Kornimate/medical-research-clean huggingface dataset:
ed90 of 0.75% bupivacaine for bilateral tubal ligation (btl)

Conditions: Pain

Summary: the purpose of this study is to determine the dose of bupivacaine that provides effective pain management in 90% (ed90) of patients undergoing bilateral tubal ligation. this will guide anesthesiologists on the most effective dose to minimize intraoperative pain during this procedure. the goal is to make women as comfortable as possible when they undergo this procedure while also minimizing the amount of time they are required to remain in the hospital afterwards for monitoring.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * american society of anesthesiology class ii or iii * bilateral tubal ligation exclusion criteria: * patient refusal * bmi ≥ 50 kg/m2 * american society of anesthesiology class iv or above * contraindication to neuraxial anesthesia * allergy to bupivacaine

Keywords: tubal ligation
mesh reinforcement during temporary stoma closure after sphincter-saving rectal cancer surgery

Conditions: Incisional Hernia After Diverting Stoma Closure

Summary: this study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (tme) for rectal cancer

this study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after tme for rectal cancer. patients are randomized in 3 groups : no mesh, synthetic mesh (parietex, covidien), biologic mesh (cellis, meccelis). meshes are placed in retromuscular position after diverting ileostomy closure. primary endpoint is radiological incisional hernia rate, assessed on ct-scan, at the end of follow-up secondary endpoints include postoperative morbidity, postoperative pain, postoperative quality of life, long-term clinical incisional hernia rate.

Eligibility criteria:
inclusion criteria: * age \> 18 * operated on for diverting ileostoma closure after sphincter saving rectal cancer surgery, irrespective of the time delay between ileostoma closure and rectal cancer surgery * signed consent * affiliation to the french social security system exclusion criteria: * emergency surgery * history of laparotomy before ileostoma closure. * surgery associated to the ileostoma closure, excluding appendectomy or liver biopsy * lactating or pregnant woman * allergy to porcine product or collagen-based product. allergy to polypropylene. * participation to another protocol focusing on ileostoma closure

Keywords: incisional hernia stoma rectal cancer synthetic mesh biologic mesh
cocktail sedation containing propofol versus conventional sedation for endoscopic retrograde cholangiopancreatography (ercp)

Conditions: Disorders of Gallbladder, Biliary Tract and Pancreas

Summary: endoscopic retrograde cholangiopancreatography (ercp) practically requires moderate to deep sedation by a combination of benzodiazepine and opioid. propofol as a sole agent may cause oversedation. a combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and may result in a lower risk of oversedation. the investigators prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ercp.

ercp patients were prospectively randomized into 2 groups; the cocktail group and the controls. for induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were injected in both groups. in the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. in the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation.

Eligibility criteria:
inclusion criteria: * patients scheduled for ercp exclusion criteria: * age under 18 years * american society of anesthesiologists' (asa) physical classification iv - v * history of sulfite, egg or soy bean allergy * emergency need for ercp * informed consent could not be obtained

Keywords: cocktail sedation ercp
efficacy and safety of methylprednisolone per os versus iv for the treatment of multiple sclerosis (ms) relapses

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. french neurologists treat such patients with intravenous corticosteroids. the aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (iv) prednisolone. the main criteria of efficacy is symptom recovery within 28 days after inclusion.


Eligibility criteria:
inclusion criteria: * age 18 to 55 * informed written consent * multiple sclerosis (mc donald criteria, relapsing-remitting * edss before relapse : 0 to 5 * relapse : increase of 1 point or more for 1 or more functional systems of kurtzke, with sf score most affected \> 1 for all functions except for sensory (\> 2); duration of symptoms \> 24 h exclusion criteria: * fever * previous relapse, and/or corticosteroid treatment \< 1 month before present relapse * first symptoms of the present relapse appeared \> 15 days before inclusion * under mitoxantrone of cyclophosphamid or natalizumab treatment * diabetes * infection not under control * liver or kidney failure * psychiatric symptoms not under control * pregnancy * hypersensibility to methylprednisolone
effect of speaking aloud after abdominal surgery.

Conditions: Postoperative Respiratory Complications

Summary: hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. positive expiratory pressure is one treatment suggested to improve lung function after surgery. we aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. in a cross-over design, 50 subjects will be randomized to start with either positive expiratory pressure maneuvers, i.e. deep inspiration followed by expiration in a positive expiratory pressure device at 10-15 cm of water, or to start with reading a text loudly. arterial blood gases will be taken at study start. patients will be monitored using noxturnal t3, res med for respiration and pulse oximetry, and online transcutaneous carbon dioxide partial pressure measurements (sentec digital monitoring systems). main outcome measurements include oxygen saturation after speaking compared with positive expiratory pressure therapy.

hypoxia and reduced vital capacity is commonly occurring after abdominal surgery. positive expiratory pressure is one treatment suggested to improve lung function after surgery, but there is a lack of evidence of effect. en passant, we observed that oxygen saturation was improved when patients talked postoperative day 1. we aim to test whether speaking improves postoperative oxygen saturation and ventilation after abdominal surgery. it was estimated that a sample size of 34 patients was needed to detect a mean and (sd) difference in oxygen saturation of 1% (2%) and to detect a difference in transcutaneous carbon dioxide partial pressure of 0.5 kpa (1 kpa) with a significance level of 0.05 and a power of 0.8. in a randomized controlled trial, 50 subjects will be randomized (1:1) to start with either positive expiratory pressure maneuvers, i.e. 3 x 10 deep inspiration followed by expiration in a positive expiratory pressure device of 10-15 cm h20 or to start with reading a text loudly during 3 minutes. patients will be monitored using noxturnal t3, res med for respiration and pulse oximetry. sentec digital monitoring systems for online transcutaneous carbon dioxide partial pressure measurements.

Eligibility criteria:
inclusion criteria: * performed abdominal surgery within 2 days at the departments of surgery, urology or gynecology at umeå university hospital exclusion criteria: * patients referred to icu because of immediate postoperative complications. * patients who are unable to perform the study.

Keywords: abdominal surgery hypoxia lung function ventilation carbon dioxide partial pressure oxygen situation postoperative positive expiratory pressure therapy
clinical trial to determine the mtd of hm781-36b in patients with advanced solid tumors

Conditions: Advanced Solid Malignancies

Summary: the main objective of this study is to determine the maximum tolerated dose (mtd) of hm781-36b continuously.

besides the main objective, there are 4 other objectives as follows: 1. to determine dose-limiting toxicity (dlt) of hm781-36b 2. to determine maximum tolerated dose (mtd) of hm781-36b 3. to determine the effect of food on the pharmacokinetics after dosed hm781-36b continuously 4. to evaluate anticancer activity of hm781-36b in patients with advanced solid malignancies

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed advanced solid tumor 2. patients who have experienced progressive disease despite of conventional anticancer therapy. patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3. previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to d0 and all adverse events are resolved 4. aged ≥19 5. eastern cooperative oncology group (ecog) performance score of less than or equal to 2 6. a life expectancy greater than 12 weeks 7. adequate bone marrow, renal and liver function. 8. subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures exclusion criteria: 1. patients with hematopoietic malignancies,uncontrolled infection, cns metastasis. 2. patients who have undergone hematopoietic stem cell transplantation (hsct) or are candidates for planned hsct 3. patients who have gi malabsorption or difficulty taking oral medication 4. patients who have psychiatric or congenital disorder 5. subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 6. pregnant or breast-feeding patients; women of childbearing potential without adequate contraception (men must use adequate contraception.)

Keywords: hm781-36b
predictors of hospital-based care in asthma

Conditions: Asthma; Lung Diseases

Summary: to identify clinical predictors of episodes of hospital-based care in people with asthma.

background: this study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. these studies were of limited value for the practicing physician who sees the vast majority of patients with asthma. results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. these results can be used for physician and patient education programs as well as to target medical intervention. design narrative: the study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. the experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. the key advantage of this population was that all the care occurred within the health plan. characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. the outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. based on these data, models were developed which assigned relative risk to each of the independent variables. these models were validated in a subset of the population. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
atorvastatin versus ezetimibe and fenofibrate as a lipid-lowering strategy

Conditions: Dyslipidemia; Vascular Disease

Summary: the primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (ldl-c) cholesterol. additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

it has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (ldl-c) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. these medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives. ezetimibe is a relatively new medication in canada, approved for use in patients with cholesterol problems. it is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. alone, it has a modest effect in the lowering of ldl-c. fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. alone it also has a modest effect in the lowering of ldl-c. recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of ldl-c is greater than that of either drug alone. this combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of ldl-c, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.

Eligibility criteria:
inclusion criteria: -study is confined to subjects with elevated ldl-c levels 3.0 mmol/l and greater. exclusion criteria: * abnormal liver enzymes (ie, ast, alt greater than three times the upper limit of normal); * creatine kinase levels more than two times the upper limit of normal; * uncontrolled ethanol use (this may affect compliance); * pregnant or breastfeeding women or women not using adequate contraceptive methods; * previous history of intolerance or adverse effects with statins; * previous history of intolerance or adverse effects with fibric acid derivatives; * previous history of intolerance or adverse effects with ezetimibe; * uncontrolled diabetes (hba1c \> 10%); * recent myocardial infarction (within 6 weeks); * concurrent enrollment in another study.

Keywords: randomized non-blinded prospective open-label ldl-c hdl-c
hand oa and methotrexate use

Conditions: Reduction in Pain; Reduction of Inflammation; Improvement in Function

Summary: osteoarthritis (oa) is a common disabling condition, for which no effective therapy currently exists. synovitis has been demonstrated in hand oa imaging. synovial inflammation due to the release of cytokines is an important cause of pain. methotrexate (mtx) helps to decrease synovitis in many inflammatory joint diseases, particularly rheumatoid arthritis. the aim of the present study is to assess the efficacy of mtx in decreasing pain and inflammation in symptomatic hand oa. methods: one hundred and twenty patients with american college of rheumatology (acr) clinical and radiographic criteria of primary knee oa with hand pain, \[\>4 on the 24-hour average pain severity scale (0-10) using mean of daily ratings from week preceding randomization\] for \> 14 days/month during 3 consecutive months preceding enrollment will be included in this randomized double-blind placebo-controlled trial. patients meeting the eligibility criteria were randomized in a 1:1 ratio to receive either 25mg/week oral mtx (n=60) or placebo (n=60) together with their usual therapy provided the dosages were kept constant for 28 weeks. pain will be assessed using the visual analogue pain scale, (vas, 0-100 mm). functional assessment will be performed using the western ontario and mcmaster universities osteoarthritis index (womac) and activities of daily living (adl) scores. alterations in dosage of analgesic/nsaid drugs used will be recorded. safety and tolerability will also be assessed. synovitis will be detected by ultrasound imaging.


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis * persistent pain * synovitis exclusion criteria: * rheumatoid arthritis * gout and pseudogout * traumatic arthritis * other secondary arthritis * renal disease * liver disease

Keywords: methotrexate, osteoarthritis, pain, function, synovitis
lenvatinib, sintilimab plus sirt for unresectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus y-90 selective internal radiation therapy (sirt) for patients with unresectable intermediate-advanced hepatocellular carcinoma (hcc).

this is a single-center, prospective study to evaluate the efficacy and safety of lenvatinib, sintilimab plus sirt (len-sin-sirt) in patient with unresectable hcc. 30 patients with unresectable intermediate-advanced hcc (bclc b/c stage) will be enrolled in this study. the patients will receive lenvatinib (body weight ≥60kg, 12mg; body weight \<60kg, 8mg; p.o. qd) and sintilimab (200mg i.v. q3w) at 3-7 days after sirt. sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. the primary end point of this study is progression free survival (pfs) per mrecist. the secondary endpoints are pfs per recist 1.1, objective response rate (orr), disease control rate (dcr), overall survival (os) and adverse events (aes).

Eligibility criteria:
inclusion criteria: * unresectable hcc (bclc stage b/c) with diagnosis confirmed by histology/cytology or clinically * at least one measurable untreated lesion * intrahepatic tumors can be treated with 1-2 session of sirt * child-pugh score 5-7 * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 * life expectancy of at least 3 months * patients with active hepatitis b are allowed, but they need to receive antiviral treatment to achieve a hbv dna\<10\^3 iu/ml * patients with hepatitis c need to finish the anti-hcv treatment exclusion criteria: * tumor extent ≥70% liver occupation * tumor thrombus involving main portal vein or both the first left and right branch of portal vein * vena cava invasion * central nervous system metastasis * metastatic disease that involves major airways or blood vessels * patients who previously received hepatic arterial infusion chemotherapy (haic), transarterial chemoembolization (tace), transarterial embolization (tae), radiotherapy, systemic therapy, or immunotherapy for hcc * history of organ and cell transplantation * prior esophageal and/or gastric varices bleeding * history of hepatic encephalopathy * peripheral blood white blood cell count\<3×10\^9/l, platelet count\<50×10\^9/l * prolongation of prothrombin time ≥ 4 seconds * severe organ dysfunction (heart, lungs, kidneys) * history of malignancy other than hcc * hbsag and anti-hcv antibody positive concurrently * human immunodeficiency virus (hiv) infected

Keywords: hepatocellular carcinoma lenvatinib sintilimab yttrium-90
symbenda post-marketing surveillance (pms)

Conditions: Lymphoma, Non-Hodgkin; Lymphocytic Leukemia; Multiple Myeloma

Summary: this is a pms of symbenda injection (bendamustine hydrochloride) in korean patients. the main objective is to obtain safety information related to symbenda treatment from clinical practice.


Eligibility criteria:
subjects who are prescribed with symbenda per approved prescribing information of symbenda will be enrolled in the study. this study will be conducted as complete surveillance method; subjects who meet the inclusion/exclusion criteria and administrate symbenda for the first time after conclusion of agreement will be enrolled. inclusion criteria: patients who meet the following criteria will be eligible for inclusion in the study: 1. patients with approved indication for symbenda in korea 2. patients who have verbal or written consent for use of personal and medical information for the study purpose investigators will refer to approved indications and contraindications regarding inclusion criteria. exclusion criteria: investigators will refer to approved indications and contraindications regarding exclusion criteria.

Keywords: symbenda non-hodgkin's lymphomas chronic lymphocytic leukemia multiple myeloma bendamustine hydrochloride
evaluation of the effect on glucose control of ac2993 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: this is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of ac2993 as compared to placebo in patients with type 2 diabetes. patients will be randomized into one of two ac2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening * bmi= 27-45 kg/m2 * hba1c value between 7.5% and 11% exclusion criteria: * treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening * patients treated previously with ac2993 * patients presently treated with insulin

Keywords: type 2 diabetes mellitis