Kornimate/medical-research-clean huggingface dataset:
intravitreous bevacizumab and standard metabolic control for diabetic macular edema - a contrast sensitivity study

Conditions: Diabetic Macular Edema

Summary: to evaluate the effects on contrast sensitivity (cs) measurements of intravitreal bevacizumab injections associated with standard metabolic control in eyes with diabetic macular edema (dme) associated with standard metabolic control.

prospective, randomized, masked and interventional study. patients with diabetes mellitus (dm) 2, glycated hemoglobin (hba1c) less than 11% and previously treated macular edema three months before will be randomized in two groups. the baseline examination consisted of visual acuity (va), cs using the pelli-robson charts, optical coherence tomography (oct) and fluorescein angiography for all eyes. the same tests will be repeated above, in both groups, again, in the week 2,6 and 12, when the data is then collected for analysis and so ended the closed phase. on the same day will start the open phase, which will be applied intravitreal injection of bevacizumab in both groups and the same tests of closed phase will be held in the week 14,18 and 24 when the study will be completed then \[table 1\] . patients will be monitored and controlled clinically including blood pressure measurements, laboratory blood tests such as blood glucose, glycated hemoglobin, urea, creatinine, total cholesterol and fractions.

Eligibility criteria:
inclusion criteria: * age at least 18 years old, of both genders; * patients with diabetes mellitus type i or type ii; * macular edema presence of clinically significant diabetic in their mixed or diffuse; * visual acuity worse than 20/40 corrected (\< 68 letters etdrs) * glycated hemoglobin ≤ 11%; * systolic and diastolic blood pressure \< 170 and \< 100 mmhg, respectively; * women not pregnant; * free and informed consent term signed the screening visit; * ability to adhere to the visits. exclusion criteria: * failure to comply with any of the inclusion criteria; * treatment for dme within the prior 3 months; * vitreoretinal traction within 1 disc diameter (dd) of the fovea, clinically confirmed or with oct; * atrophy or fibrosis surrounding the fovea; * any level of cataract; * vitreous hemorrhage or any opacity means; * eye disease related to diabetic retinopathy that can derail the central vision (eg age macula degeneration, chorioretinitis scar, ...) * best-corrected visual acuity to 20/40 (\> 68 letters etdrs) * inability to understand the treatment and the term of consent; * debilitating systemic disorders that preclude the patient's admission to the study, according to the clinical judgment of the investigator;

Keywords: diabetic retinopathy intravitreal bevacizumab contrast sensitivity
study of a birth dose of glaxosmithkline biologicals' 251154 vaccine

Conditions: Infections, Rotavirus

Summary: the purpose of the study is to evaluate the safety and immunogenicity of a birth dose of gsk biologicals' reduced-antigen-content tri-component pertussis (251154) vaccine followed by routine paediatric vaccination.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/lar(s) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/lar(s) of the subject. * a male or female infant between, and including, 2 and 5 days of age at the time of randomisation. * subjects who are born after an uncomplicated gestation period of 36 to 42 weeks inclusive. * subjects born to a mother seronegative for hepatitis b surface antigen. * subjects with a birth weight \>= 2.5 kg. * subjects with a 5-minute apgar score \>= 7. * healthy subjects as established by medical history and clinical examination exclusion criteria: * use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period. * born to a mother known or suspected to be seropositive for hiv. * family history of congenital or hereditary immunodeficiency. * children in care.. * neonatal jaundice requiring systemic treatment. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of any vaccine since birth or planned administration during the study period with the exception of inactivated influenza vaccines. * 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. * 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 vaccines. * major congenital defects or serious chronic illness, including perinatal brain damage. the following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met: • current febrile illness or temperature \>= 38.5°c on oral or axillary setting, or \>= 39.0°c on rectal setting, or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: neonatal vaccination
charlson comorbidity index and outcome of cardiopulmonary resuscitation in geriatric patients in hong kong

Conditions: Comorbidities and Coexisting Conditions; Cardiopulmonary Resuscitation; Geriatrics

Summary: the goal of this observational study is to learn about the factors affecting the outcome (survival) of cardiopulmonary resuscitation in older persons in a hospital. the main questions it aims to answer are: * whether age would affect outcome * whether charlson comorbidity index would affect outcome * whether the conditions (e.g. heart rhythm) immediately before resuscitation would affect survival. researchers would compare the patients who deceased with the patients who survived.

the goal of this review was to investigate the impact of age, existing medical conditions. and other factors before cardiac arrest in predicting outcome of in-hospital cardiopulmonary resuscitation (cpr) of older persons. it was conducted on all patients aged ≥ 65, who underwent cpr in acute medical and geriatric wards (excluding intensive care unit) in united christian hospital from january 2017 to december 2018.

Eligibility criteria:
inclusion criteria: * all adults aged 65 or above with in-hospital cardiac arrest and undergoing cpr in wards of department of medicine and geriatrics (excluding intensive care unit (icu)) in united christian hospital (total bed 1,174 with 16 icu beds) in hong kong from 1 january 2017 to 31 december 2018 * in patients with multiple resuscitation events, only the first in-hospital cpr was included. exclusion criteria: * patients with existing do-not-attempt-cardiopulmonary-resuscitation (dnacpr) order * patients younger than 65 years old * out-of-hospital cpr in the index admission * cpr occurred in icu / emergency department / operating theatre / wards other than medical wards
mechanism of action of fluticasone furoate in childhood obstructive sleep apnea syndrome

Conditions: Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Summary: the purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (osas), works on certain cells within a child's adenoids. we hypothesize that intranasal steroids lead to an upregulation of t regulatory cells in the adenoid tissues of children with osas. this will result in a local reduction in inflammation and edema explaining the improvement in osas.

the objective was to determine the effect of intranasal corticosteroid therapy on t-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. adenoid tissue was obtained at the time of the procedure.

Eligibility criteria:
inclusion criteria: * age: between 2 and 12 years * polysomnogram results showing ahi \>5/hr irrespective of saturations * no other significant medical problems except well controlled asthma * no chronic medication intake except bronchodilators and leukotriene receptor antagonists * no systemic steroids within the past month * no intranasal steroids within the past 2 weeks exclusion criteria: * patients with osas who are overweight (bmi\>95th percentile for age) or who have neurological or craniofacial abnormalities as these tend to have osas related to these factors per se. * females of the specified age group who have already had their first period.
the use of the voms tool with military personnel to track mtbi recovery and rtd status

Conditions: Mild Traumatic Brain Injury

Summary: the purpose of the proposed project is to determine if the voms is an effective screening tool to identify and track recovery of vestibular and ocular motor impairment and symptoms following mtbi, that corpsman-level medical personnel can successfully implement in combat and non-combat environments. a second purpose of the project is to determine if impairment and symptoms on the voms is more pronounced following blast compared to blunt mtbi.

vestibular impairment and symptoms are prevalent following mild traumatic brain injury (mtbi) and may play a role in prolonged recovery. researchers have indicated that ocular motor dysfunction and symptoms are common among personnel exposed to blast mtbi. in fact, researchers have suggested that vestibular and ocular motor outcomes such as vor and vestibulo-spinal reflex (vsr) may be useful in identifying the effects of blast from blunt mtbi. there are currently no brief, clinical screening tools to identify vestibular/ocular motor impairment and symptoms in military personnel following mtbi. our research team recently developed the vestibular/ocular motor screening (voms) tool to screen for vestibular/ocular motor impairment and symptoms following mtbi. our preliminary research indicates that voms- a 5-min clinical screening tool that can be deployed by corpsman-level (i.e., special operation combat medics \[socm\], special forces medical sergeants \[18d\]) medical personnel with minimal training and materials- was nearly 90% accurate in identifying patients with mtbi from healthy controls. these preliminary findings suggest that voms may augment current clinical screening tools- such as the mace- used by the u.s. military. the proposed project addresses the "studies to develop standardized metrics for vestibular assessment and monitoring for return to duty" area in the diagnostics subsection of the hearing loss/dysfunction, balance disorder, and or tinnitus section under the clinical trial research focus area.

Eligibility criteria:
inclusion criteria: * all participants: * military personnel; * age 18-40 years; * normal or corrected normal vision * mtbi participants: * diagnosed with mtbi (blast, blunt, or combo) within past 7 days * clear mechanism of injury * glasgow coma scale (gcs) = 13-15 * reported or observed signs (loss of consciousness \[loc\], amnesia, disorientation/confusion) at time of injury * current reported symptoms and/or impairment (cognitive, balance, visual) exclusion criteria: * history of vestibular disorder; * history of neurological disorder; * history of previous moderate to severe tbi

Keywords: concussion vestibular ocular-motor
primary vaccination study with a pneumococcal conjugate vaccine in healthy children 6-12wks of age

Conditions: Infections, Streptococcal

Summary: the purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine gsk1024850a have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. the study will be conducted in singapore and malaysia.


Eligibility criteria:
inclusion criteria: * male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination. * subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. * free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study). * born after a gestation period of \>= 36 to \<= 42 weeks. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * a family history of congenital or hereditary immunodeficiency. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis b immunoglobulins at birth). * previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b, haemophilus influenzae type b and/or streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life). * planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after dose 1 and dose 2 and 30 days after dose 3. * history of, or intercurrent diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis, h. influenzae type b and rotavirus disease. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurological disorders or seizures. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * gastroenteritis within 7 days preceding the study vaccine administration. * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Keywords: pneumococcal vaccine immunogenicity primary vaccination safety pneumococcal disease
a study to evaluate the safety and efficacy of single day or single dose famciclovir for the treatment of recurrent herpes labialis

Conditions: Recurrent Herpes Labialis

Summary: the study is designed to assess the efficacy and safety of patient-initiated therapy with famciclovir 1500 mg o.d. or 750 mg b.i.d. for one day treatment in adult men and women with recurrent herpes labialis


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * a history typical for recurrent herpes labialis. the subject must have experienced three or more episodes of cold sores in the last 12 months, and have a history of prodromal symptoms, as defined by the patient, preceding at least 50% of these cold sores, and must also have a history of vesicular lesions in at least 50% of the recurrent episodes of cold sores. * general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's account of his/her medical history * women of child bearing potential had to use an accepted method of birth control (surgical sterilization; intra-uterine contraceptive device; oral contraceptives; hormone delivery systems such as norplant® or depo-provera injections; a diaphragm in combination with contraceptive cream, jelly, or foam; or a condom in combination with contraceptive cream, jelly or foam). patients unable or unwilling to use one of the methods of birth control listed above for the duration of the study could not enter the study. * for women of child-bearing potential, a negative pregnancy test (urine) at screening was required * signature on the informed consent document exclusion criteria: * previous herpes vaccination * patients using topical immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) on or near the face or systemic immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) within 30 days of screening * patients known to be immunosuppressed due to underlying disease (e.g. hiv infection) or concomitant treatment (e.g. cancer chemotherapy) * recent history of alcohol or drug abuse, which in the opinion of the investigator, could interfere with that study patient's compliance with study requirements * significant skin disease such as atopic dermatitis or eczema that would interfere with the assessment of lesions * allergy or hypersensitivity to formulations containing acyclovir, penciclovir, famciclovir, and/or other nucleoside analogues * women who were lactating or breast feeding * had already been randomized once into the study * patients who had received an investigational drug in the past four weeks

Keywords: herpes labialis
peri-procedural smoking cessation program in patients with chronic pain

Conditions: Chronic Pain; Smoking

Summary: this single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.


Eligibility criteria:
inclusion criteria: * chronic pain of 3 months or greater * scheduled for interventional pain procedure exclusion criteria: * cancer related pain * current participation in smoking abstinence program * history of schizophrenia or other pyschotic disorder * history of dementing illness * pregnant patients * diagnosis of depression or anxiety
study to evaluate amyloid in blood and imaging related to dementia

Conditions: Alzheimer Disease; Alzheimer Dementia

Summary: the purpose of this study is to determine how well a blood test can detect amyloid beta, a protein involved in alzheimer's disease. participants will be asked to complete an initial blood collection and cognitive testing, and a subset of participants will be asked to complete a larger blood collection, amyloid pet imaging, and an mri.

alzheimer's disease is the most common cause of dementia and currently has no disease-modifying treatments or simple, accurate diagnostic tests. amyloid beta builds up in the brain and forms plaques in people with alzheimer's disease, and the buildup of this protein is found decades before symptoms of dementia begin. a blood test may be able to quickly and inexpensively screen people for alzheimer's disease clinical trials and eventually diagnose alzheimer's disease in the clinic.

Eligibility criteria:
inclusion criteria: 1. at least 60 years of age exclusion criteria: 1. unable to perform one or more activities of daily living (eating, bathing, dressing, ambulating, toileting) due to cognitive impairment or dependent on others due to cognitive impairment. 2. body weight of \<100 pounds 3. active infectious disease (e.g., hiv, hepatitis b, hepatitis c) 4. bleeding disorder 5. taking an experimental drug for ad 6. blood donation in the last two months 7. blood transfusion in the last three months 8. on hospice
physical activity referrals to the community

Conditions: Overweight; Obesity

Summary: the purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. we hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.


Eligibility criteria:
inclusion criteria: * aged 6-18 years * body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18 * fluent in english * parent of participant must be fluent in either english or spanish exclusion criteria: * medical conditions that preclude participation in physical activity

Keywords: obesity pediatric obesity physical activity physical fitness primary health care referral and consultation
clinical trial evaluating the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza

Conditions: Influenza

Summary: clinical trial with an active ingredient of a pharmaceutical specialty marketed in spain vs. placebo. randomized, double-blind, multicenter phase iii clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.


Eligibility criteria:
inclusion criteria: 1. aged ≥ 18 years. 2. diagnosis of influenza a or b virus infection by antigen or rt-pcr (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage). 3. hospitalized patients with an estimated hospital stay of more than 24 hours. 4. in previous treatment or concomitant start of treatment with oseltamivir. 5. for women of childbearing age, use of contraceptive methods until day 30 after completion of treatment. 6. signed informed consent. exclusion criteria: * 1. patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours. 2. pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methyl-prednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone). 3. inability to administer oral oseltamivir. 4. patients on ecmo (extracorporeal membrane oxygenation). 5. pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids. 6. patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator. 7. patients co-infected with sars-cov-2 or rsv.