Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of vedolizumab combined with upadacitinib in patients with ulcerative colitis

Conditions: Crohn Disease

Summary: it's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (uc). vedolizumab (vdz) is known for its high safety profile and confirmed therapeutic efficacy in uc treatment. however, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. upadacitinib (upa), however, works quickly, which complements the defect of slow onset of vdz induction. however, the safety of upa used in situations such as infection and tumors is inferior to that of vdz, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. therefore, if the advantages of long-term maintenance therapy safety of vdz and rapid induced remission of upa are fully utilized, the combination of vdz and upa induction for 8 weeks, followed by the use of single drug vdz in maintenance therapy, can maximize the clinical benefits of uc patients. due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe uc patients with vdz and upa.


Eligibility criteria:
inclusion criteria: * diagnosed uc for at least 3 months, including endoscopic evidence supporting uc and histopathological evidence supporting uc diagnosis * suffering from moderate to severe uc, defined as modified mayo score ≥ 4 and endoscopic subscale (ess) ≥ 2 * indications for vdz or upa application exclusion criteria: * patients who are unable to take oral upa and receive regular intravenous vdz infusion therapy * evidence of toxic megacolon was found during screening * previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to uc * subjects who require surgery due to uc or plan to undergo elective surgery during the study period * there is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases * evidence of active hepatitis b or c infection during screening
oral health education for caregivers of children with disabilities

Conditions: Developmental Disability

Summary: considering the impact of caregivers' oral health knowledge, attitudes and practices on the oral health of their children; we introduced an educational program to the parents and caregivers of children with developmental disabilities about the oral healthcare of their developmentally disabled children to rise up with the oral health status of those children.

* target population; parents of children with dd enrolled in selected special education centers in khartoum state, khartoum, sudan, and their developmentally disabled children. * a convenient sample of two special education centers were selected randomly from a list of all the 105 special education centers registered at the state ministry of education, and allocated into intervention and control groups. * one center was used as case who received the educational program and the other center was used as a control group. * eligibility criteria: child aged 3-18, with a developmental disability, caregivers approval to participate (signed the informed consent). * all the children who met the eligibility criteria in both centers were examined and all their parents were interviewed, before and after the intervention. * an interview questionnaire for the parents of children with dd in both centers was used to evaluate their knowledge and attitude toward the oral health care of their children before and 3 months after the intervention. * oral examination was carried out to determine the baseline oral hygiene level and treatment needs of the children with dd, before the educational session. * a second examination was carried out after a period of 3 months after the educational session, to determine any change in oral hygiene and treatment needs of the children after their parents and or caregivers' attendance to the educational session. * the baseline and follow up examination were carried out blindly by a calibrated dentist. * the same examiner carried out the baseline and follow up examinations to avoid any inter-examiner variations. * oral examination was arranged according to oral health surveys basic methods recommended by who in 2013. * the simplified oral hygiene index (measuring debris index and calculus index). * dentition status and treatment needs chart provided in oral health assessment forms for children by the who 2013 was used to determine the amount of unmet dental needs and help in evaluating the caregivers' oral healthcare behaviours and the frequency of dental visits.

Eligibility criteria:
inclusion criteria: * has a developmental disability. * enrolled in any of the randomly selected special education schools. * caregivers signed the informed consent. exclusion criteria: * not a student in any of the randomly selected special education schools. * caregivers refused to participate and sign the informed consent. * age not in the range of 3 - 18 years old.

Keywords: disability developmental disability special healthcare needs
safety and immunogenicity study of a booster dose of gsk biologicals' 10-valent pneumococcal conjugate vaccine.

Conditions: Infections, Streptococcal

Summary: this study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of gsk biologicals' pneumococcal conjugate vaccine compared to prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or prevenar™ in study 105553. antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (nct00307554). the immune response to a booster dose of gsk biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with gsk biologicals' vaccine but with prevenar™. the study has 3 groups. 1 group of children primed with gsk biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with prevenar™ will receive a booster dose of prevenar™ (control group). 3rd group of children primed with prevenar™ will receive a booster dose of gsk biologicals' pneumococcal conjugate vaccine. all children will receive concomitantly a booster dose of dtpa-hbv-ipv/hib vaccine.


Eligibility criteria:
inclusion criteria: * a healthy male or female, 12 to 18 months of age at the time of vaccination, who received at least one dose of either pneumococcal conjugate vaccine or prevenar™ during study 105553 and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the vaccination, or planned use during the entire study period (active phase and safety follow-up). * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before vaccination up to visit 2. * administration of any additional pneumococcal vaccine or dtpa-combined vaccine since end of study 105553. children with a history of seizures or neurological disease, allergic disease, immunosuppressive or immunodeficient condition.

Keywords: streptococcus pneumonia, pneumococcal conjugate vaccine
pharmacogenomics of mood disorder in chronic kidney disease patients

Conditions: Chronic Kidney Disease(CKD); Depression

Summary: by using genetic information we could predict the prevalence of mood disorder and response to treatment.

this prospective cohort study enrols patients with chronic kidney disease and gathers genetic information. by the patient's biochemical information, including genetic information, we could predict the prevalence of mood disorder and response to the antipsychotherapy.

Eligibility criteria:
inclusion criteria: * ckd patients aged 18 to 90 years exclusion criteria: * no ckd patients, aged below 18 or above 90 years

Keywords: ckd mood disorder
trial investigating cyanoacrylate glue to prevent surgical site infection following breast surgery

Conditions: Surgical Wound Infection

Summary: surgical site infections (ssi) represents a significant complication in plastic surgery. infections can result in a prolonged recovery and impair long-term cosmetic appearance. one potential method to reduce infection is by applying a thin layer of dermal glue over the sutures at the site of incision immediately after the surgery. conventional closures, such as sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48 hours. in contrast, dermal glue provides an instant, waterproof barrier and it has been shown to have intrinsic bacteriostatic properties. the glue is supplied as a liquid enclosed in a vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of moisture to form a solid adhesive. 2-octylcyanoacrylate (2-oca)-based glue is formulated to be more flexible than previous preparations. the application of dermal glue is rapid, simple and requires no specific follow-up as it naturally sloughs off overtime. the purpose of this study is to determine if 2-oca-based glue can reduce the rate of surgical site infection following surgery. patients undergoing breast surgery will be recruited and randomized to either a group receiving a layer of glue over sutures following surgery or no treatment. patients will be followed up at 30 days and at 8 months for signs of infection, additional complications and the visual appearance of the scars. the cost of treating and infection will be calculated to determine if using dermal glue to prevent infection is economically feasible. this research has the potential to find a method to reduce surgical site infection, which can be applied to other surgeries.


Eligibility criteria:
inclusion criteria: * patient has provided signed consent * undergoing surgery on the breast exclusion criteria: * infection within 30 days * previous hypersensitivity to cyanoacrylates or formaldehyde

Keywords: cyanoacrylates mammaplasty mastectomy
the norwegian physical therapy study in preterm infants

Conditions: Movement Disorders

Summary: this is a pragmatic randomized controlled study. the purpose of the study is to evaluate the practice and effect of customised physiotherapy on preterm infants'motor development when the intervention is performed over a period of three weeks while the infant resides in the neonatal intensive care unit. the study will also attempt to analyze the parents' experiences in being actively involved in education and practice of the intervention designed to promote the child's motor development, and the effects on the parent-child relationship in the short and long term.the children are followed up until a corrected age of two years. this study consists of a pragmatic randomized controlled trial and a qualitative study.

infants born preterm with an gestational age below 32 weeks have an increased risk of developing different grades and types of abnormalities, among them delayed motor development, co-ordination difficulties and cerebral palsy. the prevalence of serious developmental abnormalities increases the lower the gestational age and birth weight. the reported incidence of mild developmental abnormalities is 15-20 % in children with a gestational age \<28 weeks or with a birth weight under 1000 g, 10-20 % in children with a gestational age of 28-31 weeks or a birth weight between 1000-1500 g and only 5 % in children born at term. the incidence of cerebral palsy is 10-20% amongst children in the first group, 5-10% in the second group and only 0,1 % in children born at term.with such a high risk of developing motor abnormalities for infants born preterm together with limited evidence-based knowledge of early physiotherapy approaches that facilitate motor development, it is essential that more research is done in this area to ensure that physiotherapy if used, is in the right manner to prevent and reduce such difficulties.

Eligibility criteria:
inclusion criteria: * child born before or at 32nd gestational week. * child that tolerates being handled at 34th week postmenstrual age. * parents that can perform the intervention understand and speak norwegian. * follow up of the child in the hospital where the intervention is given. exclusion criteria: * child born later than 32nd week. * child who cannot tolerate being handled for up to 10 minutes at 34th postmenstrual age. * triplets or more. * child who has undergone surgery. * child with large deformities. * parents that can perform the intervention but do not understand and speak norwegian. * follow up of the child is not taking place in the hospital where the intervention is given. * all children who fill the inclusion criteria will be included to begin with. * if at a later stage they are unable to manage the tests due to their condition they will be excluded.

Keywords: infants born preterm early physiotherapy intervention motor development parental participation parental competency
safety and efficacy of cvi-lm001 in patients with hypercholesterolemia

Conditions: Hyperlipidemia

Summary: the purpose of this study is to determine if cvi-lm001 is effective and safe versus placebo in drug-naive subjects with elevated ldl cholesterol. there will be 4 groups receiving 100mg, 200mg, 300 mg and placebo treatment for 12 weeks respectively.

this study is a phase ii study in subjects with elevated ldl cholesterol. as designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. after run-in, eligibility is confirmed with required laboratory tests at day -1 prior to randomization. the eligible subjects are randomly assigned to cvi-lm001 100 mg, 200 mg, 300mg qd group or placebo qd group with ratio 1:1:1:1 to receive a 12-week double-blind treatment. after 12-week treatment, all investigational compound and placebo should be discontinued, followed by 4 week for safety evaluation.

Eligibility criteria:
key inclusion criteria: * 1. aged 18-70 years, inclusive * 2. men and nonpregnant, nonlactating women * 3. hypercholesterolemic subjects with ldl-c level between 3.36mmol/l\~4.88mmol/l at screening, inclusive exclusion criteria: * 1. fasting tg ≥3.99 mmol/l before randomization * 2. history of significant cardiovascular , renal, pulmonary and liver diseases * 3. history of diabetes * 4. alt or ast\>1.5xuln at screening
phase analysis and obstructive cad on rubidium pet

Conditions: Coronary Artery Disease

Summary: rubidium myocardial perfusion pet is an imaging test used to diagnose patients with abnormal blood flow to the heart secondary to narrowing of the heart vessels. phase analysis is a computer method that is applied after the pet test is done. it is used to determine when a region of the heart contracts relative to other heart regions in the heart beating cycle. initial data suggest that regions of the heart with abnormal blood flow change the pattern of contraction from rest to stress conditions. that is, regions of the heart with abnormal blood supply become dyssynchronous when compared to the normal regions of the heart. this study will investigate whether phase analysis may aid the visual interpretation of rubidium myocardial perfusion pet studies by determining the areas of the heart that are not beating in synchrony with the normal heart regions. this information will be used as a proxy for poor blood supply. the gold standard will be coronary angiography by which the percent narrowing of the heart vessels is assessed.


Eligibility criteria:
inclusion criteria: * male or female patients * referred for myocardial perfusion imaging for suspected obstructive cad * 18 years of age or older. exclusion criteria: * contraindications to regadenoson radionuclide imaging including severe reactive airway disease, unstable crescendo angina, high grade av block, caffeine within 24 hours * documented prior myocardial infarction * severe claustrophobia * patients who may be pregnant.
study of fesoterodine in pediatric overactive bladder patients aged 8-17 years

Conditions: Overactive Bladder; Neurogenic Detrusor Overactivity

Summary: the purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.


Eligibility criteria:
inclusion criteria: * a total body weight \>25 kg (55 lbs). * symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, or * stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage. exclusion criteria: * treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose * ongoing use of potent cyp3a4 inhibitors or inducers or cyp2d6 inhibitors * ongoing use of another drug for treating overactive bladder * uncontrolled narrow angle glaucoma, urinary or gastric retention

Keywords: study of fesoterodine in pediatric overactive bladder patients
the correlation between gut microbiome/metabolite and end stage renal disease (esrd)

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to investigate the differences of gut microbiome/metabolite between esrd patients and healthy subjects. two hundred and twenty three hemodialysis patients and 70 healthy subjects are recruited, and a cross-sectional study is performed.


Eligibility criteria:
for healthy subjects inclusion criteria: * age over 18 years old * liver and kidney function is normal * 18.5≤bmi≤29.9 * agree to sign the informed consent form exclusion criteria: * diagnosed as metabolic syndrome * diagnosed as cirrhosis * diagnosed as kidney disease * taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study * taking antibiotics or antifungal drugs within 30 days before the study for esrd patients inclusion criteria: * age over 18 years old * patients who diagnosed as esrd with hemodialysis * fixed hemodialysis cycle (average 3 times a week) * agree to sign the informed consent form exclusion criteria: * taking antibiotics or antifungal drugs within 30 days before the study * taking fermented food (live lactic acid bacteria drinks, cheese, yogurt, probiotic products, etc.) within 14 days before the study * reasercher are not sure whether the subjects are willing or able to complete the study * subject participated in other research projects within two months before the study

Keywords: kidney failure, chronic uremic toxins gastrointestinal microbiome metabolomics
mangafodipir as an adjunct to folfox6 chemotherapy in colon cancer stage dukes' c

Conditions: Chemotherapy; Colon Cancer

Summary: the present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy according to the folfox6 regimen in patients operated upon colon cancer in stage dukes' c.

mangafodipir, manganese (mn) dipyridoxyl diphosphate, is a catalytic antioxidant and iron chelator recently (2006) suggested for cancer treatment in an editorial in journal of the national cancer institute. preclinical research has shown that mangafodipir protects normal tissues without loss of anti-tumour activity during chemotherapy. other advantages are that mangafodipir is already approved for use in patients as a contrast agent for magnetic resonance imaging (mri) of liver, and that the experience for more than a decade reveals high safety with mainly minor and tolerable side-effects. the present study will include 14 patients who will be followed throughout 3 treatment cycles. each cycle will be preceded by infusion of mangafodipir or placebo in two groups, each consisting of 7 patients. the primary endpoints will be the most frequent manifestation of folfox6, namely neutropenia and neurosensory toxicity. the secondary endpoints will be the frequency and severity of other folfox6-related adverse events and quality of life.

Eligibility criteria:
inclusion criteria: 1. histologically proven colon cancer stage dukes' c. 2. patient over 18 years. 3. who performance status \<1. 4. adequate haematological function (hb ≥ 100 g/l, anc ≥ 2.0 x 109/l, platelets ≥ 150 x 109/l) 5. adequate renal and hepatic functions: serum creatinine and total bilirubin ≤ 1.25 times upper normal limits (asat and alat ≤ 3 times upper normal limits) 6. clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy 7. use of adequate contraception (males with reproductive potential) 8. written informed consent given exclusion criteria: 1. other tumour types than colon adenocarcinomas 2. current severe neutropenia, leucopenia or thrombocytopenia 3. severely reduced liver or renal function 4. unresolved bowel obstruction or sub-obstruction, uncontrolled crohn's disease or ulcerative colitis 5. current chronic diarrhoea 6. contraindication for corticosteroid administration 7. history of prior serious allergic or pseudo-allergic reaction 8. any other serious illness or medical condition 9. symptomatic peripheral neuropathy ≥ grade 2 10. received mangafodipir ≤ 5 weeks before planned start of chemotherapy 11. received any of the folfox drugs ≤ 5 weeks before planned start of chemotherapy 12. any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study 13. fertile females 14. males with reproductive potential not implementing adequate contraception measures 15. phaeochromocytoma