Kornimate/medical-research-clean huggingface dataset:
what embryoselection for what chance of success ? embryoselect study

Conditions: Infertility

Summary: the aim of the research is to evaluate the results of the first in vitro fertilization (ivf) attempt according to the type of embryo culture. from the fertilization to the day 2 transfer, embryos are cultured in standard incubator or in a time lapse technology (tlt). tlt offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture in standard incubator involves discontinuous morphological embryo evaluation. the principal objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of women less than 39 years-old.

embryo evaluation and selection is fundamental in clinical ivf in order to obtain a live birth in a shorter delay as possible, but minimizing the risk of multiple pregnancies. tlt was introduced few years ago in clinical practice and allows the continuous follow up of the embryo development. in ivf centers, embryos are preferentially cultured in tl system with undisturbed environmental conditions. this provides information about the development of the embryos in time intervals of 15min and adds kinetic criteria for embryo evaluation and selection. in conventional incubator, the follow up of embryo development consists in 3 static time point observations. many reviews and observational studies have discussed the value of time-lapse monitoring but it is as yet unclear, however, whether the tlt improves the results of ivf. it has been suggested that the clinical benefits of applying new technologies should be verified and documented by randomized controlled trials. moreover, the cumulative live birth rate and the delay for conception were rarely reported. the study aims to evaluate the results of the first ivf attempts comparing classical embryo culture in standard incubator and embryo culture and follow up in tlt. the hypothesis is that the undisturbed culture and the selection based on continuous time-lapse images improve the results of the single embryo fresh transfer and increase the cumulative live birth rate. patients will be randomized the day of the puncture for the type of culture: standard incubation or tlt. the results of the fresh and successive vitrified-warmed embryo transfer will be prospectively collect and patients will be followed until live birth. the attempt will be considered ended after a live birth, if all the frozen embryos are transferred, after 24 months follow up or after surrender.

Eligibility criteria:
inclusion criteria: * first ivf/icsi attempt with fresh transfer, * women ≥18 years-old and \<39 years-old, * signed informed consent exclusion criteria: * attempts with donor, * comprehension problem, * frozen gametes, * bmi\>35 kg/m2, * history of 3 or more miscarriages, * uterine pathology, * serodiscordant patients

Keywords: embryo in vitro fertilization selection, time lapse single embryo transfer
ranibizumab in patients with branch retinal vein occlusion

Conditions: Retinal Vein Occlusion

Summary: in a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (brvo) is closely correlated to the visual outcome after three months. this could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of vegf in brvo. the present study evaluates the response of retinal vessel diameters to anti vegf treatment with lucentis in patients with brvo. this is done in an effort to gain insight into the retinal hemodynamic consequences of anti vegf treatment in brvo. the hypothesis that anti vegf treatment is associated with a vasoconstrictor response in retinal vessel in patients with brvo is tested.

to investigate the response of retinal vessel diameters to lucentis treatment in patients with brvo and to correlate these changes with changes in functional outcome after 3 months. pilot study in patients scheduled for intravitreal anti-vegf (lucentis™) treatment with brvo 30 patients with brvo scheduled for intravitreal anti-vegf treatment intravitreous administration of ranibizumab (lucentis ™) main outcome measure: retinal vessel diameters secondary outcome measures: retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with microperimetry, objective functional response assessed with mferg, anatomic changes in the macula region as assessed with stratusoct and prototype of a cirrus-oct(which is available at the department of ophthalmology, medical university of vienna), angiographical outcomes.

Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age. * ophthalmoscopic evidence of recent brvo, that is, a history of 3 months. * macular edema secondary to brvo in the study eye scheduled for intravittreal anti-vegf as primary treatment. * retinal thickness of \> 300 µm by oct in the central subfield of the study eye at baseline. * va decrease attributable to the edema. * written informed consent has been obtained. * female patients of childbearing potential must have a negative urine pregnancy test. exclusion criteria: * uncontrolled sytemic disease * symptoms of a clinically relevant illness in the 3 weeks before the first study day * any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia) * history of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios. * contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.

Keywords: lucentis, macular edema, branch retinal vein occlusion
study to evaluate the efficacy and tolerability of venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with daflon

Conditions: Chronic Venous Insufficiency; Disease

Summary: the objective is to evaluate the effectiveness of the safety of daflon in decreasing symptoms resulting from chronic venous insufficiency when compared with daflon.

"a clinical multicenter, phase iii, prospective, randomized, double-blind, comparative study to evaluate the efficacy and tolerability of venaflon use in reducing the symptoms caused by chronic venous insufficiency when compared with daflon."

Eligibility criteria:
inclusion criteria: * patients of any ethnic group, both sexes and aged at least 18 years and a maximum of 65 years * women and men of childbearing age who agree to use acceptable contraception throughout the study. * be patient with chronic venous insufficiency of lower limbs varicose comdiagnostico clinical ceap 0-3 by ceap * presence of at least 23 symptoms (pain, heaviness and discomfort, symptoms of heat and burning sensation in the legs) in the lower limbs, with a score equal to or greater than 4, as measured by visual analog scale * being the 7 days without any medication or treatment related to the venous system. * patients able to make proper use of medication * patients who consent to participate in the study by signing the instrument of consent. exclusion criteria: * pregnant or breastfeeding women * women who are breastfeeding * women and men of childbearing age who do not accept to use acceptable contraception throughout the study * patients under 18 or over 65 years * patients with a history of hypersensitivity to any component of the formula * presence of signs and symptoms of different conditions of venous disease to justify the pain or swelling * use of elastic compression in the last two weeks * venous obstruction of the lower limbs * patients who have previously used or venaflon daflon and did not benefit; * deep vein thrombosis in the last 6 months before entering the study; * use of diuretics in the last 4 weeks * previous venous surgery * patients with renal and liver failure * patients with gastritis or gastric ulcer * patients with blood clotting disorders * any condition which in the opinion of the physician researcher is significant and can make the patient unsuitable for study or you can place it under additional risk

Keywords: chronic venous insufficiency daflon venaflon
linq for impedance measurement while off from hf medication study

Conditions: Heart Failure

Summary: the purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is to assess the sensitivity of the linq icm to measure derived-subcutaneous impedance in patients with heart failure during periods when diuretics and/or hf-medication consumption is increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect safety information related to hf status and to medication consumption changes.

up to 30 subjects with a clinical diagnosis of heart failure will be enrolled in the study. it is expected that the subjects will be enrolled over a period of approximately 6 months. 3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the linq icm implant. the total expected duration of the study is of about 1 year. according to the enrolment chronological order, each subject will be allocated to diuretic suspension group (ds), diuretic increase (di) or diuretic+mra medication suspension (dms), which will define the medication regimen before the follow-up visit. primary objective of the study is detecting the variation of impedance magnitude and the time of occurrence after medication regimen changes will be evaluated at each follow-up.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure * plasma nt-probnp (\>250ng/l in sr and \>1,000ng/l in af) * lvef \<50% measured in the year before enrolment * treated routinely with a daily dose of loop diuretic * receiving other guideline-indicated therapy for heart failure * willing to sign the informed consent form. * greater than 18 years of age. exclusion criteria: * pregnant patients (all females of child-bearing potential must have a negative pregnancy test before linq icm implant) * egfr \<30 ml/minute. * any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study. * patients with implanted pacemakers or defibrillators * severe aortic or mitral valve disease * breathlessness at rest or on minor exertion. * chest pain at rest or on mild or moderate exertion. * patients deemed too unstable to miss 48 hours of heart failure treatment * enrolled in another study that could confound the results of this study, without documented pre-approval from medtronic study manager

Keywords: heart failure
two versus four weeks of antibiotic treatment in native joint arthritis

Conditions: Arthritis, Septic

Summary: the optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. the investigators perform a randomized study allowing up to 3 surgical lavages and allocating patients into a two-week's and a four week's randomization arm

the optimal duration of systemic antibiotic administration for native joint septic arthritis is unknown. the investigators perform a randomized study allocating patients into a two-week's and a four week's randomization arm. the adult patients are hospitalized for septic arthritis. a computer program randomizes 1:1 between a two week's and a four week's arm of targeted antibiotic treatment of which at least the first week is intravenously. the randomization may occur until day 5 of admission. up to three surgical interventions are allowed. the investigators allow the inclusion of all bacterial arthritis and all joints.

Eligibility criteria:
inclusion criteria: 1. age \>17 years 2. microbiologically-confirmed septic arthritis 3. at least one surgical drainage/lavage exclusion criteria: 1. presence of osteosynthesis material in the vicinity of the articulation 2. presence of a concomitant infection needing more than 2 week's of antibiotic therapy 3. more than 3 surgical drainages 4. life expectancy less than 6 months 5. chronic osteomyelitis in vicinity of the arthritis

Keywords: septic arthritis surgery antibiotic duration remission sequelae
irdye800cw-bbn pet-nirf imaging guiding surgery in patients with lower grade glioma

Conditions: Glioma

Summary: this is an open-label positron emission tomography/near infrared (pet/nirf) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68ga-bbn-irdye800cw in patients with lower grade glioma. a single dose of 40μg/111-148 mega-becquerel (mbq) 68ga-nota-bbn and 1.0- or 2.0- mg/ml irdye800cw-bbn will be injected intravenously before the operation and intraoperative respectively. visual and semiquantitative method will be used to assess the pet images and real-time margins localization for surgical navigation.

lower grade gliomas (who grades ii and iii) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. an integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. bbn, with the amino acid sequence of gln-trp-ala-val-gly-his-leu-met-nh2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (grpr), a member of the g protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioma. for interests in clinical translation of grpr targeting dual modality probe, an open label dual modality imaging pet/ nirf study was designed to investigate the imaging guiding performance in lower grade glioma patients. to investigate whether the preoperative pet with bbn can predict the success of the fluorescence guided surgery with same peptide intraoperatively. the sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.

Eligibility criteria:
inclusion criteria: * must be able to provide a written informed consent * suspected lower grade gliomas on contrast-enhanced mri exclusion criteria: * consisted of conditions of mental illness * severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μμ) * any hepatic enzyme level 5 times or more than normal upper limit * severe allergy or hypersensitivity to iv radiographic contrast * claustrophobia to accept the pet/ct or pet/mri scanning * pregnancy or breast feeding

Keywords: fluorescence guided surgery; dual-modality imaging
monotherapy study of mp-513 in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of mp-513 (teneligliptin) in patients with type 2 diabetes for 12 weeks administration.


Eligibility criteria:
inclusion criteria: * patients who are 20 - 75 years old * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug * patients whose hba1c is between 6.5% - 10.0% * patients who were not administered diabetes therapeutic drugs within 12 weeks before administration of investigational drug. exclusion criteria: * patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (cushing disease, acromegaly, etc) * patients with class iii/iv heart failure symptoms according to new york heart association (nyha) functional classification * patients with serious diabetic complications. * patients who are habitual excessive alcohol consumption. * patients with severe hepatic disorder or severe renal disorder. * patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Keywords: insulin resistance
adherence connection for counseling, education, and support (access) ii

Conditions: HIV Infections

Summary: the primary objective of the proposed clinical trial, adherence connection for counseling, education, and support (access)-ii, is to test the efficacy of access-ii on antiretroviral treatment (art) adherence and hiv-viral load in black and hispanic hiv-infected (hiv+) adolescents and young adults (aya), ages 18-29 years (n=120) using a longitudinal (12 and 24 week outcomes), two-group, randomized control trial (rct). participants in the intervention condition will use videoconferencing to connect synchronously with trained hiv+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral/motivational sessions for improved art adherence. participants in the control will connect asynchronously to a web-based hiv art adherence education condition.

to achieve these aims, a longitudinal (12 and 24- week study outcomes), two-group, randomized control trial (rct) is proposed in a sample population of 120 perinatally and behaviorally, hiv-infected youth (ages 18-29 years). participants in the intervention condition will use videoconferencing to connect synchronously with trained hiv+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral47-50 motivational18 sessions for improved art adherence. participants in the control will connect asynchronously to a web-based hiv art adherence education condition. study participants will access the intervention and control conditions outside of the clinical setting using study funded smart phones. self-reported adherence and viral load (extracted from the medical records) of study participants will be measured, and uploaded to redcap. art knowledge, adherence self-efficacy, hiv stigma, social support, psychological distress, and substance use will be measured using survey measures. statistical analyses will be computed to assess the potential impact of access on adherence and hiv viral suppression, and will also be computed to assess changes in art knowledge, adherence self-efficacy, hiv stigma, social support, psychological distress, and substance use among participants in both the intervention and control conditions.

Eligibility criteria:
inclusion criteria for participation in this study are: * hiv seropositive status (perinatally and behaviorally infected youth) * ages 18-29 years * english speaking * currently being prescribed an antiretroviral treatment regimen * evidence of virologic failure or (detectable quantitative hiv serum viral load\>200 copies/ml) * no neuro-cognitive deficits which would impede participation in videoconferencing sessions or completion of study measures
efficacy of topical tacrolimus in different subtypes with cutaneous lupus erythematosus (cle)

Conditions: Cutaneous Lupus Erythematosus

Summary: the purpose of this study is to evaluate the efficacy of topical tacrolimus in different subtypes of cutaneous lupus erythematosus. as shown by several groups activated memory t lymphocytes play a key role in the pathogenesis of lupus erythematosus. tacrolimus targets t lymphocytes and suppresses their activation by inhibiting the expression of cytokine genes, such as il-2. therefore, treatment of cutaneous lupus erythematosus with topical tacrolimus might result in an improvement of skin lesions in such patients.

in patients with cutaneous lupus erythematosus (cle), topical corticosteroids are the mainstay of treatment; however, a long-term use can lead to numerous side effects including skin atrophy. recently, topical tacrolimus has been suggested to be effective in patients with different manifestations of cle as single or additive therapy. its anti-inflammatory effect can be explained by inhibition of calcineurin and suppression of proinflammatory cytokines such as interleukins-2, -3, -4, granulocyte colony-stimulating factor, and tumour necrosis factor alpha. in this study, we evaluate the efficacy of tacrolimus in 30 patients with different forms of cle (acle, scle, dle, let). during a period of 3 months tacrolimus ointment and its placebo are applied on two separate skin lesions. clinical follow-up examinations including photo documentation are performed every 4 weeks.

Eligibility criteria:
inclusion criteria: * cutaneous lupus erythematosus confirmed by histological analysis * topical use of glucocorticosteroids stopped at least two weeks before the start of the study * presence of two primary skin lesions with a clinical score ≥ 1 * written informed consent available prior to any screening procedures exclusion criteria: * systemic medication if taken for lupus erythematosus (e.g. chloroquine or hydroxychloroquine) started at least 6 months prior to the beginning of the study * women of childbearing potential using inadequate birth control measures * pregnancy and lactation * known hypersensitivity to tacrolimus or any of the excipients * patients receiving systemic immunosuppressive drugs and cytotoxic agents other than antimalarial agents

Keywords: cutaneous lupus erythematosus tacrolimus ointment topical treatment skin lesions
apple: aspirin to prevent pregnancy loss and preeclampsia

Conditions: Pre-Eclampsia; Pregnancy Loss

Summary: the goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. the main questions it aims to answer are: does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations? does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.


Eligibility criteria:
inclusion criteria 1. provision of signed and dated informed consent form. 2. stated willingness to comply with all study procedures and availability for the duration of the study. 3. ability to take oral medication and be willing to adhere to the prescribed aspirin regimen. 4. patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of lmp or art date). 5. patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including: 1. preeclampsia in a previous pregnancy, 2. gestational diabetes in a previous pregnancy, 3. any documentation of fetal growth restriction or low birth weight in a prior pregnancy, 4. preterm birth in a previous pregnancy, 5. known multifetal gestation at enrollment, 6. chronic hypertension, 7. pregestational diabetes, 8. kidney disease, 9. systemic lupus erythematosus, 10. nulliparity, 11. pre-pregnancy body mass index \>30, 12. family history of preeclampsia (i.e., mother or sister), 13. black persons (due to social, not biological reasons), 14. maternal age 35 years or older, 15. lower income (will be determined by qualification of public health insurance), 16. conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination), 17. history of one or more prior pregnancy losses \<20 weeks gestation, 18. history of stillbirth in a prior pregnancy, 19. an interval of greater than 10 years since the last pregnancy. exclusion criteria 1. known allergies to aspirin or non-steroidal anti-inflammatory agents (nsaid); 2. clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia; 3. clinical indication for chronic use of nsaids during pregnancy; 4. medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer. 5. patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical os suggesting active miscarriage or severe pain requiring evaluation for ectopic pregnancy)