Kornimate/medical-research-clean huggingface dataset:
evaluation of childhood blood pressure and lipid screening

Conditions: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia; Hypertension

Summary: to help clarify the validity, reliability, and utility of blood pressure (bp) and lipid screening in childhood.

background: to be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. however, information was sparse regarding reliability of measurements, accounting for which could improve validity. the efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. in addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. the results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults. design narrative: the study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of bp and lipid measurements (i.e., the reliability of the test) and its impact on tracking of bp and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood bp and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for bp control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) recor

Eligibility criteria:
no eligibility criteria
follicular helper t cells: biological marker and involvement in the physiopathology of the igg4-related disease

Conditions: IgG4-related Disease

Summary: igg4-related disease is a rare and very recently identified pathology, whose frequency is certainly underestimated. the clinical presentation varies among affected organs, and most often, patients have at least three organ damage. these organs exhibit tissue infiltration mononuclear polymorphic cells with often severe fibrosis progression resulting in a loss of function. the biomarker, though not specific, is a polyclonal elevated serum igg4, and histological marker, currently held by several teams, is the presence within the inflammatory infiltrate, of a predominance of igg4-expressing plasma-cells with a relative plasma-cells igg4 + / igg +\> 50% on tissue immunostaining. the investigators project provides a global assessment of t lymphocyte abnormalities and specifically the tfh (follicular helper) during this igg4-related disease compared to so-called groups "control" subjects suffering from sjogren syndrome or healthy subjects.


Eligibility criteria:
inclusion criteria: * igg4-related disease patients or * sjogren syndrome patients or * healthy subjects exclusion criteria: * presence of autoimmune or inflammatory associated disease * age less than 18 years
study of anxiety and avoidance of others in patients previously treated for head and neck cancer

Conditions: Anxiety Disorder; Head and Neck Cancer; Lung Cancer

Summary: rationale: patients who undergo treatment for head and neck cancer may become anxious and avoid contact with other people. learning how cancer treatment may cause anxiety in patients with head and neck cancer may help improve the quality of life in these patients. purpose: this clinical trial is studying anxiety and avoidance of others in patients previously treated for head and neck cancer.

objectives: * determine the relationship between treatment-provoked social anxiety and avoidance in patients previously treated for head and neck cancer. * determine the relationship between pre-cancer psychiatric diagnosis and post-treatment social anxiety and avoidance in these patients. * determine the effect of social anxiety and/or avoidance on the quality of life of these patients. * investigate the specificity of these relationships in patients with head and neck cancer by comparing patients with head and neck cancer to patients with lung cancer. outline: this is a cross-sectional study. patients are stratified according to prior treatment type (significantly impairing \[surgery\] vs less impairing \[chemotherapy/radiotherapy\]). patients undergo a face-to-face interview with a mental health clinician over 2 hours. patients complete multiple psychiatric/psychological assessments during the interview, including the structured clinical interview for dsm-iv (scid); the liebowitz social anxiety scale (sas); the performance status scale for head and neck cancer patients (pss-hn); the social phobia and anxiety inventory (spai); the state-trait anxiety inventory (stai); response to stress questionnaire, cancer version (rsq-cv); the functional assessment of cancer therapy (fact-hnc (head neck cancer) or lc); the voice handicap index (vhi); and the body image scale (bis). cancer treatment and medical history information are gathered from patients' medical records.

Eligibility criteria:
patient characteristics: * diagnosis of 1 of the following: * head and neck cancer * lung cancer (control group) * must have received treatment for head and neck cancer or lung cancer within the past 5 years patient characteristics: * able to speak and read english to answer surveys, interviews, and questionnaires prior concurrent therapy: * see disease characteristics

Keywords: anxiety disorder long-term effects secondary to cancer therapy in adults head and neck cancer non-small cell lung cancer small cell lung cancer
supraphysiological doses of levothyroxine as adjunctive therapy in bipolar depression

Conditions: Bipolar Disorder

Summary: there is growing evidence that thyroid axis dysfunction may contribute to the pathophysiology of bipolar illness. open-label studies have consistently demonstrated that the behavioral expression of bipolar disorder can be modified by a change in thyroid status, and in many instances the course of illness is improved through the use of adjunct thyroid hormone treatment. recent evidence emerged from acute intervention studies that add-on treatment with supraphysiological doses of levothyroxine is an effective augmenting agent in patients with a major depressive episode. the primary goal of this international multicenter trial (5 sites) is to determine in a 13-week, randomized, placebo-controlled design (1 week single-blind placebo run-in, 6 week double-blind, 6 week open-label) the efficacy and safety of add-on treatment with levothyroxine (300 mcg/d) in combination with mood stabilizer/antidepressant therapy in the treatment of patients with bipolar depression. the main hypotheses is: treatment with levothyroxine will result in a significantly greater mean reduction of hrsd total score and in a higher number of responders and remitters compared to placebo treatment. this proposal will build on our pilot data and provide evidence for the use of levothyroxine as an effective augmentation strategy in the treatment of bipolar depression.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i or ii disorder, currently depressive episode according to the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * hamilton rating scale for depression (ham-d) 17-item score ≥14, a ham-d item 1 (depressed mood) score ≥2 at the screening and randomization visits * young mania rating scale (ymrs) score ≤12 at the screening and randomization visits. * pretreatment with a mood stabilizer and/or an antidepressant at standard doses (bauer et al. 2007a) for at least six weeks since the last dose adjustment, and for at least two weeks before enrollment * serum levels of mood stabilizer were required to be within therapeutic ranges * tsh levels in normal range (serum tsh 0.3 - 4.7 mu/l) exclusion criteria: * any axis i disorder other than bipolar disorder * recent ultra-rapid cycling course (12 or more episodes in previous year), - - a diagnosis of substance dependence (dsm-iv) or substance use (except for nicotine) within 12 months before the screening visit * clinically significant medical illness, especially severe cardiovascular diseases * organic brain disorder * current serious suicidal or homicidal risk by clinical judgment of the investigator * history of previous or current thyroid disease * thyroid hormone treatment

Keywords: bipolar disorder bipolar depression thyroid abnormality mood stabilizer antidepressants currently depressed
sub-optimal response to anti-tumor necrosis factor's in inflammatory bowel disease in emerging markets

Conditions: Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Summary: the purpose of this study is to establish the incidence of sub-optimal response to anti-tnf therapy in uc and cd participants.

participants with historical diagnosis of cd and uc who were naïve to anti-tnf therapy were observed in this retrospective study. the study will look to identify the local barriers in prescribing anti-tnf therapy, treatment patterns and indicators of sub-optimal response to anti-tnf therapy in uc and cd participants in real-world clinical practice in the em countries, along with the associated incidence of sub-optimal response and impact on health care resource utilization (hcru). the will enroll approximately 2000 participants. the study consists of two periods, eligibility period followed by a data abstraction period. during the eligibility period participants who had initiated first anti-tnf therapy during 01 march 2010 up to 01 march 2015 will be recruited and observed. participants will be followed up for a period of minimum 2 years (other than death) and a maximum of 5 years from the date of first treatment of anti-tnf therapy for cd and uc (index date). during the data abstraction period participants who have eligible medical charts will be identified and all retrospective data will be collected. this multi-center trial will be conducted in argentina, china, colombia, mexico, russia, saudi arabia, singapore, south korea, taiwan and turkey. the overall time to abstract data during the data extraction period from the web-based electronic data capture (edc) system will be approximately 1 year from march 2017 to february 2018.

Eligibility criteria:
inclusion criteria: 1. who are 18 years or older at index date and diagnosed with uc or cd. 2. who were naive to anti-tnf therapy and received their first dose of any anti-tnf therapy (index date) for uc or cd within the eligibility period from 01 march 2010 through 01 march 2015. exclusion criteria: 1. diagnosed with indeterminate/unspecified type of ibd. 2. were part of an ibd-related clinical trial during the observational period should be excluded (that is, index date up to the date of chart abstraction). 3. who received an anti-tnf therapy for any non-uc or non-cd conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer). 4. who received an anti-tnf/biologic therapy at any point that was administered outside of the labelled dosing regimen (example, episodic use of anti-tnf therapy). 5. with uc who had a total colectomy prior to their first anti-tnf therapy. 6. charts not available.

Keywords: drug therapy
effect of orthodontic treatment on periodontally compromised dentition- randomised control trial

Conditions: Periodontal Bone Loss

Summary: the main aim of this prospective, randomized controlled clinical study is to: • to evaluate and compare the effect of a combined orthodontic -periodontal treatment protocol versus periodontal treatment alone on osseous and non -osseous parameters in periodontally compromised patients.

all the patients of both the groups will receive a detailed periodontal evaluation and then therapeutic management of patients will be done as per their periodontal requirement. this will include oral hygiene instruction, scaling and root planning and re-evaluation after 2 weeks and periodontal surgical treatment if indicated will be re-evaluated 4-6 weeks. after an observation period of 2 months confirming patient cooperation and their ability to maintain good oral hygiene as well as stability of the periodontal results orthodontic treatment will be started in the test group whereas the control group will be kept on monthly recall for the first 3 months and then every 3 months as per the oral hygiene status requirement of the patient.periodontal charting will be done at every 3 months till finish of treatment and supra gingival scaling will be provided as per requirement in both the groups.changes in periodontal status in terms of clinical and radiographic parameters will be compared between the groups. cone beam computed tomography will be taken at the baseline t0 and study end point t2 for assessment of changes in the bone level around maxillary and mandibular teeth

Eligibility criteria:
inclusion criteria .• patient age criteria 20-40 years. * periodontally compromised dentition with moderate to severe periodontitis ≥2 teeth with pocket depth (pd) ≥5 mm and loss of clinical attachment level (cal) ≥ 4mm. and radiographic bone loss * good general health status. * malocclusion that needs orthodontic treatment exclusion criteria: * systemic illness known to affect the periodontium or outcome of periodontal and orthodontic therapy. * patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term nsaid therapy. * pregnant or lactating women. * smokers(≥5 cigarettes∕ day). * noncompliance to oral hygiene measures after phase i therapy. * presence of trauma from occlusion (tfo). * patients with aggressive periodontitis
r-chop14 or r-chop21 &consolidation pet-oriented radiotherapy (rt) in dlbcl patients

Conditions: Diffuse Large B Cell Lymphoma

Summary: prospective, multicentre phase ii study with r-chop- 14 or r-chop-21 \& consolidation pet-oriented radiotherapy (rt) in diffuse large b cell lymphoma (dlbcl) patients

prospective, multicentre phase ii study with r-chop- 14 or r-chop-21 \& consolidation pet-oriented radiotherapy (rt) in diffuse large b cell lymphoma (dlbcl) patients with low risk profile according to age-adjusted ipi (0 with bulky or 1)

Eligibility criteria:
inclusion criteria: * histological diagnosis of dlbcl (cd20+), follicular lymphoma grade iiib, t-cell rich large b cell lymphoma * age 18-80 years (patients \>70 years old: fit according to vgm evaluation). * aaipi=1 +/- bulky and aaipi=0 with bulky (\>7.5 cm) * ecog-ps \< 3 unless due to lymphoma * ventricular ejection fraction ≥ 50% * pulmonary, renal and hepatic tests within normal range * negative hiv and hbv tests. in case of hbcab positive and hbsab +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. anti-hcv positive patients can be included in the absence of viral replication (hvr-rna absent or less than 500 copies/ml. * written informed consent * life-expectancy \> 3 months main exclusion criteria: * t-cell lymphoma * follicular lymphoma (grade i, ii, iiia), marginal zone and mantle lymphoma * ps\> 3 (if not due to lymphoma) * age-adjusted ipi = 0 in the absence of bulky disease * age\> 80 and \<18 years (see inclusion criteria) * hiv positivity * significant cardiopathy

Keywords: dlbcl
microvascular function in primary aldosteronism

Conditions: Primary Aldosteronism; Essential Hypertension

Summary: patients with primary aldosteronism, which is the most prevalent form of secondary hypertension, have an increased rate of cardiovascular events, compared to patients with essential hypertension, even with equal severity of hypertension. this might be partially attributed to the association of increased aldosterone levels with insulin resistance. how this relation can be explained from a pathophysiological point of view, is insufficiently established. recently, microvascular dysfunction has been proposed as a link between insulin resistance and hypertension. loss of no-mediated vasodilation is an important feature of microvascular dysfunction; in addition, an impaired insulin-mediated microvascular no production has been suggested to underlie the reduction in insulin-stimulated glucose disposal that is characteristic of insulin-resistant states. increased aldosterone levels are not only associated with insulin resistance, but also with endothelial dysfunction. in addition, they interfere with the vascular effects of insulin. therefore, the investigators hypothesize that in patients with primary aldosteronism, increased aldosterone levels induce microvascular dysfunction through reduction of no-availability, which contributes to the development of insulin resistance, and of hypertension, in addition to the sodium-retaining effects of aldosterone.


Eligibility criteria:
inclusion criteria: patients with primary aldosteronism * age 18-70 years * confirmed diagnosis of primary aldosteronism * serum potassium \> 3.5 mmol/l with or without supplementation patients with essential hypertension * age 18-70 years * secondary causes of hypertension excluded exclusion criteria: * cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death) * diabetes mellitus * unstable or severe pulmonary disease * inflammatory diseases * alcohol use \> 2 u/day (women) / \> 3 u/day (men) * (frequent) use of acetylsalicylic acid, nsaid's, dipyridamole and corticosteroids * egfr \< 60 ml/min * impairment of hepatic function * pregnancy or lactation
implementation of neuro lung protective ventilation

Conditions: Acute Brain Injury; Traumatic Brain Injury; Intracerebral Hemorrhage; Stroke; Cerebral Edema; Anoxic Brain Injury

Summary: patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. it is proven that using lower ventilator volume settings improves outcomes. in patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. these 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. the investigators have designed a computerized ventilator protocol in icentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required. this is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the icentra electronic medical record system at intermountain medical center. we hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 ml/kg predicted body weight, and will improve outcomes.


Eligibility criteria:
inclusion criteria: 1. acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury. 2. initiation of mechanical ventilation in the emergency department or intensive care unit at an intermountain healthcare hospital 3. age ≥ 18 years exclusion criteria: 1. transition to comfort care in the emergency department or on the same day of admission to the icu 2. death on the same day of admission to the emergency department or icu

Keywords: lung protective ventilation
a phase iii study of tmc435 in treatment-naive, genotype 1, hepatitis c-infected patients

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of tmc435 compared with placebo in combination with peginterferon alfa-2a (pegifn alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis c virus (hcv) infection in japan.

this is a randomized (study drug assigned by chance), 2-arm, double-blind study to evaluate the efficacy and safety of tmc435 (also referred to as jnj-38733214-aaa) versus placebo in combination with the standard of care (soc) therapy (peginterferon alfa-2a \[pegifn alfa-2a\] and ribavirin) in adult treatment-naïve patients (who never received treatment for hcv) with chronic genotype 1 hcv infection in japan. the study objective is to evaluate and compare the efficacy of tmc435 vs placebo by the proportion of the patients with undetectable hcv ribonucleic acid (rna). in the tmc435 treatment group, patients will receive 12 weeks of treatment with tmc435 (100 mg) once daily plus soc followed by an additional 12 or 36 weeks of treatment with soc. in the placebo treatment group, patients will receive 12 weeks of treatment with placebo once daily plus soc followed by an additional 36 weeks of treatment with soc. tmc435 is a 100-mg capsule and will be taken orally by mouth. the soc treatment will be given for 24 or 48 weeks. pegylated interferon is supplied as a vial containing 1.0 ml solution with 180 mcg pegifn alpha-2a and administered subcutaneously (injected by a syringe under the skin) once weekly. ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg based on body weight), and taken orally by mouth two times a day after meals.

Eligibility criteria:
inclusion criteria: * patient must have chronic genotype 1 hcv infection with hcv rna level \>= 5.0 log10 iu/ml * patient has never received treatment for hcv * patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication exclusion criteria: * co-infection with any other hcv genotype or co-infection with the human immunodeficiency virus (hiv) * diagnosed with hepatic cirrhosis or hepatic failure * a medical condition which is a contraindication to pegifn or ribavirin therapy * history of, or any current medical condition which could impact the safety of the patient in the study

Keywords: hepatitis c, chronic hepatitis c hepatitis c virus interferon alfa-2a ribavirin viral rna