Kornimate/medical-research-clean huggingface dataset:
oxytocin maintenance infusion in labouring women undergoing cesarean delivery: an up-down sequential allocation study

Conditions: Postpartum Hemorrhage

Summary: this study is designed to determine the minimal effective oxytocin maintenance infusion required in labouring women undergoing cesarean delivery to achieve the best effect. oxytocin is a drug that is routinely used to help the uterus to contract and keep it contracted after delivery. consequently, it will help to reduce blood loss after delivery. in order to determine the minimal effective dose, the investigators will conduct a dose-finding study. the first patient will receive a set oxytocin infusion. the next patient's infusion dose of oxytocin, will either increase or decrease, depending on how the previous patient responds in terms of uterine tone. if the response is satisfactory with the infusion dose used, the next patient will either receive the same infusion dose or it will be decreased depending on a probability of 1:9. if the response is not satisfactory, then the infusion dose will increase for the next patient. the dose for each patient will be determined based on the results of the uterine contraction of the previous patient. the investigators hypothesize that the ed90 of the oxytocin infusion rate to maintain adequate uterine tone in labouring women with induced or augmented labour undergoing cesarean delivery, following an initial effective bolus dose, would be lower than 0.74 iu/min (44 iu/h), which was found as the ed90 in a previous study, without an initial bolus dose prior to the infusion.

this study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. the objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in laboring women. for the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ed90.

Eligibility criteria:
inclusion criteria: • all patients with induced or augmented labour undergoing cesarean delivery under neuraxial anesthesia (at least 3 hours of prior exposure to oxytocin during labour) exclusion criteria: * all patients who refuse to give written informed consent * all patients who declare allergy or hypersensitivity to oxytocin * a history of hypertension and/or severe cardiac disease(s) * all patients who have contraindications for neuraxial anesthesia * all patients who will be converted to general anesthesia intraoperatively * all patients with placenta previa and multiple gestation

Keywords: cesarean delivery oxytocin uterotonic pregnancy labour
divalproex sodium in the treatment of the cutaneous manifestations of scleroderma

Conditions: Scleroderma; Systemic Sclerosis

Summary: to investigate the ability of divalproex sodium, a histone deacetylase inhibitor, to improve the digital manifestations of scleroderma including digital edema, calcinosis cutis, digital ulcers, and joint contractures.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of scleroderma as defined by the american college of rheumatology (acr) * presence of at least one digital manifestation occurring within the past 6 months, i.e. digital swelling/edema, digital ulcer, calcinosis cutis, restricted digital range of motion. * females of childbearing potential must take an oral contraceptive pill or use an equivalent birth control method during the study. exclusion criteria: * age \<18 years old * ongoing use of high dose steroids (\>10 mg/day) or unstable steroid dose in past 4 weeks. * an investigational drug or disease-modifying agent has been started within the past 6 months, including but not limited to systemic corticosteroids, methotrexate, cyclosporine, azathioprine, cyclophosphamide, bosentan, mycophenolate mofetil, thalidomide, colchicine. * patient taking a medication with a significant drug-drug interaction with divalproex sodium, e.g. clomipramine and lamotrigine. * patient has another connective tissue disease or other condition that could affect rest pain and hand function, e.g. systemic lupus erythematosus, rheumatoid arthritis, or osteoarthritis. * patient has uncontrolled diabetes, chronic kidney disease, chronic hepatitis. * any of the following laboratory abnormalities at baseline: anemia (hb \ 1.3 or known bleeding disorder, estimated gfr \ 2.0 mg/dl, hyperbilirubinemia or elevation of ast or alt * pregnancy or breast-feeding. * history of severe depression (i.e. depression requiring medical treatment by a psychiatrist), suicidal ideation, epilepsy, bipolar disorder, or schizophrenia.
light filters in intraocular lenses (iols) and its influence on colour and contrast vision.

Conditions: Cataract

Summary: visible-light-filtering iols are implanted increasingly often in cataract surgery. several studies examined the effect of light-filters on contrast and colour vision. however, the study outcomes were varying. the present study investigated the effect of two light-filtering iol on colour perception and contrast acuity using highly sensitive measurement methods.

prospective, randomized, double-masked study with intraindividual comparison. implantation of a polylens y30 iol in one eye and an orange series model pc 440 y in the contralateral eye.

Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * age 55 to 80 years * expected postoperative visual acuity of at least 1.0 exclusion criteria: * amblyopia * corneal scars * diabetes * arterial hypertonia * pseudoexfoliation-syndrome * earlier ocular surgeries or laser treatments * intraocular tumors * color abnormalities * expected postoperative visual acuity lower 1.0

Keywords: intraocular lens light filtering intraocular lens contrast acuity color vision
early detection of endometrial/ovarian cancer and hereditary predisposition of these cancers

Conditions: Diagnoses Disease

Summary: early stage high-grade cancer, endometrial and ovarian, has few, if any, symptoms or signs. when symptoms appear, the disease is commonly in advanced stage meaning it has left the gynaecological organs and metastasized to the pelvic/abdominal cavity. the mcgill research group had showed in the dovee trial (nct02296307), that fast-track assessment with transvaginal ultrasound scans (tvus) and serial ca125 of women with vague symptoms associated with ovarian and endometrial cancer did diagnose these cancers earlier in the disease trajectory, with low-volume resectable disease, but only after the cancer had already become stage iii. one way to detect these cancers earlier is to screen asymptomatic women. unfortunately, none of the currently available tests, including tvus and ca-125 have been shown to be useful for screening for ovarian or endometrial cancer. the mcgill team has developed a genomic assay to screen and detect these cancers earlier in the trajectory than is currently the case. the test identifies pathogenic somatic mutations (necessary early steps in the development of these cancers), in an uterine cytological sample. it is able to do so by incorporating a machine-learning derived classifier that can discriminate the mutational signature of these cancers from benign disease with a sensitivity of 80% and a specificity of 100% in a healthy population of peri- and post-menopausal women. in addition to the uterine sample, the test includes a saliva sample that acts as an internal control but can also identify germline pathogenic variants that predispose to hereditary endometrial/ovarian cancers as well as breast, pancreas, and colon cancers. the test was developed in a retrospective population in whom the assay was done pre-operatively and the diagnosis of malignancy versus benign gynecological disease was confirmed by detailed pathological analysis of the uterus, tubes, and ovaries after surgical resection (nct02288676). the test is now ready to be tested as a phase iii diagnostic test in the general population to see if these results are just as promising in the community at large.


Eligibility criteria:
inclusion criteria: - capacity to understand study and provide informed consent exclusion criteria: * prior hysterectomy * be pregnant * be nursing * be undergoing any fertility treatment * have had recent history of uterine perforation

Keywords: ovarian cancer endometrial cancer genomics screening early detection
evaluation of cytidine deaminase for patient suffering of a myelodysplastic syndrom or an aml treated by azacytidine

Conditions: Myeloid Leukemia; Myelodysplastic Syndromes

Summary: myelodysplastic syndrome (mds) is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells. depending on the severity, mds reduces the quality of life to the point of being life-threatening. there is a probability of death at all stages of the disease, due to complications and co-morbidities, with progression to acute myeloid leukemia (aml) being the worst evolution. azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes. although generally well tolerated, severe and sometimes life-threatening toxicities were unexpectedly observed in some patients. genetic polymorphism affecting cytidine deaminase (cda), the liver enzyme responsible for azacytidine detoxification step, could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients, and on the other hand on treatment failure in ultrametabolizer patients.this clinical study aims at correlating the values in cda levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment.


Eligibility criteria:
inclusion criteria: * the patients have to be capable of submitting themselves at the rate of the visits, in the plan of treatmen, in the balance assessments of laboratory and other procedures of the study. * patient treated by azacytidine exclusion criteria: * patients having an infection unchecked who could compromise the participation in the study * patients having other grave and/or unchecked concomitant diseases which could compromise the participation in the study
bioresorbable vascular scaffold in patients with myocardial infarction

Conditions: ST Elevation Acute Myocardial Infarction

Summary: evaluation of the feasibility and safety of bioresorbable vascular scaffold (bvs) in patient treated with primary pci (ppci).

background. drug-eluting stent (des) implantation may offer benefits in terms of repeat revascularization in patients with st elevation myocardial infarction (stemi). the everolimus eluting bioresorbable vascular scaffold (bvs) has shown efficacy and safety in stable patient but not in acute coronary syndromes. the study tested the feasibility and safety of bvs in patient treated with primary pci (ppci) methods. consecutive stemi patients admitted within 12 hours of symptom onset and undergoing primary angioplasty and stent implantation at a tertiary center with 24-hour primary pci capability will be randomly assigned to everolimus eluting stent (ees) or bvs. primary endpoints are procedural and clinical success. the mace (cardiac death, non fatal myocardial infarction, target lesion revascularization (tlr)) and definite or probable st will be evaluated at six months.

Eligibility criteria:
inclusion criteria: 1. chest pain for more than 30 minutes; 2. st-segment elevation of 1 mm or more in 2 or more contiguous electrocardiograph leads or with presumably new left bundle-branch block exclusion criteria: 1. active internal bleeding or a history of bleeding diathesis within the previous 30 days; 2. contraindication to dual antiplatelet therapy for 12 months; 3. known allergy to everolimus; 4. a history of stroke within 30 days or any history of hemorrhagic stroke; 5. history, symptoms, or findings suggestive of aortic dissection; 6. high-likelihood of death within bvs resorbtion time; 7. cardiogenic shock; 8. infarct artery reference diameter, \ 3.7 mm (i.e. not suitable for currently available bvs sizes); 9. pregnancy; 10. participation in other trials

Keywords: myocardial infarction primary pci stent
study to identify and characterize bacteria causing acute otitis media in young children in turkey

Conditions: Infections, Streptococcal

Summary: the purpose of this study is to identify and characterize the bacteria causing complicated acute otitis media episode in children \>= 3 months to \< 5 years in turkey.


Eligibility criteria:
inclusion criteria: * age: \>= 3 months and \< 5 years at the time they are seen by the paediatrician. the subject becomes ineligible on the fifth birthday. * signs, symptoms, and conditions: * one of the functional or general signs of otalgia ,conjunctivitis, fever and either * paradise's criteria or * spontaneous otorrhoea of less than 24 hours. * subjects if classified as recurrent acute otitis media or treatment failure as described below: * recurrent acute otitis media: defined as a subject who has an episode of acute otitis media representing the third new episode within the past 6 months, or the fourth new episode within the past year. * treatment failure: defined as a subject who was diagnosed with acute otitis media and received antibiotic treatment from a physician, but is still symptomatic 48-72 hours after initiation of the treatment. as with other acute otitis media cases, the onset of signs or symptoms should have been within 72 hours prior to the initial visit to the physician. * written informed consent obtained from parent or guardian prior to study start. exclusion criteria: * hospitalised during the diagnosis of acute otitis media or during treatment. * otitis externa, or otitis media with effusion. * presence of a transtympanic aerator. * systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment. * receiving antimicrobial prophylaxis for recurrent acute otitis media. * provision of antibiotic by paediatrician at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous otorrhoea. * patients that are on antibiotics for acute otitis media, and are clinically improving.
esomeprazole and symptomatic response in patients with or without an elevated risk for non-steroidal anti-inflammatory drug (nsaid)-associated gi damage

Conditions: Heartburn

Summary: the purpose of this study is to compare the treatment effect in patients with upper gastro-intestinal complaints with an elevated risk for nsaid-associated gi-damage to those without an elevated risk for nsaid-associated damage (as determined by the treating physician).


Eligibility criteria:
inclusion criteria: * patient with upper gastro-intestinal complaints (defined as heartburn and/or regurgitation and/or nausea and/or bloated feeling)and treatment with esomeprazole 20mg once daily is started because of this (consult 1). upper gastro-intestinal complaints are thought to be related to nsaid use * patient is using an nsaid\*\* with the following conditions: * nsaid use has started at least one week before 1st consultation and is expected to be continued unchanged during the coming period (at least until consult 2) * nsaid is taken at least 3 days a week (\*\*)otc or prescription nsaid (\*\*)conventional nsaid or cox-2 selective nsaid exclusion criteria: * use of a ppi and/or h2ra in the month preceding the study * a history of reflux disease, not related to nsaid use

Keywords: upper gi-symptoms heartburn nsaid risk ppi bloating regurgitation
moderate-vigorous intermittent physical activity (m-vilpa) in stroke

Conditions: Physical Inactivity; Stroke

Summary: stroke is the leading cause of disability in spain. additionally, it is the second leading cause of death in women and the third in both sexes. regular physical activity (pa) helps prevent and manage stroke. it also helps with hypertension, maintains a healthy body weight, and improves mental health, quality of life, and well-being. pa plays a prominent role in inpatient care after stroke. however, stroke survivors become more sedentary when discharged from the hospital. they have muscle weakness, reduced balance, and fatigue. consequently, pa levels of community-dwelling post-stroke individuals remain lower than their age-matched counterparts. continued pa can help this population maintain and improve physical function, and reduce long-term functional limitations, and mortality risk.

previous studies that performed a comparative analysis of physical activity between individuals with and without stroke have consistently reported that stroke survivors tend to spend less time in moderate to vigorous physical activity the 2021 aha guideline recommends smaller sessions of pa, with suggestions such as 10 minutes of moderate activity, 4 times a week, or 20 minutes of vigorous activity twice a week. this contrasts the weekly physical activity recommendations in 2011 (30 minutes of moderate to vigorous, 1 to 3 times) and 2014 (40 minutes of moderate to vigorous, 3 to 4 times). we hypothesise that older stroke survivors are physically active more frequently but for smaller durations than younger stroke survivors who are physically active for longer durations but less regularly. understanding these subtle changes will not only help to tailor physical activity interventions based on specific recommendations but also help design future recommendations. moderate-to-vigorous pa could be an adequate approach for stroke survivors as it requires less time to achieve the same benefits as light pa. more concretely, a new concept called moderate-to-vigorous intermittent lifestyle physical activity (mv-ilpa) has recently emerged for adults who do not habitually exercise in their leisure time. mv-ilpa refers to brief and sporadic bouts of moderate-vigorous intensity pa performed as part of the activities of daily living, such as bursts of very fast walking, sitting and standing up from a chair, or stair climbing. mv-ilpa is associated with a substantially lower risk of all-cause cardiovascular disease and cancer mortality. however, there is no evidence to directly support the potential benefits of mv-ilpa in the elderly post-stroke patients.

Eligibility criteria:
inclusion criteria: * adults aged ≥57 in the late subacute phase post-stroke. * who live in the community * whose clinician confirmed a diagnosis of stroke (ischaemic/haemorrhagic) * discharged from hospital inpatient regimen * with independent mobility skills (barthel index ≥ 40 points). exclusion criteria: • other neurological diseases (e.g. parkinson disease) or severe lower limb injuries.

Keywords: physical activity stroke moderate-vigorous physical activity
aortic replacement using individualised regenerative allografts - arise (the "surveillance")

Conditions: Heart Valve Disease

Summary: evaluation of decellularized human heart valves for aortic heart valve replacement in comparison to current valve substitutes. safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

this is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in europe. the surveillance is designed as a study, where * arise av is prescribed in the usual manner in accordance with the terms of the approval. * assignment of the patient to a particular therapeutic strategy is not decided in advance by this surveillance protocol but falls within current practice and the prescription of arise av is clearly separated from the decision to include the patient in the surveillance. * no additional diagnostic or monitoring procedures shall be applied to the patients. * and epidemiological methods shall be used for the analysis of collected data.

Eligibility criteria:
inclusion criteria: i. indication for aortic valve replacement according to current medical guidelines in valvular heart disease ii. informed consent of legal guardians or patients, assent of patients exclusion criteria: i. the patient has not provided surveillance informed consent. ii. the patient shall not suffer from: * generalized connective tissue disorders (eg, marfan syndrome), or . * active rheumatic disorders, or * severe asymmetric calcification of the valve ring. iii. the coronary arteries of the patient shall not be in abnormal position or heavily calcified. iv. patients shall not show hypersensitivity against sodium dodecyl sulphate (sds), sodium desoxycholate (sdc), human collagen (or other elastic fibers) or benzonase®.
nebivolol and the endothelin (et)-1 system

Conditions: Prehypertension; Hypertension

Summary: the investigators hypothesize that nebivolol will reduce et-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.

1. the investigators hypothesize that nebivolol will reduce et-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. 2. the investigators further hypothesize that reducing et-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.

Eligibility criteria:
inclusion criteria: * subjects will be men and women of all races and ethnic backgrounds aged 45-65 years. * subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure \>130 mmhg and \ 80 mmhg and \< 100 mm hg. * all of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (hrt) currently or in the preceding 3-year period. * lastly, candidates will be sedentary as determined from the stanford physical activity questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study. exclusion criteria: * candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits) * potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible. * fasting plasma glucose \>126 mg/dl. * potential candidates with a resting heart rate of \< 50 beats/minute will be excluded. * use of hormone replacement therapy. * in hypertensive subjects, a seated systolic blood pressure greater than 160 mmhg or a seated diastolic blood pressure greater than 100 mmhg.