Kornimate/medical-research-clean huggingface dataset:
study of surufatinib as second-line treatment in patients with biliary tract carcinoma

Conditions: Biliary Tract Cancer

Summary: a phase ii, single-arm, open-label, multicenter study to assess the efficacy and safety of surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma

this study adopt simon's two-stage designs method based on the primary endpoint of 16-week pfs rates. in the first stage, 16 patients will be recruited. if there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients. surufatinib will be orally administered within 1 hour after breakfast once a day (qd) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent form (icf) prior to any study specific procedures 2. aged at least 18 years 3. histologically or cytologically confirmed advanced btc that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (ehcc), intrahepatic cholangiocarcinoma (ihcc) or gallbladder biliary carcinoma (gbc) 4. first-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities 5. ecog 0-1 6. patients must have measurable lesions exclusion criteria: 1. anti-tumor therapy received within 4 weeks prior to initiation of study treatment 2. previous therapy with approved or investigational anti-vegf (or vegfr) tyrosine kinase inhibitors or monoclonal antibody 3. liver metastases ≥50% of liver volume 4. child-pugh classification score of liver function\> 7 5. history or presence of a serious hemorrhage (\>30 ml within 3 months), hemoptysis (\>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack and/or stroke events) within 12 months 6. active malignancy (except for definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5 years 7. patients receive cyp3a4 potent inducer or inhibitors within 2 weeks 8. pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women

Keywords: surufatinib biliary tract cancer second-line
one year study of rifaximin delayed release (dr) tablets in crohn's disease

Conditions: Crohn's Disease

Summary: the primary objective is to determine the efficacy of rifaximin dr also referred to as extended intestinal release (eir) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate crohn's disease. a key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

recd3125 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin dr tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate crohn's disease. participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. ileocolonoscopy will be performed on all participants at baseline, between weeks 16 and 17 (end of the induction phase), and following completion of the 36-week long term treatment phase (week 52).

Eligibility criteria:
major inclusion criteria: * moderate, non-fistulizing crohn's disease in the ileum and/or colon prior to randomization; and a ses-cd score of ≥7 (confirmed by centralized endoscopy reading). * during the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools. major exclusion criteria: * pregnant or lactating females. females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study. diagnosis of ulcerative or indeterminate colitis. * diagnosis of celiac disease. * bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for crohn's disease during the study period. * presence of an ileostomy or colostomy. * known fixed symptomatic stenosis/stricture of the small or large bowel. * had more than one segmental colonic resection. * had more than 3 small bowel resections or symptoms associated with short bowel syndrome. * current evidence of peritonitis. * history or evidence of colonic mucosal dysplasia. * history or evidence of adenomatous colonic polyps that have not been removed. * unwilling to be tapered off corticosteroids by week 8 or the participant is known by the investigator to be steroid-dependent. * has used a biologic within 12 weeks of randomization. * used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization. * had rectal administration of 5-aminosalicylic acid (5-asa) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.

Keywords: crohn's disease rifaximin clinical remission with endoscopic response inflammatory bowel disease
estimation of economic consequences linked with different care management pathways of differentiated thyroid cancers

Conditions: Thyroid Cancer

Summary: the incidence of thyroid cancer (tc) has increased over the last thirty years, in france and worldwide. this increase is mainly due to good prognosis micropapillary tc (mptc). sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. the increase of diagnosis of mptc and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs. the primary aim of this study is to estimate the cost related to different care management pathway of tc patient during a lifetime period using a multi-state markov model. this is a retrospective, observational population based cohort study, using data from a cohort study of tc patients implemented by the oncomip network which initially aimed to perform an audit of clinical practices for the management of tc, and from database of the french social health insurance of midi-pyrenees region to calculate observed costs of tc management during 24 months.


Eligibility criteria:
inclusion criteria: * all patients with a good prognosis of the tc * diagnosed in 2014 * whose medical file discussed in multidisciplinary team meeting (mdtm) in midi-pyrenees exclusion criteria: * patients whose surgical management was carried out outside midi pyrenees are excluded and other morphological types are excluded (medullar, anaplastic, lymphomas, sarcomas)

Keywords: health economics care management pathways overtreatment
effectiveness of simulation based training in implementing one hour bundle sepsis

Conditions: Medical Education; Simulation Training; Sepsis

Summary: this study aimed to compare simulation training with conventional training (case-based discussion only) to improve team performance in implementing one-hour sepsis bundle in the intensive care unit

this was an experimental randomized single-blind study to examine the role of simulation-based training in improving team performance in conducting sepsis management. subjects were sixteen doctors and twenty-four nurses working in the intensive care unit. the subjects were randomly divided into two treatment groups: the discussion group and the simulation group. each treatment group was further divided into four small groups consisting of two doctors and three nurses. prior to the training, every subject received a pretest for cognitive evaluation and a posttest at the end of the training. the performance of both groups in implementing one-hour sepsis bundle was assessed by solving a sepsis case in high fidelity manikin.

Eligibility criteria:
inclusion criteria: * doctors working in dr. cipto mangunkusumo public hospital's icu * nurses working in dr. cipto mangunkusumo public hospital's icu exclusion criteria: * doctors and nurses who are not fit or healthy to undergo this training

Keywords: medical education simulation training sepsis high-fidelity manikin one-hour bundle sepsis
indocyanine green-guided lymphadenectomy in laparoscopic total mesorectal excision for low rectal cancer after neoadjuvant chemoradiotherapy

Conditions: Rectal Cancer; Lymph Node Cancer Metastatic

Summary: the goal of this clinical trial is to assess the number of harvested locoregional lymph nodes in rectal cancer patients undergoing laparoscopic total mesorectal excision and indocyanine green (icg)-guided lymphoadenectomy after neoadjuvant chemoradiation. the main questions it aims to answer are: * does the use of icg increase the total number of harvested lymph nodes? * does the use of icg increase the number of harvested extra-mesorectal lymph nodes? participants will intraoperatively receive a trans-anal administration of icg near to rectal cancer; during laparoscopic surgery, icg-fluorescent nodes beyond the mesorectum will be separately excised and sent for pathology. a comparison will be performed with a recent cohort of patients affected by rectal cancer treated with standard surgery without the use of icg.


Eligibility criteria:
inclusion criteria: * low or middle rectal adenocarcinoma * indication for sphincter-saving surgery * neoadjuvant chemoradiation * indication for laparoscopic surgery * signed informed consent exclusion criteria: * distant metastases at diagnosis, included peritoneal carcinomatosis * squamous cell cancer * allergy to indocyanine green
ketamine sickle cell disease

Conditions: SC Disease; Pain, Chronic

Summary: sickle cell disease (scd) often results in acute vaso-occlusive crisis (voc), an obstruction of blood vessels resulting in ischemic injury and pain. the pain experienced during these episodes is due to a wide range of pathophysiological processes. though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. opioids and non-steroidal anti-inflammatory drugs (nsaids) remain the predominate treatment for voc. however, the efficacy of these treatments has come into question. a large sub-set of patients with scd report continued pain despite treatment with opioids. tolerance and opioid-induced hyperalgesia (oih) may be responsible for unresponsiveness to opioid-centric treatment modalities. new classes of drugs are being tested to prevent and treat acute pain associated with scd, but in the meantime physicians are looking to existing therapies to bridge the gap. the n-methyl-d-aspartate (nmda) receptor has been implicated in both tolerance and oih. as a nmda receptor agonist, ketamine has been shown to modulate opioid tolerance and oih in animal models and clinical settings. ketamine utilized as a low dose continuous infusion could benefit patients with scd related pain that are unresponsive to opioid analgesics. based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with scd-related pain.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with sickle cell anemia * adults aged 18 and older * subjects who have given written consent exclusion criteria: * subjects who are pregnant * subjects younger than 18 years * subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications * subjects who have a contraindication to ketamine

Keywords: ketamine
diagnosis of ascites in infants and children

Conditions: Ascites

Summary: ascites is the pathologic accumulation of fluid within the peritoneal cavity. causes of ascites in infants and children :hepatobiliary disorders,serositis, neoplasm, cardiac, genitourinary disorder, metabolic disease and others. diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, symptoms and signs of (hepatic ,cardiac,renal disease, tuberculosis and malignancy). lnvestigation:complete blood count, complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test, chest and abdominal plain films,abdominal ultrasound, upper gastrointestinal endoscopy, abdominal paracentesis for ascitic fluid analysis .

definition : ascites is the pathologic fluid accumulation within the peritoneal cavity . causes of ascites in infants and children : * hepatobiliary disorders (cirrhosis, congenital hepatic fibrosis, acute hepatitis b,c ,budd -chiari syndrome, bile duct perforation) * serositis (crohn's disease, eosinophilic enteropathy , henoch- shonlein purpura ) * neoplasm (lymphoma, wilm's tumor ,glioma, germ cell tumor, ovarian tumor,mesothelioma, neroblastoma ) * cardiac (heart failure ) * metabolic disease * gastrointestinal disorder (nephrotic syndrome, peritoneal dialysis ). diagnosis of ascites :history of abdominal distention, increasing weight, respiratory embarrassement, jaundice, bleeding (haematemsis, melena, and epistaxis ),pruritus ,growth failure ,abdominal pain, fever,cyanosis, ,dyspnea during suckling, orthopnea, buffy eyes, lower limb swelling, haematrruria . by examination : tachycardia ,tachypnea ,hypertension ,cyanosis, jaundice, clubbing of fingers ,limb edema ,hepatomegaly, splenomegaly, dilated abdominal wall veins. investigations : laboratory tests :complete blood count , complete urine examination, liver function tests, plasma proteins, renal function tests, clotting screen, tuberculin test. imaging studies :chest and abdominal plain films, abdominal ultrasound, upper gastrointestinal endoscopy ct, mr i, abdominal paracentesis for ascitic fluid analysis :cell count / cytology ,gram 'stain and culture, total proteins (albumin /globulin ratio ), glucose, amylase, lactase dehydrogenase, triglycerides,bilirubin. serum ascites albumin gradient (saag )is the best single test for classification of ascites into portal hypertensive (saag \>1.1g/dl) and non-portal hypertensive (saag \<1.1g/dl) causes.

Eligibility criteria:
inclusion criteria: * age from 1month to 18 year * infants and children with ascites (hepatic, cardiac, renal, malignant or tuberculous ) * infants and children with peritonitis exclusion criteria: * age \<1month * surgical conditions as ruptured viscous or located abscess
erector spinae plane block versus quadratus lumborum block for open renal surgeries in children

Conditions: Postoperative Pain, Acute

Summary: open renal surgeries are associated with significant postoperative pain; early control of the perioperative pain is associated with decrease of hemodynamic variations during the surgery, early mobilization, better quality of functional recovery \& early discharge of patients. side effects of systemic opioids, as well as difficulty to monitor their response, are major limitations to their use. pediatric regional anesthesia (pra) is one of the most valuable and safe tools to treat perioperative pain, and is an essential part of modern anesthetic practice. neuraxial analgesia for pediatric patients is a mode of pain control that gained popularity in the last few decades as it decreases opioid exposure, shortens recovery room time \& hospital stay. caudal block is the most commonly used neuraxial anesthesia in pediatric patients. however, its major side effect is urinary retention and excessive motor block. considerable progress has been made in the practice of pra over the past few years including incorporation of ultrasound guidance, with promising novel regional anesthesia techniques, especially the anterolateral and the posterolateral trunk blocks. in this study, the investigators will compare the ultrasound guided quadratus lumborum block (qlb) with erector spinae plane block (espb), regarding the duration and quality of postoperative analgesia in pediatric patients undergoing unilateral open renal surgeries under general anesthesia. the study hypothesis is that qlb can provide a more superior postoperative pain relief to espb in children undergoing open renal surgeries.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) class i and ii 2. children undergoing unilateral open renal surgeries exclusion criteria: 1. parents refusal for the block 2. bleeding disorders (platelets count \ 1.5; pc \< 60%) 3. skin lesion, wounds or infection at the puncture site. 4. known allergy to local anesthetic drugs
a study to evaluate edp 938 regimens in children with rsv

Conditions: Respiratory Syncytial Virus (RSV)

Summary: a 2-part study to evaluate the safety, pharmacokinetics and efficacy of edp-938 in children with rsv infection.

this is a randomized, double-blind, dose ranging, placebo-controlled study in respiratory syncytial virus (rsv) among hospitalized and non-hospitalized children aged from 28 days to 36 months, assessing the safety, tolerability, pharmacokinetics, clinical outcome and antiviral activity of a 5 day treatment with edp-938.

Eligibility criteria:
inclusion criteria: * male or female who is either ≥6 months to ≤36 months (for age group 1) or ≥28 days to \<6 months (for age group 2), defined at the time of randomization. subjects in age group 2 must have been born ≥29 weeks of gestation to be eligible. * subjects diagnosed with rsv infection * subjects with signs of an acute respiratory illness with onset ≤7 days for part 1 and ≤5 days for part 2 before the time of signing the icf * in the investigator's opinion, the subject's caregiver understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and the subject is likely to complete the study as planned exclusion criteria: * use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness * underlying immune deficiency, (e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin a deficiency) * receipt of (within 12 months before screening) or on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening) * receiving chronic oxygen therapy at home before admission * subjects whose mother received an investigational rsv vaccination while pregnant with the subject if they were born at term (≥37 weeks of gestation) and are less than 12 months of age * in part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat rsv infection within the following times before the first dose of study drug: ribavirin 35 days; palivizumab 100 days; nirsevimab 350 days; other rsv-specific monoclonal antibody 5 half-lives of the specific antibody; rsv vaccines 12 months.

Keywords: respiratory syncytial virus, rsv, pediatric study
spinal cord stimulation and functional mri

Conditions: Complex Regional Pain Syndrome (CRPS); Neuropathic Leg Pain

Summary: the overall objective of this study is to assess patterns of fmri cortical activation with spinal cord stimulation (scs) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and scs.

the main objective is to define, using functional magnetic resonance imaging, the effects of spinal cord stimulation (scs) on cortical and subcortical bold effects in patients with neuropathic leg pain. our hypothesis is that scs will demonstrate a consistent pattern of bold activation that will correlate with symptomatic improvement.

Eligibility criteria:
inclusion criteria: * age 18-55 years at time of enrollment. * have previous implantation of thoracic epidural medtronic restore ultra, prime advanced and restore advanced scs in place for the treatment of cprs-type 1 or chronic refractory neuropathic leg pain following fbss. the implantation must be 3 or more months prior to enrollment. * patient must have reported significant pain improvement (\>50%) following implantation of the scs. * have consistently reproducible pain relief (\> 50%) within 10 minutes of switching scs from an off state to an on state (with "optimal" parameters - see below). * the scs battery is implanted in the buttocks region. * unilateral or bilateral extremity pain. * able to provide informed consent. exclusion criteria: - contraindication to mri such as: scs lead in the cervical epidural region cardiac pacemaker intracranial aneurysm clips, metallic implants or external clips within 10mm of the head metallic foreign metals within the orbits pregnancy; (urine pregnancy test will be done to confirm) claustrophobia * pattern of response to spinal cord stimulation inconsistent response of pain to spinal cord stimulation long interval (\> 10 minutes) before pain relief following switching scs from an off state to an on state (with "optimal" parameters) - long "washout" period lack of significant pain improvement (\< 50%) following implantation of scs * positive history of significant brain lesions or pathology including: * prior ablative neurosurgery * history of large vessel strokes or brain tumors * psychological screening
postoperative analgesia after total hip replacement

Conditions: Total Hip Replacement

Summary: there are several treatments for postoperative pain after hip replacement surgery. however, some require an intravenous line which may interfere with rehabilitation after surgery. this study aims to evaluate which method of pain treatment is best after hip replacement surgery. patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. in the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

this is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. the conventional analgesia includes both intrathecal morphine at surgery and patient controlled analgesia (pca) with morphine in the first 48 hours after surgery. this will be compared with two experimental groups which will receive either intrathecal morphine and pca with placebo or intrathecal placebo and pca with morphine. escape medication with intramuscular morphine is available in all groups. a total of 120 patients will be randomized. vas- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as pca-bolussum and morphine im.

Eligibility criteria:
inclusion criteria: * patients accepted for fast-track total hip replacement, i.e.asa 3 or lower exclusion criteria: * not able to speak dutch * communication problems * dementia * mental retardation

Keywords: total hip replacement pain treatment