Kornimate/medical-research-clean huggingface dataset:
cav regimen for r/r aml

Conditions: Acute Myeloid Leukemia

Summary: this study aims to investigate the efficacy and safety of cladribine, combined with low-dose cytarabine and venetoclax (cav regimen) for relapsed/refractory acute myeloid leukemia (r/r aml).

patients with relapse/refractory (r/r) acute myeloid leukemia often show resistance to conventional chemotherapy and have dismal prognosis. salvage therapy using venetoclax combined with hypomethylation drugs achieved an overall response rate of only approximately 40% in r/r aml. cladribine, a purine analogue, exerts cytotoxic, proapoptotic, and antiproliferative effects on aml cells.the efficacy of cladribine plus cytarabine and venetoclax in r/r aml has not been reported.

Eligibility criteria:
inclusion criteria: 1. aged 16-70 years old. 2. diagnosed with r/r aml. 3. patients with aml must meet one of the following criteria, a or b: a: refractory aml disease was defined as follows: (1) failure to attain cr following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (bmcdi) \ 20% after 1 course of standard or intensive induction therapy. b: relapsed aml disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after cr; or (2) detection of ≥ 5% blasts in the bm not attributable to another cause (e.g., bm regeneration after consolidation therapy); or (3) extramedullary relapse. 4. ecog performance status score less than 2. 5. expected survival time ≥12 weeks. 6. without serious heart, lung, liver, or kidney dysfunction. 7. able to understand and provide informed consent. exclusion criteria: 1. patients who are allergic to the study drug or drugs with similar chemical structures. 2. pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. active infection. 4. active bleeding. 5. patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. patients with mental disorders or other conditions. 7. liver function abnormalities (total bilirubin \> 1.5 times of the upper limit of the normal range, alt/ast \> 2.5 times of the upper limit of the normal range or patients with liver involvement whose alt/ast \> 1.5 times the upper limit of the normal range), or renal dysfunction (ccr\<50ml/h). 8. patients with a history of clinically significant qtc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, ii-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. patients who relapsed after allogeneic hematopoietic stem cell transplantation. 10. drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. patients who have received organ transplants. 12. patients not suitable for the study according to the investigator's assessment.

Keywords: venetoclax cladribine cytarabine relapsed/refractory aml
incorporating multidimensional psychosocial interventions improves the well-being of individuals with epilepsy

Conditions: Epilepsy; Seizure Disorder

Summary: the purpose of this study is to incorporate multidimensional self-management programs into the routine care of epilepsy patients. consenting patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression.

though tremendous advances have been made in the diagnosis and treatment of individuals with epilepsy, much remains to be done when it comes to improving their psychosocial well-being. many individuals with epilepsy have difficulty adhering to treatment, documenting their seizure types, coping with memory difficulties, dealing with stress, and suffer from depression. these factors limit the quality of life of epilepsy patients and prevent them from realizing their full potential. patients will enroll in one of four interventions that help improve medication adherence, increase seizure awareness and documentation, improve memory and deal with stress and depression. patient assessments will be conducted before and after intervention to gauge the efficacy of the programs. the specific aims of this study are to assess the feasibility and patient acceptability of incorporating multidimensional self-management and psychosocial interventions into routine epileptic care, as well as, determine whether these incorporations improve self-management, quality-of-life, and other measures of well-being.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of epilepsy using established criteria * patient self-identified as own primary caregiver * english fluency * ability to provide informed consent * ability to complete the study assessments exclusion criteria: * history of non-epileptic seizures * history of cognitive impairments that prevents them from providing informed consent and completing study assessments

Keywords: memory problems stress depression adherence seizure documentation
impact of early renal involvement on the development of severe in-hospital renal failure

Conditions: Kidney Failure, Acute; Renal Insufficiency, Acute; Kidney Failure; Renal Insufficiency

Summary: the purpose of this study is to determine whether renal team involvement early at the onset of kidney injury will prevent further developement of more severe renal failure and worse hospitalization outcomes.


Eligibility criteria:
inclusion criteria: * hospitalized, elevation in creatinine meeting definition exclusion criteria: * cdk5, esrd,solid organ transplant

Keywords: kidney failure, acute renal insufficiency, acute kidney failure renal insufficiency
evaluating subjective well-being in schizophrenic patients treated with quetiapinexr® and other atypical antipsychotics

Conditions: Schizophrenia

Summary: to evaluate the qol (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia * treatment with one atypical antipsychotic\* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit. * patient takes an aap according to local spc and current medical practice * the patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write exclusion criteria: * treatment with an additional aap or ap to the initial prescribed aap within the 2-8 weeks before the patient is included in the study * since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'aap are excluded. * previous enrolment or treatment in the present nis * known allergy to the prescribed aap or any of its substances

Keywords: schizophrenia remission subjective well-being and effectiveness quality of life
inhaled iloprost, dynamic hyperinflation, and oxidative stress in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (copd). to accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with copd and changes in oxidative stress and lung volumes during exercise will be measured.

chronic obstructive pulmonary disease (copd), the 3rd leading cause of death in the us, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. oxidative stress, in part arising from inducible nitric oxide synthase (inos) released by the pulmonary vasculature, is critical for the development and progression of copd; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in copd patients. this will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of copd patients. potential mechanisms include reductions in dynamic hyperinflation during exercise in copd patients or improvements in oxidative stress

Eligibility criteria:
inclusion criteria: * 40 years old or older * physician diagnosis of chronic obstructive pulmonary disease * 10 or more pack-year smoking history * fev1/fvc \<0.70 * fev1 35-80% of predicted exclusion criteria: * acute exacerbation of copd within the last 30 days * pregnant or breast-feeding * contraindications to cardiopulmonary exercise testing * known intolerance or allergy to iloprost * on oral corticosteroids (may be included if off for 7 days prior to testing) * supplemental oxygen need * known inflammatory disease other than copd * active solid organ/hematologic malignancy

Keywords: chronic obstructive pulmonary disease pulmonary vasculature inhaled iloprost inhaled prostacyclin dynamic hyperinflation oxidative stress cardiopulmonary exercise testing b-type natriuretic peptide
development of a personalized growth hormone treatment profile (pgtp) report for pediatric endocrinology

Conditions: Growth Hormone Deficiency (GHD)

Summary: the goal of this observational study is to learn how to make growth hormone treatment more personalized for children. the main questions it aims to answer are: * how can information about treatment adherence and patient experiences help improve care? * what insights can help doctors create treatment plans that are more tailored to each child? the study will include 40 families of children who are using a connected injector device for their growth hormone treatment. these devices track how often the treatment is taken, and families will also share their experiences through surveys. the information will be used to develop a new tool, similar to tools used in diabetes care, to help doctors create better, personalized treatment plans for children with growth hormone needs.


Eligibility criteria:
inclusion criteria: * pediatric patients (up to 18 years old) diagnosed with growth hormone deficiency or disorders requiring growth hormone treatment. * patients are currently undergoing growth hormone therapy. includes both naive patients (those newly starting weekly treatment) and those already on treatment. * families willing to use connected injector devices and participate in mobile-based psychometrics for the study duration. * families are able and willing to regularly provide patient-reported outcomes (pros) and adherence data through the adhera®️ caring digital program. * participants willing to sign the informed consent form, confirming their understanding of the essential aspects of the study, including the potential risks, benefits and rights as participants. exclusion criteria: * families/patients already enrolled in other study protocols, including the use of connected injector devices and participation in mobile-based psychometrics. * patients with other significant medical conditions that could interfere with growth hormone treatment or the study's data collection processes. * inability to understand or communicate in the language used for data collection and study participation, unless appropriate translation services are available and can be consistently utilized.

Keywords: growth hormone disorder digital health pediatric endocrinology personalized growth hormone treatment profile
niv application in the treatment of asthmatic children

Conditions: Asthma; Child; Bronchial Spasm

Summary: asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.

pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately. there is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of cpap and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the bie.the aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the bie.

Eligibility criteria:
inclusion criteria: * age between 5:11 years; * both sexes; * do not be included in any regular physical activity program; * having a diagnosis of asthma, according to the global initiative for asthma (gina); * not having received theophylline or aminophylline and oral corticosteroids in the last 30 days; * not have presented respiratory infection in the last two months; * signature of ic exclusion criteria: * have done inhaled bronchodilator in less than 12 hours before the assessment; * inability to understand or perform any of the tests, due to physical and mental limitations; * intolerance proposed activities; * have heart disease inflammatory, congenital or ischemic origin; * being in the presence of any infectious process with fever.
biomarkers of injectable extended release naltrexone treatment

Conditions: Heroin Dependence; Opioid Dependence

Summary: this study evaluates the biological markers of treatment of opioid dependent individuals with an extended release formulation of the opioid antagonist naltrexone. the biological measures include functional mri, blood levels of naltrexone and its metabolites, urine toxicology and behavioral tests probing various aspects of personality, memory, reward processing and attention.

this study is using blood oxygenation level dependent (bold) functional magnetic resonance imaging (fmri) to examine the brain predictors of adherence and outcomes of opioid antagonist therapy. opioid-dependent intravenous heroin users are offered up to 3 monthly injections of the extended-release naltrexone (xrntx) contingent upon successful outpatient non-opioid detoxification, with an additional 4 weeks of follow up. brain responses to heroin-related pictures are recorded using fmri prior to the 1st xrntx injection and approximately 2 weeks thereafter the 1st xrntx injection. primary clinical variables include the number of injections (maximum of 3) accepted by participants, change in self-reported craving for opioids after exposure to drug-related visual cues during the brain fmri sessions, urine levels of ten commonly abused substances and self-report of cigarette use.

Eligibility criteria:
inclusion criteria: 1. dsm-iv-tr diagnosis of opioid dependence, active opioid use, confirmed by urine toxicology screen and self-reported monthly intravenous heroin use for more than 2 weeks in the past 3 months 2. urine toxicology screen negative for opioids after detoxification 3. good physical health as indicated by history and physical examination, screening blood work-up and urinalysis. exclusion criteria: 1. chronic medical illnesses; 2. current use of medications potentially confounding brain activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers; 3. current dsm-iv-tr axis i psychiatric disorders other than opioid and nicotine dependence; 4. life time history of concurrent iv cocaine and heroin (speedball) administration; 5. pregnancy or breastfeeding; 6. history of clinically significant head trauma; 7. contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (\> 3 times upper limit of normal), failure to complete opioid detoxification 8. contraindications for mri, i.e. indwelling magnetically active foreign bodies and phobia to enclosed spaces

Keywords: naltrexone neuroimaging heroin addiction dependence opioid vivitrol® functional magnetic resonance imaging
a study of dcr-ph1 in patients with primary hyperoxaluria type 1 (ph1)

Conditions: Primary Hyperoxaluria Type 1

Summary: a phase 1 study of dcr-ph1 in patients with primary hyperoxaluria type 1 (ph1) to determine the safety, tolerability, pharmacokinetic (pk) and pharmacodynamics (pd) effects of dcr-ph1 administered via-intravenous infusion (iv)


Eligibility criteria:
inclusion criteria: * male or female, at least 12 years of age * diagnosis of ph1, confirmed by genotyping * 24-hour urine oxalate excretion as defined in the protocol * egfr ≥ 40 ml/min normalized to 1.73 m2 bsa * written informed consent for adults (≥18 years old, or per local regulatory requirement); written informed assent for adolescents (12 to \<18 years old, or per local regulatory requirement) exclusion criteria: * prior renal and/or hepatic transplantation * participation in any clinical study involving administration of any investigational drug within the 30 days before enrollment * pregnancy or lactation at the time of screening or enrollment * women of child-bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * patients with a known history of human immunodeficiency virus (hiv) or active infection with hepatitis b virus or hepatitis c virus * moderate to severe liver impairment * liver function test abnormalities: alanine transaminases (alt) and/or aspartate transaminases (ast) \> 2 times upper limit of normal (uln) * history of severe reaction to a liposomal product or a known hypersensitivity to lipid products. * unable to collect required study samples or follow study procedures * no clinically significant health concerns

Keywords: primary hyperoxaluria type 1 ph1 calcium oxalate stones kidney stones liver enzyme deficiency genetic diseases inborn kidney diseases metabolic diseases inborn errors urological diseases carbohydrate metabolism hyperoxaluria agt rnai sirna dcr-ph1
novellusdx functional profiling of oncogenic mutations in lung cancer patients

Conditions: Lung Cancer

Summary: novellusdx technology identifies tumor-specific driver mutations, but unlike sequencing-based tests, novellusdx has a functional assay that detects dis-regulated translocation of mutated signaling proteins to the nucleus. this allows novellusdx to identify functionally-impactful driver mutations regardless of whether the mutation has previously been described or linked to a tumor type.


Eligibility criteria:
inclusion criteria: * patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction exclusion criteria: * patients without lung cancer

Keywords: patient diagnosed with lung cancer
testing -on post-trial observational cohort study

Conditions: IgA Nephropathy; ESRD; Glomerulonephritis; Kidney Diseases

Summary: the primary aim of this study is to extend follow up of testing study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on end stage kidney disease (eskd), according to dose (full-dose vs reduced-dose), ethnicity (chinese vs other) and kidney function (egfr above and below 60 ml/min/1.73m2).

in the original testing study, the median follow-up for full vs reduced dose cohort was 6.1 vs 2.5 years. we learned from the testing trial that the composite endpoints (eskd, 40% reduction in egfr or death due to kidney disease) tend to start occurring 2-3 years after randomization. at the time of overall study completion, most of the reported endpoints had occurred in participants from the initial, full-dose testing cohort. although we found the effect of corticosteroid is consistent in both doses, longer follow up is required to confirm the beneficial effects on clinically important renal outcomes of the apparently safer reduced reduced-dose cohort, and to confidently compare the effects across doses. as the trial is assessing the effects of a time-limited 6-9-month period of steroids, a post-trial observation cohort study is a critical, cost and resource-efficient method of answering a number of key questions: 1. is the apparent benefit of glucocorticoid sustained over long term follow-up? 2. does a lower dose of steroids safely produce similar benefits on long-term kidney outcomes? the primary aim of testing-on is to extend follow up of testing study participants and to assess the long-term effects of a 6-9-month course of oral methylprednisolone on end stage kidney disease (eskd), according to dose (full-dose vs reduced-dose), ethnicity (chinese vs other) and kidney function (egfr above and below 60 ml/min/1.73m2). the working hypothesis of testing-on is that a 6-9-month course of oral methylprednisolone will lead to persistent benefits over a long period of time. testing-on is a post-trial observational study of those participants randomized into the testing trial who are still alive, haven't reached eskd and didn't withdraw consent during the trial. follow-up will continue for up to five years, with further ongoing follow-up should funding allow.

Eligibility criteria:
inclusion criteria: 1) only participants who were randomised into the testing trial exclusion criteria 1. participants who have reached kidney failure requiring maintenance dialysis or kidney transplantation during the testing trial 2. participants who died during the testing trial 3. participants who had withdrawn their consent during the testing trial 4. participants who are unable to provide consent for some other reason

Keywords: kidney
gut recovery in patients following surgery

Conditions: Gastrointestinal Diseases; Ileus

Summary: the purpose of the study is to determine if the myoelectrical measurements made by the g-tech wireless patch system correlate with clinical markers of postoperative recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness. subsequently the data will be studied to establish which information in the signals is important in determining when to feed patients and possibly discharge them..

measure myoelectric signals with the g-tech wps and determine if a correlation exists between signal strength and the rate of gastrointestinal recovery following surgery. determine the relationship between gastrointestinal myoelectrical signal strength and clinical markers of recovery such as passage of flatus/bowel movement, oral tolerance of diet and discharge readiness.

Eligibility criteria:
inclusion criteria: * willing and able to follow all study requirements * eighteen (18) years of age or older * subject is willing and able to follow all study requirements * subject will undergo a colectomy exclusion criteria: * subject is pregnant or suspects pregnancy * known allergy to medical grade adhesive