Kornimate/medical-research-clean huggingface dataset:
potentially inappropriate prescription associated to multimorbidity

Conditions: Chronic Disease

Summary: a prospective multicenter cohort study in 5 hospitals in spain will be initiated in 2016. objectives: 1. to estimate and describe patterns of multimorbidity and polypharmacy in patients over 64 admitted for a chronic disease exacerbation. 2. to analyze the potentially inappropriate prescribing (ppi) drugs according to stopp / start (ss) criteria. 3. to evaluate the relationship between multimorbidity and ppi and adverse medication (ram) preventable reaction. the cohort will include 800 patients \>64 years admitted in internal medicine and / or geriatric department of 5 hospitals of the national health service. application of the ss criteria (released in 2015) on admission and at discharge, and collection of demographic and clinical variables including comorbidities, baseline chronic medication, geriatric syndromes, functional capacity and ram. descriptive analysis and bivariate parametric or nonparametric tests will be applied to analyze relationship between morbidity, polypharmacy, ss criteria and ram. intraobserver agreement will be assessed for ss criteria. multiple regression techniques will be applied, where the dependent variable will be the ppi or the ram.


Eligibility criteria:
inclusion criteria: * patient admitted to the internal medicine or geriatrics department * admitted to hospital because of an exacerbation of any previous chronic condition exclusion criteria: * terminal ill patients at admission * patients with lower forecast life than 1 year * patient admitted to the hospital only because an acute problem * in patient home care

Keywords: multimorbidity polypharmacy appropriateness stopp start
study of sunitinib with capecitabine in breast cancer

Conditions: Advanced/Metastatic Breast Cancer

Summary: to evaluate efficacy, safety and pharmacokinetics of sunitinib plus capecitabine in japanese patients with advanced/metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent * measurable disease as per recist. measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy. * prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings. exclusion criteria: * histology of inflammatory carcinoma with no other measurable disease. patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease. * brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease. * prior treatment with 5-fluorouracil (5-fu) and 5-fu derivatives such as furtulon (5'-dfur), futraful/ sunfural (tegafur), uft/uft-e (tegafur/uracil), ts-1 (tegafur/gimeracil/oteracil) or mifurol (carmofur) in metastatic disease setting
open-label multicenter study to evaluate the efficacy of plx-pad for the treatment of covid-19

Conditions: COVID; ARDS

Summary: this clinical trial will examine if a new treatment of mesenchymal-like adherent stromal cells (called plx-pad) can help patients intubated and mechanically ventilated due to covid-19 to recover more quickly with less complications.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent, or with a legal representative who can provide informed consent. * male or non-pregnant female adult 18-85 years of age at time of enrollment. * laboratory-confirmed sars-cov-2 infection as determined by pcr, in any specimen up to 21 days prior to randomization. * meets definition of ards according to berlin criteria. key exclusion criteria: * body weight under 55 kg (121 lbs) * serum creatinine level of over 1.5 mg/dl at time of randomization. * total bilirubin ≥2 mg/dl at time of randomization. * known allergy to any of the following: dimethyl sulfoxide (dmso), human serum albumin, bovine serum albumin. * stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. * chronic obstructive pulmonary disease gold stage above ii.
efficacy and tolerability of human fsh versus recombinant fsh (follitropin alpha) in icsi.

Conditions: Infertility

Summary: purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous fsh preparations (fostimon® ibsa vs gonal-f® serono) when administered in patients undergoing icsi

this is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase iii) of two parallel groups, one receiving the test drug fsh (fostimon® , ibsa) and the other the reference drug fsh (gonal-f®, serono). the groups will be paired on the major prognostic criteria. in effect, a double blind trial is not really feasible since the drugs presentations are very different. however, in ivf, drugs are usually dispensed and/or injected by a nurse and therefor the investigator can be blind. moreover, the used preparations will contain the same amount of gonadotrophin units (75 iu), will be repackaged in anonymous boxes and the following sentence will be written in the patient information sheet: "you are required not to inform the investigator about the product's name". the randomisation is necessary to get groups as comparable as possible for all the other aspects. the multicentric design has the double interest of facilitating the patients' recruitment and of decreasing the biases related to attitudes in a specific centre.

Eligibility criteria:
inclusion criteria: women undergoing ovarian stimulation for intracytoplasmic sperm injection (icsi) with the following characteristics: \>/= 18 and \< 40 years old bmi between 19 and 30 kg/m2 less than 3 previous completed cycles basal fsh level less than 10 iu/l within the 6 months prior to the study exclusion criteria: age \ /= 40 years primary ovarian failure or women known as poor responders, i.e. requiring more than 225 iu of fsh as starting dose in previous treatment cycles or having less than 3 oocytes retrieved or with an oestradiol serum concentration \ 20 mm oocyte donation thawed embryos replacement patients affected by pathologies associated with any contraindication of being pregnant ascertained or presumptive hypersensitivity to the active principle and/or their ingredients abnormal bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias severe impairment of the renal and/or hepatic functions women deprived of their freedom by administrative or legal decision

Keywords: ovarian stimulation infertility icsi fsh
evaluating decisional regret among mothers

Conditions: Extreme Prematurity; Birth, Preterm; Pregnancy Preterm

Summary: the anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. the goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the us will be surveyed.


Eligibility criteria:
inclusion criteria: * mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe. * mothers who had a documented perinatal consult * greater than 18 years old exclusion criteria: * potential life limiting fetal diagnoses aside from prematurity and non-english primary language

Keywords: decisional regret comfort care palliative care infant resuscitation
cultural arts programme for older chinese

Conditions: Depressive Symptoms; Ageism; Older Adults; Psychosocial Intervention; Art

Summary: this study examines the effectiveness of an innovative cultural arts program in reducing depressive symptoms and age-related self-stigma among older chinese as compared to service as usual through a randomized waitlist controlled trial.

depressive symptoms are common among community-dwelling older people, and prevention and early detection can reduce the incidence of depressive disorders. however, internalized ageism and stigma of mental illness may disempower older people and impede help-seeking behaviors among those at risk of depression. nonpharmacological interventions may reduce stigma, and among different approaches, arts-based programs are gaining attention because arts are deemed enjoyable, stigma-free, and conducive to mental health. this study adopts a waitlist-controlled trial and examines the effectiveness of an innovative cultural art programme to combat internalised ageism and reduce depressive symptoms compared with service as usual. community-dwelling older adults (age 60 years and over) at risk for depression will be recruited and randomised to receive cultural arts (experimental group) or service as usual (waitlist control group). assessments will be administered by trained researcher(s) at baseline (t0), and completion of the 9-session intervention (t1). effectiveness analyses will be based on changes in assessments at different time points between intervention and control groups.

Eligibility criteria:
inclusion criteria: * aged 60 years or above; * at risk for depression, i.e., patient health questionnaire (phq-9) score under 10; or * having at least one risk factor of depression, including frequent loneliness, lack of social interaction, lack of meaningful/enjoyable activities, chronic pain, more than four chronic diseases, or bereavement. exclusion criteria: * known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, parkinson's disease, or dementia; * illiterate; * physically frail; or * significant suicidal risk.
proton and carbon ion radiotherapy for cervical cancer

Conditions: Cervical Cancer

Summary: the aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (pcrt) for cervical cancer.

to retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. the acute and late toxicities, overall survival (os), local control rate (lc), progression-free survival (pfs) and distant metastasis-free survival (dmfs) were analyzed.

Eligibility criteria:
inclusion criteria: 1. . histologically diagnosis of squamous cell carcinoma of the cervix; 2. . international federation of gynecology and obstetrics (figo) stage (2014) ib2 - iiib, without rectum invasion; or figo stage ia - ib1, who refused surgery or were contraindication for surgery due to comorbidity diseases; 3. . received proton and carbon ion radiotherapy (pcrt) with or without chemotherapy for curative intention; 4. . follow-up data available. exclusion criteria: 1. a previous history of other malignancy; 2. squamous cell carcinoma of the cervix patients who had received surgery; 3. rectum was invaded.

Keywords: proton and carbon ion radiotherapy
novel exercises to facilitate recovery of supination and pronation for distal radius fractures managed with a volar plate

Conditions: Distal Radius Fracture

Summary: the primary objective of this study is to evaluate the influence of elbow position on achieving forearm supination and pronation and wrist rom postoperatively. it is anticipated the results will show recovery of functional motion in a shorter period of time (27 days average). as for the secondary objective of the study, it is anticipated there will be limited pain and cost-containment. these data elements will serve as secondary factors to evaluate.

the current standard of care for forearm range of motion exercises is to position the elbow in 90 degrees of flexion at the side of the body for both supination and pronation.5,6 this study will compare standard of care forearm rotation exercises to exercising with the elbow in extension to facilitate pronation and exercising with the elbow in full flexion to facilitate supination in patients who have undergone surgery with a volar plate for distal radius fractures. we hypothesize that forearm motion will be achieved in a shorter number of days and with a greater arc of motion when the exercises are done in extremes of elbow flexion and extension. this will be a prospective, unblinded, randomized study to evaluate forearm range of motion across two groups: control group: subjects will be instructed to exercise the forearm with the elbow positioned by their side, in 90° of flexion. test group: subjects will be instructed to exercise the forearm with their elbow fully flexed to achieve supination and the elbow extended to achieve pronation. randomization will occur post-operatively after the patient has signed consent to participate. randomization will occur through a computerized random allocation and groups will be assigned by the clinical research manager or designee.

Eligibility criteria:
inclusion criteria: * • subjects 18 years of age and older * subjects with distal radius fractures with a volar plate * subjects attending therapy at the indiana hand to shoulder center or affiliated satellites. * subjects that attend the initial therapy visit between 5 and 10 days postoperative and begin the home therapy program (patient handout) exclusion criteria: * • subjects under the age of 18 * additional surgical procedures or other factors preventing early active rom of the forearm and/or wrist within the initial 10 days following surgery * pre-existing medical conditions or injuries with resultant limitation in elbow, forearm or wrist rom, patient-reported limited function, or limited ability to comply with home program (cognitive skills). * while undergoing therapy the initial 6 weeks, subjects provided with custom-fabricated or pre-fabricated devices, orthoses, or braces for the specific purpose of passively improving rom of the elbow, forearm or wrist during the initial 6 weeks of therapy.
efficacy and safety study of oral solithromycin compared to intramuscular ceftriaxone plus oral azithromycin in the treatment of patients with gonorrhea

Conditions: Uncomplicated Urogenital Gonorrhea

Summary: this study will compare a single dose of oral solithromycin to the standard of care (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with urogenital gonorrhea. a completed open-label phase 2 study with single doses of solithromycin resulted in 100% microbiological eradication in male and female patients with uncomplicated urogenital gonorrhea.


Eligibility criteria:
inclusion criteria: * at least 1 of the following: 1. untreated male with urethral gonorrhea as determined by a screening laboratory test (either naat or culture) for n. gonorrhoeae within 2 weeks prior to study drug administration. 2. untreated female with cervical gonorrhea as determined by a screening laboratory test (either naat or culture) for n. gonorrhoeae within 2 weeks prior to study drug administration. 3. urethral (male) or cervical (female) gram stain demonstrating gram-negative intracellular diplococci and leukocytes. * the patient must be willing to abstain from anal, oral, and vaginal sexual intercourse or use condoms for all of these until study completion. * females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment. exclusion criteria: * confirmed or suspected complicated or systemic gonococcal infections such as pelvic inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated gonococcal infection. * individuals who have already received antibiotic treatment for their gonorrhea. * use of systemic or intravaginal antibiotics within 7 days prior to study drug administration. * women who are pregnant or nursing. * men with suspected or confirmed rectal gonorrhea and symptoms of proctitis. * history of significant intolerance or allergy to macrolide or cephalosporin antibiotics.

Keywords: gonorrhea chlamydia solithromycin
risk factors for allo-immunization in sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell patients have a high prevalence of alloimmunization. this high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly caucasian donor population and the sickle cell patients of african origin. genetic and environmental risk factors have also been described. the main risk factors that have been shown in retrospective or cross-sectional studies are some hla alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (ced) transfused, the number of transfusion episodes, the age of the ceds, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.there is also evidence of an impaired th response but the underlying immunological mechanism is not fully understood. the aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization in pediatric and adult patients with sickle cell disease (with a ss genotype) who are being followed at queen fabiola university children's hospital (huderf) and at the chu brugmann hospital. the identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.


Eligibility criteria:
inclusion criteria: - sickle cell disease patients (hbss genotype) with a history of blood transfusions within the chu brugmann and the queen fabiola university hospitals. exclusion criteria: - none

Keywords: sickle cell disease allo-immunization
objective measures in implantable hearing devices

Conditions: Mixed Hearing Loss

Summary: the purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

a new technique, called direct acoustic cochlear stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. a piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named dacs. unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. in this project, the objective auditory evoked potentials, like auditory steady-state response (assr), will be used to measure the efficacy of this method of inner ear stimulation. this highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

Eligibility criteria:
inclusion criteria: * adults * mixed hearing loss exclusion criteria: * children

Keywords: hearing thresholds coupling to the inner ear
evaluation of intravenous levosimendan efficacy in the short term treatment of decompensated chronic heart failure.

Conditions: Heart Failure, Congestive

Summary: the purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.


Eligibility criteria:
inclusion criteria: * a written informed consent must be obtained for hospitalized male or female patients over 18 years old of age. * the eligible patients must be diagnosed with worsening heart failure as evidenced by dyspnea at rest, poor ejection fraction and have been treated with iv diuretics. * it is allowable for the patients to be treated with iv inotropes and vasodilators. exclusion criteria: the following criteria would exclude the patient from study: * invasive cardiac procedure (e.g. cardiac surgery, lvad, cardioversion, cardiac re-synchronization), * rhythm disorders (e.g. earlier torsades de pointes, increased heart rate), * severe ventricular outflow obstruction, * angina, * hypotension, * uncorrected hypokalemia, * cns (e.g. stroke, tia), * respiratory (e.g. copd, intubated patients, oral, * intravenous or intramuscular steroids), * renal insufficiency (e.g. increased serum creatinine, dialysis), * hepatic impairment (e.g. significant increase in liver enzymes), * decompensation from active infection and acute bleeding (e.g. severe anemia). * female patients of child bearing potential must have a negative pregnancy test and use adequate contraceptive precautions. * also excluded is the use of amrinone and milrinone prior to randomization, a history of hypersensitivity to levosimendan or any of the excipients and previous participation in a clinical trial with any experimental treatment within the last 30 days.

Keywords: decompensated chronic heart failure
hemorrhagic mi prediction score model

Conditions: Acute Myocardial Infarction

Summary: developing a prediction score model for predicting the likelihood of hemorrhagic mi


Eligibility criteria:
inclusion criteria: * age \> 18 yrs * index mi * primary pci exclusion criteria: * history of prior myocardial infarction, * thrombolysis before pci * contraindication to cardiac mri

Keywords: acute myocardial infarction prediction score machine learning hemorrhagic mi
visual feedback of tongue by ultrasound echography for speech trouble rehabilitation

Conditions: Speech Disorders

Summary: speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.). the present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation. two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage. the principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback. the progress will be regularly measured by means of standard batteries of speech articulation tests.


Eligibility criteria:
inclusion criteria: * articulatory troubles needing speech therapy * french mother tongue * adult patients \[18 ≥ age \< 80 years\] who underwent buccopharyngeal surgery after cancer diagnostic or children \[8 ≥ age \< 18 years\] suffering from central nervous system damage exclusion criteria: * incapacity to easily understand the speech therapist instructions * people protected by the law * people deprived from freedom by judiciary decision * potential allergy to the water-based conducting gel used to ensure good skin - probe contact * overweight if large fatty mass under chin * major edema under chin limiting echogenicity * non corrected vision or hearing problems * for the adults: central or peripheral neural damage * history of ear, nose, and throat surgery or radiotherapy * for the adults: isolated articulatory trouble, former articulatory trouble not treated, disfluency * massive orofacial dyspraxia * posture trouble * motor problem in upper limbs

Keywords: speech disorders speech therapy visual feedback buccopharyngeal surgery central nervous system damage