Kornimate/medical-research-clean huggingface dataset:
using ex-vivo normothermic machine perfusion with the organox metra™ device to store human livers for transplantation

Conditions: End-stage Liver Disease

Summary: this trial will examine the safety and feasibility of using the organox metra device to transport and store donor livers under normothermic conditions prior to transplantation. participants will be followed for 3 months following transplantation and their outcomes recorded.

liver transplantation is a life-saving procedure but its success has been limited by a shortage of suitable donor organs. much emphasis is now placed on optimising the condition of those organs that are available, to enable more higher risk organs to be transplanted safely. an effective means of pre-transplant viability assessment would not only allow greater use of higher risk donors but also minimise the risk of primary non-function by identifying and excluding non-viable organs before subjecting a patient to the risk of surgery. organ storage under normothermic perfusion conditions enables organ function to be evaluated prior to transplantation and further has been shown to prevent organ injury which is sustained during standard cold storage. this trial will examine the safety and feasibility of using the organox metra device to transport and store donor livers under normothermic conditions prior to transplantation. this study will evaluate liver function post-transplantation using standard clinical parameters. participants will be followed for 3 months following transplantation and their outcomes recorded. participants will undergo no other study procedures. feasibility will be measured using the ratio of actual / eligible candidate donors recruited to the study and will also encompass logistical issues with respect to transportation, and ease of use. safety will be assessed by rates of device failures resulting in organ discard, primary graft non-function, re-transplantation, and recipient death.

Eligibility criteria:
inclusion criteria: * adult patients (18 years or more) * active on the waiting list for liver transplantation * able to give informed consent exclusion criteria: * age less than 18 years * acute/fulminant liver failure * transplantation of more than one organ (e.g. liver and kidney) * refusal of informed consent * unable to give informed consent * re-transplantation diagnosis of hepatopulmonary syndrome

Keywords: deceased donor liver transplant normothermic machine perfusion
a study of nopan treatment of acute suicidality

Conditions: Suicidality

Summary: anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist nopan to be an effective antidepressant with a rapid onset of action. it is therefore hypothesized that nopan may be a novel and quick-acting treatment for acute suicidality. depression, suicidality, and overall functioning will be assessed before, during and after a four-week nopan/placebo trial. it is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of these variables.


Eligibility criteria:
inclusion criteria: * suicidal behavior or ideation (bsi\>6) exclusion criteria: * ect history within the last month * psychotic features within the last 3 months * history of schizophrenia, substance or alcohol abuse within the last two years * benzodiazepine dependence within the last two years * any significant systemic illness or unstable medical condition which does not permit inclusion, according to the research physician * pregnant women * patients who currently suffer from severe impairment or severe dysfunction of liver, kidney, adrenal, gall, closed brain injury, urinary retention or respiratory system.
the effect of audio based nutrition education on dietary intake practice, and egg-based diet intervention on nutrient adequacy, and gestational weight gain among pregnant women and newborn's birth weights in the north sidama zone, ethiopia.

Conditions: Nutritional Deficiency

Summary: background: inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight. likewise, majority of ethiopian pregnant women have inadequate nutrient intakes. these may be due to their poor dietary habits. nutrition education is well-established intervention to enhance optimal dietary practices and is crucial to design appropriate diet interventions like multiple micronutrient and protein-energy supplements to optimize pregnancy outcomes. however, in this country, integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied. therefore, this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women, and newborn's birth weight in north sidama zone. materials and methods: these studies will employee mixed study designs sequentially to address each specific objective. baseline survey: a mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of north sidama zone in february 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women. following the baseline survey, four-arm cluster- randomized controlled trial (crct) will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice, nutrient adequacy, and gestational weight gain among pregnant women and birth weight from march to august 2024. a total of 300 pregnant women will be selected randomly from participants of the baseline survey, and enrolled in four arms in a 1:1:1:1 allocation ratios: a multi-level mixed-effect logistic regression model will be used for quantitative data analysis, and a paired and independent t-test will be employed to measure the mean change in dietary intake practice, gestational weight gain and nutrient density between intervention and control groups. the qualitative data will be analyzed using atlas-ti software according to the inductive thematic content analysis approach. budget and work plan: for this study 1,102,200 etb will be required. the study will be funded by norad project, hawassa university, sidama regional government and other possible grants in future. the study period will be march to august 2024.


Eligibility criteria:
inclusion criteria:- .pregnant women less and equal 12 weeks of pregnancy. .exclusion criteria: pregnant women who had been diagnosed with:- * confirmed hypertension * diabetes mellitus

Keywords: birth weight,
sensitivity of targeted biopsy within sydney protocol for gim

Conditions: Intestinal Metaplasia

Summary: sensitivity of targeted biopsy within sydney protocol by using narrow band imaging for extensive gastric intestinal metaplasia diagnosis objective: the aim of this study is to evaluate the sensitivity of targeted biopsy within sydney protocol by using narrow band imaging for extensive gastric intestinal metaplasia diagnosis research design: diagnosis study sample size: 105 cases data analysis: the outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using mcnemar's test

background and rationale: gastric cancer has been in the top-5 of cancer-related death worldwide. early detection by screening program in high risk patients is very important. if we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. however, the screening protocol for gastric intestinal metaplasia remained unclear. recently in july 2019, british society of gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. the image-enhanced endoscopy (iee) is recommended as the best modality for assessing gastric intestinal metaplasia. additionally, they recommended taking biopsy by using sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. we aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (gim) diagnosis in this study. methodology: * all patients with history of gim will be enrolled and undergone standard with white light esophagogastroduodenoscopy (egd). * those with suspected lesions of gim will proceed to narrow band imaging (nbi)-mode endoscopy. * targeted biopsy will be done at the suspected gim lesions. random biopsy will be while will be done if no suspicious gim lesion seen. data collection: all data will be processed and recorded by one physician.

Eligibility criteria:
inclusion criteria: * at least 18 year of age * suspected gim by previous tissue pathology * able to provide informed consent for participation exclusion criteria: * previous gastric surgery including gastrectomy and bypass surgery * coagulopathy * pregnancy * active upper gi bleeding
prospective s&e study of wavefront-guided prk for myopia with idesign advanced wavescan studio™ system and star s4 ir™

Conditions: Stable Myopic Refractive Error, With or Without Astigmatism

Summary: prospective, multicenter, bilaterally-treated, open-label, non-randomized clinical trial.


Eligibility criteria:
note: enrollment open only to military personnel inclusion criteria: * signed informed consent and hipaa authorization. * refractive error, based on the idesign displayed refraction must be myopia with or without astigmatism with sphere up to -8.00 d, and cylinder between 0.00 d and -4.00 d with maximum se of -10.00 d. * anticipated residual stromal bed thickness of at least 250 microns as calculated by the idesign system. * distance best spectacle corrected visual acuity (bscva) of 20/20 or better * bscva ≥2 lines (≥10 letters) better than distance uncorrected visual acuity (ucva). * less than or equal to 0.75 d difference between cycloplegic and manifest refraction sphere. * stable refractive error as defined by a change of ≤1.00 d in mrse over at least a 12 month time period. * any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability * agreement between manifest refraction (adjusted for optical infinity) and idesign system refraction chosen for treatment. * willing and capable of complying with follow-up examinations for the duration of the study. exclusion criteria: * women who are pregnant, breast-feeding, or intend to become pregnant, or not using an adequate method of birth control. * concurrent use of systemic (including inhaled) medications that may impair healing. * history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis. * subjects with a cardiac pacemaker, implanted defibrillator or other implanted electronic device. * history of prior intraocular or corneal surgery, active ophthalmic disease or abnormality, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma. * evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography * known sensitivity or inappropriate responsiveness to any of the medications used in this study. * if either eye does not meet all inclusion criteria * desire to have monovision. * participation in any other clinical study, with the exception of the fellow eye in this study.

Keywords: myopia
pet ownership and glucose control in early adolescents with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Adolescent Behavior

Summary: this study evaluates the short-term effects of incorporating the structured care of a pet fish into a diabetes self-care routine on glucose control in early adolescents with type 1 diabetes.

efficacy of treatment for type 1 diabetes mellitus (t1dm) is dependent on adherence to self-care behaviors and collaborative parental involvement. adolescence is a vulnerable time for the deterioration of glycemic control in patients with t1dm. in particular, parental monitoring declines during early adolescence. this often occurs before the child has developed self-efficacy and competence in independently performing diabetes-related tasks, including blood glucose monitoring. consequently, there is a great need for innovative strategies in early adolescents that promote self-efficacy development and facilitate parental involvement.

Eligibility criteria:
inclusion criteria: * age 10-13 years * diagnosis of t1dm * duration of t1dm for at least one year * fluency in english * two recent consecutive hba1c values 8.0 - 13% exclusion criteria: * clinical or laboratory characteristics suggestive of type 2 diabetes mellitus * involvement in foster care * dual-home living situation * severe psychiatric disorders * developmental delay or cognitive impairment * current participation in another study that may impact glycemic control * regular usage of a continuous glucose monitor * hba1c \> 13% (because these individuals may need a more intensive intervention than this is intended to provide).
investigation of new intermittent catheters in healthy volunteers

Conditions: Retention, Urinary

Summary: investigation of non-ce marked intermittent catheters. the study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

the cp322 study investigated a novel non-ce marked intermittent catheter for males and females, designed in two different variants, variant 1 and variant 2, respectively. the study was conducted in denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers. for each participant, the study thus contained three test visits/treatment arms (comparator, variant 1 and variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). there were 4-14 days between the test visits.

Eligibility criteria:
inclusion criteria: * minimum 18 years of age and with full legal capacity * written informed consent and signed letter of authority and secrecy agreement given * willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits * urine multistix negative for erythrocytes (hematuria) exclusion criteria: * participation in any other clinical investigations during this investigation * known hypersensitivity towards any of the test products * symptoms of urinary tract infection (uti) (investigators judgement) * pregnancy or breastfeeding
peramivir treatment response in adults hospitalized for influenza-associated lower respiratory tract infections

Conditions: Influenza

Summary: peramivir is the first intravenous neuraminidase inhibitor (nai) available for treatment of uncomplicated influenza in adults. data from placebo-controlled trials in outpatients have shown antiviral efficacy, safety, and tolerability. although the unmet need for intravenous therapy lies mainly with patients hospitalized with complicated diseases, such data are limited because of feasibility and ethical considerations for placebo-controlled studies. in this study, the investigators aimed to examine more specifically treatment effects of peramivir in adults hospitalized with influenza-associated lower respiratory tract complications (lrtc). such findings may have important implications on clinical management.

the primary objective was to assess the virologic response of peramivir in influenza-associated lower respiratory tract complications (lrtc). the secondary objective was to assess safety and tolerability. adults confirmed with influenza by polymerase chain reaction (pcr) and/or immunofluorescence assays during the seasonal peaks of 2011-2014 were assessed for eligibility. consented individuals were randomized to receive either peramivir 600mg every 24 hourly or 300mg every 12 hourly for 5 days. in subjects not achieving clinical resolution by day 5, the same regimen could be continued until day 10 (virologic results unknown to clinicians).renal-dosage adjustment, if required, was performed according to protocol. the study's primary endpoint was change in influenza rna load over time. the secondary endpoints were viral shedding indicated by culture and rna negativity at day 5, and drug tolerability. additionally, a priori comparisons of these endpoints with historical controls treated with standard courses of oral oseltamivir (75mg bid for 5 days) in the same clinical settings were performed.

Eligibility criteria:
inclusion criteria: * symptoms/signs of influenza, and * confirmation of lower respiratory tract infection (e.g. radiographic pneumonia, dyspnea caused by acute exacerbation of underlying airway diseases, bronchitis, or combinations). exclusion criteria: * late presentation \>1 week from onset, * hemodynamic instability, * hepatic/renal failure, * dialysis, * immunosuppression (e.g. transplant, chemotherapy), and * pregnancy.
assessing the effect of virtual reality gamification on anxiety and pain management during extraction of mih-affected lower first permanent molars in pediatric patients

Conditions: Virtual Reality; Distraction; Gamification; Tooth Extraction

Summary: the aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with mih under local anaesthesia.

dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. to alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. one innovative method of distraction is gamification, which involves the use of virtual reality (vr) to redirect patients' focus to something relaxing instead of the treatment itself. the aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (mih) affected lower first molars under local anaesthesia. in prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. through vr goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.

Eligibility criteria:
inclusion criteria: * indication for the extraction of both lower first molars due mih grade 4. exclusion criteria: * exclusion criteria for the study encompassed individuals with systemic disease, special needs, patients with a history of epileptic seizures or episodes of dizziness, as well as patients suffering from claustrophobia.

Keywords: virtual reality distraction gamification tooth extraction mih
post-surgery extracorporeal life support

Conditions: Cardiogenic Shock; Extracorporeal Life Support; Extracorporeal Membrane Oxygenation Complication; Post Cardiac Arrest Syndrome; Post-cardiac Surgery

Summary: extracorporeal life support (ecls) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. however, indications and effectiveness of ecls engagement post-surgery remains a concern. the investigators sought to analyze indications, modality and outcomes of ps-ecls, to identify predictors of early and midterm survival after ps-ecls. the investigators have recorded prospectively, and analysed data of 209 consecutive ps-ecls patients between january 2004 and december 2018. demographic and clinical data before, during and after ps-ecls were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. multivariate analysis of pre ps-ecls implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, sts, type of surgical procedure data, pre-ecls blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.


Eligibility criteria:
inclusion criteria: * patients underwent cardiac surgery exclusion criteria: * age \< 18 years

Keywords: extracorporeal life support ecls ecmo outocome prognostic factors extracorporeal membrane oxygenation
a study of gemcitabine and carboplatin (plus herceptin in human epidermal growth factor receptor 2 positive [her2+] patients) with metastatic breast cancer

Conditions: Breast Cancer

Summary: the purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab any side effects that might be associated with these compounds. whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. how long the treatment will stop the growth of the cancer.


Eligibility criteria:
inclusion criteria: 1. diagnosis of metastatic breast cancer 2. able to visit the doctor's office at least every 14 days during the actual treatment 3. able to care for yourself, even if you cannot work or participate in other normal activities 4. your blood results must be adequate for therapy. 5. if you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug. exclusion criteria: 1. have received gemcitabine, paraplatin, or trastuzumab for your cancer. 2. be pregnant or breastfeeding 3. have cancer to the brain and has not been treated 4. have another active cancer besides breast cancer 5. have received stem cell or bone marrow transplant for hematologic (blood type) cancer
radiation exposure during endoscopic retrograde cholangiopancreatography between prone and left lateral decubitus

Conditions: Exposure to Ionizing Radiation

Summary: the objective of this study is to evaluate the radiation dose to patient at two positions (prone and left lateral) and to medical staff during endoscopic retrograde cholangiopancreatography (ercp) procedure using dose area product (dap) meter and thermoluminescent dosimeter (tld). data were recorded on 20 patients at prone position and 20 patients at left lateral position.

the radiographic-fluoroscopic system manufactured by siemens model polystar was used for ercp procedure at king chulalongkorn memorial hospital. dose area product (dap) manufactured by ptw model diamentor e, a transmission ionization chamber was attached to x-ray collimator to record the dose-area (cgy.cm2) in order to determine the entrance surface air kerma (esak, mgy) of the patients at two positions (prone and left lateral) while the kodak portal pack for localization imaging was placed on the patient's couch to determine the exposed area (cm2) on the surface of the patient. tld was attached at five positions, left eye, thyroid, left forearm, lower abdomen and left leg of the medical staff during ercp procedure.

Eligibility criteria:
inclusion criteria: * patients with common bile duct (cbd) stone and underwent ercp * age over 18 years * asa class i-ii exclusion criteria: * pregnant * abnormal coagulation * asa class iii-iv * emergency/urgency conditions * unstable vital signs * denied to participate the study

Keywords: radiation exposure ercp