Kornimate/medical-research-clean huggingface dataset:
development of a clinical screening, diagnostic and evaluation tool for patients with lower limb lymphedema: aim 5

Conditions: Lower Limb Lymphedema

Summary: this clinical study evaluates the reliability, concurrent validity, and clinical feasibility of a new method to determine leg volume, namely the structure sensor scanner. the volume of both legs will be determined using three different measurement methods: 1. a scanning method using a structure sensor scanner: for this, both legs are scanned all around with an ipad with the structure sensor attached to the tablet. this is performed while standing. the sensor captures depth images, which are then converted into a three-dimensional image of both legs. a computer program is then used to determine the volume of both legs and specific segments of the legs. 2. the circumference measurement using a perimeter: the perimeter consists of a flexible metal strip with a tape measure attached every 4 cm, each ending in a small weight. the person must sit and place only the foot on a small bench so that the entire leg is free. the perimeter is then placed on the leg. finally, the tape measures are wrapped around the leg, and the circumferences are read. the leg volume is then calculated using the formula of the truncated cone. 3. the optoelectronic volumetry using the perometer®: for this, the person must stand in shoulder-width stance on the perometer platform, with one leg inside the frame. the frame is then moved upward. the frame captures silhouettes from which circumference and volumes are calculated through elliptical approximation. to investigate the reliability, the intra-class correlation coefficient (icc) is calculated as well as the sem, srd and a two-tailed paired samples t-test or a wilcoxon signed rank test (in case of not-normally distributed data). to investigate the concurrent validity of the structure sensor scanner, the results from the scanner method will be compared with those of the two other methods. regarding the clinical feasibility the duration of each measurement is recorded and a purpose-designed feasibility questionnaire which is completed by the assessors is used.


Eligibility criteria:
inclusion criteria: * unilateral or bilateral, primary or secondary lll * objective diagnosis of lymphedema: ≥ 5% volume difference or ≥ 2 minor/ 1 major criteria on lymphoscintigraphy or presence of icg dermal backflow * age ≥ 18 years * able to read, understand and speak dutch exclusion criteria: * pregnant participants * presence of chronic venous insufficiency c4, c5, c6; deep venous thrombosis; post-thrombotic syndrome * presence of skin infections of wounds at the level of the lower limbs at the moment of inclusion

Keywords: lymphedema measurement clinical evaluation reliability validity lower limb structure sensor scanner
multicentre study on rapid versus slow withdrawal of antiepileptic monotherapy

Conditions: Epilepsy

Summary: the main objective of the present study will be to establish whether a slow (within 160 days) or a rapid (within 60 days) withdrawal schedule of antiepileptic monotherapy influence relapse rate in adult patients with epilepsy, who have been seizure free for at least 2 years. secondary objectives will be to establish the compliance rates with these two schedules and the differences in terms of severity of relapses, based on the occurrence of status epilepticus, seizure-related injuries and death.


Eligibility criteria:
inclusion criteria: * diagnosis of focal or generalized epilepsy (according to international league against epilepsy 1989 criteria) * age at epilepsy onset of 16 years or older * seizure freedom for at least 2 years * treatment with one of the antiepilepsy drugs currently available for monotherapy in italy: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid zonisamide) * adherence to the protocol and visit schedules. exclusion criteria: * inability to understand the aims or modalities of the study; * current pregnancy or plans to become pregnant during withdrawal period; * history of seizure relapse after discontinuation of treatment; * history of psychogenic non-epileptic seizures (pnes); * history of status epilepticus
nosocomial pneumonia with suspected or proven methicillin-resistant staphylococcus aureus (mrsa)

Conditions: Methicillin Resistant Staphylococcus Aureus (MRSA)

Summary: to determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to methicillin resistant staphylococcus aureus (mrsa) in adult subjects. subjects entered in to the study will have proven healthcare-associated methicillin-resistant staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.


Eligibility criteria:
inclusion criteria: * hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus. * chest x-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia. * suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry. exclusion criteria: * subjects who were treated with a previous antibiotic with mrsa activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding). * subjects with severe neutropenia (\<500 cells/mm3) * subjects with hypersensitivity to oxazolidinones or vancomycin.

Keywords: staphylococcal pneumonia methicillin-resistant staphylococcal pneumonia healthcare-associated pneumonia
investigation into the microorganisms in pregnant women

Conditions: Cervical Insufficiency; Preterm Birth

Summary: pregnant women with short cervical length (\<25 mm) in second-trimester ultrasonographic assessment are at high risk for preterm birth, a major cause of perinatal mortality and morbidity worldwide. some of these short-cervix women proceed to a more advanced stage manifested as a painless prematurely dilated cervix in the second trimester. it is not fully understood why some women have short cervical length or prematurely dilated cervix (cervical insufficiency), although evidence is mounting that there is an association between short cervical length and infection by microorganisms. the investigators hypothesize that the cervical microorganisms in pregnant women with a shortened or dilated cervix are different, compared with those in women with normal cervical length and a closed cervix.

previously, culture-dependent methods were used to detect bacterial or fungal infection, but the sensitivity was low, since not all species grew well in culture. recently, molecular methods based on pcr amplification of the bacterial 16s ribosomal rna (rrna) gene or the fungal internal transcribed spacer (its) followed by capillary sequencing has been used to identify bacteria and fungi. however, the resolution of such capillary sequencing-based method (\ 40,000 sequencing reads/sample), which has been proven to capture the majority of microorganisms in a sample.

Eligibility criteria:
inclusion criteria: * women with or without cervical insufficiency (cervical length \<25 mm or dilated cervix in the second trimester or the late first trimester) exclusion criteria: * multiple pregnancies and pregnancies associated with fetal chromosomal abnormality

Keywords: preterm birth cervical insufficiency cerclage pessary
barrier-protect study

Conditions: Infection

Summary: this study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. minimizing contamination during the implant procedure can be one of the potential improvements to prevent cied infections. patients requiring a lead change, battery change or device upgrade will be eligible. this is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.


Eligibility criteria:
inclusion criteria: 1. patient aged 18 2. second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket. 3. padit risk score ≥ 5 exclusion criteria: 1. unable or unwilling to provide informed consent. 2. de novo device implantation. 3. active device infection. 4. iodine allergy 5. life expectancy less than 2 years

Keywords: cardiac device
a study to evaluate the efficacy and safety of ct-p27 in acute uncomplicated influenza a infection

Conditions: Influenza A

Summary: this study is a phase iib, randomized, double-blind, multicenter, placebo-controlled study evaluating the efficacy and safety of ct-p27 in subjects with acute uncomplicated influenza a infection.

this study is a phase iib, randomized, double-blind, multicenter, placebo-controlled study. all enrolled subjects will be given a single dose of 90 mg/kg ct-p27, 45 mg/kg ct-p27, or placebo intravenously over 90 minutes (±15 minutes) on day 1 and then followed by day 110.

Eligibility criteria:
inclusion criteria: * male or female subjects between the ages of 19 and 64 years, both inclusive * diagnosed with influenza a at screening using rapid influenza diagnostic test * onset of influenza symptoms and fever is within 48 hours at screening * at least 2 of symptoms (moderate to severe in intensity) * ≥38.0'c body temperature at screening exclusion criteria: * taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug * positive influenza b or a+b infection

Keywords: efficacy safety
study of medi-524 (motavizumab) for the prophylaxis of serious respiratory syncytial virus (rsv) disease in high-risk children

Conditions: Respiratory Syncytial Virus Infections

Summary: the primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (im) injection for the reduction of the incidence of rsv hospitalization among children at high risk for serious rsv disease. a secondary objective was to compare the incidence of medically-attended lower respiratory infections (lris) between treatment groups.

a randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 northern hemisphere rsv seasons with an intervening season in the southern hemisphere. each child only participated during a single rsv season. approximately 6,600 children at risk for serious rsv disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by im injection every 30 days for a total of 5 doses.

Eligibility criteria:
inclusion criteria: * 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (cld) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization or: * 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday) exclusion criteria: * hospitalization at the time of randomization (unless discharge was anticipated within 10 days) * mechanical ventilation or other mechanical support (including continuous positive airways pressure \[cpap\]) * life expectancy \< 6 months * active rsv infection (a child with signs/symptoms of respiratory infection must have had negative rsv testing) * known renal impairment * known hepatic dysfunction * chronic seizure or evolving or unstable neurologic disorder * congenital heart disease \[chd\] (children with uncomplicated chd \[e.g., patent ductus arterious (pda), small septal defect\] and children with complicated chd that were currently anatomically and hemodynamically normal could be enrolled) * known immunodeficiency * mother with hiv infection (unless the child has been proven to be not infected) * known allergy to ig products * receipt of palivizumab, rsv-igiv, or other rsv-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis b ig, ivig, vzig) within 3 months prior to randomization * anticipated use of palivizumab or ivig during the study (blood transfusions permitted) * previous receipt of rsv vaccines * participation in other investigational drug product studies

Keywords: respiratory syncytial virus (rsv) motavizumab palivizumab synagis
association between a peri-traumatic dissociation state and the occurrence of post-traumatic stress syndrome

Conditions: Severe Trauma; General Anaesthesia

Summary: patients will be selected after studying clinical records.patients who had general anesthesia due to an injury related to severe trauma within 6 to 12 months prior to inclusion will be included. three self-survey will be completed by the patient: pdeq, pcl-5 and a demographic questionnaire. according to the pdeq and pcl-5 scores, an association between a peri-traumatic dissociation state and a post-traumatic stress disorder can be established.


Eligibility criteria:
inclusion criteria: * patients with general anesthesia for a surgical wound with violent trauma in the road, a fall of more than 6 meters, burn, accident at work, explosion, aggression) in the 6 to 12 months before the inclusion * time between trauma and general anesthesia should not exceed 48 hours * patient agreeing to participate in the study. exclusion criteria: * minor patients * patients under curatorship, and tutorship * patient deprived of liberty * patients who do not speak french * patients who are not in satisfactory neurological state to answer the questionnaire (pyschotic, demented states) * patients who have been sedated (apart from general anesthesia) when receiving or having a glasgow score \<14

Keywords: severe trauma general anaesthesia peri-traumatic dissociation state post-traumatic stress disorder
study of the effect of single doses of mk2637 and dextromethorphan on cerebral cortex excitability (2637-008)

Conditions: Schizophrenia

Summary: this study will assess transcranial magnetic stimulation (tms) as a biomarker and characterize tms readouts of the activity of mk2637 and dextromethorphan. resting quantitative electroencephalography(qeeg) readouts are also characterized with mk2637 and dextromethorphan.


Eligibility criteria:
inclusion criteria: * subject is right-handed * subject is in good health * subject is a nonsmoker exclusion criteria: * subject works a night shift * subject has a history of any illness that might make participation in the study unsafe or confound the study results * subject has a history of head injury
evaluation of hemodynamic and ventilatory effects of negative pressure ventilation

Conditions: Cardiac Output, Low

Summary: investigation of the effects of negative pressure ventilation after cardiac surgery in adults onto performance of the left and right heart and the lungs.


Eligibility criteria:
inclusion criteria: * patients with pulmonary artery catheter after cardiac surgery exclusion criteria: * minimally invasive surgery * unstable conditions * bleeding * unability to fit cuirass
reducing frailty for older cancer survivors using supplements

Conditions: Frailty; Inflammation

Summary: the purpose of the study is to examine the feasibility and safety of twelve weeks oral supplementation of epigallocatechin-3-gallate (egcg) in older survivors of cancer


Eligibility criteria:
inclusion criteria: 1. be age 65 or over. 2. be diagnosed with stage i-iii cancer. 3. have completed curative intent treatment ≤10 years prior to screening. (patients on endocrine therapies are allowed to enroll.) 4. have a fried's frailty score (ffs) of ≥ 2. 5. able to provide informed consent, or have consent given by patient-designated health care proxy per institutional policies and university of rochester cancer control guidelines. exclusion criteria: study subjects must not: 1. have chemotherapy planned for the during of the study. 2. have abnormal liver function tests (alt, ast and bilirubin ≥3 times institutional upper limit of normal) per most recent available lab test (within 3 months of screening). 3. have uncontrolled or unmanaged liver disease. 4. consume more than 6 cups of green tea per day. 5. have known allergies to caffeine. 6. be diagnosed with a major psychiatric illness requiring hospitalization within the last year. 7. be diagnosed with dementia. 8. cannot provide informed consent due to lack of decision making capacity (as determined by the patient's oncologist) and has no patient-designated health care proxy per institutional policies and university of rochester cancer control urcc guidelines.
periprosthetic fractures of the femur treated by osteosynthesis

Conditions: Periprosthetic Fracture of the Femur

Summary: observational retrospective study on 36 consecutive patients having had surgery for a periprosthetic fracture of the femur between 2010 and 2015. the goal of the study is to test whether osteosynthesis was a secure choice at a certain age and with any type of vancouver fracture.


Eligibility criteria:
inclusion criteria: * consecutive patients having had surgery between 2010 and 2015 within the chu brugmann hospital for a periprosthetic fracture of the femur (osteosynthesis). exclusion criteria: * death during surgery.

Keywords: periprosthetic fracture of the femur hip prosthesis
china survey of peptic ulcer bleeding

Conditions: Peptic Ulcer Hemorrhage

Summary: this will be a multicenter prospective observational study carried out in china. the investigators will collect data in a pre-specified case report form. main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. the proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. high risk is defined as the patients with endoscopy forrest classification ia to iib. the rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. the surgery rate and mortality rate in high risk and overall patient population will be calculated.


Eligibility criteria:
inclusion criteria: * female and/or male aged 18 years and above * admitted to the hospital with an overt upper gi bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper gi tract) * endoscopy demonstrated peptic ulcer bleeding (forrest i-iii) exclusion criteria: * if participating in any clinical trial, the subject cannot take part in this study.

Keywords: peptic ulcer bleeding high risk none-interventional study he proportion of peptic ulcer bleeding patients who are at high risk (forrest ia-iib)
ischemic memory imaging with myocardial contrast echocardiography

Conditions: Myocardial Ischemia

Summary: the overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.


Eligibility criteria:
normal control group inclusion criteria: * normal control individuals exclusion criteria: * history of cardiovascular disease (coronary artery disease, mi, peripheral artery disease) * allergy to eggs or ultrasound contrast agents * known or detected right to left shunt * presence of a wall motion abnormality * pregnancy acs group inclusion criteria: * patients with diagnosis of acute coronary syndrome with either unstable angina or non-st-elevation mi * referred for primary percutaneous intervention * at least 1 high risk features (st changes, positive troponin, wall motion abnormality) exclusion criteria: * allergy to eggs or ultrasound contrast agents * hemodynamic instability or shock * known or detected right to left shunt * pregnancy * multivessel cad requiring multivessel pci
performance of ultrasound in women with postmenopausal or abnormal uterine bleeding between white and black ethnic groups- a retrospective cohort study.

Conditions: Postmenopausal Bleeding; Endometrial Cancer

Summary: primary objective: to assess whether there is a higher incidence of uninformative ultrasound in black vs white women

retrospective cohort study study subjects: women 45 years or over seen in the 'two-week wait' rapid access gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022. only people with documented ethnicity will be included. study procedures: cases will be identified by searching our two-week referral and ultrasound records . clinical data collected includes age, bmi, previous abdominal uterine surgery (caesarean section or open myomectomy) and parity. symptoms will be categorised into postmenopausal bleeding with no hormone use, unscheduled bleeding on hormone replacement therapy (hrt) or abnormal perimenopausal bleeding (in women over 45 years of age). ultrasound data recorded will be the presence or absence of fibroids, whether transabdominal ultrasound was needed in addition to transvaginal or transrectal ultrasound, whether the endometrium could be seen clearly (i.e whether the ultrasound examination was informative) and the endometrial thickness in those where it was. clinical outcomes recorded will be the need for endometrial sampling, mode of sampling and histology results. the local cancer registry will be checked for the year following the study to check for any subsequent cancers in women discharged without endometrial sampling.

Eligibility criteria:
inclusion criteria: * women seen in the 'two-week wait' rapid access gynaecology clinic with suspected endometrial cancer due to abnormal vaginal bleeding over the course of 2022 * 45 years of age or older * ethnicity documented in their clinical notes exclusion criteria: * ethnicity data not available