Kornimate/medical-research-clean huggingface dataset:
multi-center study to examine changes to the environment surrounding the electrodes in the cochlea and to capture the most challenging listening environments experienced by persons with a cochlear implant

Conditions: Hearing Loss

Summary: this early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.

this is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical investigation in adults with a ce labelled cochlear implant. no randomisation nor blinding to avoid bias is applicable in this study since there is no comparator. subjects will attend two scheduled study visits over a two-month study period. at and in between study visits, subjects will undergo hearing assessments and safety monitoring. the subjects will perform daily impedance test tasks and complete a questionnaire in order to obtain the first primary endpoint, i.e. characterization of daily impedance fluctuations. furthermore, the subjects will do ema tasks to obtain the secondary objectives to capture daily-life, real-world listening environments and challenging listening environments.

Eligibility criteria:
inclusion criteria: * aged 18 years or older (no upper age limit). * implanted with cic4-based implant with a contour advance, slim straight or slim modiolar electrode array with at least 6 months experience. * candidate is a fluent speaker in the language used to assess speech perception performance, as determined by the investigator. * willing and able to provide written informed consent. exclusion criteria: * score below 3 on the screening subset of questions from the mobile device proficiency questionnaire (digital literacy check). * a failed ece1 or ece2 (i.e. flagged, open circuit or short circuit) * additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues. * unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. * investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * cochlear employees or employees of contract research organisations or contractors engaged by cochlear for the purposes of this investigation. * current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation)
somatic symptom disorders in patients with myocardial bridge

Conditions: Myocardial Bridge; Somatic Symptom Disorder

Summary: the purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with myocardial bridge and to describe the relationship between clinical features and the occurrence of somatic disorder.

myocardial bridge (mb), a congenital cardiac anomaly, is an unignored contribution to chest pain. patients with mb often complain about chest discomfort more serious than the degree of vessel compression. the symptoms are also often inconsistence with the degree of coronary stenosis. reports suggested that patients with mb may companioned with depression and anxiety. moreover, patients with mb often have other systemic complaints including stomach pain, pain on the back, ear blockage, et al. investigators assume that somatic symptom disorder (ssd) may play a part in aggregating the severity of symptoms. in order to screen ssd, investigators previously developed the somatic symptom scale-china (sss-cn) questionnaire. it is a somatic and psychological symptom scale which was developed based on the dsm-5 to assess a combination of psychological, behavioral and somatic symptoms. it is designed to assess the presence and severity of the symptoms. investigators have validated its reliability and validity in a previous study. the purpose of this study was to investigate the prevalence of physical and mental disorder in the population of patients with mb and to describe the relationship between clinical features and the occurrence of somatic disorder.

Eligibility criteria:
inclusion criteria: * cardiology inpatients with the age older than 18, complained with chest discomfort and was suspected with coronary artery disease. * undertook somatic symptom scale-china (sss-cn) questionnaire, patient health questionnaire-9 (phq-9) and generalized anxiety disorder-7 (gad-7) questionnaires. * underwent cardiac angiography. * agree to participate. exclusion criteria: * patients who are in emergency or unconsciousness. * patients who refuse to participate or with unfinished questionnaire. * the questionnaires were undertook after the angiography. * patients who have previously been confirmed to have mental disorders, mental retardation or dementia, cannot finish questionnaires * patients who currently take anti-anxiety or anti-depression agents. * patients who have been confirmed to have heart diseases other than coronary vascular disease. * patients who have been previously confirmed to have other physical diseases.

Keywords: myocardial bridge somatic symptom disorder sss-cn
bone forming at prosthetic surfaces. fingerprint2

Conditions: Osteo Arthritis

Summary: what is the intensity of f-pet uptake in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?

a clinical study of 26 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in four groups plus a reference group of same 26 patient´s contralateral healthy hip. intervention will be surgery with a total hip arthroplasty. the studied endoprosthetic components are: cemented lubinus sp ii stem with a ceramic 32 mm head, a cemented lubinus cross linked cup (waldemar link, hamburg, germany). palacose cement with gentamycin, applied with 3:rd generation cementation technique will be used for those cemented implants. uncemented ha-coated corail stem with a ceramic 32 mm head (depuy, johnson \& johnson, usa), a fibrous metal regenerex ringloc cup (biomet, warsaw, il, usa) all cups will have cross linked ultra-high-molecular-weight polyethylene (uhwmp). clinical score, radiography and pet uptake of fluoride tracer (suv) adjacent to the prosthetic surfaces will be analyzed.

Eligibility criteria:
inclusion criteria: * patients diagnosed to have unilateral hip osteo arthritis (charnley group a) aimed for tha at the orthopedic clinic gävle hospital. exclusion criteria: * systemic disease or medication affecting the skeleton

Keywords: total hip arthroplasty bone metabolism mineralisation
mobile app logging for diabetes in pregnancy

Conditions: Gestational Diabetes Mellitus in Pregnancy; Type 2 Diabetes

Summary: to determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.

women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). this is often the first time they've had to keep such strict logs. patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. mobile apps can be used to record blood sugar as well. this study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. subjects will be recruited from the augusta university downtown location obstetric clinics. qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (gtt) \> 200mg/dl or 3h gtt with 2 or more abnormal values. exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, preexisting use of a continuous glucose monitor (cgm) or application to track blood sugar readings, and type 1 diabetes.

Eligibility criteria:
inclusion criteria: * 18 years and older * verified intrauterine pregnancy * at least 12 weeks gestation * diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus. exclusion criteria: * patients with less than 4 weeks anticipated to be remaining in pregnancy * pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking * type 1 diabetes mellitus * non-english speaking patients

Keywords: technology in medicine mobile applications blood glucose monitoring diabetes in pregnancy
outcome of resection anastomosis and long term stenting with montgomery tube operations in management of grade 3 benign laryngotracheal stenosis

Conditions: Grade 3 Benign Laryngotracheal Stenosis

Summary: laryngotracheal stenosis is a challenging problem in the field of laryngology. in the majority of patients, acquired stenosis of the larynx and trachea is due to accidental trauma, prolonged intubations, or tracheostomy. congenital stenosis, caustic injury, and granulomatous diseases are also etiological factors in laryngotracheal stenosis (grenier pa et al, 2009). tracheal stenosis can occur following tracheostomy or endotracheal intubation with inappropriate cuff pressure. it is due to pressure necrosis at the site of the cuff. initially, there is inflammation of the damaged mucosa with increased secretion and secondary infection. prolonged ischemia and secondary infection cause necrosis of the tracheal wall and exposure and sequestration of the cartilaginous rings. this damage results in the formation of granulation tissue and collapse of the tracheal wall (satish nair et al, 2014). the tracheal stenosis is classified as simple, which is a soft, short segment web-like narrowing often limited to the mucosa only or complex stenosis, which is a hard, long-segment stricture with destruction of tracheal cartilages and fibrosis. post tracheostomy stenosis occurs most commonly at the stoma site or less commonly at the site where the tip of the tube has impinged on the tracheal mucosa (liu j et al, 2015). the symptoms are generally insidious. most arise 1 to 6 weeks after extubation, and early symptoms are often not recognized. the most common symptoms include shortness of breath, cough, recurrent pneumonia, wheezing, stridor, and cyanosis over time. dyspnea is often the symptom until the tracheal diameter is 50% smaller than normal. when the tracheal diameter is 25% of its normal size, dyspnea and stridor may occur even at rest. these symptoms can be confused with other respiratory diseases (rubikas r et al, 2014).


Eligibility criteria:
inclusion criteria: - patients who are diagnosed with layngotracheal stenosis either post tracheostomy or post intubation exclusion criteria: * the exclusion criteria will be patients who underwent laryngeal split and cartilaginous grafting; patients who underwent carinal resection; patients with incomplete records; and resection due to conditions other than post intubation tracheal stenosis (e.g., airway tumors, idiopathic stenosis, trauma, wegener' granulomatosis and chronic relapsing polychondritis).
alcohol self-reporting during pregnancy. autoquest study.

Conditions: Alcohol Drinking; Pregnancy

Summary: the effects of alcohol consumption during pregnancy have been known for decades. however, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. during pregnancy, standardized self-reports such as t-ace would help identify early women with high-risk alcohol consumption. t-ace appears to be one of the most used during pregnancy but its diagnostic value is not objectively known. to evaluate the diagnostic value of t-ace self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood. material and methods multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of north of france. the self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. when they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of t-ace. an alcohol consumption will be considered " at high risk " if blood phosphatidylethanol is ≥ 20 µg/l. with a predictable 25% rejection rate and a positive 4% t-ace frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv) of t-ace with a satisfactory 95% confidence interval in this population. the evidence of a link between positive t-ace and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy. the t-ace within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the north of france is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. if t-ace appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.


Eligibility criteria:
inclusion criteria: * pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care * and having returned her self-report * and having given her written consent * no exclusion criteria exclusion criteria: * woman under 18 years old * or not pregnant * or not having returned her self-report * or woman who refused to participate in the study (absence of written consent)

Keywords: screening alcohol consumption pregnancy self report
effects of right lower limb orthopedic immobilization on braking function

Conditions: Automobile Driving With an Aircast Walker; Automobile Driving With a Walking Cast

Summary: research on the implications of orthopedic injury and surgery on automobile driving ability has been limited. only a handful of orthopedic issues have been studied to date, especially the safe postoperative resumption of driving. however, effects of orthopedic immobilizations of the lower right limb on fitness to drive are largely unknown, and the physician is left with little guidance. only one study (tremblay et al. 2009) have looked at the impact of wearing such devices on braking performances. the results have shown a statistically significant increase of braking times while wearing a removable aircast walker and a walking cast in healthy subjects under simulated driving conditions. despite this, the study have not demonstrated that driving with orthopedic immobilization is dangerous since the increase in braking times were minimal. limitations of this study include the important fact that driving simulation is not real-time driving. in order to assess the validity of the driving simulator used in this study, a similar experimental study during real-time driving was thus devised.


Eligibility criteria:
inclusion criteria: * healthy subjects between 25 to 60 years old * possession of a valid quebec driver's license * driving for at least 5 years * exclusively use the right foot for accelerating and braking exclusion criteria: * visual acuity deficits or other visual problems uncompensated * history of drug or alcohol abuse * use of psychotropic drugs * any illness of the central nervous system such as epilepsy * sleep disorders * metabolic problems * cardiovascular disease * cerebrovascular disease * peripheral vascular disease * psychiatric illness * renal disease * musculoskeletal disease * motion sickness

Keywords: automobile driving fracture fixation/instrumentation lower extremity orthopedic fixation devices orthopedic procedures reaction time task performance and analysis time factors
liposomal bupivacaine versus standard of care in total knee surgery

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.

liposomal bupivacaine (exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. it is designed to be injected at the time of surgery into the local soft tissues. because of its unique liposomal delivery system, liposomal bupivacaine (exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. this makes it an attractive option in total knee arthroplasty patients. combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (exparel®) may provide extended pain relief following total knee arthroplasty. this has the potential to avoid the need for opioid medications. with better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * scheduled to undergo total knee arthroplasty (tka) performed by the principal investigator exclusion criteria: * age \<18 years * pregnant or breastfeeding * non-english-speaking * unable to give informed consent * patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc. * patients unable to complete a device-assisted 140 foot walk at baseline * patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (iv morphine, ketorolac, or methylprednisolone). * patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin) * patients undergoing simultaneous bilateral tkas, as this would increase the dose of exparel per patient (we are limited to one dose per patient)

Keywords: total knee arthroplasty total joint arthroplasty knee replacement osteoarthritis of the knee
phase ii clinical study of gemox hepatic arterial infusion combined with lenvatinib and toripalimab for advanced and unresectable intrahepatic cholangiocarcinoma and gallbladder cancer

Conditions: Intrahepatic Cholangiocarcinoma (Icc); Gall Bladder Cancer

Summary: for advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. however, the efficacy rates remain low. hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects. this study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. the aim was to improve treatment efficacy and create opportunities for conversion surgery. the primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pcr), overall survival (os), and the incidence of adverse reactions.


Eligibility criteria:
inclusion criteria 1. age 18 or above 2. histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer 3. a tumor that cannot be removed by three independent surgeons. 4. expected lifespan ≥ 12 weeks 5. ecog ps score 0-1 points 6. the patient voluntarily participates and signs an informed consent form; 7. expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements. exclusion criteria: 1. use any systemic research anti-cancer drugs 2. active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy) 3. asthma requires the use of bronchodilators for medical intervention 4. congenital or acquired immune dysfunction, such as human immunodeficiency virus (hiv) infection 5. clinical symptoms or uncontrolled heart disease 6. severe infection within 4 weeks before the first use of medication 7. history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation 8. vaccination with attenuated live vaccine within 4 weeks before treatment 9. other systemic malignant tumors in the past 5 years

Keywords: gemox, lenvatinib, toripalimab
a brief affirmation intervention on hiv-related distress and positive living in lesotho

Conditions: Self-affirmation Plus Positive Living Counseling; Counseling

Summary: this study is interested in the stress associated with being hiv positive and looking at ways to reduce that stress. individuals who are hiv positive face a number of nontrivial threats and stressors: the burden of illness, loss of work, stigmatization, and the chance of death. the study investigates the use of self-affirmation to reduce some of these threats and stressors. self-affirmation may helping people to cope with these threats and stressors by reminding individuals of other valued aspects of themselves, thus reducing the impact, both psychologically and physiologically, of these threats. experimentally induced affirmations in which individuals are asked to write about values that are important to the self have been shown to reduce physiological stress among healthy student populations (sherman, bunyan, creswell, \& jaremka, 2009). this research will be conducted in collaboration with the global health organizations, psi who is already providing counseling to those living with hiv on how to reduce the spread of hiv and how to live a healthy life with hiv. these counseling sessions take place at local clinics and hospitals while individuals are waiting to be seen for treatment and are completely voluntary.


Eligibility criteria:
inclusion criteria: * hiv+ * a cd4 count of less than or equal to 500 cells/mm3 or have significant symptomatology and hiv co-illness (who hiv clinical stage 3 or 4) to be eligible to start antiretroviral therapy exclusion criteria: -