Kornimate/medical-research-clean huggingface dataset:
trial of the reactogenicity, safety and immunogenicity of the flu-m vaccine manufactured by fsue spbsrivs fmba

Conditions: Influenza

Summary: to trial the reactogenicity, safety and immunogenicity of the flu-m inactivated split influenza vaccine in volunteers aged 18-60 years

all subjects will be followed up for 21 days post-randomization. the subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Eligibility criteria:
inclusion criteria: * written informed consent of the volunteers to participate in the clinical trial; * healthy volunteers (men and women) aged 18-60 years; * volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits); * if the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period) exclusion criteria: * allergic reactions to chicken protein or any previous influenza vaccination; * leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis b and c, syphilis in the past medical history; * volunteers who received immunoglobulin or blood products within the last 3 months before the trial; * guillain-barré syndrome (acute polyneuropathy) in the medical history; * long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial. * any confirmed or suspected immunosuppressive or immunodeficiency condition; * respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during visit 1; * severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination; * being (or having been) a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary; * acute infectious and/or non-infectious diseases at the time of inclusion in the trial; * exacerbation of chronic diseases; * chronic alcohol abuse and/or use of drugs in the past history; * pregnancy and lactation; * participation in another clinical trial within the last 3 months; * immunization with influenza vaccines in the last 6 months

Keywords: influenza flu vaccine flu-m
biomarker guided intervention for prevention of acute kidney injury

Conditions: Acute Kidney Injury

Summary: this study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.

this study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. the advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (aki) in high risk surgical patients, since clinical signs of aki (rise in creatinine/decline of estimated glomerular filtration rate (egfr), decline of diuresis). if used biomarkers are above a predefined cutoff within \< 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with kidney disease improving global outcomes (kdigo) guidelines. in the intervention population patients receive individual volume therapy (= balanced electrolyte solution (ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (cvp).

Eligibility criteria:
"inclusion criteria": * major surgery with a duration \> 4 hours plus one of the following criteria: * age \> 75 years, or * sepsis, or * shock, or * polytrauma, or * need for invasive ventilation or catecholamines, or * intra-operative application of contrast-medium, or * preexisting chronic kidney disease (ckd1-4), * informed consent exclusion criteria: * age \< 18 years, * end stage renal disease (esrd), * preexisting dialysis, * withdrawal of consent, * pregnancy, * breastfeeding

Keywords: renal replacement therapy
a phase 2 study of wu-cart-007, an anti-cd7 allogeneic car-t cell therapy in t-cell acute lymphoblastic leukemia and lymphoblastic lymphoma

Conditions: T-cell Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma

Summary: the main purpose of this study is to evaluate the composite complete remission rate (crc) of wu-cart-007 in relapsed/refractory (r/r) t-cell acute lymphoblastic leukemia (t-all)/lymphoblastic lymphoma (lbl) patients and to evaluate the efficacy of wu-cart-007 to induce complete minimum residual disease (mrd) negative response

this is a phase 2, single-agent study in patients with r/r t-all/lbl and t-all/lbl in remission but remaining mrd positive. the study is divided into 2 disease cohorts. the relapsed/refractory (r/r) cohort will evaluate patients with relapsed or refractory disease, defined as ≥5% blast in the bm and/or extramedullary disease (emd) only. an exploratory mrd positive cohort will evaluate patients in complete remission with mrd positive disease (\>0.1 but \< 5% blasts in the bm) data for each age group will be reviewed by the data safety committee (dsc) following enrollment of 12 patients.

Eligibility criteria:
key inclusion criteria: * disease criteria: evidence of t-all or t-lbl, as defined by world health organization (who) classification, and either relapse/refractory or mrd positive, defined as: * relapsed or refractory cohort: disease defined by bone marrow with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (emd). * minimal residual disease (mrd) cohort: evidence of mrd, defined as \< 5% blasts in bone marrow but ≥ 0.01% blasts determined by central laboratory flow cytometry assay * adequate organ function * age: lower age limit of ≥ 1 year. * eastern cooperative oncology group (ecog)/karnofsky performance status 0 or 1/60 and above at screening (adults age \> 16) or lansky performance status 60 and above (pediatrics/ adolescents age ≤16). key exclusion criteria: * treatment with any prior anti-cd7 therapy. * patients with decompensated hemolytic anemia. * presence of grade 2 to 4 acute or extensive chronic gvhd requiring systemic immunosuppression (e.g. steroids). grade 1 gvhd not requiring immunosuppression or grade 2 skin gvhd if treated with topical therapy only are acceptable.

Keywords: car-t therapy
the impact of culture in cognitive behavior therapy (cbt) for patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease (IBD); Cognitive Behavior Therapy

Summary: introduction inflammatory bowel disease (ibd), which includes crohn's disease and ulcerative colitis, is a chronic condition that affects the gastrointestinal tract and has a significant impact on patients' quality of life (qol) and mental health(barberio, zamani et al. 2021). cognitive behavioral therapy (cbt) has been recognized as a potential therapeutic approach to address the psychological comorbidities associated with ibd(seaton, hudson et al. 2024). however, the effectiveness of cbt in ibd is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes(naeem 2019). the effectiveness of cbt in ibd is not solely a clinical issue but is also intertwined with cultural factors that can influence treatment outcomes . this has implications for the delivery of cbt in ibd care, as cultural beliefs and values can affect help-seeking behaviors and responses to treatment. cultural factors are integral to the successful implementation of cbt in ibd care(hinton and patel 2017, naeem, sajid et al. 2023). further research is needed to understand how cultural adaptations can enhance the efficacy of cbt for ibd patients from diverse backgrounds. it is essential to consider cultural nuances in the development and delivery of cbt to ensure that it is both effective and acceptable to patients with ibd across different cultures. objective: to identify gaps in the current understanding of the role of culture in cbt for ibd, including the variety of cultural contexts and ibd populations studied . to provide insights that can guide clinical practice in offering culturally competent cbt to ibd patients and inform policy decisions regarding mental health services for diverse populations with ibd .


Eligibility criteria:
inclusion criteria: 1. patients over 18 years of age with diagnosed ibd. 2. age: 18 years and older. 3. residing in china, able to verbally communicate and read in chinese, with access to the internet to ensure participation in the online intervention. 4. able to commit to attend the 6weekly sessions of 1 hours' duration. 5. no change in antidepressant medication (dose or type) within 3 months of trial onset. exclusion criteria: 1. individuals scheduled for major surgery in the next 3 months. 2. current psychological treatment. 3. individuals with severe schizophrenia/psychotic disorder.

Keywords: inflammatory bowel disease cognitive behavior therapy
study of the zymōt sperm selection method and its effect on embryo ploidy.

Conditions: Infertility, Male; Sperm Count, Low

Summary: it has been described that 11% of men with semen values within the normal range established by the world health organization (who) have sperm dna fragmentation. this has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. the use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. however, these methods use centrifugation in their protocol, a procedure that has been associated with sperm dna damage. the zymōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower dna fragmentation rate without centrifugation of the semen sample. this new sperm selection method maintains all the advantages of conventional techniques, but decreasing dna fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. this quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of dna fragmentation. however up to date there is evidence-based data supporting such improvement. the main objective of the present project is to evaluate the zymōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. at the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of sdf(sperm dna fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes.


Eligibility criteria:
inclusion criteria: * couples undergoing an icsi cycle with pgt-a (preimplantational genetic test for aneuploidy). * males over 18 years of age whose semen sample meets the basic conditions predetermined by the zymōt multi 850µl chip. * fresh semen samples. * embryos are to be deposited in a time-lapse incubator. * women over 37 years of age who have obtained in follicular puncture a number of mii oocytes greater than or equal to 4. exclusion criteria: * males with severe asthenozoospermia (\<10% progressively motile spermatozoa), globozoospermia (spermatozoa with morphological alterations and lack of acrosome) and/or azoospermia (absence of spermatozoa in the ejaculate). * seminal samples obtained by testicular biopsy. * samples incubated with calcium ionophore. * males and females with previously known abnormal karyotype. * oocytes coming from the oocyte donation program.

Keywords: zymöt sperm fragmentation embryo development euploidy
control of edema in the knee in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis; Edema; Edema Leg

Summary: the aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.

this study will be a prospective randomized controlled study. it is planned to include 75 patients with knee osteoarthritis in this study. it was categorized as osteoarthritis(oa) stages according to kellgren-lawrence criteria. patients were randomly divided into three groups. the investigators first group is the control group (kg) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the kg. the third group will be given classical massage in addition to the classical physical therapy applied to the kg. the treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. the data obtained will be analyzed statistically.

Eligibility criteria:
inclusion criteria: * being between the ages of 30-65 * patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to kellgren-lawrence criteria(1) and also with measurable edema exclusion criteria: * inability to continue treatment regularly * situations that prevent you from doing the exercise * inflammation that interferes with massage.

Keywords: massage
recombinant zoster vaccine in young adult solid organ transplant recipients

Conditions: Varicella Zoster

Summary: this goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. in this study, participants will receive the recombinant zoster vaccine. they will be monitored for adverse events and tested for antibody and cellular immunity.

this is an open-label, non-blinded study to assess the safety and immunogenicity of the recombinant zoster vaccine (rzv) in young adult recipients of solid organ transplants (heart, liver, kidney). after obtaining consent, the patient will have pre-vaccine baseline varicella zoster virus (vzv) anti-ge antibody testing performed by the weinberg lab and then will be given first dose of vaccine. participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. testing for both antibody and cellular immunity to vzv will be performed throughout the study. telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of vzv reactivation, any vaccine-related side effects or any signs of acute rejection.

Eligibility criteria:
inclusion criteria: * 19 years of age or older and willing to provide written informed consent for the study participation. * prior recipient of solid organ transplant more than one year prior to participation. * stable immunosuppressive medication regimen for last 6 months prior to participation * participant must have a working telephone number, email address or patient electronic health record (ehr) portal access and be willing to be contacted for study follow-up by any of these means. * for participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose. exclusion criteria: * active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection. * more than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment * history of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components * receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mrna vaccine 30 days before/after dose #1 * history of herpes zoster, primary varicella or vzv vaccination within past 1 year prior to study entry * active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine * febrile illness with temp ≥39°c and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day 1. * any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

Keywords: solid organ transplant vaccine
patent foramen ovale in children with migraine headaches

Conditions: Migraine Headaches

Summary: this study will be the first to provide data about the relationship between pfo and migraine in children. by establishing the actual prevalence, we will better understand if pfo plays a role in the occurence of pediatric migraine and, thus, provide the incentive to perform additional studies evaluating whether pfo closure is an effective treatment option for pediatric migraine. for children with migraine headaches, discovering novel and effective treatments would be life altering.

specific aim 1 using contrast transthoracic echocardiography, compare the prevalence of a pfo in children with migraine headache with the established incidence of pfo published for the general population. specific aim 2 using contrast transcranial doppler, examine the relationship between the degree of right to left atrial shunting with the presence or absence of aura in children with migraine.

Eligibility criteria:
inclusion criteria: * greater than or equal to six years of age and less than 18 years of age. * diagnosis of migraine headache based on the international headache society criteria. * english speaking patients (and parent/guardians where appropriate). * signed informed consent/assent (as appropriate) given by patient, parent or legal guardian. exclusion criteria: * inability to cooperate with imaging studies. * known congenital heart disease. * parent or guardian is unwilling to have their child undergo contrast echocardiography.

Keywords: children migraine headaches
prospective and retrospective, non-interventional study to evaluate the safety and effectiveness of obizur in real-life practice

Conditions: Acquired Hemophilia A

Summary: the study addresses the safety, utilisation and effectiveness of obizur in the treatment of bleeding episodes in real-life clinical practice in europe and the united states.


Eligibility criteria:
inclusion criteria: * adult participant (or legal representative) is willing to provide informed consent * participant is being treated or was treated (treatment initiation within 30 days) with obizur in routine clinical practice exclusion criteria: * participant has known anaphylactic reactions to the active substance, hamster protein or to any of the following excipients: polysorbate 80; sodium chloride; calcium chloride dihydrate; sucrose; tris base; tris hcl; tri-sodium citrate dihydrate; sterilized water for injections * participant has participated in a clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device at study entry
quality of recovery after childbirth

Conditions: Quality of Life; Childbirth; Maternal Health

Summary: in this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. the investigators will identify risk factors, especially those that are modifiable and associated with a poorer obsqor score and hence a poor quality of recovery after delivery. this data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

traditional postpartum outcome measures do not describe the patient experience or quality of recovery (qor) after childbirth. a recent obstetric-specific recovery tool (obsqor-10) has been developed to assess the quality of recovery in patients in various mode of delivery on aspects of pain, drug side effects, comfort, control, ability to hold and feed the baby, independent mobilization and achievement of personal hygiene. however, this questionnaire is not yet validated in asian population, especially in chinese- and malay-speaking patients. the investigators aim to investigate the validity, reliability, feasibility, and responsiveness of the chinese and malay translated versions of obsqor-10. the investigators will first perform a pre-test in 5-10 patients for each language, of which an interview will be conducted to seek for their feedback and suggestions. modification of questionnaire will be done if necessary, followed by recruitment of 112 patients at postpartum day 1 to fill in the chinese/malay translated obsqor-10 and other questionnaires related to their mood, anxiety and pain. in this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. the investigators will identify risk factors, especially those that are modifiable and associated with a poorer obsqor score and hence a poor quality of recovery after delivery. this data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

Eligibility criteria:
inclusion criteria: * aged 21-50 years old; * able to read and understand written chinese; * primiparous and having singleton pregnancy; * delivered via spontaneous vaginal delivery, or elective cesarean delivery; * ≥38 gestational week. exclusion criteria: * failed neuraxial analgesia in those receiving elective cesarean delivery; * general anaesthesia; * intrapartum cesarean delivery; * women whose infants have died; * mother or baby requiring icu after delivery; * assisted/ operative vaginal delivery.