Kornimate/medical-research-clean huggingface dataset:
chidamide with r-chop regimen for dlbcl patients

Conditions: Diffuse Large B Cell Lymphoma

Summary: it's a prospective, single arm, open label phase ii clinical trial, in which the safety and efficacy of chidamide plus r-chop regimen is accessed in de novo dlbcl patients, who have received 2 courses of r-chop but only achieved pr or whose mrd tests for ctdna revealed positive results. abbreviation: r-chop: the chemo-therapy regimen composed of rituximab, cyclophosphoamide, etoposide, vincristine and prednisone. pr: partial remission; mrd:minimal residual disease;


Eligibility criteria:
inclusion criteria: 1. diagnosed as diffuse large b-cell lymphoma with positive cd20 results; 2. age between 18 to 75 years old; 3. world health organization-eastern cooperative oncology group performance status (ecog) 0-2; 4. no history of malignant tumors, having no tumor other than dlbcl at the time of enrollment; 5. life expectancy no less than 6 months 6. the patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; 7. ipi mark\>1. exclusion criteria: 1. history of autologous stem cell transplantation; 2. history of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; 3. with uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; 4. lymphoma originated in the central nervous system; 5. left ventricular ejection fraction ≦50％ 6. abnormal lab results in enrollment: 1. neutrophil count: \<1.5\*109/l； 2. platelet count \<75\*109/l； 3. ast or alt \>2 times the upper limit of normal level，akp and total bilirubin \>1.5 times the upper limit of normal level; 4. serum creatinine \>1.5 times the upper limit of normal level; 7. other uncontrolled medical conditions which the investigators think might influence the results of the trial; 8. patients with mental illnesses or other diseases that might not comply with the trial plan; 9. women during pregnancy or lactation; 10. hiv positive patients; 11. hbsag (+) patients with hbv dna(+), can be enrolled only when his/her hbv dna turns negative; patients with hbsag(-) hbcab(+) can be enrolled only when his/her hbv dna turns negative;
percutaneous nephrolithotomy without a ureteral catheter

Conditions: Nephrolithotomy Percutaneous; Kidney Calculi

Summary: conventional percutaneous nephrolithotomy (pcnl) surgery requires the patient to first undergo retrograde transurethral ureteroscopic insertion of the ureteral catheter in the lithotomy position, and then change the patient to the prone position. however, repeated operation on the ureter can bring about immediate and long-term negative effects, such as ureteral false way formation, ureteral damage, perforation, avulsion, catheter insertion into the vena cava, pricking the kidney, increased postoperative pain, urinary extravasation, scar formation, and ureteral narrowing. the study planned to perform the operation in the prone position without reverse insertion of a ureteral catheter in the pcnl surgery.

the purpose of this single-center, single-blind, randomized trial was to evaluate the safety and efficacy of pcnl without reverse insertion of a ureteral catheter. it is planned to start in november 2022 and is expected to end in november 2024. based on inclusion and exclusion criteria, 200 subjects were expected to be recruited. in a parallel group design, subjects were randomly assigned to two groups: the experimental group received pcnl without reverse insertion of a ureteral catheter , and the control group received traditional pcnl. the primary end point of the study was the incidence of postoperative complications according to the modified clavien-dindo complication grading system. secondary end points included stone-free rate, operation time, length of hospital stay, and medical costs. measurement data were expressed as mean ± standard deviation (x ± s), and student's t-test was used for intergroup comparisons. the counting data were expressed as frequency and percentage, and the chi-squared or fisher's exact probability test were used for intergroup comparisons. the rank-sum test was used for grade data. p\<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: · patients with upper urinary tract stones who were 18 years of age or older and eligible for pcnl surgery. exclusion criteria: * patients with infectious calculi confirmed by preoperative ct examination and blood biochemical indexes. * patients with severe cardiac and pulmonary insufficiency, coagulation dysfunction and other obvious surgical contraindications. * patients with previous history of pcnl surgery on the affected side or nephrotomy. * patients with indwelling double j tube or nephrostomy tube before operation. * patients with renal trauma or congenital anomalies of urinary system.
accidental reactions in peanut/tree nut allergic children

Conditions: Peanut and Tree Nut Allergy

Summary: food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities. peanut is a plant from the botanical family of the fabaceae, more commonly known as legumes. the prevalence of peanut and tree nut allergy is increasing. in france (elfe cohort), it is estimated to 0.93%. the tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and brazil nut. allergy's prevalence is estimated to 0.54% in children up to 5.5 years. peanut allergy is a main cause of anaphylaxis and deaths due to food allergy. recurrence of food allergy is a main concern. the risk has been estimated to 10% per year for peanut. in france, data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking. the objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.


Eligibility criteria:
inclusion criteria: * confirmed allergy to peanuts and/or nuts exclusion criteria: * other chronic diseases, except allergic comorbidities (asthma, rhinitis, atopic dermatitis, other food allergy)

Keywords: peanut allergy tree nut allergy peanut immunotherapy anaphylaxis real life
the clinical trial to evaluate the pharmacokinetics, safety and tolerability of zl-2306 (niraparib) in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: niraparib is a potent and highly selective parp-1/-2 inhibitor. the primary objective of this trial is to evaluate the pharmacokinetic (pk) properties of zl-2306 (niraparib) and its metabolite m1 in patients from mainland china with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.


Eligibility criteria:
inclusion criteria: 1. signed informed consent . 2. female, age ≥ 18 years. 3. histologically confirmed diagnosis of figo stage iii or iv ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. 4. has received no further than second-line platinum-based chemotherapy, and has clinical complete response (cr) or partial response (pr) at least following 4 courses of the last platinum-based chemotherapy. 5. ecog 0-1. 6. has good organ function, including: 7. patient of childbearing potential, has a negative pregnancy test when enrolled and promises to use an adequate method of contraception or abstain from activities that could result in pregnancy from enrolment to the end of study and during the 3 months after the last dose of the study treatment, or be of non-childbearing potential, can be enrolled in the study. 8. is able to adhere to the protocol. 9. has recovered from previous chemotherapy induced toxic side effects to ≤ grade 1 ctcae or basal level, apart from ≤ grade 2 ctcae peripheral neuropathy or hair loss symptoms at steady state. exclusion criteria: 1. has a known hypersensitivity to the active or inactive ingredients of zl-2306 (niraparib) or compound which has similar chemical structure to zl-2306 (niraparib). 2. has symptomatic uncontrolled brain or leptomeningeal metastasis. 3. major surgery or chemotherapy within 3 weeks of starting the study or patient has not recovered from any effects of the surgery. 4. receive palliative radiotherapy encompassing \> 20% of the bone marrow within 1 week of entering the study. 5. be diagnosed any invasive cancer other than ovarian cancer (apart from cured basal cell carcinoma and squamous cell carcinoma) within 2 years prior to study enrolment. 6. has a history or current diagnosis of myelodysplastic syndrome (mds) and acute myeloid leukaemia (aml). 7. has other serious or uncontrolled disease 8. has any disease, treatment and laboratory abnormality that may interfere the study results and affect the fully attendance of study. or the patient is considered to be not suitable for the study by the investigator. cannot receive platelet or red blood cell transfusion within 4 weeks of study drug administration. 9. pregnant, breastfeeding or expecting to conceive children during the study treatment period. 10. corrected qt (qtc) interval \> 470 msec. 11. use proton pump inhibitors, antacids or histamine 2 (h2) blockers within 48hrs prior to the first drug administration for pk measurement.

Keywords: parp inhibitor brca mutation
pulmonary inflammation and microbiome changes with bariatric surgery in obese asthma

Conditions: Asthma; Obesity

Summary: the purpose of this study is to gain understanding of mechanisms whereby bariatric surgery modulates pulmonary inflammation and pulmonary microbiome composition and how these changes direct the pathobiology of human obese asthma.


Eligibility criteria:
inclusion criteria: asthma subjects * outpatient adults of either sex 21-60 years of age with an initial asthma diagnosis at \ 12 years of age (late-onset), as defined by the nhlbi naepp guidelines (17). * subjects with obesity (bmi ≥ 30 kg/m2). * physician diagnosis of asthma. * eligible and scheduled for bariatric surgery (roux-en-y gastric bypass, sleeve gastrectomy or duodenal switch) and receiving care within the duke health system. fev1 within acceptable limits (\>45% predicted before and \>55% predicted after, bronchodilator administration). * relatively healthy subjects able to undergo sputum induction without complications. * willing and able to give informed consent and adhere to visit/protocol schedules. * read and write in english. non-asthma control subjects * outpatient adults of either sex 21-60 years of age. * subjects with obesity (bmi ≥ 30). * eligible and scheduled for bariatric surgery (roux-en-y gastric bypass, sleeve gastrectomy or duodenal switch) at duke regional hospital and receiving care at the duke metabolic and -weight loss surgery center. * normal lung function. * no clinical history of atopy. * no significant medical or psychological issues. * healthy subjects able to undergo sputum induction without complications. * willing and able to give informed consent and adhere to visit/protocol schedules. * read and write in english. exclusion criteria: * children \< 21 years of age. * inpatient status. * ineligibility or not scheduled for bariatric surgery at the duke metabolic and weight loss surgery center. * fev1 is less than 45% predicted before, or less than 55% predicted after, bronchodilator administration. * upper or lower respiratory tract infection within one month of the study. * use of systemic corticosteroids within four weeks of study. * smoking (tobacco, e-cigarette, vaping or inhaled drugs) history \> 5 pack years or smoking or vaping within the previous six months. * significant non-asthma pulmonary disease (stable obstructive sleep apnea is not excluded). * an ed visit or inpatient admission for a primary respiratory diagnosis within 60 days of enrollment. * poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator. * all patients on anticoagulants. * uncontrolled sleep apnea.
the treatment efficacy of combination atypical antipsychotics with sertraline in patients with schizophrenia

Conditions: Schizophrenia

Summary: a randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients

objective: this study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients methods: 1. atypical antipsychotics and dose: including four atypical antipsychotics to form eight treatment groups: 1) olanzapine (7.5-10mg/day) combined with sertraline (50-100mg/day) group 2) only olanzapine (12.5-20mg/day) group 3) risperidone (2-3.5mg/day) combined with sertraline (50-100mg/day) group 4) only risperidone (4-6mg/day) group 5) paliperidone (3-4.5mg/day) combined with sertraline (50-100mg/day) group 6) only paliperidone (6-9mg/day) group 7) ziprasidone (60-100mg/day) combined with sertraline (50-100mg/day) group 8) only ziprasidone (120-160mg/day) group 2. blood biochemical examination: including blood routine examination, liver function, renal function, thyroid function, glucose and lipid level, prolactin, and related hormones and proteins 3. electrophysiological examination: including electrocardiograph, electroencephalography (eeg), and brain evoked potential 4. scale assessment: each patient was assessed by four clinical psychiatrists using the following scales: 1) psychopathology: positive and negative symptoms scale (panss) and clinical global impression scale (cgi-s) 2) emotional symptoms: hamilton depression rating scale (hamd) and hamilton anxiety rating scale (hama) 3) social function: personal and social performance scale (psp) 4) side-effect: treatment emergent side-effect scale (tess) and rating sale for extrapyramidal side-effect (reses) 5. blood drug concentration assay: including the drug concentration of olanzapine, risperidone, paliperidone, ziprasidone and sertraline, respectively 6. weigh gain measurement: to measure height, weight for each patient the above measurement data were collected at baseline, week4, week8, week 12 and week24.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia by two senior psychiatrists * between 18 and 60 years and han chinese exclusion criteria: * a diagnostic and statistical manual of mental disorders (dsm)-iv axis i diagnosis other than schizophrenia * documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, huntington's disease, multiple sclerosis * acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)

Keywords: schizophrenia sertraline olanzapine risperidone paliperidone ziprasidone
observational study of nelarabine in children and young adults

Conditions: Leukaemia, Lymphoblastic, Acute

Summary: this international, multicentre, single arm, phase iv study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory t-lineage acute lymphoblastic leukaemia (t-all) or lymphoblastic lymphoma (t-lbl) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. it is a post-authorisation safety study (pass) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. the study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).


Eligibility criteria:
inclusion criteria: * ≤ 21 years of age * relapsed or refractory t-lineage acute lymphoblastic leukaemia (t-all) or lymphoblastic lymphoma (t-lbl) * prior treatment with at least two chemotherapy regimens * selected for treatment with nelarabine exclusion criteria: * known hypersensitivity to the active substance. * women of childbearing potential who are unable or unwilling to use adequate contraceptive measures * males with partners of child bearing potential who are not willing to use condoms or abstinence * patients with persistent neurological toxicity (ctc grade \> = grade 2) * adolescents (aged 16 years and over) and adults for whom the physician prescribes the 1500mg/m2 dose of nelarabine.

Keywords: t-all safety post authorisation safety study t-lbl lymphoblastic lymphoma acute lymphoblastic leukemia
remimazolam bolus for general anesthesia

Conditions: Loss of Consciousness

Summary: it is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. we will determine the ed50 and ed95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.


Eligibility criteria:
inclusion criteria: * patients aged 19 years old or older, with american society of anesthesiologists physical status 1-3, and scheduled for general anesthesia exclusion criteria: 1. patients scheduled for liver surgery 2. uncontrolled hypertension 3. uncontrolled diabetes mellitus 4. liver disease 5. kidney disease 6. intolerance or hypersensitivity to benzodiazepine 7. addiction 8. glaucoma 9. heart failure 10. peripheral vascular disease 11. obstuctive lung disease 12. patients scheduled for regional anesthesia before general anesthesia 13. pregnancy
comparison of efficacy and side effects between the obtryx and solyx band with 5-year follow-up.

Conditions: Stress Urinary Incontinence

Summary: boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the solyx™ single incision sling (sis) system compared to the gold-standard obtryx™ ii sling system, in patients with stress urinary incontinence (sui) and long-term follow-up (5 years).

randomized prospective non-inferiority study, in which we evaluate patients with stress urinary incontinence (sui) who undergo surgical treatment consisting of a minimal incision in the suburethral area of the vaginal mucosa for a mesh insertion in order to: main objective: to compare the continence rate (objective) between solyx and obtryx ii meshes in patients with sui. this rate will be determined by an effort test. secondary objectives: * to compare the continence rate (subjective) between both meshes. * to compare variations in pad-test. * to asses patient satisfaction. * to evaluate both techniques regarding quality and sexual life modifications. * to compare both techniques regarding early complications (up to 30 days post implantation). * to compare the appearance and persistence of late complications (from 30 days onwards).

Eligibility criteria:
inclusion criteria: * patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands * age \> or = 40 years * informed consent signed by the patient exclusion criteria: * patients who are pregnant or wish to become * patients who need anticoagulant * active vaginal or urinary infection * previous surgical interventions for the treatment of incontinence * body mass index \> 35

Keywords: stress urinary incontinence
a study to evaluate itca 650 for the treatment of type 2 diabetes in patients with high baseline hba1c

Conditions: Type 2 Diabetes

Summary: an 39-week plus extensions, open-label study to estimate the reduction in hba1c in patients with initial hba1c \>10% \</=12% who are treated with itca 650 20 mcg/day for 13 weeks followed by itca 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with itca 650 60 mcg/day


Eligibility criteria:
inclusion criteria: * men or women age 18 to 80 years with type 2 diabetes * on stable treatment regimen of diet and exercise alone or in combination with a stable \& optimal or near-optimal dose of metformin, sulfonylurea, tzd or combination of these drugs * hba1c \>10.0% and ≤12.0% exclusion criteria: * prior treatment with any glp-1 receptor agonist * history of hypersensitivity to exenatide or liraglutide * fpg \>300 mg/dl * history of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2 * taking dpp-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis
interest of preoperative immunonutrition in liver surgery for cancer

Conditions: Hepatectomy; Elective Hepatectomy; Malignant Tumors

Summary: to study the efficacy of preoperative immunonutrition in reducing postoperative morbidity after liver resection for cancer.

perioperative immunonutrition has been developed to improve the immuno metabolic host response and outcome in postoperative period and has been proven to be beneficial in reducing significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors. to date, the effects of preoperative oral immunonutrition (oral impact) in non cirrhotic patients undergoing liver resection for cancer are unknown. the purpose of this study is to determine whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for malignant tumours.

Eligibility criteria:
inclusion criteria: * age \> 18 years * non cirrhotic patient * elective liver surgery for cancer (primary or secondary malignant tumours) * hepatectomy including at least 1 segment or 3 wedge resections exclusion criteria: * liver resection for benign lesions * liver resection associated with biliary tract surgery * liver resection associated with gastro-intestinal surgery * cirrhosis, defined by transient elastography (fibroscan®) or by liver biopsy * renal failure * pregnancy or nursing women * history of hypersensitivity or allergy to arginine, omega-3 fatty acids, or nucleotides * inability to take oral nutrition * mental condition rendering the subject unable to understand the nature, end-points and consequences of the trial

Keywords: liver surgery hepatectomy immunonutrition cancer morbidity postoperative complication