Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, and withdrawal and retreatment with brodalumab in moderate to severe plaque psoriasis subjects

Conditions: Psoriasis

Summary: the purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses.

the purpose of this study is to assess the safety and efficacy of brodalumab taken every two weeks at two different doses in participants with moderate to severe plaque psoriasis. a second purpose of this study is to assess the safety and efficacy when brodalumab is replaced with placebo in some participants compared with the participants who are still receiving the brodalumab.

Eligibility criteria:
inclusion criteria: * subject has had stable moderate to severe plaque psoriasis for at least 6 months * subject must be considered, in the opinion of the investigator, to be a suitable candidate for treatment with a biologic per regional labeling * subject has involved body surface area (bsa) ≥ 10%, pasi ≥ 12, and spga ≥ 3 at screening and at baseline exclusion criteria: * subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations * subject has known history of crohn's disease * subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol * subject has stopped using certain psoriasis therapies as defined in the study protocol * subject has previously used any anti-il-17 biologic therapy

Keywords: psoriasis, brodalumab (amg 827)
insulin clamp ancillary study for assessment of insulin resistance

Conditions: Type 1 Diabetes

Summary: insulin clamp ancillary study for assessment of insulin resistance will be conducted as a sub-study to the main protocol, metformin therapy for overweight adolescents with type 1 diabetes (nct01881828). the purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (ir) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to \ 85th percentile ( total daily insulin dose \>0.7 units/kg, and hba1c 7.0%-9.9%).


Eligibility criteria:
inclusion criteria: 1. meets eligibility criteria of the main study, metformin therapy for overweight adolescents with type 1 diabetes (nct01881828). exclusion criteria: 1. low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a hematocrit \<30% or hemoglobin \<10 gm/dl
suicide prevention algorithm in the french overseas territories

Conditions: Suicide Attempt

Summary: in france, suicide behaviours are a major public health concern that triggered the creation in 2013 of a national observatory of suicide. in continental france, the "algos" protocol was found to be effective for the prevention of suicide attempts reiterations. this protocol is based on a procedure that keeps telephone and postal contacts with the suicide attempter and allows, via an algorithm, to assess the risk of suicide attempt recurrence, in order to intervene if necessary. nevertheless, algos does not involve primary care health practitioners, who could add a substantial additional efficacy, especially if they intervene downstream and in supplement to algos. in addition, this kind of protocol has never been evaluated in the french overseas territories.

since (1) algos was never implemented in the french overseas departments (fod) and does not involve primary care practitioners (pcp), (2) the additional effect of pcp involvement over and beyond algos alone in unknown, and (3) little research on suicide behaviours has been conducted in the fod, this proposal has the following main aim: to assess the effectiveness and the efficacy of the intervention, in supplement and downstream to algos, of a healthcare professional, on the recurrence of suicide attempts in the fod; the healthcare professional will be the patient's general practitioner, whenever possible.

Eligibility criteria:
inclusion criteria: * man or woman over 16 years of age * leaving the hospital within 15 days of the suicide attempt * giving (him/herself or his/her legal representative)an oral consent to participate in the study * having healthcare insurance * reachable by phone, with possibility of confidential conversation, and by mail * resident of guadeloupe, french guyana, martinique, or reunion island * able to understand and speak french exclusion criteria: * homeless person * disabled adult, person under judicial/court protection, legally incompetent adult * participant unable to understand the study protocol, its risks and side effects, or declining to participate

Keywords: suicide suicide attempted secondary prevention relapse prevention case management intervention study
screening single-operator cholangioscopy for neoplastic bile duct lesions

Conditions: Cholangiocarcinoma; Bile Duct Neoplasms

Summary: this is the prospective observational study to explore whether the spyglass ds ii system could be used to screen early-stage neoplastic bile duct lesions in selected patients.

it is difficult to diagnose neoplastic bile duct lesions (including cholangiocarcinomas) via direct endoscopic evaluation of the bile duct. most evaluations of biliary lesions have used indirect imaging modalities such as ct, mri, or ercp. however, ct and mri do not yield tissue diagnoses, unlike ercp, although the diagnostic accuracy for the latter remains unsatisfactory. recently, remarkable advances in cholangioscopic systems have been made. of the currently available cholangioscopic systems, the spyglass (boston scientific co, natick, mass, usa) is a disposable cholangioscope permitting 4-way deflected steering by a single operator. we aimed to evaluate the efficacy of single-operator cholangioscopy (spyglass ds ii system) to screen for neoplastic bile duct lesions in patients with bile duct stones, which is one of the risk factor of cholangiocarcinoma.

Eligibility criteria:
inclusion criteria: 1. aged \> 18 years 2. patients with risk factors for cca (viral hepatitis, parasitic infection, choledochal cyst, primary sclerosing cholangitis, biliary stones, and toxins) 3. patients who undergo ercp for confirmation of cbd clearance 4. dilated common bile duct (\> 10 mm) 5. previous sphincteroplasty, such as major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation exclusion criteria: 1. presence of biliary tract cancer 2. presence of distal cbd stricture 3. bleeding tendency (inr\>1.5 or platelets \<50000 mm3) 4. contraindications of ercp
lung ultrasound in pediatric cap

Conditions: Pneumonia

Summary: community-acquired pneumonia (cap) represents the single largest cause of death and morbidity in children worldwide (1). respiratory viruses are the most common cause of cap in preschool children, followed by bacteria. the atypical bacteria mycoplasma pneumoniae and chlamydia pneumoniae are common causes of pneumonia in children \&gt;5 years. the identification of the causal agent is pivotal, especially in children who require hospital admission, as it guides the choice of appropriate treatment. however, the microbial diagnosis of cap in children is not easy to establish without invasive procedures, and chest x-ray has failed to identify the aetiology of cap. clinical features of bacterial pneumonia, atypical bacterial pneumonia or viral pneumonia frequently overlap and cannot be used reliably to distinguish between the various aetiologies, as well as blood tests like white blood cell, c-reactive protein, including the more recently introduced serum procalcitonin (85% sensitivity and 45% specificity in identifying children without typical bacterial cap. as a consequence, children with cap usually receive unnecessary empirical antibiotics, contributing to the spread of antibiotic resistance or to side effects. therefore, new methods, possibly fast, non- invasive and easily accessible in the outpatient settings (point-of-care) to optimize and personalize the management of children with suspected cap are urgently needed specific aim 1 to perform a clinical prospective study aimed to evaluate clinical, laboratory, microbiolical and outcomes data and to define lus patterns (ultrasonomic) in children with cap of different aetiologies: (viral, bacterial and atypical cap) in different italian regions (lazio, puglia). specific aim 2 development and validation of multi-factorial prediction models for the personalized diagnosis and management of paediatric cap and building of a decision support system (dss) based on validated prediction models that will be build based on the collection of \&quot;ultrasonomic\&quot;, clinical, laboratory, treatments, outcomes and microbiological data collected from all partners. in particular, we will: i) develop, validate, and improve prediction models for the prediction of aetiology, outcome and treatment response; ii) take advantage of prediction models to better inform patients/caregivers on the risks and benefits of the proposed treatments; iii) use the outcome of the prediction models to individualize the management


Eligibility criteria:
inclusion criteria: * bambini con diagnosi clinica di infezione delle basse vie respiratorie acuta (alrti) (basata su anamnesi, esame clinico, esami del sangue (se eseguiti) e cxr (se eseguiti) sottoposti a lus entro sei ore dalla prima valutazione clinica exclusion criteria: * pazienti con patologie preesistenti, tra cui anomalie del tratto respiratorio, immunodeficienza, paralisi cerebrale, malattie neuromuscolari, cardiopatie congenite e tumori maligni
lipografting versus steroid injections for treatment of carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: this study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. the investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.

carpal tunnel syndrome (cts) is the most common entrapment neuropathy affecting up to 13% of americans; cts is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for cts treatment may be indicated. lipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. from observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions this study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.

Eligibility criteria:
inclusion criteria: * primary mild to moderate carpal tunnel syndrome (cts) * report symptoms longer than 6 months * night pain * weakness * sensory deficits * fluent english-speaking adult (\>18) exclusion criteria: * \<18 years old * non-english speaking * injection in past 6 months * previous hand surgery * previous hand trauma (fracture or dislocation)

Keywords: carpal tunnel injection steroid lipografting numbness tingling median nerve
acupuncture for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: little is known about acupuncture's efficacy for irritable bowel syndrome (ibs). this trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. in addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. cortisol levels (an important stress hormone) will also be assessed. this will be a 3-arm trial: active acupuncture, placebo acupuncture, and wait list.


Eligibility criteria:
inclusion criteria: diagnosis of irritable bowel syndrome based on rome ii criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features: * relief with defecation * onset associated with a change in stool frequency * onset associated with a change in form/appearance of stool exclusion criteria: * history of severe or intractable ibs, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day * previous acupuncture treatment * concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study * history of laxative abuse * previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable) * history of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis * other significant illness as determined by investigator * history of drug or alcohol abuse w/in 2 years; * insufficient knowledge of english to complete self-assessments to participate in study

Keywords: irritable bowel syndrome acupuncture
safety and immunogenicity of cyt004-melqbg10 vaccine with and without adjuvant in advanced stage melanoma patients

Conditions: Malignant Melanoma

Summary: the purpose of this study is to evaluate a specific cellular immune response in melanoma patients that have been vaccinated with a melan-a vlp vaccine alone or in combination with different adjuvants.


Eligibility criteria:
inclusion criteria: * histological confirmed stage iii or iv malignant melanoma * hla-a\*0201 haplotype * expected survival of at least 9 months * willing and able to comply with all trial requirements (e.g. diaries, cts) * given written informed consent * females only if non-reproductive or if they agree to consistently practice an effective and accepted method of contraception exclusion criteria: * any contraindication to any study related test or assessment * current or planned use of contraindicated concomitant medication * presence or history of relevant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological and psychiatric disease * infection with hiv, hbv or hcv * pregnancy or lactation or females planning to become pregnant during the study * abuse of alcohol or other drugs * use of investigational drug within 30 days before enrolment * previous participation in a clinical trial with a qb-based cytos vaccine.
investigating variation in hospital acute coronary syndrome outcomes

Conditions: Acute Myocardial Infarction

Summary: to investigate the causes of hospital variation in outcomes from acute coronary syndromes in england and develop recommendations for improving patient care.

over the last few years the chance of dying from a heart attack in england and wales has reduced dramatically. even so, there remain huge differences in mortality between hospitals. for example, up to a third of patients with a heart attack who attend hospitals in england are more likely to die than would be expected. that is, the type of treatment and the risk of death depend upon where a patient lives and which hospital they attend. in part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation. it may also relate to other factors such as depression, cardiac rehabilitation, patient experience of hospital care and whether patients take their medication after discharge from hospital. notably, the challenges posed by poor drug adherence to secondary prevention medications are recognised by the world health organisation as the highest area of priority for improving individual health throughout the world. in addition, patient reported outcome measures (proms) are set to be the cornerstone of the evaluation of patient experiences of national health service quality of care. using statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in england and investigate the 'postcode lottery of care'. our aim, using regional data about heart attacks is to identify and measure the effects of hospital care. this research will identify hospital qualities that promote improved patient care. in doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.

Eligibility criteria:
inclusion criteria: age \> 18 years, both sexes, acute admission to the acute trust with suspected acute coronary syndrome (acs). exclusion criteria: patients at a terminal stage of any illness, and those in whom follow up would be inappropriate or impractical.

Keywords: mortality acute myocardial infarction drug adherence drug compliance health-related quality of life
comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (bio-resort)

Conditions: Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable; Myocardial Infarction; Coronary Artery Disease; Coronary Stenosis; Coronary Restenosis

Summary: the introduction of drug-eluting stents (des) in the treatment of coronary artery disease has led to a significant reduction in morbidity. however, the first generation of these devices had no positive impact on the mortality after pci (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of des with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. while such biodegradable polymer des are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer des.


Eligibility criteria:
inclusion criteria: * minimum age of 18 years. * significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement. * capable of providing informed consent. * patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated. exclusion criteria: * known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy. * planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization. * participation in another randomized drug or device trial before reaching primary endpoint. * adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year. * known pregnancy

Keywords: drug-eluting stent zotarolimus everolimus sirolimus all comers population target vessel failure coronary artery disease durable polymer biodegradable polymer
a study of memp1972a in patients with allergic asthma inadequately controlled on inhaled steroids and a second controller (costa)

Conditions: Asthma

Summary: this randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of memp1972a in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.patients will be randomized to 4 arms to receive subcutaneous repeating dose of either memp1972a 150 mg, 300 mg, or 450 mg, or placebo. patients will continue their usual asthma medication throughout the study. anticipated time on study treatment is 36 weeks, with a 48-week follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 75 years of age inclusive * body weight \>/= 40 kg * physician's diagnosis of asthma for at least 12 months * evidence of documented bronchodilator reversibility as defined by protocol * prebronchodilator fev1 \>/= 40% and \</= 80% predicted at visit 1 * required daily use of ics and a second controller for a minimum of 3 consecutive months prior to visit 1 * history of at least one protocol-defined asthma exacerbation in the 18 months prior to visit 1 * inadequately controlled asthma despite compliance with asthma controller therapy exclusion criteria: * asthma exacerbation requiring systemic steroids in the 30 days prior to visit 1 * pre-existing active lung disease other than asthma * any infection * clinically significant medical disease that is uncontrolled despite treatment or is likely to require a change in therapy during study or is of unknown etiology * known immunodeficiency, including but not limited to hiv infection, regardless of treatment status * current substance abuse * former smoker with \>10 pack-year history or current smoker; former smokers must have stopped smoking more than 12 months prior to visit 1 * history of anaphylaxis * pregnant and lactating women