Kornimate/medical-research-clean huggingface dataset:
maintaining implementation through dynamic adaptations (midas) suicide prevention 2.0 clinical telehealth

Conditions: Suicidal Self-directed Violence; Suicidal Preparatory Behavior

Summary: scientific advances are constantly leading to better treatments. however, it is quite challenging for healthcare systems, including va, to ask very busy providers to change the way they practice. the midas queri program helps providers improve the way they treat va patients. this project will focus on increasing referrals to the suicide prevention 2.0 clinical telehealth (sp 2.0) initiative through the delivery of academic detailing and leap (a team-based quality improvement program). sp 2.0 provides accessible, evidence-based suicide prevention treatment to all veterans with a history of suicidal self-directed violence or preparatory behaviors in the past 12 months.

sustained integration of evidence-based practices (ebps) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. the veterans affairs (va) maintaining implementation through dynamic adaptations (midas) quality enhancement research initiative (queri) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of ebps. the current project focuses on increasing referrals to the suicide prevention 2.0 clinical telehealth (sp 2.0) initiative. the investigators have recruited 4 sites for this non-randomized intervention project. sites have agreed to participate in pre-implementation interviews to gather information regarding barriers and facilitators to use of the sp 2.0 initiative. sites will then be provided with tailored feedback regarding interview findings and potential use of academic detailing and leap to address these. sites may then select to receive either academic detailing and/or leap which will be provided by midas queri. primary outcome will be rate of sp 2.0 referral adjusted for pre-intervention rate.

Eligibility criteria:
inclusion criteria: note- the investigators are recruiting clinics/medical centers - not individual patients. prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the ebp: * 1) a team leader or champion * 2) an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation * 3) readily accessible data to measure process and impact of the implementation and use of the ebp * 4) availability of required resources exclusion criteria: * n/a

Keywords: implementation science implementation strategy suicide prevention academic detailing quality improvement
influence of risk factors on isr and nonintervened lesions

Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease

Summary: this study enrolled patients who used to received pci therapy with nonintervened coronary lesions. baseline characteristics and laboratory testing were collected to find out the risk factor difference between isr and nonintervened coronary lesions.


Eligibility criteria:
inclusion criteria: * (1) pci therapy with drug-coated stents was performed in the past, and nonintervened coronary lesion remained except in the target vessel. (2) cag was performed again due to re-examination, recurrent angina symptoms, positive treadmill exercise test or coronary cta showing moderate to severe vessel diameter stenosis. (3) long-term regular oral administration of statins and lipid monitoring were conducted after pci. exclusion criteria: * patients with a history of cabg, renal replacement therapy, autoimmune disease, and malignancy

Keywords: isr, nonintervened coronary lesions, risk factor
effectiveness of hortitherapy on the immediate well-being of elderly people with alzheimer's disease or related in day care

Conditions: Horticultural Therapy

Summary: currently, there are an estimated 47 million people with dementia worldwide, with approximately 10 million new cases diagnosed each year. this figure is expected to triple to 130 million in 2050. in france, the number of dementia cases is estimated at 754,000 and could reach 1,813,000 in 2050. in a recent literature review, researchers highlighted the many benefits of horticultural therapy and garden environments for people with alzheimer's or cognitive disorders. they include: alleviating pain, improving attention, decreasing stress, relieving agitation, decreasing the use of medications, such as antipsychotics, as well as reducing falls. gardening offers a non-pharmacological approach to achieving these goals and could improve the quality of life for people with alzheimer's disease or another dementia. as part of a care solution, support services that include social activities, such as gardening, reduce the need for more intrusive and expensive care solutions. the objective of this research is to evaluate the impact of horticultural

this research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is prospective, multicenter and non-randomized. the study will take place with users of the lépine versailles day care centre, the la porte verte hospital and the les magnolias geriatric center, living with cognitive disorders. for the purposes of this study, understanding the instructions is required. the people welcomed will participate in their usual day supervised by the day reception team. part of the group having agreed to participate in the study will carry out the horticultural workshop while the other group will benefit from the workshop usually offered. the study will be done with 52 users with the participation of a supervisor to animate the workshops of the different groups. each site will have a workshop that will take place in the morning from 11 a.m. to 12 p.m. and one in the afternoon from 2:30 p.m. to 3:30 p.m. this will make it possible to compare the well-being of users according to the time of the workshop.

Eligibility criteria:
inclusion criteria: * patient having signed an informed and written consent, * patient aged over 60, * patient with alzheimer's or related disease, * patient benefiting from day care, * patient under guardianship or curatorship. exclusion criteria: * patient in period of adaptation in day care, * patient in temporary care at day care, * patient having participated in less than 4 horticultural workshops during the cycle, * patient with severe asthma and/or an allergy that does not allow workshops to be carried out, * patient with major behavioral problems that make it impossible to carry out the workshops.
bacterial vaginosis carriage in early pregnancy and preterm delivery in martinique, f.w.i

Conditions: Bacterial Vaginosis

Summary: preterm delivery is a public health priority in martinique, a french oversees territory located in the caribbean, with a rate of 10,5% substantially higher than in continental france (7,5%). bacterial vaginosis is an imbalance of vaginal flora known to be associated with preterm delivery risk. studies driven in the united states have pointed out that 50% of the excess in preterm birth rate observed in afro-american population compared to caucasian population may be attributable to infection. bacterial vaginosis appears much more prevalent in our population than in continental france (approximatively 30% versus 7%) and may constitute an explanation to the discrepancy in preterm delivery rate.

bacterial vaginosis during pregnancy is considered as a risk factor for preterm birth since the 1990's. a meta-analysis realized in 2003 found an odds ratio of 2.4 for preterm delivery among women with bacterial vaginosis carriage, culminating at 7.5 when carriage before 17 weeks gestation was considered. preterm delivery is a pregnancy complication known to be more prevalent among patients of african descent. various hypothesis have been tested to account for this observed discrepancy and several authors consider that up to 50% of the difference in preterm delivery rate between afro-american and caucasians may have and infectious origin, with up to 30% attributable to a very different bacterial vaginosis carriage among patients of various ethnic origin. several factors may interfere in the link observed between bacterial vaginosis and preterm delivery, which are also unevenly distributed among women of different ethnic origin. exposure to stress, low socio-economic status, single marital status or low access to prenatal care are among those factors. thus analyzing a relation between bacterial vaginosis and preterm delivery mandates to control for such factors. the present study will proceed to a vaginal sampling before 17 gestational age (ga) to diagnose a bacterial vaginosis through the nugent score which is the standard diagnostic method for this pathology. at the same time, a written survey concerning stressful events in the past 12 months is submitted to volunteer patients in order to use the social readjustment rating scale by holmes and rahe and to account for the role of stress as a potential confounding factor. socio-demographic data, obstetrical history and complications during pregnancy were also recorded and patients followed-up prospectively until delivery. caregivers were blinded to the results of initial vaginal sampling. no alteration of the normal pregnancy follow-up was required by the study design.

Eligibility criteria:
inclusion criteria: * all women followed-up since the beginning of pregnancy in the study center and supposed to deliver in this same center exclusion criteria: * previous preterm delivery, * previous late abortion, * multiple pregnancy, * cervical cerclage before inclusion

Keywords: bacterial vaginosis, preterm delivery, martinique, stress
surgical management of multiple mucoepidermoid carcinoma and adenocarcinoma

Conditions: Adenocarcinoma; Mucoepidermoid Carcinoma

Summary: a case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded

this case series presents mucoepidermoid carcinoma. palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. post-operative radiotherapy was recommended by pathologist due to evident perineural spread. the patient is tumor free after one year follow-up. clinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. each tumor should be diagnosed and treated separately according to its nature and extension.

Eligibility criteria:
inclusion criteria: * patients suffering from salivary gland tumor exclusion criteria: * healthy patients with no tumors

Keywords: salivary gland tumor
phase 1 study of bcd-245 in subjects with neuroblastoma

Conditions: Neuroblastoma

Summary: the aim of the study is to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of bcd-245 after its single and multiple intravenous infusions at escalating doses in subjects with relapsed/refractory neuroblastoma.

the study includes 2 stages: 1) data collection and safety analysis for the first four subjects 12 years of age and older from cohort 1 2) data collection and analysis of safety, pharmacokinetics, pharmacodynamics and immunogenicity in all cohorts (cohorts 1-4). the design of this phase i study is based on standard 3 + 3 design approaches. cohort 1 includes 4 subjects aged 12 years old and older, and 2 subjects aged 3 years old and older. cohorts 2-4 include 3-6 subjects aged 3 years and older.

Eligibility criteria:
inclusion criteria: * age 3 years and older (12 years and older for the first four subjects) at the time of signing the informed consent form * established diagnosis of neuroblastoma (confirmed by the study site laboratory where the subject will be treated) based on: a) histological examination of the tumor tissue (with or without immunohistochemistry) or b) presence of typical tumor agglomerates in the bone marrow and/or meta-iodobenzylguanidine-accumulating focus (foci) and an increase in the level of catecholamine metabolites in serum and/or urine * relapsed or refractory neuroblastoma resistant to the anti-relapse therapy adopted at the study site * satisfactory performance status (\>70 on the lansky or karnofsky scale) * life expectancy \>8 weeks exclusion criteria: * indications for radiation therapy, surgical intervention for the primary disease at screening * isolated cns relapse of neuroblastoma * planned use of any anticancer drugs concomitantly with bcd-245 in this clinical trial * the need for continuous use of anticonvulsants * clinically significant neurological deficit or grade \>2 peripheral neuropathy (ctcae 5.0) * the need or probable need for systemic continuous use of glucocorticosteroids or other immunosuppressive drugs * signs of respiratory distress (dyspnea at rest and oxygen saturation \<94% without oxygen supplementation) * any severe organ dysfunction (\> ctcae 5.0 severity grade 2) at screening, except for hematological abnormalities. * body weight less than 10 kg. * subject receiving anti-gd2 monoclonal antibody therapy within 6 weeks or less prior to intended study drug infusion
n-terminal pro-brain natriuretic peptide hormone and persistent pulmonary hypertension

Conditions: Persistent Pulmonary Hypertension of Newborn

Summary: babies who are suspected of having persistent pulmonary hypertension (pphn) will be included in this study. pphn is a condition in which the blood is restricted from flowing to the lungs in a normal way making it hard for babies to breath and placing strain on the heart. this study will observe whether certain hormones that measure stress (n-terminal pro-brain natriuretic peptide) can help determine how well a baby will do when they have pphn.

pphn occurs in infant \> or = 34 weeks gestation and is characterized by an elevation in pulmonary vascular resistance (pvr) and right-to-left shunting of the blood at the atrial, ductal, and pulmonary levels, leading to hypoxemia. management of these infants is complex (and the clinical course) is often difficult to predict. brain natriuretic peptide (bnp) is a cardiac hormone that is secreted from cardiac myocytes and cardiac fibroblasts. upon activation, the prohormone is cleaved into a biologically active bnp and an inactive n-terminal probnp (nt-probnp). bnp and nt-probnp levels are increasingly being used for diagnostic purpose in adults and have been correlated to adult pulmonary hypertension. multiples studies have been performed to determine normal values for nt-probnp in the pediatric population. one study measured nt-probnp levels in umbilical cord blood during the second trimester and at delivery of uncomplicated pregnancies and determined normal reference values of nt-probnp. it is thought that nt-probnp has potential for use in term infants with pphn. the objective of this research is to correlate nt-probnp levels to left ventricular dysfunction in term infants with pphn. secondarily, we want to assess the possible use of nt-probnp to predict response to inhaled nitric oxide and the ability to successfully wean off inhaled nitric oxide.

Eligibility criteria:
inclusion criteria: * \>/= 34 weeks gestation at birth * clinical diagnosis of pphn exclusion criteria: * newborns with evidence of structural heart disease, congenital anomalies and prior use of inhaled nitric oxide.

Keywords: persistent pulmonary hypertension n-terminal pro brain natriuretic peptide
eating window and sleep disorders on glycemic control, cardiovascular risk, and weight loss

Conditions: Type 2 Diabetes Mellitus (T2DM); Hypertension; Obesity and Type 2 Diabetes; Cardiovascular Diseases

Summary: this project aims to offer a quantitative and qualitative nutritional approach, along with educational nutritional guidelines for participants with non-communicable chronic diseases. the main goals are: 1- regularization of eating habits and windows; 2- modulation of biochemical, anthropometric, and cardiovascular parameters; 3- increase in knowledge about healthy eating. in this way, participants will undergo a complete nutritional assessment, comprising anthropometry, biochemistry, clinical, and dietary evaluations.

the study will be conducted at the endocrinology and hypertension clinic of the são josé do rio preto medical school from 2025 to 2027, aiming to collect data for a thorough analysis of the participants. the study participants will be randomly assigned to 2 groups (intervention 1 and intervention 2). participants in the first group will follow a daytime eating window (7 am - 7 pm). participants in the second group will follow a nighttime eating window (12 pm - 12 am). nutritional consultations will be individual and will occur once every 3 months until the conclusion of the study, according to the clinic's scheduling availability. the average duration of each session will be approximately 1 hour per participant. all participants will be reminded of their appointments via phone/whatsapp.

Eligibility criteria:
inclusion criteria: * age: adults \>18 years \< 80 years; diagnosis of obesity, diabetes, and hypertension; gender: male and female; availability to attend quarterly meetings over a period of 18 months; sedentary. exclusion criteria: * difficulties in responding to the requested instruments; impediments to regular attendance in data collection; no diagnosis of obesity, diabetes, and hypertension; use of insulin therapy, sodium-glucose cotransporter-2 (sglt-2) inhibitors, and glucagon-like peptide-1 (glp-1) analogs; chronic kidney disease patients; normal weight or undernourished individuals; physical exercise practitioners (\>150 minutes of exercise/week).

Keywords: type 2 diabetes hypertension obesity cardiovascular diseases nutritional intervention sleep eating window
optical coherence tomography to investigate ffr-guided deb-only elective coronary angioplasty

Conditions: Stable Angina; Coronary Stenosis

Summary: we aimed to evaluate feasibility and the 6-month angiographic and oct results of ffr - guided use of paclitaxel-eluting balloons (sequent please™, b braun) with provisional bare metal stenting for elective pci of de novo coronary lesions.

restenosis rates after plain-old balloon angioplasty (poba) are with 30-50 % very high. therefore, this interventional concept is of limited use today. however, dual antiplatelet therapy (dapt) is not necessary after poba. contrary, 3rd generation drug-eluting stents (des) proved to be very effective showing delayed restenosis only in 5-15%, but require dapt for at least 6 months. drug-eluting balloons (deb) might be a promising trade-off between poba and des, since they effectively inhibit neointimal proliferation despite minimal duration of dapt. however, there is still very limited data on this interventional strategy. thus, we aimed to investigate feasibility of fractional flow reserve (ffr) - guided use of paclitaxel-eluting balloons (sequent please™, b braun) with provisional bare metal stenting for elective pci of de novo coronary lesions, evaluating the 6-month outcomes by angiography and optical coherence tomography (oct).

Eligibility criteria:
inclusion criteria: * indication for elective pci according to the guidelines of european society of cardiology, american heart association and american college of cardiology * age \> 18 years, written consent * native de novo coronary lesion suitable for angioplasty and oct imaging exclusion criteria: * pregnancy and breast feeding mother * co-morbidity with an estimated life expectancy of \< 50 % at 1 year * scheduled major surgery in the next 6 months * not able to give informed written consent or non-compliance * participation in other pci trial * acute coronary syndromes and cardiogenic shock * known allergy to aspirin, thienopyridines or against taxol derivates * culprit lesion within the proximal 10 mm of the right or left coronary artery * saphenous vein grafts * estimated lesion length \> 30 mm

Keywords: pci drug-eluting balloon (deb) fractional flow reserve (ffr)
psychiatric day hospital treatment

Conditions: Depressive Disorders; Schizophrenia; Anxiety Disorders; Personality Disorders; Adjustment Disorders

Summary: the aim of the study was to compare the effectiveness of acute psychiatric day care to conventional inpatient care within a cross-national multi-site randomised controlled trial.


Eligibility criteria:
inclusion criteria: * patients must have presented with a mental disorder with current symptoms that had either led to at least a moderate disturbance in performance in more than one area of daily living or had jeopardized the residential, financial or occupational status of the patient or his family * treatments other than inpatient or day hospital care must have been inadequate or not sufficiently effective for the patient's current mental state exclusion criteria: * temporary admission for diagnostic purposes or for other reasons * under 18 or over 65 years * admission without consent of the patient (according to country-specific legal regulations) * one-way journey to hospital longer than 60 minutes * suicidal risk * risk to others * degree of severity of the disorder requires measures restrictive of the patient's freedom on the day of admission, or a 1:1 supervision, or deems such probable * acute intoxication * main clinical diagnosis: addictive disorder * presence of a somatic disorder requiring inpatient care * direct transfer from a different hospital * homelessness * need for constant pick-up and delivery service * inability to give informed consent with respect to participating in the study
evaluation of glycemic control in adults with type 1 diabetes when switching to insulin degludec

Conditions: Type 1 Diabetes

Summary: retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using insulin degludec (tresiba®) on measures of diabetes control. people with type 1 diabetes who switched to insulin degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included. glycemic control from 12 months before the switch to insulin degludec will be compared to glycemic control of the 12 months after the switch.


Eligibility criteria:
inclusion criteria: * people with t1d ≥18 years at the moment of switch to insulin degludec * diagnosed with t1d ≥2 years before switch to insulin degludec * on basal-bolus insulin therapy with insulin pens ≥2 years before switch to insulin degludec * ≥6 months use of insulin degludec at moment of datacollection * using continuous glucose monitoring ≥2 years before switch to insulin degludec exclusion criteria: * people with t1d \<18 years at the moment of switch to insulin degludec * people without t1d or with t1d \<2 years before switch to insulin degludec * women with t1d who are pregnant or planning pregnancy during -12 and +12 months * not using basal-bolus insulin therapy with insulin pens during -24 and +6 months * start to use non-insulin antidiabetic agents between -12 and +12 months * having received treatment with oral or injectable corticosteroids during -12 and +12 months * undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months * \<6 months use of insulin degludec at moment of datacollection * not using continuous glucose monitoring or \<2 years before switch to insulin degludec

Keywords: insulin degludec continuous glucose monitoring