Kornimate/medical-research-clean huggingface dataset:
age differences in influenza and herpes zoster vaccine responses (influenza-shingrix)

Conditions: Influenza; Herpes Zoster

Summary: vaccines are used to prevent infectious diseases worldwide. unfortunately, many vaccines, like the flu vaccine, are less effective in older adults. this single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination. exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development.

rationale: vaccination of the older adults is often advised as they are a high-risk population; however, vaccine efficacy generally decreases with age. this is mainly due to a decrease in adaptive immune responses known as immunosenescence, which is a factor influencing the response to influenza vaccination. on the other hand, there are vaccines that show high efficacy (more than 95%) in older adults, one of the most effective being the as01 adjuvanted herpes zoster vaccine, shingrix. the differential immune pathways associated with vaccine responsiveness as well as the immune mechanisms by which adjuvants overcome immunosenescence remain poorly understood. targeting key immune pathways could be a way to improve vaccine efficacy in older adults. objective: to explore immunological features between young and older adults after administration of an adjuvanted herpes zoster (shingrix) or influenza unadjuvanted (fluarix) vaccine that could explain differences in vaccine immunogenicity. study design: a single centre open label, randomised, and partially placebo-controlled trial study population: approximately 140 healthy adults, 80 of which are between 18-35 years old, the other 60 are 60+ years old. intervention: two groups of young and elderly volunteers receive recombinant zoster vaccine (shingrix), while two other groups will receive a quadrivalent influenza vaccine (fluarix). two groups of young volunteers will receive a placebo. main study parameter: to identify immune senescence-related differences contributing to vaccine immunogenicity

Eligibility criteria:
inclusion criteria: * age between 18-35 years old or age ≥60 years old * written informed consent exclusion criteria: * known allergy to (components of) the influenza or herpes zoster vaccine * immunocompromised subjects and subjects with active malignancy within the last two years * previous herpes zoster vaccination in the last year * receipt of any vaccination 4 weeks prior to the start of the study or plans to receive any other vaccination in the first 2 months after inclusion * use of systemic immunomodulatory drugs:steroids, anti-inflammatory biological treatments (e.g. anti-cytokine monoclonal antibodies) * acute or active illness within two weeks prior to the start of the study * pregnant, breastfeeding or planning to become pregnant during the study period

Keywords: vaccination trained immunity immunosenescence inflammaging
acupuncture and integrative care in gynecological surgery

Conditions: Quality of Life

Summary: patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness.the purpose of the proposed study is to explore the impact of complementary and integrative medicine (cim) treatments (including acupuncture) on anxiety, pain, and general qol of patients referred to gynecological oncology surgery. the investigators working hypothesis is that an intensive cim treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.

patients undergoing surgical procedures for gynecological cancer are frequently challenged by intense anxiety prior to surgery, reflecting the accompanying uncertainty regarding the diagnosis, treatment and prognosis of their illness. following operation, pain and other quality of life-related concerns further exacerbate the emotional distress, which may itself aggravate pain and other symptoms. clinical, controlled studied among patients with gynecological cancer undergoing chemotherapy had demonstrated effectiveness of complementary and integrative medicine (cim) treatments for improving quality of life (qol) and related symptoms, such as pain, gastro-intestinal concerns, fatigue, and anxiety. the purpose of the proposed study is to explore the impact of cim treatments (including acupuncture) on anxiety, pain, and general qol of patients referred to gynecological oncology surgery. the investigators' working hypothesis is that an intensive cim treatment program, provided to patients within 24 hours prior to and during surgery will reduce perioperative anxiety and pain, and will reduce the need for intra-operative and post-operative analgesia.

Eligibility criteria:
inclusion criteria: female patients age ≥ 18 years, who were referred to surgery for suspected/established gynecological-oncology cancer at the carmel medical center; patients diagnosed with class1-3 peri-operative risk according to american society of anesthesia. exclusion criteria:unwillingness to sign the research participation form and/or limitations in comprehending the informed consent; during pregnancy; patients with chronic pain treated with opiates within one month preceding surgery.

Keywords: integrative medicine acupuncture gynecological oncology surgery analgesia pain anxiety
a single ascending dose study to characterize the pharmacokinetics, safety, and tolerability of sar441566 in healthy adult japanese male participants.

Conditions: Rheumatoid Arthritis

Summary: this is a cross-over, phase 1, 3-treatment period single sequence study. the purpose of this study is to characterize pharmacokinetics (pk), safety, and tolerability of single ascending oral doses of sar441566 in healthy male japanese participants, 18-55 years of age.

the duration of the study for a participant will be up to approximately 65 days.

Eligibility criteria:
inclusion criteria: * japanese participants whose japanese ethnicity is defined according to the following criteria: born in japan or born outside of japan, and are descendent of 4 ethnic japanese grandparents who were all born in japan. * male participants between the ages of 18 and 55 years, inclusive * certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination including 12-lead ecg, and clinical laboratory tests) * body weight between 50.0 and 100.0 kg, inclusive, and body mass index (bmi) between 18.0 and 30.0 kg/m\^2, inclusive. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, dermatological (including phototoxic dermatitis), osteomuscular, articular, psychiatric, systemic, ocular, immune disorders or infectious disease, or signs of acute illness. * receipt of live (attenuated) vaccines within 3 months and/or non live vaccines (eg, covid-19 vaccination) within 4 weeks prior to first dose on day 1, or planned to receive these vaccines at any time throughout the study. * history of tuberculosis and/or a positive quantiferon-tb gold (qft) test. * positive result on any of the following tests: hepatitis b surface (hbs ag) antigen, anti-hepatitis b core antibody (anti-hbc ab), anti-hepatitis c virus antibody (anti-hcv ab), anti-human immunodeficiency virus 1 and 2 antibodies (anti-hiv1 and anti hiv2 ab), sars-cov-2 * any medication within 14 days before inclusion (before first study treatment administration) or within 5 times the elimination half-life or pharmacodynamic half-life of the medication whichever the longest. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
impact of intermittent hypoxia on neutrophil extracellular traps

Conditions: OSA

Summary: this prospective observational study will enroll 60 moderate-to-severe osa patients (ahi≧15/hour, 30 obese \[bmi\>=27\] \& 30 non-obese \[bmi\<27\]) and 40 age-, gender-, bmi-matched controls without osa. venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (nets) under the effect of pma (phorbol 12-myristate 13-acetate). the test will be repeated if osa patients receive cpap therapy (continous positive airway pressure therapy).

obstructive sleep apnea (osa) is a common disease, affecting around one billion people worldwide. this disorder is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (ih). the severity of osa is gauged by ahi(apnea-hypopnea index), which can be determined by a sleep test, polysomnography. literature revealed osa confers a higher risk for incident pneumonia and sepsis-related adverse outcomes, suggestive of defective immunity in those patients. cpap therapy (continous positive airway pressure therapy) is the mainstay treatment for osa. this research is aimed to investigate the impact of ih on the ability of neutrophils to produce neutrophil extracellular traps (nets). we will enroll 60 moderate-to-severe osa patients (ahi≧15/hour, 30 obese \[bmi\>=27\] \& 30 non-obese \[bmi\<27\]) and 40 age-, gender-, bmi-matched controls without osa. venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce nets under the effect of pma (phorbol 12-myristate 13-acetate).

Eligibility criteria:
inclusion criteria * adults with clinical diagnosis of moderate or severe osa (ahi \>=15/hour) * must be willing to participate in this study and sign permit exclusion criteria * not willing to participate in this study * ever treated with continous positive airway pressure (cpap) or other therapy for osa * age \< 20 years * have comorbid disease or condition, which could impact immunity (such as malignancy, chemotherapy, immune disease, diabetes etc)

Keywords: obstructive sleep apnea intermittent hypoxia neutrophil extracellular traps
validation of indiana's early evaluation hub system

Conditions: Autism

Summary: the investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.

determine whether eye-tracking biomarkers can reliably differentiate young children with and without autism in a community referred sample. the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. differences in metrics between children with and without autism will be compared to validate potential eye-tracking biomarkers. determine whether a combination of clinical (i.e., ee hub pcp measures) and eye-tracking biomarkers can be used to accurately predict autism diagnostic outcome in a sample of young children evaluated for autism in the primary care setting.

Eligibility criteria:
inclusion criteria: young children ages 14-48 months seen at an ee hub and referred for a comprehensive autism evaluation. children must have english-speaking caregivers. children must have a legal guardian that is able to provide consent. exclusion criteria: child is younger than 14 months or older than 48 months. child's caregiver(s) is/are not english-speaking.

Keywords: primary care biomarkers eye-tracking diagnosis
a study of pemetrexed plus oxaliplatin as first line therapy in advanced gastric carcinoma

Conditions: Advanced Gastric Carcinoma

Summary: open label single arm phase ii study of pemetrexed plus oxaliplatin in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 43 patients will be enrolled in this local trial. the primary objective of this study is to determine the response rate of the treatment.schedule for this study is as follows: 6 cycles/21 days of pemetrexed 500 mg/m2 followed by oxaliplatin 120 mg/m2. this study will also include pharmacogenomic and pharmacogenetic investigations in order to assess determinants of efficacy and toxicity of the treatment with pemetrexed and oxaliplatin in the study population.


Eligibility criteria:
inclusion criteria * histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction) * stage iiib or stage iv disease, according to american joint committee on cancer criteria, not amenable to curative surgery or radiation * disease status must be that of at least of one measurable disease as defined by recist criteria. * performance status of 2 on the ecog scale. * adequate organ function including the following: * bone marrow: absolute neutrophil count (anc) \>or equal to 1.5 \* 109/l, platelets \>or equal to 100 \*109/l, hemoglobin \> or equal to 10 g/dl. * hepatic: bilirubin \ or equal to3g/dl. * renal: calculated creatinine clearance major or equal to 45 ml/min (using the standard cockcroft-gault formula). exclusion criteria * no prior palliative chemotherapy for advanced disease * previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed at least 30 days before study enrollment * known or suspected brain metastasis * second primary malignancy (except for in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence) * inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids) 2 days before, the day of, and 2 days after the dose of pemetrexed plus oxaliplatin
visuo-vestibular vr-based stimulation effects on balance and gait in stroke survivors

Conditions: Stroke

Summary: this pilot study aims to evaluate the effect of a specfic virtual-reality-based rehabilitation training in patients with stroke. a total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the fondazione santa lucia irccs in rome, will be included in the present study. participants will be randomized into two groups: a real group and a sham group. both groups will undergo a rehabilitation intervention using an immersive virtual reality system. the real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the sham group will be exposed to the same scenarios but without specific stimuli. all participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. all treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. another aim will be to assess the user's satisfaction with the new proposed protocol.


Eligibility criteria:
inclusion criteria: * subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event) * patients aged between 18 and 80 years * absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (minimentalstate evaluation \> 24) * functional ambulation category ≥ 3 * absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study exclusion criteria: * patients with stroke (less than 6 months from the acute event); * patients aged under 18 and over 80; * presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study; * presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (minimentalstate evaluation ≤ 24); * epilepsy.

Keywords: stroke vestibular rehabilitation virtual reality balance gait quality of life
to assess the level of adherence of subjects receiving saizen® via easypod™ in south korea

Conditions: Growth Disorders

Summary: this is a national, multicentre, observational registry to study adherence and long term outcomes of therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment from hospital in korea in order to assess the level of adherence of subjects receiving saizen® via easypod™.

subjects will be enrolled in a multicenter, longitudinal, observational registry. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program designed to improve their adherence and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: to assess the level of adherence of subjects receiving saizen via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf-1) (i.e. above, below or within normal ranges) * temporal profile of igf-1 and igfbp-3 levels

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristics (smpc) * over the age of \>2 years * under \<18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the registry, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country. exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the summary of product characteristics (smpc) * use of an investigational drug or participation in an interventional clinical study

Keywords: growth disorders saizen easypod™ growth hormone pediatric subject
treatment of mild and moderate cases of gynaecomastia

Conditions: Gynecomastia

Summary: this study aims to compare liposuction and periareolar surgical excision in mild and moderate cases of gynecomastia as regard cosmosis, complications, patient satisfaction, operation time, and hospital stay. this study will be carried out on patients with gynecomastia presented to the plastic surgery department, sohag university, in the period between january 2021 to january 2022 as a retrospective and prospective study. patients will be divided into 2 groups: group a treated with suction-assisted liposuction. group b treated with peri-areolar surgical excision. each group contains 20 patients.


Eligibility criteria:
inclusion criteria: - the age of patients ranges from 18-60yrs. mild and moderate cases of gynecomastia. exclusion criteria: * patients with endocrine causes. patients with genetic causes. severe cases of gynecomastia. patients who refused surgical intervention. patients who are not fit for surgery. patients with chronic illness.
patients undergoing total intracorporeal or extracorporeal anastomosis after segmental resection for deep endometriosis

Conditions: Deep Endometriosis

Summary: impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis undergoing either a totally intracorporeal or extracorporeal procedure

surgery is the treatment of choice for deep endometriosis with bowel involvement and endometriosis nodules will be treated by segmental resection and subsequent anastomosis packing. anastomosis packing with a totally intracorporeal approach may be a successful solution to reduce some of the complications after discoid or segmental resection with conventional laparotomic approach for extracorporeal anastomosis. setting up the colorectal anastomosis with a totally intracorporeal approach represents a surgical method that has been recently introduced but is already approved in terms of safety and reproducibility. however, experience with this technique is currently limited and there is no established consensus regarding patient suitability or data on longer-term outcomes. new studies are therefore needed to further validate the technique and to fully assess its long-term benefits resulting in increased quality of life for operated patients or to identify any associated complications. the aim of the study is therefore to describe the impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis who underwent either a totally intracorporeal or extracorporeal procedure. in addition, the aim is to detect any differences in the duration of the operating time, compare the duration of the postoperative hospital stay and determine the success rate of the totally intracorporeal procedure

Eligibility criteria:
inclusion criteria: * women between 18 and 54 years of age * diagnosis, by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected intestinal involvement * intraoperative indication for segmental resection for intestinal endometriosis * obtaining informed consent for study participation and data processing exclusion criteria: * patients with a known concomitant inflammatory bowel syndrome (inflammatory bowel syndrome) * patients undergoing emergency/emergency surgery

Keywords: endometriosis gynaecology surgery anastomosis segmental resection