Kornimate/medical-research-clean huggingface dataset:
multimodal analgesia in laparoscopic radical gastrectomy with gastric cancer: a multi-center study

Conditions: Gastric Cancer

Summary: the study is aimed to explore the effects of multimodal analgesia consisting of ropivacaine's wound infiltration, parecoxib's intravenous injection and oxycodone-acetaminophen tablets' oral administration on postoperative pain and rehabilitation after laparoscopic radical gastrectomy for patients with gastric cancer.

postoperative pain attracts the attention of surgeons, and optimal postoperative pain management contributes to reducing complications and accelerating postoperative rehabilitation. traditionally, the opioids were used for postoperative pain control. however, the opioids may increase the time to recover bowel function and lead to postoperative ileus. multimodal analgesia is recommended in recent years, but studies on multimodal analgesia after gastrectomy are scarce. in this study, we introduced a multimodal analgesia strategy consisting of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of an oxycodone/paracetamol mixture and evaluated the effects of this strategy compared with pcia analgesia which is used widely for pain after gastrectomy.

Eligibility criteria:
inclusion criteria: 1. requirements of informed consent and assent of participant, parent or legal guardian as applicable. 2. patients underwent laparoscopic radical gastrectomy under general anesthesia and between the age of 18 and 75 years old without considering sex. 3. american society of anesthesiologists (asa) physical status i-iii. 4. participants can follow the drug doses and visit plan exclusion criteria: 1. patients certified by a doctor that doesn't fit to participate in this study. 2. patients allergic to opioids, sulfas, parecoxib, non-steroidal drugs, acetaminophen, tramadol etc.. 3. patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or their cardiac function \> ii (nyha) patients, patients received coronary artery bypass grafting (cabg) recently, and patients with severe hypertension (systolic pressure≥180mmhg or diastolic pressure≥110mmhg). 4. patients with gastric cancer with distant metastasis. 5. patients with severe infection, respiratory dysfunction, coagulation disorders, severe liver and renal dysfunction (child - pugh≥ 10; creatinine clearance \< 25 ml/min). 6. patients with suspect or have a history of drug abuse. 7. pregnancy and lactation women, or have a pregnancy plan within a month after the test of the subjects (also including male participants). 8. sponsors or researchers directly involved in the testing or their family members. 9. patients with conversion, palliative resection. 10. patients with chronic pain（nrs≥3）or using opioids or nsaids before surgery.

Keywords: gastric cancer gastrectomy multimodal analgesia parecoxib
effects of ultrasound-guided genicular nerve block in knee osteoarthritis patients on proprioception and static balance

Conditions: Osteoarthritis; Osteoarthritis, Knee; Proprioceptive Disorders; Balance; Distorted

Summary: genicular nerve block (gnb) is a novel and promising interventional method for pain in knee osteoarthritis (koa). however ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. these proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. this study aims to evaluate pproprioception and static balance after ultrasound-guided gnb in patients with knee osteoarthritis.

genicular nerve block (gnb) is a novel and promising interventional method for pain in knee osteoarthritis (koa). however ,it contains afferent fibers that receive impulses from proprioceptive and deep sensory receptors located in the joint capsule, ligaments, muscles, tendons and periosteum. these proprioceptive stimuli are effective on joint position and biomechanics, protect the joint from injuries and help maintain balance. this study aims to evaluate pproprioception and static balance after ultrasound-guided gnb in patients with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * chronic knee pain more than \>3 according to visual analog scale (vas) and difficulty in function more than 3 months * grade 2-3 koa according to the kellgren -lawrence radiological grading system * no significant improvement in response to conservative treatments such as analgesics and physiotherapy. exclusion criteria: * history of trauma, fractures, malignencies, surgery and inflammatory diseases of knee * limitation of range of motion in unilaterally and/or bilaterally in knee joint * allergies of pharmacological agents using during procedure (lidocaine) * presence of intra-articular or peri-articular injection such as hyaluronic acids, corticosteroids or collagen supplements at last 6 months * other neurologic or rheumatological conditions that may lead vertigo or vestibular disfunction or presence of impairment in proprioception such as polineuropathy * presence of diabetes mellitus due to risk of small fiber neuropathy * cognitive impairment and uncontrolled systemic conditions.
the transitions project: efficacy trial

Conditions: Lung Cancer

Summary: the aim of this study is to evaluate the efficacy of a brief psychoeducational intervention to improve quality of life in patients with lung cancer who are transitioning from active treatment to surveillance.

this is a randomized controlled trial to test the efficacy of a brief psychoeducational intervention relative to a control condition for improving quality of life in patients with lung cancer who are transitioning from treatment to surveillance. in this study, participants will complete survey questions and will be randomly assigned to receive a 5-session program or a 1-session program. it is expected that about 100 people will take part in this research study. the american lung association is supporting this research by providing funding for the research study.

Eligibility criteria:
inclusion criteria: * age 21 or older * able to read and respond in english * diagnosis of non-small cell lung cancer or small cell lung cancer * documented curative treatment plan including systemic therapy +/- radiation and +/- surgery * completed cancer treatment within past 3 weeks * if final treatment is systemic therapy +/- radiation: within 3 weeks after cancer care team determination that treatment is complete * if final treatment is surgery: within 3 weeks after hospital discharge following surgery exclusion criteria: * comorbid health condition that would interfere with study participation * current participation in cognitive behavioral therapy treatment

Keywords: lung cancer supportive care
team: testosterone supplementation and exercise in elderly men

Conditions: Healthy

Summary: the purpose of this study is to evaluate the effects of testosterone supplementation (androgel) on body composition, strength, endurance, cognition, and function in older men.

studies suggest that testosterone (t) replacement in healthy elderly men has beneficial effects on body composition, muscle, bone, memory, and behavior, but the risks of chronic treatment, especially on the prostate, heart, and sleep quality, are not entirely clear. therefore, it is most desirable to supplement into the lowest "effective" range in elderly men. however, the effects of lower than usual replacement t doses have not been well studied. furthermore, the possible important interaction of exercise to enhance the positive effects of t supplementation, yet mitigate the possible side effects, has not been studied in older men. this one-year study will enroll 150 men with low-normal to slightly below normal serum total t levels. participants will be randomized into one of 6 treatment groups to receive t supplementation (androgel) of 25mg/day, 50 mg/day or a placebo crossed with progressive resistance training (prt) exercise 3 times a week versus none. at the end of the study, participants in the exercise-control group will be offered prt. please see link below for updated version of full protocol.

Eligibility criteria:
inclusion criteria: * generally healthy, untrained men 60 years or older with low-normal testosterone levels (200-350ng/dl) * must reside in the denver metro area exclusion criteria: * prostate/breast cancer * unable to exercise safely * severe obesity (\>34 body mass index \[bmi\]) * polycythemia * diabetes * use of drugs that could affect t levels * cognitive dysfunction (mmse less than 24) * psa above the age-adjusted normal level or aua greater than 19 * unable to pass stress test due to active cad

Keywords: andropause hypogonadism androgel exercise prt testosterone t supplementation
investigating the efficacy and safety icatibant for the treatment of patients with sars-cov-2 (covid-19) infection

Conditions: COVID-19 Pneumonia

Summary: to study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by covid-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.


Eligibility criteria:
inclusion criteria: 1. adult patients (18 years or older), both sexes 2. sars-cov-2 infection confirmed by pcr less than 4 days before randomization 3. hospitalized with a diagnosis of sars-cov-2 pneumonia 4. radiographic evidence of pulmonary infiltrates 5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition 6. po2/fio2 \<380 7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception 8. obtaining the informed consent of the patient or the legal representative. exclusion criteria: 1. imminent death (life expectancy less than 72h) 2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation 3. invasive mechanical ventilation 4. participation in any other clinical trial 5. alt or ast \> 5 x uln 6. creatinine clearance \<50 ml/min using the cockcroft-gault formula for participants '18 years old \[cockcroft 1976\] 7. patients with recent acute coronary syndrome (\<1 month) 8. patients with a history of stroke 9. positive pregnancy test 10. pregnant or lactating woman

Keywords: icatibant
study of hl-085 in nras mutant advanced melanoma

Conditions: Melanoma

Summary: this is a phase i/ii, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with nras mutant advanced melanoma .


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed unresectable stage iii or stage iv melanoma according to ajcc (version 7, 2010). 2. subjects must have nras mutation in melanoma. 3. chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study treatment. surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the study treatment. 4. ecog performance status of 0-1. 5. life expectancy ≥ 3 months. 6. ability to take the medicine orally. 7. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. prior therapy with a mek-inhibitor 2. patients with known hypersensitivity to study drug ingredients or their analogues. 3. active central nervous system (cns) lesion. 4. ecg qtcb≥480msec in screening, or history of congenital long qt syndrome. 5. subjects with bleeding symptoms at grade 3 (nci-ctcae v4.03) within 4 weeks prior to starting study treatment. 6. uncontrolled concomitant diseases or infectious diseases. 7. retinal diseases (retinal vein occlusion (rvo) or retinal pigment epithelial detachment (rped) , et al.). 8. history of hiv,hcv,hbv infection. 9. interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded. 10. serum hcg test is positive. 11. other conditions that influence the results and increase the risk of study.

Keywords: melanoma nras
investigation of the role of brain natriuretic peptide and lactate in early goal-directed therapy for patients with severe sepsis and septic shock

Conditions: Sepsis; Septic Shock

Summary: b-type natriuretic peptide (bnp) is a cardiac neurohormone which rapidly released by the ventricle in response to myocardial stretch. bnp has been used as a biomarker of sepsis related cardiac dysfunction and volume overload in critical ill patients. it is also a marker associated with prognosis in patients with severe sepsis and septic shock. however, the clinical utility of bnp level in management of early severe sepsis and septic shock over the first 48 hours is not clear. besides, lactate represents as a maker of tissue hypoperfusion, which has been used as a guide therapy for sepsis patients and high serum lactate level is independently associated with mortality in severe sepsis. today, in management of early severe sepsis and septic shock, current guideline emphasize the early goal-directed therapy (egdt) with achieving the central venous pressure (cvp) level 8-12 mmhg by fluid support first, then targeting the next goal to maintain mean airway pressure (map) at least 65 mmhg by vasopressor agent (ie, norepinephrine) and finally keeping central venous oxyhemoglobin saturation (scvo2) \> 70% via optimal hct \> 30% and dobutamine usage within first 6 hours of emergency department admission. however, the role of bnp and lactate in patients with severe sepsis and septic shock with or without myocardial dysfunction under egdt management are not clear. the investigators will conduct a prospective observational study to investigate the change of bnp and lactate within 48 hours in early severe sepsis and septic shock under egdt management, their association of cardiac dysfunction and their role in predicting various clinical outcome. the investigators also want to see if bnp and lactate could be useful tools to guide the adjustment of optimal fluid supply and the timing of inotropic agent intervention.


Eligibility criteria:
inclusion criteria: * patients \> 18 years old * severe sepsis with or without septic shock exclusion criteria: 1. previous known heart failure or cardiomyopathy history 2. acute coronary syndrome 3. clinical pulmonary hypertension with various cause (ipah, congenital heart disease, cteph, copd with cor pulmonale) 4. patients with acute pulmonary embolism 5. chronic af with lvh 6. acute cerebral vascular event 7. respiratory failure with high peep \> 10 cmh2o) 8. various cancer with distant metastasis 9. patients with bosmin therapy 10. patients received cpr (ihca or ohca) 11. massive gi bleeding or hypovolemic shock 12. pregnancy 13. contraindication to central venous catheterization 14. drug overdose 15. burn injury, trauma patients 16. a requirement for immediate surgery 17. liver cirrhosis child c
pet scan combined with ct scan in evaluating treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma

Conditions: Sarcoma

Summary: rationale: diagnostic procedures, such as pet scan and ct scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment. purpose: this clinical trial is studying how well pet scan combined with ct scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.

objectives: * determine whether an fda-approved device that combines fludeoxyglucose \^18f positron-emission tomography (fdg-pet) and ct scanning (fdg-pet/ct) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma. * determine whether fdg-pet/ct scanning is effective in evaluating the response of sarcoma to treatment. * determine whether the new fdg-pet/ct device improves the ability to evaluate treatment response early and accurately. * correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival. * correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery. outline: this is a prospective, pilot study. patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma). patients undergo fludeoxyglucose \^18f positron-emission tomography (fdg-pet)/ct scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans). projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed bone or soft tissue sarcoma * scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma * negative pregnancy test * fertile patients must use effective contraception * not claustrophobic * able to lie supine for 1 hour * patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dl exclusion criteria: * pregnant * other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence

Keywords: recurrent adult soft tissue sarcoma stage i adult soft tissue sarcoma localized osteosarcoma metastatic osteosarcoma recurrent osteosarcoma stage ii adult soft tissue sarcoma stage iii adult soft tissue sarcoma stage iv adult soft tissue sarcoma
robotic assisted laparoscopic prostatectomy with or without pelvic drain placement in reducing adverse events after surgery in patients with prostate cancer

Conditions: Perioperative/Postoperative Complications; Prostate Cancer

Summary: this randomized phase iii trial studies robotic assisted laparoscopic prostatectomy (ralp) with pelvic drain placement to see how well it works compared to ralp without pelvic drain replacement in reducing adverse events after surgery in patients with prostate cancer.

primary objectives: i. to determine if eliminating placement of a pelvic drain in patients during robotic assisted laparoscopic prostatectomy (ralp) increases incidence of early postoperative adverse events occurring within 90 days from prostatectomy, compared to patients who have a pelvic drain placed during ralp. secondary objectives: i. to determine the incidence of early postoperative adverse events in patients with and without a pelvic drain when adjustments to confounders associated with these events are made (confounders: demographic, surgical and pathologic; age, body mass index \[bmi\], pathologic stage, gleason sum, extent of lymph node dissection). ii. to report peri-operative and postoperative outcomes, including but not limited to, length of hospital stay, re-admissions, continence, potency and incidence of medical interventions for patients with and without pelvic drain. iii. to compare early postoperative adverse event rates between patients with and without a pelvic drain in patients who had extended pelvic lymph node dissection during ralp. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients undergo ralp. arm ii: patients undergo ralp and placement of pelvic drain. after completion of treatment, patients are followed up at 1 week and then 1, 3, 6, 9, and 12 months.

Eligibility criteria:
inclusion criteria: * male patients diagnosed with prostate cancer and scheduled to undergo ralp at city of hope national medical center * written informed consent obtained in accordance with institutional policies approved by the u.s. department of health and human services * patients with prior transurethral resection and other prostate procedures are eligible with the exception of the procedures indicated in the exclusion criteria exclusion criteria: * non-compliance * prior radiotherapy to the pelvis or prostate * prior extensive pelvic surgery such as low anterior reception, abdomino-perineal resection, or proctocolectomy continent stool pouch, or any other extensive abdomino-pelvic surgery that would render the patient high-rick for complications as deemed by the surgeon * demonstrated intra-operative anastomotic leakage when irrigated with 120 ml of normal saline at the end of surgery * intra-operative injuries (for example: rectal injury) * inadequate hemostasis
hfhs-1801-a pilot study of immunotherapy as consolidation therapy for patients with recurrent head and neck cancer

Conditions: Head and Neck Neoplasms

Summary: the study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. the current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. however, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or older, of either gender, with the ability to consent to participation in the study. * patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors. * all patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy. * all patients must have undergone salvage surgery in an attempt to excise all recurrent disease. * salvage radiation therapy must not be an option available to the patient. * patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism. exclusion criteria: * patients with macroscopic residual disease * patient is eligible for radiation therapy. * performance status more than 2. * contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline. * patients with other previous cancers excluding cin, dcis, non-melanoma skin cancers * patients previously treated with immunotherapy \<12months prior * patients with synchronous cancers "not included in the inclusion criteria"

Keywords: recurrent head and neck cancer recurrent head and neck neoplasms