Kornimate/medical-research-clean huggingface dataset:
performance evaluation of two silicone hydrogel toric lens designs in habitual soft contact lens wearers

Conditions: Astigmatism

Summary: the objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

this study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. each lens type will be worn bilaterally for approximately one month.

Eligibility criteria:
inclusion criteria: 1. is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. self-reports having a full eye examination in the previous two years; 4. anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week; 5. is willing and able to follow instructions and maintain the appointment schedule; 6. habitually wears of toric soft contact lenses binocularly. 1. no more than 1/3 of the participants should be wearing daily disposable soft toric lenses; 2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows: * i. total30 for astigmatism: maximum of 3 (∼10%) (no target percentage) * ii. biofinity toric: maximum of 13 (∼40%) (plus a target of minimum 10 (∼30%)) * iii. air optix for astigmatism (inclusive of +hydraglyde): maximum of 10 (∼30%) (plus a target of minimum 7 (∼20%)) * iv. ultra for astigmatism: maximum of 5 (∼15%) (no target percentage) * v. acuvue vita for astigmatism: maximum of 3 (∼10%) (no target percentage) * vi. acuvue oasys for astigmatism: maximum of 10 (∼30%) (no target percentage) * vii. other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage) 7. has refractive astigmatism of at least -0.75dc but no more than -2.75dc in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25dc; 8. is ammetropic and requires a spectacle spherical component of +8.00 to -10.00d inclusively; 9. can be fit and achieve binocular distance vision of at least 20/32 snellen with the available lens parameters exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active ocular disease and/or infection that contraindicates contact lens wear; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable; 5. has known sensitivity to the diagnostic sodium fluorescein used in the study; 6. self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. has undergone refractive error surgery or intraocular surgery.
fibromyalgia, cognitive rehabilitation software

Conditions: Fibromyalgia; Cognitive Rehabilitation

Summary: in recent years, especially in developed countries, fms has emerged as a serious social problem by decreasing labour force and quality of life. especially clinicians have started to consider cognitive dysfunction in fms as a separate clinical condition. in the light of the data obtained, can say that cognitive dysfunction increases in the presence of depression, anxiety, sleep disorders, endocrine imbalances and pain. neuroscience and technological advances make it possible to meet the demand for care and improve the quality of stimulation by enabling the automation of many cognitive training procedures, improving patient record reliability and optimising performance of disability functions. the recently implemented rehacom and headapp programmes (schuhfried, austria). excellent results have been reported in clinical practice with no significant adverse effects. this study will investigate the effectiveness of a cognitive rehabilitation programme using computer software in female patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * being a woman * diagnosed with fibromyalgia * 18-65 years old exclusion criteria: * concomitant neurological disorder, learning disorder or cognitive impairment * current alcohol or recreational drug dependence or long-term (≥5 years) history of substance abuse * visual or hearing impairment that would interfere with cognitive testing * diagnosis of untreated obstructive sleep apnoea, * atypical sleep/wake patterns (e.g. night shift workers) * lack of computer and internet access
distal tibia sarcoma treatment using allograft arthrodesis of the ankle

Conditions: Bone Neoplasm

Summary: the study show the clinical results of limb salvage for primary malignant bone tumor of the distal tibia using block excision of the tumor and reconstruction with allograft arthrodesis with different methods of fixation (plates or intramedullary nail system)

it is well known that before the 1980's the usual treatment for the sarcomas of the distal tibia was amputation (1). currently, however, after the improvement of the chemotherapy treatments, potential reconstructions of the area in well studied patients are possible, and for that we have a wide range: auto graft, allograft and prosthetic reconstructions (2, 3) is important to know that osteosarcoma still meant the principal diagnosis, followed by the ewing sarcoma and synovial sarcoma, but their malignant potency is lower than when they are present in the rest of the body (4, 5, and 6) the purpose of this study is to recollect the patients' data followed from different institutions and countries that have the criteria for their inclusion in the study (primary malignant bone tumor of the distal tibia that underwent block excision of the tumor and reconstruction with allograft arthrodesis from the patient management for any of the multidisciplinary sarcoma team including in this study).

Eligibility criteria:
inclusion criteria: - all patients with histopathologyc diagnosis of a primary malignant bone tumor at the distal tibia that went through a tumor resection and received reconstruction with allograft as first surgical treatment exclusion criteria: * none histopatologic proved diagnosis * patients that received other kind of surgical treatment

Keywords: allograft distal tibia sarcoma
this trial is a prospective observational study of newly diagnosed diffuse large b cell primary breast lymphomas

Conditions: Diffuse Large B-Cell Lymphoma of the Breast

Summary: in this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized pbl. patients will be treated with 6 cycles of rchop-14 or rchop-21. the administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective ielsg study, but will be at the discretion of the treating center.


Eligibility criteria:
inclusion criteria: * previously untreated patients with dlbcl of the breast. * patients must have cd20 positive tumors. * stage ie or iie. * must have at least one objective measurable or evaluable disease. baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. * patients must have an ecog performance status 0-2. * patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration): * creatinine clearance \> 50 ml/min * total bilirubin \< 2.0 mg/dl and ast \< 2 x upper limit of normal. if documented hepatic involvement with lymphoma, total bilirubin can be \< 3 x uln, and ast \< 5 x uln. * absolute neutrophil count \> 1500/mm3 and platelet count \> 100,000/mm3. if documented bone marrow involvement with lymphoma, absolute neutrophil count \> 500/mm3 and platelet count \> 50,000/mm3. * patients must be age \> 18 years. * patients must have a normal left ventricular ejection fraction to be eligible. exclusion criteria: * historical or radiographic evidence of cns metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. * pregnant or breast feeding patients. women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. * active infection requiring parental antibiotics. * known hiv infection
effect of spirulina on zinc, vitamin e and linoleic acid levels in palm skin following chronic exposure to arsenic

Conditions: Arsenical Keratosis

Summary: patients of arsenical keratosis may be treated with spirulina. is this improvement related to the levels of zinc, vitamin e and linoleic acid at the site of the keratosis (palm)? to understand this, patients of palmer arsenical keratosis (n=10), arsenic exposed controls (n=10) and healthy volunteers (n=10) will be treated with spirulina powder 10 g/day orally for 12 weeks. skin extracts will be collected both before and after supplementation from the palm and dorsum for estimation of zinc, vitamin e and linoleic acid levels.

patients of arsenical keratosis remain untreated due to unavailability of effective drug. to find out an effective drug, the pathogenesis of keratosis should be understood. spirulina is one of the dietary supplements, that improves the symptoms of keratosis. is this improvement related to the levels of zinc, vitamin e and linoleic acid at the site of the keratosis (palm)? ten patients of moderate palmer arsenical keratosis will be treated with spirulina powder 10 g/day orally for 12 weeks. skin extracts will be collected both before and after supplementation from the palm and dorsum using a mixture of chloroform and ethanol. zinc, vitamin e and linoleic acid levels will be estimated from the extracts. similar protocol of spirulina administration and the collection of skin extracts will be done in arsenic exposed controls (n=10) and healthy volunteers (n=10).

Eligibility criteria:
inclusion criteria (patients): * moderate palmer keratosis * drink arsenic contaminated water (\>50 µg/l) for at least 6 months * voluntarily agree to participate inclusion criteria (arsenic exposed controls): * no symptoms of keratosis * family member of the patient * drink arsenic contaminated water (\>50 µg/l) for at least 6 months * voluntarily agree to participate inclusion criteria (healthy volunteers): * no symptoms of keratosis * drink arsenic safe water (\<50 µg/l) * voluntarily agree to participate exclusion criteria: * pregnancy * lactation * chronic diseases: diabetes mellitus, rheumatoid arthritis, tuberculosis * arsenicosis patients under treatment in the previous 3 months

Keywords: arsenic keratosis linoleic acid palm spirulina vitamin e zinc
coronary artery disease severity in newly diagnosed dysglycemia

Conditions: Coronary Artery Disease; Dysglycemia

Summary: this cohort study will measure how severe is the coronary artery disease (cad), at time of cad diagnosis, clinically and angiographically in the different cohorts of newly diagnosed diabetes and prediabetes versus normal glycemia patients in the study center.


Eligibility criteria:
inclusion criteria: * all adult patients with consents. * first time diagnosis of cad and no prior diagnosis of diabetes milletus (dm), or prediabetes. * coronary artery disease confirmed by invasive coronary angiography. exclusion criteria: 1. patients with known significant anemia, increased hemoglobin turnover, active hemoglobin drops or on erythropoietin therapy. 2. pregnant and post-partum patients (up to 3 months post-delivery). 3. patients with severe chronic renal failure (estimated glomerular filtration rate (egfr) \< 30 ml/min/1.72 m2). 4. patients on any medications with glucose lowering effects.
food habit programming: influence of genetics and early nutrition in a population of preterm infants

Conditions: Preterm Infants

Summary: influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.


Eligibility criteria:
inclusion criteria: * preterm infants \< 33 sa who stayed at least 2 weeks after birth in nantes hospital, included in the " grandir ensemble " network, 2 years old in 2008 and 2009

Keywords: newborn nutrition genetic feeding behaviour psychomotor development long-term effects nutritional imprinting.
bioequivalence study of cj-30061 in healthy male volunteers

Conditions: Hypertension; Hyperlipidemia

Summary: to compare the pharmacokinetics and safety after a single dose administration of cj-30061 and co-administration of exforge® 5/160mg, lipitor® 20mg in healthy adult volunteers


Eligibility criteria:
inclusion criteria: * healthy male aged 19 to 55 years at the time of signing informed consent form. * subject with bmi from 19kg/m\^2 to 27kg/m\^2 * decided to participate in the study and provided signed informed consent form volutarily after receiving explanation of the objectives, contents, and property of investigational products of the study exclusion criteria: * subject who had a medical history of severe hepatobiliary, renal, gastrointestinal, cardiovascular, respiratory, endocrinological, neuropsychological, hematological, musculoskeletal disease. * subject who fall under the criteria below in laboratory test. * ast/alt, total bilirubin, ggt, uric acid \> unl (upper normal limit) x 1.5 * cpk \> unl x 2.5 * crcl \< 60ml/min * subject who fall under the criteria below in blood pressure test (sisbp \< 100mmhg/sisbp ≥ 150mmhg or sidbp \< 70mmhg/sidbp ≥ 100mmhg)
safety and immunogenicity of haemophilus influenzae type b conjugate vaccine，freeze-dried

Conditions: Haemophilus Influenzae Type b Infections

Summary: the study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (hib) in healthy children 2 months to 5 years of age who have not been previously immunized with a hib vaccine. children 2 to 5 months of age will receive 3 doses of hib vaccine, children 6 to 11 months of age will receive 2 doses of hib vaccine, children 1 to 5 years of age will receive 1 dose of hib vaccine, with each dose given approximately 1 month apart.


Eligibility criteria:
inclusion criteria: * healthy permanent residence 2 months to 5 years old. * subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. * axillary temperature ≤37.0 ℃. exclusion criteria: * history of haemophilus influenzae type b infection or vaccination of haemophilus influenzae type b conjugate vaccine. * allergic history or any sae after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. * receipt of blood or blood-derived products in the 3 months preceding vaccination * participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. * receipt of any live virus vaccine in the 15 days preceding vaccination. * receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. * febrile illness (temperature ≥ 38°c) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. * thrombocytopenia. * history of treatment for thyroid gland disease. * functional or anatomic asplenia. * history of eclampsia, epilepsy, encephalopathy and mental disease or family disease. * any condition that, in the judgment of investigator, may affect trial assessment.

Keywords: vaccine haemophilus influenzae type b
a study of patient concerns and treatment satisfaction in patients being treated with finacea foam for rosacea

Conditions: Rosacea

Summary: to survey rosacea patients about their concerns, treatment satisfaction, and quality of life associated with their finacea foam treatment


Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of rosacea by a medical professional * currently using finacea foam as topical monotherapy for rosacea * willing and able to provide voluntary, informed consent to participate in this study exclusion criteria: - use of any other topical treatment for rosacea at the time of enrollment
evaluation of pulse oximetry sensors in neonates

Conditions: Premature Birth

Summary: the purpose of this study is to evaluate sensor longevity and skin integrity with two different models of neonatal pulse oximetry sensors currently used for monitoring oxygen levels in small infants.

a common method for assessing the respiratory status of hospitalized children is the use of pulse oximetry. this noninvasive device typically is placed on a finger, foot/palm of a child. red and infrared light is shined through the tissue under the sensor and the information is sent back to a monitor for calculation of oxygen saturation. use of this noninvasive method provides continuous information on the oxygenation status of patients and has greatly reduced the number of arterial blood samples required for patient care. while the advantages of noninvasive pulse oximetry are significant, there are a number of factors which can negatively impact the performance of the device. patient movement and sensor adherence to the skin have been some of the challenges to optimal device performance. while much of the clinical research on pulse oximetry sensors over the years has evaluated device accuracy and reliability, limited data is available on sensor longevity under conditions typical of clinical use. a particular challenge with neonatal pulse oximetry monitoring is insuring proper sensor adherence within the warm, moist environment of incubators used in neonatal care. furthermore, limited data are available on the impact of sensor adherence on skin integrity in premature infants who are at high risk for skin breakdown. objectives. the purpose of this study is to evaluate sensor longevity and impact on skin integrity in neonatal patients with two different models of pulse oximetry sensors. research method. a sample of 32 premature infants will be recruited to participate in this study in which an adhesive sensor and a nonadhesive sensor are compared. both sensors will be simultaneously tested in each subject, for a period of 14 days, with one sensor on the right foot and the other sensor on the left foot. data will be collected on sensor longevity, skin integrity at the sensor site, reason for sensor replacement and ease of use rating by the clinician. data will be summarized using descriptive statistics.

Eligibility criteria:
inclusion criteria: * gestational age \< 34 weeks * weight \< 3.0 kg * postnatal age \< 2 weeks * anticipated pulse oximetry monitoring for at least 14 days exclusion criteria: * presence of any skin irritation or breakdown on either foot * foot impediments which would preclude proper placement of the test sensors * known allergies to adhesive materials

Keywords: pulse oximetry pulse oximetry sensors skin integrity prematurity neonatal intensive care unit infant, premature
effect of glucomannan supplementation on body weight in overweight and obese children

Conditions: Obesity; Overweight

Summary: glucomannan (gnn), a water-soluble dietary fiber derived from the plant amorphophallus konjac, is marketed for weight reduction. the exact mechanisms by which gnn might exert its actions are unclear. nonetheless, it has been shown that gnn slows gastric emptying by forming a viscous gel of large volume, which increases the feeling of satiety. current evidence on the effectiveness of gnn for weight reduction is sparse, and well-designed trials performed in children are needed to assess the efficacy of this modality. we aim to systematically evaluate the efficacy of gnn consumption for the management of overweight and obesity in children.

methods and analysis children aged 6 to 17 years with overweight and obesity (based on the who growth criteria) will be randomly assigned to receive gnn or placebo (maltodextrin) (both at a dose of 3 g/day) for 3 months and will be followed up for 3 months. prior to the intervention, all children will receive dietetic advice, and they will be encouraged to engage in physical activity. the primary outcome measure will be the bmi-for-age z-score difference between the groups at the end of the intervention.

Eligibility criteria:
inclusion criteria: * age 6-17 years; * overweight or obesity based on the who (world health organization) growth charts/references (\>+1 standard deviation \[sd\] or \>+2 sd, respectively) exclusion criteria: * drug therapy for a chronic disease (including drugs that influence appetite or body weight); * type 1 or 2 diabetes; * history of surgical treatment of obesity; * participation in another program for treating obesity during the project and/or 3 months prior to recruitment; * secondary causes of obesity; * pregnancy.

Keywords: glucomannan obesity children overweight adolescents treatment
the impact of preoperative aromatherapy upon time to first analgesia request after cesarean section

Conditions: Pain

Summary: one of the main aims of anesthesia is to reduce postoperative pain. however, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding . recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

pain is amongst the most common problems after surgery (1). pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them * the uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing * so, one of the main aims of anesthesia is to reduce postoperative pain. however, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Eligibility criteria:
inclusion criteria: * age between 20 and 40 years * body mass index (bmi) of 18-35 kg/m2 * patients with the american society of anesthesiologists (asa) physical status i/ii, * patients scheduled for elective cesarean section. exclusion criteria: * patient refusal * allergy to local anaesthetics * anosmia * coagulopathy, * chronic pain syndromes * prolonged opioid medication * patients who received any analgesic 24 h before surgery.