Kornimate/medical-research-clean huggingface dataset:
validation study of physical measurement of tophi

Conditions: Gout

Summary: the purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.

gout is a chronic urate crystal deposition disorder. left untreated, gout may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment due to gouty nephropathy. hyperuricemia, defined as a serum urate concentration greater than 7.0 milligrams per deciliter (mg/dl), is the underlying metabolic aberration leading to urate crystal deposition in gout. gout has several clinical presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of monosodium urate monohydrate crystals in joints, bones and even parenchymal organs (tophaceous gout); renal impairment; and uric acid nephrolithiasis.1 as serum urate levels increase beyond greater than 7.0 mg/dl, the risks for gouty arthritis or for renal calculi increase. febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine oxidase/dehydrogenase inhibitor. febuxostat is being developed as an orally administered agent for the management of hyperuricemia in patients with gout. subjects with palpable tophi \>10 millimeters (mm) in length and width and as round as possible will have the tophus measured on two separate visits by two different raters to assess the inter- and intra-rater reproducibility of direct physical measurement.

Eligibility criteria:
inclusion criteria: * must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to acr criteria. * the tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width. * joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed. * must be on stable treatment for gout with no medication changes in the past 30 days. exclusion criteria: * must be able to return to the clinical site within 10 days. * must not have allergy to ink.

Keywords: hyperuricemia tophi tophus drug therapy
the clinical outcomes of the modified broström vs anatomic reconstruction operation in clai and gjl

Conditions: Ankle Sprains; Instability, Joint; Joint Hypermobility

Summary: investigators designed this prospective cohort study to compare the clinical outcomes of modified broström operation and anatomical reconstruction for the treatment of clai and gjl.

the modified broström operation is still the first line to treat chronic lateral ligament instability (clai). however, some studies indicate the modified broström operation may bring a higher rate of re-injury in generalized joint laxity (gjl). anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with clai. however, the clinical outcomes of the two operations are not discussed in clai and gjl. so, investigators designed this prospective cohort study. the primary outcomes are karlsson, foot and ankle outcome score (faos), and foot and ankle ability measure (faam) scores. the secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Eligibility criteria:
inclusion criteria: clinical diagnosis of lateral ankle pain and instability beighton score ≥4 age with 18 to 60 years exclusion criteria: patients with an acute or subacute ankle injury (within 3 months) injury of the deltoid ligament alignment of lower extremity greater than 5 degrees fractures of the lower extremity stage iii or iv osteoarthritis patients who refused to participate in the study

Keywords: chronic lateral ankle instability generalized joint laxity re-injury modified brostrom operation anatomic reconstruction
effect of acarbose and mixture of pioglitazone and metformin in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Blood Glucose Fluctuation

Summary: monotherapy with dpp-iv inhibitors, sglt-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. it was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.


Eligibility criteria:
inclusion criteria: * willing to participate in this present study; * patients with type 2 diabetes receiving stable monotherapy of dpp-iv inhibitors, sglt-2 inhibitors or insulin secretagogues for more than 3 months; * screening glycated hemoglobin (hba1c) between 7.0% and 10.0%; * regular diet and exercise; * body mass index (bmi) ≥ 18.5 kg/m2 exclusion criteria: * intolerance of metformin, pioglitazone and acarbose; * severe liver disease or elevated transaminases (2.5-fold the upper limit); * renal dysfunction or elevated creatinine (1.3-fold the upper limit); * systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months; * infection or stress state in the past 4 weeks; * pregnancy or lactation; * patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study.
intraoperative findings and complications in bariatric surgery

Conditions: Bariatric Surgery; Complication of Surgical Procedure; Obesity, Morbid

Summary: retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single institution. the objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. all operative information was collected prospectively and aimed to describe any of the previous situations. secondarily, a morbidity analysis was performed, correlating intraoperative complications with postoperative complications and length of stay.


Eligibility criteria:
inclusion criteria: * patient submitted to bariatric surgery * all patients met the guidelines defined by the national institutes of health (nih) consensus: bmi equal or greater to 40kg/m2 or bmi 35 - 40 kg/m2 with some comorbidity exclusion criteria: * patients with incomplete surgery data sheet and those subject to another type of bariatric surgery
nc/tmd ratio as a difficult airway predictor in obese patients

Conditions: Difficult / Failed Intubation

Summary: to assess accuracy of nc/tm distance ratio in terms of sensitivity, specificity, negative predictive value (npv) and positive predictive value (ppv) for predicting difficult intubation in obese patient with intubation difficulty score (ids) as gold standard.

at preanaesthesia clinic patients , neck circumference to thyromental distance ratios of obese patients with bmi \>30kg/m2 will be calculated and patients will be divided into two groups on the basis of nc/tmd ratio as anticipated easy intubation ( nc/tmd\<5) and anticipated difficult intubation ( nc/tmd ≥5). intra-operatively, patients intubation difficulty scale score will calculated and the data obtained from ids score will be compared with nc/tmd ratio as a predictor of difficult intubation and diagnostic accuracy of nc/tmd as a reliable indicator of difficult intubation in obese patients will be calculated by statistical analysis.

Eligibility criteria:
inclusion criteria: 1. asa physical status i to iii 2. body mass index (bmi) of 30kg/m2 or more 3. age 18-65 years exclusion criteria: 1. non consenting 2. asa class greater than iii, 3. patients undergoing general anesthesia without tracheal intubation or under regional anesthesia, 4. patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.

Keywords: difficult intubation nc/tm distance ratio intubation difficulty score
a study of tarceva (erlotinib) in patients with advanced non-small cell lung cancer naive to chemotherapy

Conditions: Non-Small Cell Lung Cancer

Summary: this study will evaluate the efficacy and safety of tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. one group, consisting of patients who have never smoked, will receive tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive tarceva 150 mg/day increasing to a maximum of 300 mg/day. the anticipated time on study treatment is 1-2 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * histologically documented advanced non-small cell lung cancer (stage iiib/iv); * eastern cooperative oncology group (ecog) performance status 0-2; * no previous chemotherapy. exclusion criteria: * previous therapy which acts on epidermal growth factor receptor (egfr) axis; * clinical evidence of brain metastasis; * any unstable systemic disease; * unable to take oral medication; * any significant ophthalmological abnormality.
enhanced primary care for elderly

Conditions: Frail Elderly Syndrome

Summary: the present health care situation for the elderly in many countries is insufficient and not designed according to the health care needs of the aged population. in a pragmatic multicenter primary care setting (n= 1600), the investigators use an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization and apply a differentiated and directed medical and social care to this risk group, in comparison to usual care. the intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc). the project has high potential impact on the development of future care of elderly. in addition to the intervention study, several academic sub-studies focusing on patient's perspective, professional roles, equality, implementation and governance management of health care will be performed.

the current project is a multidisciplinary research project covering several aspects of a shift in elderly care, with outcome measures not only related to primary medical or functional measures. the analyses will widen the view to overall societal costs and effects of changes in key institutions of social security as well as to hidden mechanisms in the governance system of care and health care of elderly. the primary aim of the present study is to investigate the extent to which a differentiated (personalized) and targeted primary care intervention provided to a statistically predicted risk population of elderly, results in care that is more effective and of higher quality than that of a control group receiving standard care. in a pragmatic multicenter primary care setting (n= 1600), an evidence based prediction model to find elderly (75+) with high risk for complex medical care or hospitalization is used followed by a differentiated and directed medical and social care to this risk group, in comparison to usual care. the intervention will include all the latest evidence based tools in the care of elderly (multi-professional team, social support, medical care home-visits, telephone support, general practitioner visits, etc). the investigators also aim to study the care model in a broader sense; experiences of the elderly, their social networks and diversity. finally, the project will also investigate how the health care system, from specific health care professionals (primary care nurses, doctors, para-medical staff) to management levels and politicians influence the implementation of the present and future care models. one specific subproject focuses on the mechanisms behind the inability of steak holders/politicians and top administrative executives to find efficient governance principals for elderly care and health care, despite already available knowledge sources.

Eligibility criteria:
inclusion criteria: * age 75 years and older living in county of östergötland exclusion criteria: * no exclusion criteria

Keywords: elderly frail primary care
study of the impact of a pediatric nurse's consultation on parental anxiety during a febrile convulsion in children

Conditions: Febrile Seizure

Summary: febrile seizures are considered a very common syndrome presented in the pediatric emergency room. witnessing these seizures may can cause anxiety in parents and generate them psychological sequelae such as major depressive disorder in the short term, or sleep disorders in the long term. an appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology and its care, and thus to reduce their anxiety and prevent potential inappropriate or even deleterious behavior and maneuvers towards the child.

febrile seizures occupy a large place in pediatric practice in the emergency room, their prevalence varies between 3 and 8% in children under 7 years old, hence the notion of a very common syndrome. when parents witness this event, they can experience it as terrifying, and which can alone cause anxiety and generate psychological sequelae. in the literature, it is described that a third of the parents present a major depressive disorder after the event and a third of the parents still describe sleep disorders after one year. after the arrival at the pediatric emergency room following the febrile seizure, the priority is given to the care of the child and parents are given succinct medical information. due to parental anxiety, which may still be significant at this time, this information may not be understood. all of this can make the parent's level of knowledge about this pathology and its management low, potentially leading to future behaviors and maneuvers (such as shaking) that are inappropriate or even harmful to the child. a different course with appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology, its care and to reduce parent's anxiety. this is why the consulfe childcare consultation is proposed in this research.

Eligibility criteria:
inclusion criteria: * participant being an adult parent who attended the febrile seizure of their child aged 1 to 5, episode lasting less than 15 minutes occurring within 24 hours * participant having signed the free and informed consent * affiliation to a social security scheme exclusion criteria: * parent who already has experience of febrile seizures in one of the siblings * parent of a child with a convulsive or neurological history * non-french speaking parents * parent with a diagnosed psychiatric illness * parent benefiting from a legal protection measure * parent participating in a study related to the management of anxiety

Keywords: anxiety fever convulsion seizure children
a pilot study on effect of sky on psychosocial parameters of type 2 diabetic patients after a 6 days

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this study is to determine whether sudarshan kriya yoga intervention has effect on the quality of life , anxiety and depression of type 2 diabetic patients.

diabetes is a psychologically and behaviorally demanding disease; therefore psychosocial factors are relevant to nearly all aspects of its management. research findings have demonstrated that depression is more common in patients with diabetes than in the general population, at least 15 % of patients have clinical depression.yoga is a mind-body alternative therapy which can be used to prevent and treat type 2 diabetes mellitus and related complications. sudarshan kriya yoga is a unique yogic breathing practices which involves several types of cyclical breathing patterns, ranging from slow and calming to rapid and stimulating. it is recommended for relaxation, stress management, control of psycho physiological states and to improve organ function. in this pilot study investigator recruited 24 type 2 diabetic patient and those who consent were provided with 6 days yoga course for a duration of 3 hours and trained to practice sky at home for 12 week. at baseline and after 6 days of sky, questionnaire on anxiety, depression and quality of life were provided to them. biochemical parameters were measured at baseline and after 12 weeks of yoga. two follow up yoga session were provided to the participants. primary outcome were pre to post intervention change in the mental health and quality of life.

Eligibility criteria:
inclusion criteria 1. patients showing stress as per the stress indicators. 2. patients of both gender of age 30 to 65 years on oral anti diabetic agents 3. patient is able to perform yoga postures and breathing exercise. 4. patient is able to consent for the study. 5. patient should be able to understand english as that is the medium used. exclusion criteria 1. bipolar disorder 2. antidepressant drugs 3. type 1 diabetes 4. pregnancy 5. any acute coronary symptoms in past 6 months 6. artificial pace-maker 7. previous (sky) or any type of spiritual meditation practiced within 6 months
testing brief personalized feedback integrating ema alcohol cue information

Conditions: Alcohol Drinking; Problem Drinking

Summary: this study aims to develop a brief intervention that incorporates ecological momentary assessments (emas; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. the intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. this brief intervention will be used in a randomized controlled trial (rct) comparing young adults who receive the intervention with those who only complete identical assessments.

the purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. the aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. the intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking. this brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the emas but do not receive any personalized feedback. assessments include an eligibility survey, baseline assessment, 17 days of emas (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. the 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from day 17 of the ema period, because the intervention was delivered on day 17. the intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Eligibility criteria:
inclusion criteria: * 1) between ages 18-24, 2) lives in washington state, 3) reports drinking at least two days per week in the last six months, 4) reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) open to changing drinking behavior, 6) schedule allows for participation in study with daily surveys, 7) able to attend zoom training session, 8) must have cellphone for daily surveys. exclusion criteria: * 1) actively seeking treatment for alcohol use, 2) currently participating in another study in our research center regarding young adult drinking behavior.

Keywords: alcohol intervention young adults personalized feedback
prevention of icu-related anxiety in lung transplantation by virtual reality therapy - pirat study

Conditions: Transplantation, Lung; Depression, Anxiety; PTSD

Summary: icu patients frequently face complicated recovery processes, including long-term anxiety disorders. lung transplantation (ltx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. among the disorders usually encountered in the postoperative period of ltx are anxio-depressive disorders. these anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. other psychological disorders are also anchored in the patient's experience of this post-surgical icu period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (ptsd). various models of management of anxio-depressive disorders and ptsd are proposed in the literature. to our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. exposure therapies using virtual reality (etvr) have in the past demonstrated their effectiveness in many areas of psychiatry. in our study, experimental arm patients will be offered etrv support with a virtual reality headset. a scenario with progressively increasing stress levels linked to the icu environment and different situational contexts (alarms, etc.) will be presented to patients. this habituation to the potentially anxiety context of icu will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.


Eligibility criteria:
inclusion criteria: * age above 18 years * registration on the lung transplant waiting list * signature of consent exclusion criteria: * minor patient, pregnant or breastfeeding woman, or not affiliated to the social security scheme * patient under guardianship or curatorship * patient with a history of mental illness * patient not mastering the french language * patient deprived of liberty * patient carrying a transplanted organ (liver, kidney, heart ...) * lung re-transplantation
retrospective study on the walkon afo in children or teenagers with neurological pathologies

Conditions: Cerebral Palsy (CP); Spastic Paraplegia; Spinal Cord Injuries (SCI); Spina Bifida; Neuropathy (Disorder)

Summary: the goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (afo) in children and teenagers with central or peripheral neurological pathologies. the main question it aims to answer is: does prefabricated carbon afo improve gait and provide user satisfaction? in current practice, all patients with gait impairments were fitted with this orthosis and had a 3d gait analysis with and without afo. biomecanical and follow-up data collected in current practice are analysed in this study in order to answer the question.


Eligibility criteria:
inclusion criteria: * patient, child or adolescent, whose gait is affected by central or peripheral motor impairments * patient who has carried out a one-off trial of a walkon afo (ankle-foot orthosis) within the last 3 years prior to the beginning of the study (inclusion period) * patient whose quantified gait analysis with the walkon afo and without orthosis is available in the medical file and whose date is within the inclusion period * the investigator has verified that the patient and the parental authorities have received the information note concerning the study * the investigator has verified that the person and the parental authorities do not object to the processing of data necessary for the study exclusion criteria: • patients or holders of parental authority objecting to the processing of data within the framework of the study