Kornimate/medical-research-clean huggingface dataset:
comparing strategies for translating self-management support into primary care

Conditions: Diabetes Mellitus, Type 2

Summary: this project will test different ways of helping primary care practices to do a better job of self-management support (sms) for their patients with diabetes.

the specific aims of the proposed study are: * primary specific aims 1. to conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (re-aim) of connection to health (cth) for patients with type 2 diabetes in primary care practice settings. primary effectiveness outcomes will include hemoglobin a1c, body mass index (bmi), blood pressure and low desity lipprotein (ldl) cholesterol. 2. to determine the incremental benefit, using the re-aim framework, of brief targeted practice coaching on the implementation of cth in diverse primary care practices. * secondary specific aims 1. to identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact cth re-aim. these results will inform dissemination of the cth intervention. 2. to determine the relative costs associated with implementing cth and practice coaching to further inform dissemination efforts.

Eligibility criteria:
inclusion criteria: * age 21 years old or over * type 2 diabetes mellitus diagnosed for a minimum of 12 months * able to read in english or spanish * plan to remain in the practice during the study period exclusion criteria: * developmentally disabled * decisionally challenged * pregnant women

Keywords: diabetes mellitus, type 2 diabetes mellitus primary health care self care
lipid lowering effect of a cereal based snack bar with added plant stanol ester

Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Summary: the purpose of the study is to investigate the cholesterol lowering efficacy of a cereal based snack bar with added plant stanol ester when used between meals as part of a habitual diet by subjects with mild to moderate hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * serum total cholesterol 5.2-8.5 mmol/l * serum triglycerides \< 3 mmol/l * signed written informed consent exclusion criteria: * abnormal liver, kidney and thyroid function * use of lipid lowering medication * consumption of other plant sterol or plant stanol containing food products or supplements, or other foods or supplements for cholesterol lowering 1 month prior to visit 2 * history of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) within the previous 6 months * diagnosed type 1 or type 2 diabetes requiring medical treatment * history of recent temporal ischemic attack or malignant diseases (\< 5 yrs) * celiac disease, or allergy or intolerance to the ingredients of the test products * medically prescribed diet/medication for slimming or a special diet like very low calorie diet or obesity drug, or vegan and gluten-free diet * subjects with alcohol abuse (\> 4 portion per day) * pregnancy or planned pregnancy or lactating
study of ub-312 in healthy participants and parkinson's disease patients

Conditions: Parkinson's Disease; Parkinsonism

Summary: this is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation part a study in healthy participants, followed by a part b in participants with parkinson's disease with a selected doses from part a.

this is a first-in-human phase 1 study to determine the safety, tolerability, and immunogenicity of ub-312 in healthy participants and in participants with parkinson's disease (pd). ub-312 is a ubith®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, pd. the study consists of two parts. part a of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. part b of the study will consist of two cohorts of participants with parkinson's disease (pd). dosing for part b will be based on safety, tolerability and immunogenicity from part a. all eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.

Eligibility criteria:
inclusion criteria: * male or female aged 40 to 85 years old, inclusive at screening * expected to be able to undergo all study procedures * other inclusion criteria apply for part b only: * a diagnosis of pd, confirmed by a neurologist * hoehn \&yahr stage ≤ iii at screening * stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for mao-b inhibitors, and expected to remain stable throughout the study exclusion criteria: * clinically significant abnormalities, as judged by the investigator * history of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study * acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (hiv), hepatitis c virus (hcv) or hepatitis b virus (hbv) * history or evidence of an autoimmune disorder * history of anergy. * participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at asyn * other exclusion criteria apply for part b only: * other known or suspected cause of parkinsonism other than idiopathic pd * history or evidence at screening of pd-related freezing episodes, falls, or orthostatic hypotension * dopamine transporter single-photon emission computerized tomography scan (datscan) inconsistent with dopamine transporter deficit. * clinically significant neurological disease other than pd
evaluating neostigmine effect on reducing gastric residual volume as compared with metoclopramide and ondansetron

Conditions: Delayed Gastric Emptying

Summary: one big problem in mechanically ventilated icu patients is delayed gastric emptying. delayed gastric emptying in these patients, causes intolerance and high gastric residual volume (grv) that can lead to abdominal distention, vomiting, increased aspiration risk and consequently increased the length of hospital stay. in this study, investigators will evaluate neostigmine's effect in reducing grv in mechanically ventilated patients and compare its effect with metoclopramide and ondansetron .

it has been shown that delayed gastric emptying and high grv in critically ill patients are associated with increased mortality in these patients. different kinds of drugs including metoclopramide, erythromycin and cisapride are used, but none of them had conclusive evidence of better eﬀects on each other. moreover, complications such as dysrhythmia and extrapyramidal side eﬀects limit the use of these drugs. another drug that can be used to increase gastric emptying in critically ill patients is neostigmine. although several studies have evaluated the efficacy of neostigmine on postoperative ileus, very few studies have evaluated the effect of this drug on grv in icu patients. the aim of the current study will be to compare the effects of neostigmine on gastric residual volume in mechanically ventilated patients in the intensive care unit. a comparative controlled study by ondansetron.

Eligibility criteria:
inclusion criteria: * mechanically ventilated icu patients * with nasogastric tube feeding * gastric residual volume \>120 ml (3hours after the last gavage) exclusion criteria: * history of diabetes * heart block * bradycardia (heart rate \<60/min) * systolic blood pressure less than 90 mm hg * renal insufficiency * using any prokinetic agents such as erythromycin or cisapride within 8 hours before study initiation * recent surgery (10 days or less) on the stomach or digestive system * pregnancy and lactation * occurrence of extrapyramidal side effects * gastrointestinal (gi) bleeding

Keywords: gastric residual volume neostigmine ondansetron mechanically ventilated patients
clinical value of metagenomic sequencing in neonatal sepsis

Conditions: Neonatal Sepsis

Summary: this study aimed to enroll 2000 neonatal patients with suspected sepsis or clinical diagnosed sepsis. these patients will undergo both conventional methods and metagenomics sequencing to detect the pathogenic microorganisms of sepsis. the purpose of this study was to assess the clinical value of metagenomics sequencing for the diagnosis and treatment of neonatal sepsis.

infectious diseases remain leading causes of mortality and morbidity in children. rapid and accurate diagnosis of infectious diseases in children is important for developing an effective treatment and management strategy. however, the current diagnosis of infectious agents mainly depends on culture and molecular testing. both of the methods either has long turnaround times or narrow detection range. metagenome next generation sequencing (mngs) has been applied to the diagnosis of central nervous system infection, lower respiratory tract infection and sepsis, which showed high positive rate, short turnaround time. as a multi-center prospective observational clinical study, the study intends to enroll 2000 suspected neonatal sepsis cases from multiple centers. culture, classical pcr and mngs were performed simultaneously. this study is one of the few multi-center studies in china to evaluate the value of mngs in the diagnosis and treatment of neonatal sepsis, and will provide representative data for the distribution characteristics of pathogen spectrum of children in the real world and the clinical diagnosis and treatment value of mngs.

Eligibility criteria:
inclusion criteria: * neonates with suspected early-onset sepsis or late-onset sepsis; * neonates diagnosed with clinical sepsis. exclusion criteria: * died before the results of conventional methods test or metagenomics test were obtained; * suffering from diseases of the blood system; * suffering from malignant tumor; * birth defects, congenital heart disease or autoimmune disease.

Keywords: neonatal sepsis metagenomics high-throughput nucleotide sequencing
strengthening exercise and activities of daily living instructions for patients with lumbar disc herniation

Conditions: Lumbar Disc Herniation

Summary: lumbar disc herniation (ldh) is one of the most common causes of mechanical low back pain (lbp) associated with radiating leg pain. conservative treatment, including exercise, analgesic, and physical therapy, is regarded as the first-line treatment of ldh. this randomized clinical trial was conducted to evaluate the effectiveness of back and hip strengthening exercises combined with activities of daily living instructions (adlis) to reduce pain intensity in patients with ldh.

a total of 70 patients with ldh were randomly allocated to either the intervention group (ig) or the control group (cg). patients in ig received different back and hip strengthening exercises five days a week for six weeks. the patients in cg were treated with naproxen (500 mg) and baclofen (10 mg) tablet twice a day for three weeks, followed by hot moist compression for the next three weeks. in addition, the patients in both groups were instructed to follow the adlis during the intervention and at least 3 months after the intervention. the straight leg raising (slr) test and the visual analogue scale (vas) score were used to evaluate the patients' pain intensity. outcomes were measured at baseline, at three weeks, and six weeks of the intervention. patients were followed up after 3 months of the intervention.

Eligibility criteria:
inclusion criteria: * age: 18 - 59 years. * clinically diagnosed ldh that was confirmed by mri. * duration of the pain: ≥ 3 months exclusion criteria: * painful spinal deformity * cauda equina syndrome * progressive neurological signs and/or muscle-wasting * history of spinal surgery, spine fracture, scoliosis, tuberculosis, and tumours. * treated with epidural injections. * pregnancy

Keywords: low back pain disc herniation strengthening exercise adl instructions
telithromycin, treating adult outpatients with mild to moderate community-acquired pneumonia (cap) in high bacterial resistance areas

Conditions: Pneumonia

Summary: demonstrate efficacy of telithromycin over single-agent oral antibiotics usually prescribed by local guidelines ("usual care") for treating adult outpatients with mild to moderate community-acquired pneumonia (cap) in high bacterial resistance areas.


Eligibility criteria:
inclusion criteria: * adult outpatients with mild to moderate cap. diagnosis of cap was based on the presence of fever and/or hyperleucocytosis and the new and sudden onset of at least two clinical signs and symptoms of pneumonia (cough, dyspnea or tachypnea, chills, pleuritic chest pain, purulent sputum or change in sputum character, auscultatory findings). clinical diagnosis of cap had to be confirmed by chest x-ray findings (e.g. presence of presumably new infiltrate). specimens for microbiological documentation had to be collected within 24 hours prior to enrollment. exclusion criteria: * subjects requiring parenteral antibiotic treatment. * subjects with severe cap requiring hospitalization. the cap was to be considered as severe in the presence of any of the following conditions: * chest x-ray showing a multilobar consolidation (\> 1 lobe)3 and/ or an increase in the size of the opacity by greater than or = to 50% within 48 hours of the current evaluation * shock * altered mental status (disorientation to person, place or time that is not known to be chronic, lethargy, stupor or coma) * total peripheral white blood cell count \< 4,000/mm3 * requirement for mechanical ventilation * requirement for vasopressors * acute renal failure the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
detecting diabetes sooner with a risk survey for the family doctor:comparing internet and traditional methods of communication for patients and doctors

Conditions: Diabetes

Summary: this pilot rct study aims to develop and evaluate the uptake, feasibility, and potential value of a strategy for web-diabetes risk assessment versus paper-based methods in an undiagnosed diabetes population over 40 years of age from all listed fht provided through an electronic medical record database. following randomization, intervention participants will have the option to decide to use web-based self-screening and the control group will receive only a paper-based method. there will be two options for web-based screening; one involves completion of the can-risk screening tool as part of a personal health record self-management program (myoscar) versus a one off online risk-assessment. the intervention and control group will be compared with respect to risk-assessment uptake. educational sessions and further assessment of diabetes conducted by the clinical health care team will be offered to all participants who scored a high risk of diabetes in accordance with the can-risk results. actual numbers of diabetes cases in those with a high risk score will be compared between the intervention and control groups as well as compared to the usual method of diabetes screening in a randomly chosen non-identifiable sample from the same clinical setting in the same one year period. the assessment of patient acceptability in feasibility of the implementation of the self-screening tool will be accomplished through surveys designed to be completed by patients and staff.


Eligibility criteria:
inclusion criteria: * patients aged 40 and over who did not have diagnosis of diabetes and no previous use of personal health record (myoscar) exclusion criteria: * people with diabetes, and those who are already registered as myoscar (personal e-health record) users

Keywords: diabetes self-screening web-based technology follow-up clinical care randomized control trial
nanocrystalline megestrol for first-line treatment of advanced gastric or colorectal cancer with cancer-related fatigue

Conditions: Cancer-related Fatigue， Gastric Cancer，Colorectal Cancer，Nano-crystalline Megestrol Acetate，Megestrol Acetate，First-line Treatment

Summary: this study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for the first-line treatment of patients with cancer-related fatigue in gastric or colorectal cancer.


Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤75 years. * eastern cooperative oncology group (ecog) physical status score of 0-2. * expected survival ≥ 6 months. * locally advanced or metastatic gastric/gastroesophageal junction (g/gej) adenocarcinoma or colorectal adenocarcinoma not amenable to radical treatment with histologic or cytologic confirmation. * no prior systemic systemic antitumor therapy for gastric/gastroesophageal junction (g/gej) adenocarcinoma or colorectal cancer. * have at least one measurable tumor lesion according to recist v1.1. * compliance with a fatigue visual analog scale (vas) score of ≥ 4 (consistent with moderate or severe fatigue). * complain of anorexia. * good organ function as determined by the following requirements. exclusion criteria: * suffered significant surgery or traumatic injuries within the past 1month. * having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting. currently undergoing tube feeding or parenteral nutrition. * suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain. * received erythropoietin or blood transfusion within the past 1month. * comorbidities such as serious cerebrovascular, heart, kidney, or liver disease. * a history of hypersensitivity to the components of the trial medication. * other conditions that were considered inappropriate as determined by the investigators.

Keywords: cancer-related fatigue， cancer-caused fatigue，fatigue，appetite stimulants gastric cancer，colorectal cancer，gastrointestinal tumor，cancer，tumor，carcinoma， nano-crystalline megestrol acetate，megestrol，megestrol acetate， antineoplastic agents, hormonal，central nervous system stimulants，appetite stimulants
changes in the sagittal pharyngeal airway dimension following leveling and alignement in class ii division 2 patients

Conditions: Class II Division 2 Malocclusion

Summary: aim of the study: is to compare the changes in the sagittal pharyngeal airway dimension (spad) and mandibular position before and after the levelling and alignment stage of orthodontic treatment in class ii division 2 patients.


Eligibility criteria:
inclusion criteria: * class ii/2 subjects as per the british standard institute classification. * age ranging from 12-16 years, with cervical vertebral maturational index (cvmi) stages 4, and 5. * contact between maxillary and mandibular incisors, with the presence of a deep bite of at least 70%. * full permanent dentition, aside from the third molars exclusion criteria: * previous orthodontic treatment. * patients with severe transverse problems, pain and/or clicking sound in the temporomandibular joint (tmj). * patients with craniofacial anomalies or diagnosed syndromes
trophy - candesartan cilexetil long-term hypertension prevention trial

Conditions: Hypertension

Summary: the purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. patients will be randomized to either candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.


Eligibility criteria:
inclusion criteria: * subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process * have an average clinic bp in the high normal range of \< 139/85-89 mmhg or 130-139/\< 89 mm hg (high normal bp range) (mean systolic and/or diastolic pressure based on 3 consecutive measurements) derived from the average of clinic visits 1,2 and 3. exclusion criteria: * have proteinuria \>1 + (by dipstick method) * have a stroke, myocardial infarction (mi), transient ischemic attack (tia), the presence of any clinically significant evidence of atherosclerosis or hypertensive target organ involvement or any significant medical condition that may compromise participation in this study.
studies in patients with multiple myeloma and renal failure due to myeloma cast nephropathy

Conditions: Chronic Renal Failure With Uremic Nephropathy

Summary: myre is a phase iii multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (mcn). its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (bd), compared with cyclophosphamide, plus bortezomib and dexamethasone (c-bd) in patients with inaugural mcn not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven mcn and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (theralitetm) or a conventional high-flux dialyser, while receiving chemotherapy with bd.

myre is a phase iii multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (mcn). its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (bd), compared with cyclophosphamide, plus bortezomib and dexamethasone (c-bd) in patients with inaugural mcn not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven mcn and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (theralitetm) or a conventional high-flux dialyser, while receiving chemotherapy with bd. study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3 cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30% response rate in the control arm; and (2) in patients requiring hemodialysis, using the prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a benefit of at least 20% from an assumed rate of 50% in the control arm. a total sample size of 284 patients was computed to be enrolled (type i and ii error rates at 5 and 20%, respectively).

Eligibility criteria:
inclusion criteria: * age \>=18 years old * serum creatinine \> 170µmol/l and/or dfg \< 40 ml/min/1.73 m2 * myeloma cast nephropathy (mcn) * multiple myeloma * informed consent * neutrophils \>= 1 giga/l and platelets \>= 70 giga/l exclusion criteria: * amylosis * chronic renal failure with edfg \< 30 ml/min/1.73 m2, unrelated to myeloma * peripheral neuropathy * contraindications to either corticosteroids or bortezomib * patient refusal * known hiv infection * concomitant severe disease including neoplasias (except basocellular carcinoma) * liver failure, cytolysis, and/or cholestasis * fertile women who refuse or cannot use effective contraception; women pregnant or nursing; women with positive test pregnancy (test before treatment initiation)