Kornimate/medical-research-clean huggingface dataset:
incidence of glaucoma-related adverse events in pediatric secondary intraocular lens implantation

Conditions: Lens Implantation, Intraocular

Summary: to compare the incidence of glaucoma-related adverse events of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (iol) implantation in pediatric aphakia

treatment of pediatric cataract, one of the leading causes of childhood blindness globally, remains challenging because of extremely high incidence of glaucoma-related adverse events (aes) after iol implantation. the investigators aim to compare the incidence of glaucoma-related aes of in-the-bag versus ciliary-sulcus-fixed secondary intraocular lens (iol) implantation in pediatric aphakia.

Eligibility criteria:
inclusion criteria: * aged between 18 months and 14 years * had a primary diagnosis of congenital cataract. * underwent cataract extraction between the ages of 2 and 24 months exclusion criteria: * primary iol implantation * pre-existing ocular disease which might affect the location and outcome of secondary iol implantation (including and not restricted to microphthalmia, microcornea, microcornea, corneal opacity, pseudopterygium, iris anomaly, glaucoma diagnosed before cataract extraction, uveitis, persistent fetal vasculature or trauma) * suture fixation for secondary iol implantation

Keywords: pediatric aphakia secondary intraocular lens implantation glaucoma-related adverse events in-the-bag iol implantation sulcus iol fixation
endodontic management of primary molars

Conditions: Endodontically Treated Teeth

Summary: the purpose of this study was to describe the clinical and radiological outcome of root canal treatment with orthomta in primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed.

the study included 13 primary mandibular second molars with infected pulp and congenitally missing second premolars in which traditional root canal treatment with gutta-percha was contraindicated. pulpectomy was performed in each tooth and the canals were filled with orthomta. the clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9, and 12 months. fractal analysis was used to detect changes in the trabecular bone after the treatment. repeated measures analysis of variance test and two independent t-tests were used to evaluate the data.

Eligibility criteria:
inclusion criteria: * selected to be preserved after an orthodontic consultation * absence of permanent tooth germ under second primary molars * sensitivity to percussion and palpation, complaints of spontaneous or persistent pain * presence of irreversible pulpitis or pulp necrosis, and abscess or fistula, presence of pathological mobility, * presence of internal and external pathological root resorption * furcal lesions * presence of infection exceeding 1/3 of the root * pathological loss of substantial bone support * loss of periodontal attachment * contraindication of traditional root canal treatment exclusion criteria: * presence of any systemic disorder * presence of any syndrome * a history or suspicion of allergies * age \<7 years, * teeth selected to be extracted after an orthodontic consultation * a score of 1(-) or 2(--) according to the frankl behavior scale * parents who refused treatment, children who refused to receive the intended treatment once it was initiated

Keywords: primary teeth root canal filling fractal analysis
corneal confocal microscopy in patients with type 1 diabetes

Conditions: Diabetic Neuropathies

Summary: assessing the use of corneal confocal microscopy to evaluate for early neuropathy changes in subjects with type 1 diabetes.

rationale: poorly controlled diabetes mellitus is associated with microvascular complications, which includes peripheral neuropathy. peripheral neuropathy associated with diabetes is a painful condition. its diagnosis is hampered by painful and long nerve conduction studies which fail to diagnose small nerve neuropathy. it is important to study methods of noninvasive methods of early detection, which are sensitive and specific in diagnosing early neuropathy and we propose a novel study that this can be detected in the cornea of the eye. aims: * estimate corneal small nerve fiber damage in young t1dm subjects (corneal fiber density, nerve branch density, and fiber length) and compare the results to healthy controls using corneal confocal microscopy (ccm). * estimate corneal nerve fiber damage in subjects with diabetes, with peripheral neuropathy and subjects with diabetes without peripheral neuropathy, diagnosed by skin biopsies and nerve conduction studies * obtain much needed normative values for ccm in adolescents and intraepidermal nerve fiber density from skin biopsies in subjects with type 1 diabetes. * as a secondary outcome measure, to compare serum biomarkers including leptin, tnf alpha, and fibrinogen in patients with diabetes in those with neuropathy vs. without neuropathy.

Eligibility criteria:
inclusion: * subjects with diabetes: * 18-30 years (cohort 1), adolescents ages 13-17 years (cohort 2). * type 1 diabetes diagnosed via standard ada criteria matched controls: * match for age and gender * hemoglobin a1c \<6.5% exclusion: for all subjects: * contact lens wearers * diseases that could damage the cornea, other than diabetes. * neurologic disease * psychiatric disease * amputation * foot ulcers * pain not of neuropathic origin. * presence of lupus, sjogren's syndrome and celiac disease * hyperlipidemia requiring lipid-lowering medications * peripheral vascular disease * neuropathy due to anything besides diabetes * presence of any medical condition that may affect nerve conduction (e.g., radiculopathy). for healthy controls * family history of type 1 diabetes
drug order for rapid sequence intubation

Conditions: Acute Respiratory Failure

Summary: this is a randomized, blinded trial comparing the order of drug administration for rapid sequence intubation in the emergency department.

based on data (excluding outliers) from protocol 16-4146, the intubation time with the paralytic and sedative first administered is 86 s, and 93 s, respectively, with a standard deviation of approximately 25-30 s. using these assumptions, 470 patients (235 per group) will need to be enrolled to detect an 7 s absolute difference between groups with 80% power. because a greater difference is anticipated in those who receive rocuronium rather than succinylcholine (because succinylcholine takes action faster), goal enrollment is 470 patients who receive rocuronium as the paralytic who are intubated successfully on the first attempt. the total enrollment will be higher, accounting for those who receive succinylcholine and those who are not successful on the first attempt. the data for those who receive succinylcholine first will be reported and is planned to be used to determine the feasibility of a future trial. the primary group of analysis will be those receiving rocuronium, because this medication acts somewhat slower than succinylcholine. patients who receive either drug will be analyzed, but it is pre-specified that the group of interest are those receiving rocuronium. the primary outcome, first intubation attempt duration, and apnea duration will be measured only in those with a successful first attempt because these timing events will be confounded by attempt failure; in these cases the altered duration will have more to do with device or patient characteristics than with drug order. the remainder of the outcomes will be measured in all enrolled subjects in an intention to treat analysis. an analysis for patients by rsi drug order actually received, regardless of treatment allocation, will also be presented.

Eligibility criteria:
inclusion criteria: * the patient must be undergoing orotracheal intubation in the emergency department * the patient must be receiving both a sedative and paralytic immediately prior to intubation (i.e. undergoing rapid sequence intubation). * the patient must be presumed to be 18 years of age or older at the time of enrollment. exclusion criteria: * prisoner or in custody * known or suspected to be pregnant, based on the opinion of the attending physician. * intubation performed by a physician assistant (this is rarely done in our ed; each physician assistant intubates less than twice per year, so the intubation outcomes would hinge more on their experience rather than drug order).
surfactant for neonatal respiratory distress syndrome at high altitude areas:a prospective cohort study

Conditions: Surfactant

Summary: the traditional concept believes that the etiology of neonatal respiratory distress syndrome (rds) is immature development of lung,especially the surfactant synthesis system,and rds is still one of the major causes of mortality and morbidity in newborns, especially premature infants.in recent years, using pulmonary surfactant replacement therapy (ps treatment) in the treatment of respiratory distress syndrome (rds) is a major breakthrough in neonatal medicine.combined with clinical practice and experience,and through meta analysis of related randomized controlled trials (rcts),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (bpd) or 28-day-old mortality.for rds in preterm infants whose gestation is \<35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.due to less relevant research for using ps treatment to cure newborn rds in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

in order to explore feasibility and efficacy for ps treatment of newborn rds in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of rds cases in qinghai and tibet these two high-altitude area,and use rds cases under the unique conditions to do statistics and analysis.

Eligibility criteria:
inclusion criteria: * the preterm infants less than 37 weeks were included in the study;diagnosed with nrds exclusion criteria: * parents' rejecting to join;major congenital abnormalities
a single arm, prospective, open label, multi center, phase ib study to evaluate the safety, tolerability and initial efficacy of a single intra-tumoral injection of intragel's polymer-based cisplatin-loaded gel (tumocure) in subjects with progressive or radio-resistant primary head and neck tumor

Conditions: Head and Neck Cancer

Summary: intragel's polymer-based cisplatin loaded gel (tumocure) is a single injectable compound, aimed at localized chemotherapy treatment. the treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment


Eligibility criteria:
inclusion criteria: 1. male and female aged 18-80 years. 2. subjects who are willing to comply with study procedures. 3. subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent. 4. subjects with a known diagnosis of primary head and neck cancer, with or without metastases. 5. subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments. 6. subjects with a measurable tumor by either ultrasound, mri or ct. 7. subjects with ecog performance status of 0 -2. exclusion criteria: 1. subjects with life expectancy of less than 3 months. 2. pregnant or breastfeeding women. 3. known copd or other chronic pulmonary or respiratory disease, with pft's indicating a fev\<50% predicted for age. 4. known reduced renal function, defined s-creatinine ≥ 1.5xuln or creatinine clearance \< 40 ml/min, calculated by using the cockroft and gault formula. 5. reduced hepatic function, defined as asat, alat, bilirubin \> 1.5xuln and pk-inr \> 1.5, or a known medical history of liver cirrhosis or portal hypertension. 6. blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl. 7. subject who was treated with systemic chemotherapy during the 4 weeks preceding screening. 8. participation in any other clinical trial that included an investigational device or medicinal product. 9. any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
treatment of coronary bifurcation lesions: comparing reverse t and protrusion versus double-kissing and crush stenting

Conditions: Coronary Artery Disease

Summary: treatment of bifurcation coronary lesions may be challenging, and the best technique to be used in these settings remains to be established. while a single stent strategy is simpler and has been often encouraged, a number of studies show that the use of modern stent implantation techniques may bring some advantages in terms of target lesion failure during longer follow-up. further, single-stent procedures are not possible at all in some settings, for instance when both main and side branch have similar diameters and present both relevant disease, particularly when the angle between the vessels is lower than 70°. recent randomized data demonstrate the superiority of the technique called double kissing and crush (dk-crush) over provisional stenting in this setting. the dk-crush technique is however cumbersome, time-consuming and requires very experienced operators. the investigators therefore plan to undertake a randomized study comparing a novel interventional technique against dk-crush in the setting of true bifurcation lesions (medina lesions type 1,1,1 or 0,1,1).


Eligibility criteria:
inclusion criteria: patients must meet all of the inclusion criteria: * documented heart team (as per guidelines) decision for revascularization via pci * planned percutaneous coronary intervention (pci) for a bifurcation stenosis with both branches \>2.5mm and with a stenosis \>50% and clinical indication to percutaneous intervention, including: * ischemic symptoms, or * positive non-invasive imaging for ischemia, or * positive flow fractional reserve (ffr), or * mean lumen area (mla) \<6mm\^2 for the left main or \<4mm\^2 for epicardial vessels as assessed by intracoronary imaging (ivus, oct) * vessel diameter ≤5.00mm * true bifurcation lesion type 1,1,1 or 0,1,1 * patient ≥18 years old exclusion criteria: * cardiogenic shock * trifurcation if all vessels are ≥2.75mm diameter * either bifurcation vessel not suitable for stenting * history of stenting in target bifurcation lesion * participation in another investigational drug or device study * patient unable to give informed consent * women of child-bearing potential or lactating * in-stent restenosis

Keywords: bifurcation coronary lesions interventional technique of coronary lesions double kissing and crush dk crush reverse tap reverse t-and-protrusion
mcs110 in patients with pigmented villonodular synovitis (pvns)

Conditions: Pigmented Villonodular Synovitis; PVNS; Giant Cell Tumor of the Tendon Sheath; GCCTS; Tenosynovial Giant Cell Tumor Localized or Diffused Type; GCTS

Summary: this study, designed as a proof of concept study of mcs110 in pigmented villonodular synovitis, assessed the clinical response to mcs110 treatment in pigmented villonodular synovitis (pvns) patients, after a single or multiple intravenous doses of mcs110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.


Eligibility criteria:
inclusion criteria: * males and females aged ≥ 18 years (≥ 12 years in part c) with pvns or gctts with, at least, one measurable site of disease on mri. * patients expected to get surgery (part a of study only). * vital signs within the ranges: systolic blood pressure 80-150 mmhg , diastolic blood pressure 50-100 mmhg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°c. * patients with normal level of serum ionized calcium and phosphate. * women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion. exclusion criteria: * patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy. * presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression. * use previously of intra-articular treatment within 4 weeks prior dosing. * patients with dermal change indicative of lymphedema or phlebolymphedema. disease. * patients with elevated troponin t and/or ck levels (\> 1.5 x uln for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease. * patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing. * patients engaged in a resistance exercise training program. * patients with pacemakers or any metallic objects as exclusion for mri * patients with concomitant disease know to get influence on bone metabolism * patients who have history of drug or alcohol abuse within 12 months prior study dosing. * pregnant or nursing (lactating) women. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pigmented villonodular synovitis pvns giant cell tumor of the tendon sheath gccts tenosynovial giant cell tumor (localized or diffused type) gcts mcs110
a 24-week study to evaluate the safety and efficacy of advair diskus® inhaler 250/50mcg plus spiriva handihaler® inhaler versus spiriva handihaler® inhaler plus placebo diskus® inhaler in subjects with chronic obstructive pulmonary disease (copd).

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of the study is to determine the efficacy and safety of the combination of advair diskus® 250/50mcg (fluticasone propionate/salmeterol combination product) plus spiriva® handihaler® inhaler 18mcg (tiotropium) compared to spiriva® handihaler® inhaler 18mcg (tiotropium) in patients with copd. spiriva® and handihaler® are trade marks of boehringer ingelheim pharma gmbh \& co. kg. advair diskus® are registered trademarks of the gsk group of companies.


Eligibility criteria:
inclusion criteria: * copd diagnosis * at least 10 pack year smoking history * post-albuterol fev1 greater than or equal to 40% to less than or equal to 80% of predicted normal * an fev1/fvc ratio of less than or equal to 0.70 exclusion criteria: * current diagnosis of asthma * other respiratory disorder other than copd * abnormal and clinical significant ecg * chest x-ray clinically significant abnormality not believed to be due to copd * body mass index of greater than or equal to 40/kg/m2 * use of long term oxygen therapy * lung resection surgery * women pregnant or lactating at visit 1 * previously diagnosed cancer unless in complete remission for 2 years at visit 1

Keywords: spirometry copd
image-guided radiation therapy for bladder-cancer patients undergoing radiotherapy and concurrent gemcitabine chemotherapy

Conditions: Bladder Cancer

Summary: the purpose of this study is to test the safety of different amounts (doses) of external radiation therapy (high-energy x-rays that shrink or destroy cancer) combined with chemotherapy.


Eligibility criteria:
inclusion criteria: * mskcc-reviewed pathologically proven diagnosis of primary bladder urothelial carcinoma without evidence of regional (nodal) or distant spread (ct1-t4a, nx or n0). * karnofsky performance scale (kps) ≥ 70% * age ≥18 years old * adequately functioning bladder, defined as continent and without the need for an indwelling catheter * absolute neutrophil count (anc) ≥ 1500/ml; platelets ≥ 100,000/mm3 serum bilirubin \< 1.5 x the upper limit of normal (uln); aspartate aminotransferase (ast) and/alanine aminotransferase (alt) ≤ 1.5 × uln * adequate renal function: calculated creatinine clearance \> 30 ml/min/1.73 m2 using the following formula modified cockcroft and gault formula for estimated creatinine clearance * patients must be considered able to tolerate systemic chemotherapy and pelvic radiation therapy. * patients must have the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * evidence of distant disease or histologically-proven nodal metastases. patients with radiologic evidence of lymphadenopathy must have biopsy proof of n0 status. * previous pelvic radiation therapy * prior systemic chemotherapy non-cisplatin based neoadjuvant for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible) * prior cisplatin based neoadjuvant systemic chemotherapy for more than \>4 cycles * active inflammatory bowel disease (i.e., crohn's disease or ulcerative colitis) * women who are pregnant or lactating

Keywords: bladder radiotherapy gemcitabine chemotherapy 10-031
comparison of pcr rate after neadjuvant chemotherapy guided by result of in vitro cell culture drug sensitivity or physician's choice

Conditions: Breast Cancer; Neoadjuvant Chemotherapy; Drug Effect

Summary: neoadjuvant chemotherapy is an important treatment for breast cancer patients. patients with triple negative or her2 enriched subtype who achieved pcr after neoadjuvant chemotherapy would have longer survival. but the overall pcr rate of breast cancer was about 20%. so, different methods have tried to improve pcr rate.drug sensitivity screening in vitro for different chemotherapy drugs was a promising method for improving pcr rate. but there was no method could select effective drugs accurately for breast cancer patients until now. this study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could improve pcr rate compared with traditional neoadjuvant chemotherapy. breast cancer patients who were candidates for neoadjuvant chemotherapy will be allocated two group. one group will receive neoadjuvant cheotherapy according physician's choices. another group will receive neoadjuvant chemotherapy according results of drug sensitivity results by in vitro cell culture. pcr rate will be compared between two groups to explore whether drug sensitivity screening could improve pcr rate.

neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. patients with triple negative or her2 enriched subtype who achieved pcr after neoadjuvant chemotherapy would have better survival. but the overall pcr rate of breast cancer was about 20%. and patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. improving pcr rate maybe could achieve better survival. so, different methods have tried to improve pcr rate.drug sensitivity screening in vitro for different chemotherapy drugs was a promising method for improving pcr rate. but there was no method could select effective drugs accurately until now. this study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could improve pcr rate compared with neoadjuvant chemotherapy depend on physician's choice. 200 breast cancer patients who were candidates for neoadjuvant chemotherapy will be allocated to two group. one group with 100 patients will receive neoadjuvant cheotherapy according physician's choices. another group with 100 patients will receive neoadjuvant chemotherapy according results of drug sensitivity results by in vitro cell culture. pcr rate will be compared between two groups to explore whether drug sensitivity screening could improve pcr rate.

Eligibility criteria:
inclusion criteria: * invasive breast cancer candidate for neoadjuvant chemotherapy normal liver and renal function agreed to participate in this experiment exclusion criteria: * inflammatory breast cancer patients can not receive operation after neoadjuvant chemotherapy distant metastasis