Kornimate/medical-research-clean huggingface dataset:
nopro - norwegian hernia prophylaxis study

Conditions: Incisional Hernia After Midline Laparotomy; Quality of Life (QOL); Burst Abdomen; Surgical Site Infections

Summary: a multicenter randomized controlled trial comparing midline laparotomy closures using the small-bite suture technique alone to those using the small-bite suture technique with an additional onlay prophylactic polypropylene mesh. the primary endpoint is the incidence of incisional hernias in both groups after one year.

an incisional hernia (ih) is a defect in the abdominal wall at the site of a surgical scar, leading to the protrusion of abdominal contents through the defect. it is a common complication following midline laparotomy, with incidence rates ranging from 9% to 40% in the general population, and up to 69% in high-risk patients. several studies have been conducted on the prevention of ih, and one established intervention is the use of a synthetic mesh to reinforce the suture closure of the abdomen after midline laparotomy. however, the use of mesh in this context is not widespread in norway, and there are no norwegian studies on ih prevention following midline laparotomy. this study aims to contribute to the broader knowledge base and encourage norwegian surgeons to consider using prophylactic meshes. the study will involve three norwegian hospitals: hamar hospital, gjøvik hospital, and lillehammer hospital. participants will be patients scheduled for midline laparotomy at these hospitals who consent to participate, meet the inclusion criteria, and do not meet any exclusion criteria. participants will be randomly assigned to two groups, each receiving a different variation of fascia closure during laparotomy. one group will undergo closure using the standard small-bites technique only, while the other group will undergo closure with the small-bites technique in addition to an onlay polypropylene mesh. the primary outcome is the occurrence of incisional hernia one year after surgery, identified through clinical examination and ct scan. additionally, surgical site occurrences (e.g., hematoma, infection, seroma, wound dehiscence) will be recorded four to six weeks post-surgery. quality of life and pain levels will also be assessed at both four to six weeks and one year after surgery.

Eligibility criteria:
inclusion criteria: * surgery predominantly done my midline laparotomy * age 18 years old or older * written consent by patient/family * midline laparotomy with delayed closure * no exclusion criteria exclusion criteria: * age under 18 years * pregnancy * previous abdominal midline hernia mesh repair * abdominal compartment syndrome * linea alba closure not possible * life expectancy under six months * hernia in the midline with transverse diameter lager than 2 cm

Keywords: prophylactic mesh onlay incisional hernia midline laparotomy
comparing the efficiency of cervical ripening balloon (cook) to the dinoprostone (propess) for the cervical maturation in case of unfavorable cervix (bishop = 30 kg/m²)

Conditions: Delivery

Summary: at the moment in france, one delivery on four is induced for a medical indication. in this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature. there is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (propess®). other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (cook®). the population of the obese women is a population in constant increase in france and presenting deliveries to higher risks of maternal and foetal complications. at these patients, the medicinal releases seem also more difficult and at greater risks of failures. the investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * term ≥ 37 weeks of amenorrhea * singleton pregnancy * cephalic presentation * medical indication of release and unfavorable cervix (bishop \<6) * bm pre-pregnancy ≥ 30 kg/m2 * having given their agreement for the participation of the study * patient receiving social coverage exclusion criteria: * age \< 18 years * term \< 37 weeks of amenorrhea * multiple pregnancy * favorable cervix (bishop ≥ 6) * contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse * evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites) * not affiliated with a legal protection regime * patient trust, guardianship, under legal protection measure, deprived of freedom balloon's contraindications: * abnormal pelvis structure * evolutive genital herpes * invasive cervical cancer * anomaly of foetal heart rate * breech presentation * maternal heart disorder * hydramnios * serious and uncontrolled arterial high blood pressure * rupture of membranes * medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness * presentation above superior pelvic strait dinoprostone's contraindications: * scarred uterus * prostaglandin's hypersensitivity

Keywords: unfavorable cervix obese pregnant women
virtual sedation during elective procedures in the cathlab

Conditions: Anxiety; Pain

Summary: this study aims to investigate the effectiveness of virtual reality (vr) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab). to assess the effectiveness of vr in the clinical setting of daily practice within the cathlab, a comparative effectiveness trial will be conducted. a sample of patients scheduled for a planned procedure in the cathlab of uz brussel will be selected using convenience sampling. participants eligible for this study will be assigned to either the control group or the intervention group after signing the informed consent form. the control group in this study will receive standard care according to current practice for the planned procedure, while the intervention group will receive standard care along with the virtual reality headset intervention. the primary outcome of anxiety will be measured using the visual analog scale (vas) for anxiety and the state-trait anxiety inventory (stai) questionnaire. the secondary outcome of pain will be measured using the vas scale for pain. other outcomes such as satisfaction and potential nausea during the procedure will be assessed through a questionnaire that participants will fill out after the procedure. the physician who performed the procedure in the intervention group, as well as the involved nurses during the procedure, will complete a similar questionnaire to evaluate the use of the vr headset from the operators' perspective. the outcomes of the two groups will be statistically compared using the spss software package.


Eligibility criteria:
inclusion criteria: * undergoing elective procedure in line with the following criteria in the cathlab of the uzb: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours. * agreeing to participate via signed informed consent. * being at least 18 years of age. * being fluent in either english, french or dutch language. exclusion criteria: * ailments which would make wearing of the headset uncomfortable or impossible. * cognitive impairment such as dementia or delirium. * severe hearing impairment, as this will limit the immersion. * severe visual impairment not compensated by glasses, such as blindness.
study of nnz-2566 in patients with traumatic brain injury under efic

Conditions: Brain Injuries

Summary: the purpose of this study is to determine whether nnz-2566 is safe and effective in the treatment of traumatic brain injury (tbi).

moderate to severe traumatic brain injury frequently results in persistent problems with memory, attention span, mood and more complex brain functioning such as planning and organizing. there are currently no drugs available to reduce the brain damage or the persisting symptoms that result from tbi. the longer term goal of this study is to provide physicians with a safe and effective treatment for tbi

Eligibility criteria:
inclusion criteria: * non-penetrating tbi. * age 16-75 years. * admission to hospital. * post resuscitation gcs 4-12. * have at least one reactive pupil. * able to receive investigational product within 8 hours of injury. * hemodynamically stable after resuscitation (systolic blood pressure (sbp) \>100 mm hg). * able to read and write english and have sufficient motor dexterity prior to injury to undertake the neuropsychological and activities of daily living (adl) testing, in the opinion of the investigator, at 1 month (defined as 4-6 weeks) and 3 months (defined as 12-14 weeks) post injury. exclusion criteria: * penetrating brain injury. * spinal cord injury. * presence or known history of prior cerebral injury requiring hospitalization that would, in the opinion of the investigator, interfere with or bias the assessment of efficacy. * non-traumatic brain injury. * known history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the investigator, interfere with or bias the assessment of efficacy. * significant non-central nervous system (cns) injuries sustained at the time of the tbi would, in the opinion of the investigator, interfere with or bias the assessment of efficacy. * weight \>150 kg. * participation in another clinical trial within the previous 4 weeks. * clinical state requiring greater than 6 l blood, colloid or crystalloid fluid resuscitation prior to randomization. * pregnant or nursing mothers. women of child-bearing potential must have a negative urine or blood test prior to randomization. * prior enrollment in this study. * qtc exclusions. the study will use the exclusion criteria as defined in ich guideline e14 to exclude patients with a risk of qt/qtc prolongation, as follows: * a marked baseline prolongation of corrected qt/qtc interval \>450 ms. * history of risk factors for torsade de pointes (e.g. heart failure, hypokalemia (serum potassium at screening \<3.0 mmol/l)or family history of long qt syndrome).
exercise capacity under various fio2 and oxygen flow rates using hfnc

Conditions: High-flow Nasal Cannula; Exercise Capacity; Respiratory Failure

Summary: the purpose of this study is to compare the exercise capacity (6-min walking distance) under the following 4 conditions using high-flow nasal cannula (hfnc); 1. fio2 value that the minimum spo2 value in a 6-minute walking test (6mwt) is 86-88%, and a flow of 10 l/min 2. fio2 value that the minimum spo2 value in a 6mwt is 86-88%, and a flow of 40-50 l/min 3. fio2 value that the minimum spo2 value in a 6mwt is 92-94%, and a flow of 10 l/min 4. fio2 value that the minimum spo2 value in a 6mwt is 92-94%, and a flow of 40-50 l/min

in the pervious study, the investigators demonstrated that 4 weeks of training using both high fio2 and high flow through an hfnc significantly improved the 6mwd compared with training using a 6 l/min nasal cannula. however, it was unclear whether the effects of pulmonary rehabilitation under hfnc were due to high fio2, high flow rate, or a synergistic effect. it is also unknown whether there are differences in the effects of pulmonary rehabilitation under hfnc for each underlying disease.

Eligibility criteria:
inclusion criteria: * subjects with a minimum spo2 of 88% or less during performing 6mwt under hfnc (fio2 0.21 and a flow rate of 10l/min) * subjects who have been clinically stable for the last 2 weeks * subjects with written informed consent to participate in this study exclusion criteria: * subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure * subjects who needed antimicrobial agent or steroid administration for pneumonia and exacerbation of respiratory disease in the last 2 weeks * subjects who cannot undergo 6mwt due to severe heart failure, arteriosclerosis obliterans or spinal disease

Keywords: hfnc 6mwd
antimalarial and covid 19 in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the antimalarial agent hydroxychloroquine(hcq) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus. these compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. among rheumatic diseases, the primary role of hcq is in the management of articular and skin manifestations of systemic lupus erythematosus (sle) and the treatment of mild to moderately active rheumatoid arthritis (ra).

the antimalarial agent hydroxychloroquine(hcq) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus.(1) . these compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. among rheumatic diseases, the primary role of hcq is in the management of articular and skin manifestations of systemic lupus erythematosus (sle) and the treatment of mild to moderately active rheumatoid arthritis (ra). it is difficult to carefully evaluate the onslaught of information that has emerged regarding potential covid-19 therapies within a few months' time in early 2020. a brief but detailed approach regarding how to evaluate resulting evidence of a study has been presented by f. perry wilson, md, msce. by using the example of a case series of patients given hydroxychloroquine plus azithromycin, he provides clinicians with a quick review of critical analyses.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis recieving hydroxychloroquine chest infection exclusion criteria: * patients not used hydroxychloroquine
broccoli sprout dose response: bioavailability and effects of air pollutants

Conditions: Environmental Carcinogenesis

Summary: this study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

this is a 10-day placebo control phase ii broccoli sprout intervention to be conducted in qidong, p.r. china. up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

Eligibility criteria:
inclusion criteria: * in good general health with no history of chronic illness * normal liver function tests * normal renal function tests exclusion criteria: * personal history of cancer except for non-melanoma skin cancer * use of prescribed medicines * for women, a positive pregnancy test
conversations you want about corona virus disease (covid-19)

Conditions: Covid19

Summary: web-enabled virtual topical guide: develop virtual conversations for each concern and intensity level

study will pilot test the virtual topical discussion guide with diverse health care professions and community members to confirm it is clear, relevant, understandable, and culturally appropriate

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * english or spanish speaking only exclusion criteria: * less than 18 years of age * not english or spanish speaking

Keywords: vaccines
countermeasures to reduce sensorimotor impairment and space motion sickness resulting from altered gravity levels

Conditions: Vestibular

Summary: the investigators will study adaptation of motion perception and manual control in altered gravity, including the effects of a drug (promethazine). the investigators will also study whether promethazine affects motion perceptual thresholds.

adaptation to altered gravity has been of concern from the earliest reports of space motion sickness, through the apollo exploration era, and into current planning of exploration missions. the proposed research program takes a new approach which could lead to an effective, practical and acceptable protocol for preadapting astronauts to space flight. by using the gravito-inertial alterations possible with centrifugation in different body orientations the investigators will quantify an individual's sensory adaptation capability and use it to predict and to minimize the consequences of movement in any other gravity environment - eventually including weightlessness. the investigators will also study whether a drug (promethazine) affects motion perception and motion sickness.

Eligibility criteria:
inclusion criteria: * subjects must be in general good health exclusion criteria: * anyone who is not generally in good general health does not qualify * cardiovascular disease * severe diabetes * respiratory condition (e.g. asthma or emphysema) * narrow angle glaucoma * prostatic hypertrophy * gastrointestinal disorders
weight watchers online 2015

Conditions: Obesity; Overweight; Body Weight

Summary: the purpose of this study is to conduct a randomized controlled trial to compare the weight losses produced by the weight watchers online program revised for 2015 (wwo2015) and wwo2015 plus the provision of an electronic scale and weekly email feedback on weight loss (wwo2015 enhanced), over a 6-month period.


Eligibility criteria:
inclusion criteria: * age 18-70 years * body mass index (bmi) between 27 and 40 kg/m2 * both genders will be recruited; at least 10% of participants will be men. enrollment of women will be capped at n = 324 (90%) to meet this goal. * all ethnic groups will be recruited, with a goal of recruiting 10% minorities * english speaking * have access to the internet via a computer, and basic computer skills exclusion criteria: * report health problems that make weight loss or unsupervised exercise unsafe or unreasonable * report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire1 * are currently pregnant or breastfeeding, or intend to become pregnant in the next 12 months * are planning to move outside of the state within the next 12 months * report any cognitive or physical limitations that preclude use of a personal computer * have participated in a study conducted by the wcdrc or ut in the past 2 years * have followed a commercial weight-loss program within the previous 6 months or who are currently following a commercial weight loss program * weight loss of ≥ 5% of initial body weight in the last 6 months * history of clinically diagnosed eating disorder excluding binge eating disorder. * previous surgical procedure for weight loss * currently taking weight loss medication * treatment of cancer within the last 6 months
effects of a self-regulation program on self-care behaviour of heart failure patients

Conditions: Heart Failure

Summary: this rct study aims to examine the effects of a self-regulation programme on the self-care behaviour and quality of life of patients with heart failure. the following hypothesis was tested: heart failure patients who receive the self-regulation program will report significant improvements in self-care behaviours after four weeks of the self-regulation programme. in contrast, patients in the control group showed no significant differences.

eight two patients with heart failure were randomly assigned into the intervention (n = 41) or control group (n = 41). the intervention group participated in a 4-week self-regulation programme, including 20 to 30 minutes of individual self-regulation education and 15 to 20 minutes of telephone follow-up twice per week for four weeks. the control group received only routine outpatient care. self-care behaviour was measured by the self-care of heart failure index at baseline, 4 weeks and 8 weeks after patients were enrolled. quality of life was measure with the minnesota living with heart failure questionnaire

Eligibility criteria:
inclusion criteria: * aged 20 years or older with heart failure diagnosed by a cardiologist (icd-9:428) * willing to communicate and participate in this study * had clear consciousness exclusion criteria: * a diagnosis of cancer * a diagnosis of mental illness including anxiety and depression * had cognitive impairment * a diagnosis of lung disease, such as asthma or chronic obstructive pulmonary disease * a diagnosis of renal failure

Keywords: self-care behaviour self-regulation heart failure
clinical evaluation of the amnisure rom test

Conditions: Rupture of Fetal Membranes

Summary: to show that having less qualified personnel (non-laboratory trained professionals) perform the test yields the same result as if a laboratory trained professional performed the test.

the main goal of this study is to show that when performed by less qualified personnel, the amnisure® rom test is so simple and accurate that the likelihood of erroneous results by the intended-user is negligible and that the test poses no unreasonable risk of harm to the patient if performed incorrectly.

Eligibility criteria:
inclusion criteria: * subjects must be pregnant. * subjects must be between 18 and 50 years of age and have a gestational age of 11.0-42.0 weeks. * subjects reporting suspicion, signs, or symptoms suggestive of rom, prom, pprom. * subjects providing informed consent. exclusion criteria: * subjects who have placenta previa. * subjects who have heavy vaginal bleeding. * subjects who have had digital vaginal examination immediately prior to evaluation for rom.

Keywords: rom prom pprom (preterm premature rupture of membranes)