Kornimate/medical-research-clean huggingface dataset:
penta fosamprenavir study

Conditions: Infection, Human Immunodeficiency Virus

Summary: twice daily fosamprenavir, in combination with low dose ritonavir (fpv/rtv bid), is indicated for the treatment of hiv-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-hiv medicines. safety data from two glaxosmithkline (gsk) clinical trials (apv29005 - involving twice-daily doses of fpv with or without rtv and apv20003 - with once daily dosing of fpv/rtv among 2-18 year olds) indicated that gastrointestinal events were the most commonly reported aes, but that the majority of events were mild and of short duration. treatment emergent grade 3 / 4 neutropenia was reported in 20% of children in the apv20003 trial; and neutropenia was identified as a potential safety concern by the european medicines agency (emea). the objectives of this study were to conduct an observational cohort study of the usage and safety of fpv/rtv in children and adolescents (aged 6 ≤ 18 years) with hiv infection in several european hiv paediatric cohorts. data will be collected for 3 years (2008, 2009 and 2010).

viiv healthcare is the new sponsor of this study, and glaxosmithkline is in the process of updating systems to reflect the change in sponsorship.

Eligibility criteria:
inclusion criteria: * hiv-1 infected children aged 6-18 years exposed to licensed paediatric dose of fpv/rtv january 1 2008 (or date of exposure to fpv if earlier to this but still exposed at 1/1/2008) from the participating cohorts exclusion criteria: -

Keywords: hiv antiretroviral therapy protease inbitor fosamprenavir paediatrics
the effect of manual lymph drainage in the treatment of breast edema

Conditions: Breast Cancer and Rehabilitation

Summary: breast conserving surgery (bcs) is widely used in the treatment of breast cancer. breast edema can be seen frequently after bcs and radiotherapy applications. breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. therefore, it is important to treat and prevent its development. in the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.


Eligibility criteria:
inclusion criteria: 1. patients who underwent breast-conserving surgery and received adjuvant radiotherapy 2. patients with sentinel lymph node biopsy or axillary lymph node dissection 3. female patients between the ages of 18-75 4. patients who cannot read and write turkish exclusion criteria: 1. a previous cancer 2. decompensated heart failure 3. untreated congestive heart failure 4. active infection 5. uncontrolled hypertension 6. acute kidney failure 7. patients with acute deep vein thrombosis 8. metastasis and/or recurrence during treatment 9. patients who have undergone another surgery related to the breast and chest area 10. patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.
wean early with hfnco vs nppv in patients with ahrf

Conditions: Patients With Acute Hypoxemic Respiratory Failure

Summary: the main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.


Eligibility criteria:
inclusion criteria: 1. orotracheal intubation； 2. pao2 \<60mmhg（venturi mask，fio2=0.5），and paco2 ≤45mmhg； 3. meeting criteria for weaning readiness； 4. spontaneous breathing trial failure. exclusion criteria: 1. age\<18； 2. duration of invasive ventilation \<48h； 3. tracheotomy； 4. percentage of cuff leak volume in tidal volume\<15.5%； 5. unable to spontaneously clear secretions from their airway； 6. recent oral，nasal，facial or cranial trauma or surgery； 7. recent gastric or esophageal surgery； 8. active upper gastro-intestinal bleeding； 9. severe abdominal distension； 10. lack of co-operation； 11. chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.
precision antiplatelet therapy guided by platelet aggregation function in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke; Clopidogrel Resistance

Summary: the objective of this clinical trial is to evaluate the efficacy and safety of platelet aggregation function - guided precision anti - platelet therapy in patients with acute cerebral infarction. the main question it aims to answer is: among the cerebral infarction patients with possible clopidogrel resistance detected by platelet aggregation function tests, what is the efficacy and safety of using ticagrelor to replace the clopidogrel treatment regimen.


Eligibility criteria:
inclusion criteria: * 1.aged between 18 and 80 years old; 2.diagnosed with non-cardiogenic ischemic stroke or tia according to who criteria, confirmed by cranial ct or mri to exclude hemorrhagic stroke.; 3.this stroke onset is ≤ 48 hours; (the duration of onset is defined as the time from the last time the patient was seen normal to the time of taking 300 mg of clopidogrel and 100 - 300 mg of aspirin in combination) 4.the nihss score is ≤ 5 points before randomization, or for tia patients, the abcd2 score is ≥ 4 points; 5.within 48 hours after the patient's onset, 5 - 20 hours after receiving anti - platelet therapy with a combination of 300 mg of clopidogrel and 100 - 300 mg of aspirin, the measured maradp is ≥ 35%; 6.the patient or their family member signs a written informed consent form. exclusion criteria: * 1.imaging examination indicates hemorrhagic stroke or hemorrhagic transformation. 2.there is a history of diseases such as atrial fibrillation, left ventricular thrombosis, cardiomyopathy or valvular disease. 3.there are the following congenital heart diseases: patent foramen ovale, ventricular septal defect, atrial septal defect and tetralogy of fallot. 4.other p2y12 receptor inhibitors (e.g., ticagrelor, prasugrel) except clopidogrel have been taken within 7 days. 5.there is a history of gastrointestinal bleeding, intracranial bleeding, recent massive bleeding or blood transfusion (excluding a small amount of hemoptysis and a small amount of abnormal vaginal bleeding), as well as a history of other hemorrhagic diseases caused by abnormal blood coagulation function (such as purpura, etc.). 6.there are contraindications or intolerance to anti - platelet drugs. 7.patients with severe cardiac, pulmonary, hepatic and renal insufficiency, and those with serious comorbidities (e.g., cancer, chronic obstructive pulmonary disease, severe dementia, severe heart failure). 8.those with poor compliance who cannot cooperate to meet the requirements of the study.
a randomized, controlled pilot study of a patient-initiated approach to increasing weight communication in primary care

Conditions: Obesity; Primary Care; Health Communication

Summary: this study tests the feasibility, acceptability, and preliminary efficacy of using a brief pamphlet in the primary care waiting room focused on promoting patient-initiated weight-related discussions in primary care appointments.

obesity is a chronic and complex disease that many national and professional organizations recommend be discussed frequently in primary care. however, rates of weight-related communication in primary care are suboptimal. when patients and physicians communicate about weight (defined as usage of any the 5as-ask, assess, advise, agree, and/or assist-in a weight-related conversation), patients are more likely to improve dietary habits, demonstrate more motivation for health behavior change, attempt weight loss treatment, and lose more weight as compared to patients who do not engage in weight-related communication with their physicians. interventions have attempted to increase the rates of weight-related communication in primary care. however, they have focused solely on physicians and have only yielded modest efficacy. intervention with patients on proposed patient-related barriers may be key to improving the rate of weight-related communication in primary care. the waiting room prior to appointments is an underutilized intervention setting. prior waiting room interventions have shown promising results for increasing health communication between patients and physicians. however, no prior study has focused on weight-related communication. thus, this study aims to test the feasibility, acceptability, and preliminary efficacy of an experiential pamphlet delivered in the waiting room targeting patient-related barriers to weight communication.

Eligibility criteria:
inclusion criteria: * present for an appointment at the family medicine office * indicate that they can speak and read english * indicate that their shape is \> or = 5 on measure (stunkard, sørensen, \& schulsinger, 1983) * indicate that they are 18 years or older exclusion criteria: - indicate that they are pregnant
first in human study of 68ga/64cu-fapi-xt117 pet/ct in patients with malignant solid tumors

Conditions: Malignant Solid Tumors

Summary: this is the first-in-human study of 68ga/64cu-fapi-xt117, which is an prospective, single-arm phase i clinical study.

20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18f-fdg pet/ct imaging were recruited. 68ga/64cu-fapi-xt117 and 18f-fdg pet/ct were performed for each patient in any order(the interval was more than one day and less than four weeks). they were assigned to three 68ga/64cu-fapi-xt117 dose groups, including 3±10% mci、5±10% mci and 7 ±10% mci. pet/ct images were acquired 30min, 60min, 120min after injection. the primary end point was safety, secondary endpoints were accuracy (ac), sensitivity (se), specificity (sp), positive predictive value (ppv), and change in management. exploring end point was image quality, including qualitative and quantitative evaluation.

Eligibility criteria:
inclusion criteria: * 1. signed the informed consent * 2. ≥18 years old * 3. confirmed as malignant solid tumor by histopathology or clinical judgment * 4. patients will undergo 18f-fdg pet/ct examination exclusion criteria: * 1. known allergy to components of the investigational drug or its analogues * 2. suspected to have a certain disease or condition that is not suitable for the study drug * 3. known pregnant or lactating women

Keywords: 68ga-fapi 64cu-fapi
endo-brain: effects of endocrine adjuvant therapy with aromatase inhibitors on the cognitive function of breast cancer patients

Conditions: Cognitive Side Effects of Cancer Therapy; Hypoestrogenism

Summary: the principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use ai, comparing it with age-matched healthy controls, utilizing cognitive assessments and functional magnetic resonance imaging (fmri). additionally, the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms, including vasomotor symptoms, and to evaluate a possible correlation with endothelial damage studied through angio optical coherent tomography (angio oct). patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic. after informed consent, the will be asked for detailed demographic data, medical, oncological and gynecological history. hypoestrogenism symptoms will be collected through validated questionnaires. the cognitive assessment will be performed on the same day, by trained staff. the fmri and angiooct will be booked and performed depending on patient and clinic availability.


Eligibility criteria:
inclusion criteria: * breast cancer patients undergoing endocrine adjuvant therapy with ai, with or without gnrh agonists, depending on menopause status at diagnosis (cases only) * at least 18 years old * good comprehension of oral and written italian language exclusion criteria: * incomplete ovarian suppression (cases) * previous neoplastic diseases other than the presently treated breast cancer for cases * known neurological or psychiatric disorders * use of hormonal contraception or hormonal replacement therapy (controls)

Keywords: breast cancer cognitive side effects hypoestrogenism ovarian function suppression aromatase inhibitor
informational app development for mhealth for patient self-management of opioid use disorder

Conditions: Opioid-Related Disorders

Summary: this study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. this study is designed to test the prototype app, not to determine health outcomes. the study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.

the overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study. step 1: a one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. if the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see step 2, below). if not, modifications to the app will be made and the one-week study will be repeated in a new group of participants. step 2: after completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. at the end of four weeks, participants will complete usability and user satisfaction surveys.

Eligibility criteria:
inclusion criteria: * male or female outpatients 18 years of age or older * currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder * currently stable in opioid use disorder outpatient treatment for 4 weeks or longer * ability to access the app via smart phone, or tablet. exclusion criteria: * unwilling or unable to comply with study requirements * have a psychiatric or medical disorder interfering with ability to use the app * incarcerated * pregnant
reducing behavioral risk factors of ncds: protocol for a school-based health education program in bangladesh

Conditions: Non-communicable Disease Risk Factors

Summary: this is a before-after designed intervention study conducted in two randomly selected secondary schools- one was selected randomly as intervention school and the another as control school. a baseline survey was conducted among the students of both schools by a pre-tested questionnaire to attain their current status of knowledge, attitude and practices related to ncds. afterward, students were enrolled in the intervention group who met the eligibility criteria from the intervention school. the intervention was given through a health promotion session to a group of students, not more than 25 at a time, by trained facilitators. a post-intervention end line survey was conducted among all the participants from both schools using the same questionnaire three months after the baseline survey. an intervention has been developed based on some principals of two psychosocial theory- motivational interview and social cognitive theory. emphasis was given on motivating the adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices about the preventive measures of ncds. this intervention is expected to increase awareness by equipping the adolescents with specific knowledge and skills and thus, facilitate an eventual change in their practiced risk behaviors.


Eligibility criteria:
inclusion criteria: • practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking exclusion criteria: • physically disabled or having limited movement

Keywords: ncds risk behaviors adolescents health education intervention
optimizing hepatitis b vaccine response through the use of a topical immune modulator

Conditions: Hepatitis B

Summary: this study will look at what happens to the level of protection against hepatitis b (hb) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis b vaccine.


Eligibility criteria:
inclusion criteria: * previously vaccinated with conventional hepatitis b vaccine series 10 or more years ago * generally healthy * is and has been free of hb disease and/or is negative to core antibody * known to have sero-converted to positive after vaccine series (without extra doses) * speaks and understands english adequately * available for all 4 visits within the designated timelines (30 days) * no allergies to hb vaccine or components * no blood or blood components within previous 6 months * not pregnant or breastfeeding

Keywords: topical immune modulator resiquimod gel hepatitis b booster response vaccine evaluation prevention of hepatitis b disease
simulated clinical use testing on safety lancets (test a)

Conditions: Needle Stick

Summary: a simulated clinical use testing on the htl-strefa's safety lancets

this study aims to evaluate the safety of the use of the safety lancets: ergolance and acti-lance in the prevention of nsi and to evaluate the user's opinion with regards to the handling characteristics of the medical devices. the simulated use clinical study will involve healthcare professionals (hcps) who routinely use safety lancets to collect blood samples and lay persons.

Eligibility criteria:
inclusion criteria: the inclusion criteria for hcp and lay person evaluators have been chosen based on fda guidance: * (hcp evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts) * evaluators will be united states (us) residents * evaluators can read, write, and speak english * evaluators are at least 18 years old * evaluators are able to understand and provide signed consent for the study * evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires. * evaluators have no concerns about the ability to perform the simulated skin pricking. lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. ul-wiklund will recruit some lay person evaluators with reduced vision and dexterity. users without safety lancet experience may also be included in this simulated clinical use study. exclusion criteria: hcps: * they do not routinely use safety lancets to collect capillary blood samples, * they cannot read, write, and speak english, * they or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or * they have participated in a product evaluation or marketing study involving safety lancets within the last six months lay people: * they cannot read, write, and speak english, * they or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or * they have participated in a product evaluation or marketing study involving safety lancets within the last six months

Keywords: needlestick needlestick injury safety lancet sharps injury prevention capillary blood sampling
ultrasound and biomarker tests in predicting cancer aggressiveness in tissue samples of patients with bladder cancer

Conditions: Bladder Papillary Urothelial Carcinoma; Stage 0a Bladder Urothelial Carcinoma; Stage 0is Bladder Urothelial Carcinoma; Stage I Bladder Cancer With Carcinoma In Situ; Stage I Bladder Urothelial Carcinoma; Stage II Bladder Urothelial Carcinoma; Stage III Bladder Urothelial Carcinoma; Stage IV Bladder Urothelial Carcinoma

Summary: this research trial studies two types of tests, an ultrasound test and a biomarker test, to see how well they predict how aggressive (invasive) bladder cancer is in samples from patients with bladder cancer. the aggressiveness of a tumor means how likely it is to invade the body and spread. the ultrasound test uses a fluorescent dye and stimulates cells under a microscope to see how they respond. this may allow doctors to predict how likely the cancer cells are to spread in the body. the biomarker test uses laboratory testing of samples from patients to study genes and other molecules that may predict the cancer invasiveness. comparing two different ways of predicting cancer aggressiveness may help doctors identify how well they work, and may eventually allow doctors to predict aggressiveness without needing to take a biopsy.

primary objectives: i. to establish an association between bladder cancer disease stage and the level of invasiveness as measured by a novel ultrasound assay. ii. to establish an association between bladder cancer disease stage and expression of novel invasiveness biomarkers related to the re1-silencing transcription factor (rest) gene. outline: previously collected tumor tissue samples, bladder washings, and urine cells are stained with calcium dye, washed and immersed in external buffer solution, and then transferred to the ultrasound imaging system. tissue, bladder wash cells and urine cells samples are also analyzed for biomarkers of invasiveness derived from or related to rest gene via quantitative reverse transcriptase polymerase chain reaction (qrt-pcr), western blot, and fluorescence in situ hybridization (fish).

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of ucc, having one of the stages (ta, tis, t1, and t2 or higher) * patients with ucc who are undergoing a standard procedure to remove cells/tissue from their bladders (cystoscopy, biopsy, or surgery) * ability to understand and the willingness to sign a written informed consent exclusion criteria: * patients who have had chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier