Kornimate/medical-research-clean huggingface dataset:
the epidemiology of aortic diameter in china

Conditions: Vascular Disease; Diabetes; Hypertension; Hyperlipidemia

Summary: aortic aneurysms are the major disease processes affecting the aorta and becoming a relatively common cause of death because of rupture or dissection. the most common location for aneurysms is the infrarenal abdominal aorta, followed by the ascending thoracic aorta. unlike coronary heart disease, the incidence of abdominal aortic aneurysm (aaa) in the united states and europe has been increasing, and this increase may not be due to higher levels of screening for this condition alone. aortic diameter is central to the diagnosis of aortic aneurysm. furthermore, it was demonstrated that non-aaa patients with an enlarged diameter of the infrarenal aortic diameter are also at high risk for all-cause mortality. and aortic root dimension was associated with several coronary artery disease (chd) risk factors and measures of subclinical disease and was predictive of incident congestive heart failure (chf), stroke, cardiovascular disease (cvd) mortality, and all-cause mortality, but not of incident mi. up to now, there are limited studies on the epidemiology of aortic diameter, especially in chinese population.

the purpose of this study was to analyze the size of the entire aorta at different anatomic levels in a large group of chinese population with clinically evident arterial disease or cardiovascular risk factors to further explored the risk factors and potential alternative pathomechanisms for the development of aortic dilatation. comprehensive transthoracic m-mode, 2-dimensional, and doppler echocardiographic studies will be performed using commercially available equipment. the aortic dimensions were assessed at end-diastole at the different levels: (1) the annulus, (2) the mid-point of the sinuses of valsalva, (3) the sinotubular junction, (4) the ascending aorta at the level of its largest diameter, (5) the transverse arch, (6) the descending aorta posterior to the left atrium, and (7) the abdominal aorta just distal to the origin of the renal arteries. the extension of dilation is defined as the number of dilated aortic segments. the relations among aortic dimensions and clinical characteristics will be assessed by multiple regression analysis. the current study was to determine the association of risk factors of cvd and atherosclerosis diseases with aortic dimension in chinese patients with clinical event atherosclerotic disease or risk factors of atherosclerotic disease.

Eligibility criteria:
inclusion criteria: * patients aged 40 to 100 were referred to the hospital with a recent diagnosis of clinically evident arterial disease or a cardiovascular risk factor. exclusion criteria: * those with connective tissue disease, congenital heart disease, cardiomyopathy, congestive heart failure,rheumatic arthritis, secondary causes of hypertension, or active cancer.

Keywords: aortic dimension atherosclerosis vascular disease risk factors
partnership in implementation science for geriatric mental health (prism)

Conditions: Behavioral and Psychological Symptoms of Dementia (BPSD)

Summary: the partnership in implementation science for geriatric mental health (prism) project proposes an evidence-based physical exercise intervention for older adults who exhibit behavioral and psychological symptoms of dementia (bpsd). the proposed evaluation study will conduct a randomized controlled trial with a hybrid type 3 design to compare the intervention arm that implements the culturally-adapted gto model (gto-thai) to deliver implementation support, with a control arm, which receives usual top-down administrative instruction for implementing a policy initiative.

the overall goal of this project is to establish a hub to integrate implementation research for scaling up sustainable, evidence-based mental health interventions with research capacity-building activities for east asia. specific scale-up study aims include: aim 1: assessing readiness for implementing the evidence-based physical exercise intervention for improving mental health of older adults in participating provinces of thailand; aim 2: developing the gto-thai implementation support model through a pre-implementation case study and formative evaluation; and aim 3: evaluation of implementation strategies and clinical outcomes through a hybrid type 3 randomized trial to test an evidence-based implementation support strategy (i.e., the gto-thai model) that emphasizes a systematic process to address implementation barriers to the delivery of the evidence-based physical exercise intervention (pei), compared with the existing standard administrative procedures for delivering the same pei.

Eligibility criteria:
inclusion criteria: * (a) adults who are aged 55 and older, * (b) screen positive for dementia, * (c) screen positive for bpsd, and * (d) having a caregiver who is willing to participate in the study. exclusion criteria: * (a) caregivers who are cognitively not intact, and/or * (b) not willing to participate in the intervention.
(cost)-effectiveness of optical coherence tomography (oct) in basal cell carcinoma (bcc)

Conditions: Basal Cell Carcinoma; Optical Coherence Tomography

Summary: a multi-centre randomized non-inferiority trial investigating the (cost-)effectiveness of optical coherence tomography (oct) versus regular punch biopsy in the diagnosis and subtyping of basal cell carcinoma (bcc).

skin cancer incidence rises worldwide due to high sun exposure and ageing. basal cell carcinoma (bcc) is the most prevalent form, with a lifetime risk of 16-20% in the netherlands. currently, the gold standard for diagnosing and subtyping bcc is a punch biopsy. since this technique is invasive, new non-invasive diagnostic methods have been developed, including optical coherence tomography (oct). in patients with clinical and dermoscopic suspicion of bcc, oct makes it possible to confirm and subtype bcc with high confidence, thereby obviating the need for a punch biopsy in a substantial part of patients. hence, bcc diagnosis and treatment can be accomplished in one day. as a result, patients experience less distress and costs can be saved. by discussing diagnosis and treatment with the patient directly, care can be provided more efficiently, preventing treatment delay and saving extra hospital visits. the investigators hypothesize that the use of oct is a cost-effective strategy when compared to regular care (always punch biopsy). however, it is important to evaluate whether an alternative oct guided diagnostic approach does not lead to an unacceptable increase in risk of recurrent bcc.

Eligibility criteria:
inclusion criteria: * adult patient (\>18 years) * clinical and dermoscopic suspicion of bcc * bcc is in the differential diagnosis and a biopsy would normally be obtained to confirm the diagnosis and subtype or exclude other skin lesions. exclusion criteria: * patients with bcc in the high-risk zone of the face (ear, nose, eye region) * patients with a large bcc referred to our (tertiary care) head and neck tumour working group.

Keywords: basal cell carcinoma optical coherence tomography punch biopsy
prognostic value of implementing vce on top in constitutional vwd-patients with gi-bleeding

Conditions: Von Willebrand Diseases

Summary: inclusion criteria: only constitutional vwd-patients fulfilling the inclusion criteria of the french reference center for vwd will be included. patients with acquired von willebrand syndrome will not be included. material and methods: a 15-items survey that will be sent to the 30 centers involved in the french network for bleeding disorders (mhemo) to identify vwd-patients referred for endoscopic exploration of at least one gi-bleeding from january 2015 to december 2017. only constitutional vwd-patients fulfilling the inclusion criteria of the french reference center for vwd will be included. constitutional vwd diagnosis will be confirmed confirmed centrally in all patients by the french reference center for von willebrand disease. a gi-bleeding episode will be defined as any overt or occult gi-bleeding (unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 g/dl from baseline). we will analyze patient characteristics, gi-bleeding pattern, vwd type/subtype, nature (gastroscopy, colonoscopy or vce) and results of the endoscopic exploration and management that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-vwf replacement therapy, use of antiangiogenic drugs. if angiodysplasia without another bleeding source is identified, gi-bleeding will be categorized as angiodysplasia, if another lesion is identified gi-bleeding will be categorized as "no-angiodysplasia" and if no bleeding source is identified, gi-bleeding will be categorized as obscure gi-bleeding. recurrence will be defined as evidence of overt gi-bleeding or a drop of hemoglobin level by more than 2 g/dl from baseline.


Eligibility criteria:
inclusion criteria: - at least one overt or occult gi-bleeding (unexplained iron deficiency anemia causing a drop of hemoglobin level by more than 2g/dl from baseline) episode between january 1st 2015 and december 31th 2017 exclusion criteria: * acquired von willebrand syndrome

Keywords: gastrointestinal bleeding videocapsule endoscopy angiodysplasia
anatomic and visual function assessments on asymptomatic hiv-positive patients

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Summary: the purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (oct) on patients infected by hiv virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (fdt).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of aids * best-corrected visual acuity 20/25 or better * refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters * normal intraocular pressure (≤21mmhg) exclusion criteria: * cataract or any visible media opacity * hiv-related infectious retinopathy * risk factors for the development of glaucoma
comparative effectiveness research for two medical home models for attention deficit hyperactivity disorder

Conditions: Attention Deficit/Hyperactivity Disorder

Summary: the purpose of this study is to compare the effectiveness of two care models on adhd outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered medical home; and another, which combines the medical home with theory-based care management strategies to address common reasons for adhd treatment failure.


Eligibility criteria:
inclusion criteria: * child is being evaluated for a potential diagnosis of adhd by a primary care pediatrician at one of our sites. * child is 6 to 12 years of age * family plans to remain in the boston area for the duration of the follow-up period * mother is comfortable in english or spanish exclusion criteria: * child already has a confirmed diagnosis of adhd * child already receives ongoing specialty care in one or more of the following clinics: pediatric psychiatry, developmental behavioral pediatrics
family intervention for obese children using portion control strategy for weight control

Conditions: Obesity

Summary: obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. a simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. the purpose of this study is to assess the efficacy of a family intervention using a portion control tool to help control weight in obese children. the investigators hypothesize that the use of portion control tools by the parents and child will result in a greater decrease in the child's bmi over a 6 month period compared with the control group.

this study is a randomized controlled trial designed to assess the efficacy of a portion control tool to help improve body mass index in obese children over a 6 months period. this study will also assess whether this weight control strategy results in improvement of blood pressure, waist circumference, and biomarkers of obesity including plasma visfatin, adiponectin, fasting lipid profile and apolipoprotein b, liver function tests and fasting insulin and glucose. both the intervention and the control group will receive a one hour session of standard dietary counseling from a registered dietician at baseline regarding healthy eating habits, appropriate portion sizes and the canada food guide. the duration of this study will be 6 months. baseline measurements will be taken at the initial visit and again at 3 months and 6 months. each participants' height and weight will be measured, and bmi will be calculated. waist circumference and blood pressure will also be measured. a blood sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin, and glucose levels. measurement of plasma visfatin and adiponectin levels using elisa will be carried out.

Eligibility criteria:
inclusion criteria: * age 8 years old to 16 years old * bmi greater than or equal to the 85th percentile for age and gender exclusion criteria: * patients currently taking a weight loss medication * gastrointestinal disorder * psychiatric illness under the care of a psychiatrist * cushing's syndrome * hypothalamic or genetic etiology of obesity * uncontrolled or untreated thyroid disease * current diagnosis of cancer * history of an eating disorder such as bulimia or anorexia nervosa * surgery in the past 3 months * surgery planned in the ensuing 6 months * any chronic illness that could affect weight status

Keywords: obesity children dyslipidemia hypertension
dapagliflozin evaluation in patients with inadequately controlled type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

study classification: safety, efficacy and pharmacokinetics/dynamics

Eligibility criteria:
inclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) * central laboratory c-peptide \< 0.7 ng/ml (0.23 nmol/l) * insulin use for at least 12 months per patient reported or medical records * method of insulin administration (mdi or csii) must have been unchanged for at least 3 months prior to screening * subjects must be on a total insulin dose of ≥ 0.3 u/kg/day for at least 3 months prior to screening * if on mdi insulin administration, subject must be on ≥ 3x injections per day * screening visit: central laboratory hba1c ≥ 7.7% and ≤ 11.0% * body mass index (bmi) ≥ 18.5 kg/m2 exclusion criteria: * history of type 2 diabetes mellitus (t2dm) or maturity onset diabetes of the young (mody), pancreatic surgery, or chronic pancreatitis that could result in decreased beta cell capacity * taking any non-insulin antihyperglicemic agent within 1 month prior to screening * taking glp-1 receptor agonist within 2 months prior to screening for once weekly administration and within 1 month prior to screening for once or twice daily administration * taking metformin and/or thiazolidinediones within 2 months prior to screening * history of diabetes ketoacidosis requiring medical intervention within 1 month prior to screening * history of hospital admission for glycemic control (either hyperglycemia or hypoglycemia) within 1 month prior to screening * frequent episodes of severe hypoglycemia (more than one episode requiring medical assistance, emergency care), and/or glucagon therapy administered by a third-party individual within 1 month prior to screening * history of addison's disease

Keywords: dapagliflozin efficacy safety add on to insulin oral antidiabetic type 1 diabetes
clot formation and clot stability in patients with severe haemophilia a

Conditions: Hemophilia A

Summary: in the present study we are examining the clot formation and clot stability in patients with severe haemophilia a after they receive recombinat factor viii and after addition of tranexamic acid. our hypothesis is that addition of tranexamic increases the clot stability. the perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia a.

in the present study we are examining the clot formation and clot stability in patients with severe haemophilia a after they receive recombinat factor viii and after addition of tranexamic acid. our hypothesis is that addition of tranexamic increases the clot stability. the perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia a.

Eligibility criteria:
inclusion criteria: * severe haemophilia a * above 17 years old * thrombocyt count above 100 x 109/l within the past two years exclusion criteria: * received recombinant factor viii with in the past 3 days * inhibitor against recombinant factor viii * hiv-positive * ongoing treatment for hepatitis c * known kidney disease * allergy against tranexamic acid * not able to give informed consent

Keywords: haemophilia a thrombelastography recombinant factor viii thrombin generation
sofosbuvir with pegylated interferon and ribavirin hepatitis c virus (hcv) genotypes 1,4,5,6

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (gs-7977; psi-7977) administered in combination with pegylated interferon and ribavirin (peg/rbv) in treatment-naive patients with hcv genotypes 1,4,5,6, or indeterminate genotype.


Eligibility criteria:
inclusion criteria: * males and females with chronic hepatitis c (hcv) genotype 1,4,5,6, or indeterminate * naive to previous hcv treatment exclusion criteria: * positive for hbsag, anti-hbc igm ab, or anti-hiv ab * history of any other clinically significant chronic liver disease

Keywords: hepatitis c hcv chronic hepatitis c
a study to assess the efficacy and safety of induction and maintenance therapy with ro7790121 in participants with moderately to severely active crohn's disease

Conditions: Moderately to Severely Active Crohns Disease

Summary: this phase iii, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with ro7790121 in participants with moderately to severely active crohn's disease (cd).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cd * moderately to severely active cd * bodyweight \>= 40 kilogram (kg) * demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced cd therapy * males and females of childbearing potential must meet protocol criteria for contraception requirements exclusion criteria: * current diagnosis of ulcerative colitis (uc) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis * participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum) * diagnosis of short gut or short bowel syndrome * presence of an ileostomy, colostomy or ileoanal pouch * participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon * presence of abdominal or perianal abscess * presence of rectovaginal fistulas or perianal fistulas with \>3 openings * current diagnosis or suspicion of primary sclerosing cholangitis * pregnancy or breastfeeding, or intention of becoming pregnant during the study * past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed * history of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer * evidence of infection with clostridioides difficile (c. difficile; formerly known as clostridium difficile), cytomegalovirus (cmv), human immunodeficiency virus (hiv), hepatitis b (hbv), hepatitis c (hcv) * has evidence of active tuberculosis (tb), latent tb not successfully treated (per local guidance) or inadequately treated tb * has received protocol-specified prohibited medicines, including known exposure to any type of anti-tl1a therapy
clinical trial studying a personalized cancer vaccine in patients with non-metastatic kidney cancer

Conditions: Kidney Cancer; Renal Cell Carcinoma

Summary: this is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with autologous hsppc-96 or no adjuvant treatment. all patients will undergo complete surgical removal of their tumors.

this is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with hsppc-96 or no adjuvant treatment. all patients will undergo complete surgical removal of their tumors. the primary objective of the study is to determine whether patients who receive adjuvant autologous hsppc-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). eligible patients will have a 50% chance of receiving adjuvant treatment with hsppc-96. patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. both groups of patients will be followed regularly for assessment of their disease status. hsppc-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. a portion of the tumor tissue is sent to antigenics' manufacturing facility where it will undergo processing to create a vaccine.

Eligibility criteria:
this does not represent the full set of inclusion/exclusion criteria inclusion criteria: * patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent * tumor size \> 5 cm or macroscopic nodes or vena cava thrombus by radiologic evaluation * at least 18 years old * signed informed consent exclusion criteria: * prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer * history of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin * current malignancies of any type in other sites * no active uncontrolled infection, other serious medical illnesses, or splenectomy * history of primary or secondary immunodeficiencies

Keywords: kidney cancer renal immunotherapy vaccine