Kornimate/medical-research-clean huggingface dataset:
ocular allergy treatment practical impact trial

Conditions: Allergic Conjunctivitis; Rhinoconjunctivitis

Summary: to study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.

to assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(lastacaft™)

Eligibility criteria:
inclusion criteria: 1. patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens 2. total ocular symptom score (toss) on the day of enrollment of 4 or more. 3. have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment. 4. are willing/able to follow instructions from the study investigator and his/her study staff. 5. have signed infromed consent approved by institutional review board or independent ethics committee. - exclusion criteria: 1. active ocular infection; 2. history of retinal detachment, diabetic neuropathy, or any progressive retinal disease; 3. ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study. 4. history of unstable, or uncontrolled disease of any nature. 5. pregnancy or lactation; 6. have a known hypersensitivity tp lastacaft™ (alcaftadine) -
a study of ql1706 in combination with bevacizumab and/or chemotherapy as first-line treatment in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to assess the efficacy and safety of ql1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: 1. subjects participate voluntarily and sign informed consent. 2. age ≥ 18 and ≤ 80 years old, male or female. 3. histological or cytological or clinical diagnosis of hcc 4. barcelona clinic liver cancer stage c. bclc stage b, not suitable for radical surgery and/or local treatment. 5. no prior systemic therapy for hcc. 6. child-pugh ≤7 , no history of hepatic encephalopathy. exclusion criteria: 1. histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc. 2. history of malignancy other than hcc within 5 years prior to the start of study treatment. 3. history of liver transplantation, or planned to receive liver transplantation. 4. moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion. 5. has known active central nervous system (cns) metastases and/or carcinomatous meningitis. 6. involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.
glivec/gleevec pediatric (age 1 to less than 4) pk study in cml, ph+ all patients and other glivec/gleevec® indicated hematological disorders.

Conditions: Chronic Myeloid Leukemia (CML); Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL); Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)

Summary: this study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens


Eligibility criteria:
inclusion criteria: 1. patients must be 1 to less than 4 years of age at study entry 2. written informed consent must be signed by the patient's parent or legal guardian. 3. patients must have the diagnosis of cml or ph+ all 4. lansky score must be ≥ 50 (table7-2) 5. patient must have adequate end organ function as defined by * total bilirubin \< 1.5 x uln * sgpt (alt) and sgot (ast) \< 2.5 x unl * creatinine \< 1.5 x uln exclusion criteria: 1. patients who have received drugs a) known to be metabolized by cyp3a4 or 3a5, b) are cyp inhibitors and inducers, within 2 weeks prior to visit 2 (except for imatinib) 2. patients who previously received radiotherapy to ≥ 25% of the bone marrow, with the exception of patients who received total body radiation as part of a preparatory regimen for hematopoetic stem cell transplant (hsct) 3. patients receiving antibacterial and antipyretic medication to treat active infection 4. patients with international normalized ratio (inr) or partial thromboplastin time (ptt) \> 1.5 x uln, with the exception of patients on treatment with oral anticoagulants 5. patients whose parents or legal guardians, in the opinion of the investigator, were unlikely to comply with the protocol or safety monitoring requirements other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic myeloid leukemia cml philadelphia chromosome positive acute lymphoblastic leukemia phglivec, gleevec, hypereosinophilic syndrome, hes, chronic eosinophilic leukemia, cel, myelodysplastic syndrome, mds, myeloproliferative disease, mpd+ all
primary percutaneous pericardiotomy for malignant pericardial effusion (pmap)

Conditions: Pericardial Effusion Malignant

Summary: pericardial effusion is a common complication in patients with metastatic malignancy. while pericardiocentesis provide effective relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial effusion after pericardiocentesis is common. we hypothesize that percutaneous balloon pericardiotomy in addition to standard pericardiocentesis with prolonged drainage can prevent pericardial effusion recurrence in patients with malignant pericardial effusion.

pericardial effusion is a common complication in patients with metastatic malignancy with an incidence as high as 21%. the occurrence of malignant pericardial effusion significantly impacts on patient's survival and quality of life. while pericardiocentesis provide effective relieve from life-threatening situation such as cardiac tamponade, recurrence of pericardial effusion after pericardiocentesis is common and occurs in as high as 31% of patients. retrospective data has shown that prolonged pericardial drainage might reduce the recurrence rate but at the cost of increased risk of infection and prolonged hospital stay. surgical pericardiotomy was used in the past but was not shown to reduce recurrence over prolonged pericardial drainage and is associated with a higher rate of complications. surgical pericardial window creation via a mini-thoracotomy might be an effective treatment and can be considered in patient with pericardial tamponade. the safety and feasibility of percutaneous balloon pericardiotomy (pbp) has been first described 1993 and has been shown to be an alternative treatment for patient with malignant pericardial effusion. however, no data is available on the efficacy of pbp in reducing the recurrence of pericardial effusion, in comparison with standard pericardiocentesis with prolonged drainage. we aim to perform a single centre, randomized, prospective, open label controlled pragmatic trial to compare percutaneous balloon pericardiotomy (treatment) to standard pericardiocentesis with prolonged drainage (control) in preventing pericardial effusion recurrence in patients with malignant pericardial effusion.

Eligibility criteria:
inclusion criteria: * patients with confirmed active malignancy and, * presence of at least moderate (\>10cm) pericardial effusion on ct or echocardiography exclusion criteria: * patients unable to give an informed consent, * previous history of open-heart surgery * previous history of pericardial window or pericardial instillation of sclerosing therapy. * scheduled thoracic or cardiac surgery within the next 3 months * patients with contraindications for endovascular procedure such as disseminated intravascular coagulopathy or significant ongoing bleeding tendency, and systemic septicaemia. * patient with small or loculated pericardial effusion that is not accessible by subxiphoid approach.

Keywords: pericardial effusion, malignancy, pericardiotomy.
adherence and coagulation assays in dabigatran-treated patients with atrial fibrillation

Conditions: Atrial Fibrillation; Medication Adherence; Blood Coagulation Tests; Anticoagulants; Circulating, Hemorrhagic Disorder; Drug Effect; Drug Use; Drug Toxicity; Drug Intolerance; Blood Clot; Blood Coagulation Disorder; Laboratory Problem; Bleeding; Thrombosis

Summary: in patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the danish national prescription registry and pillcount and will be related to plasma levels of dabigatran measured by liquid chromatography tandem mass spectrometry (lc-ms/ms) and coagulation assays. the aim of the study is to measure the level of adherence and evaluate the usefulness of different coagulation assays to measure adherence in these patients. furthermore, the aim is to determine the correlation between the anticoagulant effect of dabigatran using different coagulation assays and plasma levels of dabigatran. most studies so far have been performed in vitro with plasma samples spiked with dabigatran. in this study the present knowledge from results of coagulation assays in dabigatran spiked plasma samples will be compared to the results of coagulation assays using blood samples from real-life patients.


Eligibility criteria:
inclusion criteria: * age 18 years or older * non-valvular atrial fibrillation * indication for dabigatran etexilate exclusion criteria: * use of anticoagulant medication within the last month * contra-indication to dabigatran etexilate * unable or not wishing to give informed consent
treatment of ipf with laparoscopic anti-reflux surgery

Conditions: Idiopathic Pulmonary Fibrosis; Gastroesophageal Reflux

Summary: this study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (ipf) and abnormal gastroesophageal reflux (ger) will slow the decline of forced vital capacity (fvc) over 48 weeks.

this protocol proposes to test the following hypothesis: treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (ipf) and abnormal gastroesophageal (ger) reflux will slow the decline of forced vital capacity (fvc) over 48 weeks. this study will randomize approximately 58 subjects with ipf and abnormal acid reflux on 24-hour impedance / ph monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). subjects will be followed for 48 weeks or until the time of lung transplantation or death. we aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in fvc over 48 weeks in patients with ipf and abnormal ger; correlate the reduction in acid and non-acid reflux events with the change in fvc over 48 weeks in patients with ipf and abnormal ger; determine the safety of laparoscopic anti-reflux surgery in patients with ipf and abnormal ger; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with ipf and abnormal ger; identify molecular markers of ipf disease activity and gastroesophageal reflux in biological samples from patients with ipf and abnormal ger.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of idiopathic pulmonary fibrosis * abnormal ger on 24-hour ph monitoring (demeester score \> 14.7) * able to provide informed consent * willing to undergo laparoscopic anti-reflux surgery exclusion criteria: * fvc \< 50% predicted * fev1/fvc ratio \< 0.65 * resting room air pao2 \< 60mm hg * unable to walk 50 meters on 6 minute walk test * acute respiratory illness in last 12 weeks * experimental medication for ipf in last 28 days * listed for lung transplantation at screening * unable to safely undergo surgery * history of esophageal / bariatric / gastric surgery * history of cancer (other than non-melanoma skin cancer) in last 3 years * pregnant at time of screening or enrollment * unable to obtain pre-authorized approval from a third party payer for surgery and related costs * life expectancy \< 48 weeks due to another illness * bmi \> 35 * known severe pulmonary hypertension (mean pressure \> 35 mm jg on rhc; rvsp \> 50 mm hg on echo)

Keywords: idiopathic pulmonary fibrosis ipf gastroesophageal reflux ger gerd
scar tissue analysis after intraoperative application of stromal vascular fraction cells into suture line

Conditions: Wound Heal; Scar; Hypertrophic Scar; Delayed Wound Healing

Summary: the study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.

patients undergoing primary or secondary deep inferior epigastric perforator (diep) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study. after bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the diep flap donor site. the other site of diep flap donor site (most lateral 5 cm) will serve as a control. part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. ten months after diep flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. at that time photographs will be taken and scars will be analysed by patient and observer assesment scale (posas).

Eligibility criteria:
inclusion criteria: * breast cancer patients scheduled for primary or secondary diep flap breast reconstruction exclusion criteria: * bmi * age * immunosuppressive disease
rivastigmine for the prevention of postoperative delirium in patients undergoing cardiac surgery

Conditions: Delirium

Summary: the purpose of this study is to determine whether rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.

postoperative delirium is a frequent complication after cardiac surgery. in the literature an incidence ranging from 0 - 72 % is reported. the aetiology of this complication is multifactorial. a decline in cerebral cholinergic transmission as well as perioperative cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal circulation have been suspected. advanced age is the most important patient-related risk factor. a perioperative delirium is an extremely unpleasant experience for the affected patients. equally important is the fact that a delirium is associated with a prolonged length of stay on the intensive care unit and in hospital. furthermore, patients who develop delirium have an increased six-month mortality. recently successful treatment and prevention of the delirium with cholinesterase inhibitors such as rivastigmine have been reported. the proposed study will test the hypothesis that prophylactically administered rivastigmine is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly patients undergoing elective cardiac surgery with extracorporeal circulation. this study is designed as a double blind randomised placebo controlled trial. half the patients will receive placebo. the other half will receive rivastigmine 1.5m-1.5mg-1.5mg (oral solution), starting on the evening preceding the operation and for the first seven days postoperatively. patients in both groups who develop delirium will be treated with a rescue medication consisting of lorazepam and haloperidol. measurements will include the incidence of delirium assessed using the confusion assessment method (cam). the severity of symptoms will by characterised by the mini mental score and clock drawing. further measurements will include the prescribed doses of rescue medication, the length of stay on intensive care and in hospital, the time of extracorporeal circulation, and laboratory parameters such as crp, albumin, lymphocyte count, vitamin b12 and folic acid levels. side effects of rivastigmine will be quantified. the primary endpoint of this study is the incidence of delirium. secondary endpoints will be the severity of delirium, the used doses of rescue medication, and length of stay (intensive care and hospital).

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery with use of extracorporeal circulation * aged 65 or more exclusion criteria: * "redo" procedures * anticipated use of succinylcholine during operation * contraindications to rivastigmine * preoperative mini mental score \< 15
a post-marketing observational study of the use of zonisamide (zns) in the adjunctive treatment of adult patients with partial onset seizures (study e2090-e044-410) (zoom)

Conditions: Partial Onset Seizures

Summary: this is a non-interventional prospective study. centres will enroll adult patients with partial onset seizures for whom the clinician has decided to initiate zns as an adjunctive therapy prior to the decision to take part in this study. patients to be enrolled into the study are not sufficiently controlled with one dug licensed for the use of monotherapy in partial onset seizures. patients will be seen at baseline and then during normal clinical visits at intervals which are appropriate to the typical practice of the treating clinician. patients will be assessed at baseline and then at least 3 and 6 months after the baseline.

open-label, multi-centre, multi-national post-marketing, non-interventional observational study

Eligibility criteria:
inclusion criteria: * the decision to prescribe zns was made by the physician before and independently of his/her decision to include the patient in the study * patients treated with one drug licensed for the use as monotherapy in partial onset seizures * based on the physician's clinical judgment, the patient seizure activity is not controlled sufficiently with the current monotherapy and it is in the patient's best interest to be prescribed adjunctive zns * patient was prescribed zns no longer than 2 weeks before baseline * treatment with zns has to be commenced in line with the drug's license and zns smpc (summary of product characteristics) * aged 18 years or older * capable of understanding the purpose of the study, fully informed and having given written informed consent. exclusion criteria: * patients that have started zns outside the approved smpc at enrolment * simultaneous participation in an interventional clinical trial and/or taking an investigational drug * any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.

Keywords: zns aed partial onset seizures retention rate seizure control antiepileptic secondary generalization seizure freedom rates
referral guidelines for imaging exams: impact on exam relevance and associated delays

Conditions: Emergency Department Admission; Imaging Techniques

Summary: the main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. the latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.

the secondary objectives of this study are to assess the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on the following: a. how exam results are classified in relation to the initial, suspected diagnosis. b. further aspects of exam relevance. c. delays associated with exams d. changes in practice in terms of type of examination, clinical situations, the number of tests ordered per patient, and emergency situations e. radiation and contrast agent exposures

Eligibility criteria:
inclusion criteria: * the patient (or his/her guardian/parent/person-of-trust) was correctly informed about the study * a participating er doctor has requested an imaging exam for the patient during one of the trial observation periods (ie the "before" period or the "after" period). exclusion criteria: * the patient is under judicial protection * the patient (or his/her guardian/parent/person-of-trust) refuses to participate in the study

Keywords: guidelines referral guidelines exam delays exam relevance
expression of anxa2 in the extracellular space in the microenvironment of periumoral edema promotes glioma invasion

Conditions: Glioma

Summary: the prognostic value of anxa2 expression in tumor tissue and ptbe was analyzed, so as to seek new therapies to inhibit glioma invasion and improve the prognosis of glioma patients

the main reason for the poor prognosis of glioma is the invasion of tumor cells along the extracellular space (ecs) in the periatumoral edema zone (ptbe).previous studies have shown that anxa2 is highly expressed in glioma and promotes tumor growth and invasion, while its expression in the ptbe microenvironment of glioma and its mechanism of action on tumor invasion have not been reported.previous study found that anxa2 was overexpressed in gliomas and was associated with poor prognosis, and the low expression of anxa2 significantly inhibited tumor invasion in vitro.relevant studies have also confirmed that as an exocrine protein, it mainly plays a role in ecs, and it has previously been carried out on the tissue structure of ecs in tumor microenvironment.therefore, investigators planned to study the mechanism of anxa2 expression in ptbe microenvironment ecs on tumor invasion.this project aims to take glioma related issues as the research object and analyze tumor tissue and tumor tissue

Eligibility criteria:
inclusion criteria: * patients who have undergone microneurosurgical resection of the tumor in our hospital and are pathologically confirmed to be supratentorial glioma; * preserving the remaining tissue samples of paired gliomas and ptbe for pathological examination; * the patients agreed to be enrolled and signed the informed consent; * the clinical data of the patients are complete and not lost; * no serious complications occurred after surgery. exclusion criteria: * all glioma patients who did not meet the inclusion criteria

Keywords: glioma anxa2 expression periatumoral edema zone