Kornimate/medical-research-clean huggingface dataset:
annual study to investigate inactivated subunit influenza vaccine due to new virus strains for the 08/09 season.

Conditions: Influenza

Summary: influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. in europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. the current study is a phase iiia clinical trial with a commercially available vaccine (influvac®) supplied in pre filled syringes. it is part of the ongoing clinical trial program for influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \ = 61 years of age (elderly).


Eligibility criteria:
inclusion criteria: * willing and able to give informed consent and able to adhere to all protocol required study procedures. * men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. * being in good health as judged by medical history, physical examination and clinical judgment of the investigator. exclusion criteria: * known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. * a serious adverse reaction after a previous (influenza) vaccination. presence of any significant condition that may prohibit inclusion as determined by the investigator. * having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period. * a history of guillain-barré syndrome or active neurological disease.

Keywords: influenza vaccine chmp criteria
evaluation of a spherical hydrophilic acrylic intraocular lens

Conditions: Cataract Senile

Summary: evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

to show safety and the effectiveness in regard to the monocular corrected distance visual acuity (cdva) at 12-24 month postoperative.

Eligibility criteria:
inclusion criteria: * patients of any gender, aged 18 years or older at the time of the surgery * patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery * currently implanted with the study iol into the capsular bag in at least one eye * one-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit * patient is willing and capable of providing informed consent * patient is willing and capable of complying with visits and procedures as defined by this protocol exclusion criteria: * preoperative corrected distance visual acuity (cdva) better than 0.3 logmar (0.5 decimal) or cdva not available preoperatively * preoperative documented endothelial cell count of less than 2000/mm2 (if available) * any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss * any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) * any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) * any preoperative documented clinically significant condition that could affect iol stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) * any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis * any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection) * any previous preoperative intraocular and corneal surgery * preoperative documented uncontrolled glaucoma or iop higher than 24mmhg under ocular hypertension treatment * preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision * any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion * women during pregnancy and/or lactation at time of enrollment into the study * patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial * patients whose freedom is impaired by administrative or legal order * subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
study to evaluate safety & effectiveness of vascular sealant system

Conditions: Peripheral Vascular Disease

Summary: to evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.

vascular surgery encompasses a wide range of surgical procedures. in these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. suture hole bleeding is common following using synthetic and biological grafts for vascular repair. several topical hemostatic ans sealing agents have been developed to control suture line bleeding. this new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. the primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.

Eligibility criteria:
inclusion criteria: subject was \> 18 years of age. scheduled for elective vascular surgery that entails placement of a ptfe vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. subject was willing and able to comply with all aspects of the treatment and evaluation schedule. informed of the nature of the study, and has provided written informed consent, approved by the appropriate institutional review board (irb) of the respective clinical site exclusion criteria: subject had a known local or systemic infection. subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count \ 1.5. subject was participating in a clinical trial that requires treatment with another investigational device or drug. subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. the investigator determined that the subject should not be included in the study for reason(s) not already specified
asthma, missed immunizations, and vitamin d deficiency in atopic dermatitis

Conditions: Atopic Dermatitis; Vitamin D Deficiency; Asthma

Summary: atopic dermatitis is a chronic skin disease with pruritus as one of its main features. because of the symptomatic nature of their condition, pediatric patients with atopic dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling behind in visits to their primary care provider. this cross-sectional study in patients attending the dermatology clinic at children's hospital of wisconsin will screen for common conditions associated with atopic dermatitis and subsequently treat or refer patients for appropriate care. the investigators hypothesize that milwaukee county pediatric patients with atopic dermatitis will have a high prevalence of asthma needing treatment, missed immunizations requiring catch-up, and vitamin d deficiency necessitating replacement therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with atopic dermatitis by a children's hospital of wisconsin (chw) pediatric dermatologist * age 1- 18 years old * primary residence in milwaukee county exclusion criteria: * other chronic, systemic diseases other than asthma or environmental allergies * hyperimmunoglobulin e or job syndrome * ichthyosis disorder other than ichthyosis vulgaris * prior systemic therapy or phototherapy for atopic dermatitis * ongoing or prior treatment for known vitamin d deficiency * on chronic systemic corticosteroids for asthma

Keywords: missed immunizations
comparison between imv and simv/ps for ventilatory support of children: a randomized clinical trial

Conditions: Respiratory Failure

Summary: objectives: to compare intermittent mandatory ventilation (imv) with synchronous intermittent mandatory ventilation associated with pressure support (simv/ps) related to duration of mechanical ventilation/weaning and length of stay in picu (ls). design: randomized clinical trial. setting: pediatric intensive care unit at a university-affiliated hospital.

objectives: to compare intermittent mandatory ventilation (imv) with synchronous intermittent mandatory ventilation associated with pressure support (simv/ps) related to duration of mechanical ventilation/weaning and length of stay in picu (ls). design: randomized clinical trial. setting: pediatric intensive care unit at a university-affiliated hospital. patients: children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving mechanical ventilation (mv) for more than 48 hours. patients were randomly assigned into two groups: imv (imvg; n=35) and simv/ps (simvg; n=35). children with acute respiratory distress syndrome and tracheostomy were excluded. ventilation and oxygenation data were recorded at admission and beginning of weaning. results: groups were not statistically different for age, gender, mv indications, prism score, comfort scale, sedatives, and ventilation and oxygenation parameters. median of mv duration was 5 days for both groups (p\>0.05). also, there were no statistical differences for duration of weaning \[imvg: 1 day (1 - 6) vs. simvg: 1 day (1 - 6); p\>0.05\] and ls \[imvg: 8 days (2 - 22) vs. simvg: 6 days (3 - 20); p\>0.05\]. conclusion: there was no statistically significant difference between imv and simv/ps in these children related to mv and weaning duration, and picu length of stay.

Eligibility criteria:
inclusion criteria: * children aged between 28 days and four years, who were consecutively admitted to the picu and required mv for more than 48h were included. exclusion criteria: * children who had chronic respiratory failure, tracheostomy, those transferred from the hospital, or died were excluded as were patients with acute respiratory distress syndrome (ards).

Keywords: mechanical ventilation; respiratory failure
a primary care based intervention to prevent childhood obesity among low-income latino children

Conditions: Obesity, Childhood

Summary: the goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices among low-income latino infants and toddlers. infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. half of the participants will receive the futuros fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). the other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). we will look at the impact of the futuros fuertes 2.0 intervention on child bmi and various health behaviors.


Eligibility criteria:
inclusion criteria: * parent/caregiver self identifies as latino * parent/caregiver speaks spanish or english * parent/caregiver intends to receive primary care for infant at participating clinic * infant gestational age of 37 weeks or greater * infant birthweight of 2600 grams or greater * for multiples (twins, triplets), one sibling will be chosen at random to participate exclusion criteria: -infant has a serious medical condition that affects feeding or growth
phase ii randomized study of collagenase in patients with residual type dupuytren's disease

Conditions: Dupuytren's Contracture

Summary: objectives: evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual dupuytren's disease.

protocol outline: this is a randomized, investigator-blinded, placebo-controlled study. patients receive a single dose of either collagenase or placebo into the target finger on day 0. patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if ige antibody levels are no greater than 15 ng/ml. following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of residual dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --prior/concurrent therapy-- surgery: at least 30 days since surgery for dupuytren's disease other: at least 30 days since prior investigational drug --patient characteristics-- hematopoietic: no history of hematologic disease hepatic: no history of hepatic disease renal: no history of renal disease cardiovascular: no congestive heart failure within 6 months no angina within 6 months no myocardial infarction within 6 months pulmonary: no history of respiratory disease other: hiv negative not immunocompromised no history of significant illness, e.g., endocrine or neurologic disease no history of illicit drug abuse or alcoholism within 1 year no psychosis at least 2 weeks since infectious illness no chronic or debilitating disease no ige antibodies to collagenase greater than 15 ng/ml no known allergy to collagenase or any of the inactive ingredients in the injection not pregnant or nursing fertile patients must use effective contraception

Keywords: dupuytren's disease arthritis & connective tissue diseases rare disease
a music-based vr intervention for upper limb motor rehabilitation in hemiparetic patients

Conditions: Hemiparesis

Summary: hemiparesis affects the majority of stroke patients in the acute phase. in post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. research showed that virtual reality (vr) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based vr intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. the treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. participants wear a vr headset through which they observe egocentric 180° 3d videoclips. the experimental condition (group a) will be compared with a no-music condition (group b), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group c), to test the efficacy of the approach. the investigators expect that the patients undergoing the experimental intervention (group a and group b) will show a greater upper limb motor function improvement, as compared to the active control group. as a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.


Eligibility criteria:
inclusion criteria: * post-stroke patients in acute/subacute phase * upper limb hemiparesis (ashworth scale: 0-2; mrc scale: 3-5) * age between 18 and 80 years * currently enrolled in inpatient rehabilitation exclusion criteria: * psychiatric disorders, * neglect * epilepsy * mmse rating \< 24 * difficulty with visual-spatial exploration * visual deficits.

Keywords: music motor coordination embodied cognition rehabilitation virtual reality action observation
innovation of custom-made silicon insoles for diabetic patient

Conditions: Diabetic Foot

Summary: "diabetic foot ulcers, caused by diabetes-related nerve and blood vessel damage, can lead to amputations. silicone insoles help prevent ulcers but are often expensive. affordable, customized insoles are available, making prevention more accessible.

this research aims to create affordable, locally manufactured silicone insoles for diabetic foot ulcers, reducing costs and improving accessibility. six-month study at the pakistan.

Eligibility criteria:
inclusion criteria: * adults aged patients, * both genders will be included * diagnosed with diabetic ulcers/diabetes * reporting pain and mild ulcers on foot, exclusion criteria: * recent history of foot injuries * presence of other musculoskeletal conditions affecting the foot * inflammatory conditions such as rheumatoid arthritis or gout * neurological conditions affecting foot or leg functions
effect of suplementation of vitamin d in gestational diabetes mellitus

Conditions: Vitamin D3; Gestational Diabetes Mellitus in Pregnancy

Summary: randomized double-blind placebo-controlled clinical trial. consists of the administration of 5,000 iu of vitamin d3 vs placebo in patients with gestational diabetes mellitus during eight weeks. the objective is to analyze the effects of the intervention on the biochemical parameters that are part of the glycemic profile (insuline, hba1c, glucose)

two groups of patients diagnosed with gestational diabetes mellitus. once the selection criteria are verified, they will be assigned randomly in one of the two arms,one of them will recive 5,000 iu of vitamin d and the other one placebo (talcum food grade). baseline measurements of vitamin d, glucose,insulin, hba1c, calcium, phosphorus. at the end of the eight weeks will be determined again the aforementioned biochemical parameters.

Eligibility criteria:
inclusion criteria: patients with a single pregnancy. * patients diagnosed with gdm, which were diagnosed by a glucose tolerance curve 100 grams of glucose, with two altered results from the following: fasting\> 95 miligrams / deciliter, 1 hour\> 180miligrams / deciliter, 2 hour\> 155miligrams / deciliter, 3hous\> 140 miligrams / deciliter. * gestational age between 24 -30 weeks confirmed with ultrasound of the 1st or 2nd trimester * age between 18 and 40 years. exclusion criteria: patients with pre-existing diabetes mellitus * patients with predictive factors for vitamin d hypovitaminosis such as: use of anticonvulsants, renal disease, glomerular filtration rate \<60milliliters / minute, thyroid disease or any other pre-existing endocrinological disorders. * hypercalciuria\> 300 miligrams / day * patients taking vitamin d supplementation during the 6 months prior to the study (does not include polyvitamins with lower vitamin d concentrations \<500 iu) * active and passive smoking patients.
phecheck feasibility study

Conditions: Phenylketonurias

Summary: the goal of this feasibility study clinical trial is to compare the accuracy of phecheck™ for the rapid quantitative detection of phenylalanine (phe) with the gold standard (hplc amino acid analyzer), in patients with pku. the main aims are: * evaluate the accuracy of phecheck as compared to the gold standard * evaluate ease of use by lay participants

the primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of phecheck™ for the rapid, quantitative detection of phenylalanine (phe) from capillary blood compared to the gold standard (hplc amino acid analyzer) which quantitatively measures phe in venous blood. the study will enroll subjects into one study cohort. it will include patients 10 years or older, monitored for phenylketonuria (pku), hyperphenylalaninemia or pku during pregnancy.

Eligibility criteria:
inclusion criteria: * 10 years of age or older * being monitored for phenylketonuria (pku), hyperphenylalaninemia or for pku during pregnancy signed informed consent exclusion criteria: * younger than 10 years of age * not being monitored for phenylketonuria (pku), hyperphenylalaninemia or for pku during pregnancy * lack of signed informed consent * previous enrollment in the study and has completed study visit 1 and 2
emergency contraception (ecp): reducing unintended pregnancies

Conditions: Contraception; Pregnancy

Summary: emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. emergency contraceptive pills (ecps) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). this study will compare these two methods of providing ecps.

ecps can give women a "second chance" to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. by using ecp, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ecp use. this study will compare the use and cost of two ecp distribution patterns: advance provision and emergency provision. it will also identify environmental, situational, and behavioral factors associated with ecp acceptance and use. participants in this study will be recruited from four family planning clinics in the philadelphia area and five family planning clinics in the pittsburgh area. participants from the philadelphia clinics will be given ecps as part of a regular clinic visit (advance provision); participants from the pittsburgh clinics will be given ecps on an emergency basis (emergent provision). each participant will complete a short intake form and will be issued a pager. participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ecp, contraceptives, and pregnancy status. approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and months 9 and 18. clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.

Eligibility criteria:
inclusion criteria * patient at a participating clinic exclusion criteria * pregnant * medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy) * norplant or iuds * desires to become pregnant

Keywords: female