Kornimate/medical-research-clean huggingface dataset:
comparison on outcomes of four iols in patients with cataracts

Conditions: Cataract; Intraocular Lens; Visual Outcomes

Summary: the objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (iol) in patients underwent cataracts surgery. this was a retrospective study. patients with age-related cataract underwent phacoemulsification combined with iols implantation. patients were divided into 4 groups. uncorrected distant visual acuity(udva), uncorrected intermediate visual acuity (uiva), uncorrected near visual acuity (unva),and the best corrected visual acuity (bcva) 1 month and 3 months after the surgery were determined. the defocus curve, contrast sensitivity, and customized vf-14-oriented visual function index questionnaire were performed 3 months postoperatively. kruskal-wallis test and generalized estimating equation(gee) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

the objective of this study was to compare the objective visual outcomes and subjective fuctional vision of four different intraocular lens (iol) in patients underwent cataracts surgery. this was a retrospective study. patients with age-related cataract underwent phacoemulsification combined with iols implantation. patients were divided into group a (tecnis pcb00 iol), group b (humanoptics diff-aay iol), group c (tecnis symfony zxr00 iol) and group d (zeiss at lisa tri 839mp iol). uncorrected distant visual acuity(udva), uncorrected intermediate visual acuity (uiva), uncorrected near visual acuity (unva),and the best corrected visual acuity (bcva) 1 month and 3 months after the surgery were determined. the defocus curve, contrast sensitivity, and customized vf-14-oriented visual function index questionnaire were performed 3 months postoperatively. kruskal-wallis test and generalized estimating equation(gee) were used to analyze and compare the difference between objective visual outcomes and subjective visual quality among different groups.

Eligibility criteria:
inclusion criteria: * age-related cataract with myopia≤-6.0d and over 0.0d * axial length≤26mm and corneal astigmatism≤1.5d * well-cooperation of finishing preoperative examinations * completion of all follow-up visits exclusion criteria: * previous eye diseases that affect vision including keratopathy, glaucoma, uveitis, amblyopia, fundus diseases, etc. * patients with decreased cognitive ability, unable to cooperate with preoperative examination, or suffering from severe anxiety, depression and mental illness * serious complications during operation, including corneal injury, iris injury, expelling choroidal hemorrhage, posterior capsule rupture, etc * serious postoperative complications, including displacement of intraocular lens, macular edema, endophthalmitis, etc * follow-ups less than 3months
a combination of acalabrutinib with r-chop in subjects with previously untreated non-gcb dlbcl (ace-ly-312)

Conditions: Diffuse Large B-Cell Lymphoma

Summary: phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (r-chop) vs placebo plus r-chop in subjects ≤75 years of age with previously untreated non-germinal center diffuse large b-cell lymphoma.

phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (r-chop) as compared with placebo plus r-chop in subjects ≤75 years of age with previously untreated non-germinal center diffuse large b-cell lymphoma (activated b-cell (abc) and unclassified).

Eligibility criteria:
inclusion criteria: * men and women, age ≥18 and ≤75 years * pathologically confirmed dlbcl, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review. * no prior treatment for dlbcl * eastern cooperative oncology group (ecog) performance status of ≤ 2. * international prognostic index (ipi) score of 1 to 5 * disease stage ii to iv by the ann arbor classification * adequate organ and marrow function * agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab exclusion criteria: * evidence of severe or uncontrolled systemic diseases * known history of a bleeding diathesis (i.e., haemophilia, von willebrand disease) * history of stroke or intracranial haemorrhage in preceding 6 months. * known cns lymphoma or leptomeningeal disease * known primary mediastinal lymphoma * known high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangements * prior history of indolent lymphoma or cll * history of or ongoing confirmed pml * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification * malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * uncontrolled active systemic fungal, bacterial, viral, or other infection * prior anthracycline use ≥150 mg/m2

Keywords: untreated non-germinal center diffuse large b-cell lymphoma lymphoma lymphoma, b-cell lymphoma, large b-cell, diffuse neoplasms lymphoproliferative disorders lymphatic diseases lymphoma, non-hodgkin prednisone cyclophosphamide rituximab doxorubicin vincristine acalabrutinib calquence
potassium supplementation in ckd

Conditions: Renal Insufficiency, Chronic; Potassium Depletion; Hypertension; Hyperkalemia

Summary: the current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). indeed, the anti-hypertensive effects of potassium supplementation are well-established. hypertension is even more prevalent and resistant in patients with chronic kidney disease (ckd) and contributes to further decline in kidney function. four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. all studies recommended an intervention study with potassium supplementation in patients with ckd, but this has not been performed. the aim of this study is to study the renoprotective effect of potassium supplementation in patients with ckd (stage 3b or 4, i.e. estimated glomerular filtration rate \[egfr\] 15 - 45 ml/min/1.73 m2).


Eligibility criteria:
inclusion criteria: * ckd 3b or 4 (45 - 15 ml/min/1.73 m2) * δ egfr (as estimated by the ckd-epi equation) \> 2 ml/min/1.73 m2/year (in preceding ≥ 1 year with at least 3 measurements) * hypertension (defined as office blood pressure \> 140/90 mmhg or use of anti-hypertensive medication) exclusion criteria: * hyperkalemia (serum potassium \> 5.5 mmol/l) at study visit v0 * medical reasons to continue dual raas-blockade, mineralocorticoid receptor blockers, potassium-sparing diuretics, or oral potassium binders. * patients with previous history of ventricular cardiac arrhythmia * patients with a life expectancy \< 6 months * expected initiation of renal replacement therapy \< 2 years * incapacitated subjects * women who are pregnant, breastfeeding or consider pregnancy in the coming 2 years.
retrospective observational study on efficacy and safety of norditropin® in children with prader-willi syndrome

Conditions: Genetic Disorder; Prader-Willi Syndrome

Summary: this study is conducted in europe. the aim of this observational study is to collect data from children with prader-willi syndrome, who have been treated off-label with norditropin® for more than 12 months to seek approval for norditropin® treatment with prader-willi syndrome.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * genetically diagnosed prader-willi syndrome * received at least one dose of norditropin® treatment * pre-pubertal at start of treatment; assessed by tanner stage 1, or testicular volume below 4ml (according to tanner 1976) exclusion criteria: * pre-treatment with other growth hormone preparation prior to treatment with norditropin®
a first in man study of mabp1 in patients with advanced cancers

Conditions: Advanced Cancers

Summary: the purpose of this study is to block interleukin-1 alpha activity with a true human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process. an adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.


Eligibility criteria:
inclusion criteria: * pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for \>/= 3 months * measurable or non-measurable disease at baseline * at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy * will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol * age \>/= 18 year, male or female * eastern cooperative oncology group performance status 0,1,or 2 * serum potassium and magnesium levels within institutional normal limits. total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal. * adequate renal function, defined by serum creating \</= 1.5 x uln * adequate hepatic function * adequate bone marrow function wocbp, a negative serum pregnancy test result at screening. * wocbp or men whose sexual partners are wocbp who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication * signed and dated irb approved icf before any protocol specific screening procedures are performed exclusion criteria: * serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy. * uncontrolled or significant cardiovascular diseae * dementia or altered mental status that would prohibit the understanding or rendering of informed consent * not recovered from the adverse effects of prior therapy at the time of enrollment \</= grade 1 * symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy * received extensive prior radiation therapy to the bone marrow * immunocompromised, including subjects know to be infected with hiv * history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding * wocbp or men whose sexual partners are wocbp who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
sequential cd19 and cd22 car-t therapy for newly diagnosed ph+ b-all

Conditions: B-Cell Acute Lymphoblastic Leukemia, Adult

Summary: clinical trial for the efficacy and safety of sequential cd19 and cd22 car-t therapy for adult patients with newly diagnosed ph chromosome positive b-cell acute lymphoblastic leukemia

this study was designed as a prospective, open-label, single-center study. it aims to evaluate the efficacy and safety of cd19 car-t cells in combination with dasatinib for the treatment of newly diagnosed ph-positive b-cell acute lymphoblastic leukemia in adult.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. subjects with a diagnosis of b-cell acute lymphoblastic leukemia according to the 2016 edition of the who classification criteria for acute leukemia; 3. subjects whose chromosomal and fusion gene analysis showed positivity for the ph chromosome, bcr/abl1 fusion gene; 4. leukemia cells were cd19 and cd22 positive; 5. patients with newly diagnosed b-all were not treated with standard chemotherapy regimens; 6. serum total bilirubin ≤ 51 mol/l, serum alt and ast both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/l; 7. echocardiography showed a left ventricular ejection fraction (lvef) ≥50%; 8. subjects had no active pulmonary infection and oxygen saturation ≥92% without oxygen; 9. the prognosis for survival is more than 3 months; 10. ecog score 0-2; 11. subjects volunteered to participate in this trial and signed an informed consent form. exclusion criteria: subjects with any of the following exclusion criteria were not eligible for enrollment in this trial: 1. those with a history of epilepsy or other central nervous system disorders; 2. those with a history of prolonged qt period or severe cardiac disease; 3. women who are pregnant or breastfeeding (the safety of this therapy for the unborn child is not known); 4. those with uncontrolled active infection; 5. active hepatitis b or hepatitis c virus infection; 6. those who have previously used any gene therapy product; 7. those with insufficient amplification (\<5-fold) in response to cd3/cd28 co-stimulatory signals; 8. creatinine \> 2.5 mg/dl or alt / ast \> 3 times the upper limit of the normal range or bilirubin \> 2.0 mg/dl; 9. those who suffer from other uncontrolled medical conditions that, in the opinion of the investigator, make them unsuitable for enrollment; 10. hiv-infected persons; 11. any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the test.

Keywords: cd19 car-t cd22 car-t ph chromosome positive b-all newly diagnosed
olanzapine in oud patients

Conditions: Opioid Use Disorder

Summary: this study is designed to examine whether olanzapine (2.5 to 20mg/day) impacts opioid use in patients with opioid use disorder and comorbid smi symptoms who are taking buprenorphine-naloxone. the specified outcomes (e.g., illicit opioid use, other drug use, sleep, mat adherence, withdrawal and craving, thought and mood disorder symptoms) on olanzapine will be examined within-subjects for change (improvement) across the trial. approximately 48 subjects will be enrolled. after enrollment, subjects will complete safety and baseline assessments and will be assigned open-label to 9-weeks olanzapine. olanzapine will then be tapered over a 1-week period (or maintained if clinically indicated). urines will be collected 2x/week throughout. the study has 4 distinct phases: 1) screening (approx. 1-2 wks); 2) baseline and medication initiation visit (1 visit; includes safety, baseline and phenotyping measures, study medication dispensed) 3) outpatient treatment (9 wks; 2 visits/wk, includes daily olanzapine and daily buprenorphine-naloxone (through the participants usual community treatment site and on-medication phenotyping measures); 4) follow-up visit (1 wk after last dose of study medication).


Eligibility criteria:
inclusion criteria: * meet criteria for opioid use disorder * have symptoms of smi * on stable dose of buprenorphine-naloxone * females must either be of non-child bearing potential or on highly-effective contraception exclusion criteria: * abnormal ecg * cocaine, alcohol, psychoactive use disorders * metabolic syndrome or diabetes 1 and 2 * history of seizures * stable regimen of an antipsychotic
meditative slow breathing or isha kriya meditation in improving cancer-related symptoms in hospitalized participants with cancer

Conditions: Malignant Neoplasm

Summary: this trial studies how well meditative slow breathing or isha kriya meditation works in improving cancer-related symptoms in hospitalized participants with cancer. meditative slow breathing or isha kriya meditation may help to decrease perceived stress and enhance well-being in hospitalized cancer participants.

primary objectives: i. test the feasibility of the meditation practice. secondary objectives: i. explore the acceptability of meditation in cancer patients through modified global symptom evaluation (gse) and on day 7 +/- 1 day and day 28 +/- 3 days. ii. explore the effect of meditative practices in cancer patients through edmonton symptom assessment scale (esas) on the day of enrolment and a weekly basis until the end of study at four weeks. outline: participants are randomized to 1 of 3 groups. group i (msb): participants are instructed on the meditative slow breathing (msb) technique and then perform msb over 15 minutes twice daily (bid) for 28 days. group ii (ik meditation): participants are instructed on the 3 steps of isha kriya (ik) meditation and then perform ik meditation over 15 minutes bid for 28 days. group iii (waitlist): participants are placed on a waitlist and receive standard supportive care for 28 days. after 28 days, participants may crossover to group ii.

Eligibility criteria:
inclusion criteria: * diagnosis of malignancy * admitted to the hospital * able to follow instructions * eastern cooperative oncology practice (eastern cooperative oncology group \[ecog\]) score of 3 or below * fluency in english exclusion criteria: * patients with life expectancy less than 2 months per attending physician or advance practice provider's note or assessment of prognosis * patients with cognitive dysfunction * patients who are admitted for observation for \< 48 hours will be excluded from the study, as one day would be difficult to provide the necessary information * patients who are delirious * patients who are unable to follow instructions due to their medical condition * patients admitted to the intensive care unit * patients with esas \> 4/10 on dyspnea * patients requiring oxygen more than 2 liters * patients who are current meditation practitioners
a first in human study to assess the safety, tolerability of lb54640 in in healthy overweight and obese subjects

Conditions: Obese; Overweight; Healthy

Summary: the aim of this 4-weeks randomized double-blind placebo-controlled single and multiple ascending dose study is to assess the safety and tolerability of lb54640 in healthy overweight and obese subjects

the study was conducted in 2 parts: part 1 (single ascending dose) this study part included 6 sequential dose cohorts (s1-s6), enrolling 8 healthy subjects per cohort. cohort s3 was evaluate the effect of food. part 2 (multiple ascending dose) this part included 7 sequential dose cohorts (m1-m7), enrolling 8 subjects per cohort. cohorts was evaluate safety, pharmacokinetics and pharmacodynamics parameters in healthy overweight and obese subjects. they were dosed once daily for 28 days with lb54640 or placebo.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 to ≤ 70 years. * body mass index (bmi) ≥ 27 kg/m2, with stable body weight by history for 3 months (defined as change \< 5%) * hba1c \< 6.5%. * female subjects must be non-pregnant and non-lactating. females of childbearing potential must use at least two of the medically accepted contraceptive methods, table at least 4 weeks prior to the screening. * ability to provide written informed consent. exclusion criteria: * history or current diagnosis with t1dm or t2dm. * history or current diagnosis of any malignancy. * history of pheochromocytoma or insulinoma. * history or current diagnosis of cardiac dysrhythmias or heart disease * history of surgical treatment for obesity or any other gastrointestinal surgery * history of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder. * use of approved weight-lowering pharmacotherapy * has a clinically significant history of suicidal ideation or suicidal behavior as assessed
rehabilitation following lumbar disc surgery

Conditions: Lumbar Disc Herniation; Radiculopathy

Summary: the proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. the study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). both groups will begin treatment 2 weeks post-surgery. subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. the general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.


Eligibility criteria:
inclusion criteria: * 18-60 years old * diagnosis of ldh based on imaging (mri or ct scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon) * appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy). * able to attend weekly treatment sessions. exclusion criteria: * prior surgery to the lumbar spine * spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging * unable to speak and understand english * peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation. * multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)