Kornimate/medical-research-clean huggingface dataset:
phase i study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the phoenix-01 trial

Conditions: Locally Advanced Pancreatic Cancer

Summary: the physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. the higher rbe of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in os. early data from japanese centers have shown convincing results. the phoenix-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.


Eligibility criteria:
inclusion criteria patients meeting all of the following criteria will be considered for admission to the trial: * histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated ca-19-9 * macroscopic tumor after biopsy * age ≥ 18 years of age * karnofsky performance score \>=60 * for women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.) * female participants: no pregnancy present (pregnancy test required) * ability of subject to understand character and individual consequences of the clinical trial * written informed consent (must be available before enrolment in the trial) exclusion criteria: patients presenting with any of the following criteria will not be included in the trial: * distant metastases * refusal of the patients to take part in the study * previous radiotherapy of the abdomen * patients who have not yet recovered from acute toxicities of prior therapies * known carcinoma \< 5 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * pregnant or lactating women * participation in another clinical study or observation period of competing trials, respectively
intraoperative hyperspectral imaging for fluorescence guided surgery in low grade gliomas

Conditions: Neurosurgery; Neuro-Oncology; Brain Tumor

Summary: the purpose of this study is to obtain images of brain tumours during surgery using a new type of surgical camera. the study will assess how the information obtained from the images during surgery matches the removed tissue. data will also be used to develop the system's key computer-processing features. this will enable real-time information to be given to the surgeon whilst they are performing the procedure and has the potential to make neurosurgery safer and more precise.

high grade gliomas (hgg) and low grade gliomas (lgg) are the commonest cns cancers, with lggs accounting for 6.4% of all adult cases (ostrom 2019). despite lggs typically being slow-growing, over 70% of them transform into higher-grade tumours or become aggressive within a decade (jooma 2019). median survival for lgg patients spans 5.6 to 13.3 years (brown 2019). gross total resection (gtr) improves 5-year lgg survival rates from 60% to 90% when compared to subtotal resection. however, gtr (\>96% tumour removal) is frequently not achieved because despite advanced techniques being available, surgeons are unable to clearly visualise the tumour and its boundaries in real-time during surgery. there is an acute need to improve outcomes for affected brain tumour patients. patients undergoing surgery have significantly improved outcomes and increased life expectancy if complete tumour removal is achieved. however, close to 30% of patients are left with residual tumour tissue after surgery. successful surgery indeed mandates maximal safe tumour removal: surgeons need to avoid damaging sensitive areas that undertake vital functions and preserve crucial nerves and blood vessels. even with the most advanced current techniques, it is not possible to always identify tumour and critical structures reliably during surgery. furthermore, because one cannot objectively measure the blood supply and oxygenation of brain tissue during surgery, it is difficult to judge if injury is being caused during the operation. to address the pressing clinical need of improved surgical precision and patient safety during low grade glioma surgery, we aim to develop an imaging system capable of quantitative wide-field fluorescence imaging for seamless real-time surgical guidance. this project aims to improve patient survival by delivering a precise assistive tool for neurosurgeons performing lgg surgery by evaluating this device in patients undergoing glioma surgery.

Eligibility criteria:
inclusion criteria: * adult patients aged 18 years and over * patients with a diagnosis of a probable glioma (any grade), who are scheduled for elective surgery * patients able to provide written informed consent exclusion criteria: * patients under 18 years of age * patients who have previously had brain surgery * patients unable to provide written informed consent
using vasopressor medication to support blood pressure during intubation procedure

Conditions: Respiratory Failure; Hypotension and Shock; Hypotension on Induction; Intubation Complication; Anesthesia Intubation Complication

Summary: the purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. the hypothesis is that use of vasopressors during rapid sequence intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

aim: prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.

Eligibility criteria:
inclusion criteria: * respiratory failure requiring intubation exclusion criteria: * pregnancy * patients intubated during code blue clinical scenarios * requiring surgical airway * failed intubations * map less than 65 or systolic blood pressure (sbp) less than 90mmhg pre-intubation * systolic blood pressure greater than 150mmhg * prisoners

Keywords: mean arterial pressure rapid sequence intubation vasopressor norepinephrine hypotension from intubation
role of ebus-tbna in diagnosing tb in mediastinal/hilar lymph nodes

Conditions: Tuberculosis

Summary: this is an observational prospective study. role of ebus-tbna (endobronchial ultrasound transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or hilar lymph nodes. the investigators analyse the specificity and sensibility of this technique to diagnose tuberculosis in mediastinal and/or hilar lymph nodes. patients with mediastinal and/or hilar lymph nodes on x-ray or ct thorax where a tuberculosis is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and without other lymph nodes that are more easily accessible or palpable will be included in this study.


Eligibility criteria:
inclusion criteria: * patients with enlarged mediastinal and/or hilar lymph nodes on chest ct highly suspicious of tuberculosis (suggestive clinical history, suggestive echographic findings ...) without pulmonary lesions suspicious for tuberculosis or in whom the first evaluation with sputum examination, classical bronchoscopy, induced sputum didn't result in any diagnosis. * patients aged 18 years or older * patients need to sign the consent form after reading the information form exclusion criteria: * synchronic pulmonary lesions suspicious for tuberculosis or already proven tuberculosis by microscopic exam, pcr-technique and/or culture * other affected ganglionary sites more easily accessible (cervical, supraclavicular, axillary ... region)

Keywords: mediastinal tuberculosis endoscopy ebus tuberculous lymphadenopathy endobronchial ultrasound
brain training system using electroencephalography (eeg) for neurorehabilitation of hand function after stroke

Conditions: Stroke

Summary: in this project we will design a control algorithm to identify the focalized motor-related clusters for hand function on each stroke patient. a real-time feedback will control the robotic hand when motor imagery is successfully identified. finally, the focalized bci-robot training will be compared in a randomized controlled trial to evaluate the training effectiveness and changes in the eeg patterns.


Eligibility criteria:
inclusion criteria: (1) sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (mini-mental state examination (mmse) score\>25) ; (2) subcortical location of the ischemic lesion within the territory of the middle cerebral artery; (3) have moderate to severe motor disability at the paretic upper limb (assessed by fugl-meyer assessment (fma), modified ashworth score of fingers (mas), and action research arm test (arat)) exclusion criteria: (1) severe hand spasticity, open hand wound or hand deformity; (2) visual field deficits; (3) aphasia, neglect, and apraxia.
delivery room cpap in extremely low birth weight infants

Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Bronchopulmonary Dysplasia; Continuous Positive Airway Pressure

Summary: this pilot study was designed to determine the feasibility of randomizing extremely low birth weight (elbw) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (cpap) or positive pressure ventilation (ppv) with positive end-expiratory pressure (peep), if the infant required ppv (the intervention group); or (b) 100% oxygen and no cpap and no peep if the infant required ppv (the control group).

previous studies suggested that early continuous airway positive pressure (cpap) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (bpd) in extremely low birth weight (elbw) infants. these studies did not test for the optimal timing of cpap initiation or compare cpap/peep initiation in the delivery room against standard resuscitation methods. current practice at the time was for the elbw infant to be intubated early and administered prophylactic surfactant. the feasibility of initiating cpap in the dr and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of elbw infants. this pilot study was designed to determine the feasibility of randomizing extremely low birth weight (elbw) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (cpap) or positive pressure ventilation (ppv) with positive end-expiratory pressure (peep), if the infant required ppv (the intervention group); or (b) 100% oxygen and no cpap and no peep if the infant required ppv (the control group).

Eligibility criteria:
inclusion criteria: * infants delivered in a specially equipped resuscitation room(s) * \<28 weeks gestational age by best obstetric estimate before delivery * requiring resuscitation exclusion criteria: * no known major congenital anomalies * decision made not to provide full resuscitation

Keywords: nichd neonatal research network extremely low birth weight (elbw) very low birth weight (vlbw) prematurity mechanical ventilation positive-pressure ventilation surfactant intubation pulse oximetry oxygen saturation
the clinical outcome of anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Rupture

Summary: retrospective cohort study. the investigators evaluated the early, middle and long term effects of different surgical methods of anterior cruciate ligament reconstruction on knee function. in the evaluation, the investigators focused on the differences between different age groups, different genders and different basic motor states, the differences between early reconstruction and non-early reconstruction, and the differences in clinical outcomes of different surgical methods.

age 13-65 included. only include isolated anterior cruciate ligament(acl) rupture. excluded revision surgery. excluded bilateral acl rupture. excluded the contralateral acl tear after surgery. 40 patients at least in each group.

Eligibility criteria:
inclusion criteria: diagnosis of isolated anterior cruciate ligament rupture exclusion criteria: combined other ligament damage combined intraarticular injuries

Keywords: anterior cruciate ligament reconstruction patient-reported outcome meniscus cartilage
fast identification of pathogen in the setting of pneumonia using multiplex pcr

Conditions: Acute Lower Respiratory Tract Infection; Pneumonia

Summary: with this study the investigators want to determine, if a fast identification of germs, causing infections of the lower respiratory tract, is possible through the use of multiplex pcr technology - a method that allows on time detection of bacteria in medical specimen by identifying dna sequences that are known to be specific for the respective microbe. therefore aspiration samples from the respiratory tracts of ventilated patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex pcr (polymerase chain reaction) application situated on the intensive care unit. the investigators want to determine if multiplex pcr diagnostic could be a faster alternative to conventional microbiological methods. the results of the multiplex pcr analyses therefore will be compared with results of conventional microbiological methods.

in this clinical observational study it is to be investigated if multiplex pcr analyses of clinical samples from ventilated critically ill patients could be a fast and accurate alternative to conventional microbiological diagnostic methods in the identification of human pathogenic microbes in the setting of pneumonia. therefore aspiration samples from intubated and ventilated critically ill patients, which are suspected to develop such an infection, will be collected and analyzed by using a multiplex pcr application situated on the intensive care unit. the samples will be investigated for dna sequences that are known to be specific for pneumonia causing microbes. analyses will take place in a point of care setting and will be carried out by intensive care physicians. according to the standard protocols of our intensive care units, conventional microbiological investigations, including maldi-tof, will be carried out parallel to the multiplex pcr analyses.

Eligibility criteria:
inclusion criteria: * clinical suspicion for an infection of the lower respiratory tract has been raised and decision for microbiological investigation of respiratory aspirate was made exclusion criteria: * patient has been recruited for a interventional clinical trial * suspicion for an infection with a germ belonging to risk class 3 and 4 according to the german law (biostoffv and trba, e.g. mycobacterium tuberculosis)

Keywords: multiplex pcr maldi-tof pneumonia microbiological investigation intensive care
efficacy and safety of al-4943a ophthalmic solution in patients with allergic conjunctivitis using the conjunctival allergen challenge (cac) model

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study was to assess the safety and efficacy of al-4943a ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge (cac) model.

this study consisted of 5 visits. eligible patients underwent allergy testing using the conjunctival allergen challenge (cac) model, which reproduces the signs and symptoms of seasonal allergic conjunctivitis by replicating the natural disease process. patients demonstrating a positive reaction to the cac at visit 1 (screening) and visit 2 (confirmatory) were randomized to treatment at visit 3 (day 0). the test article was instilled at visit 3, with treatment efficacy cac performed at 24 hours duration of action. the test article was instilled again at visit 4 (day 14), with treatment efficacy cac performed at 16 hours duration of action. the test article was instilled a final time at visit 5 (day 21), with treatment efficacy performed at onset of action.

Eligibility criteria:
inclusion criteria: * able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. * diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of visit 1. * history of seasonal or perennial allergic conjunctivitis for at least 1 year prior to visit 1. * positive bilateral cac response at visit 1 and visit 2. * willing to discontinue contact lens wear for at least 72 hours prior to visit 1 and throughout the study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known history or presence of persistent dry eye syndrome, or currently requiring frequent use (\> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of restasis®, or topical ocular corticosteroids for dryness of eyes. * presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes. * presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of visit 1. * presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the investigator is likely to advance/worsen during the time course of the study. * any contraindications or hypersensitivities to the use of the study medication or their components. * other protocol-defined exclusion criteria may apply.

Keywords: allergic conjunctivitis ocular allergy
accurate diagnosis of the invasion depth in escc by a deep neural network analysis of nbi endoscopy data

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. the main question it aims to answer is: • to get early accurate diagnosis of the invasion depth of esophageal squamous cell carcinoma by narrow-band imaging endoscopy data. participants' clinical informations from routine examinations and treatments will be collected, there will be no harm to participants.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, regardless of gender; 2. performing esophageal esd surgery due to esophageal mucosal lesions; 3. pathological evaluation of esd specimens. exclusion criteria: pathological examination after esd surgery ruled out esophageal squamous cell carcinoma.
cardiac brief intervention: a feasibility study to promote engagement with cardiac rehabilitation

Conditions: ST Elevation Myocardial Infarction

Summary: background: an st-elevation myocardial infarction (stemi) is a specific type of heart attack. in a previous study, patients requested more mental and emotional support after a stemi. to provide this support, the research team worked with hospital staff and patients to create a brief intervention called cabin (cardiac brief intervention), which involves a short discussion between a patient and a nurse, along with a leaflet that summarises the information discussed. aim: to test if the plan for giving cabin to patients after a stemi is suitable, and to explore what impact the intervention may have on mental and emotional well-being, along with knowledge about their condition. methods: forty patients who had a stemi will be recruited from two hospital centres in northern ireland (royal victoria hospital and ulster hospital). participants will be randomly put in a group who receive the full cabin intervention or a group who receive a shortened version of cabin. both groups will receive their respective interventions before leaving the hospital, which will take about twenty minutes. participants will be asked to complete brief questionnaires before the intervention, after the intervention, 3-4 weeks from diagnosis, and 14 weeks from diagnosis. at the end of the study, patients who took part and staff from the hospitals will be asked to complete an exit interview (patients) or a focus group (staff), which will provide information about their experience of the study / intervention and changes required. outcome of study: if the study is suitable for patients and appropriate for staff to deliver, the research team will examine the effectiveness of cabin in a larger study, which may lead to the intervention being used in clinical practice to improve cardiac rehabilitation uptake and outcomes for patients after a stemi.


Eligibility criteria:
inclusion criteria: * aged 18 years and over. * confirmed diagnosis of stemi. * physically and mentally capable of participation (judged by cardiologist or nurse). * willing to provide informed consent. exclusion criteria: * lacking capacity to give consent (judged by cardiologist or nurse). * under the age of 18 years.