Kornimate/medical-research-clean huggingface dataset:
drug interactions between paracetamol and setrons in pain management

Conditions: Pain

Summary: the aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. the secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after

tonsillectomy is a common operation performed in children that is associated with marked pain and a high incidence of nausea and vomiting. therefore, national and international guidelines have recommended the use of a setron as a prevention to nausea and vomiting and also the systematic administration of paracetamol to help in the control of postoperative pain. however, a potential interaction between setrons and paracetamol has been reported in different animal studies and in human volunteers although its existence has never been found in the clinic. indeed, several hypotheses are proposed to explain the mechanism of action of paracetamol in the treatment of pain. however, a recent one involves the endocannabinoid system and spinal serotonin receptors. serotonin receptors are also involved in the mechanism of action of antiemetics such as setrons. indeed, these drugs are serotonin antagonists. therefore, the investigators hypothesized that the concomitant administration of paracetamol and ondansetron leads to an interaction that will decrease the analgesic effect of paracetamol. patients aged 2-7 years old and scheduled for a tonsillectomy will be recruited. they will all receive intraoperatively intravenous paracetamol together with either ondansetron or droperidol. pain scores using the cheops scale will be recorded for 24 hours. furthermore, patients will receive i.v. morphine during the operation and in the recovery room if necessary and a non-steroidal anti-inflammatory drug for postoperative pain; on the ward, oral codeine will be administered when needed. pain scores will be recorded regularly for up to 24 hours together with opioid consumption and the incidence of nausea and vomiting in the same period. any adverse event will also be recorded.

Eligibility criteria:
inclusion criteria: * tonsillectomy in a child 2-7 years old who is hospitalized for at least 24 hours ; * informed consent from one parent at least exclusion criteria: * hospital stay of less than 24 hours ; * patient already on pain medication ; * allergic patient with a contra-indication to one of the study drugs.
a phase 1 clinical trial to evaluate the safety and pharmacokinetic characteristics of dw1809

Conditions: Osteoarthritis; Rheumatoid Arthritis; Back Pain; Acute Upper Respiratory Tract Infection

Summary: randomized, open-label, oral, single-dose, two-sequence, four-period, crossover study


Eligibility criteria:
inclusion criteria: * healthy volunteers who are ≥19 years old * body weight ≥50.0 kg and bmi between 18.0 and 30.0 kg/m2 and exclusion criteria: * clinically significant medical history * in the case of women, pregnant(urine-hcg positive) or lactating women
zanubrutinib and eltrombopag as second-line treatment in adults with primary immune thrombocytopenia

Conditions: Immune Thrombocytopenia

Summary: randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus eltrombopag compared to eltrombopag monotherapy for the first-line treatment of adults with chronic immune thrombocytopenia (itp).

the investigators are undertaking a prospective trial of patients with itp in china. zanubrutinib is administered as 80 mg po. qd for 6 weeks. eltrombopag is given with 50 mg once daily for up to 6 weeks. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study. this study assessed the efficacy and safety of eltrombopag plus zanubrutinib.

Eligibility criteria:
inclusion criteria: 1. primary immune thrombocytopenia (itp) confirmed by excluding other supervened causes of thrombocytopenia; 2. patients with chronic low platelet count (less than 30,000/µl) for 6 months who have failed at least one treatment for chronic low platelet count 2. patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation 3. willing and able to sign written informed consent exclusion criteria: 1. secondary immune thrombocytopenia (e.g., patients with hiv, hcv, helicobacter pylori infection or patients with systemic lupus erythematosus) 2. congestive heart failure 3. severe arrhythmia 4. nursing or pregnant women 5. aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria 6. creatinine or serum bilirubin levels each 1•5 times or more than the normal range 7. active or previous malignancy 8. unable to do blood routine test for the sake of time, distance, economic issues or other reasons 9. history of clotting disorder

Keywords: btk inhibitor thrombopoietin-receptor agonist
the u.s. pda registry

Conditions: Ductus Arteriosus, Patent

Summary: the objective of this study is to demonstrate the continued safety and efficacy in a real-world setting of transcatheter device closure of the pda in premature infants less than 2kg in weight at the time of device implant using the amplatzer piccolo occluder device and other devices performed in the usa.

based on the impact registry, there are over 6000 transcatheter device closures of pda that occurs in the united states annually. however, there are no comprehensive data collection tools for this procedure. the current databases do not include multiple data points, or follow-up data, or a section for specific adverse events to be documented. moreover, until now, there has been no approved devices for pda closure in children \< 2kg. this clinical study is the first of its kind to collect data from all transcatheter device closure of pda in children \< 2kg performed in the usa.this study will be limited to children between 700 to 2000 grams who are the most vulnerable population undergoing this procedure. this will allow us to understand the real world experience (efficacy and safety) of using the amplatzer piccolo occluder and other devices in an extremely vulnerable, yet highly underserved population. the study will allow for standardization of this procedure throughout the country for the small children (\<2 kg) with a pda. this is a multi-center, single arm, observational data collection study. this will be a large population study to help analyze outcomes in subjects \<2 kg. the trial has two primary endpoints for safety and effectiveness without formal hypothesis. the safety and effectiveness results will be compared with data reported in the ado ii as ide and continued access protocol studies.

Eligibility criteria:
inclusion criteria: 1. diagnosis of pda. 2. clinical indication for transcatheter pda closure (discretion of the physician). 3. weight \<2 kg at the time of device implant. exclusion criteria: 1. weight \<700 gm or greater than or equal to 2 kg at the time of device implant. 2. age \< 3 days at the time of device implant. 3. pre-existing coarctation of the aorta. 4. pre-existing left pulmonary artery stenosis. 5. cardiac output that is dependent on right to left shunt through the pda due to pulmonary hypertension. 6. intracardiac thrombus that interferes with device implant. 7. active infection requiring treatment at the time of impant.
association of beta-blocker therapy at discharge with clinical outcomes in patients with actue coronary syndrome

Conditions: Actue Coronary Syndrome

Summary: limited data are available on the efficacy of beta-blocker therapy for secondary prevention in actue coronary syndrome(acs) patients. this study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with acs after percutaneous coronary intervention (pci).

the american college of cardiology (acc)/american heart association (aha) guidelines recommend beta-blockers for secondary prevention in patients with acs without regard to reperfusion therapy. however, evidence supporting this recommendation originated from studies conducted before the introduction of reperfusion therapy or studies in patients treated with fibrinolysis. in the present era of pci, there are no prospective randomized studies looking at the effects of long-term beta-blocker therapy on clinical outcomes in acs patients. moreover, results from registry data and post-hoc analysis on beta-blocker therapy in patients undergoing pci are inconsistent. in particular, the beneficial effect of long-term beta-blocker therapy has not been well established in patients with relatively low risk, such as preserved left ventricular systolic function or single-vessel disease. therefore, we investigated the association of beta-blocker therapy at discharge with clinical outcomes in acs patients after pci.

Eligibility criteria:
inclusion criteria: 1. consecutive patients 18 years of age or older; 2. patients diagnosed as acs(including stemi、nstemi and ua) by doctor at discharge; 3. patients undergoing primary pci. exclusion criteria: missing beta-blocker information.

Keywords: actue coronary syndrome beta-blocker percutaneous coronary intervention
the effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction

Conditions: Heart Failure

Summary: previous studies have evaluated the effects of inspiratory muscle training in patiens with heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic role of inspiratory muscle training in patients with heart failure and preserved ejection fraction. the investigators sought to evaluate whether 12-week inspiratory muscle training improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as left ventricular diastolic function, serum biomarkers and quality of life (minnesota living with heart failure questionnaire) in patients with heart failure with preserved ejection fraction and non-reduced inspiratory muscle strength.


Eligibility criteria:
inclusion criteria: * a) previous history of symptomatic heart failure (new york heart association \[nyha\] functional class ≥ii) * b) evidence of normal left ventricular ejection fraction, defined by an ejection fraction \>0.50 and an end-diastolic diameter \<60 mm by 2d echocardiography * c) relevant structural heart disease (left ventricle hypertrophy/left atrial enlargement) and/or diastolic dysfunction estimated by 2d echocardiography * d) clinical stability, including no admissions in the past 30 days exclusion criteria: * a) patients unable to perform a valid baseline exercise test. * b) unstable angina, myocardial infarction or cardiac surgery within the previous three months. * c)known chronic metabolic, orthopedic, infectious disease or previous pulmonary disease; * d)treatment with steroids, hormones, or cancer chemotherapy; * e)reduced maximal inspiratory pressure according to age and sex; * f)active smokers * g)acute decompensation; * h)other comorbidity with an expectancy of life less than one year

Keywords: heart failure with preserved ejection fraction inspiratory muscle training exercise capacity
effects of vibration stimulation combined with task-oriented training on hand motor function in chronic stroke

Conditions: Rehabilitation; Stroke; Hand Grasp

Summary: there is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. this study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. functional recovery was assessed using the fugl-meyer assessment for motor function (fma-wrist and hand), the box and blocks test (bbt) for hand dexterity, and the motor activity log (mal) for daily functional activities. minimal detectable change (mdc) and minimal important difference (mid) criteria were applied to interpret changes in assessment scores.


Eligibility criteria:
inclusion criteria: * hemiparesis after stroke * at least 6 months post-stroke * aged between 20 and 80 years * upper extremity brunnstrom stage iv or v * in stable medical condition * no cognitive deficits (able to understand and follow the instructions) exclusion criteria: * sensory impairment which may limit the participation in vibration stimulation treatment * other neurological or musculoskeletal impairments * more than 2 by the modified ashworth scale (0-5) * skin problems that prohibit participants from wearing the vibratory gloves * aphasia * apraxia * received other treatments which may influence motor or sensory abilities * participating in other studies in the past 6 months
effects of static apnea at high lung volume on hypoalgesia, cardiovascular function and respiratory function

Conditions: Pain; Hypoxia; Hypercapnia; Apnea

Summary: the aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria:
inclusion criteria: - asymptomatic subjects aged between 18 and 64 years. exclusion criteria: * cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies. * history of epilepsy. * pregnant. * pharmacological treatment. * participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
study of the efficacy and security of ibandronate for osteoporosis treatment in a hiv-infected patients cohort

Conditions: HIV Infections

Summary: this project wills to determine the incidence of osteoporosis in our population of hiv-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has already been proved.

the lower bone mineral density that has been described in patients with hiv-infection has not meant an increase of long term complications. nevertheless, it could involve an increase if the associated co-mordibity in the future, taking in care that in general population osteoporosis increases 4 times the pathologic fracture risk. that's why it is necessary to know the real prevalence of osteoporosis in this population of patients so the real dimensions of the problems can be defined. this project wills to determine the incidence of osteoporosis in our population of hiv-infected patients and to assess the efficacy and security of ibandronate, whose efficacy in post-menopausal women has been already proved. if the quarterly use of endovenous ibandronate obtains equivalent results to those obtained with oral and weekly alendronate in other studies with the same population, its use would be justified because of its posology benefits. the monthly or quarterly administration can improve compliance in patients who are recieving a big quantity of drugs, as hiv infected patients do and who probably have to be treated for life. moreover, its elimination is renal so there is absence of interactions with antiretroviral drugs what mades of ibandronate a very promising alternative. finally, there's no risk of digestive intolerance because of its parenteral administration and it has a better posology than oral bifosfonates.

Eligibility criteria:
inclusion criteria: 1. 18 years old or elder. 2. documented hiv-1 infection, with or without antiretroviral treatment. 3. presence of who osteoporosis criteria, defined as t-score under -2.5 in lumbar, hip and/or trochanter. (dexa in the last 6 months is needed) 4. willing to follow the study protocol. 5. informed consent signature. exclusion criteria: 1. in women, pregnancy or breastfeeding. 2. other possible causes of secondary osteoporosis. 3. creatinin over 2.3mg/ml 4. glomerular filter less than 50 ml/min (estimated through mdrd) 5. alendronate treatment in the last 6 months.

Keywords: osteoporosis bifosfonates ibandronate
developing prehabilitation program in patients with operable pancreatic cancer perioperatively and following surgery

Conditions: Pancreatic Cancer

Summary: the aims of this three-year study are to: 1. explore the change of fatigue, nutritional status, quality of life and care needs in patients with operable pancreatic cancer perioperatively and following surgery within 3 months. 2. develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (qol) in this population.

develop and evaluate the effect of patient-centered cancer prehabilitation care program on improving fatigue, nutritional status and quality of life (qol) in this population.

Eligibility criteria:
inclusion criteria: * patients with pancreatic cancer and are going to receive surgery. exclusion criteria: * poor functional status

Keywords: pancreatic cancer fatigue nutrition quality of life
cd22/cd19 car-t and auto-hsct sandwich strategy as consolidation therapy for b-all

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: chimeric antigen receptor t-cell (car-t) therapy has achieved remarkable efficacy in b-cell acute lymphoblastic leukemia (b-all). however, relapse after car-t has been a major issue. multi-antigen car t and combination with other regimens may reduce the relapse rate. the investigators first conducted cd22/cd19 car t-cells and auto-hsct "sandwich " strategy as consolidation therapy in patients with b-all. the main purpose of this study was to observe the safety and efficacy of this new strategy.

the patients received sequential infusion of cd22 and cd19 car-t cells (co-stimulatory molecule was 4-1bb and infusion dose was 5\*10\^6/kg respectively,car-t1) after standard induction and consolidation chemotherapy. autologous stem cells mobilization and collection were performed 6-8 weeks after car-t infusion. standard bucy as conditioning regimen for auto-hsct was used 4 weeks after successful stem cell collection. cd22 and cd19 car-t cells were re-infused 2 days after auto-hsct(car-t2). patients were followed up and minimal residual diseases (mrd) was monitored by flow cytometry and second-generation gene sequencing of igh rearrangement.

Eligibility criteria:
inclusion criteria: * subjects with a primary diagnosis of b-all who have any of the following: (a) no suitable allogeneic hsct donor. (b) refusal of allogeneic hsct. * positive expression of cd19 and cd22 in peripheral blood or bone marrow primary cells detected by flow cytometry. * cardiac ultrasound left ventricular ejection fraction ≥ 50%; creatinine ≤ 1.6 mg/dl; alanine transaminase (alt) and aspartate aminotransferase (ast) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; pulmonary function ≤ grade 1 dyspnea (ctcae v5.0) with oxygen saturation \> 91% without oxygenation. * subjects aged 15-65 years (including 15 and 65 years), regardless of gender. * t-cell amplification test pass. * expected survival \> 3 months. exclusion criteria: * patients with recurrence of only isolated extramedullary lesions. * combination of other malignant tumors. * previously treated with anti-cd19 or/and cd22 or/and cd3 therapies. * immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent. * uncontrolled active infections. * hiv infection. * active hepatitis b or hepatitis c infection. * history of severe tachyphylaxis to aminoglycoside antibiotics. * history or presence of clinically relevant central nervous system (cns) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

Keywords: cd22/cd19 car-t auto-hsct
evaluation of outcomes from treatment of benign or malignant gastrointestinal diseases

Conditions: Gastrointestinal Disease

Summary: this study will be a retrospective, registry study collecting data of patients who were diagnosed with benign or malignant gastrointestinal diseases. data will be collected from patient's chart retrospectively once the patients have completed proper treatment follow up with physicians' practice.

it is reported in the literature that the treatment of any gastrointestinal disease process, whether benign or malignant, continues to be a huge challenge. for example, patients with gastrointestinal cancer continue to be diagnosed at an advanced stage with medical and surgical options that are improving in terms of outcome measurements but with much more room for improvement. the goal is to continue to review our treatment outcomes to further improve overall survival, overall symptom control, mortality and morbidity. the main aim of this study is to evaluate and compare the outcomes from our treatment of benign or malignant gastrointestinal diseases through medical chart review. there is a need to understand and improve the current diagnosis and treatment algorithm for gastrointestinal pathologies. continued evaluation and study is imperative to ensure that national guidelines are improving to enhance patient cure and/or recovery.

Eligibility criteria:
inclusion criteria: * all patients diagnosed and treated for gastrointestinal diseases, benign or malignant from 2005 to 2030. * age ≥18 years exclusion criteria: * patients that are not diagnosed with or treated for gastrointestinal diseases * age \<18 years