Kornimate/medical-research-clean huggingface dataset:
rotavirus gastroenteritis and vaccine usage in rhode island

Conditions: Rotavirus Gastroenteritis

Summary: the goals of this study are to see what effects the introduction of rv5(rotateq) vaccine has had in the community both on the number of rotavirus-associated hospitalizations and on the strains of rotavirus circulating in the community. the investigators will use cases of rotavirus gastroenteritis identified on the wards at hasbro children's hospital during the 2007-2009 rotavirus seasons for a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations. the investigators plan to assess rotavirus vaccine coverage in rhode island using the state vaccine registry and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in rhode island. finally using the state child health database, kidsnet the investigators plan to investigate the reasons that children may not have received rotavirus vaccine in order to better target educational efforts for parents and health care providers.

the goals of this study, conducted after the introduction of rv5 (rotateq) vaccine in the community, are: 1) to use a case-control study to estimate rotavirus vaccine effectiveness in preventing rotavirus-associated hospitalizations under field conditions, 2) to assess rotavirus vaccine coverage and to examine whether and to what extent rotavirus vaccine was used outside the recommended age limits (off label) during the first 2 years of its implementation in rhode island and 3) to investigate risk factors for non-receipt of rotavirus vaccine to inform educational efforts for parents and providers, and 4) to characterize the strains of rotavirus circulating in the community both prior to and after introduction of vaccine to determine if serotype replacement is occurring.

Eligibility criteria:
inclusion criteria: * rotavirus gastroenteritis requiring hospitalization * immunocompetent * born after april 15, 2006 * greater than 2 months of age on the day of admission exclusion criteria: * rotavirus vaccine contraindicated for that child based on acip/aap recommendations * an immunization record cannot be obtained through the kidsnet database

Keywords: rotavirus gastroenteritis vaccine case-control study serotype
clinical assessment of burns in norway

Conditions: Burns

Summary: clinical assessment of burn depth and area can be challenging even for experienced surgeons. still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.there are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre. the aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.the cohort was defined as patients transferred to the burn unit at haukeland university hospital during 2014.


Eligibility criteria:
inclusion criteria: * patients transferred to the burn unit at haukeland university hospital during 2014 exclusion criteria: * readmissions * patients transported to haukeland directly from the site of the accident

Keywords: clinical assessment tbsa national burn centre
exploring the effects of probiotics on workplace related stress symptoms

Conditions: Stress; Sleep Disorder

Summary: there is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. a total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period.

this is a double blind, randomized control study, which will be conducted by national taiwan sport university. a total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. volunteers will be asked to fill in the perceived stress scale questionnaire before recruiting. subjects who meet the criteria will be asked to fill the different questionnaires to evaluate their stress, emotions, gastrointestinal tract symptoms, sleep status and blood draw is also needed.

Eligibility criteria:
inclusion criteria: * age 20 to 60 years old * perceived stress scale (pss) score is greater than or equal to 14 points exclusion criteria: * have used antibiotics or probiotic products in powder, capsule or tablet form within one month * those who are taking chinese medicine or western medicine to treat severe acute diseases * patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness * pregnant or breastfeeding * those who have participated in other interventional clinical studies in the past three months * who has conflict of interest with pi or unsuitable to participate in the research such as students directly supervised by the project host and those who are unable to read the consent form

Keywords: probiotics
the effects of atorvastatin treatment in copd patients

Conditions: COPD

Summary: rationale: retrospective studies suggest that statins improve outcomes in copd patients possibly as a result of an anti-inflammatory effect. objectives: to determine whether statins have an anti-inflammatory effect on the lungs of patients with copd. a controlled, parallel group study to compare the effects of atorvastatin in comparison to placebo as an add-on treatment to formoterol therapy in patients with mild to moderate copd in group of 20 patients. all subjects will have spirometry, lung volumes, dlco, sgrq, 6mwd, serum lipids and hs-crp measured before and after treatment. bronchoscopy and transbronchial lung biopsy (tbb) will be carried out at baseline and after 12 weeks of treatment, and tbb specimens will be processed for histology, immunohistochemistry and microarray analysis.


Eligibility criteria:
inclusion criteria: . written informed consent must be obtained before any assessment is performed. 2. male and female adults aged ≥40 years, who have signed an informed consent form prior to initiation of any study-related procedure. 3. patients with moderate to very severe stable copd (stage ii-iv) according to the gold guidelines. 4. patients with a post-bronchodilator fev1 \< 80% of the predicted normal, and a post-bronchodilator fev1/fvc \< 0.70 at visit 1. 5. current or ex-smokers who have a smoking history of at least 10 pack years exclusion criteria 1. pregnant or nursing (lactating) women 2. women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment. 5. 3. patients with a clinically significant abnormality at visit 1. 4. patients with a clinically relevant laboratory abnormality at visit 1 5. patients with a history of malignancy of any organ system (including lung cancer). 6. patients contraindicated for treatment with statins 7. patients unable to perform acceptable spirometry and lung volumes procedures. 8. patients who have had a copd exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1. 9. patients who have had a respiratory tract infection within 4 weeks prior to visit 1. 10. patients requiring oxygen therapy (\>15 hr/day) on a daily basis for chronic hypoxemia 11. patients with any history of asthma or onset of symptoms prior to age 40 years. 12. patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis). 13. patients with primary bronchiectasis. 14. patients with a diagnosis of α-1 anti-trypsin deficiency. 15. patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. 16. patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. 17. patients receiving any medications in the class listed in table 5.1 18. use of other investigational drugs within 30 days prior to visit 1.

Keywords: copd atorvastatin statins copd treatment microarrays
single-use efficiency instruments with patient specific technique (myknee®) versus traditional metal instruments with conventional surgical technique

Conditions: Osteoarthritis

Summary: to compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: single-use efficiency instruments with patient specific technique (myknee®) traditional metal instruments with conventional surgical technique


Eligibility criteria:
inclusion criteria: * age 18 to 75 years * bmi ≤35 * undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic oa) * able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks exclusion criteria: * pregnant women or those seeking to become pregnant. pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential * is participating in another clinical study * has inflammatory arthritis * has knee avascular necrosis * has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis * has retained hardware in the knee that requires removal or interferes with total knee arthroplasty (tka) procedure

Keywords: total knee replacement
long-term study of igiv, 10% in alzheimer´s disease

Conditions: Alzheimer´s Disease

Summary: the purpose of this long-term study is to provide additional evidence of safety and efficacy of igiv, 10% treatment in participants with alzheimer´s disease who have completed the phase 3 baxter precursor study 160701. all participants will receive igiv, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in baxter study 160701. participants and investigators will be blinded to dose unless otherwise notified by the sponsor.


Eligibility criteria:
main inclusion criteria: * completed 18 months of study treatment and assessments in baxter precursor study 160701 * diagnosis of probable alzheimer´s disease (ad) * able to comply with testing and infusion regimen (including adequate corrected visual acuity and hearing ability) * has a caregiver (study partner) who is willing and able to participate main exclusion criteria: * significant neurological disease other than ad * clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent heart attack) * contraindication to undergoing mri (e.g. pacemaker \[with the exception of an mri-compatible pacemaker\], severe claustrophobia, ferromagnetic implants such as a metal plate) * specific findings on brain mri (microhemorrhages, superficial siderosis, vasogenic edema, a macrohemorrhage, major stroke, or multiple lacunae) * active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment * uncontrolled major depression, psychosis, or other major psychiatric disorder(s) * poorly controlled diabetes * serious problems with liver or kidneys * known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin) * current or recent treatment with immunomodulatory therapies (with the exception of immunoglobulin and non-systemic and low-dose systemic corticosteroids) * recent use of investigational drugs or biologics, including those aimed at altering ad progression (with the exception of immunoglobulin) * active immunization for the treatment of ad at any time there are reasons why it might not be appropriate to participate in this trial. please contact medical information at medinfo@baxter.com for details.
shifting sleep timing in teens

Conditions: Sleep Insufficiency; Sleep; Adolescent Behavior

Summary: the goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. the main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.


Eligibility criteria:
inclusion criteria: 1. aged 14-18 and a full-time student in grades 9-12 2. male or female 3. willing and with a schedule permitting them to go to bed at an earlier time 4. planning on sleeping at home in their bedroom for at least 75% of the study exclusion criteria: 1. currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders 2. sleep only in the prone (face-down) position
dielectric property test compared with frozen pathological section in the rapid diagnosis of lung nodules/mass

Conditions: Lung Nodules; Lung Mass

Summary: patients with lung nodules/mass found by ct (computed tomography) or pet (positron emission tomography) who agree to receive lung resection are arranged to test the dielectric property before receiving the frozen pathological examination. and the final pathological results are recognized as the standard diagnosis. then the sensitivity and specificity of the dielectric property test will be evaluated comparing with the frozen pathological examination.


Eligibility criteria:
inclusion criteria: * patients with lung nodules/mass found by ct or pet who agree to receive lung resection; * diameter of the lung nodule/mass is longer than 8 millimeters; * more than 50% of the lung nodule/mass is solid component by image examination; * diameter of the solid component is longer than 5 millimeters by intraoperative exploration. exclusion criteria: * cutting open the resected nodule/mass will interfered with the pathological examination; * diameter of the solid component is shorter than 5 millimeters by intraoperative cutting open; * cutting open the lung nodule/mass will cause great damage to the patient, such as inducing allergic shock.

Keywords: dielectric property lung nodules differential diagnosis frozen pathological examination
diamond bur microblepharoexfoliation, intense pulse light and meibomian gland expression for evaporative dry eye

Conditions: Dry Eye Disease

Summary: the goal of this clinical trial is to assess the efficacy and safety of microblepharoeexfoliation (mbe), intense pulse light (ipl) and meibomian gland expression (mgx) combination in patients with meibomian gland dysfunction (mgd). the main question it aims to answer are: * does mbe-ipl-mgx treatment improve dry eye symptoms? * does mbe-ipl-mgx treatment improve dry eye signs? participants were assigned to receive either three sessions of mbe-ipl-mgx treatment and home-based therapy (treatment group) or home-based therapy alone (control group). the investigators will compare both groups to see if mbe-ipl-mgx treatment is superior to home-based therapy.

mbe is a novel in-office treatment that works by exfoliating the eyelid margins to remove the accumulated biofilm debris, epithelial keratinization and capped meibomian glands, resulting in better meibum outflow . different studies have shown that mbe improves ded symptoms \[1,2\], demodex blepharitis \[1-4\] and meibomian gland function \[2,3,5\] in addition, meta-analyses recommend combining ipl with meibomian gland expression (mgx) compared to ipl or mgx alone \[6-8\]. however, the investigators have not found any studies evaluating the benefits of mbe combined with ipl and mgx. consequently, the purpose of the current study is to evaluate whether mbe combined with ipl and mgx leads to an improvement of symptoms and signs in patients with ded due to mgd.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. ded diagnosis according to dews ii meeting one of the following conditions: (2.1) ocular surface disease index (osdi) score ≥ 13; (2.2) nibut \ 5 or 9 corneal or conjunctival stains, respectively. 3. mgd diagnosis according to the international workshop on mgd meeting two of the following conditions: (3.1) irregularity of the eyelid margin or mucocutaneous junction; (3.2) vascularity of the eyelid margin; (3.3) plugged or capped meibomian gland orifices; (3.4) meibomian gland atrophy; or (3.5) decreased meibum quality and quantity exclusion criteria: 1. skin pathologies that prevent ipl treatment 2. all corneal disorders that affect diagnostic tests, such as: (2.1) active corneal infections; and (2.2) corneal dystrophies. 3. active ocular allergy. 4. pregnant or lactating women.. 5. patients who did not understand or comprehend the informed consent.

Keywords: microblepharoexfoliation intense pulse light meibomian gland expression meibomian gland dysfunction
a fixed triple combination cream for solar lentigines associated to cryotherapy

Conditions: Solar Lentigines

Summary: to evaluate safety and efficacy of tri-luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

to evaluate safety and efficacy of tri-luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy. the study has 13 weeks for each subject. five visits will take place: at baseline, week 2, 5, 9 and 13 after the cryotherapy.

Eligibility criteria:
inclusion criteria: * subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol; * female and male subjects; * phototype ii to iv; * subjects aged between 40 and 65 years; * subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter * history of post-inflammatory hyperpigmentation on body or face * medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation; * subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study; * availability of the subject throughout the study; * subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study; * subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol. exclusion criteria: * pregnant women or women intending to become pregnant in the following 5 months after screening; * lactation period; * subjects participating in other clinical trials; * any prior cosmetic procedures, including fillers, or scars that may interfere with the study results; * subjects with neoplastic, muscular or neurological diseases; * subjects with inflammation or active infection in the area to be studied; * subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula, * subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol; * any condition that, in the opinion of the investigator, can compromise the evaluation of the study.

Keywords: lentigines cryotherapy hyperpigmentation
detection of false positives from first-trimester preeclampsia screening (stoppre) at the second-trimester of pregnancy

Conditions: Pre-Eclampsia

Summary: pregnant women at a higher risk for pre-eclampsia (pe) should be offered preventive daily treatment with acetylsalicylic acid (asa) started before 16 weeks of gestation. to select patients at higher risk for pe, multiparametric assessment combining maternal history, biochemical factors and biophysical factors should be used during the first trimester of pregnancy. multiparametric risk assessments have a detection rate for early-onset pe around 80% at a false positive rate of 10%. owing to the low prevalence of early-onset and preterm pe, more than 90% of patients considered at high risk, at the first-trimester screening, will not eventually develop pe. thus, asa treatment would be innecessary and could be safely discontinued in these patients. the sflt-1 to plgf ratio has a high negative predictive value for pe during the second and third trimester of pregnancy. thus, it could be used to detect false-positive patients from the first-trimester screening. this is a multicentric, randomized, open, parallel, controlled, phase iii trial, where 1,080 patients under treatment with asa for being at high risk for preeclampsia from the first-trimester screening, will be candidates to participate. patients with a sflt-1/plgf \<38, from 24 to 27+6 weeks of gestation will be randomized at a 1:1 ratio and allocated to either continue asa until 36 weeks or to stop asa treatment.

the main objective of the study is to demonstrate that in patients considered to be at high risk for pe (from the first-trimester screening) and with sflt-1/plgf ratio \<38, between 24+0 and 27+6 weeks, the incidence of preterm pe, after cessation of the treatment with asa, will not be superior to that of the control group.

Eligibility criteria:
inclusion criteria: * patients older than 18 years old * gestational age between 24+0 and 27+6 weeks * single pregnancy * high-risk for pre-eclampsia from the first-trimester screening for pre-eclampsia * asa treatment started before or at 16+6 weeks of gestation * maternal sflt-1/plgf ratio at 24+0-27+6 weeks of gestation * signed informed consent exclusion criteria: * multiple pregnancy * dead and/or fetal polymalformation, including also any fetal genetical and/or chromosomic disease. * von willebrand disease. * asa intolerance and /or allergy * peptic ulcer * asa compliance \<50% before inclusion * patients with misunderstanding or not able to understand the protocol, including also any condition which could compromise the compliance of the protocol, according to the investigator's opinion. * no signature of the informed consent

Keywords: pre-eclampsia pregnant sflt-1/plgf ratio asa treatment