Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of the treatment of impending and actual pathological fractures in the humerus from metastatic bone disease

Conditions: Humerus Pathological Fracture

Summary: the purpose of this study is to collect safety and performance data of the photodynamic bone stabilization system (pbss) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.


Eligibility criteria:
inclusion criteria: -general inclusion criteria 1. skeletally mature adult males and females 18 years of age or older. 2. impending or actual pathological fracture of the humerus, secondary to metastatic bone disease. 3. females: neither pregnant nor intending to become pregnant during the course of the study, defined as: 1. postmenopausal for at least 1 year or 2. documented oophorectomy or hysterectomy 3. surgically sterile or 4. if of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening 4. able to understand and provide informed consent. 5. willing and able to comply with post-operative treatment protocol and follow-up visit schedule. -impending fracture-specific inclusion criteria 6. documented presence of solitary metastatic lesion. 7. mirels criteria score ≥ 8. 8. destruction of cortical bone at impending fracture site \> 50%. -actual fracture-specific inclusion criteria 9. radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. ao classification 11a1, 11a2 and 11b1, 11b2 and 12a1,12a2 and 12b1, 12b2 and 13a1,13a2 and 13b1, 13b2. 10. fracture is closed, gustilo type i or iia. exclusion criteria: -general exclusion criteria 1. primary tumor (osteogenic origin, etc.) at site. 2. impending fracture or actual fracture location other than humerus. 3. current concomitant traumatic fracture of any other location. 4. active or incompletely treated infections that could involve the device implant site. 5. distant foci of infection that may spread to the implant site. 6. allergy to implant materials or dental glue. 7. vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site. 8. uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder). -impending fracture-specific exclusion criteria 9. mirels score \< 8. 10. destruction of cortical bone at impending fracture site \< 50%. 11. prior surgery and/or prior fracture of affected site. 12. any articular component to impending fracture site. -actual fracture-specific exclusion criteria 13. index treatment is greater than 28 days post fracture. 14. open fractures with severe contamination. 15. extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 16. delivery sheath is unable to cross fracture site after proper fracture reduction and realignment 17. patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
effectiveness of combined tobacco treatment in hospitalized subjects

Conditions: Tobacco Smoking; Tobacco Withdrawal; Nicotine Addiction; Nicotine Withdrawal; Nicotine Replacement Therapy

Summary: in the 20th century, tobacco caused the death of 100 million people worldwide and it is estimated that it will be responsible for 1 billion deaths in the 21st century. currently 8 million people die each year from smoking, 7 million are associated with active smoking, thus being the main risk factor for loss of disability-adjusted life years for men and the ninth most important risk factor for women. in previous studies it has been reported that approximately 21% (14%-30%) of subjects who have required hospitalization are active smokers, being higher in men than in women (28% vs 14%). the initiation of treatment for smoking cessation in this group of subjects has shown an effectiveness rate of up to 65% to maintain abstinence 6 to 12 months after discharge. the effectiveness has been analyzed in scenarios with only brief advice, in some others with the use of medications such as varenicline, bupropion and nicotine replacement therapy, however, the interventions have not been standardized for adequate analysis, which could contribute to the different results.

the objective is to know the effectiveness of combined treatment to maintain abstinence in participants with active smoking who are hospitalized in a reference center. bupropion and nicotine replacement therapy are the drugs used in this clinical trial. participants will be randomly assigned to two groups: nicotine replacement therapy or nicotine replacement therapy plus bupropion. all participants will have counseling, conductive behavioral therapy, follow-up at 3, 6 and 12 months with a pulmonologist. pulmonary function tests will be performed every 3, 6, and 12 months. abstinence will be corroborated with a cotinine (urine) test and an exhaled carbon monoxide test.

Eligibility criteria:
inclusion criteria: \>18 years active smokers (consumption of more than 100 cigarettes in their entire life, and who have consumed cigarettes in the last 30 days) hospitalized subjects informed consent exclusion criteria: * subjects who have had pharmacological treatment to stop smoking in the last month * subjects with contraindications for medications. sample size calculation, 80% power, unilateral, due to difference in proportions, estimated loss of 25%.

Keywords: tobacco bupropion nicotine replacement therapy abstinence
68ga-psma pet in the prostate cancer

Conditions: Prostatic Neoplasms; Metastases; PSMA-PET

Summary: efficacy of 68ga psma pet / ct in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial. to identify and compare the diagnostic efficacy of 68ga-psma pet/ct and mpmri for lymph nodes in patients with newly diagnosed prostate cancer.


Eligibility criteria:
inclusion criteria: * high risk localized/locally advanced prostate cancer patients who are candidates for radical prostatectomy plus bilateral extended plnd * isup gleason grade group ≥ 4 exclusion criteria: * prior history of any other cancer in the last 5 years excluding basal cell carcinoma proven metastases in bones or other distant metastases * general contra-indications for mri (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) * serious concomitant systemic disorders that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives * metal implants in the pelvic region which will deteriorate pet/mr/ct image quality.
mechanical ventilation in multiple fracture ribs

Conditions: Mechanical Ventilation

Summary: chest trauma is the most common injury in the emergency trauma and rib fractures is the most common trauma in chest trauma. severe rib fractures can cause paradoxical respiration and mediastinal swing, which has large effects on respiratory and circulatory system, result in acute respiratory distress syndrome. mechanical ventilation can significantly improve the hypoxemia of the patients, correct paradoxical respiration, and treat the pulmonary atelectasis

to compare between biphasic intermittent positive airway pressure (bipap) ventilation and airway pressure release ventilation (aprv) mode in patients with multiple fracture ribs as regard: * resting energy expenditure * oxygenation * stability of physiological status as cardiovascular activity * cardiac output * arterial blood gas measurement including \[ blood ph, arterial oxygen tension, arterial carbon dioxide tension, bicarbonate level and base deficit\] * lung and chest compliance * length of intensive care unit stay. * the icu mortality rate. * the development of major complications as nosocomial infection (hospital acquired pneumonia and ventilator associated pneumonia), major atelectasis and pneumothorax.

Eligibility criteria:
inclusion criteria: • isolated chest trauma patient with multiple fracture ribs patients \[ \>3 ribs\] who will be admitted to the surgical icu for ventilatory support and will be expected to continue for 2 days or longer exclusion criteria: * age \< 18 years old. * pregnant patient. * patient who will require fraction of inspired oxygen more than 0.6. * air leak from the chest tube. * patient with body temperature \> 39 celsius. * acute hepatitis or severe liver disease (child-pugh class c). * left ventricular ejection fraction less than 30%. * heart rate less than 50 beats/min. * second or third-degree heart block. * systolic pressure \< 90 mmhg despite of infusion of 2 vasopressors. * patients with known endocrine dysfunction. * patient with hypothermia * patient on positive end expiratory pressure more than 14 cmh2o

Keywords: resting energy expenditure multiple fracture ribs ventilation
comparison of using cibpb with or without iv-pca after arthroscopic rotator cuff repair

Conditions: Analgesia, Patient-Controlled; Brachial Plexus Block; Arthroscopic Rotator Cuff Repair

Summary: the goal of this study is to compare the continuous brachial plexus block with or without intravenous patient controlled analgesia(pca) in patients undergoing arthroscopic rotator cuff repair, in terms of quality of recovery, postoperative pain score, and adverse event.

the bellomic® m silicone balloon infuser, dual continuous petite type (cebika, uiwang-si, gyeonggi-do, republic of korea) has 2-channel infusion elastomeric pump with two balloon chambers. this structure allows the simultaneous use of continuous nerve block and intravenous pca. in addition, intravenous pca can be continued even when continuous nerve block is discontinued due to discomfort such as numbness, tingling sense or motor block. this is expected to contribute to the patient satisfaction and quality of recovery.

Eligibility criteria:
inclusion criteria: * having arthroscopic rotator cuff repair * american society of anesthesiologists physical status i-iii exclusion criteria: * contraindication to interscalene brachial plexus block * contraindication to fentanyl

Keywords: postoperative pain iv pca continuous interscalene brachial plexus block
a study of 5-fu versus mtx+5-fu in gastric cancer with peritoneal metastasis

Conditions: Gastric Cancer; Neoplasm Metastasis

Summary: to develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-fu continuous infusion remains the mainstay for chemotherapy against gastric cancer. on the other, sequential mtx+5-fu was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase ii studies. therefore, the randomized phase iii study of 5-fu versus sequential mtx+5-fu in gastric cancer with peritoneal metastasis was conducted.

Eligibility criteria:
inclusion criteria: 1. histologic confirmation of gastric adenocarcinoma 2. inoperable metastatic disease or recurrent metastatic disease after surgery 3. disease with peritoneal metastasis 4. 20 years or more but less than 75 years 5. performance status 2 or less on the eastern cooperative oncology group scale 6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy 7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer 8. adequate bone marrow function, adequate liver function, and adequate renal function 9. no prior transfusion for anemia 10. provision of written informed consent exclusion criteria: 1. massive pleural effusion 2. brain metastasis with symptoms 3. severe diarrhea 4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) 5. other active malignancies

Keywords: gastric cancer peritoneal metastasis randomized trial 5-fu mtx
ventricular arrhythmia ablation with the use of non-invasive ecg imaging technology

Conditions: Premature Ventricular Contraction; Ventricular Tachycardia

Summary: researchers are trying to determine if the use of software called vivo, made by catheter precision, inc. can shorten the length of time it takes to perform an ablation procedure for either premature ventricular contractions (pvcs) and ventricular tachycardia (vt).


Eligibility criteria:
inclusion criteria: * at least 18 years of age * structurally normal heart * cardiac mri/ct as part of standard of care * diagnosed with premature ventricular contractions or ventricular tachycardia and scheduled to undergo an ablation to treat these conditions exclusion criteria: * less than 18 years of age * structurally abnormal heart
study of hrs-5041 in patients with metastatic castration resistant prostate cancer (mcrpc)

Conditions: Advanced Prostate Cancer

Summary: the purpose of this study is to assess the safety, tolerability and preliminary efficacy of hrs-5041 in men with progressive metastatic castration resistant prostate cancer. the objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of hrs-5041 in phase ii study.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent. 2. age 18-80 years old, gender unlimited. 3. the physical status score of the eastern tumor cooperative group (ecog) was 0 \~ 1. 4. predicted survival ≥12 weeks. 5. histological or cytological confirmed adenocarcinoma of the prostate. 6. patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy. exclusion criteria: 1. prior treatment with an androgen receptor (ar) degrader. 2. plan to receive any other antitumor therapy during this trial. 3. receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study. 4. patients with known brain metastases. 5. any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.
ultrasound guided erector spinae plane block on post-operative pain and diaphragmatic dysfunction in epigastric hernia

Conditions: Epigastric Hernia Repair; Erector Spinae Plane Block; Post Operative Pain; Diaphragmatic Dysfunction

Summary: the aim of this study is to assess the efficacy of ultrasound guided erector spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing epigastric hernia repair.

ventral hernia repair is an operation associated with significant postoperative pain. there is a lot of modalities of pain control including regional anesthesia, intravenous opioids, and non-opioid analgesics. regional anesthesia is often helpful in improving respiratory function and analgesia. the dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper abdominal surgery is a major cause of postoperative pulmonary complications, such as atelectasis and pneumonia. sonografic evaluation of diaphragm is an accepted qualitative method of assessing diaphragmatic motion. the erector spinae plane block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the transverse processes, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves. according to previous studies, erector spinae plane block provide lower postoperative pain score and decrease consumption of both postoperative and intraoperative analgesia for patients undergoing epigastric hernia repair.

Eligibility criteria:
inclusion criteria: * fifty obese patient bmi (30-40). * aged (21-65) years asa (іι and ιιі) * scheduled for elective epigastric hernia repair exclusion criteria: * patient refusal to continue the study. * history of allergy to local anesthetics. * local infection at the site of the block. * patients with bleeding and coagulation disorders. * patients with renal, hepatic, cardiac dysfunction, or spine deformities. * patients with cognitive disorders. * patients with chronic pulmonary disease.
alleviating pre-operative anxiety with innovative 3d immersive virtual reality

Conditions: Virtual Reality; Anxiety; Preoperative Anxiety

Summary: to construct and evaluate an immersive 3d simulation to familiarize patients with the pre-operative experience, and investigate whether a) immersive 3d virtual reality video can reduce pre-operative anxiety, and b) how this approach compares to current practice of viewing traditional educational videos.

the prevalence of pre-operative anxiety is estimated as being as high as 80% in surgical populations. physiologically, this may result in higher cortisol levels, which may slow down the healing and recovery process. a multitude of perioperative clinical trials have revealed that pre-operative anxiety is associated with reduced short-term postoperative recovery, increased pain scores, nause \& vomiting, sleep disturbances, surgical wound infections, increased length of stay, and cardiac complications. it has also been linked with worse functional outcomes and quality of life up to one-year after surgery. literature looking at factors associated with preoperative anxiety outline a general theme of the fear of the unknown that is distressing. specifically, the most distressing events seem to be waiting to be collected for surgery, waiting outside the operating room (or), being transferred to the or bed and having monitors and oxygen mask applied. these moments prior to surgery are when patients are most likely to continuously ruminate over 'what comes next' and the fact of not knowing - leading to anxiety. one survey of 161 patients presenting for elective surgery inquired about factors that led to being calm prior to their procedure and found that being well informed of the pre-operative process was a critical aspect of anxiety relief. approaches such as implementation of the pre-anesthetic clinic (pac) and the use of videos of what to expect leading up to surgery have been implemented to address this issue but have been costly or have had mixed effects. virtual reality (vr) technology presents a new educational opportunity for patients in an effort to reduce pre-operative anxiety. through immersive 3d simulation, patients can experience the journey of being prepped for surgery and transferred to the or. a patient can learn about their pre-operative experience in a more engaging manner as opposed to passively reading, watching video or being verbally taught about it by the healthcare provider. a patient is educated by having the perception of being physically present in the pre-operative experience days or weeks prior to their or date.

Eligibility criteria:
inclusion criteria: * all participants less than 80 years old presenting to the pre-assessment clinic at sunnybrook health sciences centre * planned surgical procedure is 7-14 days after pre-assessment clinic visit exclusion criteria: * inability to provide informed consent * unable to complete study assessments (ie: visually impaired)
aflibercept or bevacizumab as second-line treatment of ras mutated metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: colorectal cancer is the third most frequent neoplasm after prostate and lung in man and breast and lung cancers in woman from western countries. the intensive study of predictive factors has strongly ameliorated the therapeutic flow-chart of metastatic colorectal cancer (mcrc) by allowing the selection of patients who benefit from specific therapies. in this context, the assessment of ras (n- and k-) oncogene mutations is able to predict the response to anti-egfr agents being mutated ras mcrc patients resistant to these drugs. in this group of patients the use of anti-angiogenic drugs (bevacizumab and aflibercept) is predominant. still to date there are no studies to guide oncologists in the selection of the best anti-angiogenic drug (bevacizumab beyond progression vs aflibercept) after failure of the first-line chemotherapy in ras-m mcrc patients. the present is the first observational, pragmatic, prospective study aimed to report outcomes of mcrc patients treated with folfiri plus bevacizumab versus folfiri plus aflibercept in second-line treatment of mras mcrc. furthermore, the serum levels of angiopoietin-1 (ang-1), angiopoietin-2 (ang-2), vascular endothelial growth factor-a and c (vegf-a and c), stromal cell-derived factor-1 (sdf-1), platelet-derived growth factor beta (pdgf-β), basic fibroblast growth factor (bfgf), interleukin-8 (il-8), chemokine (c-c motif) ligand 2 (ccl2), and chemokine (c-c motif) ligand 5 (ccl5) and placental growth factor (plgf), will be evaluated before starting second-line chemotherapy with bevacizumab or aflibercept in order to evidence any pattern related to response and/or prognosis. the hypothesis is that knowledge of eventual unbalance of these factors could help to select the best anti-angiogenic drug in second-line treatment of mras mcrc patients.


Eligibility criteria:
inclusion criteria: * cytological or histological diagnosis of ras mutated mcrc; * progression at first-line chemotherapy with fluoropyrimidines, oxaliplatin and bevacizumab; * stage iv; * age \<75 years; * ecog performance status 0 or 1; * life expectancy\> 3 months; * negative pregnancy test for all potentially childbearing women. exclusion criteria: * presence of primary non-treated stenosing colorectal neoplasm; * active or uncontrolled infections or bleedings; * other concomitant uncontrolled diseases or blood laboratory values contraindicating the study drugs at clinician evaluation; * presence of brain metastases; * refusal or inability to provide informed consent; * impossibility to guarantee follow-up.