Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of ikervis under controlled environmental conditions environment

Conditions: Dry Eye; Dry Eye Syndromes; Severe Keratitis

Summary: the proposed study is a prospective, open-label, unicentric, phase iv clinical trial. this study is design to find new efficacy biomarkers for ikervis® (1mg/ml ciclosporin) eye drops after 1 and 3 month after initiation of therapy. additionally, this study intends to investigate whether ikervis® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ace) and analyzing both clinical and molecular parameters.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * diagnosis of ded with severe keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously. * not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day) * fluorescein corneal staining ≥ 2 (oxford scale) in both eyes. * deq-5 \> 6 points * use of at least 4 times daily of an ocular artificial tears. * any concomitant medication that may affect ded, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study. * best corrected visual acuity (bcva) of at least 0.1 logmar at 6 meters with each eye. * signature of written informed consent form and data protection form. exclusion criteria: * known allergy or sensitivity to the study product(s) or its components. * any ocular pathology other than ded. * history of severe ocular inflammation other than that due to ded or infection in the 6 previous months to the study inclusion. * any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator. * history of refractive surgery in the previous 18 months. * contact lens use in the one previous month to study inclusion and during the duration of the study. * use of any ocular topical medication for pathologies other than ded. * use of any other ocular topical medication for ded other than artificial tears during the last one (steroids) or three months (ciclosporine, tacrolimus) . * any uncontrolled severe systemic disease that may affect the eye (except for sjögren's syndrome) * the start date of any systemic medication that may affect ded, ocular surface condition or vision is \< 3 months prior to baseline or a change in dosage is anticipated during the study. * occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study. * pregnancy or breastfeeding. * current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.
prediction of intra-abdominal infectious complication by drainage fluid analysis

Conditions: Complication; Anastomotic Leak; Intraabdominal Infections; Inflammatory Response; Gastrointestinal Cancer

Summary: in our previous study, a nomogram model was established to predict intra-abdominal infectious complications after gastrointestinal surgery. this model was based on the clinical data and the drainage fluid cytokine levels, and it received an auc \>0.9. in this study, validation of this nomogram is planned to be conducted in this prospective cohort study.

intra-abdominal infectious complications such as anastomotic leakage are the most feared but common complications after gastrointestinal surgery. in our previous study, a nomogram model was established to predict intra-abdominal complications after gastrointestinal surgery. this model was based on the clinical data and the drainage fluid cytokine levels, and it received an auc \>0.9. a predicting score (i.e. appeal-gc score) was created based on the model. in this study, validation of this score in predicting intra-abdominal complications is planned to be conducted in this prospective cohort study. in this study, all patients undergoing gastric or colorectal cancer surgery with a primary anastomosis will be included. the clinical data and complication data will be prospectively collected; the discarded drainage fluid will be collected and analyzed afterward. no additional intervention will be applied. the cytokine levels in the drainage fluid will be evaluated, and together with the clinical data, an appeal-gc score will be created for each patient. we will investigate whether the above-mentioned score is able to predict the intraabdominal complications after surgery. the predictive value (clinical usefulness) of the score will be validated in this study.

Eligibility criteria:
inclusion criteria: * planned surgery for gastric or colorectal cancer with primary anastomosis. * inform consent signed before surgery. exclusion criteria: * no drainage tube placed.
predictive factors of acute oral mucositis induced by chemo-radiotherapy for local advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Neoplasms; Stomatitis

Summary: this is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

all patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. oral mucosa grades are recorded before and during treatment. dose-volume histograms are got to analyze the associated factors.

Eligibility criteria:
inclusion criteria: 1. histologically conformed initial nasopharyngeal carcinoma 2. patients can feed through the mouth. 3. ecog (eastern cooperative oncology group) : 0-1. 4. no history of chemo-radiotherapy, immuno-therapy or biotherapy. 5. normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/l, neutrophil count\>1.5×109/l, platelet count \>100×109/l, hemoglobin≥90g/l, normal liver/kidney function). 6. informed consent signed. exclusion criteria: 1. history of malignant tumors. 2. any severe complications contraindicated chemotherapy or radiotherapy. 3. medical history of central nervous system, cognitive or psychological diseases; 4. pregnant or nursing women. 5. patients with mental disease cannot complete the questionaire. 6. patients refused the informed consent.

Keywords: radiotherapy, oral mucositis,oral mucosa protection
safety and efficacy of benefix in patients with hemophilia b in usual care settings in china

Conditions: HEMOPHILIA B

Summary: the purpose of this post-approval study is to evaluate the safety and efficacy of benefix in subjects with hemophilia b in usual care settings in china.

the purpose of this post-approval study is to provide supplementary information relating to the use of benefix in chinese subjects with hemophilia b, especially on the safety and efficacy in different populations of chinese hemophilia b patients, in particular in pediatric patients \<6 years of age, pediatric patients ≥6 to ≤12 years of age, previously untreated patients (pups) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (fix activity \<1%).

Eligibility criteria:
inclusion criteria: * male and/or female subjects with hemophilia b. * subjects/parents/legal representatives must be able to comply with study procedures (informed consent/assent process, clinical visits, reporting of infusion and bleed data, reporting of adverse events, etc) exclusion criteria: * presence of any other bleeding disorder in addition to hemophilia b. subjects with a past history of, or current factor ix inhibitor. for laboratory-based assessments, any bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 bethesda unit (bu)/ml. * subjects with known hypersensitivity to the active substance or to any of the excipients of benefix. * subjects with a known hypersensitivity to chinese hamster ovary cell proteins.
changes in ppv induced by plr test to predict fluid responsiveness in icu

Conditions: Acute Circulatory Failure

Summary: the passive leg raising (plr) test is a reversible preload challenge of around 300 ml of blood that can be repeated as frequently as required without infusing a drop of fluid. two recent meta-analyses of many studies have confirmed the reliability of the plr test to predict fluid responsiveness in patients with acute circulatory failure. nevertheless, the effects of the plr must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the plr hemodynamic effects with reliability. moreover, cardiac output must be measured continuously and in real time. in clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence. recently, it was shown that the decrease in pulse pressure variation (ppv) induced by the mini-fluid challenge (100 ml of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (\<8 ml/kg of ideal body weight). therefore, the investigators hypothesize that the changes in ppv induced by plr test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.


Eligibility criteria:
inclusion criteria: * mechanically ventilated patients * patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria: (1) systolic arterial pressure \ 2 mmol/l * patients in whom the physician decides to perform a plr test to predict fluid responsiveness * arterial catheter should be in place for invasive monitoring of arterial pressure and ppv non inclusion criteria: * age \<18 yrs * pregnancy * moribund patients * risk of fluid loading induced pulmonary edema * cardiac arrhythmias * contraindication to perform plr (intracranial hypertension, pelvic fractures) exclusion criteria : * changes in vasopressor and sedation agents dosages during the protocol * changes in ventilatory parameters during the protocol

Keywords: fluid responsiveness passive leg raising pulse pressure variation
multi-modality imaging standard cohort of cerebrovascular disease

Conditions: Cerebrovascular Disease

Summary: the aim of this study is to establish a multi-center and multi-modality imaging standard cohort of cerebrovascular disease, analyze the potential mechanisms affecting the prognosis of cerebrovascular disease based on a variety of imaging methods, and explore potential therapeutic targets.

cerebrovascular diseases are major diseases that pose a serious threat to human health and life, and have become the leading cause of death from disease among chinese residents. despite the best medical or surgical treatment options, many patients still suffer from functional disabilities, imposing a heavy burden on families and society. identifying the complex and delicate changes in brain neural activity, blood flow, oxygenation, and metabolism following the occurrence of cerebrovascular diseases can not only explore the potential mechanisms underlying poor functional prognosis, but also provide a scientific basis for targeted treatment strategies. this study is a consecutive, multicenter, prospective registration study that recruits approximately 800 patients with cerebrovascular diseases (both hemorrhagic and ischemic stroke) aged 18-80 years within 7 days of onset. the study collects baseline information and imaging data including head ct, mri, tcd, fnirs, and ophthalmic testing. the primary endpoint event was functional outcome 3 months (mrs score). secondary outcomes were in-hospital complications (including stroke progression, recurrence, and mortality), cognitive disorder, functional outcomes, recurrent stroke, new vascular events, and all-cause death at 3, 6 and 12 months .

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old; * onset of symptoms within 7 days; * clinical diagnosis of cerebrovascular disease (ischemic stroke or hemorrhagic stroke) confirmed by head imaging (ct or mri); * signed informed consent form. exclusion criteria: * diagnosed with non-cerebrovascular diseases (such as central nervous system infections, epilepsy, and metabolic encephalopathy); * patients with contraindications to multimodal ct or mri, functional near-infrared imaging, or those who cannot cooperate to complete the relevant examinations; * patients with a life expectancy of less than 3 months or those who cannot complete the study follow-up due to other reasons.

Keywords: stroke progonosis imaging cognitive disorder
robotic endomicroscopy to better define resection strategies applied to hepatic surgery

Conditions: Hepatocarcinoma; Hepatic Metastasis; Hepatic Tumor

Summary: this study aims at assessing the feasibility of probe-based confocal laser endomicroscopy (pcle) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the western countries. in france, 45.000 new patients develop colorectal cancer every year. the liver is the most common organ targeted by crlm, representing 50%. approximately, 15-25% of colorectal cancer patients have synchronous crlm at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis. the strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. this technic aims to minimize surgical margins width while removing the tumor. therefore, the current standard for resection margins is a margin width superior to 1mm. however, there is still a debate concerning the margin width. indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between r0 patients and r1 patients treated with chemotherapy. however, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce r1 margins occurrence. ex vivo study: surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pcle images. in vivo study: intraoperative characterization of sub-capsular hepatic masses and surgical margins will be assessed.

Eligibility criteria:
inclusion criteria: * over 18 years * scheduled for a surgical resection of hepatic masses * provided signed informed consent exclusion criteria: * allergy to indocyanine green (icg) * kidney failure * pregnancy or breastfeeding
tricin: prospective study on the efficacy of single topical trichloroacetic acid (tca) 85% in the treatment of cervical intraepithelial neoplasia (cin 1/2)

Conditions: Cervical Intraepithelial Neoplasia Grade 1; Cervical Intraepithelial Neoplasia Grade 2

Summary: trichloroacetic acid 85% =tca is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (cin) grade 1/2. the device system is to be used only in accordance with the approved investigational plan on subjects, who have given written informed consent. high remission and regression rates are expected after a single topical treatment with 85% tca. after a single topical treatment with 85% tca for cin 1-2 (expected 70% or higher; null hypothesis: not higher than 55%). regression is defined as improvement from high grade lesion (cin 2) at baseline to low grade lesion (cin 1) after tca treatment. regression from cin 1 normal squamous epithelium after the tca treatment is equal to remission and will be counted as a remission in combined analysis. remission is defined as complete histologic remission of cin back to normal squamous epithelium after the tca treatment, i.e., no cervical dysplasia is detectable by histology or cytology after the tca treatment. type-specific hpv clearance is defined as disappearance of the hpv type detected at screening.

visit and assessment schedule: visit1 screening: * informed consent, * inclusion/exclusion criteria, * medical history, * gynecological examination * cytology * hpv test * colposcopy * biopsy * vas (visual analog scale) * pregnancy test visit 2 treatment day with tca 85%: * colposcopy * tca treatment * vas * pregnancy test visit 3, control 1, week 10-14: * cytology * hpv test * colposcopy * biopsy * 4-quadrant biopsy * ecc * adverse event monitoring if there is no sign of cin during the colposcopic examination 10-14 weeks a 4-quadrant biopsy and a ecc are performed visit 4, control 2, week 22-26: * cytology * hpv test * colposcopy * biopsy * 4-quadrant biopsy * ecc * adverse event monitoring * pregnancy test if there is no sign of cin during the colposcopic examination 22-26 weeks after the tca treatment, a 4-quadrant biopsy and a ecc are performed. visit 5, eos , week 24-30: - results discussion

Eligibility criteria:
inclusion criteria: * histologically proven cin 1/2 * adequate colposcopy (i.e. fully visible transformation zone and margins of any visible lesion) * positive hpv test * conducted negative pregnancy test * women aged 18 to 50 years * written informed consent exclusion criteria: * exclusion criteria are a cytologically suspected cin (pap iiid, iv) * inadequate colposcopy * negative or missing biopsy * cytology results indicating invasive disease (pap v) * if the cervical lesion recedes into the endocervical canal * pregnancy * any medical circumstance considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
concomitant radio-chemotherapy in the elderly

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety of non small cell lung cancer (nsclc) treatment with cisplatin and oral vinorelbine administered weekly associated with concomitant radiotherapy in elderly patients.


Eligibility criteria:
inclusion criteria: * age ≥ 70 years * independent patients (based on the score of geriatric frailty: iadl = 0, adl = 0, no geriatric syndrome, low comorbidity (comorbidity index of charlson to 3 or 4), depression score 0-1) * performance status (ecog) ≤ 1 * weight loss \<10% of usual weight in the last 3 months * life expectancy greater than 12 weeks * hematologic function: neutrophils\> 1.5 x 10\*\*9 / l, hemoglobin\> 9.5 g / dl, platelets \> 100 x 10\*\*9 / l) * renal function: creatinine clearance ≥ 50 ml / min calculated by the formula of mdrd * normal liver function: bilirubin \< limit of normal (uln), sgot and / or sgpt \<2.5 x unl * respiratory function: fev ≥ 40% predicted, pao2 ≥ 60 mm hg, kco ≥ 60% predicted * patient affiliated to a social security regimen or beneficiary of such regimen * informed consent signed the disease * pathological anatomy: cbp non-small cell (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, undifferentiated carcinoma) histologically or cytologically proven * stage iiian2 considered inoperable stage iiib * presence of at least one measurable target * delay at least three weeks between surgery and initiation of treatment * no prior treatment with chemotherapy or radiotherapy for lung cancer exclusion criteria: * age \< 70 years * performance status (ecog) ≥ 2 * hematologic function: neutrophils \<1.5 x 10\*\*9 / l, hemoglobin \<9.5 g / dl, platelets \<100 x 10\*\*9 / l) * renal function: creatinine clearance \<50 ml / min calculated by the formula of mdrd * hepatic: bilirubin\> upper limit of normal (uln), sgot and / or sgpt\> 2.5 x uln * respiratory function: fev \<40% predicted, kco \<60% predicted, pao2 \<60 mmhg * peripheral neuropathy grade\> 1 * unstable cardiac pathology requiring treatment (heart failure, angor of effort, arrhythmia) or previous myocardial infarction older than 12 months * deafness not paired or deafness requiring major achievement of an audiogram-cons may indicate taking cisplatin * neurological or psychiatric disorders prohibiting the understanding of the test * previous history of cancer except basal cell cancer, carcinoma in situ of the cervix treated or any other cancer treated with surgery alone or radiotherapy alone extra-thoracic recurrence-free 5 years * significant malabsorption syndrome or disease affecting the functioning of the gastrointestinal tract the disease * pathological anatomy: bronchioloalveolar carcinoma, neuroendocrine carcinoma, small cell carcinoma * metastatic disease * pleural drain * carcinomatous lymphangitis * operable cancer * previously treated for lung cancer disease: radiotherapy, chemotherapy, hormonal therapy, endobronchial suctioning older less than eight days

Keywords: locally advanced lung cancer elderly patients nsclc
ispinesib in combination with carboplatin in patients with solid tumors

Conditions: Solid Tumours

Summary: the purpose of this study is to determine the dose regimen of ispinesib in combination with carboplatin in patients with solid tumors. ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). a patient may continue to receive treatment as long as they are benefiting from the treatment. blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. physical exams will be performed before each treatment with ispinesib. during the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy. * ecog (eastern cooperative oncology group) performance status of 0-2. exclusion criteria: * females who are pregnant or nursing. * pre-existing hemolytic anemia. * pre-existing peripheral neuropathy greater than or equal grade 2. greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens. * absolute neutrophil count less than 1,500/mm3. * platelets less than 100,000/mm3. * hemoglobin less than 9 g/dl. * total bilirubin greater than1.5 mg/dl. * ast/alt greater than 2.5 x upper limit of normal. * creatinine clearance less than or equal to 50 ml/min (calculated by the cockcroft gault formula). * known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.

Keywords: solid tumors dose limiting toxicity carboplatin tolerability safety