Kornimate/medical-research-clean huggingface dataset:
nilotinib with chemotherapy for the treatment of philadelphia chromosome positive acute lymphoblastic leukemia

Conditions: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Acute Lymphoblastic Leukemia

Summary: patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-abelson murine leukemia (bcr-abl) protein or the philadelphia chromosome have a poor prognosis with standard chemotherapy. the prognosis seemed to improve following the adition of imatinibe, a bcr-abl inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment. nilotinib is a bcr-abl inhibitor more potent than imatinib. it has been shown to be effective against most of the cells that bear mutations of the bcr-abl protein leading to resistance to imatinibe. the investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (all) will translate into more rapid bcr-abl reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (all) * bcr-abl positive positive by pcr (central lab) * no previous treatment for all except for corticoids and cyclophosphamide less than 600 mg/m2 * must be able to swallow tablets * lab results within normal limits (potassium, calcium, magnesio, phosphorus, transaminases, alkaline phosphatase, bilirrubine, amylase, lypase) exclusion criteria: * heart disease * interval qtc fridericia \> 480 msec * coumadin use * pregnancy * ps = 4 * previous medical history of etilism or/and pancreatic disease

Keywords: leukemia lymphoblastic acute philadelphia bcr-abl nilotinib treatment
impact of dapagliflozin on diastolic dysfunction in type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this study aims to assess the impact of 24-week treatment of dapagliflozin in type 2 dm(diabetes mellitus) patients on diastolic dysfunction. primary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 dm patients on subclinical diastolic dysfunction assessed by supine bicycle diastolic stress echocardiography. secondary endpoint is assessing the impact of 24-week treatment of dapagliflozin in type 2 dm patients on functional capacity, he impact of 24-week treatment of dapagliflozin in type 2 dm patients at resting diastolic function. this is single-center, randomized, double-blind, placebo-controlled, parallel-arm intervention study. this study is planned to evaluate the impact of dapagliflozin on diastolic dysfunction assessed. the dose of dapagliflozin will be 10 mg as approved. for assessment of diastolic dysfunction, supine bicycle stress exercise echocardiography was performed, and changes in diastolic functional reserve, vo2max, exercise time, and maximal exercise capacity were assessed before and after treatment. this study will be randomized, double blind, placebo controlled, to minimize the risk of bias.


Eligibility criteria:
inclusion criteria: * female and male aged 19\~75 years * type 2 dm and had not reached adequate glycemic control with a stable dose of metformin, sulfonylurea, or both drugs before screening * hba1c 7.0% \~ 10% at screening (patients who take metformin only: hba1c 6.5-10%) * patients with ≥ grade 1 diastolic function (relaxation abnormality) at resting echocardiography * patients provided with the written, informed consent to participate in this study exclusion criteria: * type 1 dm (fasting c-peptide ≤ 0.78ng/dl(or 0.26 nm/l)), secondary diabetes, gestational diabetes * history of diabetic ketoacidosis, hyperglycemic hyperosmolar status * estimated glomerular filtration rate \< 60 ml/min/1.73m2 * history of chronic cystitis or recurrent urinary tract infection * currently on loop diuretics * currently on medication known to affect glucose metabolism (e.g. corticosteroids, immunosuppressants) * abnormal liver function (ast/alt \> x3 upper normal limit) * on weight loss program or taking weight loss medication * lv ejection fraction \< 50% at resting echocardiography * uncontrolled hypertension (systolic blood pressure \>200mmhg and/or diastolic blood pressure \>110mmhg) * history of acute myocardial infarction, unstable angina, coronary artery bypass graft or stroke within 6 months * inducible ecg abnormalities at exercise * cardiomyopathy, significant valvular heart disease, or a significant arrhythmia * patients who cannot perform supine bicycle stress echocardiography * pregnant or lactating women * subjects who the investigator deems inappropriate to participate in this study
perioperative personalized blood pressure management

Conditions: Blood Pressure; Intraoperative Hypotension; Postoperative Complications

Summary: the investigators propose a pilot trial to (1) proof the concept that defining the intraoperative mean arterial pressure (map) intervention threshold based on the mean nighttime map (assessed using preoperative automated blood pressure monitoring) results in clinically relevant (mean nighttime map ± 10 mmhg) different target values compared with using an absolute population-derived map intervention threshold of 65 mmhg (primary endpoint); (2) investigate if a personalized perioperative blood pressure management is feasibly in multi-center studies, especially if the target values can be sufficiently achieved (secondary endpoint); (3) study the impact of personalized perioperative blood pressure management on the incidence of myocardial injury after non-cardiac surgery (mins) (exploratory endpoint); (4) study the impact of personalized perioperative blood pressure management on the incidence of acute kidney injury within the first three postoperative days according to the kdigo (kidney disease: improving global outcomes) definition without oliguric criteria (exploratory endpoint).

not provided

Eligibility criteria:
inclusion criteria: * age ≥ 45 * american society of anesthesiologists physical status class (asa) ii-iv * scheduled for elective major surgery under general anesthesia * surgery expected to last ≥ 120 minutes exclusion criteria: * emergency surgery * patients having liver or kidney transplantation * laparoscopic surgery * pregnancy * status of post transplantation of kidney, liver, heart, or lung * sepsis (according to current sepsis-3 definition) * impossibility of preoperative automated blood pressure monitoring * map differences between the right and the left arm of more than 20 mmhg surgery that requires controlled hypotension

Keywords: blood pressure intraoperative hypotension cardiovascular dynamics
d-chiro-inositol and aub

Conditions: Abnormal Uterine Bleeding

Summary: patients with aub will undergo 6-month treatment with d-chiro-inositol and will fill in questionnaires on aub, with the evaluation of hormonal serum levels.


Eligibility criteria:
inclusion criteria: * aub exclusion criteria: * menopause * cancer diagnosis * atypical endometrial hyperplasia * uterine fibroids * heavy symptoms requiring pharmacological intervention * progestogens treatment in the six months before the study * inositol treatment in the six months before the study
difluprednate pediatric study for the treatment of inflammation post-cataract surgery

Conditions: Cataracts; Inflammation

Summary: the primary objective of this study was to compare the safety and efficacy of durezol™ compared to pred forte™ for the treatment of inflammation following cataract surgery in a pediatric population 0 to 3 years of age.

parents or guardians instilled patients' assigned study medications once on the day of surgery (day 0) and 4 times daily (qid) beginning on the day after surgery (day 1) for 14 days followed by a tapering period of 14 days (dependent upon the investigator's determination of adequate response to treatment). patients were evaluated for safety and efficacy on the following visits: day 0 (day of surgery), day 1, day 8 ± 1 day, day 15 ± 2 days and day 29 ± 2 days (end of study drug treatment). additional safety visits occurred at 1 week after the last dose + 2 days and at 3 months + 1 week. no inferential statistical analysis was planned for this study. data was summarized using descriptive statistics.

Eligibility criteria:
inclusion criteria: * 0 to 3 years of age. * undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens. * informed consent signed by a parent or legal guardian. * other protocol-defined inclusion criteria may apply. exclusion criteria: * presence of any active or suspected viral, bacterial, or fungal disease in the study eye. * use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery. * patients with posttraumatic cataract. * active uveitis in the study eye. * ocular neoplasm in the study eye. * human immunodeficiency virus (hiv); acquired immunodeficiency syndrome (aids). * suspected permanent low vision or blindness in the fellow nonstudy eye. the study eye must not be the patient's only good eye. * patients on systemic steroids or nonsteroidal anti-inflammatory drugs. * history of steroid-induced intraocular pressure (iop) rise. * currently on medication for ocular hypertension or glaucoma in the study eye. * diabetes. * other protocol-defined exclusion criteria may apply.

Keywords: pediatric cataracts inflammation durezol pred forte difluprednate prednisolone
treatment preferences in patients with low back pain

Conditions: Low Back Pain

Summary: together with the guidance of health professionals try to obtain information from media, popular magazines and books and the internet regarding diseases and treatment methods in patients with low back pain with the development of technology. in parallel with this information which they obtained, they turn to different treatment methods. this study was carried on examining how pain duration affects treatment preferences in patients with low back pain.


Eligibility criteria:
inclusion criteria: * individuals between the ages of 18-65 with complaints of low back pain and no communication problems were included in the study. exclusion criteria: * individuals with any systemic, neurological and / or orthopedic disease diagnosed other than complaint of low back pain were excluded from the study.

Keywords: low back pain acute pain subacute pain chronic pain treatment preference
a drug interaction study to evaluate the pharmacokinetics of asp015k and methotrexate in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a drug interaction study to evaluate the effect of asp015k (twice daily) on the pharmacokinetics (pk) of once weekly oral methotrexate (mtx).

patients check in on day -1 and remain confined until all the exit procedures are performed on the morning of day 10. patients to return for 1 post-treatment follow-up visit on day 13. patients receive a single dose of methotrexate on day 1 and day 8 and asp015k (twice daily) on days 3 through 8 plus the morning of day 9.

Eligibility criteria:
inclusion criteria: 1. if female, subject must be at least 2 years post menopausal or is surgically sterile per documentation provided by a medical professional and the subject is not pregnant as documented by a negative serum pregnancy test at screening and negative urine pregnancy test at check-in 2. if male, subject must agree to sexual abstinence and/or to use a highly effective method of birth control during the study period and for 60 days after the last dose of study drug 3. subject must have a clinical diagnosis of rheumatoid arthritis (ra) at least 6 months prior to screening 4. subject must be on a stable 15 - 25 mg dose of methotrexate \> 28 days prior to screening 5. if subject is on a non-biologic disease modifying anti-rheumatic drug (dmards) therapy, the dose must be stable \> 28 days prior to screening 6. subject must be willing and able to comply with the study requirements exclusion criteria: 1. subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that would preclude participation in the study 2. subject has a known history of positive test for hepatitis b surface antigen (hbsag) or hepatitis c antibody or history of a positive test for human immunodeficiency virus (hiv) infection 3. subject has received live virus vaccination within the last 30 days prior to study drug administration 4. subject has a body mass index (bmi) \> 35 (kg/m2) 5. subject is on biologic disease modifying anti-rheumatic drug (dmards) therapy 6. subject has a current history of anemia as defined by hemoglobin of less than 12 g/dl 7. subject has a recent history (within the last 6 months) of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse/illegal drugs at screening or check-in 8. subject has received any investigational agent within 30 days of screening

Keywords: asp015k rheumatoid arthritis
positron emission mammography and liquid biopsy in women with high-risk breast screenings

Conditions: Breast Cancer

Summary: the goal of this research study is to evaluate the performance of two experimental tests, namely liquid biopsy and positron emission mammography (pem) in women at high risk of breast cancer. the plan for this study is to assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities. liquid biopsy is a blood test that can detect early tumours in patients with malignancies, while pem is an imaging tool equipped with a high-resolution camera that uses a low dose of injected positron emitting isotope to locate breast tumours. participation in this study entails a blood draw for liquid biopsy test and a pem imaging exam before undergoing a magnetic resonance imaging (mri) - guided biopsy for a suspicious breast lesion. if pem and/or liquid biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.


Eligibility criteria:
inclusion criteria: * individuals who are older than 18 years of age * individuals who are planned to undergo an mri-guided biopsy based on high- risk screening imaging detected lesions * individuals with the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * high-risk individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or mri * individuals who are pregnant or who think they may be pregnant * individuals who are breast-feeding * individuals with known allergies to f-18 fdg

Keywords: positron emission mammography (pem) liquid biopsy
protection of rectum from high radiation doses using a spacer

Conditions: Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site

Summary: the purpose of this study is to evaluate the usefulness of diluted and non-diluted duraseal product as a spacer between prostate and rectum in prostate cancer low-dose brachytherapy.

radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients. a resorbable spaces between prostate and rectum could decrease the incidence of these side effect. in this trial, men with prostate cancer with intention to curative treatment by low-dose brachytherapy will be recruited. the subjects will be randomized to receive either diluted or non-diluted duraseal product as a spacer between prostate and rectum. diluted or non-diluted duraseal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure. after the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance. the proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution. after that, duraseal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using duraseal applicator. if the subject is randomized to receive non-diluted duraseal, the procedure will be identical with the exception the duraseal components will not be diluted. the resolution of the spacer will be followed by repeated plain computer tomography (ct) of pelvis performed a day before operation, a day after the operation, and 4, 8 and 12 weeks after the operation. in addition, magnetic resonance imaging of pelvis performed 12 weeks after the operation. the space created between prostate and rectum will be documented by plain ct and magnetic resonance imaging. rectum radiation dose will be calculated based on these scans. time to duraseal resolution will be evaluated from the scans. possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.

Eligibility criteria:
inclusion criteria: * prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer exclusion criteria: * not willing to participate this study

Keywords: prostate cancer brachytherapy spacer side effect
effects of nutrition meal replacement and individualized exercise prescription on type 2 diabetes

Conditions: Overweight; Obesity; Type2 Diabetes

Summary: this study evaluates the nutritional meal replacement and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus. half of participants will receive nutritional meal replacement and individualized exercise prescription on the basis of conventional glucose-lowering treatment, while the other half will only receive conventional glucose-lowering treatment.

diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at present. although new drugs for the treatment of diabetes continue to emerge, but the effect of diabetes treatment is still not satisfactory. medical nutrition therapy (nutrition therapy medical, mnt) and exercise therapy are essential measures for prevention and control of diabetes at any stage of the natural course of the disease, especially for the overweight and obese patients with type 2 diabetes. however, at present, the majority of patients could not get the guide from nutrition specialist and sports specialist. in addition, the existing diet programs are often more complex, difficult to implement and adhere to in daily life, and exercise programs are often lack of targeted. in view of this, the shanghai peak sports management co., ltd. developed a kind of nutritional meal replacement for weight loss. the nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and strong satiety, and the heat is only 126kcal, and have a good sense of satiety. studies have shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for obese people have a role in weight loss. in theory, the meal is also suitable for diabetes patients, especially overweight and obese type 2 diabetes, such as the combination of individual exercise prescription may be better, but there is still a lack of relevant research. in view of this, we proposed a joint sports workers, explore nutritional and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus, to explore suitable for china's diabetes lifestyle intervention measures, improve the level of prevention and treatment of diabetes in china.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of overweight and obesity type 2 diabetes * must be able to swallow tablets exclusion criteria: * insulin dependent diabetes * thyroid disease
cortical activation during walking in stroke

Conditions: Stroke

Summary: after stroke, damage to one cerebral hemisphere disrupts the normal balance of activity between the two hemispheres. the affected hemisphere typically exhibits reduced excitability, whereas the unaffected side may demonstrate increased excitability. this phenomenon, referred to as interhemispheric imbalance, further inhibits activity in the affected hemisphere, thereby restricting motor recovery. according to the interhemispheric competition model, enhancing excitability in the affected hemisphere and/or suppressing excitability in the unaffected hemisphere may contribute to the improvement of motor function in individuals with stroke. furthermore, as motor function recovers, the balance of interhemispheric activation in motor-related cortical areas undergoes corresponding changes. previous studies have shown that treadmill training enhances the excitability of the primary motor cortex in both hemispheres of stroke patients, as well as increases excitability across multiple cortical and subcortical regions in both hemispheres. however, it remains unclear whether treadmill training can normalize the interhemispheric imbalance in stroke patients. additionally, the effects of forward and backward walking on the activity of motor-related brain regions in individuals with stroke are still unclear. therefore, this cross-sectional study aims to investigate the changes in motor-related brain activity during forward walking and backward walking in individuals with chronic stroke.


Eligibility criteria:
inclusion criteria: * ≥ 6 months after the diagnosis of stroke * independent walking over at least 7m with or without a walking aid * mini-mental state examination score ≥ 24 exclusion criteria: * had difficulty in backward walking * any neuromuscular disorders history * with visual or auditory disorders * unstable cardiac status or uncontrolled hypertension * any musculoskeletal disorders that would affect walking ability

Keywords: forward walking backward walking brain activity stroke
a comparison of skin grafts versus local flaps for facial skin cancer from the patient perspective: a feasibility study

Conditions: Skin Cancer, Basal Cell; Skin Cancer; Skin Cancer, Non-Melanoma; Skin Cancers - Squamous Cell Carcinoma; Patient Satisfaction

Summary: a prospective single-centered feasibility study will be conducted. the purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

a prospective single-centered feasibility study will be conducted. the purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.). upon completion of the feasibility study, a prospective pilot cohort study would be performed to measure outcomes using the face-q skin cancer module for patients receiving skin grafting or local flaps after excision of facial skin cancers.

Eligibility criteria:
inclusion criteria: patients will be included in the study if: * they are 18 years or older * presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis), * and scheduled to undergo reconstruction with either a skin graft or local tissue flap. exclusion criteria: patients will be excluded in the study if they: * present with altered level of consciousness, * cannot provide consent, * have facial nerve injury/previous facial nerve injury, have melanoma skin cancer or merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.