less than 25 or bmi over 35 * patients who had bariatric surgery * patients with food absorption disorders * active malignant disease * thyroid function disorder * active psychiatric illness * pregnancy / breastfeeding

Keywords: breakfast size blood glucose balance hormonal profile appetite hormones adipokines pro-inflammatory cytokines
immunogenicity and safety study of gsk biologicals' infanrix-ipv+hib™ vaccine

Conditions: Tetanus; Poliomyelitis; Acellular Pertussis; Diphtheria; Haemophilus Influenzae Type b

Summary: the purpose of the study is to evaluate the immunogenicity and reactogenicity of infanrix-ipv/hib™ vaccine when administered to healthy chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.


Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 60 and 90 days of age at the time of the first study visit. * born after a gestation period of 36 to 42 weeks, inclusive. * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s) or lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * child in care. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis b vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or haemophilus influenzae type b (hib) disease or vaccination. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: • current febrile illness or axillary temperature \> 37.0°c or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: infanrix-ipv+hib
phase 3 /seroquel sr acute mania monotherapy - us

Conditions: Affective Psychosis, Bipolar; Manic Disorder; Manic-Depressive Psychosis; Mania; Manic State; Psychoses, Manic-Depressive

Summary: the purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (seroquel®) in the treatment of patients with acute bipolar mania for 3 weeks. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * documented diagnosis of bipolar disorder, with most recent episode being manic or mixed * inpatient hospital admission for the first 4 days of study treatment exclusion criteria: * \>8 mood episodes within the last 12 months * use of prohibited medication * substance or alcohol abuse or dependence * current suicide risk or suicide attempt within last 6 months.

Keywords: bipolar disorder bipolar mania manic depression seroquel seroquel sr quetiapine fumarate
genes polymorphisms and metabolic effects of the second generation antipsychotic drugs in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of the study is to investigate these effects of second-generation antipsychotic (sgas) on glucose and lipid metabolic parameters in patients with schizophrenia, and explore the relationship between genes polymorphisms (such as drug metabolic enzyme, endogenous cannabinoid receptor type 1(cb1) and so on) and the sgas-induced glucose and lipid metabolic disorder in chinese han persons with schizophrenia who are taking one of the sgas(olanzapine, risperidone or ziprasidone).

sgas now is used as the main tool to treat schizophrenia, however，the mechanism of glucose and lipid metabolism disorder it brings is still unclear. based on the previous studies, the investigators found that the cb1 gene has a close connection with the metabolism disorder.the investigators suppose that the cb1 also has a significant role in regulation of energy and metabolism in hypothalamus. in this study ,the investigators will recruit 300 patients with schizophrenia who defined by diagnostic and statistical manual-5 (dsm-5), aged 18 to 60,and all the participants will receive a 6-week systematic treatment by one of the sgas(including olanzapine, risperidone oral solution, ziprasidone capsules), and a battery of assessments of treatment effect and safety. plasma concentration will be tested regularly, and these genes polymorphisms of cb1 and other associated with energy metabolism will be conducted by the second generation of gene detection techniques.this study could provide evidence and data to achieve the aim of individualized medication, reduce the drugs' side effect, also throw light on the production of medication for correct the metabolism disorder.

Eligibility criteria:
inclusion criteria: * all cases must be in accordance with the dsm-5 schizophrenia or schizophreniform disorder diagnosis standards * negative and positive symptom scale(panss)score ≥ 60 points;aged 18 to 60 * did not participate diet or other body mass reduction projects * did not have physical illness which affects diet or activities * did not use any antipsychotic drug within 2 weeks * subject to consent by the ethics committee on clinical trials of drugs,xijing hospital of the fourth military medical university , all the participants signed a written informed consent exclusion criteria: * pregnant or lactating women * patients with serious body disease, such as epilepsy, liver and kidney impairment, digestive system diseases, etc * obvious abnormalities on physical and laboratory examination * body mass index(bmi)≥25.0;fasting plasma glucose(fpg)≥6.1mmol/l or/and 2-hour postprandial blood glucose(2hpg)≥7.8mmol/l or/and somebody has been diagnosed with diabetes and treatment;fasting triglycerides≥2.2mmol/l * suffering from other mental disorders in line with dsm-5 diagnostic criteria

Keywords: genetic polymorphism metabolic side effects of drugs schizophrenia second-generation antipsychotic cannabinoid receptor type 1
study of influenza virus infection in children hospitalized in spain in two consecutive influenza seasons

Conditions: Influenza Virus Infection

Summary: this is an epidemiological, retrospective and observational study, by reviewing clinical histories, of children hospitalized for influenza virus infection, their comorbidities and the treatments that have been performed

a better knowledge in our environment of the characteristics of the influenza virus infection in the pediatric age, the clinical aspects, risk factors, the evolutionary and prognostic aspects, of morbidity and the direct medical costs, can allow a better management of the disease and a greater awareness of the importance of vaccination against influenza in the healthy child

Eligibility criteria:
inclusion criteria: * boys and girls under 15 years of age. * with a clinical diagnosis of influenza virus infection. * with infection by influenza virus confirmed microbiologically. * hospitalized more than 24 hours exclusion criteria: * age equal to or greater than 15 years. * that the clinical diagnosis is not influenza virus infection. * influenza virus not confirmed by microbiological diagnosis. * not hospitalized or hospitalized for less than 24 hours.
retrospective evaluation of copd patient care

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this project is to evaluate hospital utilisation, patient and service outcomes of a respiratory nursing service to examine current clinical care of copd. this evaluation aims to identify the important gaps in current clinical care of respiratory chronic disease nursing management. the primary outcomes of this evaluation is to determine the efficacy of clinical care in 2006, 2011, 2013 and 2015 and compare data to current nursing best practice guidelines for copd through the quantification of hospital utilisation for hospital admission, average length of stay, readmission within 28 days, emergency service attendance, outpatient review, use of hospital and home (h@h), frequency of exacerbations, disease severity and progression (fev1: gold classification), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.

study design: this study is a retrospective observational crosssectional study conducted through review of medical records, internal respiratory databases and electronic hospital patient record (oacis \& homer) over 3x12 blocks. participants: copd patients from the queen elizabeth hospital(tqeh) respiratory nursing service who were new patients in 2006, 2011, 2013 and 2015 (jan 1st to dec 31st ). data collection: demographics, clinical data, hospital service utilisation, and clinical outcomes such as exacerbation frequency and disease progression. all data will be extracted into a standardised data extraction form, which a random subset will be checked by a second researcher. demographic data will include comparison of % without comorbidities, impact of comorbid conditions using charleston comorbidity index isolating diabetes, heart failure, anxiety and depression. demographic and descriptive data will be given in means + sd and compared using a two-tailed student t-test. categorical variables will be compared using chisquared or fisher exact tests, and when appropriate the mannwhitney utest for nonparametric data. statistical significance will be determined using an alpha of p \<0.05. all analyses will be examined using spss software (version x).

Eligibility criteria:
inclusion criteria * any new client or new referral to the respiratory nursing service in the years 2006, 2011, 2013 or 2015 only * have a diagnosis of chronic obstructive pulmonary disease exclusion criteria * not a pre- existing client of the respiratory nursing service * not having a diagnosis of chronic obstructive pulmonary disease

Keywords: outreach nursing respiratory nursing guidelines
a randomized phase ii study of stereotactic ablative body radiotherapy for metastases to the lung (trog 13.01 safron ii)

Conditions: Cancer; Metastases to the Lung

Summary: the main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

stereotactic ablative body radiotherapy (sabr) is an exciting novel radiotherapy technique that is delivered over very few sessions. in the case of limited pulmonary 'oligometastases', sabr can result in long-term survival. it is non-invasive and associated with high rates of tumour control and relatively low toxicity. additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. in the future, sabr may be an attractive alternative to invasive surgery. there are two sabr techniques emerging in australia; fractionated and single fraction treatments. we aim to conduct the first clinical trial of sabr in patients with limited pulmonary metastases testing fractionated versus single fraction treatments. the primary aim of this study is to evaluate the toxicity, quality of life, clinical efficacy and cost effectiveness of single fraction sabr compared to multi-fraction sabr in patients with oligometastases to the lung. the secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction sabr and its prognostic implications for patient outcomes.

Eligibility criteria:
inclusion criteria: 1. a maximum of three metastases to the lung from any non-haematological malignancy 2. tumour diameter ≤5cm 3. targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible. 4. patients must be medically inoperable, technically high risk or have declined surgery. exclusion criteria: 1. previous high-dose thoracic radiotherapy. 2. cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators) 3. targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.

Keywords: oligometastatic neoplasia radiosurgery stereotactic ablative body radiotherapy sabr metastases to the lung non haematological