Kornimate/medical-research-clean huggingface dataset:
nilotinib vs imatinib in adult patients with philadelphia (ph+) chronic myelogenous leukemia in chronic phase (cml-cp)

Conditions: Myelogenous Leukemia

Summary: in this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their philadelphia chromosome-positive (ph+) chronic myelogenous leukemia in the chronic phase (cml-cp).

this trial was to evaluate the ccyr rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. the patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. the first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (pcyr), but no ccyr.

Eligibility criteria:
inclusion criteria: diagnosis of philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase. patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as: * 6 to \< 12 months of treatment and -have 36 - 95% ph+ metaphases, or * 12 to \<18 months of treatment and have 1 - 35% ph+ metaphases (standard cytogenetics, no fish \[fluorescence in situ hybridization\] analysis was allowed). exclusion criteria: * patient who have received more than 18 months of imatinib therapy * patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study. * prior treatment with greater than 400 mg/day imatinib. * uncontrolled or significant cardiovascular disease. * severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection). * use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) * currently taking certain medications that could affect the rhythm of your heart. other protocol-defined inclusion/exclusion criteria may apply

Keywords: leukemia bone marrow leukemia symptoms cml complete blood count lymphocyte blood cancer leukocytes chronic leukemia bone marrow biopsy leukemia research leukemia cells bone marrow disease chronic myeloid leukemia blood cancer symptoms white blood cell diseases chronic myelogenous leukemia leukemia treatment leukemia facts leucemia facts about leukemia myelogenous leukemia newly diagnosed cml suboptimal response philadelphia chromosome positive (ph+) chronic myelogenous leukemia in chronic phase (cml-cp)
using spectrally encoded confocal microscopy (secm) to image the esophagus

Conditions: Eosinophilic Esophagitis

Summary: the goal of this study is to test the feasibility and the tolerability of a tethered spectrally encoded confocal microscopy (secm) capsule and to use it to image the esophagus.

72 subjects including healthy volunteers, patients with a suspicion of having eosinophilic esophagitis (eoe) and patients with a clinical diagnosis of eoe will be recruited and asked to swallow the secm capsule while being awake and unsedated. the capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis. as the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. images are analyzed at a later stage.

Eligibility criteria:
inclusion criteria: * subject must be a healthy volunteer * or subject must have a suspicion of eoe * or subject must have a prior clinical suspicion of eoe * subject must be older than 14 years of age * subject must be able to give informed consent exclusion criteria: * subjects with the inability to swallow pills and capsules. * esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.

Keywords: secm esophagus eosinophilic esophagitis allergy
cognoa asd diagnosis aid validation study

Conditions: Autism Spectrum Disorder

Summary: the primary objective of this study is to collect data to ascertain the positive predictive value (ppv) and negative predictive value (npv) of the current version of the cognoa diagnostic device.

to assess the ability of the diagnostic device to aid in the diagnosis of asd by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on dsm-5 criteria and validated by one or more reviewing specialist clinicians

Eligibility criteria:
general inclusion criteria: * caregiver must be able to read, understand and sign the informed consent form (icf). * caregiver or hcp concern for developmental delay. * female or male, \>18 to \<72 months of age general exclusion criteria: * subjects with a prior diagnosis of asd rendered by a healthcare professional. * subjects whose age on the date of enrollment is outside the target age range. * subjects or caregivers who have been previously enrolled in any cognoa clinical study or survey.
effectiveness of interdisciplinary care compared to usual care in patients with immune-mediated inflammatory diseases

Conditions: Psoriasis; Psoriatic Arthritis; Axial Spondyloarthritis; Hidradenitis Suppurativa; Crohn Disease; Ulcerative Colitis

Summary: the overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with two or more immune-mediated inflammatory diseases (imids).

immune-mediated inflammatory diseases (imids) such as psoriasis, hidradenitis suppurative, spondyloarthritis, and inflammatory bowel disease, are associated with increased risk of somatic and psychiatric comorbidities as well as reduced socioeconomic status and a risk of further autoimmune diseases. the unmet needs in the care of patients with imids are caused by a lack of patient-centricity in the usual specialized siloed approach to these diseases. the overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared to usual care in a population of patients with the imids: psoriasis, hidradenitis suppurativa, spondyloarthritis, ulcerative colitis, and crohn's disease. this trial is designed to determine if the interdisciplinary intervention works in a real-world setting and thus has several pragmatic elements. the hypotheses will be tested in a randomized, usual care controlled, parallel-group clinical trial. consecutively enrolled subjects are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care in a hospital clinical setting. 300 subjects (anticipated) will be randomized to either multidisciplinary combined clinic intervention (200 subjects, anticipated) or usual care (100 subjects, anticipated). the study will consist of a 24-week active intervention period and an additional 24-weeks follow-up period.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from the subject prior to randomization. 2. age 18 and above. 3. diagnosis of at least two imids\* or diagnosis of one imid and clinical suspicion\*\* of another imid\* * including and limited to: psoriasis, hs, uc, cd, axspa, psa \*\* substantiated by e.g. clinical findings, imaging, biochemical results or histological examination at the discretion of the investigator. exclusion criteria: 1. non-danish speaking 2. expected to be unable to comply with the study protocol
the relationship of initial liver profile and outcome after transplantation

Conditions: Liver Failure

Summary: donation after cardiac death (dcd) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. ischemic cholangiopathy (ic) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. it typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. although ic is more common following dcd liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. the aim of this study is to correlate microrna (mirna) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of ic following liver transplantation.

study population tissue from all deceased adult liver transplant grafts will be collected. the test samples will be selected from procedures were the liver transplant recipient has developed ic. the control samples will include tissues from procedures were the transplant recipient had an uncomplicated outcome. there will be matching of test samples and control samples based on a range of clinical factors. consent standard consent for organ donation documentation has a general consent to research section. due to the small risk of damage to blood vessels when taking samples the liver transplant recipient will also be consented for these procedures to take place. tissue sampling liver and bile duct samples from each graft will be obtained at various different time points during liver transplant procedures. processing of specimens following removal of the specimens, samples will be divided then added to rnalater (life technologies, paisley, uk), 10% formaldehyde or will be snap frozen. at a later time point samples will be analysed. definition of ischemic cholangiopathy ic will be defined as strictures, dilatations, or irregularities of the intra- or extrahepatic bile ducts of the liver graft. isolated strictures at the bile duct anastomosis will be excluded. the diagnosis will be based on at least one adequate imaging study of the biliary tree, after exclusion of hepatic artery thrombosis by doppler ultrasound, computed tomography or conventional angiography.

Eligibility criteria:
inclusion criteria: * all deceased adult liver transplant donors (\>16 years of age) whose livers are being utilised for transplantation in the scottish liver transplant unit in the royal infirmary of edinburgh exclusion criteria: * paediatric liver transplant donors (\<16 years of age).

Keywords: liver transplantation
a study to assess treatment patterns, clinical outcomes and healthcare resource utilization among adult participants with moderate-to-severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to achieve a better understanding of clinical characteristics, treatment patterns and clinical outcomes of participants with moderate-to-severe plaque psoriasis (pso) as well as their unmet medical needs and disease burden in real-world setting in china.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate-to-severe plaque pso either confirmed by a dermatologist or meeting criteria of: bsa ≥ 3% or pasi ≥ 3 or dermatology life quality index (dlqi) ≥ 6. exclusion criteria: * participating in randomized controlled trial (rct) between 1st january 2018 and 31st december 2021, if there was any. * diagnosis of erythrodermic psoriasis, pustular psoriasis or guttate psoriasis.

Keywords: moderate to severe plaque pso
single lung ventilation versus two lung ventilation

Conditions: Hypoxemia; Single Lung Ventilation

Summary: hypoxia in single lung ventilation versus two lung ventilation in video assisted lung surgeries

incidence of hypoxia in single lung ventilation by double lumen endotracheal tube "of choice in lung surgeries" versus incidence of hypoxia in two lung ventilation by conventional single lumen endotracheal tube "intermittent two lung ventilation"

Eligibility criteria:
inclusion criteria: * age group: adult patients from age of 21 years to 60 years * sex: both sexes * asa classification: patients with asa classification ii, iii. * elective lung surgeries using video assisted thoracoscopic surgeries. exclusion criteria: * patients refuse to give informed consent. * asa classification: asa iv. * failure of thoracoscopic surgeries and continue as open thoracotomy * patients with ischemic heart diseases, where hypoxemia might be preexisting, or patient be more vulnerable to hypoxemia whatever the technique or time of hypoxia. * emergency lung surgeries. * patients underwent previous lung surgeries of any cause. * patients with pathology to the non-operated side.
profiles of expression in hpv+ versus hpv head and neck cancers

Conditions: Head and Neck Cancer

Summary: squamous cell cancers of the head and neck are classically correlated to excessive consumption of alcohol and tobacco and have a rather poor prognosis. however, the incidence of head and neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent hpv contamination. some studies show a difference in the expression of certain genes within the two groups of tumors (hpv+ and hpv-) including some that confer sensitivity to certain chemotherapies and others to radiotherapy. however, patients with hpv+ head and neck cancers are treated according to the same referential as hpv- head and neck cancers. there is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment.

head and neck cancers are the sixth most common cancer common worldwide causing more than 380,000 deaths each year. more than 90% of these cancers are carcinomas epidermoids arising from the mucosal surfaces of the cavity oral cavity, oropharynx and larynx. squamous cell cancers of the head and neck are classically correlated with risk factors linked to excessive consumption of alcohol and tobacco and have a rather poor prognosis (mainly hpv (human papilloma virus) negative patients). however, the incidence of head and neck cancers in patients without alcohol-smoking risk factor has continued to increase in recent years, in relation to more and more frequent hpv contamination. evolution of oral sexual practices seems to be one of the explanations for the progression of these cases of oropharyngeal squamous cell carcinoma and oral cavity hpv positive. some studies show a difference in the expression of certain genes within the two groups of tumors (hpv+ and hpv-) including some that confer sensitivity to certain chemotherapies (ccnd1, tyms) and others to radiotherapy (rbbp4). however, patients with hpv+ head and neck cancers are treated according to the same referential as hpv- head and neck cancers. there is therefore a real need for studies identifying predictive markers in order to be able to offer patients a more effective suitable and less invasive treatment. this is the context of this research project.

Eligibility criteria:
inclusion criteria: * patient with oropharyngeal squamous cell carcinoma or the oral cavity histologically proven. * primary tumor for which a biopsy or excision is required available and sufficient to carry out molecular analysis exclusion criteria: - patient with head and neck cancer other than oropharyngeal or oral cavity squamous cells carcinomas
the clinical performance validation of electronic thermometer and infrared thermometers

Conditions: Febrile; Healthy

Summary: geon corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. this study verify the accuracy and repeatability of investigational devices. efficacy verification is carried out by comparing with the referent medical devices. the main objectives of this study are: 1. to verify that the investigational devices and the reference medical devices have a reasonable deviation value. 2. to verify the consistency of repeated measurements of investigational devices.

this study carried out in accordance with the iso 80601-2-56: 2017, which included definitions for the age groups and sample sizes, the definition of fever, the flowchart for relevant procedures, and statistical methods for clinical performance. all subjects were measured by the reference device (electronic thermometer mt-b231) and three investigational devices under test evaluation (infrared forehead thermometer ge-tf03, infrared ear thermometer ge-te06, and electronic thermometer mt-b321fb). for each subject, the reference device measured one time and each investigational device measured three times respectively.

Eligibility criteria:
inclusion criteria: * newborn to 80 years old adult * male or female * the subject or parent/guardian can talk to the researcher, understand the content of the study after researcher's explanation and agree to sign the subject's consent form, and is willing to accept the trial procedure. exclusion criteria: * currently have signs or symptoms of infection or inflammation at the temperature measurement site (axillary, forehead, ear canal) * the forehead cannot be fully exposed to the environment for more than 15 minutes * using cooling blankets, fans, or placing ice cubes on the forehead * there is a catheter placed in the ear * use of antipyretics (such as aspirin, ibuprofen), barbiturates, antipsychotics in the past 2 hours * received thyroxine, corticosteroids or immunotherapy in the past 7 days * subject has been diagnosed with cognitive impairment or has a history of dementia, mental illness, mental illness, pervasive developmental disorder, illicit drug use or alcoholism, etc. * pregnant women * the researcher considers that the subject is not suitable for participating in this trial, such as taking any drugs that may change body temperature * participated in clinical trials of investigational drugs within the last 30 days * the subject is unwilling to sign the subject's consent form
effects of high-intensity interval training exercise in adolescents with hepatosteatosis

Conditions: Non-Alcoholic Fatty Liver Disease; Insulin Resistance; High Intensity Interval Training; Childhood Obesity

Summary: this is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (nafld).

the study investigators want to learn more about the effect of a type of exercise on non-alcoholic fatty liver disease (nafld), and on markers of health (for example, liver, heart, and overall health) and how the body uses energy in teenagers. the exercise we are studying is called high-intensity interval training, or hiit. some participants in this study will receive a 4-week exercise program, and the others will not.

Eligibility criteria:
inclusion criteria: initial enrollment * ages 13-18 years (inclusive) for both sexes * any ethnic/racial background * english speaking competence * teenagers ages 13-15 weighing more than 145 pounds or teenagers ages 16-18 weighing more than 170 pounds * low risk to participate in an exercise program as determined by "the physical activity readiness questionnaire for everyone" * late stages of puberty (i.e., tanner stage iv or v) based on tanner staging. inclusion criteria: control or exercise group * presence of non-alcoholic fatty liver disease (nafld) as determined by fibroscan controlled attenuated parameter (cap) score * confirmed lack of diabetes as determined by oral glucose tolerance test (ogtt) * confirmed eligibility per medical history exclusion criteria: * pre-pubertal or early stages of puberty * pregnancy * confirmed lack of nafld in the past 6 months via biopsy or mri * presence of an implantable medical device or metal objects in the body (a contraindication for fibroscan and/or mri) * high-risk to participate in an exercise program as determined by "the physical activity readiness questionnaire for everyone" * unable to cooperate with study procedures and tests including genetic or physical conditions impacting mobility over the past year * having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, type 2 diabetes, neurologic (e.g., epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (cushing's, growth hormone deficiency), hepatic (other than nafld), autoimmune, cardiac and renal disorders * current history of poorly-controlled asthma. * taking any of the following medications that can affect study outcome at the time of enrollment: insulin, metformin, or any other anti-diabetics, antipsychotics, oral steroids, and anabolic drugs (growth hormone replacement therapy, testosterone, and oxandrolone). * adolescents who have a history of claustrophobia. * adolescents who need sedation in order to complete mri. * adolescents determined ineligible by the study investigator or delegated staff.

Keywords: nafld hiit insulin fitness controlled attenuated parameter steatosis peak oxygen uptake
open-label study to evaluate metreleptin in children under 6 years of age with generalised lipodystrophy

Conditions: Generalized Lipodystrophy

Summary: this is an open-label, phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of generalised lipodystrophy * metreleptin treatment naive exclusion criteria: * weight \<9 kg at screening (visit 1)

Keywords: metreleptin
sarcopenia in older patients in the acute hospital setting

Conditions: Sarcopenia; Frailty

Summary: this study will assess whether the use of technology using the virtual gate device (vgd) will prevent or minimize the development of hospital acquired sarcopenia resulting from immobilization.

modern advances in prevention, medical care, and treatments have resulted in an ever-increasing life expectancy and aging of the population. as a result, it is imperative that health care professionals and policy makers develop strategies and new technologies that enable older people to enjoy their advancing years in good health. sarcopenia, an age-related decrease in muscle mass, is a major factor in functional decline and frailty and leads to poor quality of life and increased health care costs in older age groups. because sarcopenia is known to be exacerbated at the time of acute hospital admission, the development of new technologies for the prevention and diagnosis of sarcopenia will have important ramifications in promoting healthy aging in both the acute care and ambulatory settings. a pilot interventional self-controlled study will be performed in an internal medicine department (internal medicine ward het) at the rambam health care campus in haifa. subjects will be evaluated for the risk of sarcopenia by acceptable screening instruments as well as b-mode portable ultrasound. they will then be treated using a stocking-like virtual gait device (vgd) which will be applied to one randomly-assigned lower limb. the vgd is a technology that uses fussy-logic technology to stimulate calf muscles in synchrony with the patient's heartbeat, enabling a virtual gait in patients who have limited mobility. confidentiality will be achieved by applying a unique identifier to each trial subject in accordance with good clinical practice standards.

Eligibility criteria:
inclusion criteria: * male and female patients 75 years of age and older. * patients admitted with an acute infection (clinically from a respiratory or urinary source). * expected length of hospitalization of at least 4 days. * patients who are conscious and cognitively able to provide written informed consent as determined by a score of 0 on the 4at scale exclusion criteria: * male and female patients under 75 years of age. * expected length of hospitalization of less than 4 days. * a condition limiting the use of the virtual gate device (vgd) due to factors relating to discomfort or safety, including but not limited to: fracture, amputation, local infection, pain, paralysis of one or both lower limbs, cardiac arrhythmia or cardiac pacemaker. * patients who are unable to or do not provide informed consent for participation. * a score 1 or more on the 4at scale.