Kornimate/medical-research-clean huggingface dataset:
impact of functional insulinotherapy on blood glucose variability indicators in patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients. so, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes. this trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.

this is a prospective, open, non-controlled study with an individual benefit for the participant. this study is designed to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients. all 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class, taught by 2 nurses, 2 dieticians and 2 physicians. the participants were recruited among metabolically stable patients who had already been prescribed functional insulinotherapy. to assess the impact of functional insulinotherapy on blood glucose variability, hba1c will be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators: mage, adrr, li and lbgi. this trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress. therefore, a measure of insulin antibodies by elisa at baseline. at baseline and 6 months, lte4, txb2, 8-iso-pgf2alpha, anti-transglutaminase and anti-endomysium antibodies will also be assessed.

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class * social security membership or benefit from social security * informed consent, with a signed and approved form exclusion criteria: * underage patient, major patient under guardianship or protected by the law * pregnant, parturient or breastfeeding woman * person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the law * antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy

Keywords: type 1 diabetes functional insulinotherapy
functional exercise in virtual environment for persons with multiple sclerosis or parkinson's disease

Conditions: Parkinson Disease; Multiple Sclerosis

Summary: the aim of the study is to optimise the hand dexterity exercising program in virtual reality (vr) for patients with multiple sclerosis and parkinson's disease. little research has been published on this topic, but the preliminary results are promising. different levels of difficulty of a vr game will be tested. the patients will be assessed using neuropsychological tests of executive functions, visuospatial abilities, mental speed, flexibility and motor speed. functional ability, coordination and cognitive abilities will also be assessed.

each patient meeting the inclusion criteria will be randomised to one of the four groups (i.e., 10cubes game difficulty level). the patients will perform five exergaming sessions, each session lasting for 1 hour, on five consecutive working days within the period of two weeks. the 10cubes task requires that all 10 cubes are moved within 2 minutes. each patient will perform the task 5 times in succession with 1-2 minute breaks. the patients will be assessed using the box \& blocks test, frontal assessment battery (fab), delis-kaplan executive function system (d-kefs) and judgment of line orientation (jlo) before the first session and after the last session. in addition, the patients will fill in the intrinsic motivation inventory (imi) after each session. based on statistical sample size calculations, the study plan is to include 80 patients with parkinson's disease and 12 patients with multiple sclerosis randomising them separately, so that the groups will be balanced in terms of size and diagnosis.

Eligibility criteria:
inclusion criteria: * diagnose of parkinson's disease or multiple sclerosis; * mini mental state examination score above 24; * preserved upper limb function; * for parkinson's disease patients hoehn and yahr scale score between 2 and 3. exclusion criteria: * any communicable disease; * severe vision impairment.

Keywords: exergaming virtual reality neuropsychological tests motivation
four conversations rct

Conditions: Breast Cancer

Summary: the purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (sdm) and preparedness around end of life (eol) planning through participation in reimagine's online four conversations™ program. the goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.


Eligibility criteria:
inclusion criteria: * diagnosed with metastatic breast cancer (mbc), caregiver to patient with mbc who is enrolled in this study, or mbc provider * age ≥ 18 years * internet access through a computer, laptop, tablet, or other mobile device * able/willing to have an online interaction with a reimagine pillar guide * providing informed consent * able to read/write english exclusion criteria: - none

Keywords: breast cancer stage 4 metastatic hospice palliative care end of life advance directive oncology caregiver provider coping support online
randomized, controlled, double blind trial of eszopiclone for insomnia associated with schizophrenia

Conditions: Insomnia; Schizophrenia; Schizoaffective Disorder; Sleep Disorders

Summary: the major goal of this project is to investigate established insomnia treatments in a schizophrenia population to see if the improved sleep leads to overall better quality of life. in addition, we hypothesize that the insomnia treatment may also lead to observed improvements in other symptoms associated with schizophrenia such as cognitive impairments, obesity, and negative symptoms.

the primary aim of this study is to investigate the clinical efficacy of eszopiclone for the treatment of schizophrenia-related insomnia over 8 weeks. a two-week, single-blind placebo phase followed the double-blind phase to evaluate rebound and withdrawal effects after abrupt discontinuation.

Eligibility criteria:
inclusion criteria: * be between the ages of 18 to 64 * meet dsm-iv criteria for schizophrenia or schizoaffective disorder * sleep difficulties at least 2x per week in the preceding month * be on a stable dose of antipsychotic medication * symptomatically stable in the last 2 months * english speaking. exclusion criteria: * meet criteria for current alcohol or other substance dependence * a history of dementia, mental retardation or other neurological disorder * not capable of giving informed consent for participation in this study. * ongoing pregnancy * known sensitivity to zopiclone. * insomnia associated with medical disorders likely to impair sleep. * use of any medication that affects sleep/wake function (other than antipsychotic medication), within the past 2 weeks or within a time period that is less than 7 half-lives since last use of the medication. * lack of sleep benefit from previous adequate eszopiclone treatment * history of clinically significant hepatic impairment. * subject is taking a potent cytochrome p450 3a4 inhibitor medication (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) and is unwilling or it is clinically contraindicated to stop the medication.
elvn-001 for the treatment of chronic myeloid leukemia with and without t315i mutation in japanese participants

Conditions: CML (Chronic Myelogenous Leukemia); Chronic Phase CML

Summary: the purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of elvn-001 in japanese patients with chronic phase chronic myeloid leukemia with and without t315i mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior tkis.

this first-in-human trial with elvn-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (rdes) of single agent elvn-001 in chronic phase cml with or without t315i mutations. the safety, tolerability and pharmacokinetic profile of elvn-001 will be assessed together with an evaluation of changes in bcr-abl1 transcript. an understanding of the safety profile, pk and preliminary evidence of anti-cml activity will be used to inform future development of elvn-001 in adults with cml. by virtue of its predicted pharmacological profile elvn-001 has the potential to be tolerable and achieve a deep molecular response in patients with cml with or without t315i mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior tkis.

Eligibility criteria:
inclusion criteria: * bcr::abl1 positive cp-cml that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior tkis. * ecog performance status of 0 to 2. * the patient was born in japan and both parents and grandparents are japanese. * adequate hematologic, hepatic and renal function. * prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of elvn-001. exclusion criteria: * treatment with anti-cancer or anti-cml therapy within 7 days or 5 half-lives, whichever is longer. * history of acute tyrosine kinase inhibitor (tki)-related pancreatitis within 6 months of study entry. active chronic pancreatitis, or pancreatic disease due to any cause. * qtc \>470 ms.

Keywords: cml tyrosine kinase inhibitor t315i t315i mutant bcr-abl
fixation insitu versus removal for midfoot lisfranc injuries

Conditions: Closed Fracture Dislocation, Tarsometatarsal Joint; Open Fracture Dislocation, Tarsometatarsal Joint

Summary: this study is a multicenter prospective randomized control trial comparing hardware retention (hr) to removal of hardware (rh).

eligible patients will be randomized to one of two treatment arms: hardware removal at 6 months or hardware retention for a minimum of 2 years. consenting patients having previously undergone open reduction and internal fixation of lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (rh) or hardware retention (hr). outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Eligibility criteria:
inclusion criteria: * subject has lisfranc injury that was treated within 28 days of injury. * subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation. * the patient must be medically fit for anesthesia * subject is willing and able to provide written informed consent for trial participation * subject is willing and able to comply with the study protocol including return for all follow-up evaluations * subject may have a bony, ligamentous, or combined lisfranc injury * demonstrated instability of the lisfranc complex on static, stress view or ct radiography. * associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon * adequate reduction to within 1mm of lisfranc complex at time of fixation * hardware across the midfoot (tarsal-metatarsal joints 1-3) exclusion criteria: * subject has a significant pre-existing foot injury * subject has a delay in initial treatment greater than 28 days from time of injury * subject has an active infection in the area of surgical approach requiring surgical debridement * subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury) * subject has a history of rheumatoid arthritis, diabetes, fibrous dysplasia, chronic renal failure, paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the lisfranc complex * subject has a high risk of death from surgery (asa physical status class v) * subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.) * subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires * subject is pregnant * there has been loss of fixation or reduction prior to enrollment * previous corrective foot surgery * associated fracture of calcaneus, talus, or tibial plafond. * pathologic fracture * loss of fixation or reduction prior to enrollment
high flow nasal cannula (hfnc) initiation flow rate study

Conditions: Bronchiolitis

Summary: the investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial hfnc flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. this feasibility study is projected over december 2020 to april 2023. the study is consisted of 3 arms, comparing hfnc therapy at 1 l/kg/min, 1.5 l/kg/min, and 2 l/kg/min (20 l/min max). moderate to severe bronchiolitis is defined clinician's assessment for the need for icu level of care. the primary outcome is treatment response to hfnc therapy defined by rdai/respiratory assessment change score (racs) ≥ 4 at 4 hours of therapy. secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of hfnc therapy, duration of hfnc and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and picu length of stay (los), time to treatment failure, and adverse events.


Eligibility criteria:
inclusion criteria: * patients less than 12 months of age * clinical signs of moderate to severe bronchiolitis defined by american academy of pediatrics * requires icu level of care by clinicians' discretion * requiring hfnc support exclusion criteria: * infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (nippv) or invasive ventilation * congenital heart disease, * immunocompromised state * upper airway obstruction * chronic lung disease * bronchopulmonary dysplasia, * home oxygen therapy requirement * acute trauma patients * baseline craniofacial malformations * admitted to the neonatal or cardiac icus * patients who are admitted to the floor

Keywords: bronchiolitis hfnc high flow nasal cannula infants
biomarkers in patients with anemia-induced thrombocytopenic bleeding

Conditions: Acute Leukemia; Acute Myeloid Leukemia (AML); Acute Lymphocytic Leukaemia

Summary: this pilot study aims to gather preliminary evidence on how different hemoglobin levels impact blood biomarkers related to bleeding. the feasibility of conducting a future larger clinical trial will also be assessed. red blood cell transfusions are part of the standard of care for patients with leukemia. this study evaluates two transfusion strategies: one that maintains hemoglobin levels above the standard-of-care threshold, reflecting current routine practice; and another that maintains hemoglobin levels above 110 g/l, which is closer to the normal hemoglobin range. the normal hemoglobin range is 120-160 g/l for females and 140-180 g/l for males. raising hemoglobin levels closer to normal values may reduce bleeding risk.


Eligibility criteria:
inclusion criteria: 1. ≥18 years old. 2. inpatient 3. diagnosis of acute myeloid leukemia or acute lymphocytic leukemia. 4. less than 5 days have elapsed since the start of induction chemotherapy treatment. 5. hemoglobin at enrolment is under 130 g/l. exclusion criteria: 1. failure to provide informed consent. 2. unwilling to receive blood transfusions. 3. life expectancy \<72 hours. 4. undergoing palliative chemotherapy. 5. requires specialized blood products (e.g., antigen-matched, irradiation, etc.). 6. diagnosis of acute promyelocytic leukemia. 7. diagnosis of hyperleukocytosis (a white blood cell count exceeding 100 × 10\^9/l). 8. diagnosed with coagulopathies or ongoing treatment with therapeutic anticoagulants, aspirin or nonsteroidal anti-inflammatory drugs (history of inherited or acquired coagulation disorder, known hemolytic disease, inr \> 1.5) 9. evidence of iron overload (ferritin \>800 ng/ml, transferrin saturation \>80%) .

Keywords: transfusion red blood cells hemoglobin level bleeding
resect and discard extension to fice of nice classification

Conditions: Hyperplastic Polyps; Adenomatous Polyps

Summary: the purpose of this prospective, non-interventional study is to validate the narrow band imaging international colorectal endoscopic (nice) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using fuji intelligent color enhancement (fice) technology with high-definition without optical magnification.

1. in order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. patients with at least one histologically verified \<10 mm polyp will be included. a short video-clip (around 15-20 seconds) of each polyp both at white-light and fice-light will be recorded and stored in an anonymized database. 2. once the video-library is completed, each of 7 experts will independently review all the cases. for each case, any observer will assess each of the three nice criteria (colour/vascularization/surface), the degree of confidence (low/high), and classify the lesion as neoplastic or non-neoplastic. the primary outcomes are the accuracy of fice technology with high-definition and without magnification, when adopting nice classification, to differentiate between hyperplastic and adenomatous lesions, and the inter-observer agreement in such differentiation. secondary end-points are to assess at multivariate measure the role of any individual criteria of nice classification in the discrimination between the two histotypes, and possible adaptations of nice classification in order to be applied with fice.

Eligibility criteria:
inclusion criteria: 1. the patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. the patient is at satisfactory risk to undergo abdominal surgery; 3. the patient must understand and provide written consent for the procedure. exclusion criteria: 1. patients with inflammatory bowel disease; 2. patients with a personal history of polyposis syndrome; 3. patients with diverticulitis or toxic megacolon; 4. patients with a history of radiation therapy to abdomen or pelvis. 5. patients with a history of severe cardiovascular, pulmonary, liver or renal disease; 6. personal history of coagulation disorders or use of anticoagulants 7. patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
impact of light on mood

Conditions: Depression

Summary: the investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.


Eligibility criteria:
inclusion criteria: * aged 18-60 * mild depressive symptomatology exclusion criteria: * no depressive symptomatology * severe depressive symptomatology * active or unstable medical condition * diabetes
computer-based social skills training for autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the primary objective of this study is to evaluate changes in subject performance on social skills assessments after engaging in a gaze-controlled video game that leverages aba principles of learning, in comparison to an alternative game. the secondary objectives of this study are to evaluate changes in subject gaze patterns during social skills assessments after engaging in the video game, including in comparison to an alternative game and to evaluate possible correlations in changes in social skills assessments with changes in subject game play performance.


Eligibility criteria:
inclusion criteria: 1. ages 4-14. 2. meets diagnostic criteria for asd. 3. estimated intelligence standard score of at least 40 (can be substituted for a receptive language score such as ppvt or use of the differential ability scales, 2nd edition (das-ii)). 4. parent reports difficulty with at least one of two social skills (via modified questions from the social responsiveness scale) 5. english as the child's primary/first language (key measures used in the study do not have alternate language versions). 6. attains a score equal to or less than 75% correct on the ekman 60 faces test 7. the parent who completes the questionnaires needs to be proficient in english. 8. has successfully played a video game using a microsoft xbox game controller, sony playstation game controller, or other comparable game controller. 9. parental/guardian permission (informed consent) and if appropriate, child assent. 10. wi-fi internet connection at subject's home/school/therapy center/research organization available for use by study laptop computer. exclusion criteria: 1. history of seizures. 2. history of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning. 3. certain visual, auditory, dsm 5, or conduct disorders (see below). 4. a visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes. 5. use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks. 6. auditory impairment (that cannot be corrected by a hearing aid) that would significantly impede the valid collection of test measures. 7. profound intellectual disability or sensory-motor difficulties that would preclude valid use of diagnostic instruments and/or use of a computer or mobile computing device. 8. a dsm 5 disorder or other psychiatric symptoms that would interfere with the participant's ability to participate in the study (e.g., active psychosis), per parent report. 9. history of one or more psychiatric hospitalizations. 10. presence of significant symptoms of a conduct disorder.