Kornimate/medical-research-clean huggingface dataset:
dietary intervention to stop coronary atherosclerosis in computed tomography: long-term follow-up

Conditions: Coronary Artery Disease; Diet, Healthy; Lifestyle Risk Reduction

Summary: a long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography angiography (ccta). 92 patients who completed the dietary intervention to stop coronary atherosclerosis in computed tomography study (disco-ct, nct02571803) will be followed-up.

all patients who completed the dietary intervention to stop coronary atherosclerosis in computed tomography received dietary and lifestyle recommendations and were referred to outpatient specialist care at their place of residence. as part of this study, patients will be invited for a follow-up visit consisting of a cardiological and dietician consultation and additional tests, including ccta, to assess the long-term impact of the intervention on the progression of atherosclerotic plaques, including high-risk plaque component. additionally, the occurrence of cardiovascular events, change in laboratory parameters and change in body weight composition will be analyzed.

Eligibility criteria:
inclusion criteria: * completion the disco-ct study (nct02571803) * willingness to participate in the long-term follow-up at site exclusion criteria: * contraindications to perform coronary computed tomography angiography (history of severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe renal impairment with glomerular filtration rate \< 30 ml/min) * no consent to participate
the veteran caregiver reducing stress time (vetcarerest) study

Conditions: Stress, Depression, Anxiety and Worry

Summary: caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers.recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. the veteran caregiver reducing stress time (vetcarerest) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in champaign and danville county.

recent estimates indicate that there are 275,000 to one million informal veteran caregivers. caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers. veteran caregivers are especially vulnerable because of competing demands. for instance, post 9/11 veteran caregivers are more likely to be the spouse of a veteran, and have experienced the stress of multiple deployments, have a young child in their care, and work outside the home. recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. one effective approach at reducing stress, depression and anxiety has been the use of mindfulness training, which has been shown to effectively reduce mood symptoms among professional caregivers. the veteran caregiver reducing stress time (vetcarerest) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in champaign and danville county. this study builds on dr. lara-cinisomo's (pi) experience with military spouses. the findings from this trial will serve as pilot data for a large-scale study.

Eligibility criteria:
inclusion criteria: * provide unpaid caregiver or support to a veteran * must be 18 years of age or older * willing to participate for the duration of the project * able to track his/her home practice in a handwritten log * have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal) exclusion criteria: * the presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
bupropion for the prevention of postpartum smoking relapse

Conditions: Postpartum Smoking Relapse

Summary: this two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). all participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * age 18 to 45 years old * stable health * 7-day point prevalence abstinence demonstrated at randomization * lifetime history of at least 100 cigarettes smoked * quit smoking during the current pregnancy * self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point likert-type scale * uncomplicated delivery * denies plans to become pregnant again during the trial. * full-term delivery ≥ 37 weeks gestation * home within 10 days of delivery exclusion criteria: * current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.) * current use of cessation aids (e.g., varenicline, nrt) * current use of illicit drugs or alcohol dependence * current use of antidepressant medication * bipolar disorder, eating disorder, or psychotic disorder based on the structured clinical interview * medications \& conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by cyp2d6) * family history of seizures or seizure disorder * maternal use of medications that lower seizure threshold * newborn with an elevated risk of seizure
clinical effects of limosilactobacillus reuteri probiotics as an adjunct to the treatment of periodontitis

Conditions: Chronic Periodontitis, Generalized

Summary: the purpose of this study is to evaluate the clinical efficacy of a probiotic lozenge containing limosilactobacillus reuteri as an adjunct to the periodontal non-surgical treatment of patients with stage ii, grade a, b and c, generalized periodontitis.

the main purpose of this study is to assess the effect on disease progression of the probiotic limosilactobacillus reuteri as an adjunct in the non-surgical periodontal treatment in patients with stage ii, grade a, b and c, generalized periodontitis: evaluated by bleeding on probing (bop) - lindhe, 1972. the secondary purpose is to evaluate the effect of this probiotic on the values of plaque index (pi) - silness \& löe, 1964; gingival index (gi) - löe \& silness, 1963; probing pocket depth (ppd), clinical attachment level (cal) - ramfjord, 1959, when compared to a negative control product.

Eligibility criteria:
inclusion criteria: * patients over 18 years old, who intend to voluntarily participate in the study and: * have a definitive diagnosis of stage ii, grade a, b or c, generalized periodontitis (2018, world workshop); * have at least 3 natural teeth maintained per quadrant. exclusion criteria: * • patients unable to understand the instructions necessary to participate in the study or unable to give informed consent; * patients who have received any type of periodontal treatment 2 months prior to the start of study participation; * pregnant or breastfeeding patients; * patients with associated systemic pathology, such as diabetes, hiv, asthma, hyperthyroidism, immune system pathologies, lichen erosive or other pathologies treated with corticosteroids or immunosuppressants; * patients undergoing therapy with drugs that may interfere with the response of the gingival tissues: anti-inflammatory drugs, anticonvulsants (phenytoin and sodium valproate), immunosuppressants (cyclosporin-a and tacrolimus) and antihypertensives (nifedipine and verapamil hydrochloride); * patients undergoing anticoagulant therapy; * patients allergic to both lidocaine, articaine and mepivacaine; * patients who require antibiotic prophylaxis for bacterial endocarditis; * patients who have had antibiotic therapy within 2 months of study participation; * patients using chlorhexidine, or other mouthwashes or elixirs; * patients undergoing orthodontic treatment.

Keywords: probiotics limosilactobacillus reuteri
clinical efficacy of ginkgo biloba extract in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: to assess the efficacy and safety of the ginkgo biloba extract in patients with knee oa.


Eligibility criteria:
inclusion criteria: * patients 40-75 years old with knee oa. * grade ii and grade iii according to the kellgrenn-lawrence (kl) grading system of radiographic oa. exclusion criteria: * pregnancy, breastfeeding * liver or renal problems * patient taking any drug that might interact with ginkgo extract (eg. warfarin, etc.) * patient with cardiovascular or cerebral vascular disorders, uncontrolled diabetes, allergic to ginkgo, recent surgery or hospital admission, \>75 years old. * allergic or contraindicated to using nsaids
optimising preconceptual health in subfertile pcos patients using a lifestyle modification program

Conditions: Infertility, Female; Polycystic Ovarian Syndrome; Lifestyle

Summary: patients will be randomly assigned to a group where they undergo a 12-week lifestyle modification program prior to their fertility treatment, or a group where they are entitled to start their fertility treatment without prior lifestyle modification program.

when allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio-electric impedance analysis for body composition and ergospirometry. when the patient is allocated to the interventional arm she will receive a 12-week lifestyle modification program prior to her fertility treatment. the lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. after the 12-week program the fertilty treatment will start as per routine practice. questionnaires, ergospirometry and bio-electric impedance analysis will also be performed at the foreseen moments.

Eligibility criteria:
inclusion criteria: * subfertile patients between \>18- \<38 years old requesting fertility treatment at our centre * pcos phenotypes a, b, c and d according to the nih 2012 extension of the eshre/asrm 2003 diagnostic criteria * bmi \>27 and \<38 (jiskoot et al. 2017) * nulliparous women * patient gives consent voluntarily exclusion criteria: patients will be excluded if they: * do not meet the eshre/asrm 2003 diagnostic pcos criteria * have a bmi \ 38 (jiskoot et al. 2017) * need surgical sperm retrieval * use donor eggs * need pre-implantation genetic testing (pgt) * multiparous women * cannot reliably fill out the questionnaires or comprehend the intervention, because of a language barrier
intello2 vs manual control for optimizing oxygenation in infants

Conditions: Oxygen Titration in Preterm Infants to Manage Lung Disease

Summary: the overall objective of this study is to demonstrate that the intello2 device providing automated control of fraction of inspired oxygen (fio2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. specifically, it is hypothesized that the intello2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.


Eligibility criteria:
inclusion criteria: 1. preterm infants being treated with high flow nasal cannula therapy 2. a need for supplemental oxygen as demonstrated by an required fio2 \> 0.25 at enrollment 3. requiring a flow rate of greater than 2 l/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of hfnc). exclusion criteria: 1. major congenital abnormalities 2. hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics 3. seizures 4. ongoing sepsis 5. meningitis 6. clinician's concern regarding stability of the infant

Keywords: nasal cannula, high flow oxygen therapy, pulse oximetry
the effects of nutritional support of critically ill patients requiring mechanical ventilation

Conditions: Critically Ill

Summary: the purpose of this study is to assess the impact of different feeding solutions on patients with breathing difficulty being supported by a breathing machine. the aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon dioxide production in patients with respiratory failure.

patients who agree to participate in the study and fulfil the inclusion criteria, will be randomised to one of two treatment groups. 1. standard therapy group. will receive high carbohydrate, low fat enteral feeding, (16.7% protein, 30% fat and 53.3% carbohydrate). the target rate is determined by the treating physician and dietician, for a minimum of 5 days following randomisation. 2. alternative therapy group will receive high-fat, low carbohydrate enteral feeding, (16.7% protein, 55.2% fat and 28.1% carbohydrates. at a target rate determined by the treating physician and dietician, for a maximum of 5 days following randomisation. all patients will receive enteral feeding by continuous flow for 24 hours a day. the decision to commence or cease enteral feeding will remain with the treating physician. the measurement of vo2, vco2, resting energy expenditure and respiratory quotient wil be made on all participants 12 hourly for a maximum of 5 days using the direct calorimeter. the indirect calorimeter is connected to the expiratory outlet of the ventilator, collecting and analyzing gas that is normally discharged in to the atmosphere. the hypothesis of the study is that the use of high- fat, low-carbohydrate enteral feed, significantly reduces the carbon dioxide production and the respiratory quotient in critically ill, mechanically ventilated patients with respiratory failure. compared to standard high-carbohydrate low-fat enteral feed.

Eligibility criteria:
inclusion criteria: 1. adult patient, 18 years or older admitted with acute respiratory failure (pao2/fio2 \<300), needing mechanical ventilation. are expected to be require mechanical ventilation for more than 48 hours. 2. patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube. 3. patients or their next-of-kin consent to participate in the study. - exclusion criteria: 1. patients under the age of 18 years 2. patients with contra-indications to enteral feeding 3. patients receiving total parental nutrition 4. patients who are already enrolled in another study that may influence the outcome of this study. 5. patients who are not receiving active medical management or are expected to die within 24 hours at the time of study entry. 6. patients with diabetes mellitus, renal failure or liver failure. 7. patients or next-of-kin who do not consent to participate in the study. -
venetoclax combined with azactidine in the treatment of alal

Conditions: Acute Leukemia of Ambiguous Lineage

Summary: the prognosis of acute leukaemias of ambiguous lineage is poor. the effect of chemotherapy regimen and hematopoietic stem cell transplantation are still unclear. therefore, we will explore new therapy to improve the remission rate of acute leukaemias of ambiguous lineage. venetoclax can significantly improve the remission rate and prolong pfs and os. at present, venetoclax combined with azacitidine or decitabine has become the preferred treatment regimen for elderly aml patients. it also shows a high response rate in relapsed/refractory aml or mds patients. there are few clinical studies on the treatment of alal. the purpose of this study is to explore the efficacy and safety of venetoclax combined with azacitidine in the treatment of newly diagnosed alal patients.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 15 and ≤ 65 years. 2. patients diagnosed with alal according to 5th edition of who acute leukaemias of ambiguous lineage diagnosis standard. 3. new diagnosed patients. 4. ecog performance status score less than 3. 5. expected survival time #3 months. 6. patients without serious heart, lung, liver, or kidney disease. 7. ability to understand and voluntarily provide informed consent. exclusion criteria: 1. patients who are allergic to the study drug or drugs with similar chemical structures. 2. pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 3. active infection. 4. active bleeding. 5. patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 6. patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met. 7. liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, alt/ast \> 2.5 times the upper limit of the normal range or patients with liver involvement whose alt/ast \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value). 8. patients with a history of clinically significant qtc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, ii-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment. 9. surgery on the main organs within the past six weeks. 10. drug abuse or long-term alcohol abuse that would affect the evaluation results. 11. patients who have received organ transplants (excepting bone marrow transplantation). 12. patients not suitable for the study according to the investigator's assessment.
clinical utility of early intervention including the 5-step precision medicine (5spm) method in first-episode psychosis: the clump project

Conditions: Psychosis

Summary: clump is a project of translational research that intends to bridge the gap between what we already know about pharmacogenetics of antipsychotic drugs and what we still do to treat patients with first-episode psychosis (fep). we aim to improve the adherence to antipsychotic drugs and, therefore, the outcomes of patients with fep. to achieve this aim, our objectives are to: (1) introduce a pioneering early intervention model of personalised precision psychiatry, including pharmacogenetics, for patients with fep; (2) ascertain whether such a model can reduce the elevated discontinuation rates of antipsychotic medications in this group; (3) assess the impact of this model on pragmatic efficacy and functional measures; (4) determine whether this innovation can bring cost benefit; and (5) establish a blueprint for implementing this precision model nationally and internationally. we shall compare all-cause discontinuation rates of the first prescribed antipsychotic medication (primary outcome), discontinuation rates by causes, pragmatic efficacy and tolerability measures, functional outcomes, and healthcare costs between two cohorts of patients with fep followed for one year. one cohort will be comprised of patients treated before the implementation of the early intervention model of personalised precision psychiatry, and the other of new patients treated under this model. also, we shall compare pharmacogenetic information, and its implications for clinical management, between these patients and another national cohort of patients with either longer-term psychotic disorders or other mental health problems.


Eligibility criteria:
inclusion criteria * patients with a diagnosis of first-episode psychosis, either non-affective or affective. * patients aged 12-35 years. * patients followed by clinical services for at least one year, or earlier if there was evidence of antipsychotic treatment discontinuation. * for cohort one: patients and/or their family or legal representatives must provide written consent to take part in the clump project, including pharmacogenetics analysis. * for cohort two: this will not be a mandatory inclusion criterion, but all patients will be approached by our research team seeking their consent to obtain their pharmacogenetic profile for research purposes. exclusion criteria * patients with first-episode psychosis due to organic causes, for example, brain diseases such as huntington's and parkinson's disease, hiv, syphilis, dementia, brain tumours or cysts, or brain injury. * patients with moderate to severe intellectual disability. * patients who plan to reside (cohort one) or spent (cohort two) most of the one-year follow-up period in a locality outside of the print's catchment area.

Keywords: psychotic disorders personalised precision psychiatry pharmacogenetics first-episode psychosis
combacte-cdi understanding the burden of c. difficile infection

Conditions: Clostridium Difficile Infection

Summary: clostridium difficile infection (cdi) is the most common cause of antibiotic associated diarrhoea in the western world. the infection causes significant diarrhoea, which in some cases can be serious and lead to secondary complications and even death. the infection is particularly an issue in elderly, frail patient, who are often already burdened with several other medical issues. recent work has demonstrated that numerous cases are missed, either due to inadequate diagnostic tests or lack of clinical suspicion. the public-private partnership in combacte-cdi will quantify the burden of cdi via a large, complex, multi-centre, multi-country study, and describe current management practices. an increased understanding of the cdi burden across europe and better understanding of transmission of the organism will provide a basis for the further development of public health interventions and practices. based on a previous successful study model (euclid), hospitals/laboratories of interest which carry out diagnostic testing of samples from both in-patients and community patients (including long-term care facilities patients) will be approached for inclusion in the study. samples sent to the sites on the selected study date (regardless of test requested) will be tested at a central laboratory for cdi to look for missed cases of cdi. a follow up case/control study will collect data on outcomes and risk factors. data will be used to construct transmission models and cost effective-ness models. ultimately, a best practice model for cdi management will be developed.


Eligibility criteria:
inclusion criteria: * anyone who has a diarrhoeal faecal sample submitted to the laboratories in the study for testing on the day of interest, regardless of test requested exclusion criteria: * any repeat samples