Kornimate/medical-research-clean huggingface dataset:
effect of enhanced recovery after surgery for benign anorectal conditions

Conditions: Anal Fistula; Anal Fissure Chronic; Haemorrhoid; Enhanced Recovery After Surgery (ERAS) Protocol

Summary: this study aims to assess the role of enhanced recovery after surgery(eras) protocol in reducing postoperative urine retention (pour) after surgery for benign anorectal conditions.

this study aims to assess the role of enhanced recovery after surgery(eras) protocol in reducing postoperative urine retention (pour) after surgery for benign anorectal conditions. patients of both sexes aged between 18 and 90 years old presented; with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study. eligible patients will be randomized in equal proportions to rras or routine pathways. the eras pathway was developed based on the available guidelines and protocols it includes 14 items. patients allocated to eras pathway must fulfill all the 14 items. the routine pathway will represent the routine practice which may include certain eras items or those who will not fulfill the 14 items. for the end points of the study, all patients will be followed-up by a phone call 72 hours postoperatively then in the outpatients' department for a period of a total of 30 days postoperatively. however, patients will be advised to visit the outpatients' department at any other time during the trial if they developed any unfavorable event. the primary outcome will be the 72-hours postoperative urinary retention after anorectal surgery.

Eligibility criteria:
inclusion criteria: * both sexes * aged between 18 and 65 years old * presented with benign anorectal conditions including chronic anal fissure, hemorrhoids, and fistula-in-ano will be eligible for the study exclusion criteria: * younger than 18 * older than 65 years old * pregnant female * history of relevant urological diagnosis (benign prostatic hyperplasia/prostate cancer/urethral stricture/bladder neck stenosis/detrusor underactivity/detrusor overactivity) * history of relevant urological procedure (radical prostatectomy/ transurethral prostatectomy/bladder neck or urethral surgery/pelvic radiotherapy) * use of permanent urinary catheter * intraoperative urological procedures * with any form of urinary diversion * severe cognitive impairment * who undergo other anorectal procedures

Keywords: eras postoperative urinary retention benign anorectal conditions anal fistula anal fissure haemorrhoids
electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery

Conditions: Low Back Pain; Pain, Postoperative; Failed Back Surgery Syndrome

Summary: the purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.


Eligibility criteria:
inclusion criteria: * patients whose low back pain persisted or recurred after back surgery with or without leg pain. * patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy). * patients with pain, defined as an visual analogue scale (vas) value ≥ 50mm. * patients who are 19 - 70 years of age. * patients who agreed to voluntarily participate in this study and signed informed consent. exclusion criteria: * patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions). * patients with progressive neurological deficit or severe neurological symptoms. * patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout). * patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions). * patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions) * patients who are currently pregnant or planning the pregnancy. * patients with psychiatric diseases. * patients who are participating in other clinical trial. * patients who are unable to sign informed consent. * patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write korean.
safety and efficacy study of gdc-0853 compared with placebo and adalimumab in participants with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this is a multicenter, phase ii, randomized, double-blind, placebo-controlled, active comparator (cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of gdc-0853 in participants with moderate to severe active ra and an inadequate response to previous methotrexate (mtx) therapy (cohort 1) or mtx and tumor necrosis factor (tnf) therapy who may have also had exposure to no more than one non-tnf inhibitor biologic (cohort 2).


Eligibility criteria:
inclusion criteria: * have a diagnosis of adult-onset ra as defined by the 2010 american college of rheumatology/european league against rheumatism classification criteria for ra * ra disease activity by joint counts and laboratory markers of inflammation: greater than or equal to (\>=) 6 tender/painful joints on motion (68 joint count) and \>= 6 swollen joints (66 joint count) at both screening and day 1 (randomization) * for mtx-inadequate response (ir) participants: must have had an inadequate response to mtx * for tnf-ir participants: must have had an inadequate response or intolerance to previous treatment with at least 1 and no more than 2 biologic tnf-alpha inhibitors and may have also been exposed to no more than one biologic non-tnf-alpha inhibitor * high sensitivity c-reactive protein of \>= 0.400 milligrams per deciliter (mg/dl) for cohort 1 and \>= 0.650 mg/dl for cohort 2 at screening exclusion criteria: * history of or current inflammatory joint disease other than ra or other systemic autoimmune disorder * for mtx-ir participants: history of treatment with any tnf inhibitor, including biosimilar equivalents and history of treatment with biologic non-tnf-alpha inhibitor for ra * for all participants: previous treatment with cell-depleting therapy including b cell-depleting therapy (e.g., anti-cluster of differentiation 20-directed therapy such as rituximab), tofacitinib, or other janus kinase inhibitor(s), or alkylating agents * current treatment with medications that are well known to prolong the qt interval at doses that have a clinically meaningful effect on qt * history of non-gallstone-related pancreatitis or chronic pancreatitis * evidence of serious uncontrolled concomitant cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease * evidence of chronic and/or active hepatitis b or c * women who are pregnant, nursing (breast feeding), or intending to become pregnant during the study or within 60 days after completion of the study
ultrasound study of the uterine healing process after cesarean delivery

Conditions: Myometrial Remodeling

Summary: our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery.

we are recruiting women who are presenting for their first (primary) cesarean delivery. they will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process.

Eligibility criteria:
inclusion criteria: * singleton gestation * term pregnancy * kerr uterine incision employed * age \> 18 exclusion criteria: * pain score \> 4 * current cesarean delivery for non-reassuring fetal status or other emergent situation (eg. maternal bleeding, etc.) * prior cesarean section * prior uterine surgery * hysterotomy other than kerr (low transverse) incision in current cesarean * extension of the uterine incision in current cesarean * multifetal pregnancy * maternal diabetes mellitus * maternal connective tissue disorder * uterine malformation * uterine myomas (fibroids) in the anterior lower uterine segment * chorioamnionitis * non-english speaking
rimonabant in prediabetic subjects to delay onset of type 2 diabetes

Conditions: Prediabetic State

Summary: primary objective: to evaluate the effect of long-term administration of rimonabant on the time of progression to type 2 diabetes in patients with prediabetes (i.e. impaired fasting glucose (ifg) or impaired glucose tolerance (igt) or both at baseline). secondary objectives: * to assess the effect on weight loss and weight maintenance; sustained effect following a washout period, effect on other markers of glycemic control (fasting glucose, fasting-insulin and hba1c), glucose tolerance and insulin responses during oral glucose tolerance tests (ogtts), and on other risk factors (hdl-cholesterol, tg), * to assess the effect on quality of life * to evaluate long term safety and tolerability.

the total duration per patient will be approximately 38 months including a 30-month double-blind treatment period.

Eligibility criteria:
inclusion criteria: * no previous history of treatment for type 2 diabetes. * diagnosis of : * impaired glucose tolerance (igt) based on one oral glucose tolerance test (ogtt) and defined as a 2 hour post-challenge glucose (after a 75-g oral glucose tolerance test) \> 140 mg/dl (7.8 mmol/l) but \< 200 mg/dl (11.1 mmol/l), at the screening visit. * and / or impaired fasting glucose (ifg) based on a fasting plasma glucose (fpg) ³ 100 mg/dl (5.6 mmol/l) and \< 126 mg/dl (7.0 mmol/l), at the screening visit. exclusion criteria: * absence of effective contraceptive method for females of childbearing potential. * presence of any clinically significant endocrine disease according to the investigator.note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. * presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study. * presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. * related to laboratory findings: * positive test for hepatitis b surface antigen and/or hepatitis c antibody; * positive urine pregnancy test in females of childbearing potential ; * thyroid-stimulating hormone (tsh) and free t4 outside central laboratory normal range. * related to previous or concomitant medications: * within 3 months prior to screening visit and/or during the screening period: * anti-obesity drugs (e.g., sibutramine, orlistat, herbal preparations, etc), * systemic long-acting corticosteroids; prolonged use (more than 10 days) of systemic corticosteroids;

Keywords: prediabetic state impaired fasting glucose impaired glucose tolerance
effect of dexmedetomidine after thyroidectomy

Conditions: Thyroid Tumor

Summary: the purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).

smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. after thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation. the purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.

Eligibility criteria:
inclusion criteria: * female patient, * aged 20-60 yr, * asa physical status 1-2, * patients undergoing elective thyroidectomy under general anesthesia exclusion criteria: * sighs of difficult airway, * history of respiratory disease or chronic cough, * cardiovascular disease, * pregnant or breast-feeding woman
concurrent nab-paclitaxel with intensity-modulated radiation therapy in patients with stage iii-iva nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma (NPC)

Summary: the goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase ii dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².


Eligibility criteria:
inclusion criteria: * pathologically confirmed nasopharyngeal carcinoma * iii-iva (ajcc8th) * age 18-70 * ps score 0-1 * normal functions to tolerate chemotherapy and radiotherapy exclusion criteria: * the presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted. * symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors

Keywords: nasopharyngeal carcinoma nab-paclitaxel concurrent chemotherapy
fecal microbiota transplantation with ruxolitinib and steroids as an upfront treatment of severe acute intestinal gvhd

Conditions: Intestinal GVHD

Summary: therapy of severe intestinal graft-versus-host disease (gvhd) despite the introduction of novel target agents is associated with worse outcome compared to the other forms. response to steroids is observed only in about 10% of patients. the most promising approaches are jak inhibition and fecal microbiota transplantation. in this pilot study we evaluate this combination treatment in the first line.

acute intestinal gvhd grade iii-iv after allogeneic stem cell transplantation the form with low effectiveness of corticosteroids. despite high response rate to systemic immunosupressive agents, long term survival in this group is poor due to recurrent septic episodes and gut colonization with multidrug resistant bacteria. fecal microbiota transplantation (fmt) from a healthy allogeneic donor, allows to restore numerous local and systemic microbiota functions, including immunomodulation and thus to reduce/stop the manifestations of gvhd. the therapeutic mechanism of action of fmt is based on competition for nutrients between obligate and pathologic bacterial strains, direct growth inhibition of the pathological pathogens, host immune system modulation, especially t-reg homeostasis, through interaction with the normal microbiota.in this pilot trial we combine fmt with ruxolitinib and steroids, one of the most effective option for refractory gvhd.

Eligibility criteria:
inclusion criteria: * age 5-70 years * histologically confirmed gastrointestinal acute gvhd * grade iii-iv gastrointestinal gvhd based on 2016 magic criteria * ability for oral drug intake * signed informed consent exclusion criteria: * requirement for oxigen and/or vasopressor support * respiratory distress \>grade i * severe organ dysfunction: ast or alt \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits,creatinine clearance \< 60 ml/min * ongoing fluconazole therapy * any malignancy requiring systemic therapy at the time of enrollment * mixed chimerism at last evaluation * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * severe concurrent illness that can interfere with study procedures * somatic or psychiatric disorder making the patient unable to sign informed consent
study to evaluate the safety and efficacy of balovaptan in participants with acute ischemic stroke at a high risk of developing malignant brain edema

Conditions: Acute Ischemic Stroke

Summary: this study is designed to evaluate the safety, efficacy, and pharmacokinetics of balovaptan compared with placebo in participants with acute ischemic stroke (ais) at risk of developing malignant cerebral edema (mce)


Eligibility criteria:
inclusion criteria: * diagnosis of lvo in the anterior circulation such that study drug administration can be initiated within 12 hours of lkw and at risk of mce development, as defined as follows: * documented occlusion of terminus ica and/or mca on cta or magnetic resonance angiogram and * aspects score \</=5 on ncct and * nihss \>15 for the non-dominant hemisphere and \>20 for the dominant hemisphere (or \> 20 if dominant/non-dominant hemisphere unknown) * present with a wus \</=8 hours from awakening provided the above criteria are met * participants with a history of seizures on anti-epileptic medications may be included if they have been on stable doses of those medications for at least 12 weeks prior to lkw, they have not experienced seizures during that time frame, and their anti-epileptic medicines are continued during the study * for women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception and agree to refrain from donating eggs * no specific contraception methods for males are required. exclusion criteria: * participants who are \>12 hours from lkw at the start of treatment with study drug or \>8 hours from awakening with wus * any mls on brain imaging * evidence of intracranial hemorrhage at screening based on ncct * contraindication to mri examination * evidence of additional anterior cerebral artery (aca) infarction * diagnosis of brain death * planned surgical decompression prior to randomization * participants with a known history of a hereditary bleeding disorder which increases bleeding risk * chronic kidney disease stage iii or higher * hepatic injury * diagnosis of diabetes insipidus * participants who have received any prophylactic hyperosmolar therapy * participants who have received treatment with any other v1a and/or v2 receptor-blocking agent or glyburide * a preexisting medical condition for which the participant is unlikely to survive the next 6 months * planned limitation or withdrawal of life-sustaining treatment during hospital admission * participants who are pregnant or breastfeeding, or intending to become pregnant
chyle leak after pancreatic operation

Conditions: Pancreatic Cancer

Summary: with the development of pancreatic surgery, the surgeon has put more emphasis on chylous fistula as the postoperative complications in recent years. the diagnostic criteria and treatment methods about chylous leakage have been developed and improved in clinical practice. however, there remains controversy about the high risk factors and efficient control measures during the perioperative period.

chylous fistula is one of the common complications after pancreatic operation, whose incidence is about 10%. the delayed diagnosis or wrong treatment in the perioperative period may lead to refractory chylous ascites, water-electrolyte imbalance, malnutrition, immune dysfunction, secondary infection and other complications. in the past, chylous fistula, as the postoperative complication, is common in abdominal aortic surgery, gynecological malignancies accompanied with posterior peritoneum lymphadenectomy and spinal surgery, etc. but chylous fistula after pancreatic operation did not attract enough attention. the comparative study or case analysis is lacked in relevant reports and there is no consensus on diagnostic criteria. in addition, once it occurs after pancreatic operation, the rehabilitation of patients will be affected, increasing the burden of hospitalization and even endangering the lives of patients due to the lack of diagnosis and treatment experience of specialists. the international study group of pancreatic surgery (isgps) proposed relevant definitions under the background of no unified diagnostic criteria of chylous fistula after pancreatic operation. but this definition still has some shortcomings; for example, it lacks the value of clinical guidance and research implementation. moreover, how to take targeted preventive measures, choose the optimal treatment method and avoid complications, and whether there is a superior treatment method need to be further considered and investigated. therefore, we performed this study, so as to better improve the relevant definition and provide guidance for the diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * must have a diagnosis of cl after pancreatic operation * aged 18 or older * of either sex exclusion criteria: * no specific exclusion criteria will be applied to a participant as long as the participant is eligible for the trial

Keywords: chylous leakage diagnostic criteria pancreas surgery therapy
suture repair vs mesh repair for incisional hernia

Conditions: Incisional Hernia

Summary: the goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. the main question it aims to answer are: • determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the herqles summary score at one year postoperatively.

this is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. this is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the herqles survey) at 1 year postoperatively. patients will be blinded to the intervention, groups will be in parallel.

Eligibility criteria:
inclusion criteria: * adults \>18 years old. * anticipated hernia defect 2-6cm in width * non-emergent case * cdc class i * patients who previously underwent primary ventral hernia repair without the use of mesh * incisional hernia exclusion criteria: * emergent cases * patients \< 18 years old * patients who are pregnant * patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. abdominal mesh in separate locations would be allowed. * ventral hernia \ 6 cm in width * primary hernia * cdc wound class ii-iv