Kornimate/medical-research-clean huggingface dataset:
does cryofixation of skin specimens affect quality of subsequent formalin fixed paraffin embedded h and e histology

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma

Summary: this prospective study of 60 slides of basal and squamous cell carcinomas of the skin aims to determine whether: 1. the process of cryofixation prior to generating formalin fixed paraffin embedded (ffpe) h\&e sections alters the histology in skin tumor specimens. 2. which specific histologic parameters are altered between previously cryofixed versus routine ffpe sections. histologic observations will be recorded by two dermatopathologists and two mohs surgeons and statistically analyzed.

generating formalin fixed paraffin embedded (ffpe) hematoxylin and eosin (h\&e) stained permanent sections from previously cryofixed tissue is a common practice used to confirm diagnosis of frozen section histology. in dermatology, this practice can be used to examine mohs layers and its debulk as well as routine nonmelanoma skin cancer (nmsc) biopsies after initial histologic diagnosis with frozen sections. even though freezing tissue can introduce histologic artifacts, there have been no studies documenting whether this occurs specifically in cryofixed tissues that are subsequently thawed for permanent ffpe h\&e histology. the purpose of our study is to determine whether the freeze-thaw process used to generate permanent sections after cryofixation introduces significantly detectable histologic differences compared to permanent sections that were not previously cryofixed. thirty debulk specimens of basal cell and squamous cell carcinomas will be prospectively collected. each specimen will be split so that half is processed as cryofixed permanents and the other half as noncryofixed permanents. the investigator will show each slide in random order to a group of four blinded participants (two dermatopathologists and two mohs surgeons). each participant must first rate the overall quality of histology. then, each participant will rate each slide on the quality of cellular morphology, nuclear morphology, color and contrast of stains, intactness of specimen, and other miscellaneous artifacts. these data will then be analyzed for statistical significance.

Eligibility criteria:
inclusion criteria: * adult patients (age 18 or over) with a biopsy proven routine basal cell or squamous cell carcinoma of the skin who are scheduled for treatment with the mohs procedure by dr. christopher miller at the university of pennsylvania's division of dermatologic surgery will be included. both female and male patients will be included. exclusion criteria: * patients with basal cell or squamous cell carcinomas of more complex histopathology will be excluded from the study. complex histopathology of a tumor is defined as features with aggressive, moderately to poorly differentiated, or unusual histopathology.

Keywords: any patient with a routine basal cell or squamous cell carcinoma of the skin diagnosed on frozen histology during a mohs procedure
root coverage using a xenograph for treatment of gingival recession

Conditions: Localized Gingival Recession

Summary: can a fetal bovine derived membrane serve as an alternative to autogenous tissue for dental root coverage procedures.

primatrix (tei medical inc) is a promising collagen membrane derived from fetal bovine dermis. the acellular porous structure of the membrane permits rapid re-vascularization and cellular re-population. the membrane contains a high proportion of type iii collagen. type iii collagen helps regulate tissue healing by promoting neoepithelialization and angiogenesis. wounds grafted with primatrix exhibited significantly faster healing rates compared to control wounds while having a minimal foreign body response and early repopulation by progenitor cells. the ability of primatrix to permit neovascularization, reepithelialization, minimal immune response, and population by progenitor cells suggests that it may serve as an ideal alternative to ctg under cpf for root coverage. in this regard, the current study aims to serve as a pilot to test the feasibility of the use of primatrix as a graft material under a cpf to attain root coverage of miller class i \& ii defects.

Eligibility criteria:
* inclusion criteria: * adults 18-90 years of age * miller class i \& ii defects on maxillary or mandibular teeth * at least 1 adjacent non-involved tooth on either side of the included recession defects * keratinized tissue width of ≥2.0 mm * periodontal probing depths of 3 mm or on included teeth * plaque index of 2 or less * bleeding on probing at 30% or less sites * current non-smoker * no active infected wounds * exclusion criteria * patients less than 18 years of age * miller class iii, or iv mucogingival defects * miller class i \& ii defects without adjacent non-involved teeth * cej not identifiable * root surface restoration at the defect site * periodontal probing depths greater than 3 mm * plaque index of 2 or greater * bleeding on probing at more than 30% of sites * uncontrolled oral disease * moderate to severe generalized chronic or aggressive periodontitis * oral manifestations of a systemic disease * history of previous root coverage procedure, graft, or gtr * current smoker or other tobacco use * alcohol abuse problems * traumatic occlusion impinging on the recession defect * use of intraoral appliances that impinge on the recession defect * intra-oral piercings that impinge on the included defect * uncontrolled systemic health conditions * debilitating systemic or infectious disease * diabetes * heart disease * uncontrolled heart disease * delayed wound healing * immunocompromised status due to medication or immune system dysfunction * active infection or non-healing wounds * currently pregnant or lactating * long-term steroid use
efficiency of art-therapy in psychotic disorders

Conditions: Schizophrenia

Summary: the main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * schizophrenia according to dsm iv exclusion criteria: * addiction problem * invalidating visual sensory problems * neurological history

Keywords: schizophrenia art-therapy visual organization
silymarin in nafld

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this study evaluates the influence of silymarin in reducing laboratory, ultrasonographic (fibroscan) and metabolic components of nafld. half of the patients will receive silymarin (verum) while the other half will receive placebo

in this study will participate patients who come to the regular ambulatory examinations (referred by gastroenterologists, nephrologists or family physicians in the department of gastroenterology and department of nephrology, dialysis and kidney transplantation kbc rijeka) and have one or more components of the metabolic syndrome (hypertension, diabetes, obesity, dyslipidemia).nonalcoholic fatty liver disease will be defined by transient elastography (fibroscan, echosens, paris); controlled attenuation parameter (cap) for assesment of liver steatosis and liver stiffness measurements (lsm) for liver fibrosis. in all patients other causes of chronic liver disease will be excluded; chronic viral hepatitis, autoimmune diseases and other metabolic liver diseases as well as use of drugs than can cause liver steatosis and fibrosis and alcoholic liver disease. this study will include 350 patients. taking into account the possible drop-out rate around 15% of the patients during the study period, a total of 400 patients will be randomized. patients will be randomized into two groups. the first group will be consisted of the patients with nafld who will be receiving verum therapy during the 6 month period. the second group will be consisted of the patients with nafld who will be receiving placebo during the 6 months period, which will be identical to the verum preparation in its packaging and form. after the 6 months of therapy in all patients will be evaluated: liver enzymes and metabolic laboratory parameters of nafld (insulin resistance, lipidogram and serum glucose), as well as the te-cap in order to evaluate the efficiency of silymarin for the treatment of nafld.

Eligibility criteria:
inclusion criteria: * nafld patients * signed informed consent * possibility to follow instruction and the protocol exclusion criteria: * chronic b or c hepatitis * usage of hepatotoxic drugs in the period of 6 months before inclusion * chronic kidney insufficiency (grade 4 and 5), hemodialysis * any other chronic liver disease * opioid dependancy * any malignancy * hiv seropositivity * alcohol abuse * pregnancy * inability to follow the protocol

Keywords: nafld; fibroscan silymarin
real-world study of myopia prevention and control in children

Conditions: Myopia; Refractive Errors; Children; Cohort

Summary: this prospective, school-based cohort study aims to enroll approximately 15,000 primary school students from multiple districts in shanghai, china and to observe the outcomes on myopia prevention and control in children with varying refractive status (including sufficient hyperopia reserve, relative insufficiency in hyperopia reserve, pre-myopia and myopia) who are exposed to a school-based categorized and integrated interventions strategy in real-world settings. the primary objective of this study is to observe the change in the incidence and prevalence of myopia as well as the the progression of myopia among primary school students population under a school-based interventions, including increasing outdoor activities and wearing special designed optical lenses. the second objective is to identify factors influencing the outcomes and assess the compliance of different intervention methods. additionally, a cost-effectiveness analysis will be conducted to assess the implementation process, providing technical solutions and operational models for wider application.


Eligibility criteria:
inclusion criteria: 1. all students from the enrolled schools; 2. participants must be able to cooperate with and complete all required ophthalmic examinations; 3. written informed consent must be obtained from their parents or legal guardians. exclusion criteria: 1. ocular abnormalities (e.g., strabismus, amblyopia, or other significant eye diseases); 2. systemic diseases that may affect ocular health; 3. current participation in other myopia intervention programs.

Keywords: myopia premyopia outdoor activities myopia prevention myopia control children compliance defocus optical lenses
a phase ii trial of genexol-pm and gemcitabine in patients with advanced non-small-cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: to evaluate the efficacy and safety genexol-pm(crel-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic nsclc patients


Eligibility criteria:
inclusion criteria: * age over 18 * histologically or cytologically confirmted non-small cell lung cancer * stage iiib with pleural effusion or stage iv * ecog ps 0-2 * at least one measurable lesion * expected life span more than 3 months * normal bone marrow, liver, renal function * no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases * more than 6 months from the last adjuvant chemotherapy exclusion criteria: * active infection * severe comorbitidies * pregnant or lactating women * other invasive malignancies * poorly controlled symptomatic brain metastases

Keywords: non-small cell lung cancer gemcitabine genexol-pm paclitaxel
a clinical evaluation of the eclipse™ system, a vaginal bowel control (vbc) therapy for fecal incontinence in women

Conditions: Fecal Incontinence

Summary: multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the eclipse™ system after 3 and 12 months of use.


Eligibility criteria:
abbreviated inclusion criteria: * history of fecal incontinence (fi) for at least 6 months * subject willing and able to give written informed consent to participate in the study * subject can read, write and communicate fluently in english * subject willing and able to comply with visit schedule * subject is able to physically manage the insertion and removal of the insert abbreviated exclusion criteria: * vaginal childbirth within the last 18 months * currently pregnant or planning pregnancy during the study period * acute infections or genito-urinary injuries that would impact comfortable device use * current treatment for fecal incontinence other than medical management * removal or diversion of any portion of the bowel * recent urogenital or colorectal surgeries * chronic abdominal pain in absence of diarrhea * chronic (\>6 mos) rectal, anal or pelvic pain * chronic watery diarrhea, unmanageable by drugs or diet * inflammatory bowel disease (ibd) such as chron's or ulcerative colitis * rectal prolapse (mucosal or full thickness) * grade iii or iv hemorrhoids * pelvic organ prolapse beyond the plane of the hymen * concurrent use of intra-vaginal pessary or other device * anal or pelvic malignancy within last 5 years * history of pelvic irradiation for cancer * other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk
icare3: monitoring circulating cancer dna after chemotherapy in mds and aml

Conditions: Acute Leukemia; Myelodysplastic Syndromes; AML; MDS

Summary: this study will use droplet digital pcr (ddpcr) method to quantify and track peripheral blood plasma mutant allele frequency (maf) in mds and aml patients before, during and after chemotherapy treatment. quantification of maf from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor dna (ctdna) for ddpcr.

the greatest challenge in cancer is relapsed disease. despite best available therapies, approximately 20% of acute myeloid leukemia (aml) patients and 80% of myelodysplastic syndrome (mds) patients die of relapsed disease. minimal residual disease (mrd) is the main predictor of refractory disease following chemotherapy. in aml and mds patients, mutant allele frequency (maf) associates with future occurrence of relapse. current oncology practice relies on painful bone marrow biopsies and light microscopy to monitor disease progression, remission, and relapse. because of the bias in disease sampling and low sensitivity testing, there is an urgent need for a higher sensitivity test to monitor the tumor burden in these patients. the investigator developed a rapid and ultrahigh sensitivity method to detect cancer-associated mutant alleles. this study will use our droplet digital pcr (ddpcr) method to quantify and track peripheral blood plasma maf in mds and aml patients before, during and after chemotherapy treatment. quantification of maf from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor dna (ctdna) for ddpcr. results from this project will generate a non-invasive means to monitor cancer response and progression months before current clinical methods, and provide an opportunity to intervene before the patient relapses. furthermore, establishing a quantitative method to measure cancer burden will empower clinical researchers to measure biological activity in phase ii and iii clinical trials of new therapeutic agents.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mds or aml; * have previously consented or prospectively consent to participate in icare for cancer (irb201500073) and the malignant hematology bank (irb201501063); and * must be 18 years of age or older. exclusion criteria: * have not previously consented or prospectively consent to participate in icare for cancer (irb201500073) and the malignant hematology bank (irb201501063); and * must be 100 years of age or less.

Keywords: acute myeloid leukemia myelodysplastic syndrome relapse pcr droplet digital polymerase chain reaction
docetaxel plus bevacizumab in metastatic non small cell lung cancer

Conditions: Non-small-cell Lung Cancer

Summary: this trial will evaluate the efficacy and safety of docetaxel plus bevacizumab in patients with pretreated, advanced non small cell lung cancer (nsclc).

docetaxel is and an effective cytotoxic agent in \> 1st line treatment of advanced or metastatic non small cell lung cancer (nsclc). recently, a phase iii study of 1st line treatment in patients with advanced or metastatic nsclc showed that the addition of bevacizumab to a platinum-based regimen provided a survival benefit. there are patients with nsclc who have not received bevacizumab and have relapsed after 1st and/or 2nd line therapy. the evaluation of bevacizumab plus chemotherapy in such patients is justified. this study will evaluate the combination of docetaxel and bevacizumab as 2nd or 3rd line treatment of nsclc.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, * unresectable locally advanced (stage iiib) or metastatic (stage iv) non-squamous nsclc * at least one and no more than two previous chemotherapy regimens for advanced - or metastatic nsclc * measurable disease, defined as at least 1 bidimensionally measurable lesion ≥ 20 x 10 mm. * age ≥ 18 years. * performance status (who) 0-2. * life expectancy of at least 12 weeks. * adequate bone marrow (anc ≥ 1,500/mm3, plt ≥ 100,000/mm3, hgb ≥ 11 g/dl), liver (bilirubin ≤ 1.5 upper normal limit, sgot/sgpt ≤ 2.5 upper normal limit in the absence of liver metastases or ≤ 5 upper normal limit in the presence of liver metastases), and renal function (creatinine ≤ 1,5 upper normal limit). * patients must be able to understand the nature of this study and give written informed consent exclusion criteria: * previous therapy with docetaxel * second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer * pregnant or lactating women * any serious, uncontrolled comorbidity on the investigator's judgment. uncontrolled infection * any sustained chronic toxicity \> grade 2 according to the nci ctcae (version 3.0) * symptomatic neuropathy \> grade 2 according to the nci ctcae (version 3.0) * brain metastases, except if radiated and asymptomatic * radiotherapy within the previous 4 weeks * previous radiotherapy to the only measurable lesion * proteinuria ≥ 500 mgr of protein daily * hemoptysis \> 10 cc per event * clinically significant hematemesis * centrally located lesion or in contact with major vessels * pulmonary lesion with cavitation * documented hemorrhagic diathesis or coagulation disorder * cardiovascular disease (class ii-iv nyha congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, lvef \< normal, ventricular arrhythmia, uncontrolled hypertension) * thrombotic event within the previous 6 months * concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents * concurrent treatment with other anti-cancer drug * major surgical procedure within the previous 4 weeks

Keywords: cancer nsclc docetaxel bevacizumab
treatments and outcomes of untreated cerebral cavernous malformations in china.

Conditions: Cerebral Cavernous Malformations

Summary: this nationwide multicenter prospective cohort study will collect the treatment information and outcomes of the patients with previously untreated cavernous malformations (u-cms) in china (at least 2000 patients from 20 centers). the investigators aim to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.

despite the availability of microsurgical excision and stereotactic radiosurgery for cavernoma treatment and known genetic causes of most familial forms of cavernoma, uncertainties remain about cause, diagnosis, prognosis, treatment, and care. according to the recently published cm treatment guideline, surgical and conservative treatments are both first-line therapeutic options in previously untreated cms (u-cms). however, given current data, neurosurgeons are still unable to counsel patients on which would be the best option. to address the absence of high level evidence to support cerebral cm treatment decisions, there is a need for a large sample size study of cerebral cm treatment with a prospective concurrent group. china has the largest population in the world and may have the most extensive and valuable clinical resources of u-cms. but, till now, the current treatment and outcome situation of the disease in china is not well known. thus, the investigators are conducting a nationwide multicenter prospective registry study in china to determine the effect of different treatments on long-term outcomes in patients with untreated cerebral cavernous malformations.at least 2000 patients with untreated cerebral cavernous malformation will be enrolled from 20 grade ⅲ a level hospitals distributed all over china. clinical data and laboratory data are prospectively collected by electric case report form (crf) and uploaded online by each neurosurgery center to form the prospective clinical database in first affiliated hospital of fujian medical university. this is a cohort follow-up study across a 5-year period with a 2 years interval of enrollment and 3 years follow up for each patient.

Eligibility criteria:
inclusion criteria: * definite diagnosis of cerebral cm on the basis of brain mri or pathologic examination; * patients without any surgical intervention (microsurgery, radiosurgery, or multimodality treatment) before enrolment; * informed consent, and willing to accept long-term follow-up. exclusion criteria: * patients receiving emergency surgery due to acute intracranial hematoma and resultant brain hernia; * patients with other never system diseases, such as aneurysms, tumors or other vascular malformations except venous development anomaly; * patients with severe underlying disease, which affects the patient's functional status and life expectancy; * patients with severe mental or psychologic disease.

Keywords: cavernous malformations, treatment.