Kornimate/medical-research-clean huggingface dataset:
an antiinflammatory diet as modulator of cardiometabolic risk and body weight in healthy subjects

Conditions: Metabolic Syndrome; Insulin Resistance; Overweight

Summary: main scientific question: a previous intervention with an anti-inflammatory multifunctional dietary portfolio (mfd) showed remarkable reductions in cardiometabolic (cm) risk markers compared with a well-designed control diet. the study was performed under weight maintenance conditions in healthy subjects in a 4w crossover design (tovar et al., 2012). mfd consumption also resulted in improved cognitive performance after 4 weeks (nilsson et al., 2013). the present project will further study the preventive potential of mfd, using its unique properties for identification of new biomarkers and to evaluate the potential role of alterations in the gut microbiota. mfd will be tested in healthy at risk subjects in a randomized parallel design in an eight-week intervention with the test or control diet, respectively, allowing for weight loss. assessment of standard anthropometric/biochemical markers of cm risk, metabolomics analysis and appetite regulating hormone evaluation are also planned. associations between the gut microbiota composition and measures of cm risk are also included. the project provides unique opportunities to identify mechanisms for the metabolic impact of mfd, for further exploitation in innovative food and/or dietary concepts. central hypothesis: the cm-preventive potential of mfd may be boosted in a medium-term trial under conditions allowing for body weight reduction. expected additional benefits may be recorded as reduced values for conventional cm-related parameters, markers of modified gut microbiota composition and specific changes in blood metabolite profiles. objectives: * to further improve the effect of mfd on biochemical/anthropometric cm risk markers in healthy subjects by administering the diet under conditions allowing for weight reduction. * to identify mfd-related changes in the gut microbiota associated with improved cm risk markers. * to assess mfd-related modification in metabolic pathways, studied with a metabolomics approach, and to correlate them with conventional clinical outcomes, aiming to identify new markers of altered metabolic risk.


Eligibility criteria:
inclusion criteria: * normal fasting blood glucose (max 6.1 mmol /l) * bmi between 25 and 32 kg/m2 exclusion criteria: * treatment for hypercholesterolemia * treatment for hypertension * history of cardiovascular complications

Keywords: cardiometabolic risk diet dietary prevention functional diet functional foods metabolic syndrome overweight
the association of fast food densities with mortality from cardiovascular disease

Conditions: Cardiovascular Diseases

Summary: in this cross sectional study, county level data for cvd and stroke mortality, and prevalence of t2d, were combined with per capita densities of ffr and fsr and analysed using multiple and simple linear regression. mortality and diabetes prevalence were corrected for poverty, ethnicity, education, physical inactivity and smoking to reduce confounding effects.

the investigators used data on mortality rate (per 100,000 individuals) for cvd and stroke (between 2011 and 2013, age\>35years) from the publicly available centers for disease prevention and control (cdc) web site (www.cdc.gov). cvd mortality was defined as the number of deaths per 100,000 person-years due to circulatory causes (international statistical classification of diseases, tenth revision, codes i00-i99). detailed information on preparation, definition, download and sorting of data on prevalence of t2d (age-adjusted), poverty and ethnicity have been explained elsewhere. in brief, county level data on the prevalence of t2d were downloaded from the usa cdc web site (www.cdc.gov). data on t2d was estimated using data from the cdc behavioural risk factor surveillance system (brfss) which is a monthly state based telephone survey of a nationally representative sample of adults aged \>20 years old. in 2012, the year for which these data were downloaded, the survey included landline telephones only and hence excluded individuals living in care homes or those without a landline telephone. more than 400,000 individuals are contacted annually to take part in the survey which has been running since 1984. individuals are judged to have diabetes if they respond 'yes;' to the question "has a doctor ever told participants that you have diabetes?", excluding females who indicate in a follow-up question that they only had diabetes during pregnancy. previous work indicates that self-report of a physician's prior diagnosis of diabetes is highly reliable compared to medical records. this question does not separate those with type 1 and t2d. in the adult population of the usa more than 96% of diabetes is type 2, the investigators therefore called the estimated prevalence that of t2d. given the magnitudes of the trends described here they cannot be attributed to differences in prevalence of the type 1 diabetes. data on rate of mortality (per 100,000 individuals) from cvd and stroke (between 2011 and 2013, age\>35years) were also downloaded from cdc web site (www.cdc.gov, national vital statistics system and national centre for health statistics). a previous variogram analysis has established that counties are an appropriate spatial level at which to explore the associations of factors to t2d prevalence.

Eligibility criteria:
inclusion criteria: 1. age\>35 years exclusion criteria: none -
meloxicam [mobic] in juvenile rheumatoid arthritis (jra)

Conditions: Arthritis, Juvenile Rheumatoid

Summary: to obtain safety, efficacy, pharmacokinetic and dosing information for meloxicam oral suspension in children with juvenile rheumatoid arthritis (jra)


Eligibility criteria:
inclusion criteria: * diagnosis of juvenile idiopathic arthritis (jia) by international league of associations for rheumatology (ilar) criteria; pauciarthritic, extended pauciarthritic, or polyarthritic current course of disease; * active arthritis of at least 2 joints * at least 2 other abnormal variables of the 5 remaining core set parameters * require nonsteroidal anti-inflammatory drugs (nsaids) * children aged 2-17 years exclusion criteria: * systemic course of juvenile idiopathic arthritis * all rheumatic conditions not included in inclusion criteria; any clinical finding or abnormal clinically relevant lab (not due to jia) that could interfere with conduct of clinical trial * weight of 9 kg or less * pregnancy or breast feeding * females of childbearing potential who are sexually active and not using adequate contraception for at least 3 mos prior to and for duration of study * history of bleeding disorder, gastrointestinal bleeding, or cerebrovascular bleeding * peptic ulcer past 6 months * more than 1 disease modifying anti-rheumatic drug (dmard) or change in dmard during 3 months prior * change corticosteroids during 1 month prior * systemic corticosteroids greater than 10 mg/d, hydroxychloroquine greater than 10/mg/d, cyclosporine greater than 5 mg/kg/d., methotrexate greater than 15 mg/m2/wk, cytotoxic agents, gold, d-penicilamine, sulfasalazine, glucosamine, and investigational products * etanercept during 1 month prior; infliximab during 2 months prior; intra-articular corticosteroids during 1 month prior * patients requiring concomitant other nsaid including topical (excluding ophthalmic) * requirement for use of other nsaids, anticoagulants, phenothiazine, lithium, or acth * insufficient effect or intolerability to naproxen or meloxicam * known or suspected hypersensitivity to trial meds or their excipients * requirement of chronic h2 antagonist * history of asthma, nasal polyps, angioneurotic edema, or urticaria with aspirin or nsaids * planned surgical procedures during study * investigational drug exposure during this trial or within 30 days (or 6 half lives, whichever greater) prior * previous participation in this trial * patients with known drug or alcohol abuse * patient, parent or legal representative unable to understand and to comply with protocol
a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture.

Conditions: Hip Fractures; Osteoporosis; Zoledronic Acid; Ambulant Nurse; Case Manager

Summary: this is a study to improve the collaboration between primary and secondary health care on the treatment of osteoporosis after a hip fracture. in akershus university hospital, patients 75 years or older with a hip fracture, are offered treatment with an infusion of zoledronic acid 5mg, combined with vitamin d and calcium supplements, to prevent new fractures. general practitioners (gps) are requested to take care of the follow-up on this treatment with annual infusions of zoledronic acid for 3 years. in the opinion of the investigators, it is expedient, safe, and sensible for parts of the subsequent treatment to be provided by gps. if hospitals take responsibility for initiating the treatment, the investigators believe that most of the subsequent monitoring and continuance of treatment can be conducted by the primary healthcare service. despite this, the investigators suspect that many patients do not get their annual infusions of zoledronic acid after discharge from the hospital. this quality assurance study aims to test a new system where ambulant nurses from the hospital support the gp in treating osteoporosis with the administration of zoledronic acid in the following 3 years after femoral neck fractures. through the project, the investigators will create procedures for the administration and follow-up of zoledronic acid fitted in the setting of the gp office. the design is a cluster randomized controlled study (rct) where the regions are prospectively randomized to either intervention or control regions. patients ≥ 75 years, which suffer a femoral neck fracture, are identified in our department of orthopedic surgery, where they are provided the first infusion of zoledronic acid 5 mg and proposed participation in the study. patients from the intervention regions will be followed by the protocol of ambulant nurse-assisted administration of zoledronic acid. patients from the control regions are offered the usual care. both patients from the control and intervention regions are asked to fill out a questionnaire after 1 year. the questionnaire will ask if the patient has got zoledronic acid as encouraged in the medical journal after discharge from the hospital. the primary study outcome is if the patients are offered treatment at a one-year follow-up or not. sample size calculation estimates a total sample of 130 patients based on a minimal clinically important difference of 20% follow-up between the groups. because of high mortality, the investigators estimate the need for 200 patients. the investigators hypothesize that the one-year follow-up is better in the intervention group than in the control group.


Eligibility criteria:
inclusion criteria: * patients 75 years or older with a hip fracture exclusion criteria: * refuse treatment * another treatment of osteoporosis is indicated * guest patient, do not live in the admission area * dementia
to evaluate the effect of different doses of sar156597 given to patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: primary objective: to assess in adult patients with idiopathic pulmonary fibrosis (ipf) the safety and tolerability of ascending doses of sar156597 administered subcutaneously (sc) once weekly over a 6-week period. secondary objectives: to assess in adult patients with ipf: * the pharmacodynamic effects of sar156597, as measured on pulmonary function tests (pfts), pulse oximetry and patient reported outcome and peripheral blood biomarkers. * the trough plasma concentrations of sar156597 * the potential immunogenicity of sar156597.

the study consists of a screening period of up to 28 days, treatment period of up to 6 weeks and a post-treatment follow-up period of up to 12 weeks. total study duration is up to 22 weeks.

Eligibility criteria:
inclusion criteria: * adult (aged \>18 years) male or female patients, * documented diagnosis of ipf according to the current american thoracic society/european respiratory society/japanese respiratory society/american latin thoracic association (ats/ers/jrs/alta) guidelines exclusion criteria: * forced vital capacity (fvc) \<50% of predicted value carbon monoxide diffusing lung capacity (dlco) (corrected for hemoglobin) \<35% predicted value * oxygen saturation \<90% by pulse oximetry while breathing ambient air at rest (sitting position for 10 min) * known diagnosis of significant respiratory disorders other than ipf * active vasculopathy or use of vasoactive drugs * known hiv or chronic viral hepatitis * patients with active tuberculosis or latent tuberculosis infection * evidence of any clinically significant, severe or unstable, acute or chronically progressive medical (other than ipf) or surgical disorder, or any condition that may affect patient safety in the judgment of the investigator * clinically significant abnormal ecg at screening * clinically significant laboratory tests at screening * current history of substance and/or alcohol abuse * females who are lactating or who are pregnant. * use of any registered therapy targeted to treat ipf within 4 weeks prior to screening * use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate and cyclosporine within 4 weeks prior to screening the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cartilage biomarkers and head-us score in severe hemophilia a patients receiving fviii prophylaxis

Conditions: Hemophilia A

Summary: patients with severe hemophilia a often develop joint complication requiring careful monitoring. this study aimed to compare the effectiveness of standard low dose weight-based fviii concentrates (cfcs) prophylaxis with pharmacokinetic-guided extended half-life fviii concentrates (ehlfviii) using cartilage biomarkers and head-us score.


Eligibility criteria:
inclusion criteria: * patients with severe hemophilia a * previously receiving standard low dose fviii prophylaxis 1-3 times per week for at least 6 months prior to enrollment in the project * no history of fviii inhibitor (\<0.6 bethesda unit/ml) * obtained consent from both patients and their parents exclusion criteria: * patients with underlying condition affecting the joints such as osteoarthritis, metabolic bone disease, etc.

Keywords: hemophilic arthropathy diagnostic ultrasound severe hemophilia a
effects of mindfulness meditation in virtual reality on craving and smoking cessation

Conditions: Tobacco Use Disorder

Summary: investigators seek to propose a non-drug therapeutic alternative, namely a mindfulness meditation protocol based on virtual reality training in order to induce progressive modifications of various indicators of craving. the study hypothesis is that the practice of mindfulness meditation in a virtual reality environment reduces the craving induced by cues and stress and therefore ultimately smoking relapse. the main objective of the protocol will be to demonstrate that mindfulness meditation can reduce long-term relapse (continuous cessation (\> 30 days) of smoking cessation). the participants will be randomized into two groups: the experimental group will perform six virtual reality sessions in a multisensory cabin at the rate of one session per week; the control group will be prescribed the gold standard treatment (nicotine patches and chewing gum). participants will be seen again at three and six months to assess whether or not there has been a smoking relapse.


Eligibility criteria:
inclusion criteria: * any patient consuming 10 to 40 cigarettes per day * woman or man aged 18 to 75 inclusive * substance use disorder according to the dsm5 classification * benefit from social security or benefit from it through a third party in accordance with french law on research involving the human person * having signed the informed consent form after having received written information. exclusion criteria: * disabling cognitive disorders * patient under 18 or over 75 years old. * patient with a psychological disorder or a psychiatric pathology requiring specialized follow-up * patient with addiction to another product. * cardiological pathologies that could compromise the participation of patients, detected by an ecg (only for patients who will be randomized in the experimental group). * advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor * pregnant or breastfeeding woman * simultaneous participation in another trial * employee of the investigator or of the clinical trial site * patients protected by law * patients who do not speak the french language * people not covered by state health insurance * patients who in the opinion of the investigator are unable to complete the questionnaires * patient claustrophobic or anxious about using the cabin * patient allergic to a molecule present in nicotine substitutes

Keywords: relapse craving
ger poses a potential risk for late complications of bpd

Conditions: Gastroesophageal Reflux; Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is a common condition in the low birth weight infants. although most of the bpd symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. these late complications have made so much trouble to the healthcare of bpd infants. how to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. in this study, a cohort of bpd infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of bpd were analyzed by logistic regression. as one of the risk factors, ger was verified whether to play a critical role in these late complications.


Eligibility criteria:
inclusion criteria: * the extremely premature infants with bronchopulmonary dysplasia exclusion criteria: * other congenital malformations such as gastrointestinal and or neurogenic disease
complications of non-surgical treatment in acute cholecystitis

Conditions: Acute Cholecystitis

Summary: acute cholecystitis (ac) is the second most frequent pathology in surgical emergencies; laparoscopic cholecystectomy (lc) is the gold standard treatment, but not all patients are fit for surgery. percutaneous cholecystostomy (pc) is an alternative to lc but has high comorbidity. there is no protocol in our institution for non-surgical treatment (nst). this study aims to analyse the complications of non-surgical treatment and a new local management algorithm

it's a single-centre retrospective study of 1652 adults with ac from 2011 to 2022, including baseline demographic characteristics, comorbidity severity defined as the charlson comorbidity index (cci), asa score, and tokyo guidelines' severity classification. the primary outcome is to study the complications of nst.

Eligibility criteria:
inclusion criteria: * diagnostic of an acute cholecystitis. * older than 18 years old. exclusion criteria: * younger than 18 years old.

Keywords: acute cholecystitis cholecystectomy tokyo guidelines non-surgical treatment mortality high-risk patient
a study to assess the long-term safety and efficacy of axs-05 in subjects with alzheimer's disease agitation

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation, Psychomotor

Summary: this study will evaluate the long-term safety and efficacy of axs-05 in subjects with alzheimer's disease (ad) agitation.

this study is a multi-center trial consisting of an open-label segment of up to 52 weeks, followed by a double-blind, placebo-controlled, randomized withdrawal segment. subjects participating in the randomized-withdrawal segment will be randomized in a 1:1 ratio either to continue to receive axs-05 or switch to placebo, for up to 24 weeks.

Eligibility criteria:
inclusion criteria: * participation in study axs-05-ad-302 or study axs-05-ad-304. * caregiver is willing to communicate with site personnel, comply with all required study procedures, and oversee administration and compliance with the subject's study treatment. exclusion criteria: * caregiver is unwilling or unable, in the opinion of the investigator, to comply with study instructions. * subject is hospitalized in a mental health facility (e.g., psychiatric hospital or ward), living in a nursing home, or living alone. * any concurrent medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or endanger the subject's well-being. * initiation of a new medication since enrolling in axs-05-ad-302 or axs-05-ad-304 which may pose a safety risk when taken concurrently with axs-05.

Keywords: ad agitation axs-05 nmda receptor antagonist dextromethorphan bupropion axsome
protective role of vitamin d in breast cancer patients treated with doxorubicin

Conditions: Breast Cancer

Summary: the study is aimed at evaluation of the potential protective effect of vitamin d in doxorubucin- induced toxicity in breast cancer patients. proposal steps: 1. 100 patients recruited from alexandria main university hospital (amuh), oncology unit are randomly assigned in to two groups: * control group (n=50) the patient will receive ac regimen (doxorubucin \& cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.) * vitamin d group (n=50) who will receive 4 cycles ac regimen in addition to vitamin d (bon one 0.5 microgram®) once daily. 2. echocardiography (echo) will be done at base line and at the end of the treatment. 3. vitamin d, ldh, troponin-t as well as il-6 will be assessed at baseline and at the end of the study.

research objectives: evaluation of the potential protective effect of vitamin d in doxorubucin- induced toxicity in breast cancer patients. proposal steps: 1. assessing breast cancer patients taking part in the study receiving adjuvant chemotherapy ac (anthracycline (doxorubucin)-cyclophosphamide) for breast cancer for 4 cycles every 21 day (i.e. 3 months.) 2. 100 patients are randomly assigned in to two groups: * control group (n=50) the patient will receive ac regimen (doxorubucin \& cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.) * vitamin d group (n=50) who will receive 4 cycles ac regimen in addition to vitamin d once daily. 3. all participants are recruited from amuh hospital oncology unit. all participants will be given their consent. the study will be approved by research ethics committee of damanhour university. 4. tumor staging is done according to american joint committee on cancer (tnm staging of breast cancer eighth edition (amin et al., 2017). 5. all patients will be submitted to: * full patient history and clinical examination. * routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests. 6. echocardiography (echo) at base line and at the end of the treatment. 7. vitamin d, ldh, troponin-t as well as il-6 will be assessed at baseline and at the end of the study. methodology: venous blood samples will be analyzed using elisa vitamin d, il-6 kits and immuno-histo-chemistry troponoin-t and ldh and kits.

Eligibility criteria:
inclusion criteria: * patients has a good performance status (ecog 0-2) according to eastern cooperative oncology group (ecog) score. * adequate complete blood picture patients. * females from (30-65) years of old. * normal renal and liver functions. exclusion criteria: * cardiac diseased or reduced cardiac output with left ventricular ejection fraction less than 50%. * hepatic impaired patients. * pregnancy or breast feeding or child bearing state. * patient with history of allergy to vitamin d. * concomitant use of other vitamins. * renal impaired patients. * history of breast cancer.