Kornimate/medical-research-clean huggingface dataset:
correlation of timing of pegfilgrastim administration and pibp.

Conditions: Pegfilgrastim; Bone Pain; Chemotherapy; Breast Cancer; Patient-reported Outcomes; Quality of Life

Summary: according to the national comprehensive cancer network (nccn) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (fn) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (g-csfs). however, pegfilgrastim-induced bone pain (pibp) remains a common and significant clinical issue without a satisfactory solution. studies have reported that the incidence rate of pibp is 71.3%, with severe bone pain occurring in 27.0% of cases. currently, the available data on pibp treatment are limited to case reports, reviews, and small randomized controlled trials. the nccn guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for pibp. however, even with these preventive measures, the incidence rate of pibp remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. severe bone pain can significantly impact the patient's health-related quality of life (hrqol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. ultimately, this may have negative implications for tumor cure rates and patient survival. based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of pibp. therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of pibp.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years and less than or equal to 70 years. 2. pathologically or histologically confirmed diagnosis of primary breast cancer. 3. able to receive the chemotherapy regimen as scheduled. 4. able to understand chinese and fill out the study-related questionnaires independently. 5. given written informed consent. 6. there is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain. exclusion criteria: 1. suffering from bone pain due to other diseases currently. 2. allergy or contraindication to chemotherapeutic agents or pegfilgrastim. 3. previous use of pegfilgrastim. 4. previous received chemotherapy. 5. pregnancy or breastfeeding. 6. concurrently accompanied by other primary malignant tumors.

Keywords: pegfilgrastim bone pain patient-reported outcomes chemotherapy breast cancer health related-quality of life
intraperitoneal aerosolized delivery of a local anesthetic for post operative pain management. a double blind, randomised controlled clinical trial.

Conditions: Pain, Postoperative; Postoperative Pain; Abdominal Pain; Obesity; Pneumoperitoneum

Summary: the purpose of this study is to determine the effectiveness of aerosolized pain medication (.5% bupivicaine) delivered into the peritoneal cavity after laparoscopic gastric bypass surgery. this double blind study will include 50 patients. 25 will receive the aerosolized pain medication and 25 will receive a placebo (normal saline). all 50 patients will receive routine/typical methods of post-operative pain management. post operative pain scores of the patients will be examined to determine the effect of aerosolization.

surgical technique 1. 30 mls of 0.5% bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity. 2. all the patients will be under a consistent intra-abdominal pressure using co2 and the laparoscopy will be carried out using the same, routine / typical surgical instruments. a. control group (n=25): aerosolized normal saline will be introduced at the end of the procedure, using a specially designed sterile catheter. the catheter will be inserted via trocar port under direct vision. the other end of the catheter will be connected to a 72" edwards lifesciences pressure tubing (ref: 50p172), which will be connected to a b\&d 20cc syringe filled with 15 ml of normal saline and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. the total dose of patient delivered normal saline will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72" pressure tubing. routine/typical methods of post-operative pain management will be employed. b. aerosolized anesthetic (n=25): at the end of the procedure, the aerosolized local anesthetic will be introduced using a specially designed sterile catheter. the catheter will be inserted via trocar port under direct vision. the other end of the catheter will be connected to a 72" edwards lifesciences pressure tubing (ref: 50p172), which will be connected to a b\&d 20cc syringe filled with 15 ml of anesthetic agent and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent. the total dose of patient delivered anesthetic will be 10 ml, with 5 ml remaining contained and undelivered within the catheter and 72" pressure tubing. routine/typical methods of post-operative pain management will be employed.

Eligibility criteria:
inclusion criteria: 1. male or female patients between the ages of 18-65 2. patients in general good health requiring elective surgery exclusion criteria: 1. female patients that are pregnant 2. patients allergic to bupivicaine 3. patients who have used narcotic drugs within 30 days of the surgical procedure.

Keywords: laparoscopy laparoscopic surgical procedures laparoscopic surgery gastric bypass drug delivery systems pain measurement
a multicenter study of rus ne

Conditions: Renal Tumors

Summary: this sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of rus ne surgical navigation system in patients undergoing robotic-assisted partial nephrectomy. the trial will compare the experimental group (n=102) using rus ne with a control group (n=102), aiming to show an 10% reduction in operation time. the study will involve 6 medical centers in south korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies. * investigational medical device: rus ne (endoscopic imaging treatment planning software) * clinical trial duration: 24 months from irb approval -target number of subjects: total of 204 participants

after selecting subjects and obtaining informed consent, randomization will be conducted. robot-assisted partial nephrectomy will be performed using rus ne or without using software. parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

Eligibility criteria:
inclusion criteria: * individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy * the diameter of renal tumor is 7cm or below * individuals aged between 19 and 80 * individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form exclusion criteria: * individuals with solitary kidney or horseshoe kidney * individuals undergo bilateral nephrectomy * individuals undergo operation other than partial nephrecotmy * individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes * individuals with severe chronic kidney disease (egfr \< 45, calculated with epi-cki equation) * individuals with american society of anesthesiologists physical status classification (asa) iv-vi * individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study * individuals who were participated in other clinical study within 4 weeks of screening * individuals who are thought to be inappropriate to participate to the clinical trial by the investigators

Keywords: renal tumor robot assisted partial nephrectomy 3d model surgical navigation
post-mortem genetic testing

Conditions: Cardiac Ion Channelopathy

Summary: this is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.


Eligibility criteria:
inclusion criteria: * unexplained still births, * no cause of death after detailed autopsy exclusion criteria: * lack of parental consent

Keywords: ion channelopathy, still birth sudden death
ph weighted chemical exchange saturation transfer mri-based surgical resection to improve survival in patients with glioblastoma

Conditions: Glioblastoma

Summary: this phase iii trial compares ph weighted chemical exchange saturation transfer (cest) magnetic resonance imaging (mri)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard mri imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard mri. mri is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. these pictures can show the difference between normal and tumor tissue. cest mri is a technique that uses differences in the tissue environment, like protein concentration or intracellular ph, to generate contrast differences. cest mri may identify tumor tissue that does not enhance with standard of care mri. ph weighted cest mri based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

primary objective: i. to assess the efficacy of potential of hydrogen (ph) sensitive mri based resections of glioblastoma. secondary objective: i. to find surgical and adjuvant therapies to treat infiltrating glioblastoma cells. outline: patients are randomized to 1 of 2 groups. group i: patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced mri. patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide orally (po) for 6 weeks. additionally, patients undergo mri during follow up. group ii: patients undergo surgical resection with intraoperative guidance using cest mri. patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide po for 6 weeks. additionally, patients undergo mri during follow up. after completion of study treatment, patients are followed up at months 3, 6, 12, and 24.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age * documentation of a newly diagnosed world health organization (who) grade iv glioblastoma as evidenced by clinical features and imaging data * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study exclusion criteria: * male or female \< 18 years of age * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data * not medically cleared for surgery * previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)
comparison of microwave ablation with breast conserving surgery for breast tumor

Conditions: Breast Tumor; Microwave Ablation; Breast Conserving Surgery

Summary: the investigators will perform this study to prospectively compare the clinical outcome after percutaneous microwave ablation(mwa) and breast conserving surgery of benign and malignant breast lesion under ultrasound (us) guidance.

a total of more than 300 patients diagnosed with breast tumor in multiple centers will be recruited in this study and underwent us-guided percutaneous mwa and breast conserving surgery treatment. information for each patient includes demographics; longest diameters of tumors; tumor numbers; tumor pathological type; location of tumor according to whether adjacent to skin, pectoralis, areola and papilla. ablation variables including session, puncture, time, and power; complete ablation, complications; reduction in volume, palpability, pain and cosmetic satisfying outcomes,recurrence,survival will be compared and analyzed.

Eligibility criteria:
inclusion criteria: 1. women, 2. with invasive ductal carcinoma of the breast according to core-needle 3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or ipsilateral grade i and ii axillary lymph node metastasis, movable(pt0-2n0-1m0 ) 4. located at least 10 mm from the skin surface and chest wall. exclusion criteria: 1. men 2. women who were pregnant or breastfeeding 3. radiologic suspicion of multifocality or extensive intraductal carcinoma 4. histologic diagnosis of lobular carcinoma 5. neoadjuvant therapy 6. previous surgery or radiation therapy of the ipsilateral breast.
chidamide plus etoposide and cisplatin/carboplatin as first-line treatment for extrapulmonary neuroendocrine carcinoma

Conditions: Neuroendocrine Tumors; Neuroendocrine Carcinoma

Summary: the purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.

this study is a single-arm, multi-center, two-stage, phase ii clinical trial conducted in china. this study adopts simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. if more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma; 3. no systematic treatments for neuroendocrine carcinoma are received before enrollment; 4. ecog ≤ 2; 5. have at least one measurable lesion according to recist version 1.1, and the lesion has not received any local treatments; 6. absolute neutrophil count ≥ 1.5×109 / l, platelet count ≥ 100×109 / l, hemoglobin ≥ 90 g/l; 7. have ability to sign a written informed consent. exclusion criteria: 1. have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment; 2. previous use of hdac inhibitors; 3. allergy to related drug components; 4. have a medical history of immune deficiency diseases, or organ transplantation; 5. have uncontrolled or significant cardiovascular disease; 6. abnormal liver function (total bilirubin \> 1.5×upper limit of normal); transaminases (alt/ast) \>2.5×upper limit of normal (\>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine \> 1.5×upper limit of normal); 7. pregnancy ; 8. have serious diseases that may endanger the safety of patients, or affect patients to complete the research; 9. any serious mental or cognitive disorder; 10. patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment; 11. any other condition which is inappropriate for the study in the opinion of the investigators.

Keywords: histone deacetylase inhibitors chidamide neuroendocrine carcinoma
preventing dyspnea during speech in older speakers

Conditions: Dyspnea

Summary: due to various comorbidities affecting the respiratory system, older speakers are at risk of experiencing breathing discomfort (dyspnea) during high-demand vocal activities such as singing, loud speaking, and speaking while exercising. dyspnea during speech can promote avoidance of certain situations involving voice production, thus leading to vocal deconditioning and decreased quality of life. the goal of this pilot study is to test the feasibility and acceptability of a 4-week remote group intervention targeting phonatory dyspnea, and to gather preliminary efficacy data. participants will receive an intervention including a 2-week socialization phase (control condition) and a 4-week speech breathing intervention phase (experimental condition). both phases will be delivered remotely and in a group setting (10 participants per group).


Eligibility criteria:
inclusion criteria: * sign the informed consent form * report dyspnea in at least one of the items of the university of cincinnati dyspnea questionnaire referring to speech * be available during the dates of the scheduled group interventions * be aged 50 years or older exclusion criteria: * do not have access to a computer and internet connection * present with a known voice pathology (other than age-related vocal fold atrophy) and/or are receiving speech therapy at the time of the study * have a known neurodegenerative disease affecting speech/voice * are a current smoker * are receiving pulmonary rehabilitation at the time of the study or are starting a new medication regimen for a respiratory disease at the time of study onset; * have a hearing loss that is not adequately managed, as judged by the principal investigator (pi) * have professional vocal training \[amateur choir singers will not be excluded\] * cannot provide informed consent or easily follow instructions * have any other condition that precludes them from participating in the behavioral interventions, as judged by the pi.

Keywords: dyspnea speech therapy communication aging breathing respiratory intervention voice
effects of vocal exercises for spasmodic dysphonia

Conditions: Adductor Spasmodic Dysphonia

Summary: the purpose of this study is to assess the effect of voice exercise and voice rest on subject's perception of vocal handicap and communicative participation following botox injections for adductor spasmodic dysphonia.

spasmodic dysphonia (sd) is a neurological disorder characterized by involuntary spasms of the vocal folds resulting in a strained and strangled voice quality. this disorder is quite disabling to patients who suffer from it, particularly affecting patients' quality of life. botulinum toxin (botox) has been found to be the most effective treatment for sd. the botox is injected into the affected muscle resulting in temporary weakening of the muscle. the patients return for injections on average every 3 - 6 months. there is a suggestion in the literature that increased diffusion of the botox injectate could improve the effects of the injection. furthermore, there is literature supporting the use of exercise to increase the diffusion of the botox. previous research examined the use of voluntary muscle activity vs. rest immediately following botox injection for writer's cramp. it was found that the active condition resulted in greater reduction of muscle strength in the injected muscle. another small study of 9 patients implemented intense exercise comprised of loud reading for one hour and a rest condition of total voice rest for 24 hours. they found that the exercise condition resulted in improved scores on the voice related-quality of life (v-rqol) measure and concluded that improvement in results of botox injections may be achieved more consistently with the implementation of exercise following the injection. the exercise used in this study was intense and may be contrary to the overall benefit as the subjects may experience phonotrauma. timing of the exercise post-injection may also be a factor. previous literature review revealed combined modality treatment of botox injection only, botox with therapy and botox with sham treatment. they found no significant differences in acoustic stability, v-rqol, or duration of injection benefit. however, the exercise was initiated 3 weeks post-injection and completed once per week for 5 weeks. investigators aim to identify what might improve or extend the duration of botox injections for adductor spasmodic dysphonia.

Eligibility criteria:
inclusion criteria: 1. female 2. 21-70 age 3. diagnosed with pure adductor spasmodic dysphonia 4. completed 2 consecutive standard of care botox injection into the thyroarytenoid (ta) and/or thyroarytenoid/lateral cricoarytenoid (ta/lca) junction with the same dosage exclusion criteria: 1. receiving botox to other laryngeal or supraglottic musculature 2. other neuro-laryngological conditions 3. those with an average of less than two injections per year

Keywords: botox injection spasmodic dysphonia voice therapy speech therapy voice rest
transpulmonary driving pressure in ards covid19 patients

Conditions: Mechanical Ventilation; SARS-CoV-2; COVID-19

Summary: a majority (65-85%) of critically ill patients admitted in intensive care units with a confirmed diagnostic of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) developed an acute respiratory distress syndrome (ards) according to berlin criteria. gattinoni et al. recently described that the ards related to sars-cov-2 was not a "typical" ards. patients affected by this infection present indeed a major hypoxemia, which was surprisingly associated in early phase with a high compliance of respiratory system, more than 50 ml/cm h2o in most cases. the cornerstone of current treatment in case of ards is the use of "lung protective" ventilation, including limited tidal volumes (vt), low end-inspiratory plateau pressures while maintaining sufficiently-high positive end-expiratory pressures (peep). however, high levels of peep in patients may have detrimental effects on hemodynamic status and fluid retention, particularly when the respiratory system compliance is normal. high peep may also lead to overdistension and an increase of alveolar dead space. the airway pressures commonly monitored does not reliably reflect the impact of pressures on the lung parenchyma. elastance of chest wall may indeed largely influence values of airways pressions. in contrast, transpulmonary pressure obtained using esophageal pressure (pes) directly reflect lung overdistension risk and lung properties. in order to better understand this new kind of ards characterized by modest recruitable profile and to better personalize mechanical ventilation setting and therapy it is obvious to precise transpulmonary pressure.


Eligibility criteria:
inclusion criteria: * major patients (18-90 years old) * hospitalized following sars-cov-2 * mechanical ventilatory support exclusion criteria: * minor patients

Keywords: elastance acute respiratory distress syndrome esophageal pressure pleural pressure