Kornimate/medical-research-clean huggingface dataset:
helm cpap versus mask cpap after major abdominal surgery

Conditions: Respiratory Insufficiency

Summary: postoperative pulmonal complications (abbreviation - ppc) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. cpap is one approach to minimize the frequency and severeness of ppc. in the investigators' organization intermittent mask cpap every 2 hour, 15min, is used routineously after major abdominal surgery. recently new devices has been designed, which give the opportunity tip deliver continuously cpap with out interruptions because of presumed better comfort. therefore better patient compliance. no studies to date have investigated the possible benefit of using continuously helm cpap versus the traditional intermittent mask cpap after major abdominal surgery. the investigators' study will investigate if there are any benefits with continuously helm cpap versus intermittent mask cpap after major abdominal surgery.


Eligibility criteria:
inclusion criteria: * elective major abdominal surgery exclusion criteria: * severe lung disease. airway deformity. need for cpap at home. ongoing oxygen therapy. cannot give informed consent.
resident training enhanced by new innovations: teleintubation

Conditions: Asphyxia Neonatorum

Summary: the overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.the investigators sought to determine if resident exposure to individual training and video laryngoscopy using the c-mac video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. the primary outcome was time to intubation after one year. the secondary outcome was the ability to retain cognitive instruction related to intubation

objective: tracheal intubation of infants and children is a critical lifesaving skill, but many upper level pediatric residents are unable to successfully intubate neonates or pediatric patients in a timely manner. simulation has been shown to be effective in teaching procedural skills, but it is not known if improvements in intubation skills can persist. the investigators sought to determine if video laryngoscopy could be used to enhance resident intubation skills that would be retained for one year. methods: there were 67 pediatric and internal medicine/pediatric residents, levels 1-4, who completed the study and were randomized by month of service into non-intervention (ni, n= 36) and intervention (in, n=31) groups. in residents observed the intubation portion of the neonatal resuscitation program (nrp) training video and received cognitive instruction and 30 minutes of hands on instruction using a video laryngoscope. at the study's conclusion, 12 months after enrollment, residents completed a survey of intubations of live patients over the past year, a cognitive assessment of intubation, and were timed on intubating a manikin. results were analyzed by student's t-test.

Eligibility criteria:
inclusion criteria: * pediatric residents exclusion criteria: * residents from other departments * neonatology fellows * medical students * medical school faculty
sofosbuvir and daclatasvir for treating hepatitis c in 200 patients co-infected with human immunodeficiency virus

Conditions: Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus

Summary: in a multi-center study 200 patients co-infected with hepatitis c virus (hcv) and human immunodeficiency virus (hiv) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (art) being used by the patient. the treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

to achieve the goal of elimination of hepatitis c in 2030 as set forward by the world health organization (who) a main group requiring treatment are subjects co-infected with hiv. these subjects offer a particular challenge as they are receiving art which frequently interferes with hepatitis treatment. the number of pills they are already taking also limits the compliance of these patients. in order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular art medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed. the treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis. the study is one of the pilots being run for hepatitis c elimination in iran.

Eligibility criteria:
inclusion criteria: * positive qualitative hepatitis c virus rna test on two occasions at least 6 months apart * positive human immunodeficiency virus test exclusion criteria: * heart rate \< 50/min, * taking amiodarone * renal failure
comparison of vaginal hyaluronic acid treatment over autologous platelet rich plasma treatment for genitourinary syndrome of menopause

Conditions: Genitourinary Syndrome of Menopause

Summary: genitourinary syndrome of menopause (gsm) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients. platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. the blood is spun using a centrifuge that separates the plasma and red blood cells. the treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. the observational cohort study will be used for the study design. questionnaires, pelvic examination, vaginal pap smear with maturation index (mi), vaginal ph, and other methods will be used to evaluate the effectiveness and side effects.

primary objective: to determine the safety and feasibility of using platelet-rich plasma (prp) treatment in menopausal patients with genitourinary syndrome secondary objective: to determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms vsq, vaginal health index, vaginal maturation index, and day-to-day impact of vaginal aging score will be used for assessments. outline: patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into prp tubes after 3 sessions of prp treatment, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * women with menopause * patients with symptoms of genitourinary syndrome of menopause exclusion criteria: * genitourinary bleeding or infection without a definitive diagnosis * coagulopathy * allergy to medication or therapy related to the treatment * chronic disease that might influence the outcome * using medication that might influence the outcome in 30 days * using hormone or steroid within 8 weeks * personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation * chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity * pelvic organ prolapse greater than stage ii * pelvic surgery within 6 months * known allergy to lidocaine or prilocaine * use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy * immunocompromised patients and patients known to be human immunodeficiency virus (hiv) positive and currently receiving antiretroviral therapy.

Keywords: genitourinary syndrome menopause platelet rich plasma vaginal atrophy
effects of exercise on vldl-tg metabolism

Conditions: NAFLD - Nonalcoholic Fatty Liver Disease; NASH - Nonalcoholic Steatohepatitis

Summary: non-alcoholic fatty liver disease (nafld) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (nash) and cirrhosis. new evidence indicates that nafld is associated with development of heart failure, abnormal ventricular glucose and fatty acid (fa) utilisation and cardiosteatosis. the mechanisms behind cardiac involvement and the progression from nafl to nash are poorly understood but must include altered cardiac and intrahepatic lipid handling. in collaboration with renowned research groups from oxford, mayo clinic and copenhagen we plan comprehensive kinetic studies of heart and liver fa uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (tg) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with nafl and nash and the relationship with heart function. in addition, we will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. we will address these questions using innovative tracer techniques (11cpalmitate, 11c acetate, 18fdg glucose pet tracers and tg tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as nmr spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. effects of acute exercise as well as glp-1 agonist and sglt-2 inhibitor treatment (alone and in combination) will be assessed. the overarching goals are to define abnormalities and differences between nafld and nash in hepatic lipid (fa and tg) metabolism and to assess hepatic, adipose and skeletal muscle lipid and substrate utilisation.


Eligibility criteria:
inclusion criteria: * • 8 obese subject men with nafl (mr spectroskopi, fibro scanner) (bmi \> 30). * 8 obese subject men with nash (mr spectroskopi, fibro scanner) (bmi \> 30). * age between 40-70 years written consent before the start of the study exclusion criteria: * known current disease * fixed medical drug consumption except antihypertensive drugs and statins. however, pause statins 3 weeks before the examination date * blood donation within the last 3 months prior to the study * participation in experiments involving radioactive isotopes within the last 3 months * alcohol abuse (over 21 items per week for men and 14 for women) * smoking * weight over 130 kg * cancer patients * large intake of medication
evaluation of safe sleep for babies: a bassinet distribution and education program

Conditions: Sudden Infant Death

Summary: this study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.

the proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. an additional comparison group will be parents who already have a baby box at the time of recruitment. this group will also receive the safe sleep pamphlet. families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes. families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference. phin will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.

Eligibility criteria:
inclusion criteria: * mothers who are 32 weeks or more gestation * infants less than 3 months of age (or post-conceptional age 44 weeks) * able to consent freely and complete face to face and/or telephone interviews in english * will be residing in winnipeg until the infant is 2-4 months of age or able to complete a telephone interview at 2-4 months of age exclusion criteria: * parent/guardian/client less than 18 years of age (unless emancipated minor) * parents who cannot consent due to intellectual capacity, medical condition, etc. * infant is discharged from hospital in the care of child and family services or a birth alert is in place
selenoproteins as prognostic markers and therapeutic targets in breast cancer.

Conditions: Breast Cancer

Summary: this is multicentric, spontaneous, observational, retrospective and prospective study.

in the retrospective part of the study, tissue microarrays (tma) will be prepared from surgical samples of breast tissue from a series of patients with tnbc type breast cancer. in the prospective part of the study will be evaluated the expression of some selenoproteins by elisa in plasma samples obtained from up to 100 healthy subjects and about 300 (\~100 per year) patients with basally metastatic tnbc breast cancer (150) and metastatic (150) before any treatment.

Eligibility criteria:
inclusion criteria: * tnbc breast cancer patients, before any drug treatment * healthy women aged 25-60 exclusion criteria: * donors suffering from diabetes, hypertension, active infectious states, hiv infection, hepatitis b or c, chronic inflammatory diseases, current or previous neoplasms, heart disease or drug treatment.
avenir müller hip stem post market surveillance study

Conditions: Osteoarthritis, Hip; Rheumatoid Arthritis; Fracture of Hip; Dislocated Hip; Osteonecrosis; Post-traumatic; Arthrosis; Subluxation Hip

Summary: this study is a post market clinical follow up study to fulfil the post market surveillance obligations according to medical device directive and european medical device vigilance system (meddev) 2.12-2. the data collected from this study will serve the purpose of confirming safety and performance of the avenir müller hip stem.

the objective of this post market surveillance study is to obtain outcome data on the avenir müller hip stem by analysis of standard scoring systems, radiographs and adverse event records, and thus to assess the long-term performance and safety of this implant. this is a multi-centre, retrospective post-market surveillance study involving orthopaedic surgeons skilled in hip surgery. each case enrolled has received the avenir müller hip stem for a primary hip arthroplasty. the avenir müller hip stem is ce marked (european conformity) and commercially available.

Eligibility criteria:
inclusion criteria: * patients able to participate in a follow-up program based upon physical examination and medical history. * patients or patient's legal representatives who have given written consent to take part in the study by signing the 'patient consent form'. * 18 years minimum. * male and female. * baseline data exist (pre-, peri- and immediate postoperative) exclusion criteria: * patients who are unwilling or unable to comply with the follow-up program. * known pregnancy. * patients who are skeletally immature.
treatment approaches to preeclampsia

Conditions: Preeclampsia

Summary: this pilot study will document the efficacy and acceptability of administration of magnesium sulfate with the springfusor pump for patients and staff at two sites where treatment or preeclampsia with magnesium sulfate is limited or not available. currently, both sites refer patients to tertiary care facilities for further treatment.

women diagnosed with preeclampsia that the clinic care team deem would benefit from treatment with magnesium sulfate will be given the option of participating in the study. those who choose to take part in the study and meet study inclusion and exclusion criteria will receive full information about the study and be required to give their written or signed informed consent. women agreeing to participate in the study will receive a loading dose and maintenance therapy using an iv infusion administered by the springfusor® pump. women will receive a 8 ml loading dose containing 4g magnesium sulfate heptahydrate (mgso4\*7h2o) 50% solution, which is approximately 2 mmol magnesium/ml. the loading dose of 8ml with 4 g mgso4 will be administered using the springfusor® pump. the administration of the loading dose will be immediately followed by a maintenance infusion. the maintenance dose of 4 g (8 cc, 50% mgso4) will be administered with the springfusor® pump continuously over four hours. clinical monitoring will occur once every hour during the treatment period. clinical monitoring will occur throughout the treatment, with reflexes, urine output and respiration to be checked at least every hour (or, if more frequent, as per standard practice at the study site). the pump will be checked at each monitoring visit. prior to discharge from the study, patients will be asked to assess their opinions about the acceptability and ease of use of the mode of administration. all requests or inquiries about termination of treatment will be recorded.

Eligibility criteria:
inclusion criteria: * exhibit systolic blood pressure \> 140mm hg or a diastolic pressure \> 100 mm hg * exhibit proteinuria \> 1+ * have not given birth, or be 24h or less postpartum * exhibit urine output \>100 ml or more during the previous 4h or greater than 25 ml/h * agree to comply with study procedures * be \> 18 years of age * give informed consent for study participation exclusion criteria: * eclamptic or seizing at the time of enrollment * received magnesium sulfate therapy 24h prior to study enrollment

Keywords: eclampsia preeclampsia magnesium sulfate
a study on the correlation between interleukin 28b genotypes with clinical and demographic characteristics in treatment-naïve and treatment-experienced patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this multicenter study will evaluate the correlation of interleukin 28b (il28b) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis c patients, including patients with hiv co-infection. there will be a single study visit for testing.


Eligibility criteria:
inclusion criteria: * adult (according to local legislation) male or female patient * chronic hepatitis c (chc) * patients naïve to chc treatment or patients who received prior interferon-based therapy for chc for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required exclusion criteria: * co-infection with hepatitis b * history or evidence of decompensated liver disease * history of major organ transplantation with an existing functional graft (including liver transplantation) * end stage renal disease
influence of angiotensin converting enzyme (ace) genotype on lung diffusion in heart failure

Conditions: Heart Failure, Congestive

Summary: in patients with chronic heart failure ace-inhibitor treatment improves lung diffusion and prevents pulmonary edema after fluid overload. in the western country, 3 population types of ace genotypes exist (dd, id, ii). it is unknown whether the ace genotype influences the response to fluid overload in ace-inhibitor treated chronic heart failure patients.

patients with chronic heart failure in stable clinical condition treated with ace-inhibitors, but not aspirin, will be evaluated by means of maximal cardiopulmonary exercise test and lung function including lung diffusion measurements. these tests will be done before and after rapid 500 ml isotonic saline infusion. patients will be grouped according to their ace genotype.

Eligibility criteria:
inclusion criteria: * new york heart association (nyha) class i and ii heart failure * chronic ace-inhibitor treatment exclusion criteria: * aspirin treatment in the previous 2 months

Keywords: heart failure pulmonary edema ace-inhibitors lung diffusion exercise capacity chronic heart failure
do some healthy adults consistently have systemic reactions to influenza vaccines?

Conditions: Influenza

Summary: this study will recruit 35 healthcare workers who had systemic reactions to influenza vaccine the last 2 times they were vaccinated, to ask whether influenza vaccine is indeed associated with systemic reactions in these workers.

randomized controlled trials of split virus vaccines in healthy adults have not been able to detect an increase in systemic adverse events compared to control vaccination. these trials do identify a non-trivial risk of systemic symptoms occurring in the week after both placebo and vaccine. there is a small population of healthcare workers who report consistent systemic symptoms after split virus vaccination which may occur because a small group of healthy adults have true physical reactions to components of the vaccine or excipients. if this is true, then alternatives - such as the use of subunit vaccines or live attenuated nasal spray vaccines - might be expected to be better tolerated by these people.

Eligibility criteria:
inclusion criteria: * employed or volunteer in a healthcare facility or an ambulatory care setting providing healthcare * by self report, have had 2 or more doses of trivalent inactivated influenza vaccine (tiiv) in the last 15 years, and after at least the last 2 vaccine doses have had the same systemic adverse event in the 7 days after vaccination, including: fever, chills, myalgia, arthralgia, fatigue, headache, or insomnia; * consent to the study, including two injections one month apart, with one being placebo and one a dose of tiiv; exclusion criteria: * has a contraindication to tiiv (previous allergic reaction to a dose of vaccine, or guillain barre syndrome with onset within 6 weeks of vaccination); * has previously received a dose of tiiv for the current influenza season. * receipt of another vaccine, or initiation of new medication within 7 days of the study injection (participant may enter the study as long as the gap between other vaccine/initiation of new medication is \>7 days); * moderate or severe acute illness or active infection or fever (temperature ≥37.8oc) on the day a dose of study medication due (participant may receive injection 48 hours after symptoms have resolved and body temperature has returned to normal without the use of antipyretics.

Keywords: influenza vaccine adult safety reactogenicity