Kornimate/medical-research-clean huggingface dataset:
observational study of bevacizumab [avastin] in patients with metastatic colorectal cancer (avastart)

Conditions: Colorectal Cancer

Summary: this observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab \[avastin\] treatment in patients with metastatic colorectal cancer. data will be collected for approximately 34 months. the target sample size is \>300 patients.


Eligibility criteria:
inclusion criteria: * adult patients =/\<18 years of age * metastatic colorectal cancer * patients for whom the physician has prescribed bevacizumab \[avastin\] for the treatment of 1st line metastatic colorectal cancer * patients, who have given written informed consent exclusion criteria: * hypersensitivity to recombinant human or humanised antibodies * pregnancy or breast-feeding
treatment of recurrent gbm with apg-157 via expanded access

Conditions: Glioblastoma; Glioblastoma Multiforme

Summary: this expanded access request will evaluate apg-157, a botanical drug under development for other cancers, as potential treatment for recurrent glioblastoma multiforme (gbm) patients.

glioblastoma patients with disease recurrence after primary, currently approved primary treatments have limited options. therefore, this expanded access trial is designed to test a new therapeutic option for these patients. patients who have progressed on a combination of both temozolomide and tumor treating field (optune) or as single treatment temozolomide (tmz) or tumor treating fields (optune) are eligible to receive apg-157. during apg-157 dosing, tmz or optune may be concurrently given at the decision of the principal investigator. apg-157 will be given until disease progression or intolerance by the patient. radiation followed by adjuvant temozolomide for 6 to 12 months which is a current standard of care (soc). upon progression of this disease after soc treatment, there are very limited further options for these patients. this expanded access administration will evaluate the potential of apg-157, a novel drug under development for head and neck cancer, as a potential treatment for these recurrent glioblastoma patients. brief description of objectives: * improve six-month progression-free survival (pfs) and overall survival (os) of the patients eligible for the treatment under expanded access protocol. * improvement in quality of life * achievements of above two objectives without any serious adverse events (saes) and adverse drug-drug interactions. brief description of plans for efficacy assessment: * improvement in quality of life * efficacy will be assessed using imaging (objective tumor response using response assessment in neuro-oncology criteria (rano), hematological assessment, and tolerance.

Eligibility criteria:
inclusion criteria: * this study will enroll patients with histologically confirmed glioblastoma (gbm). * patients must have received prior treatment with standard first-line therapy for gbm, including maximal surgical resection and postoperative external-beam radiotherapy or tumor treating fields (optune). concurrent chemoradiation with tmz or tumor treating field (optune) is allowed but not mandatory. * patients are eligible for enrollment only if they have unequivocal evidence of tumor recurrence/progression by mri a minimum of 12 weeks following completion of radiation therapy or tmz-radiotherapy or optune. patients who have received prior bevacizumab or other anti-vascular endothelial growth factor(anti-vegf) agents are not eligible to enroll. * baseline mri should be performed within 28 days prior to enrollment. * other key inclusion criteria include eastern cooperative oncology group (ecog) status of 0-1 (kps ≥ 70%) and adequate bone marrow, hepatic, and renal function at baseline. exclusion criteria: * patients with severe neutropenia

Keywords: temozolomide tumor treating field optune progression
study of abt-263 when administered in combination with either fludarabine/cyclophosphamide/rituximab or bendamustine/rituximab in relapsed or refractory chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a phase 1 study evaluating the safety of abt-263 administered in combination with either fcr or br in subjects with relapsed or refractory chronic lymphocytic leukemia.


Eligibility criteria:
inclusion criteria: * must have relapsed or refractory chronic lymphocytic leukemia (cll), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either fludarabine/cyclophosphamide/rituximab (fcr) or bendamustine/rituximab (br); * subject has an eastern cooperative oncology group (ecog) performance score of \</=1; * must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease \[80% or more\] who may use growth factor support to achieve absolute neutrophil count (anc) eligibility criteria), per local laboratory reference range at screening as follows: anc \>/=1000/mcl, platelets\>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of screening),hemoglobin \>/= 9.0 g/dl. exclusion criteria: * subject has history or is clinically suspicious for cancer-related central nervous system disease; * has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies; * has undergone an allogeneic stem cell transplant; exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration; * has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding; * currently receiving or requires anticoagulation therapy; * has active immune thrombocytopenic purpura (itp) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug); * has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
ce-ious impact on surgical strategy of liver tumours and liver metastases

Conditions: Liver Neoplasms; Liver/Hepatobiliary Cancer; Colorectal Cancer Metastatic; Metastases; Surgery; Ultrasound

Summary: contrast-enhanced intraoperative ultrasound (ce-ious) plays an increasingly important role in the surgical therapy planning of primary liver lesions as well as liver metastases. the present study was designed to evaluate the significance of ce-ious by specificity and sensitivity and particularly the impact it exerts on the surgical strategy. a secondary aim was assessing the outcome relevance of surgeries influenced by ce-ious.

ce-ious has been used during hepatobiliary surgery for almost 25 years. during this time, it has proven to be an excellent diagnostic tool for detecting and characterising previously unknown lesions. it is still unclear to what extent the findings of this imaging modality impacts the strategy of such operations. the currently planned study is intended to evaluate the impact of contrast-enhanced intraoperative ultrasound on the surgical procedure in hepatic surgery. for this purpose, patient data of the time period between 2017 and 2019 was prospectively analysed. another aim of the study was to measure the outcome relevance of ce-ious. this assessment was carried out by comparing an intervention cohort with a control cohort. the control cohort consisted of patients that were operated due similar liver lesions as the intervention cohort however did not receive ce-ious during the operation. aspects like the recurrence free time and overall survival rate of the two cohorts were compared together with the patients' characteristics of the groups themselves.

Eligibility criteria:
inclusion criteria: * operations during study period from 01/2017 until 12/2019 * elective liver surgery in the department of surgery at the university hospital regensburg * liver resections due to primary hepatic tumours (benign, malignant) or hepatic metastases * liver surgery with intraoperative use of ce-ious exclusion criteria: * intraoperative use of ce-ious outside the department of surgery * liver transplantations * use of ce-ious only for exclusion of hepatic metastasis

Keywords: ce-ious ious
intraprocedural intraaortic embolic protection with the embolx device in patients undergoing transaortic transcatheter aortic valve implantation

Conditions: Transaortic Transcatheter Aortic Valve Implantation

Summary: study hypothesis: reduction of cerebral embolic lesions during transcatheter aortic valve implantation by the use of an embolic protection device.


Eligibility criteria:
inclusion criteria: patients with symptomatic severe aortic valve stenosis (valve area \<0.8 cm2) are considered candidates for tavi (tavr) if they have a logistic european system for cardiac operative risk evaluation score (euroscore) ≥15% or surgery is deemed to be at excessive risk because of comorbidities and other risk factors not being captured by these scoring systems. indication for tavi in the individual patient is discussed in a consensus conference of cardiologists and cardiac surgeons, and patient's or physician's preference alone is not considered adequate for decision making. the performance of tavi in these patients is approved by the local authorities. all patients have to agree to participate in the study, and written informed consent is obtained. exclusion criteria: patients are excluded from tavi (tavr) in the presence of any of the following conditions: * bicuspid aortic valve * aortic annulus diameter ≤18 or ≥27 mm * procelain aorta * unprotected left main disease * recent myocardial infarction or cerebrovascular event * sepsis or active endocarditis * severe aortic atheroma * left ventricular or atrial thrombus * active peptic ulcer * bleeding diathesis * hypersensitivity to antiplatelet therapy

Keywords: transaortic tavi or tavr embolic protection device embolx efficacy during transaortic tavi reduce the incidence of new foci of restricted diffusion on diffusion-weighted mri
post-lesion administration of dexamethasone to prevent the development of neuritis after radiofrequency ablation

Conditions: Neuritis; Radiofrequency Ablation

Summary: chronic neck and back pain has become one of the leading causes of disability and loss of productivity. for many patients with facet or sacroiliac joint mediated pain who have responded to diagnostic nerve blocks, radiofrequency ablation of the nerves innervating the joints can provide long term relief. radiofrequency ablation (rfa) is a relatively safe procedure with minimal risk of adverse events. however, with any procedure involving damage to the peripheral nervous system, there is risk of post-procedure neuropathic pain. the investigators will test the hypothesis that dexamethasone injection delivered at the time of lesion effectively prevents the development of post-ablation neuritis through a placebo-controlled, double-blind, randomized trial in patients undergoing cervical, thoracic, lumbar, and sacroiliac joint radiofrequency denervations


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of either cervical, thoracic, or lumbar facet or sacroiliac joint pain who have responded to medial branch blocks and are already scheduled for bilateral radiofrequency ablations * age greater than 18 years old * english speaking exclusion criteria: * patient not previously scheduled for radiofrequency ablation of the cervical, thoracic, or lumbar facets, or sacroiliac joints * on anticoagulation * have a pacemaker * age less than 18 years old * non-english speaking
effects of peep on intracranial and intraocular pressure in robot-assisted laparoscopic radical prostatectomy

Conditions: Prostate Cancer

Summary: to investigate the effects of positive end-expiratory pressure (peep) on the intracerebral pressure (icp) and intraocular pressure (iop) in patients undergoing robot assisted laparoscopic radical prostatectomy (ralrp)

application of peepmay reduce pulmonary complication following ralrp. meanwhile, it may increase icp and iop, which has been debated for decades. moreover, trendelenburg position and pneumoperitoneum, which are mandatory for ralrp, may augment elevation of icp and iop. this study aims to investigate the effects of peep on the icp and iop in patients undergoing ralrp.

Eligibility criteria:
inclusion criteria: * patients undergoing robotic-assisted laparoscopic radical prostatectomy exclusion criteria: * history of opthalmic disease or surgery * history of brain disease or surgery * known icp elevation * known iop elevation * presence of lung bullae on chest x-ray * history of pneumothorax

Keywords: intraocular pressure intracerebral pressure
risk factors of complications regarding patients undergoing brain tumour neuro-surgery (cranioscore).

Conditions: Neuro-surgery; Brain Tumor; Post-operative Complications; Neuro-ICU Stay

Summary: patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. there are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (neuro-icu, icu,surgical ward). determining risk factors of post-operative complications could optimise resources. therefore hospitalisation in neuro-icu would be mandatory in only a little number of patients.

retrospective analysis of a prospective database to create a risk score. post-operative neurosurgery complications recording (hyponatremia \< 135mmol/l,insulin administration, nausea-vomiting, glasgow coma score, inhalation, post-operative intra-cranial bleeding requiring neurosurgery, intra-cranial hypertension, use of osmotherapy, status epilepticus, brain death, death). collection of datas as duration of mechanical ventilation, length of icu stay, length of hospital stay. validation of this score on an independent prospective cohort.

Eligibility criteria:
inclusion criteria: * patients undergoing neuro-surgery for a brain tumor exclusion criteria: * neuro-surgical emergency

Keywords: neuro-surgery post-operative complications neuro-icu resources
effects of neuromodulation and cognitive training for suicide in veterans (enacts)

Conditions: Suicide; Impulsivity

Summary: impaired executive function, such as impaired decision making and impulsivity, has been identified as an important contributor to the transition from suicidal ideation to suicide attempt. to address the epidemic of veteran suicide in the united states, this study tests the feasibility, acceptability, and preliminary effectiveness of a five day transcranial direct current stimulation (tdcs) augmented executive functioning training intervention. this intervention is delivered to high suicide risk inpatients. the ultimate goal is to reduce future suicide events (ideation, attempts, deaths) and improve quality of life (e.g. social relationships, health resource utilization).


Eligibility criteria:
inclusion criteria: * currently admitted into the mvahcs inpatient psychiatric unit * at a heightened risk for suicide (defined as a positive screen on the va comprehensive suicide risk evaluation (csre) at intake and/or a suicide attempt within the previous 12 months) * able to complete procedures and tasks exclusion criteria: * are unable to provide informed consent as determined by the modified dysken tool * have moderate/severe cognitive impairment as determined by the mini-mental state examination (score 27) * have contraindications for tdcs (history of seizures, metallic cranial plates/screws or implanted device, history of eczema on scalp) * do not have a smartphone or device running android or apple ios with which to download the mpro ema app * have been involuntarily committed

Keywords: suicide impulsive behavior
study to evaluate reactogenicity and immunogenicity of revaccination with adjuvanted influenza vaccine in elderly

Conditions: Influenza

Summary: since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of adjuvanted influenza vaccine need to be re-evaluated after repeated vaccine administration. in this study, subjects previously vaccinated with fluarix or the influenza adjuvanted vaccine, will receive a booster dose with the 2006-2007 season's formulations of either fluarix or the adjuvanted vaccine.


Eligibility criteria:
inclusion criteria: * the subjects must be healthy elderly \>/= 67 years and previously vaccinated with fluarix or the adjuvanted vaccine. exclusion criteria: * subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immunemodifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination, have a history of influenza infection since previous vaccination, or if subjects have acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination

Keywords: influenza improved vaccine elderly
italian absorb registry

Conditions: Coronary Artery Disease

Summary: the investigators aim at evaluating the long-term (5-year) clinical outcome following absorb bvs implantation in a real world, all-comers population of consecutive patients, as treated according to the indications, techniques and protocols used in the participating institutions.

long-term data after implantation of coronary bvs is scarce, especially in subgroups of patients with diabetes or chronic kidney disease, and in those with complex coronary lesions and/or multivessel disease. although the use of bvs is very promising in younger patients with one or more of the above characteristics, evidence of benefit is not available. the bvs-rai registry is a spontaneous initiative of a group of italian interventional cardiologists who are interested in assessing the results of their interventional practice with bvs, by sharing data. the bvs-rai registry has been created in joint-venture with centro di ricerche farmacologiche e biomediche "mario negri sud", and is not recipient of funding or benefits originating from the bvs manufacturer or seller. bvs devices are regularly purchased by the participating centres. each participating centre is willing to input data of all consecutive patients treated with bvs, with a minimum of 50, and to report on follow-up for at least 5 years. patient recruitment is not directed per protocol, nor is it rewarded. patients who give informed consent are included in the bvs-rai registry after bvs implant has been performed following the indications, techniques and protocols used in each of the participating institutions. baseline patient clinical data, with special attention to biochemistry and drug treatment in patients with diabetes and ckd, as well as angiographic and intravascular imaging data are entered into a web-based case report form. follow-up data from outpatient visits or phone interviews, subsequent admissions and coronary angiograms following the protocols being used in each of the participating institutions are prospectively collected and entered into the database. all data in the crf is visible to all registered participants at all times. endpoints are: target lesion and target vessel failure, bvs thrombosis, new revascularisation, myocardial infarction and death. documentation of those events is required for adjudication by an independent committee.

Eligibility criteria:
inclusion criteria: * successful implantation of 1 or more coronary bvs * age \<75 years * patient's informed consent exclusion criteria: * none
diagnostic role of serum testican and ubiquitin levels in patients with head trauma

Conditions: Moderate Traumatic Brain Injury; Testican-1; Ubiquitin

Summary: we aimed to determine if testican-1 and ubiquitin can serve as early indicators for diagnosing worsening clinical course (presence of intraparenchymal pathology) and mortality in patients with moderate traumatic brain injury.

the study specifically included patients over 18 years of age with moderate tbi (gcs: 9-13) who provided informed consent. the control group consisted of healthy individuals without any disease who voluntarily participated in the study. patients with moderate tbi were divided into two groups: those with intracranial pathology (subdural hemorrhage, epidural hemorrhage, subarachnoid hemorrhage, intraparenchymal hemorrhage, and contusion) and those without. treatment was initiated according to atls in patients with moderate tbi, and blood samples taken at the time of admission to the emergency department were placed in ethylenediaminetetraacetic acid (edta) tubes. the relationship between the patient's clinical scoring (gcs, iss and ais), brain ct results, and mortality status with testican-1 and ubiquitin levels was compared.

Eligibility criteria:
inclusion criteria: * being over 18 years old * having a gcs score between 9 and 13 exclusion criteria: * under 18 years of age * had missing data * were pregnant * had neurodegenerative disease * had central nervous system (cns) infection * had cerebral palsy * had penetrating head injury (by a cutting or piercing tool such as a firearm, knife, axe) * patients with severe (gcs: 3-8) or mild (gcs: 14-15) tbi