Kornimate/medical-research-clean huggingface dataset:
abt-378/ritonavir and efavirenz in hiv-infected patients who have taken more than one protease inhibitor in the past

Conditions: HIV Infections

Summary: the purpose of this study is to see if abt-378/ritonavir plus efavirenz is safe and effective in lowering the amount of hiv in the blood of patients who have been treated with more than 1 protease inhibitor (pi).

all patients take abt-378/ritonavir and efavirenz; there are no placebos in this study. patients take study medications for 48 weeks, during which time there will be 15 study visits. there is a possibility of a study extension after 48 weeks.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive. * have a viral load (level of hiv in the blood) of at least 1,000 copies/ml. * have been receiving stable (no changes) anti-hiv treatment that includes at least 1 pi for at least 8 weeks prior to study entry. * have received more than 1 pi for at least 12 weeks each at some time in the past. exclusion criteria patients will not be eligible for this study if they: * have had any active opportunistic (aids-related) infections within the past 30 days. * have ever received nonnucleoside reverse transcriptase inhibitors (nnrtis), such as delavirdine, nevirapine, or efavirenz. * have received certain medications. * are pregnant or breast-feeding. * abuse alcohol or drugs.

Keywords: hiv protease inhibitors ritonavir reverse transcriptase inhibitors anti-hiv agents viral load abt 378 efavirenz
head-to-head harmonization of tau tracers in alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau pet radiopharmaceuticals flortaucipir and mk-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

this is a longitudinal, multi-site, non-randomized study in which the participants will undergo flortaucipir and mk-6240 pet scans at baseline and approximately at 18-month follow-up. at each time point, participants will also have an amyloid-β pet scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. the main objectives of this study are standardizing tau pet tracers' outcomes and comparing their performance. to accomplish our objectives, the investigators propose the following specific aims: in aim 1, investigators will standardize tau pet processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize braak staging assessments between tau tracers using cross-sectional data. in aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau pet radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition. in exploratory aim 3, investigators will compare cross-sectional and longitudinal flortaucipir and mk-6240 estimates with plasma phosphorylated tau concentrations. this study will produce a benchmark dataset to develop methods for tau pet quantification and harmonization.

Eligibility criteria:
inclusion criteria: * have an informant who will be able to provide an independent evaluation of functioning. * willing and capable of undergoing repeated mr/pet imaging. * fluent in a language approved by the coordinating center. * at screening, must have no cognitive impairment, or meet criteria for single- or multiple-domain amnestic mild cognitive impairment or alzheimer's disease dementia. exclusion criteria: * inability to provide informed consent by self or by proxy. * pregnant or breastfeeding women. * have any condition or are taking any medication that could increase the risk to the participant, limit the ability to tolerate or interfere with the results of the tests and procedures (in the opinion of the investigator).

Keywords: tau pet neurofibrillary tangles alzheimer's disease tauopathies biomarkers
inflammatory response to hydroxyurea therapy in sickle cell disease

Conditions: Sickle Cell Disease

Summary: in sickle cell disease (scd), polymerisation of haemoglobin s and the resulting shape change of the red blood cells (rbc) lead to vascular occlusion and severe painful crises. permanent inflammatory state and abnormal rbc adhesion to the endothelium trigger these phenomenon. hydroxyurea (hu) is the only drug that has been shown to reduce clinical severity of scd, and this was initially attributed to the stimulation of foetal haemoglobin (hbf). however, the clinical response does not correlate consistently with the degree and time of hbf increment, suggesting that hu clinical benefits may involve other mechanisms such as the induction of natural anti-inflammatory response via the hypothalami-pituitary-adrenal axis.

plasmatic proinflammatory molecules (c-reactive protein, orosomucoid, rantes, il-6, il-8, mcp-1, il-1a, il-1b, et-1, il-4, il-10, tnfalpha, ifngamma), hormones from the hypothalami-pituitary-adrenal axis (cortisol, acth), and hypothalamic peptids (arginine vasopressin, corticotrophin-releasing hormone) will be measured from scd children treated or not with hu (20 treated children, 20 untreated children with a history of vaso-occlusive events, 20 asymptomatic children, and 20 healthy african controls).

Eligibility criteria:
inclusion criteria: 1. homozygous ss sickle cell children, aged \> 3 years, of sub-saharian africa extraction, in a steady-state of disease (free of any infectious or vaso-occlusive events for the 4 weeks prior to and 2 weeks after blood sampling, and transfusion-free for 4 months prior to blood sampling), taken no drug except penicillin-v, folate or iron supplementation, hydroxyurea, divided into three groups : * children treated with hydroxyurea 20-25 mg/kg/day since at least 3 months with clinical efficacy on vaso-occlusive events * untreated children with major vaso-occlusive events * children \> 5 year-old without a history of vaso-occlusive events signed informed consent obtained from the subjects (if possible) and their parents 2. controls : heterozygous as parents or siblings of the patients, and aa siblings or healthy african unrelated subjects, aged \> 3 years, taken no drug on the day of blood sampling. signed informed consent obtained from the subjects (if possible) and their parents exclusion criteria: * children in a acute-phase of the disease * parent's or patient's refusal * taking any drug except penicillin-v, folate or iron supplementation, hydroxyurea * un-healthy control or taking drug

Keywords: sickle cell disease, hydroxyurea, inflammation
effectiveness of rosuvastatin at preventing the progression of atherosclerosis in hiv positive patients

Conditions: Atherosclerosis; HIV Infections

Summary: rosuvastatin is a drug used to lower cholesterol, which also has other cardiovascular benefits. the goal of this project is to determine if rosuvastatin is effective at slowing the development of heart disease in people with hiv. we expect that after 2 years of treatment people treated with rosuvastatin will show significantly better results than people treated with a placebo.

hiv+ patients with at least one cardiovascular risk factor will be randomized to either rosuvastatin 10mg/day or placebo for a period of 96 weeks. b-mode carotid ultrasound will assess the primary outcome measure of average total thickness (a composite measurement of intima media thickness and total plaque area) at baseline, 24, 48, 72 and 96 weeks. we hypothesize that rosuvastatin will be significantly more effective with respect to inhibition of change in average total thickness between baseline and 96 weeks compared to placebo.

Eligibility criteria:
inclusion criteria: * hiv positive, at least one cardiovascular disease risk factor exclusion criteria: * diabetes * previous vascular disease * muscular disease * current use of other lipid lowering therapy

Keywords: statins intima media thickness plaque area
evaluating effect of the study drug praluent (alirocumab) on neurocognitive function when compared to placebo

Conditions: Hypercholesterolemia

Summary: the main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of praluent.


Eligibility criteria:
key inclusion criteria: * men and women ≥ age 40 years and ≤ age 85 years * patients with heterozygous familial hypercholesterolemia (hefh) or with non-familial hypercholesterolemia (non-fh) patients at high or very high cardiovascular risk * patients with history of coronary heart disease (chd) not having adequate control of their hypercholesterolemia with ldl-c ≥70 mg/dl, or all other patients with ldl-c ≥100 mg/dl and be on maximally-tolerated dose of statin (unless they are statin-intolerant) * patients must have successfully completed the motor screening task * patients must be willing and able to comply with clinic visits and study related procedures * patients must provide signed informed consent key exclusion criteria: * patients with known alzheimer's disease or other dementia, schizophrenia, bipolar disorder, severe depression, cognitive impairment, or patients with a sleep disorder requiring daily pharmacological treatment * recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease * certain laboratory findings obtained during the screening visit as defined in the protocol * any condition or situation, including other significant mental or neurological disorders that, in the investigator's opinion, may confound the study results, or may interfere significantly with the patient's participation in the study * pregnant or breastfeeding women * a positive human immunodeficiency virus (hiv) test note: other protocol defined inclusion/exclusion criteria apply

Keywords: hyperlipidemias dyslipidemias lipid metabolism disorders
phase i comparative bioavailability study

Conditions: Solid Tumors

Summary: the purpose of this phase i randomised cross over study is to determine and compare the bioavailability of two different oral formulations of azd2281 in advanced solid tumour cancer patients


Eligibility criteria:
inclusion criteria: * histologically confirmed malignant advanced solid tumour, which is refractory to standard therapies (except group 8 patients who must not be platinum refractory) or for which no suitable effective standard therapy exists * patients must have adequate organ and bone marrow function measured within 7 days prior to administration of study treatment * female patients must have evidence of non-child bearing status: negative urine or serum pregnancy test within 7 days of study treatment for women of child bearing, or postmenopausal status exclusion criteria: * patients receiving chemotherapy, radiotherapy (except for palliative reasons) or any other anti-cancer therapy within 4 weeks of the last dose prior to study entry. patients may continue the use of biphosphonates for bone metastases and corticosteroids * patients with symptomatic uncontrolled brain metastases * major surgery within 2 weeks of starting study and patients must have recovered from any effects of any major surgery * patients who are platinum refractory (group 8 only) * patients with myelodysplastic syndrome/acute myeloid leukaemia (group 8 only).

Keywords: poly (adp ribose) polymerases homologous recombination deficiency (hrd) advanced solid tumours
clinical validation of the prognostic value of the prts on prostate cancer patients

Conditions: Prostate Cancer

Summary: prostate cancer is the most common type of cancer among men in many countries. however current clinical tools have limited prediction accuracy to choose the optimal treatment for the individual patient, as prostate cancer risk assessment is a critical aspect of treatment decision-making. a substantial proportion of patients are undergoing over-treatment such as radical treatment, which is often associated with negative physical and psychological side effects, dramatically affecting quality of life in a negative way. moreover, the patients that are under-treated will face higher cancer mortality risks, which brings more concerns for patients and doctors. prostatype composes a one-step 4-plex quantitative reverse transcription polymerase chain reaction kit, a database based on authenic patients information and a score system (p-score), intended to measure gene expression levels of three biomarkers: igfbp3, f3 and vgll3. genetic values combined with clinical parameters in the cpma and p-score are aiming to estimate the aggressiveness of prostate tumor for a newly diagnosed prostate cancer patient. this is a single-center, retrospective, blinded validation study aim to investigate the prognostic performance of the prostatype test system.


Eligibility criteria:
inclusion criteria: * non-metastatic prostate adenocarcinoma confirmed by histopathology after taking core needle biopsy * regular visits, treatment and laboratory tests were conducted in the past * there is biopsy materials at the time of diagnosis (without staining ffpe) * the total area of tumor tissue shall be 25-30 mm2, and the proportion of tumor cells after tumor cell enrichment is at least 50% * complete records of relevant clinical follow-up information exclusion criteria: * biopsy tissue is not available, or ffpe does not meet the screening requirements of study samples * relevent clinical parameters of the patients are not available * treatment methods are not available * age of diagnosis \< 50 years * age of diagnosis \> 100 years * total tumor length \< 2 mm * the patient died of an accident, homicide or suicide
bosutinib in subjects with renal impairment

Conditions: Renal Disease, End-Stage; Renal Insufficiency, Chronic; Renal Insufficiency, Acute

Summary: this is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers. in stage 1, only subjects with severe renal impairment and subjects with normal renal function will be enrolled. subjects with mild and moderate renal impairment will be enrolled in stage 2 if the results from stage 1 suggest a substantial difference in pk profiles between subjects with severe renal impairment and subjects with normal renal function.


Eligibility criteria:
inclusion criteria: * males and females, aged 18 to 65. * adequate hepatic function. * documented creatinine clearance by cockroft-gault formula indicative of the respective level of renal impairment: severe renal impairment (crcl \ 80 ml/min/1.73m2). exclusion criteria: * use of any investigational drug or biologic within 4 weeks prior to the screening visit of during the screening period. * ongoing treatment with digoxin or strong cyp3a4 inhibitors or inducers. * uncontrolled hypertension (for renally impaired subjects only).

Keywords: renal impairment healthy volunteers
azd2115 multiple ascending dose study

Conditions: Healthy

Summary: this study will investigate the safety and tolerability of azd2115 following administration of multiple ascending doses.

a phase i, single centre, double-blind, randomised, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending inhaled doses of azd2115 in healthy male subjects.

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture * male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of first administration of the azd2115 until 3 months after administration and must not donate sperm for 3 months after follow-up * have a body mass index (bmi) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg exclusion criteria: * abnormal vital signs, after 10 minutes supine rest, defined as any of the following: * systolic bp \>140 mmhg * diastolic bp \>90 mmhg * heart rate \ 85 bpm * prolonged qtcf \>450 ms or shortened qtcf \<340 ms or family history of long qt syndrome * serum potassium concentration of \< 3.80 mmol/l on admission (day -1) * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with the same class to azd2115 or to excipients * history or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Keywords: safety tolerability healthy inhaled
comparing parenteral nutrition vs best supportive nutritional care in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: a randomised multicentre clinical phase iiib trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm a) or best supportive nutritional care (study arm b).

pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. therefore, one of the most important therapeutic targets is the improvement of quality of life. supplementation with parenteral nutrition improves quality of life in subjects with advanced cancer cachexia. the european society of parenteral and enteral nutrition recommend pn only for malnourished subjects but does not reflect situation in cancer cachexia patients at present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for. within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?

Eligibility criteria:
inclusion criteria: * written informed consent * histological confirmed advanced pancreatic adenocarcinoma * at least one previous chemotherapy (gemcitabine-based) * ≥ 18 years old * body weight ≥ 50 and ≤ 95 kg * bmi ≥ 19 * negative pregnancy test (females of childbearing potential) * willingness to perform double-barrier contraception during study * expected life expectancy \> 3 months exclusion criteria: * major surgery \< 4 weeks prior to enrollment * weight loss \> 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days * pini-index \> 10 * pregnancy or breastfeeding * \> 4 weeks of parenteral nutrition within the last 6 months * parenteral nutrition \< 4 weeks prior to enrollment * vulnerable populations (e.g. subjects incapable of giving consent personally) * subject selection conflicts with warnings, precautions and contraindications stated for any investigational product

Keywords: pancreatic cancer progression under chemotherapy parenteral nutrition pancreatic adenocarcinoma chemotherapy
dna analysis in influencing response to rituximab in samples from patients with follicular lymphoma treated on ecog-e4402

Conditions: Lymphoma

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research study is studying dna isolated from blood samples to see how well it influences response to rituximab in patients with follicular lymphoma treated on clinical trial ecog-e4402.

objectives: * to test the influence of killer immunoglobulin-like receptor (kir) and human lymphocyte antigen (hla) genotype on response to anti-cd20 antibody lymphoma immunotherapy. outline: dna samples are analyzed for killer immunoglobulin-like receptor (kir) and human lymphocyte antigen (hla) genotyping with sequence-specific primers (ssp) by real-time pcr. kir and hla typing are analyzed according to kir-hla matched vs mismatched, kir b haplotype content, and the number of inhibitory kir-hla pairs. results are then correlated to each patient's overall response and duration of response to rituximab.

Eligibility criteria:
disease characteristics: * patients diagnosed with follicular lymphoma enrolled on ecog-e4402 * treated with single-agent rituximab; the trial compared two different rituximab-dosing strategies - maintenance vs retreatment as needed * available germline dna samples isolated from peripheral blood as well as clinical evaluation of disease status prior to and at initial response to the therapy patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma
healthy eating education for latinos

Conditions: Diet, Healthy; Diet Habit; Obesity; Blood Pressure; Psychological

Summary: this intervention aims to evaluate the efficacy of a pilot educational intervention with deep-structure cultural tailoring for latino ethnic groups on diet quality compared to general, surface-level healthy-eating messages.


Eligibility criteria:
inclusion criteria: * aged 25-65 y/o * self-reported hispanic/latino heritage * able to understand and answer questions in spanish or english * living in the boston, ma metro area for the past 6 months and not planning to move in the next 6 months * has a cellphone with the capacity of receiving text messages and gives consent for the study to text this number as part of the intervention exclusion criteria: * younger than 25y or older than 65y * not hispanic/latino heritage * has condition or impairment that affects mental, cognitive, or memory abilities; such as alzheimer's disease or stroke * has been diagnosed with cancer, diabetes (type 1 or 2), heart condition, major stomach condition (examples: coronary heart disease, heart attack, stroke or stroke, allergies, or severe diet restrictions) * does not understand spanish or english * pregnant * under the care of an institution * living in another state outside of massachusetts or planning to move in less than 6 months * no cellphone with text capabilities (or cannot be used to receive texts from the study)
study to compare the efficacy and safety between levocetirizine and loratadine for chronic idiopathic urticaria

Conditions: Urticaria

Summary: study to compare the efficacy and safety between levocetirizine and loratadine for chronic idiopathic urticaria.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 60 years old (inclusive * having chronic idiopathic urticaria * at least 6-weeks history of ciu, had at least 3 days of wheals presence/week * moderate to severe ciu defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms ciu score ≥ 2 at randomization exclusion criteria: * asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn * atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids * urticaria caused by physical factors or other known factors * cholinergic urticaria * had urticaria due to other systemic disorders * were on antihistamine drug currently

Keywords: levocetirizine dihydrochloride xyzal tablets