Kornimate/medical-research-clean huggingface dataset:
venetoclax in combination with 5 days azacitidine in untreated aml patients, not eligible for standard induction therapy

Conditions: Acute Myeloid Leukemia (AML)

Summary: acute myeloid leukemia (aml): continuous oral venetoclax (ven) and 7 days of s.c. azacitidine (aza) per 28-day cycle = standard of care for intensive induction therapy ineligible aml patients in germany the venaza-5s pilot trial: aza administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.

acute myeloid leukemia (aml) is a uniformly fatal disease if untreated. the combination of continuous oral venetoclax (ven) and 7 days of s.c. azacitidine (aza) per 28-day cycle has recently emerged as the new standard of care for aml patient who are ineligible for intensive induction therapy, and has been widely adopted in germany. the venaza-5s pilot trial aims to reduce the reported hematological toxicity profile of this currently approved combination, while preserving efficacy, by modifying aza administration to 5 days within each cycle. the hypothesis is that this modification will not interfere with the response rates achieved by the combination, but will rather improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and hospitalizations, and thus result in better quality of life and favorable long-term outcomes in elderly or comorbid aml patients. this single-arm pilot study is intended to generate first data on the efficacy and toxicity of 5 days aza + ven, which will be compared to a historical control cohort treated with the current standard of 7 days aza + ven.

Eligibility criteria:
key inclusion criteria: * confirmed diagnosis of aml by world health organization (who) criteria 2016 * ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities * age ≥ 18 years * life expectancy of at least 12 weeks key exclusion criteria: * prior treatment for aml or myelodysplastic syndrome (mds) with one of the following: * hypomethylating agent (hma) * chemotherapeutic agent * chimeric antigen receptor (car)-t cell therapy * experimental therapies * note: prior use of hydroxyurea is allowed * history of myeloproliferative neoplasm (mpn) * diagnosis of acute promyelocytic leukemia (apl) * presence of favorable-risk karyotype abnormalities: t(15;17), t(8;21), inv(16) or t(16;16)

Keywords: venclyxto venetoclax azacitidine hematologic diseases acute myelogenous leukemia
intranasal dexmedetomidine sedation during intra-articular joint injections in pediatric population

Conditions: Juvenile Idiopathic Arthritis; Joint Inflammation

Summary: the main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. intranasal dexmedetomidine is compared with dinitrous oxide (n2o) which has already been proven safe and effective sedation method during painful procedures in pediatric patients. in earlier studies the median vas during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (uziel et al 2008). study hypothesis is that with intranasal dexmedetomidine sedation the vas pain levels will be 1 unit lower.


Eligibility criteria:
inclusion criteria: * patient age between ages 1year to 18 years * a joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist exclusion criteria: * patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.

Keywords: sedation pediatrics intranasal sedation dexmedetomidine dinitrous oxide intra-articular joint injection
the prognostic value of human papilloma virus in nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: it is well established that hpv infection has a casual and is a prognostic factor in several cancer types, including oropharynx. we wish to examine if hpv infection has a prognostic significance in nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * nasopharyngeal carcinoma patients treated in our institute between 2008-2018 exclusion criteria: * missing clinical data * 2nd head and neck primary cancer * very locally advanced or distant metastatic nasopharyngeal carcinoma * prior radiation therapy to the head and neck region
vitamin d, oxidative stress and inflammation in hemodialysis

Conditions: Oxidative Stress; Inflammation; Vitamin D Deficiency

Summary: vitamin d deficiency is now considered a global problem in general population, but it seemed to be more prominent in chronic kidney disease (ckd) patients, especially those on regular hemodialysis. being a key regulator in mineral metabolism, there's also emerging evidences linking vitamin d deficiency with inflammation and oxidative stress, which are both recognized as constant threats to cardiovascular outcomes in hemodialysis patients. it's prospective, randomized trial that's carried out to evaluate the effect of weekly versus, monthly oral cholecalciferol, on vitamin d (25(oh)d) levels, oxidative stress markers, inflammatory markers and secondary hyperparathyroidism in hemodialysis patients. fifty eligible hemodialysis patients were randomly assigned to either group a (oral 50.000iu cholecalciferol, once weekly) or group b (oral 200.000iu cholecalciferol, once monthly), for 3 months. serum levels of (25(oh)d), serum malondialdehyde (mda), serum superoxide dismutase (sod), serum high sensitive (hscrp), calcium, phosphorus, and intact parathormone (ipth) levels, were all assessed at baseline and at the end of the study


Eligibility criteria:
inclusion criteria: * male or female patients aged between 18-70 years, on maintenance hemodialysis for a duration of 3 months or more, in a stable clinical condition (no hospitalization in the previous 3 months), with serum vitamin d levels of \< 30 ng/ml. exclusion criteria: * patients with hypersensitivity to cholecalciferol, ongoing cholecalciferol therapy, liver failure, digestive malabsorption disease, being participating in an another clinical trial within the past 4 weeks, females that are pregnant or breastfeeding, or patients being judged to be unsuitable to be enrolled by the attending physician.
effects of intraarticular il1-ra on pain and inflammatory mediators after knee arhroscopy

Conditions: Knee Injuries

Summary: this project investigates the relation between acute pain and local inflammation. pain reported by the patients for knee arthroscopy are compared with local changes in inflammatory mediators by using microdialysis technique. patients with moderate-to-severe pain are included in a randomized placebo-controlled trial of anakinra given intra-articularly.

the effects of the recombinant il-1 receptor antagonist anakinra both on acute pain and post operative inflammation will be evaluated. on inclusion, pain intensity will be measured on a five-point verbal rating scale (0= no pain, 1=mild pain, 2=moderate pain, 3=severe pain, and 4=intolerable pain), and on a visual analogue scale (0-100mm). vas scale will be repeated at 20, 40, 60, 80, 100, 120, 140, 160, 180 and 200 minutes after inclusion / intervention. the patients will also rate pain intensity during a 5 meters walk at 200 minutes (evoked pain). the patient will rate pain at rest and evoked pain 24, 48 and 72 h after intervention.

Eligibility criteria:
inclusion criteria: 1. otherwise healthy patients (asa 1 and 2) undergoing knee arthroscopy in general anaesthesia. 2. being informed about and willing to participate in the study - exclusion criteria: 1. pregnancy or lactation. fertile women will be asked if they may be pregnant, and offered a pregnancy test if there is doubt. 2. established osteoarthritis or synovitis 3. known intolerance to anakinra 4. kidney failure (creatinine clearance \<30ml/min) 5. history of frequent infectious diseases or immunodeficiency 6. heart failure 7. history of drug -or alcohol abuse 8. participation in other synchronous clinical trials 9. perioperative steroid treatment, perioperative paracetamol (12 hrs), nsaids (24 hrs) or cox2-inhibitors (48 hrs). 10. use of tourniquet for bloodless field 11. strong preoperative pain (vrs ≥3) 12. intolerable postoperative pain (vrs=4)

Keywords: pain, inflammation, surgery
effects of meditation on mechanism of coronary heart disease

Conditions: Coronary Heart Disease

Summary: to study the effects of transcendental meditation on coronary heart disease

recent advances in our understanding of the pathophysiology of acute cardiac events - specifically, identification of the roles that arterial vasomotor dysfunction and autonomic nervous system imbalances play in the pathophysiologic cascade during such acute events - provides a platform for new mechanistic investigation of the interplay of psychosomatic stress and chd (coronary heart disease). preliminary evidence further suggests that complementary and alternative medicine (cam) practices, such as the transcendental meditation (tm) technique, can not only reduce stress but also reduce acute cardiac events in patients with chd. based on these and related data, we propose a randomized, blinded, controlled study of the effects of one cam practice, the tm technique, compared to a control group, on the primary outcomes of (1) arterial vasomotor dysfunction (brachial artery reactivity); (2) autonomic nervous system imbalances (heart rate variability); (3) transient myocardial ischemia (st-segment depression); and (4) the secondary outcomes of psychological stress and quality of life (anger, hostility, anxiety, depression, perceived health, disease-specific symptoms, and life stress/social resources).

Eligibility criteria:
inclusion criteria: * able to attend training sessions and meetings * local residence exclusion criteria: * comorbid disease precluding survival in group * mi, unstable angina, cabg or ptca within last three months. * cognitive/psychological/substance abuse impairment * atrial fibrillation, predominant pacemaker rhythm or significant conduction system disease * significant valvular heart disease * class iii or iv heart failure * renal failure * participating in a formal stress management program * participation in another trial
low-dose ibuprofen in improving cognitive impairment in patients with cancer

Conditions: Cognitive Impairment; Malignant Neoplasm

Summary: this randomized phase ii trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with cancer. anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.

primary objectives: i. to provide preliminary data on the effect of ibuprofen on alleviating chemotherapy-related cognitive impairment (crci) in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control, as assessed by the functional assessment of cancer therapy-cognitive function (fact-cog). outline: patients are randomized into 1 of 2 arms. arm i: patients receive ibuprofen orally (po) twice daily (bid) for 6 weeks. arm ii: patients receive placebo po bid for 6 weeks. after completion of study, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (rt) is allowed * answer yes to the question: "have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1 * note: if a participant answers no, they may be re-approached at a subsequent cycle * be able to swallow medication * be able to read english * have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist exclusion criteria: * have a confirmed brain tumor or brain metastases * be taking a regular daily dose of an nsaid note: daily doses of 81 mg aspirin are permitted and higher doses of an nsaid on an 'as needed' basis are permitted * be diagnosed with dementia or severe neurodegenerative disease * have a contraindication to nsaids at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to nsaid, very low platelet count from chemotherapy, full-dose anti-coagulation/high risk of bleeding, and uncontrolled conditions such as hypertension, asthma, or peptic ulcer disease) * have been hospitalized for treatment of a major psychiatric illness within the last five years * have a serum creatinine above 1.5 upper limit of normal (uln) (collected within the past 4 weeks); uln is per institutional definition * concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or to interfere with antiplatelet activities * be colorblind * have active substance abuse (e.g. alcohol, drugs) per self-report or medical record
the effect of remote ischemic postconditioning on liver graft and renal function in patients undergoing living-related liver transplantation

Conditions: Ischemia/Reperfusion Injury of Liver Graft; Ischemia/Reperfusion Injury of Kidney; Remote Ischemic Postconditioning

Summary: the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

ischemic reperfusion injury of liver graft and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing liver transplantation. the incidence of postoperative renal dysfunction was reported as high as 12 \~ 64% and is thought to be caused by ischemia/reperfusion injury. ischemic pre- or postconditioning was reported to be effective for preventing ischemia/reperfusion injury during liver transplantation. remote ischemic pre- or postconditioning was also reported to be protective for ischemia/reperfusion injury in major organs in previous animal studies. therefore, we are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Eligibility criteria:
inclusion criteria: * subjects undergoing living donor liver transplantation during the study period * subjects older than 20 yrs who can give written informed consent exclusion criteria: * re-transplanted recipients * those with peripheral vascular diseases affecting the extremities * those with hepatic encephalopathy * those with cirrhotic cardiomyopathy

Keywords: ischemia/reperfusion injury remote ischemic postconditioning
stationary bike use during ice bath and virtual reality

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness of different technologies, in particular virtual reality, inclusive of passive content, active content, cognitive load modulation, and positive encouragement coaching to increase the pain threshold as assessed by immersing a hand in ice water while utilizing a stationary bike.


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * english speaking * hearing intact exclusion criteria: * patients who do not consent * are currently taking beta blockers or other chronotropic heart medication(s) * have a history of severe motion sickness * currently have nausea * currently experiencing seizures * are clinically unstable

Keywords: ice bath virtual reality stationary bike
pharmacist-driven cgm use in the uninsured population

Conditions: Diabetes Mellitus

Summary: this is a pilot study. the purpose is to (1) provide access to continuous glucose monitoring (cgm) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.


Eligibility criteria:
inclusion criteria: 1. adult 18 years of age or older 2. diagnosis of type 1 or type 2 diabetes 3. a1c greater than 8% 4. prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (glp-1) receptor agonist exclusion criteria: 1. pregnant or breast-feeding 2. on dialysis 3. not appropriate for cgm use based on clinical judgment by the investigators 4. patients with limited english proficiency

Keywords: continuous glucose monitoring
limiting iv chloride to reduce aki after cardiac surgery

Conditions: Patients Undergoing Cardiothoracic Surgery

Summary: this primary aim of this study is to test the impact of a strategy of perioperative chloride-restriction through intravenous (iv) fluid therapy on the incidence of acute kidney injury after cardiac surgery. a prospective, open-label, single-centre 4-period sequential study of varying strategies of perioperative iv fluid composition will test the hypothesis that a perioperative protocol for the administration of chloride-poor intravenous fluids compared to chloride-rich intravenous fluids will reduce the incidence of aki after adult cardiothoracic surgery.

after an initial run-in period of approximately 1 month (using a chloride-rich fluid strategy), the first study period of 5 months will commence, also comprising a chloride-rich perioperative iv fluid therapy strategy (0.9% saline or 4% albumin). this will include intraoperative fluid and postoperative fluid for the duration of stay in the intensive care unit. this will then be followed by a 1-month transition period before a second period of 5 months will commence where perioperative intravenous fluid therapy will consist of chloride-poor fluids (lactated ringer's solution or concentrated 20% albumin). a subsequent 1-month transition period will then be followed by a third period of 5 months characterized by perioperative iv fluid therapy with an alternative combination of chloride-poor solutions (plasmalyte® 148 or concentrated 20% albumin). a final 1-month transition period will be followed by a fourth and final period of 5 months characterized by a return to perioperative iv fluid therapy with chloride-rich fluids (0.9% saline or 4% albumin). a final 1-month run-off period using a chloride-rich perioperative fluid strategy will follow prior to study completion.

Eligibility criteria:
inclusion criteria: all adult patients undergoing surgery by division of cardiothoracic surgery exclusion criteria: nil

Keywords: thoracic surgery cardiac surgery acute kidney injury hyperchloremia intravenous fluid
prevalence,natural history,prognosis factor,qualityoflife,health care consumption and social consequences of symptomatic knee and hip osteoarthritis in france

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Summary: the aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb oa patients. general objectives: to document the natural history and to identify predictive factors of the evolution and consequences of hip and knee oa in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.


Eligibility criteria:
inclusion criteria: * male and female aged between 40 and 75 years * symptomatic hip or knee, uni or bilateral oa with clinical diagnosis confirmed by a medical physician and satisfying acr classification criteria * representative of prevalent cases in france at the cohort set-up time exclusion criteria: * presence of hip or knee joint replacement surgery * comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of oa * an history of osteotomy * patello-femoral osteoarthritis without tibio-femoral osteoarthritis * other joint diseases of the target joints * adult under legal protection or not able to consent

Keywords: cohort quality of life health resource use disability prognosis
safety, radiation dosimetry, biokinetics, and effectiveness of [18f]mk3328 (mk-3328-001)

Conditions: Alzheimer's Disease

Summary: this study will estimate the radiochemical and radiation safety and assess the efficacy of \[18f\]mk-3328, a novel positron emission tomography (pet) tracer. the study safety hypotheses will test whether \[18f\]mk-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluations and adverse experiences in healthy participants, including healthy elderly (he) participants, and alzheimer's disease (ad) participants, to permit continued investigation. the study efficacy hypothesis will test whether \[18f\]mk-3328 can discriminate between ad participants and cognitively normal elderly control participants based on tracer volume of distribution, or one of its surrogates, in brain posterior cingulate gyrus.


Eligibility criteria:
inclusion criteria: part i: * participant is male or female of non-reproductive potential between 50 and 65 years old. * participant is less than 6'5" tall * participant is in good health * participant has been a non-smoker for at least 10 years parts ii and iii: * male or female of non-reproductive potential at least 55 years of age * participant is cognitively normal (he participants), or has probable mild-to moderate ad (ad participants) * participant is willing to have an arterial catheter placed in the radial artery (part ii only) exclusion criteria: part i: * participant has a history of stroke, seizures, or neurological disorder * participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable parts ii and iii: * participant has a history or current evidence of any neurological or neurodegenerative disorder other than ad that is associated with altered cognition * participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable * participant is living in a nursing home or skilled nursing facility