Kornimate/medical-research-clean huggingface dataset:
an evaluation of dose-escalation for intrathoracic tumours

Conditions: Lung Cancers

Summary: this is a pragmatic trial with patients randomized between standard of care palliative thoracic radiation therapy (rt) vs. hypofractionated, dose-escalated, esophageal-sparing (hd-es) intensity modulated radiation therapy (imrt). the investigators hypothesize that the use of advanced radiation planning techniques to optimize dose to esophagus will permit the safe delivery of a modestly dose-escalated five-fraction course of palliative radiation to intrathoracic malignancies. this approach aims to deliver higher biologically effective doses while improving toxicity when compared to conventional approaches with the goal of prolonging high-quality overall survival.


Eligibility criteria:
inclusion criteria: * intrathoracic tumour requiring palliative radiation, either for palliation of symptoms or prevention of progression that is expected to cause symptoms in the next 6 months (in the judgement of the enrolling investigator) * willingness and ability to provide informed consent * eastern cooperative oncology group performance status 0-3 * age 18 years or older * prior or planned systemic treatment (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist * concurrent palliative radiotherapy to other metastatic sites is permissible at the discretion of the treating radiation oncologist. * life expectancy greater than 3 months exclusion criteria: * prior thoracic radiotherapy which, in the opinion of the treating of radiation oncologist, precludes the delivery of further thoracic radiotherapy. if there has been prior thoracic radiotherapy, a composite of all rt plans must be created, and the dose constraints herein must still be met. an allowance for 10 percent repair is permitted if at least 12 months have passed between the prior radiotherapy and the trial protocol specified radiotherapy. * serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of radiotherapy. this includes interstitial lung disease. * pregnant or lactating women * inability to attend the full course of radiotherapy or planned follow-up visits

Keywords: lung cancer radiation therapy hypofractionated esophageal-sparing dose-escalated intrathoracic
focused research on neurofeedback therapy in eradicating depression (frontier)

Conditions: Depression

Summary: this is an exploratory study to test the efficacy of a novel eeg neurofeedback method in depressed patients. the investigators will measure the change in depressive symptoms before and after the intervention of the novel eeg neurofeedback method using the depression rating scale (primary endpoint). in addition, the investigators will measure the changes in brain activity before and after the intervention using fmri, and compare the changes in depressive symptoms over the treatment period (secondary endpoint).


Eligibility criteria:
inclusion criteria: * 1. adults (at least 18 years old at the time consent is obtained) * 2. major depressive episode as defined by the diagnostic criteria of the dsm 5 * 3. one of the following 1. hamilton depression rating score (hdrs 17) of 19 or higher 2. montgomery asberg depression rating scale score of 20 or higher 3. any other patient deemed appropriate by the pi (subprincipal investigator) * 4. with respect to taking antidepressants, any of the following 1. not taking antidepressants 2. if taking antidepressants, willingness to continue them for the duration of the program. * 5. if receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation * 6. have treated by a psychiatrist * 7. written informed consent * 8. no planned change in employment status after the study begins exclusion criteria: * 1. high risk of suicide, such as suicidal ideation or suicide attempts * 2. history of hospitalization for depression or suicidal behavior * 3. comorbid addictions (drugs, alcohol) or history of addictions * 4. organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease) * 5. history of seizures or epilepsy * 6. has a serious or unstable physical disease * 7. difficulty or inappropriateness/contraindication to mri imaging * 8. pregnant women or unwilling to practice contraception during the study * 9. participating in another clinical trial at the same time, or have participated in a clinical trial within the past 90 days, or are scheduled to participate in another clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial may interfere with the results of this study * 10. other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.
a dose-ranging study with brivaracetam in patients from 16 to 65 years with refractory partial onset seizures.

Conditions: Epilepsy

Summary: this trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.


Eligibility criteria:
inclusion criteria: * male/female from 16 to 65 years * well-characterized focal epilepsy or epileptic syndrome according to the international league against epilepsy (ilae) classification * history of partial onset seizures * subjects having at least 4 partial onset seizures during the 4-week baseline period and at least 2 partial onset seizures during the 3 months prior to visit 1 * subjects taking 1 or 2 concomitant antiepileptic drugs (aed(s)) that have been at a stable dose. exclusion criteria: * seizure type ia non-motor as only seizure type * seizures occurring only in clusters * status epilepticus during the last 2 years before visit 1 * history of cerebrovascular accident (cva) * presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Keywords: epilepsy: partial onset seizures brivaracetam
radiofrequency (rf) ablation prospective outcomes study for central nervous system - rapid for cns

Conditions: Parkinson Disease; Dystonia; Essential Tremor; Movement Disorders

Summary: the objective of this study is to compile real-world outcomes of boston scientific commercially approved radiofrequency (rf) ablation systems used in the central nervous system (cns) for use in functional neurosurgery.

the objective of this study is to compile real-world outcomes of boston scientific corporation commercially approved radiofrequency (rf) ablation systems used in the central nervous system (cns) for use in functional neurosurgery.

Eligibility criteria:
inclusion criteria: * study candidate is scheduled to be treated with a commercially approved boston scientific rf system for pain or for cns applications per local directions for use (dfu) * signed a valid, irb/ec/reb-approved informed consent form exclusion criteria: * meets any contraindications per locally applicable directions for use (dfu) * currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments
donor human milk and neurodevelopmental outcomes in very low birthweight (vlbw) infants

Conditions: Neurodevelopmental Outcomes of VLBW Infants

Summary: breastfeeding is an important health-promoting behavior. human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. infants with the highest risk of life-long disability, very low birthweight (vlbw) preterm infants, are breastfed at some of the lowest rates in the us. maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. by determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. the hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed vlbw infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.


Eligibility criteria:
inclusion criteria: * \<1501 g weight at birth exclusion criteria: * chromosomal anomalies * congenital heart disease * congenital disorders known to impair neurodevelopment

Keywords: bsid iii human milk donor human milk preterm infant breastfeeding
effect of sevoflurane and remimazolam on arterial oxygenation during one-lung ventilation

Conditions: One-Lung Ventilation; Thoracic Surgery, Video-Assisted; Remimazolam

Summary: the goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

one lung ventilation (olv) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. during one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. this is known as hypoxic pulmonary vasoconstriction (hpv). therefore, by using hpv, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation. the two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (mac) resulted in similar changes in shunt fraction as did propofol. however, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing video-assisted thoracoscopic surgery * 19 years of age or older, less than 80 years old * the american society of anesthesiologists (asa) classification i-ⅲ physical status exclusion criteria: * patients with known allergy to benzodiazepine, propofol * patients with galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * patients with hypersensitivity to dextran40 * patients with end stage renal disease requiring hemodialysis * patients with history of acute angle glaucoma * emergency operation * patients with unstable hemodynamics requiring inotropics * patients with preoperative oxygen supplement * preoperative forced expiratory volume (fev1) less than 40% of predicted * preoperative ejection fraction less than 50%

Keywords: remimazolam one-lung ventilation arterial oxygenation hypoxic pulmonary vasoconstriction sevoflurane thoracic surgery
platelet reactivity inhibition following ticagrelor loading dose and one year outcome

Conditions: Acute Coronary Syndrome

Summary: this study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.

the use of thienopyridines in patients undergoing percutaneous coronary intervention (pci) has dramatically decreased the rate of early stent thrombosis. further the cure trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (acs) . however clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors. in addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk. the ticagrelor is a new blocker of the receiver p2y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. this biological property was translated in the study plato, having compared it with the clopidogrel in the acs, by a reduction of the risk thrombotique. the ticagrelor is thus recommended in first intention in this indication. there seems be a variability of answer to the ticagrelor. besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome patient undergoing pci and eligible for ticagrelor therapy according to the guidelines. exclusion criteria: * new york heart association functional class iii or iv * cardiac arrest * contra-indications to antiplatelet therapy * platelet count \<100 g/l * history of bleeding diathesis * concurrent severe illness with expected survival of \< 1 year month * pregnant of childbearing woman * inability to provide an informed consent * contra indication to ticagrelor.
study of accuracy of ngal, a renal injury biomarker, in patients with cirrhosis

Conditions: Acute Kidney Injury; Hepatorenal Syndrome

Summary: the purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (ngal) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (aki) development in patients with cirrhosis and bacterial infection and to predict response to aki treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.


Eligibility criteria:
inclusion criteria: * cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data; * presence of ascites and/or hepatic hydrothorax; * age over 18 years old; * diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dl at admission) or acute kidney injury without bacterial infection; * agreement to participate in the study, registered by informed consent; exclusion criteria: * serious comorbidities (functional class iv heart failure, o2 dependent chronic obstructive pulmonary disease, advanced cancer); * shock, as defined by american college of chest physicians; * chronic kidney disease with serum creatinine persistently above 1.5mg/dl in the previous 6 months and/or with sonographic findings of chronic nephropathy; * intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h; * use of nephrotoxic drugs in the previous 30 days; * dialysis prior to study inclusion; * previous solid organ transplantation.

Keywords: ngal acute kidney injury cirrhosis hepatorenal syndrome
coping with chronic fatigue syndrome: development of a community-based patient education program

Conditions: Chronic Fatigue Syndrome; Coping; Patient Education

Summary: the aim of the study is to develop, carry out, evaluate and measure the effects of a new patient education program for patients with chronic fatigue syndrome (cfs)in primary healthcare. in an randomized controlled trial design the effects of the patient education program on coping, physical functioning, fatigue, pain, acceptance, anxiety, depression, quality of life, self- efficacy, and illness perception will be compared with treatment as usual. the results of the main project will lead to the elaboration of the final patient education program that can be implemented in primary health care, as well as development of a training program for future program-conductors.

the project is a single blind randomized controlled trial. a total of 150 participants will be included in this study and randomly allocated to the intervention- or the control group. the 75 participants in the intervention group will be allocated to 6 groups. the control group will be offered to take part in the patient education program as soon as they have completed the last outcome evaluations.

Eligibility criteria:
inclusion criteria: * 18 years and older * meets fukuda's research diagnostic criteria and canadian cfs case definition * has given oral and written informed consent * able to tak part in the program that lasts 2,5 hours in addition to transport to and from the location for intervention. exclusion criteria: * psychosis or other severe psychiatric diseases, severe personality disturbances and/or substance dependency * pregnancy * not being able to understand, speak and read norwegian * not willing to accept random assignment

Keywords: chronic fatigue syndrome coping patient education
predisuisse: automatized assessment of difficult airway

Conditions: Anesthesia; Intubation; Difficult or Failed; Airway Complication of Anesthesia

Summary: in the "predisuisse" research project, the investigators aim to create a reliable, reproducible, ultra-portable and radiation-free automatized software, able to identify automatically collected features, facial characteristics, and range of movements, to predict intubation difficulty. the software will generate a difficulty intubation score tailored to three commercially available videolaryngoscopes with different type of blades, corresponding to the predicted endotracheal intubation difficulty while providing the anaesthesiologist a reliable and non-subjective tool to assess individual patient's risks with regards to airway management.

the swiss multi-institutional research project "predisuisse" aims to automatically predict and classify the difficulty of intubation and airway management using three commercially available videolaryngoscopes (vl) by acquiring face/profiles photos and sequences on a training set of 900 patients during the pre-anaesthesia consultation. for each patient, with the help of recently developed machine learning (ml), artificial intelligence (ai) and convolutional neural network (cnn) techniques, a specially developed software will be trained to provide a predicted airway management difficulty index. this will be performed by correlating those photos/sequences and the real difficulty level of intubation, determined by three experts by reviewing the recordings of the intubations of the training set patients. the software will then be used in routine on a set of 900 other patients to validate the prediction performance.

Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) presenting at the pre-anesthesia consult for an elective general anesthesia necessitating a tracheal intubation * signed informed consent. exclusion criteria: * patients not speaking french (in geneva and lausanne) or italian (in lugano). * patients previously operated on the airway with anatomical modifications (ent flaps, tracheotomies). * patients unable to follow procedures or to give consent will also be excluded.

Keywords: intubation difficult airway videolaryngoscopy
dual-function semirigid thoracoscopy versus semirigid thoracoscopy for the diagnosis of pleural diseases: a multicenter open-label randomized controlled trial

Conditions: Pleural Diseases

Summary: we designed and developed a novel dual-function semirigid thoracoscope (ue fet-680; ue corporation, zhejiang, china) with a straight channel adapted to flexible and rigid forceps for pleural biopsy. our preclinical trial has proven that the dual-function semirigid thoracoscope has larger and deeper sampling while retaining the entire thoracic accessibility and flexible bronchoscopic maneuvering habits of the semirigid thoracoscope. we designed this study to directly compare the diagnostic yield, quality of sampling, and safety between the dual-function semirigid thoracoscope and semirigid thoracoscope.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * unilateral pleural effusion of unclear etiology after a less invasive diagnosis * fully informed of the purpose and method of the study, agreed to participate in the study, and signed an informed consent form. exclusion criteria: * pao2/fio2 \< 300 * tendency for uncontrolled bleeding, unstable cardiovascular status, or severe heart failure * a complete pleural symphysis, where it is not possible to create a pneumothorax * refractory cough * eastern cooperative oncology group performance status 4 * disagreements regarding study participation * participation in other studies within three months without withdrawal or termination.
study on the efficacy and safety of gelaspan

Conditions: Hypovolemia

Summary: it is the objective of the study to investigate the efficacy and safety of two different volume replacement regimens with gelatine solutions.


Eligibility criteria:
inclusion: * male or female patients ≥ 18 years of age and ≤ 80 years of age. * patients scheduled to undergo open elective abdominal or pelvic surgery. * anticipated intraoperative volume requirement for gelatine solution is at least 15 ml/kg body weight * negative pregnancy test (urine dipsticks) in women of child bearing potential. * provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the regulatory authorities of the russian federation and local ethics committee (lec) prior to all evaluations. exclusion: * patients of asa-class \> iii. * known hypersensitivity to gelatine or to any of the constituents of the solution. * patients treated with other colloid solutions and / or blood products 24 hours prior to surgery. * patients on hemodialysis. * patients suffering from: * decompensated renal function (i.e. serum creatinine \> 3.0 mg/dl) * hypervolemia; * severe heart failure; * moderate lung edema; * hyperhydration; * severe blood coagulation disorders (aptt \>2.5 x uln or fibrinogen \ 2.5 x uln); * hypernatremia (serum na+ \> 150 mmol/l); * hyperchloremia (serum cl- \> 110 mmol/l); * hypercalcemia (serum ionized ca++ \> 1.5 mmol/l); * metabolic alkalosis; * severe generalized edema; * intracranial haemorrhage; * hyperkalemia (serum k+ \> 5.5 mmol/l). * pregnancy and/or nursing. * hypertension with the systolic blood pressure \> 180 mm hg and diastolic blood pressure \> 110 mm hg identified at screening. * patients who in the investigator's opinion couldn't take part in the study. * simultaneous participation in another clinical trial. * emergencies.
a study to evaluate effectiveness and safety of bms-986322 in participants with moderate-to-severe psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate clinical effectiveness and safety of bms-986322 in participants with moderate-to-severe psoriasis.


Eligibility criteria:
inclusion criteria: * diagnosis of plaque psoriasis (pso) for ≥ 6 months * body mass index 18 to 40 kg/m\^2 and total body weight \> 50 kg (110 lbs) * deemed by investigator to be eligible for phototherapy or systemic therapy * psoriatic plaques must cover ≥ 10% of body surface area at baseline * psoriasis area and severity index (pasi) score ≥ 12 and static physician global assessment (spga) ≥ 3 at baseline exclusion criteria: * diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic) * diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with pso for which a participant requires current systemic immunosuppressant medical treatment * any significant acute or chronic medical illness other protocol-defined inclusion/exclusion criteria apply

Keywords: moderate-to-severe psoriasis bms-986322 tyk2 inhibitor