Kornimate/medical-research-clean huggingface dataset:
implementing group metacognitive therapy in cardiac rehabilitation services (pathway-beacons)

Conditions: Anxiety; Depression; Cardiac Rehabilitation

Summary: background: cardiac rehabilitation (cr) services aim to improve heart disease patients' health and quality of life and reduce the risk of further cardiac events. depression and anxiety are common among cr patients, and current psychological treatments for cardiac patients have minor effects. however, the nihr-funded pathway trial found that group metacognitive therapy (mct) was associated with improvements in anxiety and depression when added to cr and was more effective than usual cr alone. group mct was also associated with preventing anxiety and depression. the next steps will establish beacon sites for delivering mct and pilot-test additions to the national audit of cardiac rehabilitation (nacr) data capture mechanism to include an mct data field. such steps will support a quantitative and qualitative evaluation of implementation. methods: the investigators aim to address questions concerning the quality of patient data recorded, level of adoption at sites, the characteristics of patients attending mct, the impact of adding mct to cr on mental health outcomes, and patient, healthcare staff and commissioner views of barriers/enablers to implementation. the investigators will deliver training in group mct to cr staff from cr services across england. the investigators will conduct semi-structured qualitative interviews with cr staff trained in group mct to assess views on the training programme, including successes and barriers to implementation of training and delivery. the investigators will interview 8-10 cr stakeholders to identify any barriers to implementation and how these might be resolved. discussion: the study will support development of an nhs roll-out strategy and systematic data collection that can be used to evaluate wide-scale implementation. the study can benefit service users by improving patients' mental health outcomes and cr practitioners' clinical skills. results will be disseminated via peer-reviewed journals, national and international conferences and service user/voluntary sector organisations and networks.


Eligibility criteria:
qualitative inclusion criteria: all cr staff must meet the following inclusion criteria to be eligible: 1. be a healthcare professional working with cardiac rehabilitation services being trained to deliver group-mct 2. be a healthcare professional working with cardiac rehabilitation or be a professional working at the commissioner level 3. minimum of 18 years old 4. competent level of english language skills (able to read, understand and complete interviews in english). exclusion criteria: 1. below 18 years of age 2. not a healthcare professional or professional working at the commissioner level 3. does not have a competent level of english language skills audit inclusion criteria: all patients attending cr who meet the nice recommendations for acute coronary syndrome (ng185) and heart failure (ng106) will be offered group mct as part of routine cr.
micro-rna expression profiles in localised prostate cancer

Conditions: Prostate Cancer; Radical Prostatectomy

Summary: recurrence free survival the patients will be followed in regular time intervals in accordance with the eau-guidelines (2010) and the s-3 guideline for prostate cancer of the german urological association. data will be updated once yearly for until death.


Eligibility criteria:
inclusion criteria: * 35 years to 80 years * male * patients with clinically localised high risk prostate cancer exclusion criteria: -
prospective snapshot audit of distal pancreatectomy in spain

Conditions: Surgery--Complications; Pancreas Disease; Pancreatic Fistula

Summary: distal pancreatectomy is the surgical technique performed to treat many pancreatic diseases located in neck and tail of the pancreas. laparoscopic approach is the gold standard but in many centres the percentage of laparoscopic approach is still low. this technique has low mortality but 30% morbidity mostly related to pancreatic fistula. some new devices (linear stapler, energy devices and patches) seem to decrease pancreatic fistula but there is not evidence based medicine that confirm the results published usually in unicentric studies.

snapshot observational study including most of the spanish pancreatic units that perform distal pancreatectomy. one year consecutive cases. main objectives. 1. percentage of laparoscopic approach in spain 2. morbidity at 90 days measured by cci and clavien dindo 3. percentage of pancreatic fistula 4. impact of new device to decrease pancreatic fistula

Eligibility criteria:
inclusion criteria: -all distal pancreatectomies performed in involved units exclusion criteria: * no sign of informed consent for entering in the study * emergency procedures
monitoring of ceftolozane-tazobactam plasmatic levels in critical patients

Conditions: Serious Infection

Summary: the aim of this study is to determine the ceftolozane-tazobactam plasmatic levels and and analyse the clinical impact that might have the dose regimens that have been used until now.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old. * hospitalised for a serious illness. * treated with ceftolozane-tazobactam * patients that signed the informed consent. exclusion criteria: * allergic to any component of ceftolozane-tazobactam. * any surgical or medical evidence that according to the investigator could interfere with the pharmacodynamics of the medication: absorption, distribution, metabolism or excretion. * concomitant terminal illness. * unable to sign the informed consent.

Keywords: ceftolozane-tazobactam plasmatic levels serious infection dose adjustment
treatment of lateral epicondylalgia with shock waves

Conditions: Epicondylitis of the Elbow; Epicondylitis, Lateral

Summary: lateral epicondylalgia (let) is characterized by pain, decreased muscle strength of the wrist extensor muscles, and disability. among the treatments proposed in the literature, both focal shockwave therapy and radial shockwave therapy have been considered effective in the management of this musculoskeletal disorder. the objective of this study is to compare the safety and effectiveness of these two shockwave applications on the signs and symptoms of subjects with lateral epicondylalgia. in this clinical trial, subjects will be evaluated for elbow pain using a visual analog scale (vas), grip strength using a handheld dynamometer, and degree of disability using the patient-rated tennis elbow evaluation questionnaire (prtee). a six-month follow-up will be performed. patients will be randomly divided into three groups. the first group will receive radial shock waves (reswt), the second group will receive focal shock waves (feswt), and the third group, which will act as a control, will receive a placebo treatment with very low energy parameters according to the literature. subjects will receive three sessions, one session per week.


Eligibility criteria:
inclusion criteria: * pain in the lateral epicondyle \>3 months * pain when performing resisted grip * positive cozen test * positive maudsley test exclusion criteria: * pregnancy * systemic diseases (fibromyalgia, diabetes, arthritis) * local infection or cancer * recent treatments (physiotherapy, corticosteroids)-
a study of cm512 in patients with chronic rhinosinusitis with nasal polyposis （nezha-1）

Conditions: Chronic Rhinosinusitis With Nasal Polyposis

Summary: this is a multi-center, randomized, double blind, placebo-controlled phase ii study to evaluate the efficacy and safety of cm512, and to observe the life quality of subjects, the pharmacokinetics, pharmacodynamics and immunogenicity of cm512 in patients with chronic rhinosinusitis with nasal polyposis (crswnp).

the study consists of a screening period (up to 4 weeks), treatment period (24 weeks for double-blind treatment period) and safety follow-up period (12 weeks).

Eligibility criteria:
inclusion criteria: * with chronic rhinosinusitis with nasal polyposis (crswnp). * nasal polyp score (nps) of ≥5 with a minimum score of 2 in each nasal cavity. * nasal congestion score of 2 or 3 at screening period, and at least 2 at baseline. * contraception. exclusion criteria: * not enough washing out period for previous therapy, e.g., less than 10 weeks or 5 half-lives (whichever is longer) for interleukin (il)-4 receptor alpha subunit antagonists, less than 8 weeks or 5 half-lives for biologic therapy/systemic immunosuppressant, less than 6 months for sinus surgery (including polypectomy).with malignant or benign tumor of nasal cavity. * vaccination with live attenuated vaccine within 30 days before randomization or during the planned study period.
cd inform: investigating natalizumab through further observational research and monitoring

Conditions: Crohn's Disease

Summary: the primary objective of the study is to determine the incidence and pattern of serious and/or clinically significant infections, malignancies, and other serious adverse event (sae) in participants with crohn's disease (cd) treated with natalizumab. the secondary objective of this study in this study population is to evaluate disease severity over time in participants with cd treated with natalizumab based on changes in the harvey-bradshaw index (hbi).

this study was originally conducted by elan pharmaceuticals, inc. (elan) in collaboration with biogen under a protocol written by elan. biogen is solely responsible for the study since april 2013.

Eligibility criteria:
key inclusion criteria: * subjects with crohn's disease (cd) who are eligible for therapy according to us tysabri label and who are enrolled in the tysabri outreach unified commitment to health (touch) prescribing program. key exclusion criteria: * none note: other protocol defined inclusion/ exclusion criteria may apply.
evaluation of the amiens university hospital neuroradiology anticoagulation protocol

Conditions: Aneurysm

Summary: to prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. however, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. furthermore, the correlation between the point-of- care tests used at amiens university hospital and the reference methods used in the laboratory varies considerably according to the available literature.

since the beginning of the 2000s, the reference treatment for the management of aneurysmal subarachnoid haemorrhage consists of interventional neuroradiology with coil embolization of the aneurysm. although ensuring a better neurological prognosis than neurosurgical clipping, interventional neuroradiology exposes the patient to various risks: thromboembolic complications during or after embolization and re-rupture of the aneurysm during embolization. to prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. however, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. furthermore, the correlation between the point-of- care tests used at amiens university hospital and the reference methods used in the laboratory varies considerably according to the available literature.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at amiens university hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation. exclusion criteria: * patients in whom all modalities of monitoring of the efficacy of anticoagulation (laboratory tests and point-of-care tests) were not performed, incomplete embolization or radiological follow-up records. * patients presenting a contraindication to the administration of unfractionated heparin: history of heparin-induced thrombocytopenia or haemorrhagic coagulopathy (von willebrand disease, haemophilia).

Keywords: anticoagulation aneurysmal subarachnoid haemorrhage interventional neuroradiology coil embolization
energy metabolism in branched-chain organic acidemias

Conditions: Energy Metabolism; Metabolic Syndrome; Insulin Resistance

Summary: energy metabolism and insulin sensitivity were assessed in a case-control study in patients with branched-chain organic acidemias.

children and adults with branched-chain organic acidemias and matched healthy humans underwent deep metabolic phenotyping using non-invasive magnetic resonance spectroscopy, oral glucose tolerance tests and measurements of leucocyte respirometry in order to assess changes in energy metabolism and insulin sensitivity.

Eligibility criteria:
inclusion criteria: * known branched-chain organic acidemia diagnosed by enzymatic or genetic test * age\>5 years exclusion criteria: * acute inflammatory conditions with fever, cold symptoms, gastro-intestinal infection within the last 24 hours * contraindications for an oral glucose tolerance test such as fasting blood glucose \>126 mg/dl, severe chronic gastrointestinal conditions, allergy against black currant * contraindications for magnetic resonance tomography (mrt) such as claustrophobia, metallic implants which are not mrt compatible

Keywords: organic acidemias mitochondria oxidative stress fatty liver dyslipidemia
trial of prophylactic versus empirical vancomycin for the prevention of streptococcal sepsis after hematopoietic cell transplantation

Conditions: Streptococcal Sepsis; Hematologic Malignancies

Summary: this is a randomized 2-arm study to compare two different times of giving the drug vancomycin. half of the patients will begin vancomycin two days before a bone marrow transplant. the other half will get it as soon as they have the first fever. streptococci are bacteria that live in one's mouth and gut. these bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy. this can make the person who is undergoing a bone marrow transplant very sick. all patients who get this infection are treated with antibiotics. vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed. studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection. however, giving vancomycin too soon may increase the chance that the kidneys will be irritated. it may also increase the chance that other bacteria will become resistant to this drug. we, the investigators at memorial sloan-kettering cancer center, do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection.

the primary objective of this study is as follows: * to compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (hsct) patients. the secondary objectives of the study are: * to examine the safety and tolerability for each vancomycin administration approach. * to measure the incidence of vancomycin-resistant enterococcal (vre) infections for patients managed with each of the two vancomycin administration approaches.

Eligibility criteria:
inclusion criteria: * adult patients undergoing allogeneic hsct for hematologic malignancies or other disorders * conditioning regimen that includes high-dose total body irradiation (tbi) (\>1200 cgy) * the ability to understand and the willingness to sign the institutional review board (irb)-approved informed consent, including the research authorization component of the informed consent form. exclusion criteria: * non-tbi conditioning regimen * prior history of hypersensitivity to vancomycin (excluding history of "red man syndrome") * fever or infection that requires intravenous vancomycin or oral/intravenous linezolid between day-7 and day-3 before hematopoietic stem cell transplant

Keywords: streptococcal sepsis hematopoietic stem cell transplantation hematologic malignancies streptococci transplant
ins, b cells and microbiota

Conditions: Microbiota; B-lymphocytes; Glomerulosclerosis; T-lymphocytes

Summary: idiopathic nephrotic syndrome (nis) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (lgm) or segmental and focal hyalinosis (hsf). the complication of this kidney disease is the progression towards chronic renal failure and in case of kidney transplantation, its immediate recurrence on the graft . the origin of this syndrome is unknown but a number of clinical observations tend to show an involvement of immune system. a link has been highlighted between atopy, diet and nephrotic flare-ups. the speed of recurrence of this initial disease on the graft and the observation of remissions obtained after treatment by plasma exchange or immunoadsorptions support the presence of a pathogenic plasma factor. anti-cd20 treatments depleting b lymphocytes has made it possible to favorably treat a number of patients. dysfunction of regulatory t cells has also been shown in sni patients. this modification seems linked to allergies and could be due to an aberrant microbiota. the hypothesis of causality between dysbiosis, alteration lymphocyte and triggering of an sni was mentioned recently. two studies have shown intestinal dysbiosis in pediatric sni/lgm, with reduction of t circulating regulators


Eligibility criteria:
inclusion criteria : * patient treated in participating centers * in nephrotic attack, defined biologically by: proteinuria \> 3g 24h or a proteinuria/creatinuria ratio \> 3 or defined at the discretion of the clinician non inclusion criteria : * patient with a history of nis flare-ups resistant to corticosteroid therapy * patient treated with immunosuppressant * patient treated with corticosteroids \> 10 mg/d * weight \<50 kg * pregnant woman * patient under guardianship / curatorship

Keywords: idiopathic nephrotic syndrome focal segmental glomerulosclerosis microbiota b lymphocytes regulatory t cells
salivary therapeutic drug monitoring of anti-tuberculosis drugs

Conditions: Tuberculosis

Summary: in tuberculosis patients, salivary concentrations will be compared to plasma/serum concentrations of several anti-tuberculosis drugs. if salivary concentrations correctly represent blood concentrations, this non-invasive sampling of saliva could be used for tdm of the tested drugs.

tdm (therapeutic drug monitoring) with blood samples is already part of the treatment of some tuberculosis (tb) patients to reduce development of drug resistance and toxic drug concentrations. performing tdm with saliva instead of plasma or serum could reduce the burden of blood sampling. this study examines if this non-invasive sampling of saliva could be used for tdm of several anti-tb drugs. the study is an observational cohort study with adult tuberculosis patients as subjects. the drugs that are studied are isoniazid, rifampicin, ethambutol, pyrazinamide, moxifloxacin, amikacin, kanamycin, capreomycin, ethionamide, prothionamide, cycloserine, terizidone, linezolid, clofazimine, bedaquiline, delamanid, p-aminosalicylic acid (pas), imipenem-cilastatin, meropenem, ertapenem, amoxicillin-clavulanate and thioacetazone. saliva samples will be taken simultaneously with blood samples for standard tdm. serum/plasma and saliva drug concentrations will be determined with a validated lc-ms/ms (liquid chromatography-tandem mass spectrometry) method. the correlation and linearity between saliva and plasma/serum concentrations will be tested. the saliva-plasma or serum ratio based on area under the time-concentration curve (auc) is calculated for the investigated anti-tb drugs. also pharmacokinetic parameters in serum/plasma and saliva will be calculated and compared to provide a complete image of pharmacokinetics of the anti-tb drugs in saliva.

Eligibility criteria:
inclusion criteria: * tuberculosis is confirmed by culture or molecular test * patient is treated with anti-tuberculosis drugs included in study * patient receives therapeutic drug monitoring (tdm) in routine care * patient signed informed consent exclusion criteria: * patient with severe problems in the oral cavity, making saliva sampling painful
changes in angle kappa and corneal back elevations after laser in situ keratomileusis in myopic astigmatism

Conditions: Refractive Errors

Summary: refractive errors and corneal astigmatism are associated with changes in angle kappa and corneal back elevation at the thinnest point in pentacam. the purpose of this study is to track: the effect of anterior corneal astigmatism treatment on angle kappa and corneal back elevation.

this prospective observational study will be settled in ain shams university hospital, cairo, egypt.

Eligibility criteria:
inclusion criteria: myopic astigmatism exclusion criteria: corneal scar