Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of two hiv protease inhibitors in patients

Conditions: HIV Infection

Summary: the objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

thirty patients with hiv infection will be enrolled in this open-label, parallel arm pharmacokinetic study. subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. the safety of these agents in combination will also be explored.

Eligibility criteria:
inclusion criteria: * hiv-seropositive * currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside rt inhibitors or are antiretroviral treatment-naïve * if female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study exclusion criteria: * hiv-1 rna \> 400 copies/ml if currently receiving antiretroviral therapy * concurrent use of cyp450 inhibitors or inducers * concurrent use of p-glycoprotein substrates, inhibitors, or inducers * concurrent use of medications known to interact with ritonavir or atazanavir * presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics * presence of conduction abnormalities on electrocardiogram * women who are pregnant or breastfeeding * laboratory abnormalities at baseline: * aminotransferases \> 3x uln * serum bilirubin \> 5x uln * serum creatinine \> 1.5x uln * hemoglobin concentration \< 8.0 g/dl * absolute neutrophil count \< 800 cells/μl * platelet count \< 50,000 cells/μl

Keywords: antiretroviral therapy protease inhibitors drug interactions hiv infection acquired immunodeficiency syndrome treatment experienced
oral anticoagulants in diabetic and nondiabetic patients with non-valvular atrial fibrillation (organon)

Conditions: Diabetes

Summary: diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin k oral anticoagulants and with vitamin k oral anticoagulants.

parameters evaluated: * anthropometric indices * glycated haemoglobin, basal and postprandial glycemia * lipid profile * small and dense ldl; oxidized ldl * i troponin * red and white cells count; platelets count * creatinin, transaminases, iron * fibrinogen, d-dimer, anti-thrombin iii * hs-crp, metalloproteinases 2 and 9 * incidence of bleeding

Eligibility criteria:
inclusion criteria: * non-valvular atrial fibrillation * nondiabetic patients * type 1 and 2 diabetic patients exclusion criteria: * patients with cancer * patients with chronic inflammation diseases

Keywords: diabetic patients nondiabetic patients
effects of ground level gait training with body weight support (bws) and functional electrical stimulation (fes)

Conditions: Hemiparesis; Stroke

Summary: the aim of this study was to investigate the effects of gait training on ground level, combining bws and fes in people following chronic stroke.

the body weight support system (bws) associated to a treadmill as well as to a functional electrical stimulation (fes) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.

Eligibility criteria:
inclusion criteria: * elapsed time since stroke longer than 6 months * spasticity classified under level 3 according to the modified ashworth scale * the ability to walk classified at levels 2, 3 or 4 according to the functional ambulation category exclusion criteria: * heart failure, angina pectoris, arrhythmias and other cardiovascular diseases * severe lung disease * orthopedic disorders * cognitive deficits

Keywords: kinematic hemiparesis gait body weight support functional electrical stimulation
healthy eating better breathing: a feeding study in patients with asthma

Conditions: Asthma

Summary: the study is a randomized, crossover meal-replacement pilot intervention to determine feasibility of a larger scale dietary trial in asthma and gather preliminary evidence for the impact of a healthy diet on asthma outcomes. participants with doctor-diagnosed asthma were randomized to crossover trial of a 4-week dietary intervention or usual diet with a 4-week washout period. during the dietary intervention, all meals and snacks were provided by the study.

the objective of the study is to demonstrate feasibility of a randomized, controlled clinical trial of a dietary intervention in a population of adults with asthma and to determine sample size estimates for a larger, more definitive trial aimed at improving asthma clinical outcomes and improving markers of inflammation and oxidative stress. the study uses a feeding trial design comprised of a 4 week dietary intervention in which all meals are provided to study participants and a 4 week control diet comprised of usual dietary intake. participants are randomized to the intervention or control diet and then cross over to the alternate assignment after a 4 week washout period.

Eligibility criteria:
inclusion criteria: * ages 18-50, self-reported physician diagnosis and treatment for asthma within the 12 months prior to enrollment, stable asthma defined as no asthma exacerbation (emergency department visit, systemic steroid treatment, or urgent care visit) or respiratory infection in the 4 weeks prior to enrollment. exclusion criteria: * active smokers,pregnant or breastfeeding, using systemic corticosteroids or warfarin, had another major pulmonary diagnosis or significant systemic illness, reported excessive alcohol consumption (over 14 drinks per week or six or more drinks on one or more occasions per week), reported food allergy, or weighed over 350 pounds or changed weight by over ten pounds in the two months prior to screening
adjusting to chronic conditions using education support and skills

Conditions: Anxiety; Depression

Summary: medically ill patients with congestive heart failure (chf) and chronic obstructive pulmonary disease (copd) are at increased risk for developing symptoms of anxiety and depression and are among the least frequent users of mental health services and treatments. to address the needs of chronically ill patients, we created a time-limited psychosocial intervention to maximize treatment benefits and improve the efficiency and ability of mental health care practitioners to provide services within medical care settings. this study is separated into two randomized study groups. the first group of participants will receive the access intervention immediately. the second group of participants will be followed for a period of 6 months. after a period of 6 months, those who continue to have symptoms of depression and/or anxiety will be offered the access intervention.


Eligibility criteria:
inclusion criteria: 1. age 18+; 2. confirmation of chf or copd diagnosis according to medical chart review; 3. ongoing symptoms of functional limitations due to chf (nyha classification of ii , iii, or iv as obtained by telephone interview) or copd (score of 3 or greater on the medical research council dyspnoea scale \[mrc\] as obtained by telephone interview); 4. eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. clinical cutoff scores for depression will be based on the beck depression inventory - second edition (scores of 14 or more) while anxiety cutoffs will be determined using the state-trait anxiety inventory - trait subscale (score of 40 or greater); 5. eligible patients will be english-speaking, as this intervention has not yet been translated to any other language. exclusion criteria: 1. history of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from standardized structured clinical interview); 2. nyha class i, or mrc levels 1 and 2. class 1 chf patients and level 1 and 2 copd patients (by definition) will have no significantly limiting chf or copd symptoms. this information will be obtained through patient self-report of chf and copd symptoms; 3. mental status examination score in the cognitively impaired range on an established 6-item screen; 4. inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning); 5. non-english speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
pleural effusions after cardiac surgery

Conditions: Pleura; Effusion

Summary: pleural effusions occur commonly in patients recovering from cardiac surgery, however, the impact on outcomes is not well characterized. the purpose of this study is to characterize the outcomes of cardiac surgery patients with pleural effusions. all patients undergoing cardiac surgery between 2006 and 2019 were included in this observational, cross-sectional analysis using propensity matching.

pleural effusions are common in patients recovering from cardiac surgery. symptomatic patients with pleural effusions complain of shortness of breath, cough, chest pain and are more hypoxic and tachypneic. clinically significant effusions can slow recovery in the hospital and beyond, and are a critical source of hospital readmissions after discharge. it is not well characterized how this impacts hospital outcomes. further it is unknown if the effusions themselves are associated with impaired outcomes, or if pleural effusions simply arise in more complicated, older patients, thus suggesting the impaired outcomes are the result of coexisting morbidities. to better understand the impact of this complication and to address the question mentioned before, this study was carried out to determine the clinical and economic outcomes of pleural effusions in propensity-matched patients during early recovery from cardiac surgery. to compare patient groups with and without pleural effusion, the following baseline characteristics were used: e.g. age, sex, body-mass-index, priority of surgery, type of surgery, duration of surgery, apache ii score of patients on admission in the icu.

Eligibility criteria:
inclusion criteria: * in-patients of the charité universitätsmedizin berlin * at least 18 years old * female or male sex * cardiosurgical intervention (ops 5.35 and 5.36) between 01/06 and 12/19 * post-operative monitoring in the intensive care unit exclusion criteria: * previous cardiosurgical interventions during the same hospital stay * incomplete documentation.
methylation effects of cov-19 infection and vaccinations

Conditions: Covid19

Summary: this is a retrospective non-randomized clinical study of 60 patients total to assess the effects of sars-cov-2 infection and the sars-cov-2 vaccination. this study will have 2 arms evaluating the epigenomes of patients pre and post-exposure to one of the interventions. the first arm of the study will analyze 40 patients' epigenomes whose dna methylation was examined pre and post sars-cov-2 infection. the second arm of this study is analyzing 20 patients' epigenomes whose dna methylation was examined pre and post-injection of the sars-cov-2 vaccine.


Eligibility criteria:
inclusion criteria: * subjects that are healthy individuals and of any sex, ethnicity, and anyone above the age of 18 years old.
addressing barriers to physical activity in inner-city schoolchildren with asthma

Conditions: Asthma; Children; Physical Activity

Summary: this proposal will address the existent gaps in the literature by identifying barriers and facilitators to participation in physical activity in inner-city minority elementary schoolchildren with asthma, more that half of whom are also overweight; developing and refining a school-based intervention in partnership with the community to improve physical activity; and conducting a pilot randomized controlled trial of the intervention to determine feasibility and obtain preliminary data for a future large-scale trial.

four schools have been recruited for pilot wait-listed cluster randomized clinical trial to determine feasibility for a large-scaled trial. community-based participatory research approach was utilized to develop an intervention that will be delivered to two schools. two control schools will receive intervention during year 2 of the study.

Eligibility criteria:
inclusion criteria: * children with active asthma attending 2nd-4th grades in bronx exclusion criteria: * other medical conditions preventing participation in physical activity

Keywords: asthma children physical activity school
cs-7017 in combination with carboplatin/paclitaxel in subjects with stage iiib/iv non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the primary objectives of this study are to evaluate the safety and tolerability of cs-7017 administered orally twice a day in combination with carboplatin and paclitaxel, and to assess the pharmacokinetics of cs-7017 in combination with carboplatin and paclitaxel.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed unresectable locally advanced or metastatic (stage iiib or iv) non-small cell lung cancer (nsclc) * no prior systemic therapy for nsclc * male or female ≥ 18 years of age * anticipation of more than 3 months survival * eastern cooperative oncology group performance status (ecog ps) ≤ 1 * adequate organ and bone marrow function exclusion criteria: * anticipation of need for a major surgical procedure or radiation therapy during the study * remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment * history of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, new york heart association (nyha) class ≥i congestive heart failure (chf), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe chronic-obstructive pulmonary disease (copd) or asthma) * severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy * subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms) * subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis b surface antigen (hbs)- or hepatitis c virus (hcv)- or human immunodeficiency virus (hiv)- positive and receiving antiretroviral therapy * subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction * diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications * treatment with thiazolidinediones (tzds) within 4 weeks prior to start of study treatment * history of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin * poorly-controlled blood pressure as judged by the investigator

Keywords: ppar gamma agonist tumor cancer antineoplastic agent respiratory tract neoplasms carboplatin paclitaxel neoplasms
evaluation of oral screen training with iqoro as treatment for dysphagia after stroke

Conditions: Stroke; Dysphagia

Summary: purpose the purpose of the study is to evaluate if training with oral screen iqoro® improves swallowing in patients with dysphagia after stroke. method inpatient from a stroke unit in sweden who have been assessed with fiberoptic endoscopic evaluation of swallowing(fees) which proves swallowing difficulties (dysphagia) were recruited. the participants were randomise to control- or intervention group. both groups received usual care. the intervention group were instructed to oral screen (iqoro®) training for 13 weeks. follow up with fees was made 13 weeks post of recruitment. the assess with fees was recorded and the recordings are going to be analyzed afterwards to compare the swallowing ability between baseline and follow up in group and between group.


Eligibility criteria:
inclusion criteria: * inpatient at stroke unit at vrinnevisjukhuset ward 1, due to stroke. * patient assessed to have dysphagia (score ≥1 on one of the studied parameters)according to fees. * patient who is able to handle iqoro® according to instructions, independently or with support of assistance from relatives or staff. exclusion criteria: * patients with dysphagia of a cause other than stroke. * patient with impaired cognitive skill, motor and / or language ability that prevents the possibility of performing training with iqoro®, despite possible support from assistance from relatives or staff. * patient who wishes training with the muppy oral screen® related to saliva leakage.
the study to compare the treatment of angioplasty and stents in sfa occlusions.

Conditions: Arterial Occlusive Diseases

Summary: the main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (sfa) occlusions as compared to angioplasty only.

this is a multi-center prospective, randomized, two-arm study evaluating performance of the cordis smart™ nitinol self-expanding stent as compared to balloon angioplasty only. patients will be randomized on a 1:1 basis. it is anticipated that a total of 120 patients will be entered into the study. the study population will consist of symptomatic peripheral vascular disease patients with sfa occlusions. the disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. the occlusions must not extend beyond the proximal popliteal artery. for the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. the distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. trial participants will be randomized to the smart™ nitinol self-expanding stent or to balloon angioplasty only. patients will be followed for twelve months post-procedure. study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure. this study will be conducted at 8 investigational sites in the netherlands.

Eligibility criteria:
inclusion criteria: 1. symptomatic leg ischemia by rutherford classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months 2. the patient should be suitable for percutaneous transluminal angioplasty (pta) and also for stenting. exclusion criteria: 1. poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. 2. patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded. 3. gangrene in index limb (rutherford category 6).

Keywords: peripheral artery occlusive disease
study of surgical mesh for inguinal hernia repair

Conditions: Hernia, Inguinal

Summary: the purpose of this study is to assess the early outcomes when using the biomerix revive™ as a tension-free onlay patch, lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.


Eligibility criteria:
inclusion criteria: * male ≥19 years old * symptomatic and palpable inguinal hernia * candidate for unilateral, primary, open inguinal hernia repair using the lichtenstein technique * will comply with required follow-up study visits * willing and able to provide written informed consent exclusion criteria: * bmi ≥35 * life expectancy of \<3 years * strangulated hernia * urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery) * active abdominal surgical condition such as bowel obstruction or perforation * local or systemic infection or peritonitis * known disease that impairs wound healing * anti-platelet therapy (other than aspirin) for \>7 days preceding the surgical procedure * previous ipsilateral groin incision * receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area * uncontrolled insulin-dependent diabetic with hgb1ac greater than 8 * advanced cirrhosis with child-turcott class of c or higher * severe copd requiring home oxygen * diagnosed with chronic pain syndrome or is undergoing treatment for pain management * candidate for another major surgical procedure with the inguinal hernia repair * enrolled in another investigational study that may confound the results of this study * known drug abuser * on anti-psychotic medications * worker's compensation case

Keywords: surgical mesh
evaluation of atorvastatin treatment on carotid plaque.

Conditions: Cardiovascular Diseases

Summary: the purpose of the study is to evaluate the effect of 18 months treatment with atorvastatin 80mg or atorvastatin 10mg on the carotid vessel plaque morphology, in particular, the effect on evident necrotic lipid rich core of the plaque in patients.


Eligibility criteria:
inclusion criteria: * subjects with measurable carotid plaque with lipid and are eligible for statin therapy. exclusion criteria: * subjects at higher risk for cardiovascular disease with a screen ldl-cholesterol greater than 120 mg/dl, * subjects currently on high dose statin, and * subjects with contraindications for mri or statin therapy.

Keywords: hypercholesterolemia
vasoconstrictors as alternatives to albumin after large-volume paracentesis (lvp) in cirrhosis

Conditions: Ascites; Cirrhosis

Summary: this clinical trial compares a combination of two drugs that constrict blood vessels (octreotide lar and midodrine) to albumin after large volume paracentesis. subjects have cirrhosis and ascites.

this prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. the treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Eligibility criteria:
inclusion criteria: * cirrhosis of any etiology * age 18-80 years * moderate to severe ascites exclusion criteria: * no or small ascites * severe hepatic hydrothorax * recent gi (gastrointestinal) hemorrhage * active bacterial infection * cardiac failure * organic renal disease * hepatocellular carcinoma * severe comorbidity (advanced neoplasia) * serum creatinine \> 3 mg/dl * pregnancy

Keywords: albumin ascites paracentesis