Kornimate/medical-research-clean huggingface dataset:
comparison of laboratory test results of minimal-residual disease in samples from patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: diagnostic procedures that find residual disease may help predict if the disease will come back in patients diagnosed with acute myeloid leukemia. purpose: this research trial studies the comparison of laboratory test results for minimal residual disease in samples from patients with acute myeloid leukemia.

objectives: * to promote harmonization between cooperative group reference laboratories conducting minimal-residual disease (mrd) evaluation of acute myeloid leukemia by flow cytometry. outline: archived bone marrow and blood samples, distributed to the eastern cooperative oncology group, southwest oncology group, and cancer and leukemia group b laboratories, are analyzed for leukemia-associated immunophenotype (laip) assays and minimal residual disease studies by flow cytometry. results are then provided to the national cancer institute for assessment and comparability of test results.

Eligibility criteria:
disease characteristics: * non-identified cryopreserved samples of bone marrow and/or peripheral blood from patients with acute myeloid leukemia (aml) from the children oncology group (cog) studies * baseline/diagnostic aml samples * samples collected after initial treatment and representing varying levels of residual blast counts patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood acute myeloid leukemia/other myeloid malignancies
radiotherapy vs neck dissection for clinical t1/2n0 supraglottic cancer

Conditions: Supraglottic Cancer

Summary: supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. cervical nodal metastasis is an important prognostic factor in supraglottic cancer. current management, following the us national comprehensive cancer network guidelines for t1-2, n0 supraglottic cancer (nccn 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. the optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. the investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.


Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent document 2. age≥ 18 and≤ 75 years 3. histological/ cytological/ imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment 4. cervical node negative according to the imaging characteristics and the physical examination 5. kps≥ 70 6. normal bone marrow reserve function and normal liver, kidney function 7. expected survival period≥ 12 months exclusion criteria: 1. inability to provide an informed consent 2. proved distant metastasis 3. clinical stage 3-4 4. the patient has received prior surgery or radiotherapy (except for biopsy ) 5. the patient has received chemotherapy(including targeted therapies) or immunotherapy 6. prior malignancy within the previous 5 years 7. severe mental disorders 8. pregnant or lactating women 9. other disease requiring simultaneous surgery or radiotherapy 10. researchers believe that the situation is unsuitable for participation in the group

Keywords: supraglottic cancer laryngeal cancer cervical lymph node neck dissection
safety, pharmacokinetics, and preliminary efficacy of byon4413 in acute myeloid leukemia and myelodysplastic neoplasms.

Conditions: Relapsed / Refractory AML; Relapsed / Refractory MDS

Summary: this is the first-in-human trial with byon4413 to evaluate safety, pk, immunogenicity, and anti-leukemia activity of byon4413 in patients with aml or mds.

this trial includes two parts. part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of byon4413 will be determined. part 2 is an expansion study to evaluate the anti-leukemia activity and safety of byon4413.

Eligibility criteria:
inclusion criteria: * patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of: * r/r aml (who 2022) or * mds (who 2022) with ≥10% blasts in bm and have received ≥3 cycles of hma * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2; * adequate baseline organ function. exclusion criteria: * having been treated with any cd123-targeting therapies; * having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start cycle 1 day 1; * having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to ctcae grade ≤ 1; * having active central nervous system aml or aml of the apl/m3 subtype; * history of keratitis; * history of specified lung or renal disease; * having clinically significant cardiovascular disease; * known infection of hepatitis b, c or e. key inclusion and exclusion criteria details are listed here, additional requirements may apply.

Keywords: byon4413 cd123 hematologic malignancies antibody drug conjugate aml mds
study evaluating intepirdine (rvt-101) on gait and balance in subjects with dementia

Conditions: Alzheimer's Disease; Dementia With Lewy Bodies; Parkinson's Disease Dementia

Summary: this study seeks to evaluate the effect of intepirdine (rvt-101) on gait and balance in patients with alzheimer's disease, dementia with lewy bodies or parkinson's disease dementia.

to assess the effect of intepirdine (rvt-101) versus placebo on quantitative and qualitative gait and balance parameters. each subject will be randomized 1:1 to one of the following sequences: sequence 1: ab = rvt-101 35 mg during the early treatment period and placebo during the late treatment period sequence 2: ba = placebo during the early treatment period and rvt-101 35 mg during the late treatment period treatment a = rvt-101 35 mg once daily. treatment b = placebo once daily.

Eligibility criteria:
key inclusion criteria: male or female subject with a clinical diagnosis of alzheimer's disease (ad), dementia with lewy bodies (dlb), or parkinson's disease dementia (pdd). mini mental state examination score 14 to 26 gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements subjects must be on stable background acetylcholinesterase inhibitor therapy key exclusion criteria: history and/or evidence of any other cns disorder that could be interpreted as a cause of dementia (in the opinion of the investigator) any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.

Keywords: rvt-101 intepirdine alzheimer's disease dementia with lewy bodies lewy body dementia parkinson's disease dementia
48-wk open label phase iiib to evaluate efficacy and safety

Conditions: Dyslipidaemia

Summary: the purpose of this study is to assess the efficacy and safety of rosuvastatin in reducing low density lipoprotein cholesterol levels to internationally recognised goals in subjects with dyslipidaemia.


Eligibility criteria:
inclusion criteria: * fasting low density lipoprotein level as defined by the protocol. * fasting triglyceride level as defined by the protocol. exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1. * active arterial disease eg unstable angina, or recent arterial surgery. * blood lipid levels above the limits defined in the protocol. * uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Keywords: cholesterol low density lipoproteins dyslipidaemia rosuvastatin crestor
the effect of tdcs in the treatment of chronic pelvic pain associated with endometriosis

Conditions: Chronic Pain; Endometriosis

Summary: the purpose of this study is to determine if transcranial direct current stimulation (tdcs) is effective in the treatment of chronic pelvic pain associated with endometriosis


Eligibility criteria:
inclusion criteria: * age \> 18 years old, non-menopausic, with the diagnosis of endometriosis by videolaparoscopy and biopsy, able to understand and write the portuguese language, in treatment with isolated progestin for at least one month, that have worst daily pain in the analogue visual scale \> 4 cm in most of the days in the last month exclusion criteria: * left-handed women, endometriosis implantation in intestine, bladder or urether (surgical treatment indication), history of intense or frequent headache, chronic dermatologic disease, previous adverse effects to treatment with tdcs, seizures, severe cranial trauma with alteration of the cranial anatomy, metallic intracranial implants or pacemaker, history of pelvic inflammatory disease, non-compensated psychiatric disease, non-collaborative patients, history of neurologic, oncologic disease, heart, renal or hepatic failure.

Keywords: endometriosis transcranial direct current stimulation tdcs near infrared spectroscopy nirs chronic pelvic pain
estradiol transdermal spray in the treatment of vasomotor symptoms

Conditions: Hot Flashes

Summary: estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. this study will evaluate the safety and efficacy of evamist.

multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. the endpoints are the reduction in frequency and severity of hot flushes.

Eligibility criteria:
inclusion criteria: * post menopausal women, * ages 35 or older, * frequent moderate to severe hot flushes, * qualifying general medical health exclusion criteria: * disqualifying gynecological disorders, * disqualifying dermatological disorders, * disqualifying concurrent conditions

Keywords: postmenopause hot flashes estradiol polyestradiol phosphate estradiol valerate estradiol 3-benzoate estradiol 17 beta-cypionate estrogens hormones hormones, hormone substitutes hormone antagonists
evaluation of the impact of cochlear implants on cognition in older adults

Conditions: Dementia; Hearing Loss; Presbycusis

Summary: the subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for standard-of-care cochlear implant. cognitive tests will be administered preoperative, and postoperative at 6 and 12 month intervals.

patients \>65 year old who are cochlear implant candidates will be recruited for study participation. candidacy criteria will be based on current fda guidelines for cochlear implantation. after pre-operative cognitive testing, subjects will undergo cochlear implantation using standard operative techniques. patient will have routine post-operative care and will follow up with audiology per standard post-activation routine - 1 week after activation, then monthly until a stable program is achieved. hearing will be measured with standard audiometry to check for residual acoustic hearing, hearing in noise tests (hint), aided thresholds, and consonant-nucleus-consonant (cnc) words at activation, 6 and 12 months post-operatively, and as often as needed in the interim to determine function. pre-operative and 6 and 12 month post-operative cognitive testing will be performed using a battery of tests that will differentiate verbal/auditory and non-verbal cognitive abilities. written informed consent will be sought from all individuals who will participate in the proposed project. consent will be obtained by the principal investigator or key study personnel such as the research coordinator. when a potential participant has been identified, she/he will be visited in person. the participant will be given an overview of the study as well as written material that further explains the study and the responsibilities of the participant. since some of our participants may have cognitive impairment, we will also make a determination about capacity to provide informed consent. following presentation of the informed consent document, participants will be asked questions about the study (i.e. purpose, procedures, risks, and benefits). if these questions are adequately answered, then the participant will be judged to have capacity to provide informed consent. however, if these questions are not adequately answered, the participants will not be judged to have this capacity. in these latter cases, assent will be obtained from the participant and informed consent will be obtained from the participant's legally authorized representative (spouse, adult child

Eligibility criteria:
inclusion criteria: * the subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for a cochlear implant. exclusion criteria: * those patients who are not able to undergo cochlear implantation surgery due to medical co-morbidities would not be eligible for the study.

Keywords: adults
effect of nebulized and intravenous hypertonic saline 3% on the management of patients with acute respiratory distress syndrome

Conditions: Nebulization; Hypertonic Saline; Acute Respiratory Distress Syndrome

Summary: the aim of our study is to compare between the effect of nebulized and intravenous injection of hypertonic saline 3% on the outcome of patients with acute respiratory distress syndrome.

acute respiratory distress syndrome (ards) is a life threatening form of respiratory failure, characterized by acute, diffuse, inflammatory lung injury that results in increased alveolar capillary permeability and the development of non-hydrostatic pulmonary edema. clinically, ards manifests as marked hypoxemia and respiratory distress; patients often progress to respiratory failure that requires invasive mechanical ventilation in the intensive care unit. no specific pharmacological treatment is available for ards, which is associated with high morbidity and mortality. the mainstay of therapy in ards is supportive therapy and invasive mechanical ventilation based on lung-protective strategies using low tidal volume (vt) at 4-6 ml/kg of predicted body weight (pbw) and plateau pressure (p plat) below 30 cm h2o, but other adjunctive therapies have been trialed with various degrees of efficacy, including neuromuscular blockade, prone positioning, recruitment maneuvers (rms), vasodilators, and extracorporeal membrane oxygenation (ecmo). hypertonic saline 3% nacl with 513 meq/l of na and 513 meq/l of cl is a potent anti-inflammatory agent, and immunomodulator, which exerts inhibitory effects in several stages of the inflammatory cascade. hypertonic saline, at a cellular level, decreases alveolar macrophage activation, polymorph nuclear leucocyte recruitment, priming and activation, as well as cell surface adhesion molecule expression. high plasma sodium contributes to high plasma osmolality which can be lung protective and would seem to be a logical choice for treatment of ards.

Eligibility criteria:
inclusion criteria: * age from 21 to 60 years old. * both sexes. * patients with mild and moderate ards whose pao2/fio2 ratio ≥ 150 according to the berlin definition of acute respiratory distress syndrome. exclusion criteria: * refusal to participate in the study. * malignancy. * patients on chemotherapy. * decompensated renal, hepatic and cardiac disease. * patients with hypernatremia whose serum na above 155 meq/l. * patients with ards whose pao2/fio2 ratio \> 150.
a registry of cardiac pet and cardioflux magnetocardiography in patients with suspected coronary ischemia.

Conditions: Coronary; Ischemic

Summary: a multicenter observational data development registry collecting diagnostic measures via standard of care (soc) cardiac pet in order gain a better understanding of how cardioflux mcg may be used in the detection of coronary ischemia.


Eligibility criteria:
inclusion criteria: * willing to provide informed consent * male or female, aged 40 and up (inclusive) at the time of enrollment * clinical suspicion of myocardial ischemia that clinician desired cardiac pet * completed cardiac pet within 2 weeks prior to study enrollment exclusion criteria: * patients unable to fit into cardioflux device. * patients unable to lie supine for 5 minutes. * patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators). note: sternotomy wires stents are acceptable * ongoing atrial fibrillation or atrial flutter * life expectancy \<1 yrs. due to non-cardiovascular comorbidity

Keywords: magnetocardiography coronary ischemia
immunologic evaluation in patients with digeorge syndrome or velocardiofacial syndrome

Conditions: DiGeorge Syndrome; Shprintzen Syndrome; Chromosome Abnormalities; Abnormalities, Multiple; Conotruncal Cardiac Defects

Summary: objectives: i. determine the pattern of immunologic reconstitution in patients with t-cell compromise due to digeorge syndrome or velocardiofacial syndrome. ii. determine any correlation between immunologic function in these patients and chromosome 22 deletion breakpoints. iii. determine presence of sustained immunologic compromise in older patients.

protocol outline: blood samples are collected at diagnosis of chromosome 22q11 deletion and assessed for lymphocyte proliferation in response to mitogens phytohemagglutinin, pokeweed mitogen, and concanavalin a (mitogen stimulation analyses). these analyses are repeated at 4 months along with a quantitative analysis of immunoglobulin. at 8 months, patients are tested for their lymphocytes' ability to respond to antigens (candida, tetanus, and diphtheria). at 1 year, patients have lymphocyte subset, igg, iga, and igm analyses performed. quantitative evaluations of antibody titers to diphtheria, tetanus, haemophilus influenza, and hepatitis b are also performed. over 1 year of age, all studies are performed if the patient is seen for a single visit.

Eligibility criteria:
* conotruncal cardiac lesion to be repaired by surgery and chromosome 22q11 deletion by fish

Keywords: digeorge syndrome shprintzen syndrome cardiovascular and respiratory diseases conotruncal cardiac defects genetic diseases and dysmorphic syndromes rare disease
effect of thoracic block technique on atelectasis in children on mechanical ventilation

Conditions: Atelectasis; Intensive Care Unit; Children

Summary: statement of the problem: • does the thoracic block technique has effect on atelectasis in children on mechanical ventilation? null hypothesis: • there is effect of thoracic block technique on atelectasis in children on mechanical ventilation.

subjects: the study targets the children from both sexes. sample size estimation will be carried out to determine the recruited number of children, selected randomly from cairo university pediatric specialized hospital intensive care units ,cairo to participate in the study study design: randomized controlled clinical trial. a. inclusion criteria: 1. age range from 6 months to 4 years . 2. diagnosed with pneumonia, receiving mechanical ventilation. 3. start from second day of admission to intensive care unit. 4. have unilateral mild to moderate atelectasis according to medical referral . 5. should be vitally stable during the session. b. exclusion criteria: the children will be excluded from the study if they had one of the following: 1. medically unstable ( examples: tachycardia and tachypnea). 2. uncontrolled convulsion. 3. irritable or moderate to sever pain 4. rib fracture 5. pneumothorax children will be assessed by measuring heart rate, respiratory rate, chest x-ray, arterial blood gases,dynamic compliance, oxygen saturation index before and after ten days of receiving intervention

Eligibility criteria:
inclusion criteria: 1. age range from 6 months to 4 years . 2. diagnosed with pneumonia, receiving mechanical ventilation. 3. start from second day of admission to intensive care unit. 4. have unilateral mild to moderate atelectasis according to medical referral. 5. should be vitally stable during the session. b. exclusion criteria: the children were excluded from the study if they had one of the following: exclusion criteria: the children were excluded from the study if they had one of the following: 1. medically unstable ( examples: tachycardia and tachypnea). 2. uncontrolled convulsion. 3. irritable or moderate to sever pain 4. rib fracture 5. pneumothorax
the multi-modal evaluation of agitation in critically ill patients based on remote video-ultra-sensitive detection wave

Conditions: Critically Ill Patients

Summary: the goal of this observational study is to learn about the effectiveness of the multi-modal evaluation for agitation behavior in critically ill patients based on remote video-ultra-sensitive detection wave. the main question it aims to answer is: evaluate the effectiveness of multi-modal evaluation monitoring system for agitated critically ill patients participants already taking multi-modal evaluation monitoring system as part of their regular medical care for agitated critically ill patients will compare their effectiveness for agitation for 3 years.


Eligibility criteria:
inclusion criteria: * patients at risk of agitation in the icu * patients with rass score -2 and above * ≦ 65 years old, ≧ 18 years old exclusion criteria: * the affected party refused to participate in this study * missing/incomplete information * vulnerable groups such as pregnant women, those who lack the capacity for civil conduct and do not have the consent of their legal representatives * maxillofacial trauma, burns, tumors, surgery, etc. affect facial expression * patients with limb impairment and amputation * spinal cord injury, limb movement/sensory limitations * patients with pre-existing neurological/psychiatric diseases * patients with malignant tumors * patients with infectious diseases * patients with terminal disease and dying disease * abnormal behavior due to head injury or craniocerebral disease

Keywords: critically ill agitation monitoring remote