Kornimate/medical-research-clean huggingface dataset:
patient navigation for lung cancer screening in an urban safety-net system

Conditions: Non-Small Cell Lung Carcinoma; Compliance Behavior; Prevention Harmful Effects

Summary: the study proposes to evaluate a patient navigation intervention among a sample of 446 individuals referred for ct-based lung cancer screening in an urban safety-net setting.

widespread implementation of ct-based lung cancer screening is underway, but its impact on cancer morbidity and mortality can only be achieved if people are screened at appropriate intervals and abnormal findings are appropriately assessed. the degree to which individuals, especially those from medically underserved populations with highest lung cancer risks, will adhere to the complex, multi-step process of ct-based lung cancer screening has emerged as a key question with immediate need for solution. specific aims of the study are as follows: * aim 1: compare rates of completion for clinically recommended steps in the lung cancer screening process between patients referred for ct-based lung cancer screening who are randomized to the navigation intervention versus patients who receive usual care. * aim 2: compare changes in patient-reported outcomes, including satisfaction with care, psychosocial distress, and tobacco use between patients in the navigation intervention versus those who receive usual care for the ct-based lung cancer screening process. * aim 3 (exploratory): explore whether differences seen in aims 1 and 2 are moderated theory-based patient attitudes and beliefs (perceived susceptibility, severity of lung cancer, perceived benefits/barriers to screening, self-efficacy). this study will offer unprecedented insight into implementation of lung cancer screening for high-risk individuals in underserved settings. findings will show whether navigation interventions increase adherence to the screening process and affect patient-reported outcomes among underserved populations. the proposed program aims to address these issues for lung cancer screening at its inception, rather than after disparities in screening uptake have already emerged.

Eligibility criteria:
inclusion criteria: * patients referred for lung cancer screening using a low-dose ct scan modality who are considered high risk by uspstf guidelines. * patients who speak english or spanish exclusion criteria: * patients who do not speak english or spanish * patients who are or become ineligible as defined by uspstf guidelines for lung cancer screening.
the prognostic impact of extracapsular lymph node involvement in ductal pancreatic adenocarcinoma

Conditions: Pancreatic Neoplasms; Pancreatic Adenocarcinoma

Summary: extracapsular lymph node involvement (eclni) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. no studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (dpac). the goal of the investigators is to determine the prognostic value of eclni in a prospective consecutive series of 145 patients with dpac, who underwent resection of their primary tumor between 1998 and 2005.

presence and extent of extracapsular lymph node involvement (eclni) will be scored by reviewing all original pathological slides. eclni is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue. observers: 1 experienced board-certified gi pathologist, blinded for follow-up results. follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's gp/gastroenterologist in november 2007. statistical analysis: * common closing date: 1/11/2007 * kaplan-meier survival analysis (log-rank, wilcoxon) * cox logistic regression (uni/multivariate)

Eligibility criteria:
inclusion criteria: * dpac * primary resection exclusion criteria: * positive section margins * non dpac, other tumor * postoperative mortality * neoadjuvant chemo/radiotherapy

Keywords: prognosis extracapsular lymph node involvement
evaluation of template assisted monochromatic structural colored versus universal multi-shade direct composite veneers

Conditions: Tooth Discoloration

Summary: the aim of this study was to conduct a clinical trial utilizing a modified split-mouth, double-blinded, randomized strategy to clinically assess template assisted one shade structural colored versus universal multi-shade direct composite veneers

the superior mechanical qualities, superb aesthetics, and versatility of resin-based composites (rbcs) make them popular choices for direct restorative applications. compared to their predecessors, nanocomposites have shown superior qualities since nanotechnology was introduced in the production of dental rbcs. a restoration's aesthetic integration is mostly the result of its chromatic characteristics. pigments included in the composition of the restorative material typically control the selective reflection of wavelengths to emulate the natural tooth. in order to better reflect the broad color range that characterizes real dentition, rbcs have more recently employed the phenomena of "structural color" . thanks to the novel property of resins, color differences between the tooth and the restoration are eliminated or balanced out as perceived color of a region moves toward the color of the surrounding area . additionally, as opposed to multi-shade rbcs, single-shade rbcs eliminate the need to select between various resin shades, streamlining the color choosing procedure and cutting down on time lost during the clinical resin selection process. the vita classic shade guide's shades can all be matched with these materials.

Eligibility criteria:
inclusion criteria: * better dental hygiene * discolored vital anterior teeth exclusion criteria: * para functional activities * non-vital teeth
digital cognitive behavior therapy program for suicide prevention

Conditions: Suicidal Ideation; Depression; Anxiety

Summary: this study evaluates the efficacy of thrive, a computerized cognitive behavior therapy program, to reduce depression and anxiety symptoms and to reduce suicidal thinking among adults. the first 450 participants will participate in a randomized waitlist controlled trial. the remaining 550 participants will be provided the program immediately upon enrolling

the efficacy of thrive has been studied among patient and community populations and has shown to effectively reduce depression and anxiety symptoms among adults with moderate to severe depression symptoms at baseline. this study will examine whether thrive can also reduce suicidal thinking for persons exhibiting at least moderate depression symptoms. the first phase of the study will implement a randomized waitlist controlled trial. the second phase of the study will examine the effects in a open trial. outcome assessments will occur at baseline, 4- and 8-weeks (12- and 16-weeks for the waitlist group) with a 6-month follow-up assessment for all participants.

Eligibility criteria:
inclusion criteria: * montana resident * 18+ years old * have regular access to broadband internet * phq-9 score greater than 4 exclusion criteria: * no montana residency * \< 18 years old * no broadband internet access * phq-9 score less than 5
positron emission tomography (pet) interest in the follow up of colorectal cancer stage ii and iii

Conditions: Colorectal Cancer

Summary: the follow up of colorectal cancer after curative surgery has to find loco-regional relapses or synchronous metastases, and to detect adenomas and new cancer on the rest of the colon. the increase of survival after relapse of the colorectal cancer depends on the possibility of curative action or after chemotherapy response. this is a phase iii open-labeled, multicenter, multidisciplinary, randomised study, comparing 2 arms of 188 patients (i.e. 376 total patients). study period (date of first inclusion/last inclusion): 3 years. follow up: 3 years. the primary objective is the evaluation of pet performance in the earlier relapse detection of the colorectal cancer relapse in comparison with conventional control (including carcinoembryonic \[cea\] levels and other classic radiological exams).


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent * confirmed stage ii or iii (tnm) * patient with curative surgery for colorectal adenocarcinoma * total digestive endoscopy prior or post surgery. * age \> 18 years old * normal liver ultrasound and chest x-ray or thoraco-abdomino pelvic computed tomography (ct) scan. * in fertile women, efficient contraception or postmenopausal patient (amenorrhea for at least 1 year) exclusion criteria: * serious concomitant pathology * uncontrolled diabetes with a classical treatment (glycaemia \>1.4 g/l) * other malignant tumour within the last 5 years (except for curatively treated basocellular carcinoma of the skin or in situ cervical carcinoma). * uncontrolled infection * women who are pregnant or lactating * inability to understand informed consent * psychological or geographic impossibility to follow up for three years.

Keywords: colorectal cancer stage ii and iii
exercise training in pregnancy for obese mothers

Conditions: Pregnancy; Obesity

Summary: observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. there is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus. main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor

women with a self-reported pre-pregnancy bmi of 28 or more will be eligible for our study. woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation. primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. some measurements are also done at other points in time. the maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by homa-ir, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.

Eligibility criteria:
inclusion criteria: * pre-pregnancy body mass index of 28 or more * 18 years or more * singleton live fetus at the routine ultrasound scan exclusion criteria: * high risk for preterm labor or diseases that could interfere with participation

Keywords: exercise training pregnancy obesity
specimen x-rays of removed axillary lymph nodes to guide pathological sampling

Conditions: Breast Cancer

Summary: x-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.


Eligibility criteria:
inclusion criteria: males or females of all races and ethnicities * ≥ 18 years of age * must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection exclusion criteria: • any person whose final pathology could be compromised in any way by the x-ray procedure

Keywords: sentinel lymph node dissection radiology x-ray identification of nodes in a surgical specimen
icg- liver test versus new biomarkers as prognostic markers in critically ill patients

Conditions: Critically Ill

Summary: comparison of icg liver testing with copeptin and saps ii score as prognostic markers in critically ill patients.

comparison of different marker for length of stay in the icu in critically ill patients.

Eligibility criteria:
inclusion criteria: * all patients admitted to the icu exclusion criteria: * not able to understand german

Keywords: prognostic value
central mechanisms of chronic pain and fatigue subtitle: functional imaging of brain and spinal cord

Conditions: Chronic Fatigue Syndrome; Fibromyalgia

Summary: chronic pain and fatigue are characterized by peripheral and central mechanisms including low pain thresholds, temporal summation, peripheral and central sensitization. this application will focus on central factors of chronic pain and fatigue. functional brain imaging will be used to characterized brain and spinal cord abnormalities that contribute to the mechanisms of these disorders.

chronic fatigue (me/cfs) and fibromyalgia syndrome (fm) are a chronic musculoskeletal pain disorder that predominantly afflicts women. frequently associated insomnia, cognitive abnormalities, and fatigue may lead to early disability. no consistent soft tissue abnormalities have been identified so far in these patients. the cause of these disorders is unknown, no highly effective treatment is available and the current methods of diagnosis are imprecise and unreliable. the investigators previously used quantitative sensory testing to improve upon diagnoses of these disorders by supplementing the current procedure of manipulating defined pressure points by hand and noting the presence or absence of pain. the quantitative methods of evaluation involve repetitive application of brief, non-injurious thermal/mechanical stimulation that normally produces a moderate degree of temporal summation of sensation intensity. the patients and normal control subjects will verbally rate the magnitude of late sensations elicited by each stimulus, using a numerical scale. chronic pain in these patients results, at least partially, from exaggerated activation of central n-methyl-d-aspartate (nmda) receptors as a result of enhanced input from unmyelinated peripheral afferent nerve fibers supplying deep tissues. temporal summation of second pain can lead to central sensitization with subsequent signs of hyperalgesia and allodynia. functional brain imaging of me/cfs and fm patients, as proposed in this study, will be used to document their ratings of repetitive experimental stimuli and the resulting pain augmentation. successful completion of this study will provide a new method for the evaluation of chronic pain/fatigue mechanism and their response to therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of fm will require a history of chronic widespread pain as well as the presence of at least eleven out of eighteen paired tender points. * diagnosis of me/cfs will require a history of chronic fatigue persisting or relapsing for more than 6 months as well as the presence of at least four out of eight designated symptoms. * willing to reduce anti-depressants to low levels like amitriptyline 10 mg/day, trazodone 50 mg/day, citalopram 20 mg/day, for at least five half-lives of the medication. exclusion criteria: * patients unwilling or unable to discontinue or modify analgesics, hypnotics, anxiolytics, or anti-depressants during the study period will be excluded from this trial.

Keywords: pain fatigue
endoscopic rectal ultrasound with elastosonography and contrast in deep pelvic endometriosis with bowel involvement

Conditions: Endometriosis, Rectum

Summary: the aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

to diagnose deep infiltrating endometriosis, a clinical examination may be performed by a gynecologist to look for typical signs of endometriosis, but in 25% of case there can be absent. according to that, medical imaging is indispensable in diagnosis of pelvic endometriosis. trans vaginal ultrasonography, and pelvic mri are major tools in the hands of specialists, but several studies have shown the importance of endoscopic rectal ultrasound, with a sensitivity close to 90% for de diagnosis of digestive impairment. in recent years the use of elastography and the injection of microbubbles of sulfur hexafluoride in addition to endoscopic ultrasound has made it possible to improve the diagnostic accuracy of the technique in tumoral pathologies, in particular bilio-pancreatic injuries. however, no study has yet evaluated the endoscopic rectal ultrasound with elastometry and injection of contrast agent to characterize the digestive lesions of deep pelvic endometriosis. the endoscopic rectal ultrasound has demonstrated its place in the evaluation of deep pelvic endometriosis disease but its latest complementary techniques of interest have not yet been studied prospectively. the aim of the study will be to determine the diagnostic and prognostic value of elastosonography and the use of the contrast agent (sonovue®) in the endoscopic ultrasound exploration of deep pelvic endometriosis.

Eligibility criteria:
inclusion criteria: * woman over 18 years of age * diagnosis of deep pelvic endometriosis (clinical and / or mri and / or transvaginal ultrasound), defined by penetrating endometriosis lesions in the retroperitoneal space and / or pelvic organ wall at a depth of at least 5 millimeters , with digestive impairment. * presenting symptoms of deep pelvic endometriosis disabling and / or fertility difficulties and requiring an exhaustive iconographic assessment. * belong to a social security scheme. * signature of informed consent. exclusion criteria: * without medical contraindication to the realization of a low digestive endoscopy. * allergy or hypersensitivity to sulfur hexafluoride or one of the components of sonovue® (contrast agent used in endoscopy ultrasound). * severe heart rhythm disorders. * angina unstable. * recent acute coronary syndrome. * heart shunt right - left. * severe pulmonary arterial hypertension (pah) (defined as pah \> 90 mmhg). * acute or severe cardiac insufficiency stage 3 and 4 * pregnant woman and vulnerable patient population (persons deprived of administrative and / or judicial liberty, and persons under guardianship. * mental disability of the subject making participation in the trial impossible.
application of magnetic fields as adjunctive treatment for type ii diabetes

Conditions: Type II Diabetes Mellitus

Summary: the purpose of this study is to see if using a device called the resonator, that puts out a very low electromagnetic field, effects blood glucose and a1c levels in people with type 2 diabetes.

the purpose of this pilot study is to determine whether application of magnetic fields generated by the resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin a1c levels. the study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.

Eligibility criteria:
inclusion criteria: * current diagnosis of type ii diabetes mellitus with a1c level above the upper limit of normal * subject currently performs routine finger stick blood sugar testing * subject is ambulatory * none or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study. * hemoglobin a1c levels within a 0.8% range of patient mean a1c level for the last two documented determinations, that must be within 2 years of the baseline testing date. * willingness to test finger stick blood sugars according to protocol. * willingness to have lab test blood draws performed according to protocol * willingness to maintain stable diet and activity regimen for the duration of the study. * willing and able to abstain from partaking in any non-essential existing or new treatments to improve serum blood sugar levels. * adequate contraceptive measures for female subjects * male or female * any ethnic group * between 21 and 80 years of age exclusion criteria: * change in medical regimen within 6 months prior to initiation of study * any signs of type i diabetes * active infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level. * change in bmi of greater than 6% within a 6 month period prior to study initiation * any planned revascularization procedure * symptomatic congestive heart failure * leg or foot ulceration or open wounds * gangrene * history of intermittent claudication * hemodialysis * currently being treated for malignancy * currently being treated with oral or intravenous catabolic steroids. * reported consumption of more than 14 alcoholic drinks per week. * pregnant, breast feeding,or planning pregnancy prior to the end of participation. * developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements. * uncontrolled hypertension * uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia * uncontrolled seizure disorder * uncontrolled, unstable, or untreated medical conditions which may significantly impact the subjects health or ability to complete the entire study, in the opinion of the investigator
value of macrophage-colony stimulating factor as a new marker of bone lesions in multiple myeloma

Conditions: Multiple Myeloma

Summary: the primary objective of this study is to compare serum levels of macrophage-colony stimulating factor (m-csf) in a population of patients with multiple myeloma (mm), in a population of patients with monoclonal gammopathy of undetermined significance (mgus) and in a control population.


Eligibility criteria:
inclusion criteria: for the multiple myeloma group * confirmed diagnosis of de novo multiple myeloma according to the international myeloma working group criteria * bisphosphonate therapy for more than 60 days, * signature of the informed consent form, * patients over the age of 18 years. for the monoclonal gammopathy of undetermined significance (mgus) group * confirmed diagnosis of mgus according to the international myeloma working group criteria * signature of the informed consent form, * patients over the age of 18 years. for the healthy control group * signature of the informed consent form, * subjects over the age of 18 years. exclusion criteria: * patients with thyroid or parathyroid disease, * osteomalacia, rheumatoid arthritis, paget's disease, osteoporosis, * bisphosphonate therapy for less than 60 days, * absence of informed consent, * patients under the age of 18 years.

Keywords: multiple myeloma bone lesions macrophage-colony stimulating factor