Kornimate/medical-research-clean huggingface dataset:
sgi-110 in adults with untreated acute myeloid leukemia (aml), not considered candidates for intensive remission induction

Conditions: Leukemia, Myeloid, Acute

Summary: to compare efficacy and safety between sgi-110 and treatment choice in adults with previously untreated aml who are not considered candidates for intensive remission induction chemotherapy.


Eligibility criteria:
inclusion criteria: cytologically or histologically confirmed diagnosis of aml (except m3 acute promyelocytic leukemia) according to world health organization (who) classification. performance status (ecog) of 0-3. adults with previously untreated aml except for hydroxyurea or corticosteroids. prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (mds) is allowed. not considered candidates for intensive remission induction chemotherapy at time of enrollment based on either: 1. ≥75 years of age or 2. \<75 years of age with at least 1 of the following: i. poor performance status (ecog) score of 2-3. ii. clinically significant heart or lung comorbidities, as reflected by at least 1 of: 1. left ventricular ejection fraction (lvef) ≤50%. 2. lung diffusing capacity for carbon monoxide (dlco) ≤65% of expected. 3. forced expiratory volume in 1 second (fev1) ≤65% of expected. 4. chronic stable angina or congestive heart failure controlled with medication. iii. liver transaminases \>3 × upper limit of normal (uln). iv. other contraindication(s) to anthracycline therapy (must be documented). v. other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization. creatinine clearance as estimated by the cockcroft-gault (c-g) or other medically acceptable formulas ≥30 ml/min. exclusion criteria: candidate for intensive remission induction chemotherapy at the time of enrollment. candidate for best supportive care only, ie, not a candidate for any active therapy with the tc comparators. known extramedullary central nervous system (cns) aml. second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy. prior treatment with decitabine or azacitidine. hypersensitivity to decitabine, sgi-110, or sgi-110 excipients. known active human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) infection. inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed. known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol. refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring \>2 liters per minute (lpm) oxygen.

Keywords: aml acute myeloid leukemia sgi-110 dna hypomethylating agen
effects of vitamin d3 supplementation on antioxidant enzymes status in vitamin d3 deficient asthma copd overlap (aco) patients

Conditions: Vitamin D Deficiency

Summary: asthma-copd overlap (aco) is a new entity in the world of respiratory ailments. the respiratory tract of these patients are continuously exposed to oxidants (due to cigarette smoking) causing oxidative stress. antioxidant enzymes such as, superoxide dismutase (sod) and catalase (cat) neutralize these oxidants or free radicals and transform them into safer. vitamin d is a natural antioxidant which has few evidence of increasing antioxidant enzyme level in copd and asthma, but not in aco patients. to evaluate the effects of vitamin d3 supplementation on antioxidant enzymes level in vitamin d3 deficient patients with stable aco. the randomized controlled trial was conducted in department of physiology bangabandhu sheikh mujib medical university (bsmmu), shahbag, dhaka from march 2018 to february 2019. for this study, a total number of 40 vitamin d3 deficient (serum 25 hydroxycholecalceferol \<30 ng/ml) male, stable (diagnosed patient, who was not experienced any acute exacerbation, hospitalization, urgent care visits or changes in routine medication within 4 weeks prior to study) patients with aco of age ≥40 years was selected from the out patient department (opd) of the national institute of diseases of chest and hospital (nidch) and randomly grouped as a (control) and b (study). then serum superoxide dismutase and catalase level of all the patients was assessed. along with the standard pharmacological treatment of aco (according to gold criteria), oral vitamin d3 (80,000 iu per week) will be supplied to the patients of the 'study group' and placebo for 'control group' for consecutive 26 weeks. at 26th week of follow up, all the study variables were examined. with this, all patients of both the groups were advised to continue ad lib (according to their own choice) diet. the results was expressed as mean±sd and the data was statistically analyzed by spss version 16, using independent sample 't' test (between two groups) and paired student's 't' test (between paired groups before and after intervention). in the interpretation of results, \<0.05 level of probability (p) was accepted as significant.


Eligibility criteria:
inclusion criteria: * smoker * stable aco patients * vitamin d3 deficieny * duration of aco: 1-4 years exclusion criteria: * with acute exacerbation of any pulmonary diseases, as- respiratory tract infection, bronchiectasis,pleural effusion,tuberculosis, interstitial lung disease, pneumonectomy or pulmonary lobectomy. * any cardiac disease. * chronic liver disease * malignancy * use of drugs within 1 month prior to study, as- calcium supplement, phenytoin, carbamazepine, clotrimazole, rifampicin, nifedipine, spironolactone, ritononavir, saquinavir, cyproterone acetate, glucocorticoids, bisphosphonate * with biochemical evidence of - uncontrolled diabetes mellitus, renal insufficiency
a study of efruxifermin in non-cirrhotic subjects with histologically confirmed nonalcoholic steatohepatitis (nash)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a multi-center evaluation of efruxifermin (efx) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven f2 - f3 nash.


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females between 18 - 75 years of age inclusive, based on the date of the screening visit. * previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes. * fibroscan measurement \> 8.5 kpa \[kilopascal\]. * biopsy-proven nash. must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (nafld) activity score (nas) of ≥ 4 with at least a score of 1 in each of the following nas components: * steatosis (scored 0 to 3), * ballooning degeneration (scored 0 to 2), and * lobular inflammation (scored 0 to 3). exclusion criteria: * weight loss \> 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer. * presence of cirrhosis on liver biopsy (stage 4 fibrosis). * type 1 or uncontrolled type 2 diabetes. other inclusion and exclusion criteria may apply.
telephone versus videoconference communication for remote genetic disclosure in the apoe4 trial

Conditions: Alzheimer Disease; Genetic Predisposition to Disease

Summary: the purpose of this study is to compare two methods for remote genetic counseling (telephone and two-way videoconferencing) for patients who are receiving disclosure of their apoe (apolipoprotein e) genotype. the target population will consist of males and females in the age range of 60-75 years who, as potential participants in a study (generation study), will need to receive genetic counseling and disclosure of apoe genotype. subjects must be willing to receive genetic counseling and disclosure remotely. subjects must be willing to be randomized to either telephone arm or videoconference arm.


Eligibility criteria:
inclusion criteria: 1. eligible to participate in the generation study 2. ability to provide consent 3. ability to communicate and hear in english exclusion criteria: -

Keywords: telemedicine counseling, genetic
medial rectus fenestration vs recession for paet

Conditions: Partially Accommodative Esotropia

Summary: this prospective comparative study aims to compare medial rectus (mr) muscle fenestration and recession in patients with partially accommodative esotropia (paet). the main question it aims to answer is whether mr fenestration is equally effective as mr recession for paet. all patients will receive complete ophthalmic and orthoptic assessment. patients will be randomly allocated using a random table to one of two groups; group 1 will receive conventional mr recession, and group 2 will receive mr fenestration.

inclusion criteria the study will include patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is \> 15pd. exclusion criteria: 1. patients with convergence excess esotropia, defined as a near deviation with glasses exceeding that for distance by 15 pd or more. 2. patients with paralytic or restrictive strabismus. 3. patients with previous strabismus surgery 4. patients with neurologic, ocular, or developmental disorders or follow-up less than 6 months all patients will receive complete ophthalmic and orthoptic assessment including: i) a full ophthalmological assessment including history taking, measurement of uncorrected and best-corrected visual acuity, cycloplegic refraction, anterior segment examination, as well as a dilated fundus examination. ii) measurement of the deviation at distance (6 m) and near (33 cm). iii) assessment of ductions and versions in all cardinal directions of gaze patients will be randomly allocated using a random table to one of two groups: 1. group 1: unilateral or bilateral conventional mr recession. augmented formula will be used to decide the surgical dosage using the standard tables (3) 2. group 2: unilateral or bilateral mr fenestration all surgeries will be performed by one experienced surgeon (h.sh)

Eligibility criteria:
inclusion criteria: * patients with accommodative esotropia if the residual distance deviation with full cycloplegic correction is \> 15pd. exclusion criteria: 1. convergence excess esotropia. 2. paralytic or restrictive strabismus. 3. previous strabismus surgery 4. neurologic, ocular, or developmental disorders or follow-up less than 6 months

Keywords: esotropia accommodative hyperopia recession fenestration
efficacy and safety of s (+) - ibuprofen in osteoarthritis pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the efficacy of s (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.


Eligibility criteria:
main inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to american college of rheumatology (acr) criteria. main exclusion criteria: * known hypersensitivity to the formula components used during the clinical trial; * previous history of alcohol or drugs abuse diagnosed by dsm-v; * current or previous history (less than 12 months) of smoking; * have clinically relevant abnormal laboratory results according to medical evaluation; * women who are pregnant, lactating, or positive for β - hcg urine test;

Keywords: nonsteroidal anti-inflammatory pain ibuprofen inflammation anti-inflammatory pain control osteoarthritis pain relief enzyme inhibitors
adjust: a study on mdt prognostication

Conditions: Terminal Illness

Summary: this study investigates how clinicians form intuitive judgements about the prognoses of palliative care patients after receiving advice perceived as coming from either a team member or an algorithm.

using the judge-advisor system, the investigators will recruit clinicians working in palliative care for adults. participants will be asked to complete an online survey and review five patient summaries ("vignettes") based on real cases derived from a previous study. clinicians will be presented with key prognostic information and will be asked to provide an estimate of the probability that the patient will survive for two weeks (0-100%). after providing this initial estimate, participants will receive prognostic advice. while in reality all participants will receive the same advice, participants will be randomised into two groups and these groups will be informed that the advice is either: (1) provided by an algorithm; or (2) provided by a team colleague. participants will then be given the opportunity to give a second, possibly revised estimate in the light of the advice received.

Eligibility criteria:
inclusion criteria: * clinicians working in an adult palliative care service * willing and able to provide written informed consent exclusion criteria: * none

Keywords: prognostication multidisciplinary teams judge-advisor system palliative care end-of-life
association of intestinal microbiota and the onset of perianal abscess based on 16s rdna amplicon sequencing

Conditions: Perianal Abscess

Summary: the goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. the main questions it aims to answer are: question 1: to understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess. question 2: understand the structure of rectal microbial community composition in healthy people. participants will be collected with rectal secretions and stool specimens.in addition, patients with perianal abscess should also collect pus samples.


Eligibility criteria:
inclusion criteria: * observation group: ① age between 18-60 years, local resident of xi'an; ② met the diagnostic criteria for perianal abscess and underwent surgical treatment in our hospital; ③ did not use antibiotics before treatment; ④ himself and his family members were willing to participate in this study and signed informed consent. control group: ① age between 18-60 years, permanent residents in xi'an; ② had no serious chronic disease, no abnormality in physical examination in the last 1 week; ③ did not use drugs that may affect intestinal flora in the last one month; ④ himself and his family members are willing to participate in the study and sign the informed consent. exclusion criteria: * failing to retain the specimens as required
fixed dose nesp study in subjects with cri

Conditions: Pre-Dialysis

Summary: multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with chronic renal insufficiency (cri). subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. upon enrollment, subjects will receive sc darbepoetin alfa administered once every other week for 24 weeks. darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. during the study, laboratory assessments will be completed and vital signs will be taken. subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * cri with a creatinine clearance of less than 40 ml/min * hemoglobin less than 11.0 g/dl * serum vitamin b12 and folate levels above the lower limit of normal and iron replete exclusion criteria: * received rhuepo therapy in the last 12 weeks * expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant * uncontrolled hypertension * seizure activity, chf, hyperparathyroidism, major surgery, hiv-positive pregnant or breast-feeding
a multicenter investigative study of the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer for the treatment of patients with bipolar disorder experiencing a manic or mixed episode

Conditions: Bipolar I Disorder

Summary: to assess the safety and efficacy of long-term administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner in patients with bipolar i disorder experiencing a manic or mixed episode


Eligibility criteria:
inclusion criteria: * trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial. * patients have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial. * patients who meet dsm-iv-tr criteria for manic or mixed episodes and have been diagnosed as having "296.4x bipolar i disorder in which the most recent episode was manic" or "296.6x bipolar i disorder in which the most recent episode was mixed" * patients with a ymrs total score of 16 or more exclusion criteria: * patients presenting with a clinical picture and/or history that is consistent with a dsm-iv-tr diagnosis of: * delirium, dementia, amnestic disorder, or other cognitive disorders * schizophrenia or other psychotic disorder * personality disorder * patients experiencing their first manic or mixed episode * patients whose current manic episode has lasted for more than 4 weeks * patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance * patients who have met dsm-iv-tr criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders, but including abuse of benzodiazepines) * patients who have received ect treatment within 8 weeks prior to informed consent * patients who are expected to require administration of ultrashort-acting or short-acting benzodiazepine receptor agonist hypnotics and antianxiety drugs (see (1) of 4.2.2) at doses exceeding the equivalent of 15 mg/day of diazepam (only for those patients using such drugs) * patients at significant risk of developing a severe adverse event. patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the trial, or who have a history of such a condition. * patients who have received any of the following treatments during the screening period * reserpine * levodopa, dopamine receptor stimulants * monoamine oxidase inhibitors * psychostimulants * thyroid hormones, antithyroid drugs * corticosteroids (other than topical preparations) * adrenaline * all other investigational or unapproved agents * ect * light therapy * patients judged to have a diabetic blood glucose level (judgment based on use of a self-monitoring blood glucose meter permissible), or patients whose hba1c is 6.5% or higher * patients with a history or a complication of diabetes
resistant starch and whey protein on energy metabolism

Conditions: Weight Loss

Summary: recent evidence shows that dietary supplementation with resistant starch (rs) increases fat catabolism and resting energy expenditure and decreases plasma insulin and glucose responses as well as the gut-derived hormone, glucose-dependent insulinotropic polypeptide (gip). consumption of whey protein has also been shown to increase energy expenditure and favorably affect gut hormones. thus, investigators tested consumption of both rs and whey protein on energy expenditure and gut hormones in lean and obese women and men.

consumed separately, resistant starch (rs) and whey protein (wp) favorably affect energy metabolism and gut hormones, as well as suppress feelings of hunger. these findings are important because release of certain gut hormones (i.e., gip) is associated with a lower resting energy expenditure (ree) in healthy humans. interestingly, a recent study showed that ingestion of rs reduces postprandial gip and increases postprandial ree and fat utilization in healthy men and therefore may be an effective strategy in weight management. thus, there is a need to replicate these findings in a healthy cohort of lean and obese women and men. the purpose of this study was to examine the effects of rs on the number of calories burned after eating a meal, as well as specific hormones that are released from the stomach and intestines following meal ingestion in healthy lean and obese women and men. investigators used a single ingestion of a meal supplemented with or without the resistant starch and whey protein.

Eligibility criteria:
inclusion criteria: * overweight or lean but otherwise healthy exclusion criteria: * participants will be excluded if they smoke; have experienced excessive weight loss/gain of \> ±2kg in the previous 2 months; are currently taking medications for cardiovascular or metabolic disease.

Keywords: fat oxidation hunger resistant starch whey protein
prevalence of depression and anxiety in patients seeking medical care at general health care settings in china

Conditions: Adult

Summary: objectives: primary: to estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in china. secondary: * to estimate gender- and age-specific prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings in china. * to estimate the prevalence of depression and/or anxiety disorder in outpatients attending the general health care settings such as departments of neurology, gastroenterology, cardiology, and gynecology. * to describe the recognition and treatment rate by treating physicians as depression and/or anxiety for outpatients in the general health care settings in china.

this study is designed to investigate the status of identifying depression and/or anxiety disorder with somatic symptoms in general hospitals in china. the study will generate valuable information to the medical community; therefore the early and vigorous treatment is possible. it's in line with china government authorities' target to increase the recognition rate of depression and/or anxiety in primary care settings to more than 50% by the end of 2010. the study will also help to identify specific diagnosis and treatment patterns for depressive / anxious patients and their comorbid conditions.

Eligibility criteria:
main inclusion criteria: * greater than or equal to 18 years. * consecutive general internal medical outpatients attending the selected general hospitals in the investigate days(department of neurology, gastrointestinal, cardiology and gynecology). * informed consent obtained for all patients who will undergo a standardized diagnostic assessment by specialized psychiatrists. main exclusion criteria: * patients who have been screened on a previous visit. * patients who are unable to complete the survey because of mental or physical incapacity.