Kornimate/medical-research-clean huggingface dataset:
developmental delay in children exposed during pregnancy to either lamotrigine,sodium valproate, or carbamazepine

Conditions: Autism; Developmental Delay; Birth Defects

Summary: this study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (ltg), sodium valproate (vpa), or carbamazepine (cbz) monotherapies. the hypotheses to be tested include: 1. exposure during pregnancy to cbz, ltg, and vpa, each as monotherapy, is associated with developmental delay with or without signs of autism. 2. exposure to each drug (cbz, ltg, and vpa) as monotherapy is associated with an increased rate of occurrence of major malformations. 3. the child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations. 4. the occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester. the study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.


Eligibility criteria:
inclusion criteria: * 36-83 months of age * prenatal exposure to ltg, vpa, or cbz monotherapy * aed was used by mother to suppress seizures * mother was enrolled in the north american aed pregnancy registry exclusion criteria: * exposure during the first trimester to other known teratogens. * mother with mental health issues * refusal to release medical records to confirm eligibility.

Keywords: valproate lamotrigine carbamazepine anticonvulsant antiepileptic teratogen autism developmental delay
use of 2-octylcyanoacrylate with full-thickness skin grafts

Conditions: Wound Closure Techniques

Summary: the purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.

the purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.

Eligibility criteria:
inclusion criteria: * over 18 years of age * able to give informed consent themselves * patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft * willing to return for follow-up visits exclusion criteria: * mentally handicapped * unable to understand written and oral english * incarceration * under 18 years of age * pregnant women * patients on systemic steroid therapies * patients with marfans * patients with allergies to 2-octylcyanoacrylate
research of the consequences on the digestive tract following the proposed treatments for a urinary infection in children

Conditions: Urinary Tract Infections; Urinary Tract Infections in Children

Summary: the emergence of extended-spectrum beta-lactamase-producing enterobacteriaceae (e-esbl) is a major public health problem. it leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. a policy of savings of penems is desirable. among the alternatives to penems, amikacin is in the foreground. it remains active on the majority of e-esbl strains. some risk factors for e-esbl emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country. in pediatrics, e-esbls are primarily responsible for urinary tract infection. in france, e-esbls represent about 10% of the strains responsible for urinary tract infections. the pathology group pediatric infectious (gpip) of the french society of pediatrics (sfp) and the society of infectious pathology french language (spilf) have proposed different therapeutic options to treat febrile utis in children: amikacin intravenous; intravenous (iv) ceftriaxone or intramuscular (im); or cefixime per-os (po). the objective of this study is to compare the emergence of e-esbls in stools of children after febrile utis treatment with amikacin iv versus ceftriaxone or cefixime.


Eligibility criteria:
inclusion criteria: * infant and child (age ≥ 3 months and \<3 years) * patient treated for febrile urinary tract infection as monotherapy with amikacin iv, ceftriaxone (iv or im) or cefixime po \* * whose parents read and understood the newsletter and whose express consent was collected * patient affiliated to a social security scheme (social security or universal medical coverage) exclusion criteria: * child treated with more than one antibiotic (eg treatment with dual therapy ceftriaxone / cefotaxime and aminoglycoside) * antibiotherapy in progress or discontinued in the previous 7 days * hospitalized child * refusal of one of the parents
effect of maraviroc on the pharmacokinetics of digoxin

Conditions: Healthy; HIV Infections

Summary: this is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 25.5 kg/m2. * total body weight \>50 kg (110 lbs). exclusion criteria: * treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. * subjects with an estimated creatinine clearance (clcr) \<80 ml/min. * pregnant or nursing females. * females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of study.

Keywords: maraviroc digoxin p-glycoprotein pharmacokinetics drug interaction hiv
efficacy and safety of voice inception technique based u-healthcare service in patients with type 2 diabetes mellitus

Conditions: Diabetes

Summary: ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. however, previous u-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. voice inception technique based u-healthcare service is expected to improve glycemic control without specific devices. to evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between u-health care group (intervention) and conventional treatment group (control).

ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. nowadays, various methods are tried to find the most effective and easiest way for supplying u-health care. here, researchers are going to investigate the efficacy and safety of voice inception technique based u-healthcare service.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * age: 60 \~ 85 yrs * hba1c: 7.0%-11.0% * basal insulin or premixed insulin user exclusion criteria: * type 1 diabetes * short acting insulin or insulin pump user * systemic corticosteroid administered within previous 6 months * history of myocardial ischemia * heart failure, new york heart association (nyha) class ii-iv * thyroid disease with abnormal thyroid function test * anti-obesity drugs or slimming products within previous 3 months * severe liver or kidney disease
managing bacterial pneumonia in children without antimicrobials

Conditions: Pneumonia

Summary: retrospective cohort analysis of children hospitalized for pneumonia comparing disease severity on admission, clinical course, treatment and outcomes and prospective telephone based follow-up assessement.

the investigators will conduct a retrospective cohort analysis of children hospitalized for pneumonia at the filderklinik between december 2006 and november 2010. the bacterial pneumonia score, a validated composite laboratory, clinical and radiologic score developed by moreno et al, will be retrospectively applied to define cases as either viral or bacterial pneumonia. the investigators will compare disease severity on admission, clinical course, and outcomes (in terms of complications, length of stay and readmission rates) between antimicrobial and non-antimicrobial managed bacterial pneumonia cases. long-term follow-up will be assessed by telephone interviews with the parents.

Eligibility criteria:
inclusion criteria: * hospital admission at the pediatric department of the filderklinik. * admission diagnosis pneumonia (icd j12.0, j12.1, j12.8, j12.9, j14, j15.1, j15.6, j15.7, j15.8, j15.9, j16.8, j18.0, j18.1, j18.8, j18.9 - all 12s, 15s, 16s, 18s) exclusion criteria: * none
the effect of nutritional supplementation on actinic purpura: a pilot study

Conditions: Skin Health; Skin Aging of Face and Hands; Healthy; Ecchymosis

Summary: purpura is a macule or papule of blood in the skin. it is mostly seen in mature skin that is often prone to significant bruising. small lesions of less than 5 mm are called petechiae and larger ones, found mostly in subcutaneous tissue, are called ecchymosis. actinic purpura occurs almost exclusively in elderly populations. this single-blind randomized clinical trial evaluates the effect of an 8-week nutritional supplement intervention in comparison with isolated vitamin c supplements on actinic purpura in older adults. we will enroll thirty (30) otherwise healthy participants, both male and female, aged 55 years and older. changes in participants' skin condition will be assessed at visit 1 (baseline), visit 2 (4-week), and visit 3 (8-week) using questionnaires, standard digital photography, and clinical grading of the skin lesions.


Eligibility criteria:
inclusion criteria: * male or female individuals aged ≥ 55 years old. * self-reported having actinic purpura lesions at the time of enrollment or a history of actinic purpura lesions. * self-reported not using prescription or over-the-counter products that contain aluminum, iron, proton pump inhibitors (ppis), and/or topical retinol (used locally in areas of bruising). * if on a chronic medication that does not result in exclusion, participant must self-report being on a stable dose for the last 3 months prior to the start of the trial. * able and willing to read and voluntarily sign the study informed consent form (icf). * able and willing to comply with study protocol and all study-related guidelines. * not concomitantly participating in a study involving nutritional products. exclusion criteria: * not complying with the study protocol. * having a known allergy or intolerance to nuts, seeds, fruits, vegetables, oils, and fish. * having a known allergy, intolerance, or dietary restriction to any of the study ingredients (vitamin c, organic buckwheat (aerial parts) juice powder, organic buckwheat flour, bovine adrenal cytosol™ extract, oat flour, honey, ascorbic acid, and calcium stearate). * having a clinically significant condition that is severe, progressive, or uncontrolled and would compromise the study or their well-being or would prevent the participant from meeting or performing study requirements. this includes but is not limited to dysphagia (or difficulty swallowing), liver or kidney disease, bone marrow problems, ehlers-danlos syndrome, lupus, alcohol misuse, cancer, or hiv and other infections. * having active dermatological conditions. patients with active, severe skin conditions that might interfere with the study's conduct or outcomes including widespread psoriasis, untreated chronic skin ulcers, or other severe dermatological disorders.
trial of r-gemox versus r-minichop regimen in first-line treatment of elderly diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: the purpose of this study is to investigate efficacy and safety of r-gemox versus r-minichop as first-line treatment of elderly patients with diffuse large b cell lymphoma

gemcitabine and oxaliplatin(gemox) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. our previous study showed that two-weekly regimen of rituximab combined with gemox regimen acheived comparable response rate to r-minichop.the investigators therefore design this open-label,phase iii and random trial to compared the safety and efficacy of r-gemox versus r-minichop as first-line treatment of elderly patients with diffuse large b cell lymphoma. primary outcome measures: • 2-year overall survival rate secondary outcome measures: * 2-year progression free survival rate * overall response rate * safety and toxicity enrollment:258 study start date: june 2016 primary completion date: june 2019

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diffuse large b cell lymphoma（with exception of primary mediastinal large b cell lymphoma、primary central nervous system lymphoma、hiv-related lymphoma); 2. new-diagnosed and untreated; 3. age older than 80 years or older than 70 years with ecog ps ≥ 2; 4. ann arbor stage i to stage iv disease; 5. understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. exclusion criteria: 1. poor hepatic and/or renal function, defined as total bilirubin, alt, ast, cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma; 2. poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/l or platelet count less than 75×10⁹/l, unless caused by bone marrow infiltration; 3. presence of grade iii nervous toxicity with two weeks; 4. new york heart association class iii or iv cardiac failure; or ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia 5. positive hiv, syphilis,hcv, or hbv virus load(hbv dna)\> 1×10'4copies/ml; 6. cns or meningeal involvement; 7. concomitant malignancy other than aggressive b cell lymphoma and need to treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years; 8. concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial; 9. active and severe infectious diseases; 10. major surgery within three weeks; 11. any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment. 12. in any conditions which investigator considered ineligible for this study. 13. known sensitivity or allergy to investigational product.

Keywords: r-gemox r-minichop elderly patients with diffuse large b cell lymphoma
imposter syndrome in medical students and its relation with stress

Conditions: Imposter Syndrome; Medical Students

Summary: the goal of this observational study is to examine the relationship between imposter syndrome and stress in undergraduate medical students at rawalpindi medical university, with particular attention to variables such as gender, academic year, and academic performance. the main questions it aims to answer are: is there a positive correlation between imposter syndrome and stress? are gender and year of study associated with differences in stress and imposter syndrome levels? participants will: complete an online questionnaire including demographic questions fill out the clance impostor phenomenon scale (cips) to assess imposter syndrome complete the perceived stress scale (pss) to measure stress levels


Eligibility criteria:
inclusion criteria: * undergraduate mbbs students enrolled at rawalpindi medical university * students from any year of study (1st to final year) * willingness to participate, demonstrated by providing informed consent * ability to complete the online questionnaire independently exclusion criteria: * postgraduate medical students or students from other disciplines (e.g., nursing, dentistry) * participants with known psychiatric diagnoses (e.g., depression, anxiety disorders) that could confound stress or imposter syndrome assessments * incomplete or partially filled questionnaires * students who did not consent to participate in the study
outcomes of surgery for degenerative lumbar spine diseases

Conditions: Degenerative Lumbar Spine Diseases

Summary: the purpose of this study is to determine the effectiveness of surgery on the elderly patients with dsd.

this study based on observation and follow up of elderly patients underwent for surgery for degenrtative lumbar spine diseases and the effectiveness of the surgery on the quality of their life.

Eligibility criteria:
inclusion criteria: * patients of both genders with age above 65 years with low back pain and disability. * pt with clinical diagnosis of degenerative lumbar spine disease. * pt with mri showing degenerative lumbar spine disease need surgical intervention. exclusion criteria: * patients having malignancy, vertebral fractures, trauma, inflammatory illnesses, and infection. * patients with degenerative conditions in the cervical and /or thoracic spine.
oral iron substitution for orthopedic surgery

Conditions: Iron Deficiency Anemia

Summary: the aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of patient blood management in preparation for orthopedic surgery.

patient blood management (pbm) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance. in the kepler university hospital (former general hospital linz) pbm was introduced in 2006. since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron. oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. although there is risk of anaphylactoid reactions. in this study the new oral iron supplement oleovital eisen forte (available in austria) ist tested on its effectivity for treatment of iron deficiency in the course of pbm. it has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications. within this study the investigators want to examine the feasibility of this iron substitution concept oleovital and its efficacy. also the investigators want to get pilot data for a further randomized controlled trial. the increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and monitored. for comparison of the new oral substitution concept oleovital with the standard intravenous iron substitution an historic control group is going to be used.

Eligibility criteria:
inclusion criteria: * age over 55 years * indication for patient blood management for elective orthopedic surgery * listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management * haemoglobin male \< 12-13g/dl, female \<11-12g/dl * written informed consent after written and verbal information exclusion criteria: * indication for treatment with erythropoietin * pregnancy * nursing period * diarrhea or tendency to diarrhea * fructose intolerance * pre - menopause * permanent or expected blood loss * participation in other study * expected compliance problems * legal incapacity

Keywords: iron deficiency patient blood management anemia
cxl-04 a study of collagen crosslinking with ultraviolet-a in asymmetric corneas

Conditions: Keratoconus

Summary: the purpose of this study is to evaluate the efficacy of ultraviolet-a (uva)-induced cross-linking of corneal collagen (cxl) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using uva light and the photo- mediator riboflavin.

this study will evaluate the results of corneal collagen crosslinking (cxl) in patients with conditions that include keratoconus, pellucid marginal degeneration, post-lasik ectasia, and patients with radial keratotomy who experience fluctuation in their vision. this is an outcomes study, all patients receive treatment.

Eligibility criteria:
inclusion criteria: 1. 8 years of age or older 2. having at least one of the following conditions: * keratoconus * post-lasik ectasia * pellucid marginal degeneration * forme fruste pellucid marginal degeneration * ffkc * history of radial keratotomy with fluctuating vision. * terrien's marginal degeneration 3. signed written informed consent and/or assent 4. likely to complete all study visits 5. minimum corneal thickness of at least 250 microns measured by ultrasound or pentacam for all indications other than terrien's. for terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment. exclusion criteria: 1. severe corneal scarring that markedly affects vision 2. contraindications to any study medications or their components 3. pregnancy or breast feeding 4. active herpes corneal disease

Keywords: keratoconus cross-linking post-lasik ectasia pellucid marginal degeneration forme fruste pellucid marginal degeneration ffkc radial keratotomy terrien's marginal degeneration