Kornimate/medical-research-clean huggingface dataset:
phase i/ii trial of s64315 plus azacitidine in acute myeloid leukaemia

Conditions: Acute Myeloid Leukaemia

Summary: the purpose of this study is to assess the safety, tolerability and clinical activity of the combination s64315 with azacitidine in patients with acute myeloid leukaemia.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years 2. patients with cytologically confirmed and documented de novo, secondary or therapy-related aml as defined by world health organization 2016 classification (arber, 2016) excluding acute promyelocytic leukaemia (apl, french american-british m3 classification) with: relapsed or refractory disease and without established alternative therapy, or secondary to myelodysplastic syndrome and without established alternative therapy or, newly diagnosed aml, not previously treated for aml and who are not candidate for intensive chemotherapy due to age or comorbidities. 3. eastern cooperative oncology group (ecog) performance status ≤ 2. 4. adequate haematological, renal and hepatic functions based on the last assessment performed within 7 days prior to the first investigational medicinal product administration. exclusion criteria: 1. previous myeloproliferative syndrome (mps). 2. patients previously treated with any mcl-1 inhibitor. 3. patients who have not recovered from toxicity of previous anticancer therapy, including grade ≥ 2 toxicity (except alopecia of any grade) according to the national cancer institute common terminology criteria for adverse event (nci ctcae) version 5.0, prior to the first imp administration. 4. severe or uncontrolled active acute or chronic infection. 5. uncontrolled hepatitis b or c infection. 6. known carriers of hiv antibodies, history of significant liver disease, active acute or chronic pancreatitis, active central nervous system disease. 7. troponin \> uln (upper limit of reference range) or troponin t \> uln if troponin i cannot be assessed. 8. clinically significant cardiac dysfunction (including new york heart association class ≥ii heart failure, left ventricular ejection fraction (lvef) \< 50% as assessed by echocardiography (echo) or multi-gated acquisition (muga) scan). 9. qt prolongation defined as qtc (qt interval corrected for heart rate) interval (corrected with fridericia's formula) \> 450 ms for males and \> 470 ms for females, obtained from triplicate 12-lead ecg. 10. any factors that increase the risk of qtc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long qt syndrome, family history of long qt syndrome or unexplained sudden death under 40 years of age. 11. uncontrolled arterial hypertension (systolic blood pressure (sbp) \> 150 mmhg or diastolic blood pressure (dbp) \> 95 mmhg).

Keywords: acute myeloid leukaemia oncology mcl-1 inhibitor azacitidine combination phase i/ii international safety maximum tolerated dose
the effectiveness of lactoferrin in treatment of iron deficiency anemia in children with chronic tonsillitis

Conditions: Iron-deficiency

Summary: the investigators will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in children with chronic tonsillitis

iron deficiency is frequently present with chronic inflammatory disease.(1) iron deficiency anemia results from decreased body's iron content due to blood loss, poor dietary iron intake, malabsorption, or increased iron requirement. immune activation drives a diversion of iron to storage sites, particularly the mononuclear phagocytes system in liver and spleen leads to poor hemoglobinization and anemia. iron deficiency and immune activation lead to disturbances of iron homeostasis.(2) this trial will compare the response to iron deficiency anemia to lactoferrin plus ferrous poly maltose versus ferrous poly maltose in children with chronic tonsillitis

Eligibility criteria:
inclusion criteria: * children 3-17 years old with chronic tonsillitis exclusion criteria: * no other causes of iron deficiency anemia
effectiveness of caregiver-involved group-based ndbis intervention for autistic preschoolers

Conditions: Autism Spectrum Disorder

Summary: this is a study that investigate the effectiveness of ndbis for autistic preschoolers delivered in group-settings and one-on-one settings. the outcome measures assess the improvements in autistic symptoms, social communication, play skills, group behaviors, adaptation, and parent stress.

autism spectrum disorder (asd) is characterized by persistent social communication deficits and restricted behaviors. global prevalence is 1-2%, with 1% in taiwan. social interaction obstacles and repetitive behaviors impact asd individuals in various contexts, emphasizing the need for effective interventions. current treatments focus on behavioral approaches, particularly naturalistic developmental behavioral interventions (ndbis). ndbis improve social engagement, cognitive development, and language skills. parent-mediated intervention (pmi) enhances treatment effectiveness and reduces parenting stress. however, many ndbis are conducted in one-on-one settings, limiting feasibility, especially in schools. group-based interventions are beneficial and more feasible in the communities, but limited research exists. in taiwan, early interventions, covered by national health insurance, lack intensity and parent involvement. the study aims to establish an intensive, parent-involved, group-based ndbis program. the randomized controlled trial will assess its effectiveness in improving autistic symptoms, social and play skills, group behaviors, general adaptation, and reducing parenting stress.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as autism spectrum disorder * aged 2-6 years old * one of caregivers is able to participate treatment sessions. exclusion criteria: * having other major diseases.

Keywords: autism naturalistic developmental behavioral intervention effectiveness
correlation between deficits in knee rom recovery and difficulty in dorsiflexing the tibio-tarsal joint in patients undergoing total knee replacement surgery.

Conditions: Articulation Disorders

Summary: to demonstrate that the deficit in dorsiflexion-tibia-talar joint range of motion can have an effect on the knee operated by arthroplasty by limiting full extension and, in general, the recovery of a full range of motion.

the study is of a prospective, prognostic, observational nature and involves all patients who are candidates for admission to the rizzoli orthopaedic institute for primary knee replacement surgery, recruited in the orthopaedics department and subsequently followed in the rehabilitation medicine department of the drs. the recruited patients will be subjected to pre-operative measurement of the ankle rom; if they present a limitation of the same, they will be included in the exposed group, alternatively they will be included in the non-exposed group.

Eligibility criteria:
inclusion criteria:• * patients who are candidates for primary total knee replacement surgery aged 65 to 85 years; * patients who have provided informed consent exclusion criteria:• * patients with known neurological pathologies * severe joint deformations such as previous ankle surgery (arthrodesis, ankle prosthesis) congenital malformations (cavus equinus, clubfoot) * severe fractures that have compromised the joint * traumatic events affecting the lower limb that occurred less than 12 months * non-ambulatory patients in the preoperative period
cognitive and functional status and dialysis outcomes in older hemodialysis patients

Conditions: Dementia; Cognition; End-stage Renal Disease

Summary: the purpose of this study is to estimate how quickly cognitive status and functional status in older patients on hemodialysis declines.

dialysis outcome measures, which predict morbidity and mortality of younger patients on renal replacement therapy, such as dialysis clearance, do not correlate with survival of the elderly patients on hemodialysis. survival of older patients on hemodialysis is significantly worse when compared to that of the younger patients. conditions commonly affecting older adults, such as functional decline, cognitive impairment, depression and declining quality of life have not been well studied in hemodialysis population. there may be an important relationship between these measurements and outcomes in older dialysis patients. institution of appropriate age-specific interventions could result in improved health status and mortality of older patients on hemodialysis. our broad objective is to better understand global functioning of the elderly dialysis patients and its possible impact on dialysis outcomes in attempt to improve health care of the older patients receiving hemodialysis.

Eligibility criteria:
inclusion criteria: * prevalent and incident hemodialysis patients over the age of 60, receiving hemodialysis treatments at the university of chicago outpatient dialysis program. exclusion criteria: * patients 59 and younger, and patients with the following medical conditions: malignancies currently requiring chemotherapy or radiation therapy, severe heart failure (nyha class iv), known hiv infection, or currently active hepatic encephalopathy.

Keywords: dementia, cognitive disorders, hemodialysis
a pharmacokinetics (pk) study to investigate the effect of rifampin on pk of vemurafenib (zelboraf)

Conditions: Malignant Melanoma, Neoplasms

Summary: this open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the pk of vemurafenib in participants with unresectable brafv600-mutation positive metastatic melanoma or other malignant tumor type that harbors a v600-activating mutation of braf without acceptable standard treatment options. eligible participants will have the option to continue treatment with vemurafenib as part of an extension study go28399 (nct01739764).


Eligibility criteria:
inclusion criteria: * participants with either unresectable stage iiic or stage iv metastatic melanoma positive for the braf v600 mutation or other malignant tumor type that harbors a v600-activating mutation of braf, as determined by results of cobas® 4800 braf v600 mutation test or a deoxyribonucleic acid (dna) sequencing method, and who have no acceptable standard treatment options * eastern cooperative oncology group (ecog) performance status 0 to 2 * life expectancy of greater than or equal to (\>/=) 12 weeks * full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment * adequate hematologic and end organ function * female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use 2 effective methods of contraception * negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential exclusion criteria: * prior treatment with vemurafenib or other braf inhibitor within 42 days of first dose of study drug * requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 24-day period for this trial is not clinically acceptable * allergy or hypersensitivity to components of the vemurafenib formulation * experimental therapy within 4 weeks prior to first dose of study drug * major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug, or anticipation of the need for major surgery during study treatment * prior anti-cancer therapy within 28 days before the first dose of study drug * history of clinically significant cardiac or pulmonary dysfunction * history of symptomatic congestive heart failure of any new york heart association class or serious cardiac arrhythmia requiring treatment * history of myocardial infarction within 6 months prior to first dose of study drug * current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living * history of congenital long qt syndrome or corrected qt interval (qtc) greater than (\>) 450 milliseconds * active central nervous system lesions * uncontrolled or poorly controlled diabetes * current severe, uncontrolled systemic disease
spectrum analysis in ex-vivo human lungs

Conditions: Lung Cancer

Summary: this study will analyze spectral features of the radiofrequency of lung tumors in ex-vivo human lungs. the resected specimens will be evaluated using the spectrum analysis to determine the localization rate of the targets. ultrasound measurement and images will be used for correlation of ts mode image findings with pathology by using he and ihc slides of lung tumor and lymph node.


Eligibility criteria:
inclusion criteria: * any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors. * 18 years of age or older exclusion criteria: * any patients with inability to give informed consent.

Keywords: lobectomy
cosmic weather and cardiogenic pulmonary edema

Conditions: Pulmonary Edema Cardiac Cause

Summary: retrospective clinical study to evaluate whether there is any correlation between the pre-hospital incidence of cardiogenic pulmonary oedema (cpe) in the selected region and the space weather parameters.

emergency medical service of the central bohemian region is the exclusive provider of primary pre-hospital emergency care in the central bohemian region, czech republic. the region includes both the rural and urban population, in total of 1 315 299 inhabitants on a total area of 11 015 km2. a computer search of patients with dyspnoea between 1.10.2008 and 30.6.2014 will be conducted and all cases of cardiogenic pulmonary oedema will be selected. physical parameters of space weather and geomagnetic field disturbances will be obtained from the database of institute of experimental physics, slovak academy of sciences, slovak republic. the datasets will be analysed whether there is any correlation between the pre-hospital incidence of cpe in the selected region and the parameters of space weather and geomagnetic field disturbances.

Eligibility criteria:
inclusion criteria: * all patients treated by emergency medical service of the central bohemian region for cardiogenic pulmonary edema between 1.10.2008 and 30.6.2014. exclusion criteria: * dyspnea from other cause than cardiogenic pulmonary edema.
the effects of position on the oxygenation instability of premature infants as documented by spo2 histograms

Conditions: Premature Infant; Bronchopulmonary Dysplasia

Summary: spo2 instability is in the nature of premature infants. hypoxic episodes occur spontaneously in many of these infants, especially after the first week of life. different interventions have been shown to influence the incidence of hypoxemic episodes in premature infants. a few studies point towards potential clinical benefits of better oxygenation and less hypoxic events by positioning very low birth weight infants prone, though a recent meta-analysis didn't find a clear benefit of prone position. the aim of this study is to evaluate the changes in oxygenation among preterm infants receiving respiratory support when positioned prone versus supine, as documented by spo2 histograms.


Eligibility criteria:
inclusion criteria: premature infants with a weight \< 1500 g who are receiving respiratory support exclusion criteria: congenital anomalies, acute lung pathology for example x-ray confirmed pneumonia, air leak, active culture proven sepsis or on inotropic support for low blood pressure.
targeted metabolomics to decipher dietary contributions to pediatric inflammatory bowel disease (ibd) - main study

Conditions: Gut Microbiome; Inflammation; Irritable Bowel Syndrome

Summary: the overall goal of the study is to investigate the dietary differences between children with well-controlled inflammatory bowel disease (ibd) and those with active disease by using targeted food metabolomics. the utilization of the application of targeted metabolomics allows for the investigation of specific components of foods and their effects in ibd and inflammation, which may inform future dietary recommendations for ibd patients.

the investigators overall hypothesis is that higher intake of animal origin foods lead to higher concentrations of tmao and its precursors (tma, choline and carnitine), which causes gut microbiota dysbiosis, ultimately resulting in elevated inflammatory markers (systemic and/or fecal) in pediatric inflammatory bowel disease (ibd). the two primary aims include: aim 1: examine the relationship between ibd activity, dietary patterns, and diet-derived potential biomarkers in serum and urine. aim 2: investigate the association between ibd activity, dietary patterns, gut microbiome, and diet-derived potential biomarkers in stool. investigators will also explore the integrated relationship between disease activity, diet, gut microbiome, diet-derived potential biomarkers, and inflammatory markers. investigators will recruit 100 subjects with known ibd of \> 6 months duration. subjects will be asked to complete dietary questionnaires, and provide stool, urine, and blood samples.

Eligibility criteria:
inclusion criteria: * male and female * established ibd diagnosis (both well-controlled and active disease) for \> 6 months * followed by the children's hospital colorado (chco) ibd center * ages 8-18 years exclusion criteria: * vegan diet * exclusive enteral nutrition (een) currently or within 2 weeks of enrollment * history of full colectomy * ongoing active gastrointestinal infection * severe malnutrition (bmi less than 5th percentile) * presence of ostomy * recent medication changes
enhancing balance and mobility in incomplete spinal cord injury

Conditions: Spinal Cord Injuries; Walking, Difficulty

Summary: the goal of this clinical trial is to compare the effects of balance therapy with an overground gait trainer in incomplete spinal cord injury (sci). the main questions it aims to answer are: * is balance therapy with an overground gait trainer effective in improving functional ambulation in sci? * is balance therapy with an overground gait trainer effective in enhancing activities of daily living in sci? participants treated with either: • overground gait trainer along with conventional exercise therapy

background: spinal cord injury (sci) and similar pathologies not only negatively affect a person's ability to walk but also have adverse effects on their participation in social, vocational, and recreational activities. the correction of walking impairments resulting from sci is one of the most important goals of rehabilitation, as it is essential for a person's social and vocational integration. when considering balance function, the use of challenging balance and walking exercises at an adequate level is necessary to trigger motor learning. ensuring the patient's safety is the primary priority when using advanced balance and walking exercises based on the patient's current condition. in this study, andago v2.0 (hocoma ag, volketswil, switzerland) has been preferred for ensuring safety by adapting to patient movements. the main objective of the study was to assess the impact of andago on balance in patients with motor incomplete sci. the secondary aim was to evaluate its influence on quality of life and independence. methods: the study included five participants who were over 18 years of age and had experienced a spinal injury within the past year. these participants were classified as ais d (american spinal injury association impairment scale). patients underwent eight-week treatment, with walking and balance exercises on andago performed three days a week. in addition, conventional in-bed exercises, including stretching, strengthening, and mobility exercises, were administered for 40 minutes, two days a week. modified borg scale (mbs), ten-meter walking test (10mwt), timed up and go test (tug), walking index in spinal cord injury ii (wisci ii), berg balance scale (bbs), visual analogue scale (vas) for fear of falling, spinal cord independence measure (scim iii), world health organization quality of life scale-short form (whoqol - bref) were used for evaluation.

Eligibility criteria:
inclusion criteria: * spinal cord injured below t4 * time from injury \< 1 year * d level on ais (american spinal injury association impairment scale) * patients with spinal stabilization exclusion criteria: * osteoporosis * an implanted electronic device * other neurological diseases * cardio-pulmonary diseases * orthopedic diseases
digital remote monitoring of immune checkpoint inhibitor therapy induced toxicity: a feasibility study of the vigilant app (vigilant-2)

Conditions: Malignant Skin Neoplasm; Melanoma

Summary: this study is being done to better understand patient experiences with using a mobile application, known as vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

primary objectives: i. optimize the patient (aim 1) experience of the vigilant app workflow. ii. gather preliminary data on the number of patients who develop grade 3 + 4 immune-related adverse event (irae) or require er visit within 100 days of registration and treatment with ipi/nivo. outline: this is an observational study. patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile vigilant application. patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. additionally, patients complete a survey and may have their medical charts reviewed on study.

Eligibility criteria:
inclusion criteria: * any skin cancer/melanoma patient starting dual \[ipilimumab/nivolumab (ipi/nivo)\] immune checkpoint inhibitor (ici) therapy exclusion criteria: * does not meet inclusion criteria