Kornimate/medical-research-clean huggingface dataset:
improving physical health in patients with psychiatric disorders in general practice (sofia)

Conditions: Psychiatric Disorder; Schizophrenia; Bipolar Disorder; Severe Depression

Summary: people with a severe mental illness (smi) have an increased risk for premature mortality, predominantly due somatic health conditions. evidence indicates that prevention and improved treatment of somatic conditions in patients with smi could reduce this excess mortality. this paper reports a protocol designed to evaluate the feasibility and acceptability of a coordinated co-produced care programme (sofia model) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. the primary outcomes are description of study feasibility (recruitment and retention) and acceptability. the sofia trial is designed as cluster randomized controlled trial targeting general practices in two regions in denmark. 12 practices will each recruit 15 community-dwelling patients aged 18 and older with severe mental illness (smi). practices will be randomized in a ratio 2:1 to deliver a coordinated care program or care-as-usual during a 6 month period. an online randomized algorithm is used to perform randomization. the coordinated care program comprises enhanced educational training of general practitioners and their clinical staff, and prolonged consultations focusing on individual needs and preferences of the patient with smi. assessments are administered at baseline, and at end of study period. if delivery of the intervention in the general practice setting proves feasible, a future definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with smi can take place.


Eligibility criteria:
inclusion criteria: * registered at a general practice situated in the danish capital region or the region of zealand; * registered at general practice with international classification of primary care version 2 (icpc-2) diagnostic code p72 (psychotic disorders); * registered at general practice with icpc-2 diagnostic code p73 (bipolar mood disorders); * prescription of lithium (anatomical therapeutic chemical (atc): n05an); * registered at general practice with icpc-2 diagnostic code p76 and (prescription of lamotrigine (n03a09) or carbamazepine (n03af01) or valproic acid (n03ag01)); * registered at general practice with icpc-2 diagnostic code p76 (unipolar depressive disorders) and (prescription of tricyclic antidepressants (n06aa) and/or venlafaxine (n06ax16) and/or duloxetine (n06ax21) and/or monoamine oxidase a inhibitor (maoi) (n06ag) and/or non-selective maoi (n06af)). exclusion criteria: * subjected to any type of legal measure as stipulated in the danish mental health law; * registered with a dementia diagnosis icpc-2 p70 (dementia); * receiving end-of-life care; * non-danish speakers; * assumed by the patient's general practitioner to have an overall functional level that is too low for meaningful participation in trial.
study of prophylactic topical dapsone 5% gel versus moisturizer for cetuximab-induced papulopustular (acneiform) rash in patients with mcrc or hnscc without previous or concurrent rt

Conditions: Cetuximab-induced Papulopustular (Acneiform) Rash Who Have; Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to see if the investigators can prevent or reduce the severity of the cetuximab-related acne rash. two different topical agents will be applied to the skin. one topical agent is the dapsone gel and the other is a skin moisturizer. dapsone gel is an fda approved medication that you apply to the face. it is commonly used to treat acne. skin moisturizers are recommended to patients who receive cetuximab treatment. in addition to these topical agents they will be given a pill to take once a day. this pill has already been shown to help fight rashes from cetuximab.


Eligibility criteria:
inclusion criteria: * patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient * patients must provide written informed consent to participate in the study * anticipated initiation of cetuximab treatment with or without additional chemotherapy. * able to self-administer topical interventions or provide for another person to apply the topical interventions exclusion criteria: * females of childbearing potential who are pregnant or nursing * patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product * patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion) * patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days) * previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only) * previous therapy with cetuximab within 6 months of consent

Keywords: topical dapsone 5% gel moisturizer rash 13-012
to investigate the efficacy and safety of opc-6535 in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to investigate the efficacy and safety of opc-6535 in copd patients, using the measurement of trough fev1 over time as the primary endpoint.


Eligibility criteria:
inclusion criteria: * age 40 to 75 years, inclusive, at the time informed consent is obtained * ability to provide own written informed consent * agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (imp) * a rating of 1 or higher on the goddard scale in assessment of emphysema severity by chest ct scan at screening * ratio of forced expiratory volume in 1 second to forced vital capacity (fev1/fvc) of less than 70% at screening * cigarette smoking history of at least 20 pack years at screening exclusion criteria: * subjects with obstructive disorders due to bronchial asthma * subjects receiving long-term oxygen therapy * subjects with active tuberculosis or obvious bronchiectasis * complication of malignant tumor * uncontrolled cardiovascular, endocrine, blood, or nervous system disorders * uncontrolled condition with copd exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)

Keywords: chronic obstructive pulmonary disease copd emphysema
taiwan severe asthma biologic registry

Conditions: Pulmonary Disease; Asthma

Summary: this is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in taiwan. the goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients. the main question\[s\] it aims to answer are: 1. determine risk factors associated with poor asthma control. 2. support the development of effectiveness and safety of therapeutic principles 3. to discover the real-world effectiveness of different biologics ( clinical remission) 4. to discover the impact of initiating biologics for severe asthma patients. 5. to evaluate the prevalence of biologics switching and its benefits for patients. 6. to compare the achievement rate of clinical remission among different biologics. participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or tezepelumab after january 1, 2020 will be included in the study.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures. * patient should be reviewed as well as confirmed by the national health insurance administration (nhia) or by the study board member as a severe asthma case. * female and male aged over 18 years old. * patients who are treated either with omalizumab, mepolizumab, or benralizumab after january 1, 2020. exclusion criteria: * lack of informed consent for participation. * history of biologic usage before january 1, 2020, should be ruled out. * the washout period should be at least 12 months. in other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation. * comorbid pulmonary diseases (e.g.: chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than asthma.

Keywords: severe asthma registry biologic
re-enforcing safe sleep practices for caregivers with tangible incentives

Conditions: Safe Sleep Education

Summary: this study is a pilot study to test the effectiveness of incentive items to increase compliance of infant safe sleep practices among caregivers.


Eligibility criteria:
inclusion criteria: * parent of 1-month old baby * over the age of 18 * be able to speak and read english exclusion criteria: -

Keywords: sudden infant death syndrome sids safe sleep safe sleep message
the impact of food reformulation on energy intake

Conditions: Diet, Healthy; Eating Behavior; Obesity

Summary: food prepared outside of the home tends to have a high energy content, and high levels of nutrients of concern (sodium, fat, saturated fat and sugar), especially when compared to home-cooked food. a number of studies suggest that when energy density of a food is manipulated it has a linear effect on energy intake, because consumers tend to eat a constant weight of food. however, recent observational research suggested that up to approximately 1.5-2kcal/g, individuals are relatively insensitive to changes in energy density, and there is no indication of compensation through altering meal size. however, upwards of approximately 1.5-2kcal/g, the authors proposed that individuals compensate for increases in energy density by selecting and consuming smaller meal sizes. the investigators aim to measure participant's consumption (in grams and kilocalories) of three meals at low, medium and high energy densities, and to measure later food intake to observe any evidence of later compensation in response to experimental condition

see attached protocol document.

Eligibility criteria:
inclusion criteria: * currently reside in the united kingdom * over the age of 18 years * fluent english speaker * like the test foods * have a bmi between the ranges of 18.5 and 35. exclusion criteria: * pregnant/breastfeeding * partaking in a fast or other restrictive eating for religious reasons at time of participation * currently following a diet * on medication that affects appetite * being a smoker * current or historic eating disorder * dietary restrictions/intolerances including: * any allergies * vegan/vegetarian * gluten-free * dairy-free * sugar-free
late compared to early physiotherapy following knee dislocation

Conditions: Traumatic Knee Dislocation

Summary: a knee dislocation is an unusual and extremely serious injury and is defined as complete displacement of the tibia with respect to the femur, usually with disruption of 3 or more of the stabilizing ligaments. when the knee dislocates, there is often significant damage to the soft-tissues envelope surrounding the joint, including adjacent neurovascular structures. not surprisingly, this injury is a profoundly debilitating, life-altering event, with the potential to necessitate career change in athletes and laborers alike. current evidence indicates that operative management for these injuries is more effective at returning patients to pre-morbid range of motion (rom) and activity than conservative management. post operative rehabilitation programs for these patients must balance the need for stability of their surgical repair and knee rom and functionality. experimental data suggests that post-operative immobilization offers greater protection of the surgical reconstruction, whereas immediate, aggressive physiotherapy may be more effective at preventing arthrofibrosis stiffness. the investigators are proposing a randomized clinical trial comparing early physiotherapy (day one post op) versus immobilization for three weeks then initiation of physiotherapy. the physiotherapy progams will be identicalbe in all aspects except for progam initiation.


Eligibility criteria:
inclusion criteria: * ambulation without aids in pre-morbid condition * multi-ligament knee injury with or without associated peri-articular fracture * operative management within three weeks of the injury exclusion criteria: * poly-trauma with life-threatening injuries preventing rehabilitation * patients unable to comply with intensive rehabilitation * patients unable or unlikely to maintain follow-up
long term open label continuation study

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

study de020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior phase 1, 2, or 3 adalimumab study in the united states or canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). participants who maintained an american college of rheumatology 50% (acr50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. safety and efficacy data were collected over 520 weeks (10 years). both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study de020 (the full analysis set, n=846). three patients who entered the continuation study but were never dosed were excluded from all analyses.

Eligibility criteria:
inclusion criteria * participant was in a prior d2e7 (adalimumab) study * participant was age 18 or older and in good health (investigator discretion) with a recent stable medical history. exclusion criteria * participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study * participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant * participant had any ongoing chronic or active infection

Keywords: rheumatoid arthritis
adaptive personalized dietitian coaching, messaging and produce prescription to improve healthy dietary behaviors

Conditions: Hypertension

Summary: thrive intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 60 black adults with hypertension.

nearly 55% of black adults have hypertension and uncontrolled blood pressure. dietary approaches to stop hypertension (dash) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. the proposed thrive intervention will enroll 60 black adults with hypertension living in healthy food priority areas (hfpas) in a 2-arm randomized pilot study. one group will receive produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. both groups will be linked to needed social services. the investigators will assess changes in overall dash adherence, acceptability, and feasibility at 3- and 6-months post-randomization. the investigators will: 1) develop and beta test thrive among black adults with hypertension living in hfpas; 2) test feasibility and preliminary efficacy of thrive at 6 \& 12 weeks; 3) determine short-term sustainability of thrive at 6 months.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. self-identify as black/african american 3. have diagnosed hypertension stages 1 (130-139/80-89 mm hg) or 2 (\>140/90 mm hg), determined via self-report and/or electronic medical records (emr) 4. live in census tracts identified by montgomery county department of planning52 as hfpa: 1. healthy food availability index score is low (0-9.5), 2. median household income ≤185% of federal poverty level 3. \>30% households have no vehicle, distance to supermarket \>1/4 mile. 5. participants must have refrigeration, food appliances (microwave, stove), 6. cell phone to receive messages exclusion criteria: 1. age \<18 years 2. type 1 or type 2 diabetes defined as a hemoglobin a1c ≥6.5% or diabetes treatment 3. diagnosis of end-stage renal disease (esrd) 4. condition which interferes with outcome measurement (e.g., dialysis) 5. serious medical condition which either limits life expectancy or requires active management (e.g. cancer) 6. significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence 7. patients with cognitive impairment or other condition preventing their participation in the intervention 8. current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) 9. current participation in another clinical trial that could interfere with the study protocol 10. those planning to move out of the geographic area in 12 months 11. unwillingness to provide informed consent 12. other conditions or situations at the discretion of the investigative team
validating a clinical decision support tool for stratifying stroke risk for dizziness/vertigo

Conditions: Dizziness; Vertigo

Summary: this study aims to validate a machine learning model that stratifies the risk of stroke in patients who present to the emergency department with dizziness or vertigo.

this is a cross-sectional, hospital-based study, with no randomization procedure. over a 21-month period, approximately 600 subjects will be enrolled. the study will assess the risk of stroke in each patient using a machine-learning model. to detect ischemic or hemorrhagic stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. the predictive performance of the machine-learning model will be evaluated in terms of accuracy, precision, recall, f1 score, and area under the receiver operating characteristics curve.

Eligibility criteria:
inclusion criteria: * presenting to the emergency department with dizziness or vertigo * aged ≥ 20 * dizziness or vertigo lasting for at least 1 hour and \< 7 days * persistent dizziness or vertigo at the time of the examination at the emergency department exclusion criteria: * having 5 or more prior episodes similar in quality, intensity, and duration to the current symptoms, with at least one episode more than a year prior and one within the past year * having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry, dysarthria, dysphasia, ataxia, gaze palsy * consciousness disturbance, glasgow coma scale \< 13 * severe dementia * recent stroke within 3 months * dizziness or vertigo thought to be the result of head injury, hypotension, medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic encephalopathy, hydrocephalus, etc * concomitant head or neck trauma * severe degenerative cervical spondylosis * having contraindications to magnetic resonance imaging examination

Keywords: dizzy vertigo stroke machine learning
impact of guidelines on cardiovascular and economic outcomes with focus on lipid lowering drugs

Conditions: Acute Myocardial Infarction

Summary: methods: all patients \<75 years registered in the swedish secondary prevention after heart intensive care admission registry (sephia), will be followed-up within one year post-myocardia infarction (mi). the reach risk prediction and a calibrated model for recurrent cardiovascular disease (cvd) events and death will be used to estimate base case, and calibrated cvd outcomes based on gender-specific risk factors. the predicted impact of the ldl-c reduction on the risk of cvd will be based on cholesterol treatment trialists´ collaboration findings.

swedeheart is a swedish national registry consisting of several sub registries in which patients with acute coronary syndrome are prospectively registered. patient characteristics, hospital treatments, drug treatments at discharge, and outcome for patients consecutively included and treated at all swedish coronary care units are collected in this registry.sephia is a sub registry collecting data on secondary prevention and cardiac rehabilitation. follow-up are registered at six to ten weeks and at 12 to14 months post mi by office visits or phone. around 80 % of all swedish acute myocardial infarction (ami) patients below the age of 75 years are included in this register. in this study, a cohort of 5 904 (74% men) registered in the sephia registry and who had one year follow-up during 2013, will be included. data are aggregated and delivered from the swedeheart/sephia national registry. all patients were informed about their participation in the registry, the follow-up, and their right to decline participation. no written consent was obtained

Eligibility criteria:
inclusion criteria: all patients with acute myocardial infarction registered in the sephia registry and who had one year follow-up during 2013 - exclusion criteria:none -

Keywords: cardiovascular disease costs guidelines lipids myocardial infarction