Kornimate/medical-research-clean huggingface dataset:
the atlet study: can subjects with incomplete spinal cord injury learn to walk?

Conditions: Spinal Cord Injury

Summary: the atlet study will assess the effect of manual or robotic body-weight supported locomotor training of patients with stable motor incomplete spinal cord injury (sci) on gait and overall adl function as well as on estimated health care costs.

there are approximately 100 new cases of spinal cord injuries (sci) each year in norway. most of the sci occur after traumatic accidents among young people and adults during the time of their productive life. loss of walking and standing ability restricts their independent mobility and autonomy and severely impacts their quality of life. the study has two arms: 1) manual locomotor training (tromsø) and 2) robot assisted training (oslo). each study arm has 30 patients, randomized to receive standard care or intervention. the intervention group receives 60 days of intensive locomotor training over 6 months. single-blind, before/after evaluation of effect will be performed at sunnaas hospital using a standardized set of evaluation tools.

Eligibility criteria:
inclusion criteria: * motor incomplete sci grade ais-c or -d * age: 18 - 70 years * body mass index of \<30 * wheelchair dependent * at least 2 years since time of injury * cognitively unaffected and motivated for locomotor training * lives within driving distance of oslo (\< 70 km), if considered for the outpatient arm of the study. exclusion criteria: * complete sci grade ais-a or -b * cognitively reduced * bmi ≥ 30 * age: under 18 years or above 71 years * spasms and contractures which can prevent locomotor training * changes in use of spasm reducing medication during intervention * significant osteoporosis in spine and/or joints * pregnancy (adequate contraceptive use is required of women in fertile age) * physical limitations for the use of the robotic orthosis * participation in other intensive training programs * those who live 70 or more kilometers from the oslo training center, will be enrolled in the tromso arm of the study. * other medical condition which can interfere with the training protocol * previous knee- or hip replacement

Keywords: incomplete spinal cord injury locomotor activity walking function gait
apixaban prevents portal vein thrombosis after laparoscopic splenectomy and azygoportal disconnection

Conditions: Cirrhosis; Splenectomy; Venous Thrombosis; Hypertension, Portal

Summary: the purpose of this study is to determine whether apixaban is effective and safe in prevention of portal vein thrombosis in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection

after successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. from postoperative day three, patients in apixaban group will receive oral apixaban 2.5mg bid for six months, and be along with five days of subcutaneous injection of low molecular weight heparin and three months of oral dipyridamole. the doppler screening for the occurrence of portal vein thrombus (pvt) or spleno-mesenteric thrombosis will be done for all patients at baseline, on postoperative months (pod) 7, at postoperative months (pom) 1, 3, and 6. all groups will receive the therapy for six months irrespective of the doppler findings in relation to portal vein thrombus occurrence. then six months monitoring will be done as per the primary outcome.

Eligibility criteria:
inclusion criteria: 1. a clinical, radiological or histologic diagnosis of cirrhosis of any etiology 2. splenomegaly with secondary hypersplenism 3. bleeding portal hypertension 4. no evidence of pvt or spleno-mesenteric thrombosis by ultrasound evaluation and angio-ct 5. informed consent to participate in the study exclusion criteria: 1. hepatocellular carcinoma or any other malignancy, 2. hypercoagulable state other than the liver disease related 3. drugs- oral contraceptives, anticoagulation or anti-platelet drugs. 4. child - pugh c 5. recent peptic ulcer disease 6. history of hemorrhagic stroke 7. pregnancy. 8. uncontrolled hypertension 9. human immunodeficiency virus (hiv) infection

Keywords: cirrhosis venous thrombosis portal hypertension apixaban splenectomy laparoscopy
measurement and assessment of prolonged grief disorder in asia

Conditions: Prolonged Grief Disorder

Summary: the overall project includes three sub-studies. sub-study i aims to develop the content of a new cultural sensitive grief questionnaire (international prolonged grief disorder scale, ipgds killikelly and maercker, 2018) through interviews and focus groups with key (expert) informants and bereaved participants from japan, switzerland and china. the content will be piloted in paper and mobile app format. sub - study ii aims to validate the new paper and mobile questionnaire in 200 participants from each culture using a battery of questionnaires and psychometric assessment. sub-study iii will explore the relationship between grief and the cultural expression or repression of emotion. this will involve a battery of questionnaires about emotional expression and a short idiographic interview task administered to swiss, japanese and chinese bereaved participants in paper and online format.

objectives of the project: the overall aim of this project is to develop three culturally sensitive measures of grief for use in switzerland, china and japan. three sub-aims are described below: substudy 1: development of the questionnaire substudy 2: psychometric validation of the questionnaire substudy 3: relationship between emotional expression and grief the relationship between grief and the expression of emotion will be explored within and across the three cultures. outcomes of the project: sub-study 1: 1. three new culturally sensitive versions of a prolonged grief disorder measure (ipgds) 1) swiss 2) japanese 3) chinese versions: the structure and item content of this measure 2. beta draft of a mobile app version of the ipgds questionnaire sub-study 2: 3. psychometric properties of the ipgds: specific outcomes including statistical confirmation of the reliability (interrater reliability, test/retest, internal consistency) and validity (criterion, content validity, construct validity) of the ipgds sub-study 3: 4. identification and documentation of emotional expression differences in chinese, japanese and swiss culture that may impact on assessment of grief and could inform clinical assessment procedure.

Eligibility criteria:
inclusion criteria: * swiss, japanese, chinese nationality or identity * english, german, japanese, cantonese or mandarin speaking * male and female subjects 18 years to 75 years of age * written informed consent by the participant after information about the project * loss of a loved one (family or friend) at least 6 months prior, at most 10 years prior exclusion criteria: * • severe mental health disorder (e.g. major depression, suicidality, current schizophrenia), * currently in-patient,

Keywords: assessment validation prolonged grief disorder cross cultural questionnaire
magnetic resonance imaging (mri) for aortic dissection to visualise inflammation

Conditions: Aortic Dissection; Aortic Diseases

Summary: the study is a single-centre, prospective, observational cross-sectional imaging study aimed to determine if macrophage-mediated inflammation can be visualised in the aorta of patients with aortic dissection (ad) using ultrasmall super paramagnetic iron oxides (uspio)-enhanced magnetic resonance imaging (mri).

aortic dissection (ad) is a condition in which a disruption of the medial layer (in most cases provoked by a tear or an ulcer in the intima) results in separation of the aortic wall layers, with concomitant 'false lumen' formation and malperfusion of end organs. the underlying mechanism of the condition has, until recently, remained unclear. the pi of the present sutdy has shed light on a mechanism that shows that inflammation underlies the condition. the pi of the present study has showed that inflammation in the aorta is triggered by macrophage infiltration into the aortic wall in both pre-clinical models using animal models of the condition (murine) and in patient tissue samples obtained at time of surgery. macrophage infiltration into the aortic wall, as a result of activation of the cytokine, granulocyte-macrophage colony stimulating factor (gm-csf), is the trigger for an inflammatory cascade that is presently understood to underlie the pathogenic mechanism of the condition non-invasive assessment of macrophage infiltration would prove that this pathogenic mechanism exists (proof-of-concept). macrophage infiltration has been shown to be feasible by contrast-enhanced magnetic resonance imaging (mri) using ultrasmall super paramagnetic iron oxides (uspios). the hypothesis of the present study is that macrophage-mediated inflammation can be visualised in the aorta of patients with ad using the uspio-enhanced mri technique, and use the present study to confirm this (proof-of-concept).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of acute or chronic aortic dissection (\>2 week after initial intimal injury) * able and willing to comply with all study requirements. * age \> 40 years (patients under the age of 40 years will not be included as they may have a connective tissue disorder accounting for their condition) * able and willing to give informed consent * an adequate understanding of written and verbal english exclusion criteria: * past history of systemic iron overload or haemochromatosis * renal failure (estimated glomerular filtration rate \< 30ml/min) * contraindication to mri * known allergy to iron-containing compounds * participants who have participated in another research study involving an investigational product in the past 12 weeks. * female participants who are pregnant or lactating. * unwilling or unable to give informed consent
determine the clinical advantage of iv vs po acetaminophen

Conditions: Inguinal Hernia

Summary: there is limited research on the clinical outcome differences between intravenous (iv) acetaminophen versus oral (po) acetaminophen. with the costs of intravenous acetaminophen sometimes being almost 100 times the cost of po acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of iv vs po acetaminophen. the proposed research study is to determine the clinical advantages of iv vs po acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

in previous literature it has been shown that compared to placebo, iv acetaminophen can improve postoperative pain scores and reduce opioid requirements. in addition, iv acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. iv acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. comparative effectiveness trials of iv vs po administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. more research needs to be conducted to determine possible clinical advantages.

Eligibility criteria:
inclusion criteria: * asa scores i-iii * ambulatory surgery patients * ages 18-75 * surgeries requiring general anesthesia for hernia surgery exclusion criteria: * patients with contraindications to acetaminophen (history of end organ liver dysfunction) * known allergy to acetaminophen * emergency surgery * patients who were not fasted * patients who cannot tolerate po * surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen * pregnancy * weight less than 50kg * chronic daily narcotic use * patients who's anesthetic plan requires regional anesthesia * patient refusal to participate or do not have capacity to provide consent.

Keywords: acetaminophen tylenol intravenous versus oral
validation of cambodia version of five minutes hearing test

Conditions: Hearing Loss

Summary: seek the simple tool as questionnaire for screening hearing loss. the fmht was developed by american academy of otolaryngology-head and neck surgery (aao-hns). it is a standard hearing questionnaire. so, we plan to translate the fmht into cambodian language and validate by comparing its result with those of audiometry.

primary objective: to assess sensitivity of the fmht in cambodia version (cam-fmht) compared with the standard audiometry secondary objective: to assess 1. specificity of the fmht in cambodia version (cam-fmht) compared with the standard audiometry 2. likelihood ratio of the fmht in cambodia version (cam-fmht) compared with the standard audiometry 3. predictive value of the fmht in cambodia version (cam-fmht) compared with the standard audiometry

Eligibility criteria:
inclusion criteria: * age 18-60 years old * able to read and understand khmer language * volunteer to participated exclusion criteria: * aphasia patients * patients with severe mental disability * patients with other conditions that preclude audiometry
complex peri-operative intervention in older patients with cancer

Conditions: Digestive Cancer

Summary: incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. pre-operative geriatric assessment enable to identify frail or vulnerable patients at risk of post-operative complications. the coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

multicenter randomized clinical trial in 2 parallel-groups with masked adjudication of main endpoint

Eligibility criteria:
inclusion criteria: * aged 75 years or more * gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment * health insurance * at risk of post-operative complication through surgical risk calculator (\>25%) or surgeon judgment. * written consent exclusion criteria: * surgery in emergency

Keywords: age geriatric assesment co-management surgery digestive cancer
effectiveness of therapeutic exercises on spinopelvic mobility

Conditions: Osteoarthritis (OA) of the Hip

Summary: the purpose of this study is to examine the extent to which spinopelvic exercises may affect either sagittal spinal deformity or spinopelvic mobility and identifying patients at risk for hip instability following a total hip replacement.


Eligibility criteria:
inclusion criteria: 1. patients aged 18-90 scheduled for total hip arthroplasty 2. patients with primary hip osteoarthritis 3. patients with or without history of prior spinal injections exclusion criteria: 1. patients undergoing revision total hip arthroplasty. 2. patients with spinal fusion. 3. patients who exercised prior to radiographic analysis. 4. patients unable to complete imaging at the designated time of day. 5. symptomatic contralateral hip osteoarthritis. 6. patients unwilling or unable to perform therapeutic exercise program as instructed. this includes patients requiring use of assistive devices or who would be deemed unsafe to perform the exercises without a 1- or 2-person assist.
community based prevention of rotavirus gastroenteritis by a functional food supplement

Conditions: Rotavirus Gastroenteritis

Summary: rotavirus is the commonest cause of severe gastroenteritis in young children worldwide. the investigators hypothesize that use of a food based prophylactic will decrease incidence of rotavirus infection in young children in south india, prevent intestinal damage and overall result in lower infection rates and better gut function. this trial will evaluate the efficacy of prevention of rotavirus gastroenteritis when an anti-rotavirus protein or antibody fragments expressed in yeast or placebo are given daily as a food supplement to children between the ages of 6 and 12 months. the children will followed for one year and rates of rotavirus diarrhoea, antibody responses and gut function will be compared between children receiving antibody fragments or placebo.

the study will be carried out in an urban slum area in vellore, south india. children between the ages of 6 and 12 months will be recruited for participation in the study. they will be randomized to receive supplementation with arp or placebo, and will be followed for a period of one year, with weekly home visits and monitoring of all episodes of diarrhoea. in addition, every two weeks, surveillance stool samples will be collected and tested for rotavirus to identify asymptomatic infections by pcr. all episodes of diarrhoea will be investigated intensively for bacterial, viral and parasitic agents of diarrhoea using both conventional and molecular techniques and all cases will be treated appropriately at the study clinic or referral hospital as required. monthly anthropometric measurements will be carried out to estimate rates of growth and to identify growth faltering. blood samples will be taken at 4, 8 and 12 months for estimation of anti-rotavirus iga and igg antibodies. studies on intestinal absorption and permeability will be carried out at recruitment, 6 and 12 months by the lactulose:mannitol test (measured by hplc detection of sugars). all rotavirus strains obtained will be characterized by genotyping.

Eligibility criteria:
inclusion criteria: * healthy child aged 6 to 12 months, families resident in the study area, willing to participate and available for follow up for a period of one year * normal birth weight (\> 2.5 kg), child exclusively breast fed for at least four months exclusion criteria: * families not available for a follow up period of one year * children with any atopic conditions * children with gross congenital anomalies including cardiovascular, renal or hepatic disease * children with syndromic or serological evidence of hiv infection
low-calorie diet in isolated impaired fasting glucose

Conditions: Isolated Impaired Fasting Glucose

Summary: this study aims to evaluate the preliminary efficacy of a low-calorie diet (lcd) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-ifg). additionally, it seeks to assess the feasibility and acceptability of the lcd intervention.

this proof-of-concept randomized controlled trial (rct) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. intervention participants will adhere to an 8-week low-calorie dietary (lcd) regimen (\~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). control participants will maintain their habitual dietary habits and physical activity levels. primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the lcd intervention.

Eligibility criteria:
inclusion criteria: 1. aged 35 to 65 years 2. overweight (body mass index (bmi) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if asian descent) or obese (bmi ≥30 kg/m²) 3. physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity) 4. prediabetes diagnosis or score ≥5 on the american diabetes association (ada) risk tool exclusion criteria: 1. diagnosed with type 1 or type 2 diabetes 2. cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions) 3. chronic kidney disease 4. chronic liver disease (e.g., cirrhosis) 5. cancers 6. acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption 7. food allergies 8. participation in weight loss programs in the past six months 9. currently following a specific diet (e.g., ketogenic diet, mediterranean diet) 10. participation in any exercise programs in the past six months 11. currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics) 12. previous bariatric surgery or plan to have bariatric surgery during the study period 13. planning to relocate during the study period 14. intending to fast during the study period for religious or other reasons 15. pregnancy or planning to become pregnant during the study period 16. breastfeeding 17. non-english speaker

Keywords: low-calorie diet prediabetes overweight obesity fasting hyperglycemia
enterra therapy clinical study (gastric stimulation for gastroparesis)

Conditions: Gastroparesis

Summary: this study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved humanitarian device. there are two cohorts in this study based on etiology, one for diabetic and one for idiopathic. a maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the united states will be followed closely for twelve months and then once a year after that until the study closes. if you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.


Eligibility criteria:
inclusion criteria: * male or female at least 18 years of age * diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic) * have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications * have symptoms of gastroparesis that have required treatment for at least one year * experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary * willing and able to completely and accurately fill out a diary and questionnaires throughout the study * have gastric retention of greater than 10% at four hours, or greater than 60% at two hours (if unable to complete the four-hour test) on a gastric emptying test (get) exclusion criteria: * gastroparesis caused by a specific diagnosed illness other than diabetes * current eating disorder or diagnosed swallowing disorder * previous stomach surgeries * taking narcotic pain-relievers daily for abdominal pain * diagnosed with drug or alcohol dependency within 1 year before the study * life expectancy less than one year * have other implantable devices such as pacemakers * pregnancy or planned pregnancy * plan to receive diathermy treatment * have had radiation therapy of the upper abdomen * plan on having an mri performed * currently participating in another investigational device or drug study

Keywords: nausea and vomiting