Kornimate/medical-research-clean huggingface dataset:
targeting social determinants to improve chronic kidney disease care

Conditions: Chronic Kidney Disease

Summary: the primary research goals of this application are to characterize social factors including health literacy and numeracy skills of ckd patients and examine associations with knowledge, self-efficacy, self-care behaviors, and clinical outcomes, and to examine the impact of an efficient interactive educational intervention to facilitate patient-provider communication. the investigators will accomplish these goals by executing a cluster-randomized controlled trial and performing detailed analysis of baseline measures. the specific aims of this study are: specific aim 1: determine the association of social factors with patient kidney knowledge, self-efficacy, participation in self-care behaviors, and clinical outcomes in moderate to advanced ckd. hypothesis: in patients with ckd, low health literacy and numeracy is common and associated with older age, non-white race, fewer years of education, lower socioeconomic (income) status, less kidney knowledge, lower self-efficacy of self-care, and less adherence with medication and diet self-care recommendations. low literacy/numeracy is also associated with higher blood pressures, more proteinuria, and more severe dysfunction of renal clearance. specific aim 2: evaluate the impact of a tailored literacy-sensitive educational tool used cooperatively by physicians and patients to improve self-care and outcomes in ckd. hypothesis: utilization of a concise literacy-sensitive physician-delivered educational tool will be feasible and associated with higher patient kidney knowledge, self-efficacy of self-care and greater adherence to medication and nutrition recommendations compared to usual care.


Eligibility criteria:
inclusion criteria: * receiving care in the vanderbilt general nephrology clinic for at least 1 prior visit past 12 months; * serum creatinine available in the medical record in the last 12 months demonstrating chronic kidney disease (egfr\<60mls/min); * age 18-80 years; * english-speaking. exclusion criteria: * pre-existing diagnosis of significant dementia or psychosis as determined by primary provider and documented in the medical record; * corrected visual acuity \>60/20 using a rosenbaum pocket vision screen; * patient receives dialysis or has a functional kidney transplant.

Keywords: health literacy health numeracy
telephone educational intervention by the gastrointestinal endoscopy nurse. global impact on the quality of colonoscopy

Conditions: Colonic Diseases; Nurse-Patient Relations; Educational Problems

Summary: this study assesses what impact has on colonoscopy quality the implementation of a telephone educational intervention carried out individually on the patient in the days before the test. half of the study patients will receive the educational intervention and the other half will not.

a high-quality colonoscopy is an examination in with patients receive an indicated procedure, correct and relevant diagnoses are recognized or excluded, any therapy provided is appropriate, and all steps that minimize risk have been taken. but quality also refers to pre-procedure and post-procedure quality issues such as information, booking, choice, privacy, dignity, aftercare and satisfaction of patients. all those issues can negatively affect the willingness of patients to perform the test and the possibility of preparing adequately. and what is more, it can diminish the quality of the own exploration, the satisfaction of the patients and their adherence to programs of endoscopic follow-up. an action on these colonoscopy non-technical issues with a telephone educational intervention performed by the gastrointestinal endoscopy nurse can positively improve all (pre, intra and post-procedure) colonoscopy quality indicators.

Eligibility criteria:
inclusion criteria: * all outpatient referred from the primary care centers to perform a colonoscopy in our digestive endoscopy unit, regardless of the applicant's service. exclusion criteria: * hospital patients, patients who refuse inclusion in the study, patients included in another study, impossibility of carrying out the educational intervention and patients who are unable to obtain informed consent will be excluded from the study.

Keywords: colonoscopy quality telephone intervention
belimumab assessment of safety in sle

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (sle). this study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. these events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. this study is being done to help understand if treatment with belimumab increases the risk for these types of events. this study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

study participants receive standard therapy for sle in addition to receiving the study drug, either placebo (no active medicine) or belimumab. the controlled period of the study is 52 weeks. the random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. after completion of the 52-week study period, participants will be contacted by phone annually for 4 more years to assess health status. following the 52-week controlled period, participants who wish to continue treatment with belimumab may be able to do so by being prescribed commercially available belimumab. if belimumab is not commercially available in the participant's country, the participant may be able to receive belimumab under a separate continuation protocol.

Eligibility criteria:
key inclusion criteria: * clinical diagnosis of sle by american college of rheumatology (acr) criteria. * active sle disease. * autoantibody-positive. * on stable sle treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate). key exclusion criteria: * pregnant or nursing. * have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any b cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days. * have received a live vaccine within the past 30 days. * have severe active lupus kidney disease. * have severe active central nervous system (cns) lupus. * current or past positive for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c.

Keywords: antibodies lupus sle systemic lupus erythematosus autoimmune disease belimumab
safety and efficacy of lenvatinib (e7080/mk-7902) with pembrolizumab (mk-3475) in combination with transarterial chemoembolization (tace) in participants with incurable/non-metastatic hepatocellular carcinoma (mk-7902-012/e7080-g000-318/leap-012)

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with tace versus tace plus oral and intravenous (iv) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (hcc). the primary hypotheses are that pembrolizumab plus lenvatinib in combination with tace is superior to placebo plus tace with respect to progression-free survival (pfs) and overall survival (os).


Eligibility criteria:
inclusion criteria: * has a diagnosis of hcc confirmed by radiology, histology, or cytology * has hcc localized to the liver and not amenable to curative treatment * participants with hepatitis c virus (hcv) are eligible if treatment was completed at least 1 month prior to starting study intervention * participants with hepatitis b virus (hbv) are eligible * has adequately controlled blood pressure with or without antihypertensive medications * has adequate organ function exclusion criteria: * is currently a candidate for liver transplantation * has had gastric bleeding within the last 6 months * has ascites that is not controlled with medication * has significant cardiovascular impairment within 12 months of the first dose of study intervention such as congestive heart failure * has a serious nonhealing wound, ulcer, or bone fracture * has received locoregional therapy to existing liver lesions

Keywords: receptor tyrosine kinase inhibitor programmed cell death 1 (pd-1, pd1) programmed cell death ligand 1 (pd-l1, pdl1)
study 767905/008 extension study: alvimopan for treatment of opioid-induced bowel dysfunction in cancer pain subjects

Conditions: Cancer; Bowel Dysfunction

Summary: study sb-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain. study abd101684 will serve as an extension to study sb-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. the purpose of study abd101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed study sb-767905/008 and elected to participate in this extension study.


Eligibility criteria:
inclusion criteria: * completed gsk sponsored alvimopan (opioid-induced bowel dysfunction) obd study for subjects with cancer-related pain, e.g. sb-767905/008. * taking full agonist opioid therapy for cancer related pain. * met entry criteria of obd in original study and per investigator continues to require therapy for management of obd. * capable of completing paper questionnaires at the study visits. exclusion criteria: * unable to eat or drink. * taking opioids for management of drug addiction. * unable to use only rescue laxatives provided. * inappropriately managed severe constipation that puts subject at risk of complications. * has gastrointestinal (gi) or pelvic disorder known to affect bowel transit. * concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.

Keywords: opioids constipation opioid-induced bowel dysfunction
postoperative pain in single-visit and multiple-visit retreatment cases

Conditions: Postoperative Pain; Root Canal Infection; Endodontic Disease

Summary: the purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. patients whom need retreatment were included. the presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.

the aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. all of the patients have been recruited from the istanbul medipol university dental clinics in istanbul. eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. the presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. postoperative pain was recorded by each patient by using visual analogue pain scale. before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. the patients were offered local anesthetic before the treatment start. the routine root canal retreatment procedure was applied. different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. at the end of retreatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. after one week the teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Eligibility criteria:
inclusion criteria: patients who were not included the study who; * were pregnant or breast feeding during the duration of the study, * have systemic disease, * have any pain and/or any facial swelling, abscess, * were immunocompromised, * were under 18 yrs. and over 65 yrs. age, * were taking antibiotics or corticosteroids within previous three months, * have multiple teeth that required retreatment at the same time period; for eliminating pain referral, * have root canals that could not be well-treated with orthograde retreatment. exclusion criteria: the patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.

Keywords: endodontics retreatment postoperative pain visual analogue pain scale
randomized controlled trial of early intensive leg exercise to improve walking in children with diplegia

Conditions: Spastic Diplegia; Periventricular Leukomalacia

Summary: this is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function in young children with spastic diplegia.

children born prematurely are at risk of brain injury that can result in cerebral palsy, most often affecting both legs. current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (botulinum toxin) in muscles that are abnormally active, and surgery as deformities occur. active, physical therapy for weak muscles is infrequent, occurring twice a month or less. yet, recent work in mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. building on our success with early, intensive therapy for children with perinatal stroke, we will apply intensive therapy for the legs in children with cerebral palsy involving both legs. children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 6 months. the delay period controls for improvement without treatment. the children in the delay group will have the option to receive the same treatment after the delay period. the therapy will be guided by physical therapists, and centered on play. measures will be taken before, during and after the delay and treatment periods. measures will include clinical scores of motor development, proficiency of walking, participation at home, and physiological measures of motor and sensory function. all children will be followed until they turn 4 yr old, to determine if there are long term benefits. the cost-effectiveness of the intervention will be evaluated by a health economist. we anticipate that early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.

Eligibility criteria:
inclusion criteria: * bilateral motor impairment of the lower extremities * periventricular white matter injury from encephalopathy of prematurity * able to stand with some support exclusion criteria: * substantial upper extremity involvement - manual abilities classification system (macs) level ≥3 * uncontrolled epilepsy or infantile spasms in the past 6 months * cardiovascular or musculoskeletal complications that preclude participation in intensive exercise * botulinum toxin-a (btx-a) injections in the legs in the last 6 months

Keywords: physical therapy rehabilitation walking
cystic fibrosis- children and adults tai chi study

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is a progressive disease. symptoms include coughing, poor lung ventilation, recurrent infections, poor weight gain, diarrhoea, malnutrition, stress, frustration, depression, irritability, worry, insomnia, behavioural issues and missed school/work. tai chi, a chinese form of exercise, uses slow choreographed movements, breathing exercises and mindfulness. research suggests tai chi can improve physical and emotional wellbeing for various chronic conditions. this study compares methods of teaching tai chi to 70 people with cf, and evaluates the effect on symptoms and quality of life. adults and children with cf will be recruited and randomly allocated to an intervention group or a control group. the former will receive 8 individual face to face sessions of tai chi over a 3 month period and a video and handouts to aid home practice. the latter will have routine care for the first 12 weeks, followed by 8 individual online sessions of tai chi over a 3 month period, and a video and handouts for home practice. both groups will be encouraged to practice tai chi at home in the months following the taught sessions. questionnaire data on how participants and their carers are coping with cf, any general improvements in wellbeing, and differences in other clinical outcomes (medication etc.)will be collected. data will be collected at the beginning and end of the intervention, and at 6 and 9 months post intervention and differences between the 2 groups compared over time. feedback from on line focus groups will ask about their experiences, feasibility of learning and practicing of tai chi, engagement with the process, perceived health impact, and experiences of participation. it is hoped that the study may show how tai chi can help people with cf to maintain their health through mindful exercise, and improve troublesome symptoms like sleep and anxiety.


Eligibility criteria:
inclusion criteria: * diagnosis of cf * no previous experience in tai chi, but ability/potential to undertake these movements * able to commit to a 9 month study * living in or near london or brighton (depending on teacher locations) * able to understand, read and write english * 6 years old and above * to have internet access for web based learning exclusion criteria: * participant in the feasibility phase * currently taking part in another interventional research study

Keywords: cystic fibrosis tai chi
nilotinib in newly diagnosed adult philadelphia chromosome & /or bcr-abl positive chronic myeloid leukaemia in chronic phase

Conditions: CML in Chronic Phase

Summary: this study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed philadelphia chromosome positive/bcr-abl positive chronic myeloid leukaemia in chronic phase. the aim of the study is to confirm the rates of complete molecular remission (cmr) of nilotinib in newly diagnosed cml chronic phase patients in a pan-european population using the eutos standardized laboratories.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of cp-cml with cytogenetic confirmation of philadelphia (ph) chromosome * ph negative cases or patients with variant translocations who are bcr-abl positive in multiplex pcr are also eligible * who performance status 0-2 * laboratory assessments within normal limits * written informed consent prior to any study procedures being performed exclusion criteria: * known impaired cardiac function * history of acute or chronic pancreatitis * impaired gastrointestinal function or disease that may alter the absorption of study drug * concomitant medications with potential qt prolongation, or known to interact with cyp450 isoenzymes (cyp3a4, cyp2c9, and cyp2c8) * patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug other protocol-defined inclusion/exclusion criteria may apply

Keywords: leukemia myeloid myelogenous chronic bcr-abl positive nilotinib philadelphia chromosome cml in chronic phase
treatment plan for adhd with indifferent traits

Conditions: Lack of; Attention, With Hyperactivity (ADHD)

Summary: for children with adhd aged 4-10 at the time of enrollment, starting from preschool, focusing on apathy and emotional control, using psycho-behavioral measurements, eeg experiments, and eye tracking technology to evaluate and implement targeted sexual intervention and six-month follow-up. establish a diagnosis and treatment decision analysis model and psychological treatment plan for odd/cd.

destructive, conduct disorder children have emotional processing defects, including apathy and ruthless traits, emotional disorders, may be early diagnosis of conduct disorder (conduct disorder, cd) or attention deficit hyperactivity disorder (attention deficit hyperactivity disorders, adhd) comorbid cd sensitivity sexual indicators, systemic psychotherapy for these children's indifference characteristics and emotional disorders will improve related symptoms. this study will start with preschool children with adhd, design evaluation indicators for emotional traits for children aged 4-10, combined with various psychological evaluations, and use advanced brain electricity combined with eye tracking research technology to provide candidate indicators for evaluation; and on the basis of previous research, establish a treatment plan to improve pathological emotional characteristics and emotional disorders; establish a predictive intervention decision model from preschool to school-age adhd comorbid cd to provide methods for precise diagnosis and treatment options. the early prevention and intervention of adhd and cd has practical significance and maneuverability.

Eligibility criteria:
inclusion criteria: * children aged 4 years, 0 months and 10 years old and 11 months old, who have been diagnosed by a doctor who is at least the attending physician in the pediatric psychiatric department and meet the american diagnostic and statistical manual of mental disorders (fifth edition) adhd diagnostic criteria, have a total iq higher than 80, and the subjects are doing this the baseline level of the study has not received any medical treatment before. exclusion criteria: * attention deficit disorder caused by organic diseases of the nervous system, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; exclude parents or guardians from suffering severe mental illness, such as schizophrenia, mood disorders (onset period), etc., and a degree below junior high school.

Keywords: destructive cd apathy emotion regulation treatment