Kornimate/medical-research-clean huggingface dataset:
mini-implant-supported twin-block in treating patients with class ii division 1 malocclusion

Conditions: Orthodontic Appliance Complication; Malocclusion, Angle Class II, Division 1

Summary: correcting the skeletal class ii using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. however, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. this loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported twin-block appliance compared to the conventional twin-block.

many attempts have been made to modify the twin-block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. however, these modifications have not been successful in eliminating the dentoalveolar effects. this is because the twin-block and other functional appliances are supported by teeth rather than bone. as a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. no previous clinical trial described the use of the twin-block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with twin-block in functional treatment.

Eligibility criteria:
inclusion criteria: 1. the wrist radiograph (stage 4 s and stage 5 mp3 cap) 2. skeletal class ii division 1 malocclusion caused by mandibular retrusion 3. anb (5°- 9°) 4. snb (72°- 77°) 5. overjet (5 - 8 mm), 6. minimal crowding in dental arches (≤ 3 mm), 7. mm≤30° 8. lower second molars erupting. exclusion criteria: 1. previous orthodontic procedures. 2. systemic diseases. 3. temporal mandibular joint disorders. 4. poor oral hygiene
validation of a virtual model of service delivery for choroidal nevi

Conditions: Choroidal Nevus

Summary: choroidal nevomelanocytic lesions have a high prevalence affecting up to 7% of the entire population and are increasingly incidentally identified during routine eye check- ups in community optometry services. given the tendency to err on the side of caution, there is evidence of excessive referrals challenging service delivery in both tertiary eye units and specialist ocular oncology services. although previous studies have examined the natural history and risk factors for growth of choroidal nevomelanocytic lesions, optimal delivery of management remains uncertain. management approaches display diversity with respect to the number and type of baseline investigations, the duration and frequency of monitoring of relevant patients. utilisation of the skills of allied health professionals in appropriate cases would allow streamlining service delivery in a socialised healthcare system, maximise capacity, and allow community services to play an enhanced role. however, the evidence for this model of delivery is lacking. within existing models of care for these lesions, patients are faced with delays, need for more than one attendances to the hospital and increased anxiety around prognosis. this project aims to answer the question of whether these low-risk, bland incidental findings might possibly be managed by allied health professionals with the use of clinical imaging and specific algorithms to make appropriate management decisions. we aim to validate a model of service delivery on a virtual basis that will accommodate for capacity pressures to accept all relevant referrals, while offering a safe service and optimising patient experience of care. we will thus validate the setting up of a virtual choroidal nevomelanocytic clinic in terms of safety and patient acceptability. more specifically, the degree of agreement between management decisions made by non-medical graders on the basis of imaging data alone as opposed to gold standard decisions (clinical and imaging tests combined) is examined. health economics analysis of the proposed service delivery model will be undertaken to demonstrate cost-effectiveness.


Eligibility criteria:
all patients attending the cnl clinics of mreh/meh who have offered informed consent will be included in the study. patients who are then diagnosed with alternate pathologies other than cnl (erroneous referrals) will be excluded from agreement analysis. recognition of alternate pathologies by non-medical graders will, however, be an additional outcome measure for this project. cases of congenital hypertrophy of the retinal pigment epithelium (chrpe) will be classified as 'alternate pathology' for the purposes of this study. exclusion criteria will be media opacities (cornea, lens, vitreous body) precluding adequate visualisation of fundus and incomplete set of imaging data.
car t-cell therapy educational video trial

Conditions: Hematologic Malignancy; CAR-T Cell Therapy

Summary: the purpose of this study is to test a new educational video to help patients and doctors talk about car-t cell therapy, a treatment being used in cancer. - educational video tool for patients receiving car-t cell therapy.

this research study is a feasibility study, which is the first-time investigators are examining this educational video tool for patients receiving car-t cell therapy. the research study procedures include screening for eligibility, randomization and a series of questionnaires participants will be randomized to one of 2 groups: * group a: educational video tool * group b: standard care participants will be in the research study for a month after consent it is expected that about 80 participants will take part in this research study.

Eligibility criteria:
inclusion criteria: * 18 years or age or older * established diagnosis of a hematologic malignancy * under consideration for car t-cell therapy at massachusetts general hospital exclusion criteria: * significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study * undergoing car t-cell therapy for solid tumor malignancy * inability to comprehend english, as the video is currently only available in english at this time

Keywords: hematologic malignancy car-t cell therapy
efficacy and safety of hydrolysed red ginseng extract on improvement of hyperglycemia

Conditions: Hyperglycemia

Summary: this study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of hyperglycemia.

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. twenty subjects were randomly divided into hydrolysed red ginseng extract or a placebo group. fasting and postprandial glucose profiles during oral glucose tolerance test (ogtt) were assessed before and after the intervention.

Eligibility criteria:
inclusion criteria: * age 19-80 years with fasting glucose 100-140 mg/dl exclusion criteria: * weight less than 48 kg or weight decreased by more than 10% within past 3 months * have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc. * hypoglycemic agent, obesity medicine, lipid lowering agent within past 3 months * blood sugar improvement or healthy functional food within past 1 month * under antipsychotic medication therapy within past 2 months * history of alcohol or substance abuse * participation in any other clinical trials within past 2 months * laboratory test by show the following results * aspartate aminotransferase, alanine aminotransferase \> reference range 3 times upper limit * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * if a woman of childbearing doesn't accept the implementation of appropriate contraception * principal investigator judged inappropriate for participation in study because of laboratory test result, etc.

Keywords: hydrolysed red ginseng extract glucose clinical trial
pain after buffered vs non buffered articaine

Conditions: Pain

Summary: pain after buffered versus non buffered articaine.


Eligibility criteria:
inclusion criteria: * males and females, age- 18 to 60 yrs. * medically free. * need a dental treatment in the upper anterior region. exclusion criteria: * periodontally affected teeth. * radiographic bone loss. * upnormal length of the teeth.
immediate effects of two ankle mobilization techniques in the amplitude of dorsiflexion and dynamic valgus knee

Conditions: Ankle Joint Contracture; Knee Injuries and Disorders

Summary: dynamic knee valgus is an inadequate biomechanical movement of multifactorial cause that may expose the individual to various injuries. the range of motion of ankle dorsiflexion is one of the possible influencing factors. this study intends to compare the immediate effect of two techniques on ankle mobility and dynamic knee valgus.

this study aims to verify the immediate effects of ankle mobilization on dynamic knee valgus and to compare two techniques of ankle mobility. it will include 102 lower limbs that present deficit of ankle dorsiflexion and dynamic knee valgus in the same lower limb. participants will be divided into two groups, one for ankle mobilization with movement aided by the therapist and another for self mobilization of the ankle. the two intervention groups will do the same protocol, same number of sets, repetitions and rest time.there will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind. the kolmogorov - smirnov test is used to verify the data distribution normality. the characterization of the participants is performed by means of descriptive statistical analysis. parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. the evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. the difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."

Eligibility criteria:
inclusion criteria: * physically active individuals (30 minutes of moderate physical activity at least three times a week with at least 6 months of practice); men or women ranging in age from 18 to 35 years; (with a value equal to or less than 10 cm in the measuring tape and / or 2 cm difference between the limbs) and dynamic knee valgus (center of the patella surpassing the midpoint between the malleoles ) evaluated by forward step down test (fsdt). exclusion criteria: * patients who present any of these conditions will be excluded from the study: chronic ankle instability, previous surgery on the joints of the foot, ankle, knee, hip or ankle joint injury in the last 2 years that caused more than 1 month of withdrawal; recent muscular or skeletal injuries that do not allow the exercises to be performed; severe cardiac conditions or other pathological conditions that make physical therapy impossible.
clinical and histomorphometric analysis of collagen matrix versus connective tissue graft in mucogingival surgery in orthodontic patients

Conditions: Gingival Recession

Summary: there are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. in that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement. the connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of miller class i and ii recession defects. most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. but, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons. most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.

the purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery the principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery . the secondary outcomes are: 1. length of new cementum (histometry results) 2. length of the junctional epithelium (histometry results) 3. length of connective tissue attachment (histometry results) 4. complete root coverage (clinical results) 5. width of keratinized tissue

Eligibility criteria:
inclusion criteria: * patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment . * the patient must be 18 years or older * patient shows sufficient plaque control (fmps \< 20%). * the patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent exclusion criteria: * general contraindications for dental and/or surgical treatment are present. * the patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs). * untreated periodontal conditions * patients not willing to participate

Keywords: collagen matrix connective tissue graft histometry xenograft periodontal regeneration biometry
studies of sulfur metabolism in humans

Conditions: Metabolic Side Effects of Drugs

Summary: the study test whether the nsaid allosteric site of human sulfotransferase 1a1 (sult1a1) is operative in humans. the study will test the effects of mefenamic acid (mef) on the sulfonation of acetaminophen (apap, a sult1a1 specific substrate) and dehydroepiandrosterone (dhea, a sult2a1 substrate). if the allosteric site is active in vivo, mef is predicted to result in a decrease in sulfonation of apap (mef inhibits sult with high affinity (ki = 23 nm), and to have no effect on sulfonation of the dhea (mef has little or no effect on sult2a1 activity).

no patient registries associated with this study. a single, therapeutic dose of acetaminophen (apap, 1.0 g)) or dehydroepiandrosterone (dhea, 75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (mef, 0.75 g). in total, 5 experiments will be performed: 1, apap alone; 2, dhea alone; 3, mef alone; 4, apap + mef; and 5, dhea + mef. each experiment will be performed in duplicate. compounds will be taken prior to eating breakfast. one hour later, the patient has a light breakfast (cheerios and milk, and a cup of coffee) and eats normally thereafter. urine samples are collected at 15', 30', 1 h, 2h, 3h, 4h, 5 h, 6h, 7h, 8h, 9h, 10h, 11h, and 12h intervals following dosing. the study subject will attempt to completely empty their bladder at each urine-collection time point. the samples are weighed. a 10 ml aliquot is taken from each time point and the aliquots are stored at -20 °c. samples (0.5 ml) are then transferred to nuclear magnetic resonance (nmr) tubes and nmr spectra are taken to assess drug metabolites in urine. proton nmr will be performed using the 600 mhz instrument in the einstein facility.

Eligibility criteria:
inclusion criteria: * gender - one male * age - 61 y.o. * healthy * agreed to sign the consent form exclusion criteria: ● none

Keywords: sulfotransferase metabolism acetaminophen dehydroepiandrosterone mefenamic acid allostery
cycled phototherapy

Conditions: Hyper Bilirubinemia; Premature Infant

Summary: cycled phototherapy (pt) is likely to increase survival over that with continuous pt among extremely premature infants (\< 750 g bw or \<27 weeks ga).

were they not delivered early, extremely premature infants would normally develop in darkness within the uterus for 3-4 more months longer before birth. yet, the routine care of these infants has involved the use of uninterrupted (continuous) exposure to bright light during phototherapy (pt), a treatment method that neonatologists have assumed has no serious adverse effects on even the most immature of newborns. immaturity, thin translucent skin, and a multitude of other problems may make extremely premature infants highly vulnerable to the photo-oxidative injury, lipid peroxidation, dna damage, reduced cerebral and mesenteric blood flow, or other serious potential hazards of uninterrupted exposure to pt that have now been identified. such hazards were not recognized when continuous pt was widely incorporated into neonatal care, and the survival rate of extremely premature infants (\<27 wks gestation or \<750 g birth weight) was much lower than today. pt rapidly photoisomerizes bilirubin in the subcutaneous tissues and vasculature, and six trials of cycled pt have demonstrated that use of cycled pt reduces the total hours of pt and results in minimal or no increase in peak tsb over that with continuous pt in term or moderately preterm infants. recent findings from a pilot study (nct01944696) support a pt regimen for this cycled phototherapy protocol. infants born at one of the neonatal research network centers, ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best ob estimate will be considered for this study. those who qualify will be randomized to either cycled pt or continuous pt. the cycled phototherapy begins with \>15 min/h cycled pt regimen and increased to 30 min/h if the tsb is 8.0-9.9 and 60 min/h if the tsb is \>10 mg/dl. those randomized to continuous phototherapy will undergo continuous exposure,as that is commonly used in nrn centers. the pt lamp position will be adjusted to meet the irradiance (µw/cm2/nm) goal of 22 at the umbilicus. the irradiance goal in both groups will be increased from 22 to 33 at a tsb of 10-13 and to 40 at a tsb \>13.

Eligibility criteria:
inclusion criteria: 1. infants is inborn 2. infant is ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best ob estimate 3. infant is 12-36 hours of age. exclusion criteria: 1. unable to enroll infant by 36 hours of age 2. previous phototherapy 3. known hemolytic disease 4. tsb reported as \>6.0 mg/dl before 12 hours age 5. major anomaly 6. overt nonbacterial infection 7. infant is likely to expire soon: limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the ph is \ 2h.

Keywords: infant, newborn, diseases phototherapy
clinical performance of extended wear silicone hydrogel lenses

Conditions: Myopia

Summary: the primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.


Eligibility criteria:
inclusion criteria: * is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses. * is a current daily wear soft contact lens wearer. * has no clinically significant anterior eye findings. * has no other active ocular disease. exclusion criteria: * has any systemic disease that might interfere with contact lens wear * is using any systemic or topical medications that will affect ocular health. * has any pre-existing ocular irritation that would preclude contact lens fitting. * has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. * has undergone corneal refractive surgery. * is pregnant, lactating or planning a pregnancy.
postmarket study of an intraocular lens power selection system

Conditions: Cataract

Summary: the purpose of the study was to evaluate the visual acuity outcomes when using the optiwave refractive analysis (ora) with verifeye+ and barrett toric calculator for calculating intraocular lens (iol) power and axis in subjects requiring cataract surgery and implanted with a toric iol in both eyes.

surgery was done on each eye on different days, 7 to 14 days apart. subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Eligibility criteria:
inclusion criteria: * planned cataract surgery with iol implantation * able to comprehend and sign the informed consent form * preoperative astigmatism of 0.75 to 3.00 diopter * willing and able to complete all required postoperative visits * other protocol-defined inclusion criteria may apply exclusion criteria: * unclear intraocular media other than cataract * pregnant or lactating * presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the investigator. * other protocol-defined exclusion criteria may apply

Keywords: iol intraocular lens astigmatism cataract surgery
post marketing registry to assess usage, safety and effectiveness of deltyba tablets in korean patients with mdr-tb

Conditions: Multi-drug Resistant Tuberculosis

Summary: deltyba registry aims to collect the usage information of deltyba which could be a factor of developing resistance in actual clinical settings.

to collect the usage information of deltyba in actual clinical settings for the management of resistance to deltyba

Eligibility criteria:
inclusion criteria 1. patients who are prescribed deltyba® per prescribing information (pi) for the purpose of treatment can be included in the registry. exclusion criteria 1. patients with known hypersensitivity to delamanid or any excipients of deltyba® 2. patients whose serum albumin \< 2.8 g/dl 3. patients taking medicinal products that are strong inducers of cyp3a (e.g. carbamazepine). 4. patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.