Kornimate/medical-research-clean huggingface dataset:
optimization of the isolation protocol for extracellular vesicles (evs) from human follicular fluid

Conditions: Extracellular Vesicles

Summary: background: extracellular vesicles (evs) are membrane-bound vesicles found in all biological fluids, containing various regulatory molecules, including micrornas (mirnas). it has been suggested that the evs in human follicular fluid (the fluid surrounding the oocyte within the ovary) play a crucial role in oocyte development through these mirnas. however, several methods exist for isolating these evs from follicular fluid. before further research can be conducted on the pathophysiology and potential diagnostic and therapeutic applications of these evs and their content, the optimal isolation technique must be determined for future studies. each method has its advantages and disadvantages, and the purity and efficiency may vary between species and different biological fluids. there are only a limited number of studies comparing the various techniques for application in human follicular fluid. objective: this study will compare the three most commonly used techniques for isolating evs: size-based, sedimentation-based (differential ultracentrifugation), and buoyancy-based isolation techniques. methodology: in this prospective study, follicular fluid will be collected from four patients undergoing transvaginal oocyte retrieval following ovarian stimulation at ghent university hospital. patients over 40 years of age or with endometriosis, adenomyosis, or pcos (polycystic ovarian syndrome) will not be included in this study. during the oocyte retrieval procedure, follicular fluid will be collected from 2-4 oocytes per patient. since follicular fluid is not used in the patient's treatment (residual material), it does not affect the treatment. after collection, the three isolation techniques will be applied to each sample. the techniques will be compared in terms of purity (absence of contamination) and efficiency (ev concentration) using transmission electron microscopy, nanoparticle tracking analysis, and western blotting.


Eligibility criteria:
inclusion criteria: * patients planned for an oocyte retrieval at ghent university hospital. exclusion criteria: * diagnosis of endometriosis/adenomyosis * diagnosis of pcos (polycystic ovary syndrome) * macroscopic blood contamination at oocyte retrieval

Keywords: extracellular vesicles isolation
hiv immune and virological responses following the administration of il-2 either alone or combined to alvac-hiv 1433 and hiv lipopeptides in patients treated early with haart during primary infection

Conditions: HIV Infection

Summary: hiv-specific immune responses are preserved in patients treated early during primary infection.the trial evaluated whether the addition to haart of il-2 alone or combined with an immunization procedure might enhance hiv immune responses and improve viral control after haart discontinuation

hiv-specific immune responses are preserved in patients treated early during primary infection. the trial evaluated whether the addition to haart of il-2 alone or combined with an immunization procedure might enhance hiv immune responses and improve viral control after haart discontinuation.patients treated with haart are randomized to 3 arms:arm1 haart alone; arm2 with 5 cycles of il-2 at wk0 ,8 ,16 ,24 and 32;arm3 4 injections of alvac-hiv 1433 and lipo-6t at wk0,4,8 followed by 3 cycles of il-2 at w 16, 24 and 32. haart is stopped at wk 40 in patient with undetectable plasma viral load. viral loads and hiv-specific responses are monitored during the therapeutic period and after haart interruption until w52. haartis rei-initiated with viral failure.

Eligibility criteria:
inclusion criteria: * history of symptomatic hiv primary infection with p24 positive or incomplete western blot * treatment beginning before 4w after the first primary infection serology * haart with ip or nnrti since one year, wtih no change since 3 months * viral load below 50 cp since 6 months * pn over 1000/mm3;hb over 10.5g/l;platelets over 75000/mm3, creatinine below 1.5n; transaminases below 2.5n exclusion criteria: * vaccination or chemotherapy or corticosteroid since 3 months * evolutive cancer * pregnancy or breastfeeding

Keywords: hiv infection aids vaccines alvac vaccine interleukin-2 antiretroviral therapy, highly active
docetaxel, gemcitabine and bevacizumab for metastatic breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and her2 negative breast cancer.

docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. administered every two weeks, this combination has a favorable toxicity profile, and promising activity in \> 1st line treatment for metastatic breast cancer. recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. this study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * histologically- or cytologically- confirmed metastatic breast adenocarcinoma * no her2 overexpression or gene amplification * at least one previous chemotherapy regimen for metastatic breast cancer * age ≥18 years * performance status (who) 0-2 * life expectancy of at least 12 weeks * measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 x 10 mm * performance status (who) 0-2 * adequate liver function (serum bilirubin \<1.5 times the upper normal limit, ast and alt \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, plt ≥ 100,000/mm3, hgb ≥ 9 g/dl) function * written informed consent exclusion criteria: * pregnant or lactating women * progressive brain metastases according to clinical or radiological criteria * brain metastases without prior radiation therapy * radiation therapy within the previous 4 weeks * previous radiation therapy to the only measurable lesion * proteinuria ≥ 500 mgr of protein daily * uncontrolled hypertension * documented hemorrhagic diathesis or coagulation disorder * cardiovascular disease (class ii-iv nyha congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, lvef \< normal, ventricular arrhythmia, uncontrolled hypertension) * thrombotic event within the previous 6 months * concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents * major surgical procedure within the previous 4 weeks * presence of nonhealing wound or fracture * peripheral neuropathy \> grade 2 according to the nci ctcae (version 3.0) * any sustained chronic toxicity \> grade 2 according to the nci ctcae (version 3.0) * uncontrolled infection * any serious, uncontrolled comorbidity on the investigator's judgment * other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer * serious psychiatric illness

Keywords: docetaxel gemcitabine bevacizumab chemotherapy
a study of ly573636-sodium in the treatment of patients with metastatic soft tissue sarcoma

Conditions: Sarcoma, Soft Tissue

Summary: the primary purpose of the study is to estimate the time from the first dose of ly573636-sodium (hereafter referred to as ly573636) to the date your physician determines that your disease has progressed or worsened.

patients will receive a 2-hour intravenous infusion of study drug (ly573636) once every 21 days or 28 days depending on their target dose. radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. patients will be assessed for clinical progression at every visit and for response approximately every 42 days or 56 days (every other cycle).

Eligibility criteria:
inclusion criteria: * diagnosis of soft tissue sarcoma that is unresectable or metastatic * have received one or two (but no more than two) prior treatment regimens for metastatic soft tissue sarcoma, one of which must have included doxorubicin (adriamycin). * must have stopped all previous treatments for cancer, including chemotherapy, radiation therapy or other investigational treatments for cancer for at least 30 days exclusion criteria: * participants with primary bone sarcoma (for example osteosarcoma, ewing's sarcoma, chondrosarcoma), gastrointestinal stromal tumor (gist) and kaposi's sarcoma * serious pre-existing medical problems (as determined by your doctor) * have received more than two previous systemic treatment regimens for unresectable or metastatic soft tissue sarcoma * have a second primary cancer (unless cancer-free for more than 2 years) * active treatment with warfarin (coumadin)
using tailored messages to encourage healthy lifestyle choices in a brief, self-directed intervention

Conditions: Weight Control

Summary: the study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. the lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity. it was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months. conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months. it was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing. furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.


Eligibility criteria:
inclusion criteria: * 18+ years old * generally healthy * bmi between 18.5 and 35 exclusion criteria: * pregnancy within the past 6 months * current pregnancy * plan to get pregnant in the next 6 months * serious physical or psychological problems that would contraindicate participation in a weight-related program * history of anorexia or bulimia * diabetes or hypertension * current participation in a weight-loss program * bmi \ 35.0
a gene transfer study to evaluate the safety, tolerability and efficacy of srp-6004 in ambulatory participants with limb girdle muscular dystrophy, type 2b/r2 (lgmd2b/r2, dysferlin [dysf] related)

Conditions: Limb Girdle Muscular Dystrophy

Summary: the primary purpose of this study is to evaluate the safety of srp-6004 administered by intravenous (iv) infusion in ambulatory participants with lgmd2b/r2 (dysf related).


Eligibility criteria:
inclusion criteria: * possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic dysf deoxyribonucleic acid (dna) gene mutations as documented prior to screening visits. * participants must be ambulatory per protocol specified criteria. * ability to cooperate with motor assessment testing. * has accessible and intact lower and upper extremity musculature for biopsy. * have adeno-associated virus rhesus serotype 74 (raavrh74) antibody titers \< 1:400 (that is, not elevated) as determined by enzyme-linked immunosorbent assay (elisa). exclusion criteria: * exposure to gene therapy, investigational medication, or other protocol-specified treatment within the protocol specified time limits. * abnormality in protocol-specified diagnostic evaluations or laboratory tests. * presence of any other clinically significant illness, medical condition, or requirement for chronic drug treatment that in the opinion of the investigator creates unnecessary risk for gene transfer. note: other inclusion or exclusion criteria could apply.

Keywords: ambulatory gene-delivery lgmd2b/r2 dysferlin lgmd
assessment of red cell distribution width's prognostic ability in septic intensive care unit patients

Conditions: Sepsis

Summary: various biomarkers are used for predicting outcome from sepsis and septic shock, but single value doesn't give a clear-cut picture. this prospective observational study aims to approach the prognostic value of red cell distribution width for morbidity and mortality of intensive care unit patients with sepsis. and this will be achieved by: * assessment of prognostic value of red cell distribution width in septic intensive care unit patients for 28 days mortality * comparison between red cell distribution width and other inflammatory markers as c-reactive protein and serum lactate as well as other scoring systems such as sequential organ failure assessment (sofa) score, regarding their prognostic discriminative ability.

critically ill patients admitted to ain shams university hospital intensive care units who fulfill the criteria of sepsis and septic shock according to the third international consensus definitions for sepsis and septic shock (sepsis-3) will be enrolled. all patients will be resuscitated and managed according to ain shams university hospitals protocol for sepsis and septic shock. on admission, and after applying the exclusion and inclusion criteria, all clinical data will be collected from participants, which will mainly include patient's detailed medical history, site of infection, blood routine test, biochemical test, other inflammatory markers as c-reactive protein, arterial blood gas for serum lactate count, and cultures samples according to source of infection. red cell distribution width will be recorded for each patient on admission, then patients will be followed up for 28 days mortality. patient's morbidity will be defined by sequential organ failure assessment (sofa) score, it will be calculated and recorded on admission and will be followed up as well.

Eligibility criteria:
inclusion criteria: * age group: all adult patients aged more than 18 years old and less than 70 years old. * intensive care unit admitted patients with sepsis. exclusion criteria: * patients less than 18 years old and more than 70 years old. * patients with known hematological disease (e.g., leukemia, myelodysplastic syndrome), human immunodeficiency virus (hiv) infection or any immunosuppressant usage history. * patients having uncured malignancy. * patients who had a cardiac arrest event before icu arrival. * patients who had recent (less than one week) blood transfusion.

Keywords: sepsis intensive care units red cell distribution width inflammatory markers prognosis
management of moderate to severe monotraumatic pain with sublingual sufentanil in an emergency situation.

Conditions: Pain Management

Summary: pain is a common reason for emergency department (ed) visits. however, studies suggest that emergency physicians may not always provide optimal analgesic treatment due to various factors, such as time constraints, demographic factors like gender and age, and concerns about opioid use. as a result, patients with moderate to severe pain often experience long delays before receiving analgesia and may even be discharged with unresolved pain or suboptimal treatment. additionally, diagnostic procedures for patients with isolated trauma (e.g., clinical examinations, radiographs) can lead to variations in pain levels, making it difficult to assess the effectiveness of analgesia. a commonly used treatment for moderate to severe pain is intravenous opioid administration. however, this approach requires longer wait times, complex titration, and significant resources (beds, nurses, equipment), which may be limited during peak hours. while oral opioids require fewer resources, their delayed onset and limited titratability restrict their use for severe pain. the sublingual sufentanil tablet (30 mcg), delivered via a single-dose applicator, was developed for patients with moderate to severe pain in emergency or outpatient surgical settings. its unique pharmacokinetic and pharmacodynamic properties could offer advantages in non-invasive acute pain management. sublingual sufentanil received market authorization in june 2018 for the treatment of moderate to severe acute pain in adults and is already used in many hospitals. however, further studies are needed to confirm its effectiveness and potential superiority in pain management. the objective of this study is to evaluate the effectiveness of 30 mcg sublingual sufentanil in patients admitted for moderate to severe pain due to isolated trauma. this will be compared to the standard pain management protocol used in the clermont-ferrand emergency department, focusing on pain score variations using a numerical rating scale (0-10)


Eligibility criteria:
inclusion criteria: * adult patient * patient with a pain rating on the numerical rating scale (nrs) ≥ 4 * pain of monotraumatic origin in the upper or lower limb * glasgow coma scale = 15 * sao2 \> 95% in ambient air exclusion criteria: * polytrauma * analgesic treatment within the 4 hours preceding admission (except paracetamol) * woman of childbearing age without effective contraception, declaring pregnancy or at risk of pregnancy, breastfeeding woman, or positive pregnancy test at inclusion * patient requiring intravenous access upon admission (e.g., displaced open fracture) * contraindication or allergy to any of the molecules in the analgesia protocol * refusal to participate * known substance abuse or psychiatric disorders * known oxygen dependence or copd * not affiliated with social security * patient under guardianship, curatorship, deprived of liberty, or under legal protection * patient who does not speak or read french

Keywords: pain sublingual sufentanil traumatic pain
plant versus animal dietary protein and the effect on proteinuria

Conditions: Kidney Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Complications; Hypertension; Glomerulonephritis; Kidney Diseases; Kidney Disease, Chronic

Summary: the purpose of this study is to investigate if a diet high in plant protein improves kidney function in patients with kidney insufficiency and diabetes and/or hypertension and/or glomerulonephritis. the study is a non-blinded, randomized, controlled, cross-over-design with two intervention periods of each 14 days. between the two interventions periods there is a washout period of 14 days. the participants are randomized to start with an individualized diet plan containing either high amounts of animal protein or high amounts of plant protein.

the purpose of this study is to investigate if a diet high in protein (2,0 g/kg/d) of plant origin, decreases proteinuria amongst patients with diabetes, hypertension and/or glomerulonephritis with presence of micro- or mild macro albuminuria, compared to a diet high in protein of animal origin. kidney insufficiency is associated with increased morbidity and mortality, decreased quality of life and large financial costs for the health care system. evidence suggest that the source of protein may inflect the progression of the kidney disease where soy protein has shown a positive effect on estimated glomerular filtration rate and proteinuria amongst both diabetic and non-diabetic patients with nephropathy. the study design is a 6-week, non-blinded cluster randomized, controlled, cross-over study with two intervention periods of each 14 days. between interventions there is a washout period of 14 days. the participants are randomized to follow either a diet high in plant protein (hppd) or a diet high in animal protein (hapd). the diet plans are individualized to accommodate the participants energy requirements. given the high amount of protein in the diets they are supplemented with either soy protein powder or beef protein powder. to measure primary and secondary endpoint, the participants are instructed to collect two times 24-hour urine sample at the first baseline, after 14 days and after 42 days. blood samples are collected at the first baseline, after 14 days, at the second baseline and after 42 days. to gain enough statistical power a minimum of 16 participants should be included. to accommodate a drop-out rate of 25%, 20 participants should be enrolled.

Eligibility criteria:
inclusion criteria: * uacr between 30 and 800 mg/g in minimum two spot urine samples. * estimated glomerular filtration rate (egfr) \>30 ml/min. egfr must have been stabil over the past 6 months defined by a maximal fluctuation in egfr of 10 ml/min. * minimum 30 years of age. * danish speaking and writing * no changes in blood pressure medication for the past three months. exclusion criteria: * vegetarianism or veganism * pregnancy
study to evaluate the consistency of three consecutive production lots of influenza vaccine in healthy subjects 18 to 49 years old

Conditions: Influenza

Summary: the purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. in addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the united states, is compared to an inactivated influenza vaccine, licensed in the united states.


Eligibility criteria:
inclusion criteria: * 18 to 49 years of age; * in good health as determined by medical history and physical examination; * able and willing to provide written informed consent prior to any study procedure; * able to comply with all study procedures and available for all clinic visits scheduled in the study. exclusion criteria: * any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus * history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex); * known or suspected impairment/alteration of immune function * receipt of an influenza vaccine within 6 months prior to visit 1; * current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives; * laboratory-confirmed influenza disease within 6 months prior to visit 1

Keywords: influenza adults different lots trivalent subunit influenza virus vaccine (ivv) trivalent subunit influenza vaccine