Kornimate/medical-research-clean huggingface dataset:
primary care implementation study to scale up eibi and reduce alcohol related negative outcomes

Conditions: Harmful; Use, Alcohol; Hazardous; Use, Alcohol

Summary: the aim of this implementation study is to compare the effect of tailored training and support (t\&s) for general practioners with t\&s and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention.

a quasi-experimental three-arm implementation study will be undertaken in flanders (belgium) to assess the effects of tailored training and support to general practitioners (gps) alone or in an area context of alcohol community actions and compared to 'support as usual' on gp's performance in terms of early identification of hazardous and harmful drinking and brief intervention. the study will last 18 months and will take place in three cities of comparable size. in each area at least 28 gps will be recruited. the primary outcome will be the proportion of consulting adult patients screened for hazardous and harmful alcohol use at the end-point of an 18-month implementation period. the secondary outcomes will be the screening rate as assessed at 3, 6, 9, 12 and 15 months and the proportion of patients screening positive for hazardous and harmful alcohol use that receive a brief intervention at 3,6,9, 12, 15 and 18 months. furthermore, the relation between gp's views and needs and practices' contexts, and eibi performance will be explored. data regarding screening and brief intervention activities will be collected from the electronic health records (ehr).

Eligibility criteria:
inclusion criteria: * gp or gp trainee * dutch language use in practice * working in general practice in 3 cities of comparable size or their sub municipalities exclusion criteria: - no possibility of integration of e-form into the ehr-system.

Keywords: alcohol screening brief intervention implementation training and support primary healthcare scaling up community actions hazardous alcohol use heavy drinking harmful use of alcohol heavy drinking
prevalence and risk factors of anxiety and depression among policemen during the health crisis linked to covid-19

Conditions: COVID-19; Anxiety Syndrome; Depression Syndrome; Policemen

Summary: to date, there is little international data on depression and anxiety among police officers apart from studies carried out after an attack or natural disaster. at the national level, no mental health data exists for police officers, apart from those from the paris attacks, and the work of investigators after the strasbourg attack (article in press). during the covid crisis, in alsace, the police, like the rest of the population, took the full brunt of the pandemic. the police, however, are part of essential professions and have not been confined, but on the contrary, have remained in contact with the population, in particular to carry out traffic controls. studies published to date show varying mental health outcomes for essential occupations during the pandemic. the investigators hypothesize that the police officers had a feeling of being more exposed and that their mental health could be affected. for this it was decided to compare two populations of departments of similar size, but with different exposure to the pandemic: bas rhin and hérault french departments


Eligibility criteria:
inclusion criteria: * any major agent in office in june 2020 of the national police of the bas rhin department, and hérault * supported between june and september 2020 * subject not opposing, after information, the reuse of their data for the purposes of this research exclusion criteria: * subject having expressed his opposition to his data being reused for study purposes

Keywords: covid-19 anxiety syndrome depression syndrome covid crisis police officers
safety study of bevacizumab (avastin) with thoracic radiation in non-small cell cell lung cancer

Conditions: Toxicity

Summary: in spite of the use of radiation combined with conventional chemotherapy, the long-term survival prognosis for most patients with locally advanced non-small cell lung cancer is disappointing. much effort is currently focussed on exploring new molecular targeted agents that may improve upon survival. the addition of an agent that targets blood vessel formation in tumors, bevacizumab or avastin, to conventional chemotherapy has been shown to improve survival in metastatic non-small cell lung cancer. data from animal studies have shown that bevacizumab and related agents also increase tumor cure rates when administered both during and after radiotherapy. this suggests that combined bevacizumab and chemo-radiation may improve survival in local-advanced disease as well. before such clinical studies can commence, the safety and normal tissue toxicity profile of bevacizumab with thoracic radiotherapy must first be established. in this study, escalating doses of bevacizumab will be administered during radiotherapy, followed by maintenance bevacizumab.


Eligibility criteria:
inclusion criteria: 1. cytologically or histologically confirmed stages ii or iii non-squamous nsclc 2. no evidence of tumour invading major blood vessels and no active hemoptysis (bright red blood of at least ½ teaspoon) in the 28 days prior to randomization. 3. no prior systemic therapy for nsclc. prior surgery and/or extra-thoracic irradiation is permitted. 4. presence of at least one measurable target lesion 5. age 18 or greater. 6. who performance status of 0 or 1. 7. acceptable pulmonary function as defined by a fev1 of ≥30% and a dlco of ≥40% of predicted 8. life expectancy of at least 12 weeks. 9. adequate hematological, renal and hepatic functions * absolute neutrophil count \>2x109/l. * platelet count \> 100x109/l. * total bilirubin \< 1.5 x unl * asat/alat \< 2 x unl * alkaline phosphatase \< 5 x unl * creatinine \< 130 μmol/l * creatinine clearance \> 60 ml/min; measured or calculated 10. urine dipstick for proteinuria \< 1+. if urine dipstick is ≥ 1, 24 hour urine must demonstrate \< 500 mg of protein in 24 hours. 11. no pre-existing sensory neurotoxicity grade 2 (ctc) 12. no active (uncontrolled) infection requiring antibiotics exclusion criteria: 1. mixed tumor types with small cell lung cancer or squamous cell carcinoma 2. other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension 3. serious non-healing wound or ulcer. 4. asat and alat \> 1,5 x unl 5. alkaline phosphatase 5 x unl 6. evidence of bleeding diathesis or coagulopathy. 7. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. 8. participation in other trial with investigational drug or treatment modality.

Keywords: bevacizumab thoracic radiotherapy locally-advanced non-small cell lung cancer
dexibuprofen 400 mg sachet versus ibuprofen 400 mg sachet in patients with osteoarthritis of the hip or knee

Conditions: Osteoarthritis of the Hip or Knee

Summary: medical condition under investigation: osteoarthritis of the hip or knee number of patients planned: 480 adult patients main objective: to evaluate and compare the tolerability profile of dexibuprofen gebro 400 mg powder for oral suspension compared to ibuprofen 400 mg in patients with painful osteoarthritis of the hip or knee secondary objectives: to compare the overall efficacy of dexibuprofen gebro 400 mg powder for oral suspension compared to ibuprofen 400 mg in patients suffering from different complaints due to painful osteoarthritis of the hip or knee


Eligibility criteria:
inclusion criteria: * male or female patients aged between 18 and 75 years * everyday joint pain for the past three months * global pain intensity in the involved joint (hip or knee) of "moderate" to "severe" within the last 48 h exclusion criteria: * acute inflammation or ischaemic necrosis * paget's disease, chondrocalcinosis, ochronosis of the hip/knee joint * slowly progressing hip/knee arthropathy in particular of tuberculosis aetiology * hip/knee arthropathy due to diabetes mellitus * charcot's joint * villous synovitis * chondromatosis of the synovium * patients with existing gastritis or existing ulcers or bleedings in the gastrointestinal tract or patients with history of gastrointestinal ulcers or gastrointestinal haemorrhage in the past 6 months
lipid-lowering effect of phytosterols, red yeast rice and their combination

Conditions: Hypercholesterolemia

Summary: a large body of evidence confirm the cholesterol lowering effect of phytosterols and red yeast rice. because their mechanisms of action mime the ones of chemical statins and cholesterol absorption inhibitors, it is plausible that their association will provide a more relevant (and safe) ldl cholesterolemia reduction.

a large body of literature suggest that the patients are strongly interested in self-medicating them with "natural" products aimed at reducing their plasma level of ldl-cholesterol. plant sterols and red yeast rice are among the most widely marketed product with these properties in western countries. however plant sterols per se have a limited effect on cholesterolemia, while full dosed red yeast rice can induce myalgias and myopathies as statins do. in this context, the aim of the investigators' study was to evaluate if the association of both products at low dosage could induce an additive or synergistic effect in term of ldl-reduction in humans.

Eligibility criteria:
inclusion criteria: * ldl-cholesterolemia between 130 and 190 mg/dl exclusion criteria: * type 2 diabetes * previous cardiovascular disease * assumption of lipid-lowering drugs or dietary supplements * previous intolerance to red yeast rice

Keywords: hypercholesterolemia dietary supplements red yeast rice plant sterols
uh3 phase - mindfulness-based blood pressure reduction (mb-bp) : stage 2a rct

Conditions: Hypertension; Prehypertension

Summary: the primary aim is to identify the impacts of a behavioral intervention called "mindfulness-based blood pressure reduction" (mb-bp) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (multidimensional assessment of interoceptive awareness) (maia) at 6 months, via a randomized controlled trial.

effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. consequently, this study proposes to conduct a behavioral intervention study to evaluate whether mindfulness-based stress reduction (mbsr) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure. this customized intervention is called mindfulness-based blood pressure reduction (mb-bp). the study follows the nih stage model for behavioral intervention development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). the selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the sustained attention response task and mindful attention awareness scale), (2) emotion regulation (specifically the pittsburgh stress battery and the perceived stress scale), and (3) self-awareness (specifically the heart beat detection task and multidimensional assessment of interoceptive awareness). based on the degree of target engagement, mb-bp can be further customized to better engage with the targets as needed.

Eligibility criteria:
inclusion criteria: * elevated blood pressure or hypertension defined as ≥120 mmhg systolic or ≥80 mmhg diastolic pressure. * able to speak, read, and write in english. * all adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included. exclusion criteria: exclusion criteria follow standard guidelines and recommendations: * current regular mindfulness meditation practice (\>once/week) * serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation * current substance abuse, suicidal ideation or eating disorder * history of bipolar or psychotic disorders or self-injurious behaviors.

Keywords: mindfulness blood pressure hypertension prehypertension self regulation science of behavior change attention control self awareness emotion regulation
the hypovoice study

Conditions: Diabetes Mellitus; Hypoglycemia

Summary: the hypovoice study aims at identifying potential vocal biomarkers associated with hypoglycemia to pave the way towards a voice-based hypoglycemia detection approach.

while hypoglycemia has been widely studied in medical research, studies assessing vocal changes associated with this state are limited. this study aims at collecting a data set labelled with the gold standard (blood glucose) to provide a solid basis for the identification of vocal biomarkers using machine learning. additionally, physiological data are collected using wearable sensors to assess whether additional integration of vital signs (e.g. heart rate) enhances the performance of hypoglycemia detection.

Eligibility criteria:
inclusion criteria: * written informed consent * type 1 diabetes mellitus as defined by who for at least 6 months * aged 18 - 60 years * hba1c ≤9.0 % * functional insulin treatment with good knowledge of insulin self-management * native language german or swiss german * use of continuous glucose monitoring (cgm) or flash glucose monitoring (fgm) exclusion criteria: * incapacity to give informed consent * contraindications to insulin aspart (novorapid®) * total daily insulin dose \>2 iu/kg/day * pregnancy, breast-feeding or lack of safe contraception * active heart, lung, liver, gastrointestinal, renal or psychiatric disease * pacemaker or implantable cardioverter defibrillator (icd) * epilepsy or history of seizure * chronic neurological or ear-nose-and-throat (ent) disease influencing voice or history of voice disorder * illiteracy or dyslexia * active smoking * active drug or alcohol abuse * medication known to interfere with voice or to induce listlessness (e.g. opioids, benzodiazepines, etc.)

Keywords: hypoglycemia voice speech detection artificial intelligence (ai)
evaluation of gastroesophageal reflux in patients on continuous positive airway pressure ventilation for obstructive sleep apnea

Conditions: Gastroesophageal Reflux; Sleep Apnea

Summary: patients with a clinically indicated sleep study will be enrolled in this study. they will have a diagnostic and a therapeutic sleep study with continuous positive airway pressure ventilation. for both studies a ph probe will be placed nasal to measure the amount of acidic reflux during each study. baseline levels of reflux from the diagnostic sleep study will be compared to reflux episodes while on continuous positive airway pressure ventilation.


Eligibility criteria:
inclusion criteria: * 18-75 years of age, symptoms consistent with sleep apnea, agree to consent form and placement of ph probes exclusion criteria: * any unstable medical condition, previous upper gi surgery or anatomic abnormality of upper gi tract, acid suppressing medication
panobinostat with rituximab for relapsed/refractory diffuse large b cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: panobinostat is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. panobinostat has shown effects against cancer in laboratory studies. however, it is not known if it will show the same activity in humans. panobinostat has been given to participants with various types of cancers, including dlbcl, in previous research studies. in this study panobinostat will be given with the the antibody rituximab, which is fda approved to be given with chemotherapy in dlbcl.

study treatment will be given in 4 week periods called cycles. panobinostat will be taken orally on monday, wednesday, and friday of each week. rituximab will be given as an intravenous infusion weekly during cycle 1 and then once per month on day 1 of subsequent cycles. subjects can receive up to 6 cycles of treatment. blood draws and 2 ekgs (electrocardiograms) will be done weekly in cycle 1 and then once in each cycle. pet/ct (positron emission tomography/computed tomography) scans will be done every 2 months. if disease has not progressed after 6 cycles on combination of panobinostat and rituximab, subjects may continue on panobinostat alone for up to 6 additional months.

Eligibility criteria:
inclusion criteria: * relapsed or refractory dlbcl * more than 1 line of prior chemotherapy exclusion criteria: * currently receiving anticancer therapy or investigational agents * major surgery within last 4 weeks * known leptomeningeal or brain metastases * known hiv infection * uncontrolled fungal, bacterial, viral or other infection * history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 3 years * hepatitis b or c positive * gi disease * pregnant or breastfeeding * prior treatment with an hdac inhibitor including valproic acid

Keywords: dlbcl (diffuse large b cell lymphoma) panobinostat lbh589 (panobinostat) lbh-589 (panobinostat) hdac inhibitor (histone deacetylase inhibitor) dac inhibitor (deacetylase inhibitor) deacetylase inhibitor lymphoma
the effect of a suturing technique on the gingival tissues around dental implants

Conditions: Edentulous Jaw; Missing Teeth; Gingival Diseases

Summary: there is general agreement that a thick zone of the keratinized tissues around implants promotes accurate prosthetic procedures, permits oral hygiene maintenance, resists recession, and enables esthetic blending with surrounding tissues. a new procedure called choukroun's technique has been suggested, and it consists of a combination of horizontal apical mattress suture with regular suture to increase the keratinized tissue in the mandibular arch during the first stage after implantation. the proposed procedure has not been evaluated yet in a cohort of patients. therefore, this study aimed to evaluate the impact of choukroun's technique on the width and thickness of the keratinized gingiva after oral surgery.

a clinical trial will be conducted on patients referred to the department of oral and maxillofacial surgery at the faculty of dentistry, al-wataniya private university, who have been referred to undergo dental implant surgery. the inclusion criteria for the study group were as follows: patients with mandibular missing teeth, good oral health, good general health, 18 to 70 years old, at least 1 mm thickness of keratinized gingiva, and at least 1 mm width of the attached gingiva. a total of 14 patients aged 27 to 67 years will be included in the study. after inserting the dental implants, the suturing will be conducted according to choukroun's method. the width and thickness of the keratinized gingiva will be assessed before surgery and at one and two months post-surgery. repeated measures analysis of variance (anova) will be applied to detect significant differences between assessment times.

Eligibility criteria:
inclusion criteria: * patients with mandibular missing teeth * good oral health * good general health * male or female * age between 18 and 70 years old, * thickness of the keratinized gingiva is at least 1 mm, * the width of the attached gingiva is at least 1 mm. exclusion criteria: * patients who are smokers * pregnant or lactating women * patients with systemic diseases * patients who have been taking medication in the last six months that could influence wound healing after surgery and * patients with oral inflammation such as periodontal disease.
evaluation of the efficacy and safety of bempedoic acid (etc-1002) as add-on to ezetimibe therapy in patients with elevated ldl-c (clear tranquility)

Conditions: Hypercholesterolemia; Atherosclerosis; Statin Adverse Reaction

Summary: the purpose of this study is to determine if bempedoic acid (etc-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated ldl cholesterol.


Eligibility criteria:
inclusion criteria: * fasting ldl-cholesterol greater than or equal to 100 mg/dl at screening * men and nonpregnant, nonlactating women * use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily exclusion criteria: * fasting blood triglycerides greater than or equal to 500 mg/dl * body mass index (bmi) greater than or equal to 50 kg/m2 * recent history of clinically significant cardiovascular disease * use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.

Keywords: hyperlididemia ldl cholesterol statin intolerance
elnd005 in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of elnd005 as treatment for alzheimer's disease (ad).

elnd005 (formerly known as azd-103), scyllo-inositol, is being investigated as an orally administered treatment for ad. elnd005 may prevent or inhibit the build up of amyloid protein in the brains of ad patients. this is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral elnd005 in male and female participants aged 50-85 years with mild to moderate ad. approximately 340 patients will be enrolled into the study at approximately 65 study sites. patients will be randomized to receive either elnd005 or placebo. each patient's participation will last approximately 18 months.

Eligibility criteria:
inclusion criteria: * diagnosis of probable ad * age 50 to 85 years, inclusive * mini-mental status exam (mmse) score of 16-26, inclusive * brain magnetic resonance imaging (mri) scan consistent with the diagnosis of ad * fluency in english, french, or spanish * stable doses of medications (cholinesterase inhibitors and memantine allowed) * caregiver is able to attend all study visits exclusion criteria: * significant neurological disease other than ad * major psychiatric disorder * significant medical illness * history of stroke or seizure * history of a heart attack within the last 2 years * prior treatment with certain experimental medicines * presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having mri scan