Kornimate/medical-research-clean huggingface dataset:
sebbin integrity round implants

Conditions: Complication; Prosthesis Durability

Summary: this study is part of the clinical evaluation of sebbin silicone gel-filled integrity implants, included in the technical file of the device. the aim of the study is to gather additional data about the safety and effectiveness of the device.


Eligibility criteria:
inclusion criteria: * the patient is at least 18-year-old. * the patient is a woman. * the patient was prescribed with a surgery for a breast augmentation or reconstruction, unilaterally or bilaterally with silicone gel-filled sebbin integrity mammary implants. * the patient has been informed of the study, has read the patient information letter and provided consent in writing. exclusion criteria: * the patient is pregnant or breastfeeding. * the patient has silicone implants somewhere else than in the breast. * the patient was diagnosed with one of the following pathologies: * systemic lupus erythematous, sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease. * rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease. * arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease. * history of implant-associated anaplastic large cell lymphoma (bia-alcl). * symptomatic autoimmune disease. * the patient has a pathology that could delay healing (does not apply to the reconstruction group). * the patient has cancer (does not apply to the reconstruction group). * the patient has anatomical or physiological conditions that could lead to postoperative complications.
adherence and clinical correlates in persons with hiv on taf

Conditions: Hiv

Summary: this is an observational, 48-week, prospective study of pwh treated with taf in which the investigators will compare tfv-dp concentrations in dbs in virologically suppressed vs. non-suppressed individuals and evaluate the utility of tfv-dp in dbs to predict future viremia. to accomplish this, the investigators will approach pwh currently taking taf (which is being prescribed by a primary care physician) and who present to the clinic for regular hiv care and hiv vl assessment. participants will complete up to 3 visits (at least 2 weeks apart) during the 48-week study follow-up period.

antiretroviral (arv) drug exposure is directly linked to individual host factors, including age, weight, diet, and genetics. however, the main factor influencing long-term drug exposure is drug adherence. adherence is a strong predictor of hiv treatment outcomes, but measuring adherence is difficult due to the inaccuracy of self-reporting and other commonly used monitoring methods. there is no gold-standard measure to monitor arv exposure and adherence that has been implemented in clinical practice. tenofovir diphosphate (tfv-dp), the phosphorylated anabolite of tenofovir (tfv), has distinct pharmacological characteristics that make it an ideal candidate for drug adherence and exposure monitoring. the long half-life of tfv-dp (\~17 days) in red blood cells (rbc), which are abundant in dried blood spots (dbs) are properties that make it well suited for monitoring average tfv exposure over time both from tenofovir disoproxil fumarate (tdf) and tenofovir alafenamide (taf). tfv-dp in dbs in persons with hiv (pwh) on tdf has been associated with viral suppression and is predictive of future viremia, even in patient who are virologically-suppressed. however, data on tfv-dp in dbs from taf are lacking. to address this gap, this study will assess the association of tfv-dp in dbs from pwh on taf with clinically-relevant virologic outcomes.

Eligibility criteria:
inclusion criteria: 1. females or males with hiv (≥18 years), able to give informed consent and comply with study procedures who are having a blood draw as part of their regular clinical care. 2. being prescribed taf-based art \>= 3 months. exclusion criteria: 1. for females, active pregnancy or intent to become pregnant.

Keywords: hiv/aids adherence taf dried blood spots
study to determine the effects of doses of relacatib on the metabolism of acetaminophen, ibuprofen and atorvastatin

Conditions: Osteoarthritis

Summary: relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly other bone disorders. recent results suggest that relacatib interacts with the way our bodies metabolise drugs and so some drugs which are commonly prescribed to the intended target patient population could be affected by giving relacatib at the same time. the purpose of this study is to evaluate the effect of repeat dose administration of relacatib on the way subjects bodies metabolise three commonly prescribed medications in the osteoarthritis population: ibuprofen, acetaminophen, and atorvastatin.


Eligibility criteria:
inclusion criteria: * healthy * postmenopausal * body weight \> 50 kg * body mass index (bmi) between 19 and 30 * the subject is willing and able to give a signed and dated written informed consent prior to admission to the study * the subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. exclusion criteria: * subjects with known morphea or sclerodermia * subjects with a history of myocardial infarction. * subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination. * subjects with history of hypertension or systolic blood pressure * subjects with history of diabetes * history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening. * history of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening. * positive urine drug screen including alcohol (or alcohol breath test) at screening. * positive for hiv, hepatitis b virus or hepatitis c virus. * donation of blood in excess of 500 ml within 56 days prior to dosing * history of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof. * treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication. * subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.

Keywords: osteoarthritis postmenopausal osteoporosis
effects of mindfulness on ptsd

Conditions: Mindfulness; Stress Disorder, Posttraumatic

Summary: the purpose of this randomized control trial is to examine the effects of a mindfulness-based stress reduction (mbsr) program on women with posttraumatic stress disorder related to intimate partner violence.

posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. mindfulness-based stress reduction (mbsr) holds promise for treating symptoms of trauma and ptsd as evidence suggests it targets these domains. the central hypothesis is that mbsr, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve ptsd symptoms. we will examine changes in stress capacity and ptsd symptom severity among women survivors of intimate partner violence with ptsd after participation in an mbsr program.

Eligibility criteria:
inclusion criteria: * english-speaking * women * 18-64 years of age * victim of ipv * meet diagnostic criteria for ptsd * no or stable use of medications (including, for example, beta blockers). exclusion criteria: * there is suspicion or evidence of dementia or cognitive impairment (mini-mental state examination score \< 24) or inability to provide informed consent * they have ever been a perpetrator of ipv * history of schizophrenia or bipolar i disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months * active substance dependence or in remission \< 3 months * cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction) * the age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and pns tone.

Keywords: mindfulness posttraumatic stress disorder
wise-2b brain study (weight loss intervention surgical effects on brain function)

Conditions: Diabetes; Weight Loss

Summary: the goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. this study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tvns) intervention initiated 30 days post-surgery improves brain function and thinking. the study does not cover any costs associated with bariatric surgery.

there will be one group of study participants. the group will (independently of this research study) have weight loss surgery to help them with weight loss. all research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. they will also undergo a non-invasive transcutaneous vagal nerve stimulation (tvns) intervention days post-surgery, for 30 days at home with the device that is provided. the group will have an mri brain scan at each time-point to study the changes in the structure and function of the brain tissue. blood tests will be done to measure the sugar levels in the blood, and other proteins that may act as markers for disease.

Eligibility criteria:
inclusion criteria: * between age: 20-75 yrs, english speaking, physically mobile * body mass index (bmi) \>35 kg before surgery * compatible of mri scanning * willing to give a small blood sample * capable of providing informed consent exclusion criteria: * prior or current neurological disorder * major psychiatric disturbance * unstable medical conditions (cancer) * mri contraindications (claustrophobia, metal implants, waist/torso circumference)

Keywords: weight loss and brain function effects of bariatric surgery on brain function reduced glucose insulin changes and brain function tvns intervention post-surgery
aspirin responsiveness in women with coronary artery disease

Conditions: CAD

Summary: the purpose of this study is to measure the percentage of women with known coronary artery disease (cad) who are hyporesponsive to low dose (81 mg) aspirin.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent * women at least 45 years old of any race * taking 81 mg aspirin daily, for at least one month * diagnosed with known or suspected cad with at least one of the following: angiographic evidence of at least one lesion \> 50% stenosis, history of significant elevation of biomarker troponin or ck-mb, or history of ecg changes in at least 2 contiguous leads characterized by either new st depression \> 0.1 mv or transient (\ 0.1 mv, coronary artery revascularization either by pci or cabg exclusion criteria: * \ 85 years of age * clinically unstable: hypotension defined as sustained systolic blood pressure of \ 30 seconds or associated with symptoms and no icd, untreated complete heart block or untreated high grade secondary heart block * pregnant, planning to become pregnant, or breastfeeding * alcohol abuse or illicit drug abuse * allergy or intolerance to salicylates and/or excipients including a history of and/or active gi bleed * use of nsaids within seven days or planned regular use during the study * taking hrt or oral contraceptives within the past 30 days or planned use during study * use of heparin, warfarin, adp inhibitors (clopidogrel, prasugrel, or ticlopidine), or glycoprotein iib/iia inhibitors within previous 96 hours or planned use during the study * use or planned use of any other medications known to interfere with aa-induced platelet function * currently participating in another investigational drug or device study * survival less than six months

Keywords: aspirin resistance hyporesponsive cad women
study of a single dose of prs-060 administered by oral inhalation or iv infusion in healthy subjects

Conditions: Healthy Subjects

Summary: a dose escalating study of prs-060 administered by oral inhalation or iv infusion in healthy subjects

prs-060 is a new drug being developed for treatment of asthma. the main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of prs-060 in healthy subjects

Eligibility criteria:
inclusion criteria: * healthy male and female of non-childbearing potential (post-menopausal or surgically sterilized) subjects of 18 to 55 years of age * body mass index (bmi) of 18-35 * subjects who are non-smokers or ex-smokers who have not smoked in the last 6 months (determined by urine cotinine \< 500 ng/ml, at screening visit). exclusion criteria: * history or clinical manifestations of any clinically significant medical disorder that, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect the subject's ability to participate in the study. * a history of drug or alcohol abuse. * history of, or known significant infection including hepatitis a, b, or c, human immunodeficiency virus (hiv), tuberculosis (i.e., positive result for interferon (inf)-y release assay (igra), quantiferon tb-gold), that may put the subject at risk during participation in the study. * any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of day 1 or planned inpatient surgery or hospitalization during the study period. * subjects with any history of malignancy or neoplastic disease. * any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the principal investigator. * subjects who have received live or attenuated vaccine in the 4 weeks prior to day 1 subjects with a disease history suggesting abnormal immune function * inability to communicate well with the investigator (i.e. language problem, poor mental development or impaired cerebral function) * participation in any clinical study for a new chemical entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half- lives, whichever is the longer, before the first dose of study drug. * donation of 450 ml or more blood within the previous 12 weeks * women who are pregnant * males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to double methods of contraception with at least one barrier from day 1 for 90 days.

Keywords: asthma anticalin prs-060 healthy volunteers pieris il-4 receptor alpha il-13 il-4
s9811 hydroxyurea in treating patients with unresectable benign meningioma

Conditions: Adult Meningioma

Summary: rationale: drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

objectives: * determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea. * assess the quantitative and qualitative toxic effects of this drug in this patient population. outline: patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity. patients are followed at 3 months, 6 months, and then every 6 months for 3 years. projected accrual: a total of 38 patients will be accrued for this study within 13 months.

Eligibility criteria:
disease characteristics: * histologically confirmed unresectable primary, recurrent, or residual benign meningioma * measurable disease by ct scan or mri * must have disease progression within the past 10 years or progressive neurologic deficit within the past 6 months * must have undergone prior radiotherapy with subsequent disease progression or refused radiotherapy patient characteristics: age: * 18 and over performance status: * swog 0-2 life expectancy: * not specified hematopoietic: * wbc at least 4,000/mm\^3 * platelet count at least lower limit of normal hepatic: * not specified renal: * not specified other: * not pregnant or nursing * fertile patients must use effective contraception * no other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage i or ii cancer in complete remission prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior cytotoxic chemotherapy for meningioma * prior mifepristone allowed * no other concurrent chemotherapy endocrine therapy: * concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to ct scan or mri * no concurrent antitumor hormonal therapy radiotherapy: * see disease characteristics * at least 6 months since prior radiotherapy * no concurrent radiotherapy surgery: * not specified

Keywords: recurrent adult brain tumor adult grade i meningioma
a study in participants with end-stage renal disease

Conditions: Kidney Failure, Chronic

Summary: the purpose of this trial is to explore the effect of ly2127399 on those antibodies that are a barrier to kidney transplant. transplantation is currently the definitive treatment for end-stage renal disease (esrd), providing prolonged survival and improved quality of life.

in this study, ly2127399 will be tested as a potential treatment to reduce the blood proteins in some participants with esrd. these proteins are called alloantibodies and are made by the body to react with other proteins on cells of transplanted organs called human leukocyte antigen (hla) proteins. when a participant has these antibodies, they are referred to as hla-presensitized. often the presence of these antibodies, categorized by a method called the panel reactive antibody (pra), can make a person ineligible to receive a transplant or experience very long wait times on the kidney transplant waiting list. therefore the need to reduce the antibodies is significant for the successful treatment of esrd. this study will treat esrd participants for 6 months with ly2127399 and measure pra levels for a total of 18 months.

Eligibility criteria:
inclusion criteria: * have esrd and are awaiting kidney transplant * have a stable pra score \>50% exclusion criteria: * have had a tonsillectomy * have a semi-permanent/tunneled catheter * have had intravenous immunoglobulin (ivig) in the past 6 months * have had plasmapheresis in the past 6 months * uncontrolled hypertension * presence of clinically significant cardiac disease in the past 6 months * malignancy in the past 5 years, with the exception of cervical, basal cell and squamous epithelial cell cancers * have active or recent infection including herpes zoster or herpes simplex in the last 30 days * have evidence or suspicion of active tuberculosis (tb) * have had major surgery in the past 2 months * have had a serious infection with recovery in the past 3 months * have hepatitis b or c or have human immunodeficiency virus (hiv)

Keywords: end stage renal disease end stage kidney disease esrd uremia renal dialysis
a study of mericitabine in combination with telaprevir and peginterferon alfa-2a / ribavirin in participants with chronic hepatitis c

Conditions: Hepatitis C

Summary: this randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (ro5024048) (mcb) in combination with telaprevir (tvr) and peginterferon alfa-2a (peg-ifn) / ribavirin (rbv) in participants with chronic hepatitis c infection.


Eligibility criteria:
inclusion criteria: * chronic hepatitis c infection for at least 6 months duration * hepatitis c genotype 1a or 1b * participants must have discontinued prior hepatitis c treatment at least 12 weeks prior to enrollment in this study * participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (iu/ml) decrease in viral titer after at least 12 weeks of treatment with peg-ifn/rbv exclusion criteria: * hepatitis c infection with a genotype other than genotype 1a or 1b * body mass index \ = 36 kilograms per square meters (kg/m\^2) * hepatitis a, hepatitis b, or human immunodeficiency virus (hiv) infection * herbal remedies \<=1 month prior to the first dose of study drug
renal arterial resistive index for differential diagnosis of acute kidney injury

Conditions: Acute Kidney Injury

Summary: early differential diagnosis of anticipated acute kidney injury via ultrasound renal resistive index calculation

acute kidney injury is a common clinical syndrome introducing to emergency services with varying symptoms. acute kidney injury is divided into 3 subgroups: prerenal, renal and postrenal. there is not any certain laboratory or imaging modality for early detection of injury's type. calculation of renal resistive index with doppler ultrasound at emergency setting can be helpful for early detection of etiology of acute kidney injury subgroup.patient will be selected according to clinical status and detailed history and laboratory parameters.renal resistive index will we calculated with doppler ultrasound of arcuate and interlober arteries of kidneys. resistive index values of acute kidney injury patients will be compared depending on further tests and resistive indexes of suggestive etiologies will be compared according to final diagnosis.

Eligibility criteria:
inclusion criteria: 1. age over 18 2. patient with acute kidney injury diagnosed according to kdigo, akin or rifle criteria exclusion criteria: 1. end stage kidney disease 2. patients receiving renal replacement treatment

Keywords: acute kidney injury renal resistive index doppler ultrasound