Kornimate/medical-research-clean huggingface dataset:
study of high-intensity focused ultrasound (hifu) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for estrogen receptor-positive/human epidermal growth factor receptor 2-negative (er+/her2-) breast cancer (neohunter)

Conditions: ER+/HER2- Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (hifu) combined with toripalimab plus chemotherapy versus chemotherapy as neoadjuvant therapy for er+/her2- breast cancer.

study participants will be randomly allocated to either the experimental group or the control group and receive the following treatments. experimental group: hifu therapy followed by 8 cycles of neoadjuvant immunotherapy and chemotherapy; control group: 8 cycles of neoadjuvant chemotherapy alone. each cycle lasts 21 days. subsequently, all participants will undergo surgery within 6 weeks after completion of neoadjuvant therapy.

Eligibility criteria:
inclusion criteria: 1. female patients aged 18-75 years. 2. invasive breast cancer without distant metastasis, including either t1c-t2 (≥ 2 cm), cn1-cn2, or t3-t4, cn0-cn2. 3. histopathologically confirmed er-positive/her2-negative, pr \< 20% or ki67 ≥ 20%, grade 3 breast cancer. 4. eastern cooperative oncology group (ecog) performance status of 0-1. exclusion criteria: 1. female patients during pregnancy or lactation. 2. diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology. 3. has an active autoimmune disease that has received systemic treatment in the last 2 years. 4. has a known history of human immunodeficiency virus (hiv), hepatitis b, or known active hepatitis c virus infection. 5. has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent. 6. has a known history of invasive malignancy that required systemic treatment in the last 5 years. 7. uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.

Keywords: breast neoplasms high-intensity focused ultrasound pd1 toripalimab nab-paclitaxel epirubicin cyclophosphamide
a qualitative study to assess the content validity of the prescription opioid misuse and abuse questionnaire

Conditions: Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: the purpose of this study is to evaluate the patient usability and reliability of the pomaq survey to evaluate opioid misuse and abuse among adults with chronic moderate to severe pain, including patients who are opioid abusers, non-abusers, as well as non-opioid users

the food and drug administration (fda) has requested, as part of a post-marketing requirement (pmr) for new drug application (nda) holders of extended release/long-acting (er/la) opioids, to conduct a study to develop and validate a measure of the opioid-related adverse events misuse and abuse among patients with chronic pain prescribed long-term opioid therapy. this measure will be used to assess misuse and abuse in pmr study 2065-1a and pmr study 2065-4b. currently, no tool exists to meet this need except for the self-report misuse, abuse and diversion of prescription (rx) opioids questionnaire (sr-mad) which has undergone several rounds of prior content validation. the sr-mad has been modified to meet the needs of pmr studies 2065-1a and 2065-4b, and has been renamed the prescription opioid misuse and abuse questionnaire (pomaq). this study will seek to further develop and validate the pomaq using the the food and drug administration (fda) guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims (fda 2009) as a reference for conducting qualitative research throughout the process of instrument development to ensure the content validity of a measure and to evaluate the comprehensibility of included questions. this qualitative study to evaluate content validity will be conducted prior to the quantitative study to evaluate construct validity

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients who, based on the site investigator's clinical judgment, have chronic moderate to severe pain 3. willing to provide written informed consent 4. able to participate in a one-on-one interview 5. able to read, speak, and understand english and complete all study assessments. exclusion criteria: 1. cognitive, psychiatric or other impairment based on the site investigator's clinical judgment that would interfere with participating in a one-on-one discussion 2. terminal illness with life expectancy \< 6 months.
effects of pitavastatin on insulin sensitivity and liver fat

Conditions: Obesity; Fatty Liver, Nonalcoholic

Summary: hmg co-a reductase inhibitors, commonly called statins, are an effective treatment for dyslipidemia and atherosclerotic heart disease with proven mortality benefit. while the lipid-lowering effects of statins are well-known, other metabolic effects, including effects on glucose tolerance and ectopic fat distribution, are less completely understood. recent studies have shown that some statins may increase the risk of diabetes. further, research has suggested that statins may have some benefit in nonalcoholic fatty liver disease (nafld), a condition associated with obesity that includes increased fat in the liver (steatosis) and, in some cases, inflammation and hepatocellular damage (steatohepatitis). pitavastatin, approved by the united states food and drug administration (fda) in 2009, is the most recent statin to enter the market. unlike most statins, pitavastatin is not primarily metabolized through cytochrome p450 (cyp450), and thus has reduced potential for interactions with other medications that are metabolized by cyp450. previous studies have suggested that pitavastatin may be neutral to glucose homeostasis and may improve hepatic lipid. neither of these effects has been proven definitively, however, and the current proposal aims to characterize in detail the effects of pitavastatin on glucose homeostasis, hepatic steatosis, and steatohepatitis.


Eligibility criteria:
inclusion criteria: 1. men age 40-65yo 2. bmi ≥ 27kg/m2 and waist circumference ≥102cm, high probability risk factors for nafld 3. at least one of the following indicating insulin resistance: fasting glucose ≥100mg/dl and \ 2.0, and/or 2 hour glucose ≥140mg/dl and \<200mg/dl following standard glucose tolerance test. 4. 10-year cardiovascular disease risk ≥5% by american heart association(aha)/american college of cardiology (acc) pooled cohort equations cv risk calculator or ldl ≥ 100mg/dl 5. no use of any statin within 1 year of study entry and not being actively considered for statin therapy by a treating provider. exclusion criteria: 1. diagnosis of diabetes or use of anti-diabetic medications. 2. use of erythromycin, rifampin, cyclosporin, colchicine, or gemfibrozil. 3. use of statin therapy within 1 year prior to study entry as above. use of any other lipid-modifying therapy (including fish oil, fibrates, niacin, gemfibrozil) within 6 months of study entry. 4. contraindication to statin therapy. 5. creatinine \> upper limit of normal or known renal disease 6. ast or alt \> 3 times the upper limit of normal 7. hemoglobin \< 10g/dl 8. contraindication to undergoing a magnetic resonance scan. 9. atherosclerotic cardiovascular disease or low-density lipoprotein cholesterol (ldl-c) ≥ 190mg/dl. 10. triglyceride ≥500mg/dl

Keywords: obesity insulin sensitivity statin (hmg-coa reductase inhibitor) fatty liver
toxicity genetic determinants and response to azacitidine and venetoclax in aml

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this research is to see how certain genetic variations relate to side effects and outcomes experienced while receiving treatment with azacitidine and venetoclax.

this is a prospective pilot study of the association of snps and venetoclax levels with toxicity and response to azacitidine plus venetoclax (aza/ven) as well as pharmacogenomics and venetoclax levels in patients with newly diagnosed aml determined to be unfit for intensive induction. newly diagnosed aml patients over 18 years old who receive aza/ven as standard of care will be eligible for this study. buccal swabs for snps and pharmacogenomic analysis will be collected at baseline. venetoclax peak and trough levels will be obtained during soc aza/ven treatments. participants will be recruited initially at ahwfbccc locations.

Eligibility criteria:
inclusion criteria: * written informed consent and hipaa authorization for release of personal health information. * age ≥ 18 years of age at the time of enrollment * confirmed diagnosis of aml * planned initial treatment with azacitidine and venetoclax * ability to read and understand the english and/or spanish language * as determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study exclusion criteria: * none
soluble dietary fibres in the prevention of type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. this may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration a higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.


Eligibility criteria:
inclusion criteria: * overweight men and women exclusion criteria: * regular smokers, athletes, diabetes mellitus
safety and efficacy study of cd22 car-t cells for relapsed or refractory acute lymphoblastic leukemia

Conditions: B-ALL

Summary: this is an open, single-arm, clinical study to evaluate efficacy and safety of anti cd22 car-t cell in the treatment of recurrent or refractory b-all

the cars consist of an anti-cd22 single-chain variable fragment（scfv）, a portion of the human cd137（4-1bb） molecule, and the intracellular component of the human cd3ζ molecule. prior to car-t cell infusion, the patients will be subjected to preconditioning treatment. after car-t cell infusion, the patients will be evaluated for adverse reactions and efficacy. the main research objectives: to evaluate the safety and efficacy of cd22car-t in patients with recurrent or refractory b-all the secondary research objectives: to investigate the cytokinetic characteristics of cd22car-t in patients with recurrent or refractory b-all

Eligibility criteria:
inclusion criteria: 1. patients with relapsed and refractory acute b-lymphoblastic leukemia who have any of the following: 1. b-all patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation; 2. primary b-all patients who can not be completely relieved by more than two times of repeated chemotherapy; 3. high risk primary b-all patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy; 2. flow cytometry (fcm) showed cd 22 positive in bone marrow or peripheral blood; 3. there should be at least one assessable lesion in b-all patients with simple extramedullary recurrence; 4. the activity state score of the eastern cooperative oncology group (ecog) was less than or equal to 2; 5. the estimated survival time is more than 3 months; 6. need to sign informed consent. exclusion criteria: 1. serious cardiac insufficiency； 2. has a history of severe pulmonary function damaging; 3. other malignant tumors; 4. serious infection or persistent infection and can not be effectively controlled； 5. merging severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis (hbv dna or hcv rna positive); 7. patients with hiv infection or syphilis infection; 8. has a history of serious allergies on biological products (including antibiotics); 9. being pregnant and lactating or having pregnancy within 12 months; 10. any situations that the researchers believe will increase the risks for the subject or affect the results of the study（including a history of serious mental illness, substance abuse and addiction）

Keywords: cd22 car-t， b-all
analysis of motor skills in subjects aged 55 and over: the role of cognitive abilities for planning movement.

Conditions: Mild Cognitive Disorder

Summary: falling is an event that is more frequent and severe in older age. it can lead to a loss of autonomy and a decrease in quality of life. it is therefore important to understand this phenomenon in order to better prevent it. among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. however, the impact of this cognitive decline on motor skills is still poorly understood. the purpose of this research is to study how the changes induced by aging affect motor skills. this would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.


Eligibility criteria:
inclusion criteria: 1. neurotypical subjects group: * person aged 18 to 40 years * person who has given oral consent * affiliated to national health insurance * right-handed person 2. group of elderly neurotypical subjects: * person over 55 years of age * person who has given oral consent * affiliated to national health insurance * no cognitive problems (mmse score \>26) * right-handed person 3. elderly mild cognitive disorder subject group: * person over 55 years of age * person who has given oral consent * diagnosis of mild cognitive disorder made by a neurologist at the centre mémoire ressources et recherche (cmrr) of the university hospital of dijon, following the recommendations of the national institute for aging and alzheimer's association (albert et al., 2011) this diagnosis is based on psychometric tests, brain imaging and the evolution of cognitive disorders, including an mmse test. * right-handed person exclusion criteria: * neurological or psychiatric history with the exception of the tcl group. * follow-up of drug treatment in the last three months that may affect cognitive and/or motor skills. * received a shoulder prosthesis on the dominant side. * received a hip and/or knee replacement less than a year ago. * disabling joint disease of the hip or knee shoulder * protected adults (curatorship, guardianship) * person deprived of their liberty b judicial or administrative decision * pregnant, parturient or breastfeeding woman * major unable to consent
group parent training for adolescent eating disorders

Conditions: Adolescent Anorexia Nervosa; Subthreshold Anorexia Nervosa

Summary: while parents are considered essential for the effective treatment of adolescents with anorexia nervosa, the most effective manner to involve parents in treatment is unknown. given reports of high caregiver burden among parents of this clinical group, finding treatments that minimize parent burden while improving the child's eating disorder symptoms is essential. this investigation will examine the preliminary effectiveness of a parent skills group and adolescent skills group compared to family therapy for the treatment of adolescent anorexia nervosa. the target of this intervention is the improvement of eating disorder symptoms in the child and improving self-efficacy, emotion regulation, and perceived burden in the parent. the effectiveness of this experimental treatment group (group parent training for the parents/adolescent skills training for the adolescent) will be compared to the maudsley model of family therapy. the effectiveness of the group program will be examined by exploring changes within individuals over time as well as via comparisons across treatment conditions. results from this investigation will be used to calculate treatment effect sizes in the design of a larger, fully powered, randomized clinical trial.


Eligibility criteria:
inclusion criteria: * age 11-18 years old * living at home * meet criteria for anorexia nervosa or subthreshold anorexia nervosa exclusion criteria: * no active psychosis * no current suicidality * medically safe for outpatient treatment

Keywords: anorexia nervosa group parent training caregiver burden eating disorders treatment
ventilator aspiration with pneux (pneux vs standard care feasibility rct)

Conditions: Ventilator Associated Pneumonia; Aspiration; Infections; Ventilator Lung

Summary: this is a single centre, open-label, feasibility randomised controlled trial. the study aims to assess the feasibility of conducting an rct to compare the pneux ett with standard care in hospitalised patients requiring mechanical ventilation. the patient population for this study are those who are experiencing critical illness requiring intubation and ventilatory support. patients will be randomised in equal proportions into one of 2 arms: to be intubated using a venner pneux endotracheal tube (ett) or using the standard tube. for this feasibility study, a total of 50 patients will be randomised into two groups (25 in each). all patients will be recruited at a single site (university hospital of wales, part of cardiff \& vale uhb). the study will investigate several feasibility measures including recruitment, delivery of the intervention (including device-related adverse events), acceptability and adherence to the intervention and sampling, use of peptest to measure microaspiration events, rate of pepsin positive samples, rate of tracheobronchial colonisation, volume of sub-glottic aspirate, rate of vap, length of icu and hospital stay, demonstrate the validity of study documentation and provide preliminary data for 50 patients. the data will inform the pilot and main phase of the study.


Eligibility criteria:
inclusion criteria: * 18 years old (no upper age) * patient required endotracheal intubation * expect to remain intubated for 24 hours post randomisation exclusion criteria: * the person intubating the patient assesses that the patient has already aspirated. * gcs 7 or less on presentation to hospital * patient is pregnant * patient has tracheostomy * patient has gastrectomy * patients who have been intubated prior to arrival at hospital * patients who are already endotracheally intubated and require a tube change.

Keywords: ventilator associated pneumonia endotracheal tube aspiration
evaluation of blowing exercises utilizing a breathing exercise device in otitis media with effusion

Conditions: Otitis Media With Effusion (OME); Otitis Media With Effusion in Children; Breathing Exercise

Summary: otitis media with effusion (ome) is a common condition in which fluid collects behind the eardrum without signs of infection. it can cause hearing problems and discomfort. many children get better with medication, but in some cases, the condition becomes long-term and may require surgery. ome is caused by dysfunction of the eustachian tube, which helps balance the air pressure between the middle ear and the back of the nose (nasopharynx). restoring proper airflow to the middle ear is important. in addition to medication, physicians often recommend pressure-based exercises such as balloon-blowing, swallowing exercises, the valsalva maneuver, or chewing gum. these exercises help open the eustachian tube by creating positive pressure in the nasopharynx, which can improve ear ventilation and reduce symptoms by relieving negative pressure in the middle ear. this study will test the effect of a breathing exercise device called airofit pro™ (airofit, copenhagen, denmark) in children with ome. currently, there are no studies in the medical literature showing whether airofit pro™ is effective in treating ome. if this study finds that using the airofit pro™ helps children recover more quickly, it could be an important step in preventing chronic ome and reducing the need for surgery.


Eligibility criteria:
inclusion criteria: * age between 4 and 10 years. * presence of documented ome findings in otoscopic examination and audiological measurements. * absence of any ear disease that could affect audiometric or tympanometric findings. * legal guardian consent must be obtained. exclusion criteria: * presence of active upper respiratory infection symptoms. * presence of a chronic ear disease that could affect study outcomes (e.g., chronic otitis, tympanosclerosis, etc.). * presence of diseases affecting respiratory system functions (e.g., pneumonia, pleurisy, empyema, pneumothorax, hemothorax, hydrothorax, atelectasis, pulmonary edema, pulmonary hypertension, emphysema). * inability to perform respiratory exercises due to a general condition disturbance. * presence of psychomotor retardation that prevents the participant from performing blowing exercises. * refusal of the patient or their guardian to participate in the study without providing a reason.
a study to examine the safety, pharmacokinetics and pharmacodynamics of single dose of amg 623 in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this study is to evaluate the safety of amg 623 in subjects with systemic lupus erythematosus. the study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.


Eligibility criteria:
inclusion criteria: * men and women, between the ages of 18 and 55 * diagnosis of sle * have had a disease duration of at least 1 year, as diagnosed by a physician exclusion criteria: * have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of sle) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion * have active vasculitis, active cns lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection * have had signs or symptoms of viral or bacterial infection within 30 days of enrollment * have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days