Kornimate/medical-research-clean huggingface dataset:
bronchoalveolar lavages for cytologic assessment in intensive care unit patients

Conditions: Lung Diseases; Intensive Care

Summary: little is known about bronchoalveolar lavages performed for cytological assessment during bronchial fibroscopy in critically ill patients. frequency of use, indications, actual contribution to diagnosis and therapeutic decision, and complications have not been extensively assessed. the primary objective of this multi center, prospective, observational study is to describe the frequency of use of bronchoalveolar lavages for cytological assessement in critically ill patients, identify their indications, assess their contribution to diagnosis and therapeutic decisions, and estimate the frequency of induced respiratory events.

secondary objectives will be to * assess the frequency of poor quality bronchoalveolar lavages (as defined by either more than 5% bronchial epithelial cell count to less than 50,000 alveolar cells per ml) * assess the contribution of a given bronchoalveolar lavage to the diagnostic work up * assess the contribution of a given bronchoalveolar lavage results to therapeutic decision * assess the induced short term respiratory side effects * identify risk factors for poor respiratory tolerance

Eligibility criteria:
inclusion criteria: * adult patient (\> 18 yr-old) hospitalized in intensive care unit with acute and/or chronic lung disease that need bronchoalveolar lavage as part of routine diagnostic work up * patient's or family consent exclusion criteria: * consent not obtained * patient already included at previous bronchoalveolar lavage of during previous hospitalization * absence of social security number * age \< 18yr * pregnant woman

Keywords: side effects decision making indications risk factors
a patient-centric platform trial for precision oncology

Conditions: Oncology

Summary: xcelsior is a non-interventional data registry. information about treatments, treatment decisions and rationale, and patient outcomes including safety and effectiveness of anti-cancer therapy and associated supportive care will be collected for analysis.

xcelsior is patient-centric study for the registration of cancer patients, operations of a virtual tumor board, insight capture in clinical decision making, and collection of longitudinal, observational data in a cancer registry. patient intake into xcelsior will occur through the cancer commons web portal. this includes consent to participate in the data registry, including the collection and review of medical information by a virtual tumor board, generation of patient-specific treatment options with supporting rationale, access to treatment access support services, and inclusion into a registry study that includes safety and efficacy outcomes tracking. patients will be treated and tracked in their original treatment setting and the data generated will form part of a systematic framework combining expert judgment with artificial intelligence to maximize information gain and improve treatment option set development for individual cancer patients.

Eligibility criteria:
inclusion criteria: * both male and female patients with known or suspected recalcitrant or advanced cancer are eligible to enroll through the cancer commons website * patients with any performance status, comorbidity or disease severity are eligible * patients or their legally-authorized representative must be willing and able to provide written, informed consent (and assent, if applicable) exclusion criteria: * patients must be a resident of or receiving care within the united states or us territories.

Keywords: glioblastoma glioma pancreatic adenocarcinoma
bioequivalence of two mixtard® 30 formulations in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to to test for bioequivalence between two formulations of mixtard® 30 in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 18.0 and 27.0 kg/m\^2, inclusive * non-smoker, defined as no nicotine consumption for at least one year * fasting plasma glucose below or equal to 100 mg/dl (5.6 mmol/l) exclusion criteria: * previous participation in this trial or other clinical trials within the last 3 months * body weight above 87.5 kg * pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (iud) that has been in place for at least 3 * history of alcohol or drug abuse
perioperative changes of cognitive function according to jugular vein insufficiency in robot-assisted prostatectomy

Conditions: Prostate Cancer

Summary: internal jugular vein (ijv) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. ijvv incompetence (ijvvi) may result in retrograde flow which leads to brain congestion and increase of intracranial pressure, which can cause brain dysfunctions in some patients. ijvvi has been reported to be associated with transient global amnesia (tga), cough syncope, exertional headache, transient ischemic attack, and air embolism. demographic data are associated with the development of ijvvi. akkawi et al. demonstrated that old age over 50 years and male gender are the risk factors for ijvvi. a few physiologic conditions are related with ijvvi including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension. robot assisted laparoscopic prostatectomy (rlp) is one of the most common robotic surgery because of its significant benefits such as smaller incision, less severe postoperative pain, less intraoperative bleeding, and shorter hospital stay compared to traditional radical prostatectomy. the patients undergoing rlp are mostly over 60 years old, have neurologic, cardiac and pulmonary comorbidities. for rlp, patients are in trendelenburg position most of the time during surgery, which could cause increases in intra-abdominal and intrathoracic pressure.


Eligibility criteria:
inclusion criteria: * over 50 years old * asa class i or ii * scheduled for robot assisted laparoscopic prostatectomy exclusion criteria: * previous neurologic deficit * history of psychiatric disease, alcoholism or other drug dependency * serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests
evaluate the safety and efficacy of thrombectomy system in the intravascular treatment of acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. according to the requirements of the experiment, 200 subjects were selected and randomly divided into the experimental group and the control group 1:1. according to the information of the group, corresponding devices were used to receive endovascular therapy and the results were evaluated.

through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. according to the requirements of the trial, 200 subjects with acute ischemic stroke who met the inclusion criteria and did not meet any exclusion criteria were randomly divided into the test group and the control group at 1:1, and received endovascular therapy with corresponding instruments according to the information of the group and evaluated the results

Eligibility criteria:
inclusion criteria: 1. age 18-85 2. within 8 hours of the onset of stroke symptoms 3. there are clinical signs and symptoms consistent with acute ischemic stroke 4. imaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of ct or dwi image \ 1/3mca) 5. patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the m1/m2 segment of the middle cerebral artery or the a1/a2 segment of the anterior cerebral artery without clear contraindications 6. 6 points ≤nihss score \< 30 points 7. informed consent is signed by the patient or her legal guardian exclusion criteria: 1. known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel 2. mrs ≥ 2 before stroke 3. pregnant or lactating women 4. hemorrhagic cerebrovascular history within 3 months 5. refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmhg, or diastolic blood pressure ≥110mmhg) 6. bleeding prone predisposition with severe coagulopathy, such as inr \> 3.0 or platelet count \< 40x10∧9/l 7. blood glucose at screening was \ 22 mmol/l 8. patients with any of the following exclusion criteria were not eligible to participate in this study * preoperative ct or mri showed bleeding symptoms * ct or mri shows intracranial mass or intracranial tumor requiring surgical treatment * angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery * angiography revealed simultaneous acute obstruction of both carotid systems 9. participate in other drug or device clinical trials within 28 days prior to screening visit
evaluation of safety and efficacy of prohance in pediatric patients <2yrs

Conditions: Central Nervous System Diseases; Central Nervous System Neoplasms

Summary: safety and efficacy study in pediatric subjects \<2 years of age who have undergone brain or spine mri pre and post 0.1 mmol/kg prohance administration. imaging conditions will represent those in routine clinical practice. retrospective enrolment with a prospective blinded read.

the purpose of this study is to retrospectively enroll children younger than 2 years of age who have undergone brain or spine mri with 0.1 mmol/kg prohance and to gather safety data as well as to collect mr images for a prospective blinded read to evaluate the efficacy of prohance in terms of visualization and enhancing properties. the study will be conducted in 4-8 sites in the united states and europe. it is estimated that 120 patients will be enrolled to provide 108 evaluable patients. three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile will independently evaluate the mri images. the efficacy analysis will be primarily based on the blinded reader evaluations. imaging conditions will represent those in routine clinical practice, inclusive of pre and post-contrast images.

Eligibility criteria:
inclusion criteria: * is male or female and was younger than 2 years of age at the time of the mri with prohance injection at the dose of 0.1 mmol/kg (±25% in volume administered). * has demographic information, reason for the prohance-enhanced mr examination, relevant medical history, final diagnosis, and safety data available. * has documented known or highly suspected enhancing disease of cns (brain/spine) and previously underwent a cranial or spinal mr examination requiring an injection of prohance contrast agent. * has both predose and postdose t1 se/fse and/or gre and t2 se/fse, and flair mr images (when available) for submission to bracco or designee to be evaluated in a fully blinded read. * has complete information on the imaging protocol used for the prohance-enhanced mr exam including type of exam (brain or spine), mr scanner and field strength (1.0, 1.5 or 3.0 tesla) * has a documented dose of prohance administered for their mri exam and/or the volume (ml) and weight of the patient available to be used to calculate the exact dose of prohance that was administered. exclusion criteria: • exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.

Keywords: cns mri prohance gadoteridol
an international survey of the occurrence of cardiovascular disease among patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. participants will be asked to give information about their health. participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. participants' participation will be one day/one visit at their doctor. the study will last for about 6 months in total.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * male or female, age more than or equal to 18 years at the time of signing informed consent (in algeria more than or equal to 19 years; in japan more than or equal to 20 years). * diagnosed with t2dm more than or equal to 180 days prior to the day of signing the informed consent exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * diagnosed with type 1 diabetes * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * patients with known congenital heart disease/malformation
a multicenter randomized controlled clinical trial of the impact of minimally invasive abdominal surgery esophageal pressure monitoring guided individualized peep on postoperative pulmonary complications in obese patients

Conditions: PostoperativePulmonaryComplications

Summary: the aim of this study is to compare the effect of individualized peep based on transmural lung pressure and fixed peep on postoperative pulmonary complications during laparoscopic or robotic abdominal surgery in obese patients. the main questions are: 1. whether the intraoperative application of individualized peep in obese patients can reduce the incidence of postoperative pulmonary complications at 7d, 30d, and 90d postoperatively compared to fixed peep 2. whether the application of individualized peep in obese patients can optimize intraoperative respiratory mechanics, oxygenation index (pao2/fio2), paco2, and etco2 compared with fixed peep. 3 whether the application of individualized peep in obese patients can reduce the incidence of non-respiratory complications, postoperative qor-15 scores, unplanned reintubation, unplanned transfers, and unplanned extubation in the postoperative period compared with fixed peep. planned reintubation, unplanned transfers to icu and icu days, hospitalization days, 30-day and 90-day mortality. participants will: patients with bmi \>= 30 kg/m² undergoing laparoscopic or robotic abdominal surgery received peep during surgery (divided into individualized peep and fixed peep), and were followed up for 90 days to observe the incidence of pulmonary complications and related study outcomes.


Eligibility criteria:
inclusion criteria: * ≥18 years of age; asa class i-iii. patients undergoing bariatric laparoscopic or robotic abdominal surgery; bmi ≥30 kg/m²; planned operative time ≥120 minutes. exclusion criteria: - presence of other serious cardiorespiratory diseases, such as severe chronic obstructive pulmonary disease (copd, gold class iii-iv); history of severe or uncontrolled bronchial asthma, history of pulmonary resection; presence of unstable cardiovascular disease, nyha classification 3-4, such as severe arrhythmias or heart failure; presence of neuromuscular disease affecting respiratory function, such as severe spinal cord injury; intracranial injury history of esophageal-related surgery, contraindications to esophageal catheter insertion, including severe coagulopathy (platelets \ 4) severe chronic liver disease (child-pugh score ≥ 12) patients who cannot be extubated in time after surgery and need to return to the icu with an endotracheal tube or are scheduled to be reintubated after surgery. (7) general anesthesia duration less than 120 minutes
biology guided therapy for breast cancer for er positive

Conditions: Breast Cancer; Estrogen Receptor-positive Breast Cancer; HER2-negative Breast Cancer

Summary: there are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a cdk4/6 inhibitor. right now, doctors do not have a good way of choosing between these treatments. scientists we work with have come up with ways to use the biology of the tumor to try to predict which treatment is best. this study is being done to test if those predictions are right and to learn more about these tumors to design better treatments in the future.

this is an open-label phase ii study of systems biology guided therapy for breast cancer patients positive for oestrogen receptor after aromatase inhibitor and cdk inhibition. based on the solar-1 trial, 25% of tumors would have pik3ca mutation, so 25% of people would be treated with fulvestrant plus alpelisib with a median pfs in that group of 11 months and 75% of people would be treated with fulvestrant with a median pfs in that group of 6 months.(3) the weighted average of these medians is 7.25 months, but since the actual distributions of the progression free survivals are not available, we will use a conservative estimate of the expected median pfs of the historical control group (fulvestrant +/- alpelisib as second line unguided therapy) of 8 months.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of breast cancer * metastatic or incurable * prior treatment with an anastrozole or letrozole and a cdk4/6 inhibitor * progression while on or within 6 months of stopping the cdk4/6 inhibitor * at least one lesion amenable to percutaneous biopsy that is not a purely sclerotic bone lesion * ecog 0-2 * age 18 or greater * able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. exclusion criteria: * prior treatment within 2 years with fulvestrant, alpelisib, everolimus, or capecitabine * comorbid disease other than breast cancer with a life expectancy of less than 2 years * cancer other than breast cancer that is expected to need treatment within 2 years * platelets \< 100,000/microliter * inr \> 1.5
radiotherapy in hepatocellular carcinomas after hepatectomy with narrow margin (<1 cm) or portal vein thrombosis

Conditions: HepatoCellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is one of ten leading cancer types worldwide and also in asia, but the five-year relative survival rate is relatively quite low1-3. as a common complication of hcc, portal vein tumor thrombosis (pvtt) have been reported with an occurrence of 34% \~ 50% in advanced hcc and it is now become an extremely pressing problem for hepatic surgeon. nevertheless, the patients overall survival (os) varies on their clinical features or liver function4. for hcc pvtt treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. from an oncologic point of view, a narrow margin \<1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.on the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.to address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant rt for centrally located hcc after narrow margin (\<1 cm) hepatectomy on tumor recurrence.


Eligibility criteria:
inclusion criteria: * hcc with no preoperative rt * resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function * compensated cirrhosis or no cirrhosis; child-pugh a * ecog performance status of 0 or 1. * patients who had undergone transarterial chemoembolization (tace) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry exclusion criteria: * unresectable hepatocellular carcinoma patients * hepatocellular carcinoma without portal vein tumor thrombus * hepatectomy without narrow margin(more than 1cm) * presence of distant metastasis * palliative resection with tumor residual * non-hcc confirmed by postoperative pathology
grandmove project to promote elders' robustness against frailty

Conditions: Frail Elderly Syndrome

Summary: this is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program, (2) a 6-month resistance exercise program, versus (3) a 6-month psychoeducation program on healthy lifestyle for improving frailty, physical performance, and quality of life in frail/prefrail older persons. after 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence.

this is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program led by trained young-old exercise coaches, (2) a 6-month resistance exercise program led by trained young-old exercise coaches, versus (3) a 6-month psychoeducation program on healthy lifestyle led by retired nurses for improving frailty, physical performance, and quality of life in frail/prefrail older persons. a total of 390 frail/prefrail older persons are randomized into one of the three programs in groups of 6 to 10 persons. after 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence. the sequences are: (a) resistance exercise, aerobic exercise, psychoeducation; (b) aerobic exercise, resistance exercise, psychoeducation; and (c) psychoeducation, resistance exercise, aerobic exercise. the entire intervention period lasts for 18 months.

Eligibility criteria:
inclusion criteria: * screened as frail or prefrail using cutoff scores of the 5-item frail scale; * living in the community and planned to reside in the area for the duration of the study; * gave informed consent to participate in the study exclusion criteria: * heart failure, uncontrolled angina, severe pulmonary disease, or end-stage disease with a life expectancy of less than 18 months * diagnosed dementia or a cutoff score falling below threshold suggestive of dementia using the clock-face test * has another member of the household participating in the study * difficulty in communication with study personnel due to speech or hearing problems * other medical, psychiatric, or behavioural factors that may interfere with study participation or the ability to follow the intervention protocol temporary exclusion criteria: * had stroke, hip fracture, myocardial infarction, major heart surgery, deep vein thrombosis, pulmonary embolus, spinal surgery, or hip or knee replacement within the previous 6 months; * currently prescribed activity limitation or weight-bearing limitation by a formal healthcare professional; * limited physical activity due to chest pain or dyspnoea without definitive treatment by a healthcare provider; * currently consume more than 14 alcoholic drinks per week; * currently enrolling in another randomized trial involving lifestyle or pharmacological interventions