Kornimate/medical-research-clean huggingface dataset:
aspirin and antiretroviral therapy in hiv infected patients

Conditions: HIV Infection

Summary: the purpose of this study is to examine the effects of hiv treatment (antiretroviral therapy) and aspirin use on risk for cardiovascular disease among hiv infected persons.

cardiovascular disease is now a major health concern among persons with hiv infection. our general hypothesis is that hiv-mediated inflammation and injury to vascular surfaces up-regulates thrombotic pathways and leads to damage of blood vessels that is promotes development of cardiovascular disease. hiv drug treatment (antiretroviral therapy; art) may reduce inflammation and vessel injury via suppression of hiv replication, but also includes side effects or toxicity that may increase risk for cardiovascular disease in and of itself. in this context, additional anti-inflammatory and anti-thrombotic medications are needed. acetylsalicylic acid (aspirin) is an excellent candidate and is commonly used for secondary prevention of cardiovascular events in the general population, but few studies have examined it's use in persons with hiv infection. the goal of this study is to generate pilot data regarding changes in measures of cardiovascular risk, as determined by reductions in inflammatory and thrombotic blood markers and a decrease in blood vessel injury (blood markers) and dysfunction (assessment of arterial elasticity), that occur after starting art and aspirin among persons with hiv infection.

Eligibility criteria:
inclusion criteria: 1. hiv-infected (by positive hiv ab or detectable hiv rna level) 2. no art for at least previous 3 months 3. ready to start or re-start art (regimen pre-chosen by patient and provider) exclusion criteria: 1. age \ 60 years 2. pregnancy 3. current aspirin use 4. presence of known atherosclerotic cvd determined by: 1. previous myocardial infarction 2. significant coronary atherosclerosis by angiography 3. coronary revascularization procedure (coronary stent or surgical bypass) 4. previous cerebral vascular accident (stroke) 5. ischemic cardiomyopathy 6. carotid stenosis (\>25% narrowing by carotid ultrasound) 7. aortic aneurysm 8. symptomatic peripheral vascular disease (claudication) 9. surgical revascularization procedure of peripheral vessels 5. hospitalization (within prior 2 weeks of study entry) 6. concurrent self-limited bacterial infections (does not include chronic viral infections) 7. clinical or pathologic diagnosis of systemic vasculitis 8. active drug or alcohol use

Keywords: hiv cardiovascular disease endothelial dysfunction
effects of lumbar repositioning feedback and transversus abdominis training on lumbar propricption in patients with chronic mechanical low back pain

Conditions: Orthopedic Disorder

Summary: this study is conducted to answer the following question: what is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?

chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. low back pain represents a major social and economic problem. the prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in french healthcare workers. low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. low back pain has been associated with motor control dysfunction. indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. an association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area. this was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls

Eligibility criteria:
inclusion criteria: * patients with cmlbp referred from orthopedic surgeon with no radicular pain * their age is ranged between 35-55 years old (martim etal.,2008) * bmi 24-28 kg/m2 exclusion criteria: * patients who have a history of diabetic peripheral neuropathies * patients who have a history of sciatica * spinal or lower limb deformity or any pathology within the spine. * patients who have neurological disorders * patients who have a history of previous lumbar surgery * patients who have visual problems
effects of strengthening exercise on the brain for early dementia and normative older adults

Conditions: Cognitive Decline; Dementia; Alzheimer's Disease; Mild Cognitive Impairment

Summary: this study will evaluate the effects of low-intensity strengthening exercise on the brain (thinking and processing speed) for patients with early dementia, compared with normative older adults. participants will engage in 3 months of exercise 3-5 times per week using a chair and small weights. it is hypothesized that there will be a significant improvement in brain function.

1. objective(s): this study will evaluate the neuropsychological and neurophysiological effects of low-intensity strengthening exercise for patients with early dementia, compared with normative older adults. 2. research design: this is a quasi-experimental design in which change over time as a result of the exercise intervention will be compared with change over time seen in a normative sample. 3. methodology: the aim is to enroll 12 participants with early dementia and 12 normative controls, all who are interested in starting a strengthening exercise program. neuropsychological evaluation, resting electroencephalography (eeg), and event-related potentials (erp) data collection will commence prior to the start of exercise. participants will participate in an exercise class 2-3x/wk for three months. repeat neuropsychological, eeg, and erp evaluations will occur at the conclusion of three months of exercise. the exercises consist of low-intensity exercises, using a chair and small weights. a leader trained in the tufts university exercise model will conduct the classes. 4. findings: the investigators hypothesize a positive impact of exercise on neuropsychological function, especially performance on tasks requiring executive functions. this change will be compared with performance of normative controls who also exercise. changes in brain function will be explored using eeg and erp, and results are expected to be similar to prior research examining older adult exercisers which shows improvement in function.

Eligibility criteria:
inclusion criteria: * adult day program participants with early dementia able to consent or assent with surrogate permission * control participants (55-100+ yo) able to participate at location with doctor permission exclusion criteria: * history of significant tbi, psychiatric condition, substance abuse, physical conditions that preclude participation in cognitive testing or strengthening exercises

Keywords: exercise neuropsychological dementia alzheimer's disease mild cognitive impairment strength mci ad eeg neurophysiological growth factor cognitive decline executive function
iv cocaine abuse: a laboratory model - 3

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate dependent cocaine users.


Eligibility criteria:
please contact site for information.

Keywords: intravenous abuse
a safety study of lintuzumab in patients with acute myeloid leukemia and myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Myeloproliferative Disorders; Chronic Myelomonocytic Leukemia

Summary: phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of sgn-33 in patients with myelodysplastic syndrome (mds), acute myelogenous leukemia(aml), and cd33+ myeloproliferative diseases. phase 1b includes patients with aml or mds treated at the highest tolerated dose from phase 1a.


Eligibility criteria:
inclusion criteria: 1. patients must have a diagnosis of mds or aml. 2. patients must have an ecog performance status ≤ 2 and a life expectancy \> 3 months. exclusion criteria: 1. patients who have received prior therapy with gemtuzumab ozogamicin (mylotarg®) or other anti-cd33 monoclonal antibody treatment. 2. patients with a prior allogeneic transplant. 3. patients with known leptomeningeal or cns involvement of leukemia. patients with onset of cns symptoms within the past 12 months will also be excluded. 4. patients receiving chemotherapy within the last four weeks.

Keywords: lintuzumab antigens, cd33 antibodies, monoclonal leukemia, myeloid, acute myelodysplastic syndromes hematologic diseases myeloproliferative disorders leukemia
a non-invasive device to remove fluid from the middle ear

Conditions: Otitis Media With Effusion

Summary: a feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. the study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.


Eligibility criteria:
inclusion criteria: * diagnosed with ear fluids (ome) according to a doctor's examination for at least 4-6 weeks. there is a progressive hearing impairment and a matching tympanum. * in principle, these children (with ome and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons). exclusion criteria: * first encounter: acute ear infection or proper otoscopy * second session: first review: otoscopy / timpneometry / hearing test. * parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
a retrospective study to describe real-world treatment patterns and clinical outcomes among patients with myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes (MDS)

Summary: this study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued luspatercept or epoetin alfa treatment and discontinued the commands trial (nct03682536) utilizing existing data from patient medical records.


Eligibility criteria:
inclusion criteria: * participant was enrolled in and discontinued the commands trial. * participant was treated with either luspatercept or epoetin alfa and discontinued treatment while enrolled in the commands trial. * participant patient provides informed consent (only where applicable or required by local regulations). exclusion criteria: • there are no exclusion criteria for this study.

Keywords: myelodysplastic syndromes (mds)
cost comparison study of darbepoetin versus epoetin therapy to treat anemia in hemodialysis patients

Conditions: Anemia; Chronic Kidney Disease

Summary: the purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.

eligible hemodialysis patients who are currently receiving an erythropoiesis stimulating agent (esa) who enrol and sign consent will be randomized on a 1:1 basis to either remain on epoetin alfa or switch to darbepoetin alfa as their anemia therapy. patients will be dosed with the assigned drug using a study algorithm to maintain their hemoglobin (hb) level within the currently recommended range (100-120 g/l). there will be an initial "run in" period of a minimum of six weeks to ensure the patient's hemoglobin is stable within the target range. the trial itself will run for a subsequent twelve months (active phase). every effort will be made to ensure that hb stays within the target range during the study period. the primary outcome will be the total cost of each esa therapy over the twelve month active phase. data including hgb, iron indices and dosing, and clinical events will be obtained from electronic sources and from the attending physicians and/or the clinical pharmacist.

Eligibility criteria:
inclusion criteria: * age ≥19 years * receiving in-center hemodialysis two or more times weekly * anemia requiring erythropoiesis stimulating (esa) agent therapy or a hemoglobin(hb)\<100g/l in the absence of other causes of anemia * if female, must be using an approved method of contraception or judged unable to become pregnant * able to give informed consent exclusion criteria: * acute kidney injury likely to resolve * plans to change to peritoneal dialysis or home hemodialysis, or planned transplant from a living donor * expected lifespan of less than six months due to a medical condition other than chronic kidney disease * current hematologic condition that may cause anemia * use of medications known to cause anemia * use of any investigational drug or androgen within 90 days of screening * significant bleeding within 30 days of screening * red blood cell transfusion(s) within 30 days of screening * documented or suspected pure red cell aplasia (prca) * current iron deficiency * documented allergy or intolerance to intravenous sodium ferric gluconate * known or probable esa resistance * uncontrolled hypertension * an intention to relocate to a different dialysis center in the near future

Keywords: anemia hemodialysis erythropoiesis stimulating agent cost
a study to evaluate the safety and tolerability of zidovudine (zdv) in premature infants born to hiv-positive women.

Conditions: HIV Infections

Summary: the purpose of this study is to examine the safety and tolerability of zdv when given to premature infants born to hiv-positive women to prevent hiv infection. zdv has been used successfully to prevent the transmission of hiv from mother to child during pregnancy and birth. however, zdv has been given to very few premature babies, and the best dose to use has not yet been determined.

in the preliminary group of premature infants, those receiving q 6h dosing had an average trough concentration of 7.3 um (18%). however, the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity. due to the potential for altered zdv pharmacokinetics and increased toxicity in this population, an evaluation of zdv pharmacokinetics in premature infants is proposed. premature infants less than or equal to 34 weeks gestational age at birth and begun on zdv by their clinical caregivers will be entered into the protocol within the first 5 days of life. upon entry, zdv will be administered every 12 hours intravenously or orally. the study will require 9 serum samples for zdv assay collected over 30 days, some additional clinical laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection of routine clinical data.

Eligibility criteria:
inclusion criteria your baby may be eligible for this study if he/she: * requires zdv (as decided by your doctor) because you are hiv-positive. * is 1-5 days old and was born prematurely. exclusion criteria your baby will not be eligible for this study if he/she: * is not expected to live 6 weeks because of severe illness. * is having problems with blood pressure or is not urinating enough.

Keywords: zidovudine anti-hiv agents
effects of an air bolus on primary peristalsis

Conditions: Deglutition Disorders

Summary: understanding the correlation between the transmission of a bolus from the pharynx into the proximal esophagus and activating primary esophageal peristalsis.

study procedures and analyses 1. all the study subjects are required to be without oral food or fluid intake for at least 3 hours prior to the study 2. after application of local lidocaine, the high resolution manometry (hrm) catheter will be inserted through the more patent nares and positioned such that it covers the pharynx and the esophagus. affixed to the high resolution catheter will be a single lumen, end-hole catheter (length: 90 cm, outside diameter: 1.58 mm) wherein the end hole of the tube will be secured at a fixed pharyngeal site on the hrm catheter and the other end of the tube will be connected to a stopcock so that the tube may be either open or closed to atmospheric pressure. 3. study subjects will be asked to swallow their ambient saliva ten times with the stopcock open and ten times with the stopcock closed. there is a 30 second interval between swallows. 4. following completion of the study, the manometry catheter and the single lumen tube will be removed. 5. the participant will also be instructed to resume their regular diet and activity. 6. all the pressure recordings will be analyzed by two individuals in a blinded fashion. the investigators will compare motility pressure metrics like striated esophageal muscle contractile integral, esophageal smooth muscle contractile integral, peristaltic wave velocity and esophageal clearance time to evaluate the potential differences in esophageal motility metrics when an air bolus is allowed to flow into the esophagus compared to those metrics when air is shunted out of the pharynx by a trans-nasal tube vented to the atmosphere. statistical analysis will be performed in a repeated measures technique comparing metrics with and without the pharyngeal shunt stopcock closed.

Eligibility criteria:
inclusion criteria: * male and female subject with no history or present diagnosis of pharyngo-esophageal diseases or motility disorders * age 21 to 90 years exclusion criteria: * under the age of 21 * over the age of 90 * presence of pharyngo-esophageal disease or motility disorders * pregnancy * lidocaine allergy
study of ptk787 in the treatment of patients with non-metastatic androgen independent prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate ptk787/zk 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. this study will assess the safety and tolerability of ptk787/zk 222584, and evaluate serum vascular endothelial growth factor (vegf) levels.

this is an open-label, phase ii trial of ptk787/zk 222584. patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter. response assessment: in the absence of toxicity or clinical progression, patients will remain in the study until their psa (prostate-specific antigen) has doubled from pretreatment baseline.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of prostate cancer * no evidence of metastatic disease * psa-only progression despite androgen depravation therapy and antiandrogen withdrawal * patients must maintain castrate levels of testosterone (\<50ng/ml) or continue on lhrh ( luteinizing hormone-releasing hormone) analog therapy. * ecog (eastern cooperative oncology group) performance status of 0-2 (a measure of quality of life where 0 represents asymptomatic and 5 represents death) * no prior anti-vegf therapy is allowed * no investigational or commercial agents or therapies other than lhrh agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy * age greater than or equal to 18 years * life expectancy greater than 6 months * normal organ and marrow function obtained within 14 days prior to registration * must use adequate contraception prior to study entry and for the duration of study participation. exclusion criteria: * patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration. * patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy. * uncontrolled incurrent illness * patients with a "currently active" second malignancy are not eligible. * major surgery less than or equal to 4 weeks prior to randomization * prior chemotherapy less than or equal to 3 weeks prior to registration * prior biologic or immunotherapy less than or equal to 2 weeks prior to registration * prior investigational drugs of any kind less than or equal to 4 weeks prior to registration * patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration. * patients must not be on nonsteroidal antiandrogen blockade. * patients must have no evidence of disease on bone scan or computed tomography (ct) scan of the abdomen/pelvis.

Keywords: antiangiogenesis therapy vatalanib
quality of life and rehabilitation pathway in northern norway and denmark.

Conditions: Stroke; Quality of Life

Summary: the aim of this study is to analyze and describe rehabilitation pathways of stroke patients in a region of north norway and central denmark region in relation to how patients perceive quality of life, health and functioning one year post stroke. the study will consist of 1) translate, cross-cultural adapt and validate a stroke-specific health-related questionnaire 2) describe the level of quality of life and rehabilitation pathway in the two countries 3) in-depth interviews of a smaller group of patients for a more complex understanding the study is part of a larger prospective observational multicenter-study of two patient cohorts with stroke.

anticipated: 500 patients from norway and 500 patients from denmark are included in the national stroke-register datasets, and 250 patients from each country in the questionnaire-based datasets. the questionnaire includes demographic data, the stroke-specific quality of life (ss-qol) scale, hospital anxiety and depression scale (hads), the euroqol quality of life scale (eq-5d), the euroqol visual analogue scale (eq-vas), the quality of life after brain injury, overall scale qolibri-os, modified rankin scale (mrs), and additional questions about satisfaction on treatment and rehabilitation. 5-6 patients from each country will be selected for semi-structured interviews with both priori questions and exploratory questions. the mixing of methods will balance the goals of generality and complex understanding in how patients describe their quality of life and rehabilitation-chain.

Eligibility criteria:
inclusion criteria: all patients admitted to the hospitals; unn tromso,harstad, narvik (norway) and aarhus (denmark). exclusion criteria: unverified stroke and residence outside of the studyregion.

Keywords: rehabilitation
anesthesia in prostate biopsy pain obstruction study

Conditions: Prostate Cancer

Summary: this is a multicentre randomized controlled trial in comparison of the perineal nerve block approach between the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

this trial is a prospective, multicentre, randomized controlled study in which all men plan to undergo a transperineal prostate biopsy. this study aims to determine whether the perineal nerve block approach is better than the periprostatic block in the pain control in men undergo a transperineal prostate biopsy.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years old 2. a psa level of 4 - 20 ng/ml, and/or suspicious rectal examination findings; 3. fully understand the clinical trial protocol and sign the informed consent; exclusion criteria: 1. local anesthetic allergy patients; 2. symptomatic acute or chronic inflammation of the prostate; 3. cannot tolerate prostate biopsy or has contraindication to biopsy; 4. patients judged by the investigator to be unsuitable to participate in the clinical trial;

Keywords: prostate cancer transperineal prostate biopsy perineal nerve block periprostatic block anesthesia