Kornimate/medical-research-clean huggingface dataset:
evaluation of toothbrush bristles in plaque reduction

Conditions: Plaque, Dental; Gingivitis

Summary: the purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (plaque index) and objective measurement (digitally measured plaque area). this study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods. this is a randomized evaluator-masked crossover study with 10 subjects. subjects will be randomly allocated to three test groups. subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. plaque index and plaque area will be assessed before/after one time use at baseline and day 7. subjects will be assigned to another toothbrush after one week wash-out period.


Eligibility criteria:
inclusion criteria: individuals may be included in the study if they meet all of the following inclusion criteria: * must have read, understood and signed an informed consent prior to being entered into the study * must be 18 to 70 years of age, male or female * have at least 20 natural or restored teeth * must have average plaque index of ramfjord teeth at baseline greater than 2(quigley and hein) at screening * agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study * agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the appointment in the study * agree to abstain from the use of any dental products other than those provided in the study * agree to comply with the conditions and schedule of the study exclusion criteria: individuals are not eligible for participation in this study if any of the following are noted: * physical limitations or restrictions that might preclude normal tooth brushing * evidence of gross oral pathology * presence of severe gingivitis with 30 or more sites showing bleeding on probing * evidence of major soft tissue lesions or trauma at the baseline visit as determined by the investigator/examiner * chronic disease with concomitant oral manifestations * subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months * currently using bleaching trays * eating disorders * recent history of substance abuse * smoking \>10 cigarettes/day * participation in other clinical studies within 14 days of screening
analysis of influencing factors of high-order aberrations of smile with lenticule retained

Conditions: Small-incision Lenticule Extraction (SMILE) Surgery; Corneal Higher-order Wavefront Aberrations; Residual Lenticule

Summary: analysis of influencing factors of high-order aberrations of smile with lenticule retained

wavefront analysis and other objective methods are the mainstream approaches for assessing visual quality after refractive surgery, with high-order aberrations being the main observation indicators. some studies have explored the correlation between various complications after smile surgery and high-order aberrations. however, research on lenticule retained after surgery has mainly focused on clinical management and case reports of overt lenticule retained, while there is a lack of high-quality observational studies on the population with covert lenticule retained (periphery residual lenticule) to serve as evidence. this often puts clinicians in a dilemma of whether to perform another surgery to remove the remnants. in summary, although research on lenticule retained after smile surgery is gradually increasing, systematic studies on their relationship with higher-order aberrations are still insufficient. this study aims to fill the gap in existing research by comparing and analyzing high-order aberrations between patients with and without periphery residual lenticule, providing a more comprehensive assessment of postoperative visual quality. this will offer important theoretical basis and practical guidance for improving smile surgical techniques and optimizing postoperative management.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, gender unrestricted; 2. equivalent spherical refraction ≤ -10.0d, corrected distance visual acuity ≥ 1.0, myopia stable for ≥ 2 years, and no contact lens wear for at least 2 weeks; 3. the patient voluntarily participates in this study, signs the informed consent form, and agrees to follow up according to the study plan; 4. predicted postoperative residual corneal stromal thickness ≥ 280 micrometers. exclusion criteria: 1. subclinical keratoconus, keratoconus, moderate to severe corneal opacities or scars, and other ocular conditions; 2. diabetes, keloid-prone constitution, autoimmune and connective tissue diseases, etc.; 3. severe mental disorders such as generalized anxiety disorder, panic disorder, depression, schizophrenia, and bipolar disorder; inability to cooperate with physicians; 4. refusal to participate in the study.

Keywords: residual lenticule corneal higher-order wavefront aberrations small-incision lenticule extraction
genetic and molecular abnormalities in congenital cystic adenomatoid malformations

Conditions: Congenital Cystic Adenomatoid Malformation (CCAM)

Summary: the aim of this study is to identify genetic abnormalities and molecular pathways associated with the occurrence of ccam.

congenital lung malformations are rare diseases, characterized by the coexistence in the same individual of normal lung and localized lung malformation. among these malformations, congenital cystic adenomatoid malformations (ccam) represent the most important group, with an estimated incidence between 1/11 000 and 1/35 000 births. the precise mechanisms leading to these lung malformations remain poorly understood. this project aims to identify key genetic and/or molecular mechanisms associated with the occurrence of ccam. ccams are collected during postnatal surgical resection. parental agreement is required. a standardised histologic description of malformations is performed for each sample. normal lung tissue at the periphery of the malformation is considered as control. malformations will be analyzed in a systematic way by proteome and transcriptome, after laser microdissection. somatic genetic abnormalities will also systematically be sought.

Eligibility criteria:
inclusion criteria: * children \< 8 years * thoracic surgery for congenital lung malformation * parental written consent exclusion criteria: * children \> 8 years * previous infection of the malformation * parental rebutal

Keywords: congenital lung malformation congenital cystic adenomatoid malformation cystic lung disease
efficacy and safety of dlbs1425 in subjects with advanced/metastatic breast cancer

Conditions: Breast Cancer

Summary: the purposes of this study are : * to investigate the safety and clinical efficacy of sole therapy with dlbs1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and * to determine the minimal effective and safe dose of dlbs1425 in the therapy of advanced/metastatic breast cancer


Eligibility criteria:
inclusion criteria: * subjects diagnosed with stage iiib or iv breast cancer who have failed with or refuse to receive standard chemotherapies * subjects with the expression of er/pr negative; or positive er/pr expression but have failed with or refuse to receive hormonal therapy * either + or - expression of her-2/neu gene * ecog status = 0-2 * at least have 1 evaluable and measurable metastatic lesion as defined by recist criteria * adequate haematological, liver, and renal function * at least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy * at least 4 weeks has elapsed since surgical biopsy / major surgery exclusion criteria: * allergic to the trial product * any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation * concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease

Keywords: breast cancer dlbs 1425 cancer advanced/metastatic (stage iiib/iv) breast cancer
randomized controlled trial evaluating an incentive-based community eye-care programme

Conditions: Visual Impairment

Summary: elderly with visual impairment (vi) who undergo community eye screening often do not attend tertiary follow-up even if significant eye diseases are detected. investigators evaluate an incentive-care scheme (ics) to improve the attendance rates of tertiary eye-care visits of participants following community eye screening.

a randomized controlled study individuals with vi with baseline visual acuity (va) and vision-related quality of life (vrqol) assessed in the community. participants were randomised to either receiving ics or usual care (uc). ics is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals. participants in uc received a standard gp referral letter advising them to seek further care. our main outcome measure was compliance to tertiary eye-care referral. our secondary outcome measure was va and vrqol assessed at 3 months.

Eligibility criteria:
inclusion criteria: * the ability to speak english and/or mandarin, have adequate hearing with/without hearing aids to respond to normal conversation, not currently undergoing regular assessment/care with an ophthalmologist (at least yearly), have the ability to undergo visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse in either eye after best correction exclusion criteria: * refused informed consent and any other contraindication(s) as indicated by the general practitioner responsible for the participant
efficacy and safety of jinshuibao capsule on diabetic kidney disease

Conditions: Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Summary: the purpose of this study is to investigate the therapeutic effect and safety of jinshuibao capsule on diabetic kidney disease in t2dm patients.

diabetic kidney disease (dkd) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including acei and arb drugs), has to a certain extent, delayed the progression of dkd, but still cannot completely block its development. cordyceps sinensis is a traditional chinese medicine and jinshuibao capsule is its artificial preparation, with the effect of renoprotection. however, its clinical application in diabetic kidney disease is not well-defined so far. the aim of this study is to investigate the potential use of jinshuibao capsule on microalbuminuria in t2dm.

Eligibility criteria:
inclusion criteria: 1. subjects with written informed consent. 2. type 2 diabetes according to 1999 who criteria. 3. age: 30-75 years. 4. hba1c \< 11%. 5. stage iii diabetic kidney disease: 5.1 microalbuminuria: 30 mg / g \< urinary albumin creatinine ratio (acr) \< 300 mg / g, positive for at least two in three times. 5.2 renal function: egfr ≧ 30 ml / min / 1.73 ㎡. 6. stable use of a standard dose of angiotensin ii receptor blocker ≧ 3 months. 7. childbearing-age women with contraceptive measures. exclusion criteria： 1. type 1 diabetes mellitus. 2. non-diabetic urinary system diseases (urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.) 3. other serious diseases \[severe hypertension ((defined as sbp \> 200 mmhg and/or dbp \> 110 mmhg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x unl), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.\] 4. allergic to cordyceps sinensis, use of aceis, any use of cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc. 5. presence of acute metabolic disorders (dka,hhs); history of surgery, severe trauma and other stress conditions. 6. female patients who are pregnant or breastfeeding. any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.
an observational, retrospective, multicenter, national study for the monitoring of subjects who participated in the loadet clinical trial

Conditions: Ankylosing Spondylitis

Summary: previous studies suggest that an increase in doses of weekly etanercept from 50 mg to 100 mg improves the efficacy of the treatment in patients with cutaneous psoriasis, rheumatoid arthritis, and psoriatic arthritis. in this same line of study, during the 2007 2008 period, we conducted a multicenter, double-blind, 12-week study (loadet, 0881a3-102090) comparing the efficacy of etanercept at a standard dose (50 mg/week) versus a double dose (100 mg/week) in subjects with as refractory to conventional therapy. the interim results of said study do not appear to support the value of doubling the dose of etanercept in the treatment of subjects with as. once this study was finalised, the subjects continued to be monitored by their regular physician, who decided on the dose and treatment to follow according to the conditions of standard clinical practice. the objective of this observational study is to evaluate the course of the disease in the long-term (three years) under the conditions of standard clinical practice, in subjects who had participated in the loadet study. therefore, we would like to follow-up on those patients by reviewing their clinical histories for the three-year period between the finalisation of their participation in the loadet study (0881a3-102090) and now. this will allow us to assess the efficacy and survival of the drug, as well as the possible appearance of side effects in the three years following the finalisation of the study by comparing the results according to if the subjects had received 50 mg/week or 100 mg/week during the loadet study (0881a3 102090).

given that this is a follow-up study of subjects who participated in the loadet study (0881a3-102090), we have planned the inclusion of all subjects who completed said study, that is, 97 of the 108 subjects in the loadet study.

Eligibility criteria:
inclusion criteria: * as patients who had previously participated in the loadet study (0881a3-102090). * subjects who completed the loadet study. * patients who grant their informed consent exclusion criteria: * patients who participated in the loadet study but who discontinued treatment and, therefore, did not complete the study. * patients without standard follow-up by the physician since the end of the study.
secure, the cimzia ® crohn's disease post-marketing registry

Conditions: Crohn's Disease

Summary: the purpose of this study is to monitor safety outcomes of patients who have taken cimzia® as compared to a non- cimzia® control population. the secure registry's target enrollment is 3045 patients and it's objective is to monitor patients for approximately 8 years.

physicians are expected to manage patients as they would under normal practice conditions; patients will receive and use their medications according to their normal course of medical treatment.

Eligibility criteria:
inclusion criteria: * patient must have medically documented crohn's disease (cd) * the decision to prescribe cimzia or other medications has been made by the physician independent of inclusion in this study * patient (or his/her legally acceptable representative) is able to provide written informed consent to permit collection of data * patients participating in randomized, blinded clinical trials for cd or other conditions are not eligible for inclusion into the secure registry. involvement in other registries, where patients follow routine clinical practice, is permitted, however * for the cimzia cohort: patient is receiving treatment with cimzia for the first time. patient must receive cimzia treatment within 2 months of enrollment into the registry * patient is currently receiving treatment with cimzia for \<=12 months. patient must also receive a cimzia dose within 2 months following enrollment into the registry * for the comparison cohort: patient is switching cd treatment or beginning cd treatment for the first time. previous cimzia treatment is prohibited in the comparator group. patient must receive new cd treatment within 2 months of enrollment into the registry. patient is currently receiving anti-tnf treatment for \<=12 months. patient must receive anti-tnf treatment within 2 months following enrollment into the registry. patient is currently receiving immunosuppressant therapy for \<=12 months. patient must receive immunosuppressant therapy within 2 months following enrollment into the registry. patient is currently receiving systemic steroid therapy for \<=12 months. patient must receive systemic steroid therapy within 2 months following enrollment into registry. exclusion criteria: * see inclusion criteria

Keywords: certolizumab pegol, cimzia ® crohn's disease
use of autologous serum eye-drops as tears in patients with recalcitrant dry eye

Conditions: Xerophthalmia

Summary: the purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.

a group of selected dry eye patients from the singapore national eye centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. after informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. tear inflammatory proteins captured on schirmers paper pre and post treatment will be analysed as well.

Eligibility criteria:
inclusion criteria: * seen at the dry eye service at the singapore national eye centre * age between 21 and 75 years old * symptomatic for dry eye or va worse than 6/12 in snellen chart * presence of corneal punctate staining involving central zone * exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician * no contraindication for blood extraction/plasmapheresis exclusion criteria: * hiv/hcv/hbv/syphilis
pharmacokinetics of thccooh and its acyl-glucuronide after intravenous administration of thccooh

Conditions: THCCOOH; Pharmacokinetics; Metabolism; Cannabis

Summary: a study on the fate and elimination of 11-nor-delta9-carboxy-9-tetrahydrocannabinol was up to now not conducted, except of one single experiment in which (lacking) psychopharmacological activity was tested after intravenous infusion of 20 mg in a human individual. in this study, however, the authors did not trace the above questions due to analytical and methodological deficits. aim of the study is to determine the pharmacokinetics of thccooh and thccooh-glu after intravenous ad-ministration of 5 mg thccooh in healthy individuals

to determine the pharmacokinetics of thccooh after intravenous administration of thccooh (5 mg) and its formed glucuronide in healthy individuals in order to improve the possibilities for the assessment of unfitness to drive. for these purposes the following criteria will be studied: thccooh * primary: area under the plasma concentration time curve (auctotal) maximal plasma concentrations (cmax) time of cmax (tmax) terminal elimination half-life (t1/2) * secondary: systemic and renal clearance (cls, clr) volume of distribution of (vc) formed thccooh-glu * primary: area under the plasma concentration time curve (auctotal) maximal plasma concentrations (cmax) time of cmax (tmax) terminal elimination half-life (t1/2) * secondary: systemic and renal clearance (cls, clr) volume of distribution (vc)

Eligibility criteria:
inclusion criteria: * good state of health (physically and mentally) exclusion criteria: * any regular drug treatment within the last two months * any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life * any acute or chronic illness or clinically relevant findings in the pre-study examination * allergies (except for mild forms of hay fever) or history of hypersensitivity reactions * smoking (regular or irregular) * excessive alcohol drinking (more than approximately 30 g alcohol per day) * positive drug screening especially thc or known or admitted drug abuse
amniotic fluid sludge in cerclage patients as an indicator for increased risk of preterm delivery and neonatal outcome.

Conditions: High Risk Pregnancy; Incompetent Cervix; Cerclage; Amniotic Fluid Sludge; Gestation Age at Delivery.

Summary: amniotic fluid "sludge" does not increase risk of preterm delivery in cerclage patients.

177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have sludge. conclusion af sludge on ultrasound had no association with increased risk of preterm delivery in patients with cerclage.

Eligibility criteria:
inclusion criteria: * cerclage * pregnancy outcome data available * neonatal outcome data available * pre and post cerclage cervical length measurements * hx of cervical procedures, if any, available exclusion criteria: * cervical ultrasound picture(s) unacceptable * any missing maternal or fetal data as stated above * fetal anomaly * cervical dilation at time of cerclage * placental previa or abruption * preterm labor

Keywords: amniotic fluid sludge cerclage ultrasound preterm delivery neonatal