Kornimate/medical-research-clean huggingface dataset:
bougie use in emergency airway management

Conditions: Acute Respiratory Failure

Summary: this prospective, open-label trial randomizes adult patients intubated in the ed with a macintosh blade to use or not use a bougie for the first intubation attempt. the primary outcome is first pass success.

the primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway). we will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic. we plan to enroll 374 patients with a difficult airway characteristic (dac). the total enrollment for the trial will be higher, depending on the proportion of patients that have a dac. based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a dac. to help achieve balanced randomization for patients with a dac, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.

Eligibility criteria:
inclusion criteria: 1. the patient must be undergoing orotracheal intubation in the ed with a macintosh blade (using either video or direct laryngoscopy) 2. the patient must be presumed to be 18 years of age or older at the time of enrollment. exclusion criteria: 1. known anatomic distortion of the upper airway or perilaryngeal structures. 2. prisoner or under arrest 3. known or suspected to be pregnant, based on the opinion of the treating physician.
impact of a systematic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage i-iv gynecological cancers

Conditions: Caregiver; Malignant Female Reproductive System Neoplasm

Summary: this trial evaluates the impact of a systemic social work driven approach on medical power of attorney documentation, knowledge, attitudes, and beliefs in participants with stage i-iv gynecological cancers. social work counseling and education may help increase the number of participants who complete medical power of attorney documents. counseling and education may also affect attitudes about decision-making and willingness to take part in these conversations in participants with stage i-iv gynecological cancers and their family members and/or caregivers.

primary objectives: i. to evaluate medical power of attorney documents (mpoad) completion rate after a systematic social work counseling and education clinical process. secondary objectives: i. to determine change in medical power of attorney (mpoa)/primary family caregivers' knowledge, attitudes and beliefs about conditions for quality surrogate medical decision-making (mdm). ii. to determine change in mpoa/primary family caregivers' knowledge of patients' values and goals for mdm. iii. evaluate patients' and mpoa/primary family caregivers' willingness to participate in future advance care planning discussions to discuss patients' values and goals important to mdm. iv. evaluate predictors of patient subgroups most likely to respond to the social work counseling and education clinical process. v. explore aspects of the spanish language version of the advance care planning engagement survey to inform future validation studies. outline: participants (patients and family caregiver/mpoa) complete questionnaires about knowledge, attitudes, and beliefs of mpoad. participants without a mpoad watch a 4-minute educational video about the importance of the role of mpoa. after completion of intervention, participants are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * patients * diagnosis of invasive gynecologic malignancy stages 1-4. * new patient in the gynecologic oncology center. * adequate capacity to understand and complete mpoad in the opinion of the study investigator or research assistant. * able to speak and understand english and/or spanish. * provision of institutional review board (irb)-approved informed consent. * available mpoa or primary family caregiver who consents to study participation. * family caregiver/mpoa * mpoa or if none documented in electronic health record (ehr), primary family caregiver, as designated by the patient. * permission to contact provided by patient. * adequate capacity to understand and complete study measures in the opinion of the study investigator or research assistant. * provision of irb-approved informed consent. exclusion criteria: * without a mpoa or available family caregiver.
venous ethanol for ventricular tachycardia

Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy

Summary: comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -venous ethanol for left ventricular ischemic ventricular tachycardia -velvet clinical trial

patients with ventricular tachycardia (vt) in the context of ischemic heart disease suffer from significant morbidity and mortality. catheter ablation can improve outcomes but has suboptimal ablation results. ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural vt substrates. investigators will randomize patients with ischemic vt to either endocardial catheter ablation alone, or combined with venous ethanol (ve) ablation of coronary veins located on the epicardial aspect of the vt substrates. a combined primary endpoint: vt recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.

Eligibility criteria:
inclusion criteria: * male and female, ages of 18 and 85 years and with a prior icd implant * diagnosed with ischemic cardiomyopathy: prior myocardial infarction (pathological q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause) * one of the following vt events (within last 6 months): a) ≥3 episodes of vt treated with anti-tachycardia pacing (atp) or anti-arrhythmic drugs; b) ≥1 appropriate icd shocks; c) ≥3 vt episodes within 24 hr; d) sustained vt below detection rate of the icd documented by ekg/cardiac monitor * patients deemed candidates for rf ablation of vt * able and willing to comply with pre-, post-, and follow-up requirements * willing to sign the informed consent exclusion criteria: * serum creatinine \>1.5 mg/dl, or creatinine clearance \<30 ml/min * left ventricular (lv) ejection fraction ≤10% * mobile lv thrombus on echocardiography * absence of vascular access to the lv * disease process likely to limit survival to \<12 months * new york heart association class iv heart failure * cardiac surgery within the past 2 months (unless vt was incessant), * acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic st segment changes demonstrated on ekg) * another reversible cause of vt (e.g. electrolyte abnormalities, drug-induced arrhythmia) * severe aortic stenosis or mitral regurgitation with a flail leaflet * pregnancy * unwilling or unable to provide informed consent * covid-19 positive testing within 14 days of randomization procedure * enrolled, or planning to get enrolled, in another research study during his/her participation on the velvet trial

Keywords: ventricular tachycardia coronary veins ethanol ablation
community based rehabilitation model after total knee replacement

Conditions: Knee Osteoarthritis

Summary: to investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

to investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Eligibility criteria:
inclusion criteria: i) unilateral tka; ii) age 55 years old and above; iii) able to engage in outpatient physiotherapy; iii) postoperative knee flexion ≥75° and knee extension ≤5°; iv) able to ambulate independently preoperatively. exclusion criteria: i) had revision tka or fully constrained knee arthroplasty; ii) had knee replacement for indications other than osteoarthritis; iii) had post-operative complications during hospital stay; iv) were unable to participate due to cognitive impairment or language barriers; v) had acute spinal diseases or joint, muscle or systemic diseases affecting gait; iv) had comorbid health conditions that would prevent active participation (e.g. prior hemiplegic stroke, severe cardiorespiratory illnesses.
a comparison of sertraline-reboxetine combination therapy versus sertraline or reboxetine monotherapy in the treatment of major depression.

Conditions: Depressive Disorder, Major

Summary: this study was designed to determine if the novel combination of the ssri, sertraline, and the nri reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of ssris.


Eligibility criteria:
inclusion criteria: * subjects must fulfill the criteria for mdd without psychotic features as defined by dsmiv, based on clinical assessment and confirmed by structural clinical interview for dsm-iv axis i disorder-clinical version (scid-i) plus the mdd specifiers included in the research version of scid-i. * ham-d (17-item) ≥ 22 at screening (visit 1) and \> 20 at baseline (visit 2). * minimum cgi-s ≥ 4 at screening (visit 1) and at baseline (visit 2). exclusion criteria: * known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one ssri, or with two or more ssris. * subjects with \> 20% ham-d (17-item) improvement (decrease) from screening (visit 1) at baseline (visit 2). * subjects with uncorrected hypothyroidism or hyperthyroidism.
a study to evaluate plasmin for the creation of a posterior vitreous detachment (pvd)

Conditions: Vitreoretinal Traction Syndrome

Summary: plasmin is expected to create a posterior vitreous detachment (pvd) when injected directly into the eye. the pharmacological creation of a pvd may be beneficial in helping to treat a variety of conditions.


Eligibility criteria:
inclusion criteria: * patients who are in need of a vitrectomy. exclusion criteria: * a pvd in the study eye as assessed by the investigator using ophthalmic and alternative examination techniques. * a history of vitrectomy in the study eye. * a media opacity that precludes quality examination of the vitreous and fundus in the study eye.
an open-label, phase i/ii study of the pan-immunotherapy in patients with local advanced/metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the outcome of pancreatic cancer is extremely poor. nccn guidelines recommend folfirinox or modified-folfirinox as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. pd-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance t-cell-mediated anticancer immune responses. manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. this one-arm, phase i/ii study is designed to assess the safety and efficacy of manganese primed combined therapy of anti-pd-1 antibody and chemotherapy.


Eligibility criteria:
inclusion criteria: 1. subjects must have histologically proven local advanced/metastatic pancreatic cancer 2. ≥ 18 years old. 3. life expectancy of at least 6 months. 4. eastern cooperative oncology group performance status 0-2. 5. subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria. 6. subjects with anti-pd-1 antibody treatment history are eligible which must be resistance. 7. adequate organ function. 8. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. prior organ allograft. 4. women who are pregnant or breastfeeding. 5. women with a positive pregnancy test on enrollment or prior to investigational product administration. 6. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: local advanced metastatic anti-pd-1 antibody manganese chemotherapy
study of trc105 + paclitaxel/carboplatin and bevacizumab in patients with nsclc

Conditions: Non Small Cell Lung Cancer

Summary: this is a single center, open-label, nonrandomized, phase 1b, dose-finding study of trc105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage iv non-squamous nsclc.

bevacizumab is a monoclonal antibody to vascular endothelial growth factor (vegf) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (nsclc) patients when given with carboplatin and paclitaxel. trc105 is an antibody to endoglin, an essential angiogenic target expressed on proliferating endothelial cells that is distinct from the vegfr and overexpressed in response to vegf inhibition. trc105 inhibits angiogenesis, tumor growth and metastases in preclinical models and complements the activity of antibodies and small molecules that target the vegfr. in a phase 1b study, the combination of trc105 and bevacizumab produced radiographic reductions in tumor volume in bevacizumab-refractory patients, and was well tolerated. trc105 was also well tolerated with chemotherapy in a trial with capecitabine in breast cancer patients. the use of trc105 with bevacizumab and paclitaxel/carboplatin may result in more effective angiogenesis inhibition and improved clinical efficacy over that seen with bevacizumab and paclitaxel/carboplatin alone.

Eligibility criteria:
key inclusion criteria: * stage 4 non-squamous cell lung cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor) * ecog performance status ≤ 1 * measurable disease by recist key exclusion criteria: * non-small cell lung cancer of squamous histology * current treatment on another therapeutic clinical trial * patients who have received wide field radiotherapy ≤ 28 days (defined as \> 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation \< 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy * active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.
non-invasive evaluation of fluid status and cardiac output during operative treatment of pheochromcytoma

Conditions: Pheochromocytoma

Summary: non-invasive measurements of cardiac output (co), systemic vascular resistance (svr), corrected aortic flow time (ftc) and stroke volume (sv) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.

pheochromocytomas and extraadrenal paragangliomas are catecholamin-producing tumours deriving from the adrenal medulla and sympathetic ganglia. the only causal therapy is surgical resection. nowadays, laparoscopic adrenalectomy is thought to be the optimal approach. chronic volume depletion due to chronic hypertension and preoperative α-adrenoreceptor-blockade (to avoid the effects of intraoperative catecholamine-excess) often lead to hypotension after resection of the tumour. volume reload with high amounts of fluid is often needed. therefor some authors recommended invasive measurement (pulmonary artery catheter) to control cardiac output parameters and fluid balance. however, there are non-invasive methods to measure cardiac output(co), systemic vascular resistance(svr), stroke volume(sv) and corrected aortic flow time(ftc) to estimate volume status. except transesophageal echocardiography, other techniques such as transoesophageal doppler and pulse pressure methods exist but have not been investigated during surgical therapy for pheochromocytoma so far. the esophageal doppler currently represents the "gold standard" for perioperative fluid replacement therapy. the study's hypothesis is that non-invasive measurements of cardiac output (co), systemic vascular resistance (svr), corrected aortic flow time (ftc) and stroke volume (sv) are useful parameters during laparoscopic resection of pheochromocytoma (adrenalectomy) to document the intraoperative changes in volume status and to estimate the volume depletion.

Eligibility criteria:
inclusion criteria: * planned laparoscopic adrenalectomy for pheochromocytoma (biochemical confirmed adrenal and extraadrenal pheochromocytoma) * planned laparoscopic adrenalectomy for hormonally inactive adrenal tumor exclusion criteria: * risk of esophageal bleeding or perforation exists (i.e., liver disease with portal hypertension and/or esophageal varicoses, other esophageal anomalies).

Keywords: pheochromocytoma adrenalectomy cardiac output fluid managment esopagheal doppler sonography
study to evaluate the efficacy and safety of dwp14012 in prevention of nsaids induced peptic ulcer

Conditions: Peptic Ulcer

Summary: the study aims to demonstrate the preventive effect of dwp14012 20 mg for peptic ulcer is non-inferior to that of lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of dwp14012 20 mg.


Eligibility criteria:
inclusion criteria: 1. male and female adults aged ≥ 19 years at the time of informed consent 2. subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with nsaids for at least 24 weeks 3. subjects with at least one of the following risk factors for ulcer development at screening. 4. subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the egd result at screening. exclusion criteria: 1. subjects with esophagitis, gastroesophageal varix, esophagus, barrett's esophagus, acute gastrointestinal bleeding and else based on the screening egd results. 2. subjects who have undergone gastroduodenal surgery or total small bowel resection 3. subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system 4. subjects who have had a malignant tumor in the last 5 years 5. subjects who history of hypersensitivity to the ip ingredients, aspirin and nsaids
tolerability and efficacy of intravenous infusion of autologous msc_apceth for the treatment of critical limb ischemia

Conditions: Critical Limb Ischemia; Peripheral Artery Disease

Summary: msc_apceth are gmp-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of critical limb ischemia


Eligibility criteria:
inclusion criteria: 1. patients with peripheral arterial occlusive disease (symptomatic paod), diagnosis of cli defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an abpi \</= 0.5, 2. patients with staging of ≥iii according to fontaine and ≥4 according to rutherford categories, 3. patients fulfilling the criteria for an invasive re-vascularisation procedure (pta) at the discretion of the investigator, 4. patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator, exclusion criteria: 1. patients with wounds of a severity of greater than grade 2 on the wagner scale, 2. patients with life-threatening ventricular arrhythmia, 3. patients with unstable angina pectoris, 4. patients with severe congestive heart failure (i.e. nyha stage iv), 5. patients with uncontrolled hypertension (defined as diastolic blood pressure \>110 mmhg or systolic blood pressure \>180 mmhg during screening), 6. patients with an uncontrolled diabetes mellitus (hba1c \> 9%), 7. patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment, 8. patients who are unsuitable for a msc stem cell therapy in the opinion of the investigator,

Keywords: critical limb ischemia peripheral arterial occlusive disease peripheral artery disease peripheral vascular disease stem cell therapy mesenchymal stem cells
effects of pre-, pro- & anti-biotics on gut microbiota

Conditions: Human Gut Microbiota

Summary: the purpose of this study is to compare and contrast the effects of a prebiotic (trametes versicolor), a probiotic (saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. it is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.


Eligibility criteria:
inclusion criteria: * age 18 to 39 years (male or female) * good general health * able to comply with study requirements and to provide informed consent * for women of childbearing potential * a negative urine pregnancy test immediately prior to starting the study treatment * agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up) exclusion criteria: * any diagnosed autoimmune disease * history of organ transplantation * known chronic or recurrent systemic disorder associated with immunocompromise * a history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin). * history of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness). * systemic antibacterial therapy during the 3 months prior to study enrollment * new prescription medications during the 4 weeks prior to study enrollment * prescription or otc medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment * active gastrointestinal or metabolic disease * prior gastrointestinal surgery (apart from appendectomy or cholecystectomy) * history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily * any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.

Keywords: healthy volunteers gut microbiota gut microbiome prebiotic probiotic antibiotic antibiotic-associated diarrhea intestinal bacterial overgrowth