Kornimate/medical-research-clean huggingface dataset:
effect of asv and dcv therapy on the quality of immune status in chronic hcv patients

Conditions: Chronic Hepatitis C

Summary: rationale: chronic hcv infection is characterised by a weak hcv specific cd8+ t cell response, due to continuous pressure of high viral load. treatment of chronic hcv patients with asv and dcv will result in a significant drop in hcv viral load. at present, no information is available on the immunological effects of treatment with asv and dcv, nor on the early effects of viral load reduction caused by a compound that is thought not to possess direct immunomodulatory effects. this information will be crucial for a better understanding of the mechanisms that may limit the effectiveness of treatment, occurrence of viral rebound or relapses during, at the end of treatment or during the follow up period. objective: to evaluate in detail the functionality of immune cells in blood in chronic hcv patients before, during and after treatment with asv and dcv, in an ifn-free regimen. study design: this is an investigator-initiated single center open label study with one arm of 12 patients. study population: adult chronic hcv patients with genotype 1b, who are previous non-responders to the treatment. intervention (if applicable): all patients will be treated with twice daily a 200 mg oasv and once daily a 60 mg dcv for 24 weeks. main study parameters/endpoints: 1. phenotype and function of blood leukocytes during treatment; frequency of hcv-specific t cells, nk cells and monocytes 2. gene expression levels of leukocyte populations before, during and after treatment 3. gene expression levels of the type i ifn signaling pathway on whole blood samples 4. serum cytokines levels using multiplex platforms


Eligibility criteria:
inclusion criteria: * patients between 18 and 70 years of age, with a chronic hepatitis c - genotype 1b infection * patients are non-responders to previous treatment with peginterferon or conventional interferon plus ribavirin combination therapy * high viral load (\>400,000 iu/ml) * indication for antiviral therapy of hepatitis c according to current clinical guidelines * written informed consent exclusion criteria: * decompensated cirrhosis (child-pugh grade b or c) * hepatic imaging (ultrasound, ct or mri) with the evidence of hepatocellular carcinoma within the last 3 months. * females who are pregnant or breast-feeding * history or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigators, unsuitable for the study * co-infections with human immunodeficiency virus (hiv) or hepatitis b virus (hbv) * presence of contra-indications for antiviral therapy with asv and dcv: * interfering substance abuse, such as high alcohol intake (indicator: 28 drinks/ week) * any exposure to ns3 protease inhibitors or ns5a polymerase inhibitors * treatment with peginterferon/ ribavirin within 6 months before start of therapy * any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating and completing in the study

Keywords: immunity
can thought field therapy (tft) be helpful for patients with an anxiety disorder?

Conditions: Agoraphobia; Social Phobia; PTSD

Summary: the purpose of this study is to find out if thought field therapy has effect on certain anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (ptsd).

thought field therapy is an alternative treatment method that has been shown, by casuistic reports, to give good results when applied for anxiety disorders. in this study 52 patients, with one or more of the diagnoses agoraphobia, social phobia and/or ptsd, where randomized to either treatment with tft or a wait list. the treatment group all got treatment in one week. 2 1/2 months later both the treatment group and the control group were tested on the same items as before the treatment started. after this evaluation phase the control group got the same treatment as the treatment or study group. both groups were evaluated 3 and 12 months after treatment, the study group also 6 months after treatment. 4 patients were omitted because they changed groups. the study were performed from may 2002 until june 2003.

Eligibility criteria:
inclusion criteria: * one or more of the study diagnoses agoraphobia, social phobia and/or ptsd exclusion criteria: * ongoing psychosis * ongoing serious drug problems

Keywords: anxiety disorder thought field therapy psychotherapy agoraphobia social phobia post traumatic stress disorder
patients' opinions and responses to the national cancer institute's colorectal cancer risk assessment tool

Conditions: Colorectal Cancer

Summary: little is known about the impact of risk assessment tools on decision-making by patients and clinicians. in particular, even though the nci colorectal cancer risk assessment tool is one of the most prominent risk assessment tools available, no study has quantified its usability or impact on decision-making or uptake of screening. in this study, we will measure patients' satisfaction with the nci crc rat, their perception of its usability and helpfulness, and its impact on their decision-making and behavior. in addition, we will assess the impact of adding information about their chance of having an advanced adenoma.


Eligibility criteria:
inclusion criteria: * age 50-75 years old * no colonoscopy performed in last 10 years, sigmoidoscopy in last 5 years, or fecal occult blood testing (including fit) in last 1 year. * appointment with healthcare practitioner in upcoming month or within the past six months at one of five indiana university health primary care sites. exclusion criteria: * undergoing workup for signs or symptoms consistent with colon cancer, such as weight loss, iron-deficiency anemia, change in bowel habits, or rectal bleeding. * enrolled in "trial of a computer-based presentation of quantitative information about colorectal cancer screening"; dr. schwartz's study that recently completed enrollment. * diagnosis with any of the following conditions: ulcerative colitis, crohn disease, familial adenomatous polyposis (fap), hereditary nonpolyposis colorectal cancer (hnpcc), personal history of colorectal cancer or adenomatous polyp * inability to speak and read english
the lira pump trial

Conditions: Type 1 Diabetes

Summary: a randomized placebo-controlled clinical trial investigating the effects of liraglutide as an add-on to intensive insulin therapy in overweight insulin pump treated type 1 diabetes patients in suboptimal glycemic control.


Eligibility criteria:
inclusion criteria: * type 1 diabetes ≥ 1 year * bmi \> 25 kg/m2 * insulin pump ≥ 1 year * hba1c \> 58 mmol/mol * use of carbohydrate counting and the insulin pump bolus calculator exclusion criteria: * gastroparesis * impaired renal function (egfr \< 60 ml/min/1.73m2) * liver disease with alat \> 2.5 times the upper limit of the reference interval * acute or chronic pancreatitis or history of chronic pancreatitis or idiopathic acute pancreatitis * inflammatory bowel disease * history of cancer (except basal cell skin cancer) which in the investigators opinion could interfere with the results of the trial, or cancer during the past 5 years * thyroid adenoma * subjects with personal or family history of mtc or men2 * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * known or suspected alcohol or drug abuse * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. * simultaneous participation in any other clinical intervention trial * known or suspected hypersensitivity to liraglutide * inability to understand the patient information and to give informed consent * acute treatment required proliferative retinopathy or maculopathy (macular oedema) * any cardiac disorder which in the investigators opinion could interfere with the safety and results of the trial.
assessment of coronary plaque composition

Conditions: Coronary Atherosclerosis; Endothelial Dysfunction; Coronary Small Vessel Disease

Summary: the investigators' hypothesis is that local activation of the endogenous lipoprotein-associated phospholipase a2 (lp-pla2) plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. thus, this study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the lp-pla2 pathway.

the present study will be a substudy of our national institute of health (nih) funded and institutional review board (irb) approved (08-008161) protocol "lp-pla2 and coronary atherosclerosis in humans" and (10-000044) "lp-pla2 and coronary atherosclerosis in humans aim iii" in which the investigators are examining the impact of long-term inhibition of lp-pla2, with a specific novel inhibitor, on lp-pla2 activity and improvement in coronary endothelial function. the substudy will allow the investigators to also examine the additional endpoint of lipid core content of atherosclerotic plaques and hence plaque vulnerability. plaque lipid composition will be measured using the lipiscan or lipiscan ivus catheter (infraredx near infrared spectroscopy (nirs) system with or without intravascular ultrasound (ivus) capability) at baseline and again at 6 month following lp-pla2 inhibition. the study will provide insight into the role of the endogenous lp-pla2 in early coronary atherosclerosis, a potential therapeutic target for early coronary atherosclerosis in humans.

Eligibility criteria:
inclusion criteria: * patients age \> 18 years and \< 85 years * referred to our cardiac catheterization laboratory for coronary vasomotion testing- subsequently found to have coronary endothelial dysfunction. exclusion criteria: * heart failure ejection fraction \<40%, * unstable angina * myocardial infarction or angioplasty within 6 months prior to entry into the study * use of investigational agents within 1 month of entry into the study * patients who require treatment with positive inotropic agents other than digoxin during the study * patients with cerebrovascular accident within 6 months prior to entry the study * significant endocrine, hepatic or renal, disorders, local or systemic infectious disease within 4 weeks prior to entry into study * pregnancy or lactation * mental instability

Keywords: atherosclerosis endothelial dysfunction coronary vasospasm
geriatric locomotive syndrome and related factors in older adults

Conditions: Locomotive Syndrome

Summary: it has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. however, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals.

it has been reported that problems related to the musculoskeletal system, such as osteoarthritis, osteoporosis or spondylosis, increase with aging in elderly individuals. the japanese orthopedic association (joa) has defined this condition as locomotive syndrome (ls) in elderly individuals, as a condition of decreased mobility due to deterioration of locomotive organs. ls is a condition of reduced mobility due to deterioration of locomotive organs. it has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. however, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals.

Eligibility criteria:
inclusion criteria: individuals aged 65 and over, volunteering to participate in research no cooperation and communication problems (mini mental state test score above 24) exclusion criteria: individuals with neurological and orthopedic problems * uncontrolled hypertension * those with cardiac disease * those with cooperation and communication problems
internet-delivered cognitive behavior therapy compared to stress management for atrial fibrillation

Conditions: Atrial Fibrillation; Arrythmia

Summary: the aim of this study is to evaluate if internet- delivered cognitive behavior therapy (cbt), based on exposure principles and behavioral activation, improves qol and symptom burden in patients with symptomatic atrial fibrillation (af), controlling for expectancy of improvement and attention from a caregiver, using an active control group (stress management). the study will include 260 patients with symptomatic af despite optimal medical treatment in accordance with current guidelines.

atrial fibrillation (af) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. af is associated with poor quality of life (qol) and large costs for society. in a considerable proportion of patients, af symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. psychological factors can worsen af symptoms, and anxiety and depression are common among af patients. symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization. the aim is to evaluate if cbt, based on behavioral activation and exposure principles, improves wellbeing and qol in symptomatic af patients controlling for expectancy of improvement and attention from a caregiver using an active control group receiving stress management treatment (smt). method: a randomized controlled trial. participants are randomized to internet- delivered exposure-based cbt (n=130) or to smt (n=130). participants in both groups receive weekly therapist support through online written communication. the internet-delivered smt-treatment includes life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. both treatments lasts 10 weeks and are comparable regarding number of treatment modules, treatment burden and attention from the treating psychologist.

Eligibility criteria:
inclusion criteria: * paroxysmal af ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. ehra class ≥ iib); * scoring ≥ 20 on the cardiac anxiety questionnaire at screening; * age 18-75 years; * on optimal medical treatment; * able to read and write in swedish. exclusion criteria: * heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); * significant valvular disease; * planned ablation for af or ablation within 3 months before assessment; * other severe medical illness; * any medical restriction to physical exercise; * severe psychiatric disorder, severe depression, or risk of suicide; * alcohol dependency; * previous participation in any af-cbt study conducted by the research group.
phase 2b study of bms-986094 and daclatasvir, with or without ribavirin for the treatment of patients with chronic hepatitis c

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to evaluate the effectiveness of bms-986094 and daclatasvir (dcv) when given in combination with or without ribavirin


Eligibility criteria:
inclusion criteria: * males and females, ≥ 18 years of age * subjects chronically infected with hepatitis c virus (hcv) genotype 1,2,3 or 4 * hcv rna viral load ≥ 10,000 iu/ml * subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) * body mass index (bmi) of 18 to 35 kg/m2 * seronegative for hepatitis c virus (hiv) and hepatitis b exclusion criteria: * evidence of decompensated liver disease * evidence of medical condition contributing to chronic liver disease other than hcv
investigation of the accuracy of an automated refractor to provide well-tolerated eyeglass prescriptions

Conditions: Refractive Errors

Summary: at the new england college of optometry in boston, ma, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and automated refraction, by way of the quicksee plus refractor. subjects will then be randomized into one of two treatment plans: receive glasses from automated refraction first then subjective refraction second, and vice versa. after one week of wearing the first pair of glasses, patient preferences are assessed, and glasses are switched. after a week of wearing the second pair of glasses from the alternate measurement method, patient preferences are again assessed. patients may then decide which pair patient like best. this is a triple blind, case-crossover clinical trial.


Eligibility criteria:
inclusion criteria: * who have had an eye exam at the neco center for eye care of commonwealth or roslindale * who are aged between 18 years and 65 years exclusion criteria: * whose refractive error is outside of the detection range of the quicksee free pro and quicksee plus devices: -13 d to +10 d (s) and -8 d to + 8 d (c) * who are unable to provide consent * who have undergone any eye surgery * who have a history of ocular disease * who are taking systemic drugs * who wear more than one pair of single vision eyeglasses for distance * who more than occasionally wear soft contact lenses * who are unable and unwilling to wear the eyeglasses provided by the study for the required duration

Keywords: refractive errors eyeglasses
epoetin alfa in advanced non-small cell lung cancer (epo-can-20)

Conditions: Non-Small-Cell Lung Carcinoma; Lung Cancer; Anemia

Summary: the general objective of this study is to improve the quality of life (qol) of selected patients with advanced carcinoma of the lung. the specific objective is to evaluate the effect of treatment with epoetin alfa (recombinant human erythropoietin) on anemia related qol and anemia in non-small cell lung cancer patients with advanced stage disease and underlying anemia of malignancy.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed non-small cell lung cancer (squamous cell, large cell, adenocarcinoma, or some combination of these), with clinical or pathological stage iii or iv, or recurrent disease; and 2. hemoglobin level at or below 120 g/l; and 3. at least 18 years of age; exclusion criteria: 1. systemic platinum-based chemotherapy for lung cancer during the previous two months or planned platinum-based chemotherapy within the next three months; 2. patients previously treated with high dose thoracic radiation (\>10 fractions), or surgery, without objective evidence of disease recurrence; 3. planned high dose thoracic radiation therapy (\>10 fractions); 4. a clinically active malignancy, other than the underlying lung cancer which is expected to influence qol; 5. expected survival of three months or less; 6. ecog performance status of 3 or 4 (see appendix d); 7. multiple cns metastasis or a single cns lesion that does not demonstrate radiographic stability (screening ct of head required only if symptomatic, no radiographic follow-up of single resected lesions required); 8. blood transfusions within the last 14 days; 9. previous use of erythropoietin; 10. anemia due to factors other than cancer / radiotherapy (e.g. hemolysis or gastrointestinal bleeding); 11. evidence of untreated folate or vitamin b12 deficiency; 12. history of uncontrolled hypertension or diastolic blood pressure greater than 100 mm hg; 13. history of seizure disorder; 14. known hypersensitivity to mammalian cell-derived products, albumin or any component of the study drug; 15. pregnancy, lactation or parturition within the previous 30 days; 16. unwillingness or inability to complete the required qol questionnaires; 17. mental incompetence, including psychiatric or addictive disorders which would preclude meaningful completion of questionnaires; 18. geographically inaccessible for treatment or follow-up evaluations; 19. currently enrolled in an ongoing therapeutic study;

Keywords: quality of life blood transfusion
raltegravir augmentation on persistent central nervous system (cns) immunoactivation in treated hiv-1 patients

Conditions: HIV Infections

Summary: this pilot study focuses on the persistence of central nervous system (cns) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cart). attention to this issue is based on the fear that chronic cns immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. a leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (csf), yet sufficient to stimulate local immunoactivation. based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized cns hiv-1 replication will reduce continued cns immunoactivation.


Eligibility criteria:
inclusion criteria: * capacity to provide informed consent. * documented hiv-1 infection. * history of continuous cart treatment (with at least three drugs) for at least 2 years. * documentation of 'undetectable' plasma hiv-1 rna for at least 1 year. * hiv-1 rna \<50 copies/ml in plasma and csf at screening visit. exclusion criteria: * contraindication to lp (suspicion of cns mass lesion, bleeding diathesis, etc.). * prior experience with raltegravir or contraindication to raltegravir treatment, including medication interactions that might compromise ongoing antiretroviral therapy or treatment of other conditions. * active opportunistic infections or neurological diseases. * other conditions or treatments likely to interfere with treatment or evaluation. * hemoglobin \< 10 gm/dl. * pregnant or anticipating pregnancy during study. * active substance abuse. * subjects taking rifampin, phenytoin, phenobarbital or other drugs that accelerate raltegravir metabolism and might decrease its tissue concentrations.

Keywords: raltegravir central nervous system (cns) hiv-1 aids cerebrospinal fluid (csf) immunoactivation antiretroviral therapy suppression