Kornimate/medical-research-clean huggingface dataset:
il3 car-t cell therapy for patients with cd123 positive relapsed and/or refractory acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: a study of il3 car-t cell therapy for patients with cd123 positive relapsed and/or refractory acute myeloid leukemia.

this is a single arm, open-label, single-center study. this study is indicated for relapsed or refractory cd123+ acute myeloid leukemia. the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of cd123+ aml per the us national comprehensive cancer network (nccn) clinical practice guidelines for acute myeloid leukemia (2016.v1); 2. relapsed or refractory cd123+ aml (meeting one of the following conditions): 1. cr not achieved after standardized chemotherapy; 2. cr achieved following the first induction, but cr duration is less than 12 months; 3. ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; 3. the number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry); 4. total bilirubin ≤ 51 umol/l, alt and ast ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/l; 5. echocardiogram shows left ventricular ejection fraction (lvef) ≥50%; 6. no active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 7. estimated survival time ≥ 3 months; 8. ecog performance status 0 to 2; 9. patients or their legal guardians volunteer to participate in the studyand sign the informed consent. exclusion criteria: subjects with any of the following exclusion criteria were not eligible for this trial: 1. history of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases; 2. electrocardiogram shows prolonged qt interval, severe heart diseasessuch as severe arrhythmia in the past; 3. pregnant (or lactating) women; 4. patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis); 5. active infection of hepatitis b virus or hepatitis c virus; 6. concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids; 7. previously treated with any car-t cell product or other genetically-modified t cell therapies; 8. creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. other uncontrolled diseases that were not suitable for this trial; 10. patients with hiv infection; 11. any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.

Keywords: acute myeloid leukemia car t-cell therapy cd123
study comparing a dtap-hb-prp~t combined vaccine with tritanrix hepb/hib™, concomitantly with opv in healthy infants

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza

Summary: this is a study to compare the safety and immune response of a pentavalent dtap-hb-prp\~t combined vaccine with tritanrix-hepb/hib™, when both are given concomitantly with opv at 6, 10, and 14 weeks of age.


Eligibility criteria:
inclusion criteria: at screening: * 0 to 3 day old infants * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * apgar score ≥ 7 at three minutes after birth * informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) at inclusion: * six weeks of age * received a dose of hepatitis b (hb) in the first three days of life * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: at screening: * illness at a stage that could interfere with trial conduct or completion * any vaccination before hb vaccination (except bacille calmette-guérin \[bcg\] given at birth) * vaccination planned in the 4 to 6 weeks following the first trial vaccination (except bcg if not given at birth) * acute illness on the day of screening. at screening and at inclusion: * blood or blood-derived products received since birth * planned participation in another clinical trial during the present trial period * mother known as seropositive to human immunodeficiency virus (hiv) or hepatitis c, or as carrying the hb surface antigen (hbsag) * known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin b) at inclusion: * non-trial vaccine administered since birth, except bacille calmette-guérin (bcg) * participation in another clinical trial before the first trial vaccination * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * vaccination other than with the study vaccines planned in the 12 weeks following inclusion * documented history of pertussis, tetanus, diphtheria, polio, h. influenza type b, or hb infection (confirmed clinically, serologically, or microbiologically) * history of seizures * febrile (rectal temperature ≥ 38.0°c) or acute illness on the day of inclusion.

Keywords: diphtheria tetanus pertussis hepatitis b hansenula (hb) haemophilus influenzae type b
pain and stress management for fibromyalgia

Conditions: Fibromyalgia

Summary: this interventional, randomized controlled study seeks to test the effects of an innovative emotional exposure and processing treatment that targets stress resolution, by comparing it with cognitive-behavioral therapy and a fibromyalgia education comparison condition. the investigators also will test proposed mediators of the intervention, including improved autonomic regulation, and explore which subgroups of patients benefit the most from each approach.


Eligibility criteria:
inclusion criteria: * meet fibromyalgia (fm) criteria of the american college of rheumatology (acr)either: * 1990 acr criteria including tender points * 2010 acr modified clinical criteria that does not include tender points exclusion criteria: * co-morbid autoimmune disorders, including rheumatoid arthritis and systemic lupus * other serious medical conditions that can impair health status independent of fm * current psychotic disorders (schizophrenia, bipolar disorder, etc.),dissociative identity (multiple personality) disorder, active suicide risk * alcohol/drug dependence in past 2 years * cognitive impairment or dementia * currently have pending (or recently received - within 2 years) fm pain related disability or workman's compensation * unable to fluently read or converse in english * planning to move from the area in the next 14 months * judgment of principle investigator as not appropriate for this trial or all intervention arms

Keywords: fibromyalgia behavioral interventions psychological interventions
effects of inspiratory and expiratory pressure training methods in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease(COPD)

Summary: the study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.

we will study 60 patients diagnosed of chronic obstructive pulmonary disease.the monitoring will be done for 8 weeks. pressure-threshold respiratory trainers were calibrated to provide different loads according to the patients against inspiration (imst) or expiration (emst). those chronic obstructive pulmonary disease clinically stable patients stratified from mild to very severe gold stages, were blinded to randomly divided into 3 different groups: a)control group:without any training;b) inspiratory and expiratory pressure threshold training group: trained with the pressure threshold trainer twice time daily with 15minutes' duration;c)inspiratory pressure threshold training group:trained with the pressure threshold trainer twice time daily with 15 minutes' duration,different from the b group,the expiratory pressure threshold is calibrated at 0.

Eligibility criteria:
inclusion criteria: clinically stable copd with diagnosis of forced expiratory volume at one second(fev1)/forced vital capacity(fvc) \< 70% exclusion criteria: cancer unstable heart disease neuromusculoskeletal disorder mental disorder active smokers

Keywords: respiratory muscle training respiratory muscle strength respiratory endurance test 6-minute walking test
acetaminophen iv vs hydromorphone iv in the ed

Conditions: Pain, Acute

Summary: the purpose of the current study is to compare the analgesic efficacy of intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the ed.

this is a randomized, double-blind placebo-controlled clinical trial comparing intravenous acetaminophen and intravenous hydromorphone in the treatment of acute pain in the emergency department. enrolled subjects presenting to the ed with acute pain will be randomized to receive either acetaminophen 1g iv or hydromorphone 1mg iv.

Eligibility criteria:
inclusion criteria: * age 21 through 64 years of age: this is a study of adult ed patients. * pain with onset within 7 days: pain within seven days is the definition of acute pain that has been used in the ed literature. * ed attending physician's judgment that the patient's pain warrants iv opioids. * ed attending physician's judgment that the patient has capacity to provide informed consent. * patients must be able to understand english or spanish. exclusion criteria: * use of opioids or tramadol within past 24 hours. * use of acetaminophen or non-steroidal anti-inflammatory medication within the previous 8 hours. * prior adverse reaction to opioids or acetaminophen. * chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies. * medical condition that might affect metabolism or opioid analgesics or acetaminophen such as hepatitis, renal insufficiency or failure, hypo- or hyper-thyroidism, addison's or cushing's disease * pregnant or breastfeeding * alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception. * sbp \<100 mmhg: opioids can produce peripheral vasodilation that may result in orthostatic hypotension. * hr \< 60/min: opioids can cause bradycardia. * oxygen saturation \< 95% on room air: for this study, oxygen saturation must be 95% or above on room air in order to be enrolled. * use of mao inhibitors in past 30 days: mao inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. * patients using transdermal pain patches: pain patches may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments. * taking any medication that might interact with one of the study medications, such as ssri or tricyclic anti-depressants, antipsychotics, anti-malarial medications (quinidine or halofantrine), amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine or st. john's wort. * patients who have been previously enrolled in this same study: patients may only be enrolled once.

Keywords: acetaminophen hydromorphone emergency department narcotics analgesics, opioid analgesics, non-narcotic
safety study of xl844 in subjects with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the purpose of this study is to assess the safety and tolerability of different doses of xl844 when given orally to adults with recurrent or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.


Eligibility criteria:
inclusion criteria: * patients with recurrent or refractory chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) * prior treatment with at least 2 systemic chemotherapy regimens for cll * life expectancy of \>3 months * adequate liver and kidney function * absolute neutrophil count ≥500/mm3; platelets ≥50,000/dl; hemoglobin ≥9 g/dl * willing to use accepted method of contraception during the course of the study * negative pregnancy test (females) * written informed consent exclusion criteria: * chemotherapy or radiotherapy within 4-6 weeks of the start of treatment (depending on the therapy) * investigational drug within 30 days of the start of treatment * uncontrolled intercurrent illness such as infection or cardiovascular disease * pregnant or breastfeeding women * subjects known to be hiv positive
xltcs - accelerometer data collection in an epilepsy monitoring unit (emu)

Conditions: Epilepsy, Tonic-Clonic

Summary: the primary objective of this study is to collect accelerometer data from subjects monitored in an emu with concurrent video eeg.

xltcs (lne-800) is an international multicenter prospective data collection study to gather accelerometer data. the population under the study comprises patients monitored in an epilepsy monitoring unit (emu) with concurrent video eeg and who are expected to have at least one seizure with tonic-clonic convulsive movement. a maximum of one hundred and fifty (150) patients will be enrolled and will wear an accelerometer, and up to 6 sites may participate in this study. the total enrollment period will take approximately 2 years. once the accelerometer was adhered to the subject, subjects will be followed for a minimum of 2 days and a maximum of 10 days. subject participation will run concurrently with the emu admission. exit from the study occurs when the subject's stay in the emu is completed or the subject is withdrawn or withdraws from the study.

Eligibility criteria:
inclusion criteria: 1. four (4) years of age or older. 2. admitted to an epilepsy monitoring unit for video eeg monitoring. 3. based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the emu stay as determined by the investigator. 4. capable of understanding and willing to comply with instructions and study procedures. 5. subject or guardian must be willing and able to complete informed consent/assent. exclusion criteria: 1. based on medical history, expected to have only non-epileptic events during the emu stay as determined by the investigator. 2. based on medical history, known to have only absence seizures. 3. medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study. 4. participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer. 5. participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if livanova has provided written approval.
platelet-rich plasma intra-articular knee injections for knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the benefit of using platelet rich plasma (prp) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. current studies on the prp healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although prp has shown to improve joint functionality and reduce pain. hypothesis: prp intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.


Eligibility criteria:
inclusion criteria: * degenerative osteoarthritis of the knee confirmed radiologically * degenerative osteoarthritis of the knee replacement candidate * walking ability in patients with or without external support * baseline in pain vas greater than 60 exclusion criteria: * neoplastic disease * immunosuppressive states * patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months. * patients who have undergone arthroscopic surgery on the last 3 months * patients with involvement of bone metabolism except osteoporosis (paget's disease, renal osteodystrophy, osteomalacia) * fibromyalgia or chronic fatigue syndrome * liver disease * deficit coagulation (blood dyscrasia) * thrombocytopenia * anticoagulant treatment

Keywords: knee osteoarthritis comparing platelet-rich plasma intra-articular knee injections
chest physiotherapy in pediatrics patients with pneumonia

Conditions: Pneumonia

Summary: chest physiotherapy has been used to treat pediatric patients hospitalized with pneumonia however there was no evidence to support a beneficial effect in pediatric patients.


Eligibility criteria:
inclusion criteria: * children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) exclusion criteria: * severely ill patients (hospitalized in intensive care units) * pleural effusion treated with chest drainage * atelectasis detected by x-ray * pneumonia or pleural effusion in the previous six months * other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency

Keywords: physiotherapy children clinical trial
therapeutic confirmatory study to evaluate the efficacy and safety of avanafil

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to confirm the efficacy and the safety of avanafil 100mg, 200mg or placebo administered orally for 12 weeks in patients with erectile dysfunction. the efficacy is evaluated by iief, sep q2 and q3 and geaq and the safety is evaluated by laboratory tests, vital signs, physical examination and adverse events.


Eligibility criteria:
inclusion criteria: * male subjects aged 19 to 70 with history of erectile dysfunction for at least 6 months * subjects have stable monogamous relationships * their partners are free from pregnancy and lactation and well prevent conception * subjects consented to participate in the clinical study in writing * subjects attempted sexual intercourse at least 4 times in separate days during 4 weeks' free run-in period, and failure rate is over 50% exclusion criteria: * history of spinal cord injury or radical prostatectomy * subjects whose penises are anatomically deformed * erectile dysfunction due to neurogenic or endocrine cause * subjects who have uncontrolled major psychiatric disorder and do not accept therapies or have significant neurological abnormalities * history of cancer chemotherapy within 1 year * subjects who are addicted to alcohol or have continuously misused dependent drugs * subjects who have hepatic dysfunction(gop,gpt ≥ 3xunl) or renal dysfunctions(serum creatinine \> 2.0) * subjects who have uncontrollable diabetes(fpg\>180) * subjects sho have proliferative diabetic retinopathy * history of stroke, transient ischemic attacks, myocardial infarction, heart failure that needs to be medically treated, unstable angina or fatal arrhythmia or coronary artery bypass graft within 6 months * serious hypotension or uncontrollable severe hypertension * hematological disorders that is likely to be developed into priapism such as sickle cell disease, multiple myeloma, leukemia * subjects who have retinitis pigmentosa * subjects who suffered from serious gi bleeding disorder within 1 year * subjects who took other pde5 inhibitors or ed therapies within 2 weeks * subjects who use non-concomitant medications(nitrate/no donors, androgens, anti-androgen, trazodone, anticoagulant,over-the-counter drugs known to inhibit the activity of cyp3a4) * history of hypersensitivity to the pde5 inhibitors or not responded to them * subjects who have hypoactive sexual desire * subjects who have no intention of having sexual intercourses 4 times in separate days during 4 weeks' free run-in period * subjects who took other investigational products within 30 days before this clinical study * subjects who are judged to be unsuitable to the clinical study by other reasons
predicting risk for post-polypectomy colorectal cancer

Conditions: Colorectal Cancer; Colorectal Polyp; Colorectal Adenoma; Neoplasm, Colorectal

Summary: this originated as an observational study of kaiser permanente northern california (kpnc) patients with a history of adenoma diagnosed by colonoscopy who received a subsequent surveillance colonoscopy between 2014 and 2019. the original goal of the study was to develop a risk prediction model that would help identify patients at highest risk for a diagnosis of advanced neoplasia (colorectal cancer and/or advanced adenoma) at or within 6 months following their surveillance colonoscopy. candidate predictors of interest included patient demographics, medical history, and details related to the index colonoscopy. the investigators are now at the implementation stage and applying the risk prediction model to patients awaiting surveillance colonoscopy at select kpnc service areas to help identify those at highest risk for colorectal cancer based on their risk scores.

in the implementation stage, the risk prediction model is being applied to patients who are awaiting surveillance colonoscopy at select kpnc service areas to help identify those at highest risk for colorectal cancer based on their risk scores. the prediction model is being used in 2-3 service area to identify about 60-80 patients per month who are at highest risk for colorectal cancer based on their risk scores. risk scores represent one of a number of factors being considered for prioritizing patients for colonoscopy.

Eligibility criteria:
inclusion criteria: patients are on the current colonoscopy pending list; excluding those who were fecal immunochemical test-positive, screening colonoscopies, had a colonoscopy in last 12 months or on a voluntary "pause" list * hereditary colorectal cancer syndrome (e.g. lynch syndrome) * diagnostic, fecal immunochemical test -positive, or screening indication for colonoscopy