Kornimate/medical-research-clean huggingface dataset:
evaluating the effect of optical zones on correction for smile: vector analysis

Conditions: Myopia

Summary: evaluate the effect of the size of optical zones (oz) on myopia and astigmatism correction in small incision lenticular extraction.

to retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. divided into 2 groups according to the diameter of the optical zone. the vector analysis method was used to analyze the changes and errors of astigmatism in tr and sir after operation. generalized estimation equation (gee) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

Eligibility criteria:
inclusion criteria: * no ocular conditions * normal topography * central corneal thickness, \>500µm * residual stromal thickness, \>280 µm * pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm); exclusion criteria: * history of intraocular surgery * pupil diameter, \>4.9 mm or \<2.78mm * keratoconus or corneal ectasia

Keywords: small incision lenticule extraction vector analysis
nilotinib and lde225 in the treatment of chronic or accelerated phase myeloid leukemia in patients who developed resistance to prior therapy

Conditions: Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Summary: the purpose of this study is to determine the feasibility of administering the combination of nilotinib and lde225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (mtd) and/or recommended phase ii dose level (rp2d) of lde225 in combination with nilotinib.


Eligibility criteria:
inclusion criteria: 1. philadelphia chromosome positive (ph+) cml in chronic phase (cp) or accelerated phase (ap)with resistance to at least one prior bcr-abl targeting tki 2. documented chronic phase cml 3. adequate end organ function 4. female patients of childbearing potential must have a negative serum pregnancy test and must be using highly effective methods of contraception. male patients with female partners of child-bearing potential must use condoms. exclusion criteria: 1. impaired cardiac function 2. severe and/or uncontrolled concurrent disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol 3. history of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis 4. patients actively receiving therapy with strong cyp3a4 inhibitors and/or inducers, and the treatment cannot be either discontinued or switched to a different medication prior to entering the study 5. patients who are currently receiving treatment with any medications that have the potential to prolong the qt interval and the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug. 6. previously documented bcr-abl y253h, e255k/v, t315i or f359c/v mutation other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lde225 nilotinib chronic myeloid leukemia cml philadelphia positive ph+ resistant resistant philadelphia chromosome positive chronic myeloid leukemia (ph+ cml) in chronic phase (cp)
bright light therapy in seasonal affective disorder (sad)

Conditions: Seasonal Affective Disorder

Summary: the aim of this study is to investigate the efficacy of bright light therapy in sad. this is a placebo-controlled, double-blind randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * a patient has, according to the dsm-iv-tr, a major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33) * hamd-21 (included in the sigh-sad) sum score is ≥ 22 * patient is over 18 years * patient can read and understand the subject information sheet * patient has signed the informed consent form * patient is not pregnant exclusion criteria: * patient has a lifetime psychotic disorder * patient has a dsm-iv axis i disorder other than some anxiety disorder evaluated by mini * patient has some dsm-iv-tr axis ii disorder, which is likely to interfere with the study treatment according to the investigator * patient has alcohol or some other substance use dependence or misuse * life-time suicide attempt, or any thought of suicide during the last month * patients has some unstable somatic disorder * patient uses some medication on regular basis * patient uses some herbal psychotropic agencies * patient is, in the opinion of the investigator, unsuitable for any reason * patient is a member of the site personnel or their immediate families * patient has had bright light therapy during the current episode * patient has some eye disease (patient can, however, be myopic or hyperopic)
to evaluate ssd8432/ ritonavir in adults with covid-19

Conditions: COVID-19 Patients

Summary: this is a randomized, double-blind, phase 1b clinical trial to evaluate the safety, pharmacodynamics, and pharmacokinetic of ssd8432 combined with ritonavir tablets in adults with covid-19.

this is a randomized, double-blinded, placebo-controlled, dose-climbing phase ib clinical trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of ssd8432/ ritonavir versus placebo in asymptomatic, mild, and common type adult covid-19 subjects. this clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult covid-19 subjects, divided into 2 cohorts according to different doses of ssd8432: cohort 1: 16 subjects, 12 subjects will receive low-dose ssd8432/ ritonavir, and 4 subjects received placebo; cohort 2: 16 subjects, 12 subjects will receive high-dose ssd8432/ ritonavir, and 4 subjects received placebo.

Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤75, male or female. 2. asymptomatic infection, mild, or common type of covid-19. 3. initial positive test of sars-cov-2 within 5 days of randomization. 4. initial onset of covid-19 signs/symptoms within 3 days of randomization. 5. the ct value of sars-cov-2 nucleic acid test before randomization is ≤ 25, or the ct value is \>25 and sars-cov-2 serum igg and igm are negative. exclusion criteria: 1. transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ecmo is required or anticipated to be urgently required. 2. prior to current disease episode, any confirmed sars-cov-2 infection. 3. known medical history of active liver disease (other than nonalcoholic hepatic steatosis). 4. receiving dialysis or have known moderate to severe renal impairment. 5. known human immunodeficiency virus (hiv) infection. 6. suspected or confirmed concurrent active systemic infection other than covid-19 that may interfere with the evaluation of response to the study intervention.s. 7. oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization.. 8. treatment with antivirals against sars-cov-2 within 14 days. 9. current or expected use of any medications or substances that are highly dependent on cyp3a4 for clearance. 10. concomitant use of any medications or substances that are strong inducers of cyp3a4 are prohibited within 28 days. 11. has received or is expected to receive covid-19 monoclonal antibody, convalescent covid-19 plasma or other prohibited concomitant medication. 12. females who are pregnant or breastfeeding.
digestive and nutritional effects of probiotics supplementation in premature newborns

Conditions: Duration of Parenteral Nutrition

Summary: symbiotic interaction between probiotics ("living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. many studies showed a probant efficiency of probiotic supplementation in neonates on ecun, despite abnormally high ecun incidence in control group. nevertheless, our aim is to test clinical efficiency of two new probiotics strains. bifidobacterium longum and lactobacillus gg on oral nutrition (volume at day 14 and day 21) and safety (adverse events) in very premature babies.


Eligibility criteria:
inclusion criteria: 1. newborns (\< 2 weeks of life) 2. 32 weeks of gestation, 3. weight \< 1500g, 4. enteral nutrition begun, 5. clinical stability, 6. signed consent form from both parents. exclusion criteria: 1. newborns (\>= 2 weeks of life), 2. weight \>= 1500g, 3. pathology avoiding the start of the enteral nutrition, 4. other pathologies of those due to premature and its complications, 5. no signed consent form.

Keywords: digestive and nutritional effects safety and growth feeding tolerance
correlation of renal mass pathologic grade and contrast enhanced ultrasound (ceus)

Conditions: Renal Malignant Tumor

Summary: patients with renal lesions suspicious for renal cell carcinoma (rcc) have a variety of different treatment pathways available to them. imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. this is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. the world health organization (who) or fuhrman grade is the standard grading scale used by pathologists for rcc. the goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of rcc. specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.

renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which rcc is the most common. rcc comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis \[novara et al\]. the most commonly used pathologic grading systems are the who or fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence. care of patients with rcc depends on a number of factors, including size and pathologic grade. as such, radiologic surveillance with ct and mri is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. while percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and rcc. contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma \[barr et al\]. it has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. as such, it is well suited for use in patients with underlying renal pathology. this study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * previously identified renal mass with radiology and clinical features consistent with rcc * clinical care plan includes partial or total nephrectomy exclusion criteria: * less than 18 years of age * currently pregnant * renal mass with clinical care plan that does not include nephrectomy * renal mass suspected to be non rcc neoplasm by imaging and clinical data * renal mass unable to be visualized by grayscale ultrasound * known renal vein thrombosis
follow-up of the natural course of the small eus-suspected gastric gastointestinal stromal tumors

Conditions: Tumor

Summary: gastric gastrointestinal stromal tumors (gists) less than 2 cm are usually followed up conservatively. however, little is known about the natural course of small gists. the goal of this study was to evaluate the clinical course of the small eus-suspected gastric gists and to determine the size predicting subsequent progression with increased malignant potential.


Eligibility criteria:
inclusion criteria: * (1) a small tumor size, less than 3 cm; * (2) patients declined surgical intervention at initial identification of the lesion; * (3) at least two eus follow-up procedures were recorded; * (4) the eus follow-up period was more than 24 months. exclusion criteria: * (1) a tumor size, larger than 3 cm; * (2) less two eus follow-up procedures were recorded; * (3) the eus follow-up period was less 24 months.

Keywords: gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
immunogenicity and reactogenicity of dtpa-hbv-ipv/hib vaccine followed by the same vaccine and oral polio vaccine

Conditions: Hepatitis B; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis

Summary: this study will assess the immunogenicity and safety of the glaxosmithkline (gsk) biologicals' (formerly smithkline beecham biologicals') combined dtpa-hbv-ipv/hib (infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. the last dose of dtpa-hbv-ipv/hib will be given simultaneously with one dose of opv vaccine.


Eligibility criteria:
inclusion criteria: the inclusion criteria will be checked at study entry. if any of these criteria does not apply, the subject is not eligible for inclusion in the study. * healthy male and female subjects in the ≥12 and \<16 weeks of life at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the parents/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. exclusion criteria: the exclusion criteria will be checked at study entry and at each following visit. if any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. if any of these criteria becomes applicable during the study, the subject should be withdrawn. * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination). * administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after. * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib disease. * history of /or intercurrent diphtheria, tetanus, pertussis, hepatitis b, polio and/or hib disease or infection. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of seizures or of any neurological disease at study entry. * administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period. * acute disease at the time of enrolment.

Keywords: oral polio vaccine (opv) dtpa-hbv-ipv/hib vaccine
early functional outcomes in unisplaced neck of femur fracture treated with partially threaded and fully threaded cannulated screw fixation in patients of age 60 and above

Conditions: Neck of Femur Fracture

Summary: this study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. a total of 82 (41 in each group) patients of both genders, aged 60 or above. the radiographic union scale for hip (rush) and harris hip score to be used to evaluate fracture healing.

this study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. this is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. all these patients had garden type i or ii and were mobile before femoral neck fracture were included. in group-a patients cannulated screw fixation was done using partially threaded screws and in group-b patients were treated with fully threaded screws were used. patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. the radiographic union scale for hip (rush) and harris hip score were used to evaluate fracture healing.

Eligibility criteria:
inclusion criteria: * patients of garden type i or ii fractures. * all patients to be mobile before femoral neck fracture. exclusion criteria: * patients having open fracture. * patients with present or past history of chronic kidney disorder. * patients presenting with hemorrhage. * patient with nervous stroke * patients unwilling to be part of this study.

Keywords: cannulated screw fracture hip harris score
exercise in severely disabled patients with ms

Conditions: Multiple Sclerosis

Summary: in the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (ms). however, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. the purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with ms.

for many years, patients with multiple sclerosis (ms) have been advised not to participate in physical exercise. this advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. a further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. during the last decade, it has been more common to recommend exercise for ms patients, because of its recently proven beneficial effects in these patients. resistance- and endurance training constitutes the two extremes of basic physical exercise. to gain insight into the effects of exercise it therefore makes sense to understand the extremes. in mild to moderately impaired ms patients endurance training is well tolerated and providing beneficial effects. however, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. the investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled ms patients (expanded disability status scale score \> 6). patients are inpatients at one of the national ms hospitals and endurance training is added to the usual care, and compared to usual care only (control group). exercise frequency is 3 times per week, and intensity is controlled by hr measurements during exercise.

Eligibility criteria:
inclusion criteria: * signed informed consent -\>18 years * primary progressive or secondary progressive ms according to the mcdonald criteria * 6.5 ≤ edss ≤ 8.0 and pyramidal score between 1 and 4 * maximal walking distance ≤ 10m exclusion criteria: * patients are excluded if they: * have dementia,alcoholism, or pacemaker treatment * any serious medical comorbidities * are pregnant * have done systematic endurance training (\>1day/week) within the last 3 months. * complete less than 80% of the planned training sessions * medical conditions that exclude performance of a maximal endurance test.

Keywords: exercise therapy aerobic training endurance training
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell intravenous infusion for autism

Conditions: Autism

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of autism

studies have shown that stem cell treatment is safe and efficacious for the treatment of autism. patients with autism will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. the total dose for the infusion will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of autism exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety * previous organ transplant * seizure disorder * hypersensitivity to sulfur

Keywords: autism stem cell treatment
easypod united states user trial

Conditions: Growth Hormone Deficiency

Summary: this study will help to determine whether an injection log on a recombinant human growth hormone (rhgh) delivery device improves subjects' adherence with injection schedules. adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhgh delivery device and a group of subjects who are not aware of the easypod™ injection log. it is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhgh pen injection devices.


Eligibility criteria:
inclusion criteria: * be male or female from 10 to 18 years of age, inclusive, with open epiphyses * have gh deficiency diagnosed by treating pediatric endocrinologist for at least 6 months * be undergoing rhgh treatment via self-injection using the lilly humatrope® or pfizer genotropin® pen injection device for at least 6 months * be willing and able to comply with the protocol for the duration of the trial * have access to the internet * be able to read, speak and understand english * if female of childbearing potential, have a negative urine pregnancy test at screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide exclusion criteria: * known allergy or hypersensitivity to rhgh or prescribed diluent (0.3% metacresol for click.easy® cartridge) * severe illness during the previous 6 months * active malignancy (except non-melanomatous skin malignancies) * diabetes mellitus (type i or ii) * pregnancy or lactation * any medical condition that, in the opinion of the investigator, would jeopardize the subject's safety following exposure to the investigational device * participation in any other investigational study during the duration of participation in this trial