Kornimate/medical-research-clean huggingface dataset:
omega-3 supplementation and vitreal vegf levels in wet-amd

Conditions: Exudative Age Related Macular Degeneration

Summary: the purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (vegf) in exudative age-related macular degeneration (amd) in patients receiving intravitreal anti-vegf treatment. patients are randomized to receive either age-related eye disease study 1(areds-1) supplements formula with the addition of lutein or areds-2 supplementation that adds omega-3 metabolites (dha and epa) to the formula. our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-vegf injection and perform a comprehensive cytokines and lipidomic profiling. we hypothesize, based on our previous basic science discovery of a potent anti-vegf action of an omega-3 metabolite (4-hdha), that lipid metabolite composition and metobolite levels will significantly vary according to vegf levels. based on the results of this pioneering clinical study, our research team will proceed to evaluate the individual anti-angiogenic (vessel growth stopping) properties of the predominant omega-3 metabolites found.

the purpose of this trial is to detect the influence of omega-3 supplements on vitreous levels of vascular endothelial growth factor (vegf) in exudative age-related macular degeneration (amd) in patients receiving intravitreal anti-vegf treatment. patients are randomized to receive either age-related eye disease study 1(areds-1) supplements formula with the addition of lutein or areds-2 supplementation that adds omega-3 metabolites (dha and epa) to the formula. our goal is to take a limited volume of vitreous sample from these patients previous to their regular anti-vegf injection and perform a comprehensive cytokines and lipidomic profiling. we hypothesize, based on our previous basic science discovery of a potent anti-vegf action of an omega-3 metabolite (4-hdha), that lipid metabolite composition and metobolite levels will significantly vary according to vegf levels.

Eligibility criteria:
inclusion criteria: * wet amd eligible for intravitreal anti-vegf treatment. * confirmed exudation on sd-oct. exclusion criteria: * dry amd. * disciform scar. * smokers. * morbid obesity. * patients undergoing other forms of treatment for wet amd.

Keywords: wet amd omega-3 vegf lipidomics dha epa
factors issued from functional exploration associated to sahos in asthmatic children

Conditions: Asthma; Obstructive Sleep Apnea Syndrome

Summary: there is an increase in the prevalence of obstructive apnea-hypopnea syndrome (osa) in children for which the pathophysiological explanation is unknown. the main objective is to compare pharyngeal collapsibility in asthmatic children with shs score \> 2.75 or ≤ 2.75 (osa prediction score validated in french). secondary objectives: compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal no in asthmatic children with shs score \> 2.75 or ≤ 2.75. the bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.

detailed measurements and questionnaires: measurement of pharyngeal volume by acoustic pharyngometry in sitting and lying position with calculation of pharyngeal compliance. measurement of ventilation (15 minutes) and transcutaneous pco2 measurement, three apnea tests at the end of the test, hyperventilation test. pft with spirometry and static volume measurement. multiple flow measurement of exhaled no with calculation of bronchial flow and alveolar fraction of no. nasal no measurement. questionnaires for osa: the pediatric sleep questionnaire (psq) and the scr (sleep clinical record). questionnaires for functional respiratory disorder: french hyperventilation questionnaire shape and the nijmegen score

Eligibility criteria:
inclusion criteria: * confirmed asthma established on the notion of typical respiratory functional signs and the notion of reversibility of a bronchial obstruction on previous pft and/or asthma exacerbation diagnosed by the physician in an emergency room. ongoing asthma treatment (including saba on demand) exclusion criteria: * not asthmatic children
serological response to retreatment of serofast early syphilis cases with benzathine penicillin

Conditions: Syphilis

Summary: a continuing challenge to determining the response to treatment of early syphilis (primary, secondary, early latent syphilis) is exemplified by the substantial proportion of patients who fail to achieve serological cure and remain serofast. although retreatment is often done in clinical practice, optimal management remains uncertain due to the paucity of data regarding serological response to retreatment and long-term outcomes. furthermore, the investigators cannot rule out that the gradually increasing seroreversion/serological cure rates may have been due to the natural decline in rapid plasma regain (rpr) titers after initial therapy, rather than due to the additional dose of benzathine penicillin. thus, the investigators would like to conduct a clinical trial to compare the serological response rates of serofast early syphilis cases retreated with three doses benzathine penicillin and absence of any retreatment (control group).


Eligibility criteria:
inclusion criteria: * early syphilis cases determined to be serofast at 6 months after initial treatment exclusion criteria: * human immunodeficiency virus (hiv)-infected * baseline serology showed a nonreactive rpr test * follow-up is inadequate * allergic to penicillin * pregnant woman
assessing the effects of mechanical unloading on repair version-1

Conditions: Heart Failure; Transplant; Failure, Heart

Summary: the mechanism by which heart failure initiates and progresses and the mechanisms of heart repair remain unclear. the left ventricular assist device (lvad) is a therapy to stabilise patients while they await their transplant. the lvad helps pump blood around the body, giving the heart an opportunity to recover. during surgery, the apical core tissue is routinely removed to allow the implantation of the device (this tissue is normally discarded). some patients demonstrate cardiac recovery, allowing the device to be removed without later needing a transplant. as part of the lvad removal procedure, the section around the device might need to be removed (this tissue is normally discarded). to further understand the cellular and molecular mechanisms by which the heart is repaired, the investigators wish to utilise this surplus tissue for research purposes. the collection of this tissue is part of routine treatment and does not represent additional risk for the patient for research purposes. some patients might still require a transplant following vad treatment. the native heart is removed from these patients (routinely discarded) and replaced by a donor heart. the investigators wish to utilise this discarded tissue for research purposes, so that the investigators can identify the cellular and molecular factors involved in cardiac repair and which distinguish responsive and non-responsive patients. heart transplant recipients who require extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for research purposes when performed as part of routine clinical practice. there is no additional risk to the patient for research purposes. heart failure patients scheduled for transplantation (who have not received a vad) will be recruited prior to transplantation and their native heart retained for research purposes. an additional peripheral blood sample will be collected from all patients for research purposes when performed for routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients must be able to provide informed consent; informed consent may be provided retrospectively if this cannot be provided pre-surgery. * patients must be aged between 18--70 years of age. * patients who have been clinically diagnosed with chronic heart failure and require mechanical unloading using a left ventricular assist device. * patients who have received a heart transplant but require extracorporeal membrane oxygenation. exclusion criteria: * patients under 18 or over 70 years of age. * patients unable to provide informed consent. * patients who are prisoners.
development of a culturally tailored resilience-building intervention for chinese american's advance care planning discussions

Conditions: Advance Care Planning; Neoplasms; Heart Diseases

Summary: less than 15% of chinese americans complete advance directives. that is less than half of the 37% completion rate in the us general population. this disparity in the use of advance care planning between white americans and chinese americans may extend to disparities in end-of-life care. to address such disparities in end-of-life care, we will develop and assess the acceptability of a culturally tailored resilience-building intervention to help chinese americans with cancer or heart disease and their family caregivers engage in advance care planning discussions.

the overall objective of this cross-sectional pilot study is to develop a culturally tailored resilience-building intervention for chinese americans with cancer or heart disease in chicago. a qualitative analysis of semi-structured interviews will be conducted to identify how religious leaders addressed death-related topics with chinese americans with cancer or heart disease in chicago. in addition, a usability test of a resilience-building intervention prototype will be conducted to to understand the feasibility and acceptability among 18 pairs of chinese americans and their family caregivers (9 pairs with cancer and 9 pairs with heart disease).

Eligibility criteria:
inclusion criteria for patient participants: * age ≥ 18 years of age * having a cancer diagnosis or a heart failure diagnosis documented in the electronic medical record * being able to read and respond to questions in english or mandarin * having a family caregiver who is responsible for the care and willing to participate in the study * being of non-hispanic asian race/ethnicity exclusion criteria for patient participants: * having cognitive impairment per a short portable mental status questionnaire with more than 3 errors * having received heart transplantation or a left ventricular assist device • having completed an advance directive * being born in the us inclusion criteria for identified family caregivers: * age ≥ 18 years * being able to read and respond to questions in english or mandarin * being identified by the patient as a family caregiver
the therapy of large endometrioma

Conditions: Endometrioma; Endometriosis Ovary

Summary: endometrioma's prevalence is between 23 and 55%. it causes pelvic pain, decrease fertility and ovarian reserve. currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve. in lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy. this protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above. the aim of this study is to assess if cyst drainage associated with gnrh agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone


Eligibility criteria:
inclusion criteria: * endometrioma size ≥ 6cm determined by mri or ultrasonography * women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis. * cyst single or bilateral exclusion criteria: * cyst with radiographic or macroscopic in laparoscopy atypia * pregnancy * patient with contraindication to gnrh agonist (enantone® 3,75 mg et decapeptyl® 3 mg) * patient with contraindication to laparoscopy * patient with contraindication to general anesthesia * subject refusing to participate in the study

Keywords: endometriomas measuring 6 cm or more ovarian endometrioma laparoscopic drainage recurrence amh gnrh agonist therapy
the efficiency of computer guided ridge splitting using piezosurgery in horizontally deficient posterior mandible

Conditions: Edentulous Patients; Atrophic Posterior Mandible With Insufficient Width

Summary: the use of implants has significantly increased prosthetic options for edentulous patient. however, implant placement in the posterior mandibular region is often hampered significantly by insufficient atrophic width limitations

ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. the buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations. ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. this technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically. in the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. in this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption. as guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.

Eligibility criteria:
inclusion criteria: * patients with edentulous posterior area of the mandible insufficient width less than 5m, both sexes. * no intraoral soft and hard tissue pathology * no systemic condition that contraindicate implant placement. exclusion criteria: * heavy smokers more than 20 cigarettes per day. * patients with systemic disease that may affect normal healing. * psychiatric problems. * disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site. * immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
a study to assess the safety and tolerability of sss11 in healthy subjects.

Conditions: Gout

Summary: sss11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kda peg molecules. the purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose sss11 administered intravenously in healthy volunteers.

objectives: primary: • to assess the safety, tolerability of single dose sss11 in healthy subjects secondary: • to assess the pharmacokinetics, pharmacodynamics and immunogenicity of sss-11 in healthy subjects enrollment and number of arms (planned): 40 subjects will be assigned into 5 dosing cohorts (1.5, 3, 6, 12 and 24mg) with 5-10 subjects each. original primary outcome measures: safety: physical exam，ecg，clinical laboratory tests，ae，sae tolerance assessment：mdt，dlt original secondary outcome measures: pharmacokinetics: cmax, tmax, auc, cl, vd, t1/2 pharmacodynamics: level of serum uric acid immunogenicity ：anti-sss11, anti-uricase and anti-peg antibodies

Eligibility criteria:
inclusion criteria: 1. males and females, 18-45 years of age at time of consent; 2. subjects are in good health, without any clinical significant symptoms or laboratory test; 3. having a body mass index between 19 and 28 kilogram per meter square (kg/m²); 4. capable of giving written informed consent 5. understanding and being willing to comply with the requirements of protocol, participate to complete the study; 6. having recovered if received a surgery before . exclusion criteria： 1. allergic condition or having the history of allergic reactions to any drugs, pegylated products, or more than two substances; 2. use of any medicine within 4 weeks or shorter than 5 half-lives; 3. use of any medicine within 12 weeks, which is harm to any organ; 4. participated in any other clinical trial within 12 weeks; 5. history of blood donation within 12 weeks; 6. history of glucose-6-phosphate dehydrogenase deficiency; 7. history of catalase deficiency; 8. any significant disease, including but not limited to the following: digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatry system, hematological system, immune system, metabolic system abnormity. 9. abnormal significance clinical laboratory tests within 2 weeks such as routine blood test and urinalysis, blood chemistry, ecg. 10. positive serology for hepatitis b surface antigen , or antibodies to hepatitis c, or hiv and syphilis; 11. pregnancy, planning pregnancy, or breastfeeding; 12. positive pregnancy test; 13. male subject without effective contraception or his partner intend to be pregnant within 6 months; 14. history of mental disorder or disabilities legally; 15. history of alcohol abusing during the last 6 months; 16. more than 5 cigarettes per day during the last 6 months; 17. positive drug abuse or alcohol test; 18. more than 1l of strong tea, coffee or caffeine drink per day; 19. can't understand the content of informed consent form ; 20. any condition, which investigators consider, is not fit for the trial
efficacy of animated videos to foster healthy bladder behaviors in community women

Conditions: Urinary Bladder, Overactive; Urinary Incontinence, Urge

Summary: in daily life, women are exposed to a wide range of challenging situations that can negatively affect toileting management and long-term bladder health. research shows that women engage in behaviors that may lead to unfavorable consequences, such as a worrying sense of bladder urgency or an awkward moment of urine leakage. the investigators surmise that consciously or unconsciously adopted behaviors influence lifelong bladder health, toileting management, and sense of self-efficacy in this arena. adoption of research-supported behaviors that foster bladder well-being for women is dependent on women's access to learning multiple healthy behavioral strategies. studies on personal woman-centered strategies for toileting management and adoption of behaviors that foster bladder health are scarce in the scientific literature. the investigators have published encouraging results of an in-person study with a clinical sample using accessible and enjoyable videos about research-based bladder health behaviors, invented by the co-investigator of this study, janis m. miller. we now launch an additional study of 90 community-based women of midlife age using an online survey methodology that incorporates sending study participants to the website. the study has two main objectives: 1. to determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the confident bladder behavior questionnaire 2. to determine at post-intervention whether behavioral profiles of the respondents have significantly changed after being randomized into one of three groups: group 1: who watch the animated explainer videos within the confident bladder website that are predominantly related to daytime conditions, group 2: who watch the confident bladder website's animated explainer videos predominantly related to sleep/wake conditions and the additional tips and tricks section, and group 3: controls who only receive access to the the confident bladder website at study's end after post-intervention assessments. we will test the following hypothesis: viewing the confident bladder website will demonstrate an effect size at 2-weeks post intervention of greater than 0.5, as determined by comparing number and percentage of research-based behavioral strategies used by the control group to the number and percentage of strategies used by the two intervention groups who were assigned to view different parts of the website.


Eligibility criteria:
inclusion criteria: * must have a u.s. ip address * must be female between age of 40 and 64 * must be enrolled in a study participant panel accessed by qualtrics * must read and speak english exclusion criteria: * nonenglish speakers/readers * does not consent to participate * does not commit to providing thoughtful and honest answers to the surveys

Keywords: prevention learning clinical trials, randomized
combination of cryosurgery and nk immunotherapy for tumors in transplanted liver

Conditions: Liver Tumor; Evidence of Liver Transplantation

Summary: the aim of this study is the safety and efficacy of cryosurgery plus natural killer(nk) immunotherapy to tumors in transplanted liver.

by enrolling patients with tumors in transplanted liver adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nk cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: liver tumor cryosurgery nk immunotherapy
effects of different ara formulations of infant formula on fatty acid status, immune markers and infection rates in infants

Conditions: Healthy Infants

Summary: the clinical trial will investigate the effect of different formulations of ara + 0.4% dha in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. a 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.

this study is a randomized, double-blind, parallel-group study of 0% ara +0.4% dha or 0.76% ara +0.4% dha supplemented infant formula provided to 6 months old healthy infants for 6 months. infants will have been breast-fed or formula-fed prior to enrollment. the difference in total plasma fatty acid ara levels between the two groups at 6 months of supplementation will be measured. parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). all completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.

Eligibility criteria:
inclusion criteria: * singleton infants, * parent of legal age to consent, * willing to feed the child the assigned study formula for the treatment duration, * parent agrees to scheduled blood draws exclusion criteria: * exclusively breastfed or formula-fed beyond 6 months, * difficulty swallowing or other congenital malformation or metabolic anomaly, * taking omega-3 (supplemented) foods, * mother had gestational diabetes or is type ii diabetic, * born at \<37 weeks gestational age, * participating in another study

Keywords: arachidonic docosahexaenoic acid infant formula