Kornimate/medical-research-clean huggingface dataset:
electroacupuncture for postoperative ileus after laparoscopic rectal cancer surgery

Conditions: Postoperative Ileus

Summary: postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. the investigators previous study demonstrated that electroacupuncture (ea) at zusanli, sanyinjiao, hegu, and zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (tme) or abdominoperineal resection (apr) were excluded. however, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether ea will be beneficial to them. the investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of ea in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic tme or apr without the need of conversion will be recruited. all patients will undergo 1 session (20 minutes) of ea daily from postoperative day 1 till day 4. these patients will be compared with a matched historical control group (1:2) who underwent laparoscopic tme or apr without ea. the primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. secondary outcomes include time to defecation and duration of hospital stay. results of this study will help clarify the efficacy of ea in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.


Eligibility criteria:
inclusion criteria: * consecutive patients (aged between 18 and 80) with mid/low rectal cancer undergoing laparoscopic tme or apr without the need of conversion * patients with american society of anesthesiologists grading i-iii * informed consent available exclusion criteria: * patients undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases * patients undergoing laparoscopic resection of rectal cancer with en-bloc resection of surrounding organs * patients who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion * patients with intestinal obstruction * patients with previous history of abdominal surgery * patients with evidence of peritoneal carcinomatosis * patients who are expected to receive epidural anesthesia or analgesia * patients with cardiac pacemaker * patients who are pregnant * patients who are allergic to acupuncture needles
genotype-phenotype correlation study of presymptomatic and symptomatic dfna9 patients

Conditions: Vestibular Diseases; DFNA9

Summary: dfna9 (deafness autosomal dominant 9) is an autosomal dominant hereditary hearing loss which is associated with vestibular deterioration. the most recent genotype-phenotype correlation studies have been conducted more than 15 years ago. meanwhile, emerging and valuable vestibular tests have been added to the vestibular test battery. these tests were not available at the time of the correlation studies. the aim of this study is to carry out a prospective cross-sectional study on symptomatic and presymptomatic affected carriers of the pro51ser (p51s) coagulation factor c homology (coch) mutation in order to correlate vestibular data using the complete vestibular test battery with the known data on hearing and vestibular function in relation to age.

systematic review of the genotype-phenotype correlation studies in p51s carriers has shown an underrepresentation of presymptomatic affected subjects and the calculation of vestibular deterioration were based on just one vestibular parameter, whereas the combined evaluation of a complete vestibular test battery, covering the complete vestibular sensitivity range and all labyrinthine compartments separately, is nowadays considered standard practice in determining more accurate assessment of the vestibular function. for this reason, a prospective cross-sectional study on pre- as well as symptomatic dfna9 patients carrying the pro51ser (p51s) mutation in coch gene is being carried out, in order to gain more realistic data on vestibular dysfunction, consisting of pure tone audiometry and a comprehensive vestibular test battery, including electro- or videonystagmography (vng), c- and o-vestibular-evoked myogenic potential (vemp) tests, video head impulse test (vhit) and questionnaires (dhi (dizziness handicap index), oscillopsia questionnaire (os), quality of life questionnaire (eq-5d-5l), activities-specific balance confidence (abc) scale.

Eligibility criteria:
inclusion criteria: * subject must be 18 year of older * subject is a family member of the family pedigree's proband(s) carrying a p51s coch mutation exclusion criteria: * subject is younger than 18 years * subject is not a family member of the pedigree's proband(s) carrying a p51s * subject cannot undergo investigations (medical and/or mental reasons) * subject is not willing to be enrolled into the study * subject suffers other concomitant middle or inner ear disease * subject has undergone middle ear or inner ear surgery * subject suffers other concomitant vestibular disease than dfna9 * subject has undergone vestibular surgery or other non-invasive vestibular treatment (gentamicin intratympanal injections for example)
effectiveness of rapid and slow maxillary expansion in treating posterior crossbite

Conditions: Posterior Crossbite

Summary: this study will evaluate the efficacy of rapid maxillary expansion (rme) and slow maxillary expansion (sme) in treating posterior crossbite using cone beam computed tomography. the study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. the sample will be allocated randomly into two groups: rme group and sme group. the skeletal and dento-alveolar changes occurring after treatment will be assessed by using cone beam computed tomography(cbct) radiographs.

unilateral or bilateral posterior crossbite (pxb) is a common malocclusion. in recent decades, rme has gained preference as the treatment of choice for pxb. however, the side effects, such as reported pain, relapse of the expansion, tipping of the molars, bone loss, gingival recession, and root resorption, have lead some clinicians to prefer sme. in this study the investigators will treat pxb using two techniques, rme and sme. patients will be divided into two groups (a technique in each group) to evaluate the efficacy of each one using cone beam computed tomography. rme group: a hyrax appliance modified as mcnamara will be applied. sme group: a removable appliance with central expander will be applied. in order to evaluate the changes occurring, two cbct radiography will be taken for every individual: first, before treatment, second, after three months of retention for rme group and one month of retention for sme group

Eligibility criteria:
inclusion criteria: * bilateral skeletal maxillary deficiency (symmetrical) which will be clinically and radiographically diagnosed. * bilateral or unilateral functional posterior crossbite ( combined with mandibular shifting) * class i or ii malocclusion. * normal or slight vertical growth pattern. exclusion criteria: * poor oral hygiene. * previous orthodontic treatment. * patients with syndromes, clefts, or craniofacial abnormalities. * patients with low facial height. * a contraindication for rapid or slow maxillary expansion procedures.
closed-loop automatic oxygen control (clac-4) in preterm infants

Conditions: Infant Respiratory Distress Syndrome; Ventilator Lung; Newborn

Summary: two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (cpap) or non-invasive ventilation (niv) or invasive ventilation (iv)). routine manual control (rmc) of the fraction of inspired oxygen (fio2) will be tested against rmc supported by closed-loop automatic control (clac) with "slow"-algorithm and rmc supported by clac with "fast"-algorithm. the primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (spo2) target range compared to rmc only. the a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the spo2 in the target range.

background and objective in preterm infants receiving supplemental oxygen, routine manual control (rmc) of the fraction of inspired oxygen (fio2) is often difficult and time consuming. the investigators developed a system for closed-loop automatic control (clac) of the fio2 and demonstrated its safety and efficacy in a multi-center study. the objective of this study is to test a revised, "faster" algorithm with a shorter wait-interval of 30sec (= time between fio2 changes) against the previously tested algorithm (wait of 180sec) and against rmc. the primary hypothesis is, that the application of clac with the "faster" algorithm in addition to rmc results in more time within arterial oxygen saturation (spo2) target range compared to rmc only. the a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the spo2 in the target range. further hypotheses for exploratory testing are, that the "fast" algorithm will achieve a higher proportion of time with spo2 within target range and an improved stability of cerebral oxygenation (measured as rcsto2 and rcfto2e determined by near-infrared spectroscopy) compared with the slow algorithm. study design the study is designed as a two-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (fio2 above 0.21). within a twenty-four-hour period the investigators will compare 8 hours of rmc with 8-hour periods of rmc supported by clac "slow" algorithm or "fast" algorithm, respectively.

Eligibility criteria:
inclusion criteria: * gestational age at birth \<34+1/7weeks * invasive mechanical ventilation or noninvasive ventilation or continous positive airway pressure support * fraction of inspired oxygen above 0.21 before inclusion * more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion * parental written informed consent exclusion criteria: * congenital pulmonary anomalies * diaphragmatic hernia or other diaphragmatic disorders

Keywords: controller hyperoxia hypoxia ventilation cerebral oxygenation
bleeding risk assessment system for antithrombotic therapy of acs

Conditions: Acute Coronary Syndrome

Summary: antithrombotic therapy is the cornerstone of the management of patients with acute coronary syndrome (acs), which result in lower risk of mortality and ischemic events. but, accompanied side effect of bleeding always causing worsens outcomes. tools to evaluate risk/benefit ratio is useful in daily practice. the in-used scores, such as crusade, are derived from retrospective studies, without all types of acs and without long-term prediction. this project aims to establish a database of anti-thrombosis treatment and bleeding in five large centers in beijing through the observational registry of acs. with the database, establish a bleeding risk assessment system that can be used for all acs patients and can predict the full course of antithrombotic treatment.


Eligibility criteria:
inclusion criteria: 1. age18-85 years old 2. diagnosed acs 3. signed informed consent form exclusion criteria: 1. any active bleeding 2. not tolerate to anti-thrombotic drugs 3. a planned elective surgical procedure that would necessitate an interruption in treatment with antiplatelet therapy in the next 6 months after enrollment 4. patients who died of non-bleeding causes within 24 hours after admission 5. noncardiac coexisting conditions that could limit life expectancy to less than 1 year 6. pregnancy or lactation

Keywords: bleeding antithrombosis
evaluation of avatrombopag for the treatment of thrombocytopenia in japanese adults with chronic itp

Conditions: Immune Thrombocytopenia

Summary: evaluate the efficacy, safety, and pk of avatrombopag given for 26 weeks in japanese adults with chronic immune thrombocytopenia (itp).

this phase 3, multicenter, open label study will evaluate the efficacy, safety, and population pharmacokinetics (pk) of avatrombopag in japanese adults with chronic itp. at least 19 subjects will be enrolled. the study will consist of 3 phases: pre-enrollment, primary investigation, and extension phase until market authorization in japan.

Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of chronic immune thrombocytopenia (itp) (≥12 months duration) and has had an insufficient response to a previous itp treatment, in the opinion of the investigator. * subject has an average of 2 platelet counts \ 35×10\^9/l). the 2 samples must be obtained ≥48 hours and ≤2 weeks apart. exclusion criteria: * subjects with known secondary immune thrombocytopenia (e.g., with known helicobacter pylori-induced itp, subjects infected with known human immunodeficiency virus (hiv) or hepatitis c virus (hcv) or subjects with known systemic lupus erythematosus). * subjects with known inherited thrombocytopenia (e.g., myosin heavy chain 9 (myh-9) disorders) or hereditary thrombophilic disorders (e.g., factor v leiden, antithrombin iii deficiency). * history of myelodysplastic syndrome (mds). * history of arterial or venous thrombosis. * subjects with a history of significant cardiovascular disease (e.g., congestive heart failure (chf) new york heart association grade iii/iv, arrhythmia known to increase the risk of thromboembolic events \[e.g., atrial fibrillation\], angina, coronary artery stent placement, angioplasty, coronary artery bypass grafting). * subjects with a history of cirrhosis, portal hypertension, or chronic active hepatitis. * subjects with concurrent malignant disease or receiving cytotoxic chemotherapy for a reason other than itp treatment. * use of immunoglobulins (ivig and anti-d) or corticosteroid rescue therapy within 1 week of day 1/baseline. * splenectomy or use of rituximab within 12 weeks of day 1/baseline. * use of romiplostim or eltrombopag within 1 week of day 1/baseline. * use of chronic corticosteroid treatment or azathioprine within 4 weeks of day 1/baseline, unless receiving a stable dose for at least 4 weeks. * use of mycophenolate mofetil, cyclosporin a, or danazol within 4 weeks of day 1/baseline, unless receiving a stable dose for at least 12 weeks. * use of cyclophosphamide or vinca alkaloid regimens within 4 weeks of baseline visit. * currently receiving moderate or strong dual inhibitors/inducers of cyp2c9 and cyp3a4. * serum creatinine ≥1.5× the upper limit of normal (uln). * serum bilirubin ≥2×uln. * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥3×uln. * females who are pregnant (positive beta-human chorionic gonadotropin (β-hcg) test) or breastfeeding. * received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) before day 1/baseline.

Keywords: itp
the hug-up test: a new, sensitive diagnostic test for supraspinatus tears

Conditions: Rotator Cuff Tears

Summary: we developed a new test, the "hug-up test," wherein elevation is resisted as the palm is held on the opposite shoulder with the elbow held in maximal anterior translation. the purpose of this study was to describe the hug-up test and compare it with other conventional tests used for diagnosing supraspinatus tears.

the supraspinatus tendon is the most commonly affected tendon in rotator cuff tears. early detection of a supraspinatus tear using an accurate physical examination is, therefore, important. however, the currently used physical tests for detecting supraspinatus tears are poor diagnostic indicators and involve a wide range of sensitivity and specificity values. therefore, the aim of this study was to establish a new physical test for the diagnosis of supraspinatus tears and evaluate its accuracy in comparison with conventional tests. between november 2012 and january 2014, 200 consecutive patients undergoing shoulder arthroscopy were prospectively evaluated preoperatively. the hug-up test, empty can (ec) test, full can (fc) test, neer impingement sign, and hawkins-kennedy impingement sign were used and compared statistically for their accuracy in terms of supraspinatus tears, with arthroscopic findings as the gold standard. muscle strength was precisely quantified using an electronic digital tensiometer.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors from november 2012 to january 2014 exclusion criteria: * patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder diseases.
efficacy and safety of semaglutide once-weekly versus exenatide er 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (oads) in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and north and south america. the aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide er (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (oads) in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 oads (metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (tzd) and sulfonylureas (sus) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. stable is defined as unchanged medication and unchanged dose - hba1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) exclusion criteria: - females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 week follow-up period (adequate contraceptive measures as required by local law or practice) - any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - history of chronic or idiopathic acute pancreatitis - screening calcitonin value equal to or above 50 ng/l (pg/ml) - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) - impaired renal function defined as estimated glomerular filtration rate (egfr) below 60 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula (4 variable version) - acute coronary or cerebrovascular event within 90 days before randomisation - heart failure, new york heart association (nyha) class iv
luteal support and intrauterine insemination (iui) with clomiphene citrate

Conditions: Infertility

Summary: the purpose of this study is to assess the effect of luteal phase supplement (lps) on pregnancy rate in iui cycles stimulated with clomiphene citrate.


Eligibility criteria:
inclusion criteria: * age ≤ 36 years * body mass index between 18 and 29 * presence of both ovaries * basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three fsh level of \<12iu/l * patients can enter the study only once. * only the first iui attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study) * normal hsg (maximum 3 months prior starting the stimulation). * donor sperm can be included exclusion criteria: * polycystic ovarian syndrome (rotterdam criteria) * endometriosis(≥afs iii)

Keywords: iui clomiphene citrate utrogestan
diabetes-related discrimination at workplace and by insurances

Conditions: Insulin-Treated Diabetes Mellitus

Summary: diabetic subjects often report of problems at the workplace or when contracting insurances because of their diabetes. by distributing a self-report questionnaire to insulin-treated type 1 and type 2 diabetic subjects we wanted to analyse the frequency of work- and insurance-related discrimination. furthermore we wanted to detect socio-demographic and diabetes-related factors which are associated with increased discrimination at workplace and by insurances. we hypothesized that diabetes-related discrimination at workplace and by insurances exists and that certain factors like having severe hypoglycaemic events, being type 1 diabetic or being overweight would be associated with more problems at work or with insurances.

our self report questionnaire included 83 items to assess treatment goals, quality of life and discrimination at workplace or by insurances. 636 questionnaires were distributed and were answered and returned. anonymity was ensured. patients were recruited from the diabetes outpatient clinic of the university of basel hospital, 5 regional hospitals, specialist practices and general practitioner practices. the aims of this study are to investigate the prevalence of discrimination at workplace and by insurances due to diabetes mellitus. furthermore we want analyse if socio-demographic factors (age,gender,origin) show an impact on diabetes-related discrimination at workplace and by insurances. we hypothesize furthermore that certain diabetes-related factors like having severe hypoglycemias, being type 1 diabetic, having diabetic complications or being overweight/obese is associated with more problems at work and with insurances. data will be analysed by a multiple ordinal regression analysis. we will correct data for age, gender, employment status and diabetes type.

Eligibility criteria:
inclusion criteria: * german-speaking insulin-treated diabetic patients exclusion criteria: * none
preoperative 3d models and shared decision-making

Conditions: Colorectal Cancer; Shared Decision Making; Anxiety; Informed Consent

Summary: the objectives of this study will be to quantify, using validated scales, the effects of 3d-printed models on shared decision-making and patient anxiety during the pre-operative consent and education process.

in this single-center pilot cluster randomized controlled trial, the investigators will prospectively measure patient-reported outcomes on shared decision-making and change in anxiety and knowledge. this study will consist of two arms with at least 20 patients each. six surgeons will be randomly assigned using the opaque sealed envelope method to counsel patients using a modular 3d-printed model or providing standard care during pre-operative clinic visits. the eligibility criteria for the control and investigational arms will be standardized. the biostatistician will use student t-tests to compare mean scores and ancova to compare the change in mean scores after the pre-operative clinic visit.

Eligibility criteria:
inclusion criteria: * participants must be \>18 years * patients scheduled for surgical intervention that would involve partial or complete resection of the colon and/or rectum exclusion criteria: * patients requiring complex surgical reconstruction of organs other than the colon and/or rectum

Keywords: colorectal cancer 3d model shared decision making preoperative anxiety patient knowledge informed consent