Kornimate/medical-research-clean huggingface dataset:
a pilot project to facilitate dental care and reduce barriers for youth with disabilities

Conditions: Intellectual Disability, Variable

Summary: this randomized clinical trial is an innovative pilot project to determine the acceptance and impact of telehealth visits on youth with intellectual and developmental disabilities (idd), their caregivers, and dentists. the impact of the telehealth visit will be assessed by: 1) determining if the intervention group was more likely to achieve the set goals and 2) likert scaled surveys of satisfaction of caregivers and dentists. qualitative data will be collected to inform improvement on clinical interviews by the dentist.


Eligibility criteria:
inclusion criteria: * have an appointment for a routine check up at the pediatric clinic or pediatric health center at the boston university goldman school of dental medicine * diagnosis of intellectual or developmental disability (idd) * have a caregiver who is willing to participate in the study * have a dental provider who is willing to participate in the study * english speaking exclusion criteria: * none

Keywords: intellectual and developmental disabilities telehealth interview pediatric dental care pre-dental care telehealth visit
efficacy and safety of alogliptin used in combination with α-glucosidase inhibitor in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (qd) combined with an α-glucosidase inhibitor taken three times daily (tid) in type 2 diabetic patients with uncontrolled blood glucose.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. in japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies. to evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study syr-322/oct-003 (nct01263509) that was planned separately.

Eligibility criteria:
inclusion criteria: * had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (week -8) and during the screening phase. * had a glycosylated hemoglobin (hba1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (week -4). * had hba1c differences within 10.0% at the start of the screening phase (week -8) and 4 weeks after the start of the screening phase (week -4) from the hba1c value at the start of the screening phase. * was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (week -8). exclusion criteria: * had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (week -8) or during the screening phase.

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
croup dosing study

Conditions: Croup

Summary: croup is a common childhood respiratory disease that often leads to frequent emergency department visits. it is a viral infection that causes cough, throat, and airway swelling, making breathing difficult. dexamethasone is a medication that helps to reduce swelling, making breathing easier for children. a standard dose of 0.6mg/kg is used in children. however, a lower amount (due to side effects of steroids in children) has been suggested. we will examine whether 25% less than the standard dose is equally effective in treating croup. investigators will conduct a clinical study with the support of patients with lived experience (which, in this case, are the parents of the children) to better care for children with croup. if proven, this study can improve the outcome in children with croup.

croup is a common childhood respiratory disease that leads to frequent emergency department (ed) visits. it accounts for 7% and 3% of hospitalization in under 5 and children between 6 months-3 years in north america, respectively. it is a self-limiting viral infection characterized by the sudden onset of a seal-like barking cough, often accompanied by stridor, voice hoarseness, and respiratory distress. glucocorticoids are a class of corticosteroids with anti-inflammatory properties that help alleviate croup symptoms. while dexamethasone (a type of glucocorticoid) is commonly used to treat croup at 0.6mg/kg, a low dose of 0.15mg/kg (due to adverse events (aes)) has been suggested to be equally effective. investigators propose an innovative and multidisciplinary approach to investigate the noninferiority of dexamethasone at 0.15mg/kg versus 0.6mg/kg to treat croup.

Eligibility criteria:
inclusion criteria: * children aged with clinical diagnosis of croup exclusion criteria: * children who are unable to tolerate or ingest oral dexamethasone, * known hypersensitivity/allergy to dexamethasone, * other causes of stridor (such as acute epiglottitis, bacterial tracheitis, anaphylaxis, foreign body aspiration), * other underlying systemic diseases defined as chronic lung disease, chronic heart disease, chronic kidney disease, and immunodeficiency), * recent exposure to varicella, * treatment with oral or intravenous corticosteroids within the preceding 72 hours.

Keywords: croup, dexamethasone, bayesian elicitation, dosing study, patient engagement
schizophrenia for "life" - a registry and interview study among elderly with lifelong schizophrenia

Conditions: Schizophrenia

Summary: the elderly demographic is on the rise - and this includes elderly living with schizophrenia. yet very little is known about their lives, how they cope with their condition and how it develops over time. research in this patient-group is sparse; overall there seem to be a tendency for elderly patients to manifest fewer psychotic symptoms and experiencing an increase in the psychological quality of life with older age. opinions are divided on the degree and extent to which this tendency reflects remission and/or recovery in older patients. in order to identify factors associated with a positive outcome we: * investigate the course and the outcomes of the illness over the lifespan, as well as the life course and outcomes. * investigate the current status of mental and physical health, quality of life as well as functional competence of elderly (55+ yr) with schizophrenia. also the investigators - compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type 1 diabetes (a chronic somatic illness). this study will yield vital insights into how schizophrenia develops over time, isolating factors that determine how well patients fare. the perspective is to advance knowledge of elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the interventions offered to this group.


Eligibility criteria:
inclusion criteria: initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979 (both incl) interview study: residence in region of southern denmark exclusion criteria: interview study: mental retardation -

Keywords: schizophrenia elderly lifelong quality of life register questionaire
dosing study of cranberry capsules for the prevention of bacteriuria in nursing home residents

Conditions: Bacteriuria

Summary: this study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. the yale research team will be enrolling 80 subjects in total over several nursing home locations within connecticut.

each subject was enrolled after providing a baseline urine specimen. cranberry/placebo capsules were consumed for 30 days. urine specimens were obtained weekly for 4 weeks.

Eligibility criteria:
inclusion criteria: * female nursing home residents 65 years of age or older with history of urinary tract infection within the past year. exclusion criteria: * residents that are not expected to be in the nursing home for at least one month (i.e., short term rehabilitation, pending discharge, terminal \[life expectancy \< 1 month\]); * residents who are on chronic suppressive antibiotic or anti-infective (i.e., mandelamine) therapy for recurrent uti; * residents with end stage renal disease on dialysis (they do not regularly produce urine); * residents unable to produce a baseline clean catch urine specimen for collection; * residents on warfarin therapy because of a potential interaction of warfarin and cranberry juice; * residents with a history of nephrolithiasis because cranberry may increase the risk of nephrolithiasis.
budesonide vs. mesalazine vs. budesonide/mesalazine suppository combination therapy in acute ulcerative proctitis

Conditions: Proctitis

Summary: the purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.


Eligibility criteria:
inclusion criteria: * active ulcerative proctitis * diagnosis confirmed by endoscopy * established disease or new diagnosis exclusion criteria: * crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular assoc. colitis, microscopic colitis * presence of proctitis of a different origin * prior bowel resection * presence of symptomatic organic disease of the gastrointestinal tract * asthma, tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection if careful medical monitoring is not ensured * local intestinal infection * abnormal hepatic or renal function * oral/rectal/intravenous corticosteroids therapy * existing or intended pregnancy or breast-feeding * participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
study of apixaban for the prevention of thrombosis-related events following knee replacement surgery

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[dvt\]) and lung (pulmonary embolism \[pe\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (lovenox®) for preventing these clots. the safety of apixaban will also be studied.


Eligibility criteria:
key inclusion criteria: * men and non-pregnant, non-breastfeeding women * 18 years or older * scheduled for knee replacement surgery key exclusion criteria: * hereditary or acquired bleeding disorders * clotting disorders * bleeding or high risk for bleeding * drugs that affect bleeding or coagulation * need for ongoing parenteral or oral anticoagulation

Keywords: prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
phase ii study of as1411 combined with cytarabine to treat acute myeloid leukemia

Conditions: Leukemia, Myeloid

Summary: the overall aim of this study is to assess the efficacy and safety of as1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (aml).


Eligibility criteria:
inclusion criteria: * primary refractory or relapsed aml * confirmed diagnosis of aml (de novo or secondary) as defined by who classification (vardiman 2002) * aged at least 18 years exclusion criteria: * initial diagnosis of acute promyelocytic leukemia as defined by french-american-british criteria (bennett 1976) * patient in blast crisis stage of chronic myeloid leukemia * received high-dose cytarabine (total cumulative dose of \>6g/m sq)in last 6 months * interval of \<6 months between first onset of last complete remission and current relapse * those with primary refractory leukemia who have received more than three previous induction cycles * relapsed patients who have received more than three previous treatment regimens

Keywords: leukemia, myeloid + acute disease
regulatory post marketing surveillance (rpms) study of rybelsus (oral semaglutide) to evaluate safety and effectiveness in patients with type 2 diabetes mellitus in routine clinical practice in korea

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to assess the safety and effectiveness of rybelsus initiated according to label in adults with type 2 diabetes mellitus (t2dm) under routine clinical practice conditions. participants will get rybelsus as prescribed by study doctor. the study will last for about 26 weeks.


Eligibility criteria:
inclusion criteria: * the decision to initiate treatment with commercially available rybelsus has been made by the participant/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study * the participant with t2dm is scheduled to start treatment with rybelsus based on the clinical judgment of their treating physician as specified in the approved label in korea * informed consent is obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * male/female age greater than or equal to (\>=) 19 years at the time of signing informed consent exclusion criteria: * participants who are or have previously been on rybelsus therapy * known or suspected hypersensitivity to rybelsus, the active substance or any of the excipients * previous participation in this study. participation is defined as having given informed consent in this study * female participant who is pregnant, breast-feeding or intends to become pregnant and is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by korea regulation or practice) * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc)
calcium-vitamin d & periodontal therapy for improving metabolic and inflammatory profile among pregnant women

Conditions: Periodontitis; Inflammation

Summary: the improvement of maternal and child health remains a key issue in global health. production and improved accessibility of healthy and nutrient-rich milk-based products could potentially tackle health and nutrition inequalities in low-income countries. this study will assess the acceptability of a multi-component intervention, including provision of calcium/vitamin-d fortified milk and periodontal therapy (pt), for improving maternal periodontal health and metabolic and inflammatory profiles. the improve trial is a feasibility randomised controlled trial (rct) with parallel qualitative process evaluation. the target population is low-income, pregnant, brazilian women, with periodontitis, who have not seen a dentist in the last 6 months. a series of focus group discussions and interviews with the target population will be conducted to identify key barriers and enablers to adoption and implementation of the intervention in prenatal clinics in rio de janeiro/brazil. participants will be allocated to 4 groups: 1) early pt (during pregnancy) plus fortified milk; 2) early pt plus plain milk; 3) delayed pt (after delivery) plus fortified milk; 4) delayed pt plus plain milk. the final results will contribute to the understanding of the significance of calcium and vitamin d for short and long-term health and the occurrence of diseases, as well as to inform the current global debate on vitamin-d supplementation and fortification policy.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 year; * up to 16 weeks' gestation; * having ≥ 20 teeth; * diagnosis of periodontitis (≥ 1 tooth with at least one of periodontal sites with ≥ 4 mm of clinical attachment loss and bleeding on probing on the same site); * not received regular dental treatment in the last 6 months (except from those who only visited the dentist for an emergency appointment e.g. tooth extraction); * cognitively and physically able to complete an interview and oral examination; and * willing to participate (including provision of blood samples) exclusion criteria: * diagnosis of hiv/aids, psychosis, diabetes before pregnancy, thyroid disease, or disorders causing vitamin d hypersensitivity (e.g. sarcoidosis and other lymphomatous disorders); * diagnosis of lactose intolerance or milk allergy; * history of renal stones or family history of renal stone and hyperparathyroidism; * presence of extensive dental cavity and decay; * use of antibiotics or any immune-suppressants or medication known to affect vitamin d/calcium metabolism; and * consumption of ≥4 servings/day of dairy products or taking vitamin d supplements at \> 400 iu/day.

Keywords: pregnancy outcome feasibility milk fortification periodontitis pregnant women periodontal therapy
the clinical characteristics and efficacy of immunotherapy in first-line pd-l1-negative advanced nsclc patients

Conditions: NSCLC

Summary: this study aims to include patients with advanced or metastatic non-small cell lung cancer who are pd-l1 negative and receiving first-line immunotherapy in routine clinical practice.

this study aims to include patients with advanced or metastatic non-small cell lung cancer who are pd-l1 negative and receiving first-line immunotherapy in routine clinical practice. clinical treatment of patients will not be intervened unless disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances deemed appropriate by the investigator to discontinue treatment, whichever occurs first. the primary objective of the study is for investigators to assess the one-year progression-free survival (pfs) rate of immunotherapy as first-line treatment in pd-l1 negative advanced or metastatic nsclc, evaluated according to recist 1.1 criteria.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before implementing any trial-related procedures; * aged 18-80 years; * wild-type egfr/alk; * patients with locally advanced (stage iiib/iiic), metastatic, or recurrent (stage iv) nsclc confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the tnm staging classification by the international association for the study of lung cancer and the american joint committee on cancer; * pd-l1 negative； * patients receiving first-line immunotherapy (such as pd-1/pd-l1 inhibitors). exclusion criteria: * the patient refused to join this study and declined follow-up.

Keywords: nsclc pd-l1 negative immunotherapy
piperacillin sodium and sulbactam sodium for injection(2:1) for treatment of respiratory and urinary system infection

Conditions: Respiratory Tract Infections; Urinary Tract Infections

Summary: in the proposed study, the investigators plan to evaluate the efficacy and safety of piperacillin sodium and sulbactam sodium for injection(2:1) for the treatment of respiratory and urinary tract acute bacterial infection.

piperacillin sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.the antimicrobial effect of piperacillin can be enhanced by the two combined. the compound specifically aims to the mechanism of bacterial resistance, extending the life of piperacillin in the treatment-resistant pathogen infections.

Eligibility criteria:
inclusion criteria: 1. patients who qualify for moderate and severe acute respiratory or urinary tract bacterial infection of acute bacterial infections need for systemic antibiotic therapy. 2. age\>18 years old, gender: both 3. women of childbearing age were to be negative pregnancy test and agree to take contraceptive measures during the trial; 4. patients were volunteers and signed informed consent form; 5. patients did not participate in other clinical trials. exclusion criteria: 1. patients were hypersusceptibility to the test drug or other penicillins ,β-lactamase inhibitor 2. pregnant and lactating women 3. patients have severe liver,kidney,cardiovascular,cerebrovascular,endocrine and hematopoietic system of primary diseases and that of immunodeficiency,advanced cancer or mental illness. 4. patients who were complicated by other diseases and thought to affect efficacy evaluations or poor compliance.

Keywords: respiratory and urinary tract infections piperacillin sodium and sulbactam sodium for injection (2:1) phase iv
study of refeeding to optimize inpatient gains

Conditions: Anorexia Nervosa

Summary: the purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia nervosa.


Eligibility criteria:
inclusion criteria: * diagnosis of an * atypical an * no hospital admissions for the previous six months * meet hospitalization criteria: daytime heart rate (hr) \ 35 bpm or decrease in systolic bp \> 20 mmhg or decrease in diastolic bp \> 10 mmhg from lying to standing exclusion criteria: * diagnosis of bulimia nervosa \[dsm-5\] * currently in remission (as defined by weight and ede-q score) * admission for food refusal without malnutrition * current pregnancy * chronic disease (e.g. immune/endocrine disorders, pulmonary, cardiac, or renal disease) * current suicidality or psychosis * \< 60% mbmi

Keywords: anorexia nervosa eating disorders refeeding adolescent medicine nutritional rehabilitation