Kornimate/medical-research-clean huggingface dataset:
oralia trial medical treatment vs anoperineal physiotherapy for adult anal incontinence.

Conditions: Anal Incontinence

Summary: the purpose of this study is to evaluate the impact of anoperineal physiotherapy in adjunction to standard medical treatment on symptoms and quality of life of adults with anal incontinence, in comparison with standard treatment alone. a total of 443 patients will be randomized to 2 groups: standard care (medical treatment) alone or standard care associated with anoperineal physiotherapy. outcome measures include the patient own view of the effectiveness of the treatment, the continence score, quality of life and psychological status. these outcomes are measured at the end of the 4 months treatment period. following this period, the non responders to standard medical treatment will be proposed to undergo a course of anoperineal physiotherapy and the non responders to anoperineal physiotherapy will be treated by transcutaneous electrical nerve stimulation (tens). the outcomes will be measured at the end of the 4 months new treatment and again after 4 months follow-up.


Eligibility criteria:
inclusion criteria: * age 18 to 75 * anal incontinence for more than six months. * signed informed consent * jorge and wexner's anal incontinence score \> or egal 5 exclusion criteria: * previous course of anoperineal physiotherapy within the past 6 months * anorectal or perineal surgery within the past 6 months. * indication for anoperineal surgery * vaginal delivery within the past 6 months * pregnancy * major neurological disease, * significant cognitive impairment, dementia or institutionalised. * active inflammatory bowel disease. * current treatment by sacral nerve neurostimulation. * cardiac pacemaker * skin damages preventing transcutaneous electrical nerve stimulation (tens).

Keywords: anal incontinence gastroenterology anoperineal physiotherapy randomized clinical trial
irinotecan and docetaxel with or without cetuximab in treating patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. combining chemotherapy with cetuximab may kill more tumor cells. purpose: this randomized phase ii trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .

objectives: * determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas. * determine the time to progression and overall survival of patients treated with these regimens. * determine the proportion of patients with tumors that overexpress epidermal growth factor receptor. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm a: patients receive docetaxel iv over 1 hour and irinotecan iv over 30 minutes weekly on days 1, 8, 15, and 22. * arm b: patients receive docetaxel and irinotecan as in arm a. patients also receive cetuximab iv over 1-2 hours on days 1, 8, 15, 22, 29, and 36. courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter. projected accrual: a total of 92 patients (46 per treatment arm)

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic adenocarcinoma of the pancreas * sufficient tumor tissue from fine needle aspiration, core biopsy, or open biopsy available for epidermal growth factor receptor testing * at least 1 unidimensionally measurable primary or metastatic lesionge * age of 18 and over * ecog performance status 0-1 * negative pregnancy test * fertile patients must use effective contraception * creatinine clearance \> 60 ml/min * lvef normal * absolute neutrophil count \> 1,500/mm\^3 * platelet count \> 100,000/mm\^3 * bilirubin ≤ upper limit of normal (uln)\* * sgot or sgpt and alkaline phosphatase must meet the criteria for 1 of the following\*: * sgot or sgpt ≤ 2.5 times uln and alkaline phosphatase ≤ uln * sgot or sgpt ≤ 1.5 times uln and alkaline phosphatase \> uln but ≤ 2.5 times uln * sgot or sgpt ≤ uln and alkaline phosphatase \> 2.5 but ≤ 4 times uln note: \*percutaneous stenting or endoscopic retrograde cholangiopancreatography may be used to normalize liver function tests exclusion criteria: * history of uncontrolled arrhythmias * history of congestive heart failure * history of uncontrolled angina pectoris * prior chemotherapy * pre-existing neuropathy ≥ grade 2 * prior hypersensitivity to polysorbate 80 * pregnant or nursing

Keywords: pancreatic cancer metastatic pancreatic cancer egf-r irinotecan docetaxel cetuximab
assess the risk of cerebrovascular disease

Conditions: Cerebrovascular Disease

Summary: intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. asymptomatic carotid stenosis (acs) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the acs group cognitive impairment, and predict the acs risk of ischemic stroke. therefore, this topic proposed comprehensive cognitive assessment, cta, double modal mri techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the acs group and normal person the cognitive ability, the difference of nvc and local perfusion, and follow-up acs crowd of ischemic stroke and other cardiovascular events, discuss acs and cognitive impairment, the correlation of nvc and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of acs population in testing the sensitivity of the series of indicators and specific degrees.


Eligibility criteria:
inclusion criteria: 1. mild stenosis group: cta suggested carotid stenosis \< 30%; 2. moderate stenosis group: cta suggested carotid stenosis of 30-69%; 3. severe stenosis group: cta indicated carotid stenosis ≥70%; exclusion criteria: 1. dementia, mmse score \< 21; 2. previous carotid stenosis related neurological symptoms or transient ischemic attack; 3. other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia); 4. contraindications for mri examination; 5. recent use of psychoactive drugs or hormones.
surgery plus single agent chemotherapy versus primary chemotherapy for gestational trophoblastic neoplasms

Conditions: Gestational Trophoblastic Neoplasms

Summary: gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.

gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of b-hcg.

Eligibility criteria:
inclusion criteria: * females * 40 years or more * plateau or rising b- hcg titre * without distant metastasis * who score is less than 7 exclusion criteria: * less than 40 years * distant metastasis to lung and liver * chronic medical diseases * who score is more than 7

Keywords: gestaional trophoblastic neoplasm hystrectomy chemotherapy methotrxate
prebiotics in peritoneal dialysis

Conditions: End Stage Renal Disease; Gut Microbiome Dysbiosis

Summary: the prebiotics in peritoneal dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * peritoneal dialysis therapy for end-stage renal disease * ≥30 days since dialysis initiation * ability to provide informed consent exclusion criteria: * use of pre- or pro-biotics during the past 2 months * consumption of pro-biotic yogurt during the past 2 weeks * use of antibiotics within the past 2 months * presence of chronic infection * chronic gastrointestinal condition other than constipation * cirrhosis or chronic active hepatitis * stomach/intestinal resection * pd access problems * anticipated kidney transplant or transfer to another dialysis unit within 9 months * expected survival \< 9 months * pregnancy, anticipated pregnancy, or breastfeeding * incarceration * participation in another intervention study * severe anemia defined as hemoglobin \<9.0 g/dl
preoperative imaging in diep flap breast reconstruction

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether preoperative abdominal imaging using either ct angiogram (cta), or mr angiogram (mra) will impact perforator dissection time, cost, and patient outcomes in diep flap breast reconstruction.

this study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either cta or mra with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (diep) flap breast reconstruction. subjects will randomly undergo either a cta scan or an mra scan, or no scan (control) preoperatively. an operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. the diep flap procedure will be planned for controls. subjects will not be told if the operative plan is changed intraoperatively. flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. the breast-q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. groups will be compared in terms of all variables measured.

Eligibility criteria:
inclusion criteria: * candidate for diep flap breast reconstruction * speak/read/write english * have undergone or will undergo unilateral or bilateral mastectomy exclusion criteria: * previous abdominal surgery that may preclude a diep flap reconstruction * active smoker * bmi over 35 * severe claustrophobia * sensitivity to intravenous ct contrast medium (visipaque 320) or mr contrast medium (gadovist 1.0) * urgency of surgery that precludes study enrollment

Keywords: diep diep flap breast reconstruction breast cancer cta mra
effects of an internet use disorder and internet gaming disorder early intervention program

Conditions: Mental Disorder

Summary: background. in the last two decades internet usage has grown vastly. pathological internet usage (iud; internet use disorder) is associated with severe mental health problems affecting social, academic and daily life functioning. internet gaming disorder (igd) has been already included in the dsm-v. recently, the who declared to include gaming disorder (gd) in the upcoming icd-11. despite the increasing rates of adolescents with iud and (i)gd, affected people are treated unsystematically and there is a lack of evidence based treatment programs. protect+ is a low-threshold, cognitive behavioral short-term group intervention. methods. 54 patients, aged 9-19 years, received protect+ intervention in heidelberg, germany. the protect+ intervention group underwent a cognitive-behavioral 4-session group therapy. follow-up data were collected at 1, 4, and 12 months after admission. primary outcome was the change in (i)gd and iud related symptoms at the 12-months follow-up. secondary outcomes were changes in comorbid symptoms as well as in problem solving, cognitive restructuring and emotion regulation skills discussion. treatment of iud and igd is still in its early stages. recent reviews report increasing research on treatment but also a lack of well-designed studies and evidence based treatment programs. the protect+ intervention is a theory driven and evidence based therapy program which is based on the protect preventive intervention in school settings. in the intervention group a reduction of (i)gd and iud symptom severity is expected over 12 months.


Eligibility criteria:
inclusion criteria: adolescents aged 9 to 19 years self-selection exclusion criteria: severe comorbid mental health disorder
preoperative arterial embolization before oncologic esophagectomy as a technique for ischemic gastric conditioning

Conditions: Esophageal Cancer

Summary: this retrospective monocentric comparative study aims to assess the efficacy of preoperative ischemic conditioning, in preventing anastomotic leakage in esophageal cancer surgery. two groups were included : a surgery-alone group (control group) and a preopae group (study group) treated with an embolization procedure before esophagectomy. collected data included patient characteristics, embolization procedure details, surgical outcomes, and postoperative complications. the primary outcome was the efficacy of preoperative ischemic conditioning in preventing anastomotic leakage, assessed through ct scans. secondary outcomes included analyzing safety of ischemic gastric conditioning, hypertrophy of the gastroepiploic artery in embolized patients and comparing hospital stay length and postoperative mortality.


Eligibility criteria:
inclusion criteria: * all patients older than 18 years with an indication for surgical esophagectomy with cervical anastomosis using the lewis santy technique or three stages approach. exclusion criteria: * esophagectomy for ischemic or caustic oesophagitis, and patients lost for follow-up.

Keywords: embolization ischemic conditioning esophagectomy lewis santy anastomotic leakage
use of saliva for covid-19 diagnosis

Conditions: SARS-CoV2 Infection

Summary: aim of the study is to evaluate the presence of sars-cov2 rna in the saliva of patients with suspected or confirmed covid-19 in order to validate the analysis of this type of sample for the diagnosis of sars-cov2 infections.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age hospitalized in the covid-19 wards of asst monza - san gerardo hospital with positive, weakly positive or negative nasopharyngeal swabs; initially assessed at the e.r.; symptomatic or asymptomatic with indication to hospitalization. * informed consent freely granted and acquired before the start of the study. exclusion criteria: * patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.

Keywords: salivary test
comparison of quadratus lumborum block with tap block for postoperative analgesia after laparoscopic nephrectomy

Conditions: Postoperative Pain

Summary: this is a randomised controlled trial which will compare the quadratus lumborum (ql) block with the transversus abdominis plane (tap) block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy. to fulfill this purpose, three groups of patients each with 32 patients, will be formed. patients in the transversus abdominis plane (tap) group and quadratus lumborum (ql) group will each receive the respective blocks with 0.4 ml/kg of 0.25% bupivacaine, after completion of surgery. the third (control group) will not receive any blocks. after shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (pca) morphine as rescue analgesic regimen as per a set protocol. morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.


Eligibility criteria:
inclusion criteria: * patients between 18-65 years of age, * asa class i or ii, * undergoing elective unilateral laparoscopic nephrectomy * under general anaesthesia exclusion criteria: patients with any of the following: * refusal to participate in the study * coagulopathy/ thrombocytopenia * localised infection at the proposed site of injection * inability to comprehend the scoring systems to be employed or use pca due to physical or mental problems * known allergy to the drugs to be used (local anesthetics, opioids) * opioid tolerance/ dependence * renal impairment * hepatic impairment * known cardio-respiratory impairment * morbid obesity/ sleep apnoea
a study on the effect of education training on parents with autism based on denver model

Conditions: Autism; Parents

Summary: the goal of this clinical trial is to test the effects of parent training based on denver model on parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, quality of life, etc . the main question\[s\] it aims to answer are: * what is the status quo of autistic parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life * whether education and training based on denver model can improve autism parents' disease cognition level, coping style, parenting guilt, depression, anxiety and stress, and quality of life participants will receive educational training based on the denver model. the researchers will compare the denver model of early intervention with parents who receive regular autism health guidance to explore the effect of early intervention denver model


Eligibility criteria:
inclusion criteria: * the child meets the diagnostic criteria for autism in the fifth edition of the american diagnostic and statistical manual of mental disorders, and has been diagnosed by a physician； * parents of children aged 12-60 months with autism； * be the father or mother of the child, live with the child and take the main care of the child； * father ≥22 years old, mother ≥20 years old； * clear mind, normal intelligence, with normal cognitive ability. exclusion criteria: * suffering from serious heart, liver and kidney diseases and mental illness; * there are other family members suffering from serious illness or mental illness.

Keywords: denver model training intervention effect
the effect of a head elevated positioning device on position, height and depth of the cricothyroid membrane in morbidly obese pregnant women in the third trimester.

Conditions: Airway Complication of Anesthesia

Summary: the cricothyroid membrane (ctm) is situated in the anterior neck and may be readily palpated in most people. in the event of difficulties securing the airway during a general anesthetic the ctm can facilitate emergency access to the upper airway to allow rescue oxygenation and ventilation. caesarean sections are today carried out using either a spinal or epidural anaesthesia and for good reason. due to physiological effects of pregnancy a patient's airway is known to be more challenging when pregnant than outside of pregnancy. the pregnant airway can even change over the course of labor. airway ultrasound has become increasingly popular and allows accurate identification of airway structures including the cricothyroid membrane. it has already shown to be more accurate than palpation alone in identifying the cricothyroid membrane in obese pregnant women. the incidence of obesity in pregnancy continues to increase. although regional anesthesia is preferred when these women require caesarean section this is not always possible or successful. use of a device to optimise patient position for airway management is the standard of practice for obese pregnant patients. these devices are known as head elevating laryngoscopy position pillows, the troop elevation pillow ® is one such device. however, the investigators do not know if and how positioning the obese pregnant patient on a troop elevation pillow ® affects position, depth and height of the cricothyroid membrane. the investigators want to know if the troop elevation pillow ® will hinder or facilitate the performance of a surgical airway in the event of failed airway management in the pregnant obese patient. the investigators hypothesize that in pregnant obese patients in the third trimester use of the troop elevation pillow ® will change the position, height and depth of the ctm compared to the neutral position. based on previous evidence the investigators believe the position of the membrane will move superiorly in relation to the sternal notch, will increase in height and the depth from the skin to the membrane will be reduced. the investigators also hypothesize that ctm identification and marking prior to final patient positioning may be misleading.


Eligibility criteria:
inclusion criteria: * pregnant patients in third trimester (\>28/40 weeks) * morbid obesity (bmi≥40kg/m2) * ability to understand the rationale of the study assessments and to provide signed consent - ability to safely and comfortably take part in the study protocol exclusion criteria: * non pregnant patients * pregnant patients less than 28 weeks pregnant * not morbidly obese (bmi≥40kg/m2) * cervical spine pathology causing restricted neck movement or neurological compromise - previous neck surgery or irradiation * upper limb neurology * patient refusal

Keywords: cricothyroid membrane pregnancy obesity ultrasound
improving asthma outcomes in an urban pediatric population

Conditions: Asthma

Summary: little is known about how ed-based programs can help to reduce pediatric ed visits for asthma. the current study evaluated a novel intervention in which the ed itself became the site of highly individualized, comprehensive follow-up asthma care. it sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.

prospective, randomized clinical trial of a single visit to a specialized emergency department-based asthma follow-up clinic occurring 2-15 days after emergency department care for an acute exacerbation. all patients were followed for 6 months. analysis was by intention-to-treat with adjustment for baseline differences. our primary hypothesis was that this intervention would decrease subsequent unscheduled visits (both to eds and other sources of urgent care) for asthma over a six-month follow-up period. we further hypothesized that the intervention would decrease hospitalizations for asthma, improve compliance with an individualized medical plan and with trigger control, increase scheduled primary care practitioner (pcp) visits for routine asthma care, and decrease asthma symptoms while improving asthma quality of life (qol).

Eligibility criteria:
inclusion criteria: 1. age between 12 months and 17 years, inclusive; 2. prior physician-diagnosed asthma; 3. ≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months; 4. a parent/guardian available for interview; 5. residence in washington, dc or a contiguous maryland county; and 6. requirement for ≥3 doses of nebulized albuterol in the ed at the time of enrollment. exclusion criteria: 1. significant medical co-morbidities affecting the cardiorespiratory system; 2. a visit to an allergist or a pulmonologist in the prior 6 months; 3. ≥2 of the following: a current written asthma medical action plan, current use of \>1 controller medication, or a scheduled visit for asthma care with their pcp in the prior two weeks; 4. enrollment in another asthma research study; 5. unavailability for telephone follow-up; or 6. primary language other than english or spanish.

Keywords: asthma emergency department compliance randomized clinical trial