Kornimate/medical-research-clean huggingface dataset:
cd19-car-t2 cells for cd19 positive b cell malignancies

Conditions: B Cell Leukemia; B Cell Lymphoma

Summary: chimeric antigen receptor t cells (car-t cells) has been recognized a promising treatment option for treating b cell derived malignancy. the purpose of this study is to evaluate the efficacy and safety of third-generation anti-cd19 car t-cells (cd19-car-t2 cells) in patients with cd19+ relapsed or refractory (r/r) b-cell acute lymphoblastic leukemia (b-all) and b-cell non hodgkin lymphoma (b-nhl).


Eligibility criteria:
inclusion criteria: * patient with relapsed and/or refractory cd19+ b-cell leukemia or lymphoma * eastern cooperative oncology group (ecog) performance status \<2 * alt/ ast \<3 x normal * bilirubin \< 2.0 mg/dl * creatinine \< 2.5 mg/dl and less than 2.5x normal for age * lvef\< 45% * accept white blood cell collection * provide informed consent exclusion criteria: * previous treatment with investigational gene or cell therapy medicine products * active hepatitis b , hepatitis c or hiv infection * uncontrolled active infection * presence of grade 2-4 acute or extensive chronic gvhd * any uncontrolled active medical disorder that would preclude participation as outlined. * received non-diagnostic purposes major surgery within the past 4 weeks * participated in any other clinical study within the past 4 weeks * used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * pregnancy or breast-feeding women * use of prohibited drugs: * steroids: therapeutic doses of steroids must be stopped \> 72 hours prior to cd19-car-t2 cells infusion * allogeneic cellular therapy: any donor lymphocyte infusions (dli) must be completed \> 4 weeks prior to cd19-car-t2 cells infusion * gvhd therapies: any drug used for gvhd must be stopped \> 4 weeks prior to cd19-car-t2 cells infusion * any situation that may increase the risk of the test or interfere with the test results

Keywords: car-t
the long-term immunogenicity of an inactivated split-virion 2009 pandemic influenza a h1n1 vaccine

Conditions: Influenza

Summary: the aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.


Eligibility criteria:
inclusion criteria: 1. different age groups from 18 to 60 years, with normal intelligence and health. volunteers (or their guardians) are well informed of the situation and sign the consent 2. vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy 3. requests of clinical research program can be obeyed 4. no other protective product is inoculated in last week 5. axillary temperature below 37 degrees celsius exclusion criteria: 1. volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination 2. volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg 3. history of progressive or severe neurologic disorder 4. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 5. known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation 6. asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids 7. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 8. history of thyroidectomy or thyroid disease that required medication within the past 12 months 9. serious angioedema episodes within the previous 3 years or requiring medication in the previous two years 10. guillain-barre syndrome 11. self-reported seropositivity for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c 12. any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment 13. axillary temperature ≥ 38.0 degrees celsius within 3 days of intended study vaccination 14. any conditions may influence the evaluation

Keywords: h1n1 vaccine immunogenicity safety
a phase 2 study of ono-2808 in patients with multiple system atrophy

Conditions: Multiple System Atrophy (MSA)

Summary: this is a phase 2, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of ono-2808 in patients with msa. this is the first study of ono-2808 in patients with msa.

the purpose of the study is to evaluate 3 doses of ono-2808 compared to placebo in msa patients, including: 1) safety and tolerability, 2) pharmacokinetics, and 3) changes in clinical outcome assessments (coa) and biomarkers considered to be related to the pharmacodynamics and potential efficacy of ono-2808.

Eligibility criteria:
inclusion criteria: 1. female or male patients with a diagnosis of clinically-established or clinically-probable msa according to the novel movement disorder society (mds) criteria for msa diagnosis (2022), including patients with msa of either subtype (msa-p or msa-c). 2. patients at the early stages of the disease, defined as a maximum of 5 years since the onset of one of the following symptoms associated with msa: * parkinsonism * ataxia * orthostatic hypotension and/or urinary dysfunction 3. patients with an anticipated survival of at least 3 years in the opinion of the investigator. 4. patients who are able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps and then to turn around and walk at least another 10 steps. use of assistive devices (e.g., walker or cane) is allowed. 5. ability to swallow oral medication and be willing to adhere to the study intervention regimen. exclusion criteria: 1. pregnant or lactating females. 2. patients with a clinically-significant or unstable medical or surgical condition other than msa that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study (e.g., pulmonary, cardiovascular \[including bradyarrhythmia\], macular edema, and significant renal or hepatic dysfunction). 3. neurological diseases/disorders other than msa, such as parkinson's disease, dementia with lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, normal pressure hydrocephalus, pharmacological, or post-encephalitic parkinsonism. 4. patients with documented liver diseases or cirrhosis. 5. positive results at screening for active viral infections that include positive human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) and hepatitis b core antibody, and hepatitis c virus (hcv). 6. patients with suicide ideation according to the investigator's clinical judgment per the columbia suicide severity rating scale (c-ssrs) at screening or who have made a suicide attempt in the 6 months before screening.
effect of dental treatment on children's growth

Conditions: Dental Decay

Summary: severe dental decay affects children physically, emotionally, socially and thereby impacts on their quality of life. evidence from developed countries showed that children with severe dental decay weighed less than their peers and following dental treatment children's growth and quality of life improved. this suggests that treatment of severe dental decay may enhance growth and wellbeing. a study was carried out in saudi to test that hypothesis.


Eligibility criteria:
inclusion criteria: having dental caries with at least 2 teeth with pulpal involvement. exclusion criteria: 1. children with illness known to adversely affect growth. 2. children who required urgent dental treatment. 3. children on regular nutritional supplements. 4. anaemic children with hb levels lower than 11.0 g/dl
the effect of pilates on muscle strength, balance performance, gross motor skills, social skills in children with asd

Conditions: Autism

Summary: the purpose of this randomized controlled study was to determine the effects of pilates training by comparing the effects of aerobic training on muscle strength, balance performance, gross motor skills and social skills in children with autism. as a result of this study aerobic training and pilates training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in aerobic training. pilates training could be considered as an alternative training to increase physical activity in children with autism.

the purpose of this randomized controlled study was to determine the effects of pilates training by comparing the effects of aerobic training on muscle strength, balance performance, gross motor skills and social skills in children with autism. as a result of this study aerobic training and pilates training are both effective in the improvement of balance performance and gross motor skills in children with autism, with more improvement in muscle strength in aerobic training. pilates training could be considered as an alternative training to increase physical activity in children with autism. this study will answer whether pilates practice has an effect on muscle strength, balance performance, gross motor skills and social skills in children with autism. demographic information of the participants was recorded.muscle strength for shoulder flexors, hip flexors and knee extensors were performed with hand-held dynamometry.the one-legged standing test was used to evaluate static balance performance.test of gross motor development (tgmt-2) was used to evaluate gross motor skills of participants. the autism social skills profile turkish form (assp- t) was used to evaluate social skills of participants.

Eligibility criteria:
inclusion criteria: * being diagnosed with autism, * not having physical disabilities or neurological disorders, * having the ability to follow the instructions given during evaluations and training, * having the ability to perform the requested training exclusion criteria: * not being a volunteer, * having a health problem that prevents exercise.

Keywords: autism pilates training aerobic training gross motor skills muscle strength social skills
value-based medicine (vbm) for lung cancer

Conditions: Lung Cancer

Summary: this is a prospective observational monocentric trial. the primary endpoint is the validation of predictive models. these predictive models will be used to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

the goal of this prospective observational monocentric study is to validate a predictive models in patients with diagnosis of non-small cell lung cancer eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy. participants will be asked to complete quality of life questionnaires before surgery and then at 30 days, 4 months, 8 months and 12 months post discharge. the informations collected through questionnaires, along with clinical data will be used to validate the predictive models created. these models will then be utilized to develop a personalized clinical-functional risk profile for estimating in advance, prior to surgery, the probability for a patient to experience surgical complications, pain, fatigue, dyspnea, as well as issues related to physical function, role, social, and emotional well-being, up to 12 months post-discharge.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * patients with diagnosis of non-small cell lung carcinoma * only patients eligible for surgical lung resection (lobectomy/typical and atypical segmentectomy) with or without neo-adjuvant and adjuvant therapy * diagnosis of primary non-small cell lung cancer * signed informed consent * patients must be available for follow-up exclusion criteria: * patients with benign lesion * patients with recurrence who have already undergone lung surgery * conditions/pathologies that prevent the ability to give consent
human papillomatosis genotyping of children in thailand

Conditions: Recurrent Laryngeal Papillomatosis; Human Papilloma Virus

Summary: the purpose of the present study was to identify risk factors for more severe juvenile recurrent respiratory papillomatosis (rrp) through prospective evaluation of a pediatric population in thailand by the employing a protocol that includes staging of disease severity using above mentioned staging system at the time of each endoscopic debridement, as well as human papilloma virus (hpv) genotyping.

recurrent respiratory papillomatosis is caused by human papilloma virus and is the most common benign laryngeal neoplasm in children. although rrp is rarely fatal, the disease requires prolonged, extensive medical and surgical treatment, and causes physical and emotional suffering in affected children and their families. although recurrent respiratory papillomatosis is a relatively unusual problem, it accounts for significant health are expenditures.the goal of management of rrp is control of the disease, preservation of the voice and prevention of major complication .the purpose of study will identify risk factors for more severe juvenile rrp through prospective evaluation of a pediatric population in thailand by the employing a protocol that includes staging of disease severity , as well as hpv genotyping. objective: * to identify the genotypes of hpv isolated from thai rrp patients * to compare staging and severity with hpv genotypes * to correlate the following characteristics of the thai rrp patients with the hpv genotypes

Eligibility criteria:
inclusion criteria: * patients have active laryngeal papillomatosis . * patients have developed this infection before the age of 18 years old. exclusion criteria: * children whose families do not sign an informed consent to enter into study. * children whose families anticipate discontinuing care at a participating institution during the study period.

Keywords: rrp hpv
rejuvenated, washed packed red blood cells in pediatric cardiac surgery

Conditions: Heart Defects, Congenital

Summary: blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). the purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. stored blood undergoes some changes that may make it less effective in achieving this goal. the purpose of this study is to see if restoring important energy molecules (atp and 2,3,dpg) in stored red blood cells before they are transfused, with a rejuvenating solution (rejuvesol), offers any advantages to children over standard blood transfusion. this is a food and drug administration (fda) approved process that is described by the american association of blood banks for prolonging blood storage but not used for everyday transfusions. the investigators want to use this process to improve blood transfused to children undergoing heart surgery. although rejuvesol has been previously approved by the fda, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. use of rejuvesol in this study is considered investigational. this is a pilot study and data will be collected for future protocol development.


Eligibility criteria:
inclusion criteria: * children greater than 2.5 kg and less than 15kg (i.e. requiring blood for cpb prime) * children undergoing cardiac surgery with cardiopulmonary bypass exclusion criteria: * refusal of blood products * end-stage renal disease * planned avoidance of cpb * use of non- heparin anticoagulants * participation in an experimental drug or device protocol within 30 days * existing hemoglobinopathy * allergy requiring washed rbcs * immunocompromise requiring special blood product treatment.

Keywords: rejuvenated packed red blood cells
parents and tots together: a family-based obesity prevention intervention

Conditions: Obesity

Summary: the obesity epidemic has spared no age group, including our youngest children. my and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. to capitalize on this enthusiasm, i will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program. the overall goal of this study is to assess parents and tots together (ptt), a family-based intervention to prevent obesity among children age 2 through 5 years. to achieve this goal, my colleagues and i will conduct a randomized controlled trial (rct) among ethnically diverse, primarily low-income families. our specific aims are to: 1. determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (bmi) among children after a 3- month intervention and a 9-month follow-up period (primary outcome). 2. determine the extent to which the intervention, compared with a control condition, results in: 1. improved parent general parenting behaviors, i.e., increased use of positive discipline strategies. 2. improved parent feeding practices, i.e., increased responsiveness to child satiety cues. 3. improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.


Eligibility criteria:
inclusion criteria: * parents who have a child aged 2-5 years * respond to interviews and questionnaires in english or spanish exclusion criteria: * any families who plan to move during the study period * children or parents with severe health conditions that would prohibit them from participating in study activities
a cross-sectional study of serum levels of adipocytokines in children with febrile seizures

Conditions: Febrile Seizure

Summary: febrile seizure (fs) is a common neurological condition in children, affecting 2 - 14% of children. fs is defined as seizures occurring in a child aged from six months to five years that is accompanied by a fever (≥38°c) without central nervous system infection. fs is classified into simple febrile seizure (sfs) and complex febrile seizure (cfs). sfs accounts for 70-75% of fs cases and is characterized by being generalized, duration of less than 15 minutes, occurs once in 24 hours, and no previous neurologic problems. we aim to investigate serum levels of adipocytokines, specifically leptin, adiponectin, and il-6, in children with fs.

the study will include three groups of children (100 for each): children with febrile seizures (group 1), febrile children without seizures (group 2), and healthy control children (group 3). children included in this study will undergo: * thorough medical history taking: including age, gender, and seizure details for children with febrile seizures (e.g., type, duration, recurrence). * physical examination: including vital signs (particularly temperature) and comprehensive neurological examination). * laboratory investigations: * routine investigations: complete blood count, c-reactive protein, blood glucose, serum electrolytes (sodium, potassium, calcium, and magnesium), liver and kidney function tests. * serum leptin and adiponectin: venous blood samples (3 ml) will be obtained from children with fs (within 3 hours of seizures) as well as the two control groups. serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. the serum will be immediately separated and stored at -70 ℃. serum leptin and adiponectin will be assessed through enzyme-linked immunosorbent assay (elisa) kits according to the manufacturer's instructions.

Eligibility criteria:
inclusion criteria: * age from 6 months to 6 years. * seizures. * fever (≥38°c) due to acute infection. * presented for routine check-up. exclusion criteria: * central nervous system infection. * epilepsy. * previous neurological abnormalities. * inborn errors of metabolism. * immunological diseases. * endocrinal diseases (e.g., diabetes mellitus). * obesity. * eating disorders. * gastrointestinal disorders (e.g., diarrhea). * seizures. * previous neurological abnormalities * any illness in the last month
low grade lymphoma

Conditions: Indolent Lymphoproliferative Disorders

Summary: the purpose of this study is to assess the seroconversion rate and the cellular immune response after vaccination against hepatitis b virus in patients with lymphoproliferative syndrome like chronic lymphocytic leukemia stade a and follicular lymphoma without of treatment criteria.

rituximab is a human-mouse chimeric monoclonal antibody that targets the b-cell cd20. it is an indispensible drug for the treatment of b-cell lymphoproliferative syndrome which induced immunosuppression. so, the infectious complications increase. reactivation of hepatitis b virus is one such complication that can lead in asymptomatic hepatitis to death. prevention of hepatitis b reactivation is recommended like using nucleoside analog for patients with chronic hepatitis b or occult hepatitis and vaccination against virus for seronegative patients. the published data about efficacy of hepatitis b vaccination in onco-haematology are rare. therefore, we carried out a prospective study to assess efficacy of hepatitis b vaccination in patients with lymphoproliferative disorder.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * lymphoproliferative indolent type of stage a cll or follicular lymphoma with low tumor burden * no indication of chemotherapy during the seven months of the vaccination protocol. hbv serology negative for hbsag / ab hbs / hbc ab. * no history of vaccination against hepatitis b. exclusion criteria: * indication of immediate chemotherapy. * at least one hbv positive serologic marker . * history of vaccination against hbv. * known neurodegenerative disease. * pregnancy. * febrile infection untreated. * known allergy to any vaccine component.

Keywords: low grade lymphoma follicular lymphoma indolent lymphoproliferative disorders vaccin genhevac b pasteur