Kornimate/medical-research-clean huggingface dataset:
akershus early mobilisation in stroke study

Conditions: Stroke

Summary: treatment in stroke units compared with treatment in general medical wards reduces the odds of being dead or disabled. little is known about which components of acute stroke care that is responsible for this benefit. early mobilisation is one of the features of stroke unit care. in scandinavia, any intervention aimed to reduce the time to the first out of bed episode has been focused in order to prevent complications. however, therapeutic interventions for cerebral revascularisation and a more intensive unit approach for observation may postpone mobilisation. the aim of the present study is to identify whether early mobilisation (\< 24 hours after admittance to hospital)reduce disability and mortality compared with mobilisation after 24 hours. the study is a prospective, randomised controlled study with blinded assessment at the end of follow up. patients admitted to the stroke unit, akershus university hospital less than 24 hours after stroke during 2009 - 2011 are screened for recruitment. patients are randomly assigned to either mobilisation out of bed within 24 hours from admittance to hospital or mobilisation after 24 hours. except early contra late mobilisation all patients receive standard stroke unit care. patients with modified rankin scale 0 and 1, patients with a secondary intracerebral hemorrhage, patients receiving thrombolysis or patients requiring palliative care are excluded. all patients are assessed at admittance, discharge and 3 months poststroke. investigations at admittance include standard blood sample, ct/mri scan, ekg and ultrasound of carotid arteries. main outcome is mortality and disability 3 months poststroke. secondary outcome measures are neurological deficits (nih), morbidity, complications, cognitive function reflected by mini mental state examination and emotional function (hospital anxiety and depression scale) . results from this study may add important knowledge about how and when to start mobilisation of patients with acute stroke.


Eligibility criteria:
inclusion criteria: * patients admitted to the department of neurology, akershus university hospital, with acute stroke (ischemic or hemorrhagic) exclusion criteria: * admitted to hospital more than 24 hours after stroke onset * mrs 0 and 1 * mrs 5 * patients requiring palliative care * secondary/traumatic intracerebral hemorrhage * pregnancy * i.v./i.a. thrombolysis

Keywords: stroke brain infarction intracerebral hemorrhage early mobilisation
exercise training and glucose metabolism in aging

Conditions: Type 2 Diabetes Mellitus; Impaired Glucose Tolerance (Prediabetes)

Summary: diabetes and its associated complications affect more than 20 million americans, and the prevalence of type 2 diabetes and impaired glucose tolerance rises dramatically with age such that 40% of americans over age 60 are affected. in older adults, glucose metabolism may be affected by reduced skeletal muscle capillary supply, which limits insulin, glucose, and oxygen delivery to skeletal muscle. reduced capillary supply to skeletal muscle is found in older individuals with impaired glucose tolerance and we hypothesize that this is due to reduced vascular growth factor expression, and chronic inflammation. further, we hypothesize that reversal of a sedentary lifestyle through aerobic exercise training will increase insulin signaling and vascular growth factor expression, as well as decrease inflammation, to increase capillary supply to skeletal muscle, which contributes to improved glucose metabolism in older adults. this study will: 1) determine the mechanisms underlying reduced skeletal muscle capillarization in older adults with impaired glucose tolerance; and 2) determine the effect of aerobic exercise training-induced increases in skeletal muscle capillarization on glucose metabolism in older adults.


Eligibility criteria:
inclusion criteria: * age 50-75 years * non-smoker \>2 years * body mass index = 18-35 kg/m2 exclusion criteria: * history of cad or cerebrovascular disease that would preclude exercise * implantable defibrillator * active cancer * chronic pulmonary, thyroid, renal, liver, or hematological disease * hiv positive or prone to malnutrition * sickle cell anemia * type 1 diabetes, or currently on medication to treat type 2 diabetes * poorly-controlled type 2 diabetes * poorly-controlled hypertension * taking medications including: beta-blockers, oral steroids, warfarin, certain statins, hormone replacement therapy (hrt), oral contraceptives (ocp), thiazolidinediones (tzd), or chronic steroids or nonsteroidal analgesics (nsaids) that may not be safely discontinued temporarily for specific procedures (i.e. for 72 hours prior) * allergic to lidocaine or heparin * recent weight change (\>5kg in 3 months) * currently pregnant or nursing * physical impairment limiting exercise * dementia or unstable clinical depression
pharmacists coordinated care oncology model (pcom) for patients taking oral anti-cancer medications

Conditions: Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Multiple Chronic Conditions

Summary: the objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care practices (pharmacists coordinated care oncology model \[pcom\]). this is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of oaa initiation or oaa adherence on adherence to chronic medications. this pilot study and data analyses are being done in preparation for a larger, controlled study.


Eligibility criteria:
inclusion criteria: * has primary care physician * diagnosis of chronic lymphocytic leukemia (cll)/small lymphocytic lymphoma (sll), chronic myeloid leukemia (cml), or multiple myeloma (mm) * initiating an oaa, either for the first time or a change from previous oaa * diagnosis of at least 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease * patients taking at least two chronic medications, including at least one medication for one of the conditions listed above. * willing and able to sign informed consent. exclusion criteria: * cannot speak english * concurrent diagnosis of type 1 diabetes * concurrent diagnosis of human immunodeficiency virus
comparison of toric iol implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism

Conditions: Cataract; Corneal Astigmatism

Summary: with increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (iols) that correct corneal astigmatism have been introduced more widely to cataract surgery. originally toric iols were used mainly for patients with high degrees of astigmatism, especially after corneal surgical procedures such as penetrating keratoplasty. since a couple of years, toric iols are available from numerous manufacturers to correct lower amounts of astigmatism which are much more prevalent with about 30% having a corneal astigmatism of 0.75d or more in the cataract population. this should result in less spectacle dependence of patients due to the astigmatic correction. the alternative method to reduce corneal astigmatism as part of cataract surgery is to make incisions on the steeper axis of the cornea such as limbal relaxing incisions or an additional clear corneal incision opposite (occi) to the main cataract opening. these techniques are in use since more than 2 decades and are widely used in clinical routine. as with toric iols, precise alignment of the cuts with the axis of astigmatism is essential. the disadvantage of the incisional techniques is the variability of the effect between patients since it depends on factors such as the extent of scaring of the cuts after surgery as well as corneal thickness. the main advantage is the simplicity of the technique and the lower cost. aim of this study is to compare toric iol implantation and opposite clear corneal incision during cataract surgery to correct corneal astigmatism.


Eligibility criteria:
inclusion criteria: * cataract * age 21 and older * regular corneal astigmatism 1.0 up to 2.5 d * written informed consent prior to surgery exclusion criteria: * relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. marfan syndrome) * irregular corneal astigmatism on corneal topography

Keywords: cataract surgery, astigmatism, opposite clear corneal incision, toric iol, iol rotational stability
dynamics of the upper and lower airway respiratory microbiomes associated with severe infant asthma

Conditions: Asthma in Children; Asthma

Summary: nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment. exploring and understanding these data is to improve patient care and discover new therapeutic targets. the aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.


Eligibility criteria:
inclusion criteria: * infants less than 24 months old * follow-up by a pneumo-pediatrician for severe asthma in infants * requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (has 2009) * parent informed of the research and having signed consent exclusion criteria: * prematurity \<32 wa * congenital heart disease with significant left to right shunt * chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans) * antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization) * refusal of bronchial fibroscopy

Keywords: microbiosme asthma in infant
study to assess safety, tolerability and efficacy of afabicin in the treatment of participants with bone or joint infection due to staphylococcus

Conditions: Bone or Joint Infection

Summary: this is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of afabicin in the treatment of participants with bone or joint infection due to staphylococcus aureus \[both methicillin-susceptible s. aureus (mssa) and methicillin-resistant s. aureus (mrsa)\] and/or coagulase-negative staphylococci (cons) and to compare it to standard of care (soc).


Eligibility criteria:
key inclusion criteria: * able to provide written informed consent and to comply with study procedures. * diagnosis of bone or joint infection which fulfils the following conditions: a) infection is due to s. aureus (mssa or mrsa) and/or cons only; and, b) participants had received no more than 7 days of empiric antibiotics prior to initiating treatment with study drug unless the pathogen isolated was resistant to the administered empiric antibiotics; and, c) biofilm is not considered to be yet established and/or has been mechanically eradicated; and, d) infection is not associated with an ischiatic or a sacral osteomyelitis; and e) infection can involve periosteal or soft tissue. key exclusion criteria: * presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood. * participants at an increased risk of developing liver injury. * participants who have medical conditions that increase the risk of qt prolongation. * medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias. * documented history of alcohol or drug abuse within the previous 12 months. * for patients with dfo: 1. severe peripheral arterial disease (pad) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon 2. necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue). 3. patients with charcot foot (suspected neuro-osteoarthropathy according to investigator's judgment). 4. need for digital amputation. * life expectancy of less than 1 year.
canadian aesthetic experience with sculptra therapy

Conditions: Skin Aging

Summary: primary objective to evaluate the degree of correction achievable with sculptra for nasolabial folds, mid- and lower facial volume loss, jawline laxity and other signs of facial ageing. to document the types and incidence of device-related adverse events with sculptra.


Eligibility criteria:
inclusion criteria: * present with nasolabial folds, mid- and lower facial volume loss, jawline laxity or other signs of facial ageing to be treated with sculptra * the subject must be willing and able to provide written informed consent that includes a release for use of their photographs in publications. subjects who refuse the photo release will not be eligible to participate in the study. * female subjects must be post-menopausal for at least one year or have had a hysterectomy or tubal ligation; if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device (iud), or spermicide in combination with a barrier method of contraception); exclusion criteria: * personal history of allergic/anaphylactic reactions, including hypersensitivity to local anaesthetics (lidocaine); * known history of bleeding disorders; * active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease); * active hepatitis within the past year; * subjects who are pregnant or who plan to become pregnant within the study timeframe, or who are breastfeeding; * hiv positive patients; * recent history of trauma in the face (\< 1 year); * previous use of dermalive or dermadeep; * previous facial surgery within the last six months; * recent facial filler within the last six months; * planned surgical interventions (such as rhinoplasty, facelift, congenital defect repair) or use of other fillers or lasers for the initial six months post-sculptra therapy; * subjects with clinically important disease as judged by the investigator within 3 months of the start of the study (e.g., history of significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue disease, etc.), including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (severe asthma, rheumatoid arthritis, organ transplant, etc.); * subjects who have used superficial dermal resurfacing procedures in the facial area, including chemical peel, dermabrasion, or microderm treatments within six weeks of visit 1 and for the duration of the main study. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: aesthetic facial volume enhancement
risk reducing salpingectomy with delayed oophorectomy as an alternative to risk- reducing salpingo-oophorectomy in high risk-women to assess the safety of prevention - us cohort study

Conditions: Ovarian Cancer; Fallopian Tube Cancer

Summary: this is a prospective preference study that will evaluate non-inferiority of the innovative treatment (rrs with delayed rro) as compared to the standard treatment (rrso) with respect to high grade serous (ovarian) cancer incidence

the aim of the project is to evaluate rrs with delayed rro as an alternative for rrso in brca1/2 gene germline mutation carriers with respect to ovarian cancer incidence. we hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (brca1) or 45-50 (brca2) compared to current standard rrso at age 35-40 (brca1) or 40-45 (brca2) will not lead to a significant increase in ovarian cancer risk. primary objective: to evaluate non-inferiority of the innovative treatment (rrs with delayed rro) as compared to the standard treatment (rrso) with respect to high grade serous (ovarian) cancer incidence in brca1/2 gene germline mutation carriers. secondary objective: incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy. exploratory objective: estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in brip1, rad51c, and rad51d gene germline mutation carriers

Eligibility criteria:
inclusion criteria: 1. premenopausal women with a documented deleterious mutation in brca1, brca2, brip1, rad51c and/or rad51d gene germline mutation. 2. age 25-40 years for brca1 mutation carriers, 25-45 years for brca2 and 30-50 years for brip1, rad51c, rad51d 3. childbearing completed or no longer requires fallopian tubes 4. presence of at least one fallopian tube 5. participants may have a personal history of non-ovarian malignancy. 6. informed consent must be obtained and documented. exclusion criteria: 1. postmenopausal status (natural menopause or due to (cancer) treatment) 2. wish for second stage rro within two years after rrs (if clear at enrollment) 3. legally incapable 4. prior bilateral salpingectomy 5. a personal history of ovarian, fallopian tube or peritoneal cancer 6. current clinicals signs, diagnosis or treatment for malignant disease
study describing the hypertensive population treated with telmisartan and conditions of use by medical practitioners and patients

Conditions: Hypertension

Summary: primary objective: to characterize hypertensive patients treated for at least 1 month with telmisartan (alone or in combination with other drugs) in order to define the beneficiary population (those actually receiving the treatment). secondary objectives: * to describe the patients' blood pressure values (when self-monitored) and satisfaction with the treatment (ease of use, efficacy, safety) on the basis of a patient self-questionnaire, filled out 4 weeks after consultation. * to compare the characteristics of the beneficiary population to those of the initial target population defined in the spc (summary of product characteristics) for telmisartan


Eligibility criteria:
inclusion criteria: * hypertensive patients treated with telmisartan for at least one month, consulting a medical practitioner (for whatever reason) exclusion criteria:
to evaluate the immunogenicity and safety of inactivated hepatitis a vaccine (vitha-a)

Conditions: Hepatitis A Vaccine

Summary: the objective of this study is to evaluate the safety and immunogenicity after one primary dose and one additional dose (administered twice at an interval of 6 months) of inactivated hepatitis a vaccine are administered in adolescents (16 years of age or older) or adults.

for this, a two-group comparison study will be conducted using a previously approved inactivated hepatitis a vaccine (havrix inj., manufactured by gsk) as the control vaccine to prove that the immunogenicity of the test vaccine treatment group is not inferior to the control vaccine treatment group and to statistically confirm that there is no difference in safety.

Eligibility criteria:
inclusion criteria: * males and females aged 16 years or older on the day of the first vaccination * no history of hepatitis a or having hepatitis a vaccination * provided consent to the participation in the study voluntarily after receiving explanations about the objective, method, effect, etc. of this clinical study * determined by the investigator to be able to be followed up during the study period exclusion criteria: * a positive result (anti-hav 20 iu/l or above) in an hepatitis a antibody test at the time of screening * positive hepatitis type b antigen at the time of screening * the following blood test results at the time of screening * alt: more than 1.5 times the upper limit of normal * ast: more than 1.5 times the upper limit of normal * total bilirubin: more than 1.5 times the upper limit of normal * tympanic temperature of 38°c or above within 48 hours prior to the vaccination or on the day of vaccination * moderate to severe acute or chronic infectious disease on the day of vaccination * history of sensitivity to the following drugs: neomycin, formaldehyde, gentamicin sulfate, any preventive vaccines * congenital or acquired immunodeficient disease, or receiving immunosuppressive therapy * received immunosuppressive dose of systemic corticosteroids therapy within 12weeks days before vaccination * uncontrolled epilepsy or neurological disorders * administered with other vaccine within 4 weeks prior to the screening * planned with other vaccine within 4 weeks after the vaccination date * used immunoglobulin formulation or human plasma, or received a transfusion within 12 weeks prior to the screening * participated in another clinical study within 12 weeks prior to the screening, or currently participating * pregnant women or breast-feeding women * other reasons not specified above that, in the opinion of the principal investigator, may make the subject ineligible to participate in the study

Keywords: hepatitis a vaccine