Kornimate/medical-research-clean huggingface dataset:
predicting aneurysm growth and rupture with longitudinal biomarkers

Conditions: Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm, Ruptured

Summary: first aim: paris study the main aim of the current study is to determine the association between abdominal aortic aneurysm (aaa) progression and the evolution of proteases and cytokines levels.to achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. aortic tissue will only be obtained when patients undergo conventional open repair. the other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year. second aim: pearl aaa biobank for future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. this biobank will be embedded within the infrastructure of the 'parelsnoer institute' (psi) and will be called pearl aaa. the pearl aaa will be established in the extension of the paris study

the paris study aims to determine the correlation between aaa progression (growth or rupture) and the evolution of serum levels of proteases and cytokines over time. a repeated measures analysis will be done to use all longitudinal data available. the pearl aaa biobank will be established to enable the paris study, but also aims to facilitate future research. such future research should fall under the scientific aims of the pearl aaa, which are: * to gain insight in the pathogenesis of aaa * to gain more knowledge in the rupture risk of aaa * to evaluate and potentially improve treatment of aaa the 'parelsnoer institute' will facilitate the biobank pearl aaa with certain aspects such as, but not limited to the following: * standardized operating procedures for the collection and storage of the biosamples across all participating hospitals * information architect to establish a data dictionary in which all variables are defined * standardized procedures for coding of patient data before storage * standardized digital infrastructure to enhance storage of patient data and imaging data

Eligibility criteria:
inclusion criteria: * adult participant (18 years or older) * participant has an aaa or has previously been treated for an aaa * adequate comprehension of the dutch language to provide written informed consent exclusion criteria: * a patient who is decisionally impaired. the only exception to this are the patients who are decisionally impaired due to the effects of an acute aaa. this particular group is eligible for which a separate recruitment and consent procedure exists.

Keywords: biobank pathogenesis aortic aneurysm
catheter ablation as the first line therapy for typical atrial flutter

Conditions: Atrial Flutter

Summary: catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. it has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. we sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. this study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. clinical examination, quality of life questionnaires,12 leads ecg and 24-hour holter monitoring are performed at 1, 3, 6 and 12 months following randomization.the primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. the secondary end points are the cost and the cost/effectiveness ratio of these two approaches.


Eligibility criteria:
inclusion criteria: * first episode of symptomatic typical atrial flutter * \> 18 years old exclusion criteria: * prior antiarrhythmic drug treatment for atrial flutter * history of cavotricuspid isthmus ablation * pregnancy * hyperthyroidism * contraindication for anticoagulant therapy * life expectancy \< 1 year * contraindication to catheter ablation or to electrical cardioversion

Keywords: arrhythmia atrial flutter catheter ablation
a clinical study of ibi130 for subjects with unresectable, locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1/2 multicenter, open-label, first-in-human study of ibi130. it includes a phase 1 dose escalation and expansion section to identify mtd/rp2d of ibi130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of ibi130 at rp2d in specified types of solid tumor.approximately 150 evaluable subjects will be enrolled for phase 2.


Eligibility criteria:
inclusion criteria: 1. subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. male or female subjects ≥ 18 years old; 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 4. anticipated life expectancy of ≥ 12 weeks; 5. adequate bone marrow and organ function exclusion criteria: 1. enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study; 2. received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter; 3. plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study; 4. received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
neuronal and behavioral effects of an implicit priming approach to improve eating behaviors in obesity

Conditions: Overweight and Obesity

Summary: the purpose of this study is to determine how different behavioral interventions designed to alter food perceptions and behaviors affect brain responses to food, eating behaviors, and body weight.


Eligibility criteria:
inclusion criteria: * 18-65 years old * bmi of 27 or greater exclusion criteria: * mri contraindications (e.g., metal or electronic devices in the body) * pregnancy

Keywords: eating overweight obesity food weight loss magnetic resonance imaging neuroimaging brain body weight
immunogenicity study of the japanese encephalitis vaccine ic51

Conditions: Japanese Encephalitis

Summary: the objective is to demonstrate the non-inferiority of the japanese encephalitis vaccine ic51 compared to je-vax in healthy subjects aged \> or = 18 years


Eligibility criteria:
inclusion criteria: * at least 18 years of age * written informed consent obtained prior to study entry exclusion criteria: * history of clinical manifestation of any flavivirus infection * history of vaccination against japanese encephalitis (je), yellow fever and dengue fever (an anti-jev neutralizing antibody titer \>= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis) * use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine * immunodeficiency including post-organ-transplantation or immunosuppressive therapy * a family history of congenital or hereditary immunodeficiency * history of autoimmune disease * any acute infections within 4 weeks prior to enrollment * infection with hiv, hepatitis b or hepatitis c * pregnancy, lactation or unreliable contraception in female subjects
improved prediction of severe sepsis in the emergency department

Conditions: Systemic Inflammatory Response Syndrome (SIRS); Sepsis; Severe Sepsis; Septic Shock

Summary: the purposes of this study is to determine whether heparin binding protein (hbp) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years * suspected infection * one or more sirs criteria
evaluation of a new therapeutic strategy in early and active relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the aim of the study is to determine whether a therapeutic strategy combining mitoxantrone and interferon beta1b can delay disease progression of at least one point on edss scale in patients with clinically very active relapsing-remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * age : 18-45 years, * clinical disease satisfying the poser criteria (amdmt n°4) * relapsing-remitting disease (amdmt n°4) * at least 2 exacerbations within the preceding 12 months, having left sequelae, * mri activity at inclusion expressed by at least one gadolinium-enhanced lesion (cranial mri with 0.1mmol/kg gadolinium), * a significant disability at inclusion: edss score between 2.5 and 5.5 (amdt n° 4) * written informed consent exclusion criteria: * pregnancy and breast-feeding * use of an insufficiency effective contraceptive method, * general immunosuppressive therapy using cyclophosphamide, mitoxantrone,or total lymphoid irradiation * treatment with azathioprine during the 3 months preceding the study * clinical relapse or intensive corticosteroid treatment within the 30 days preceding inclusion, * associated disease (psychiatric disorder, depressive statenot controlled by appropriate drug therapy, history of heart disease at inclusion examination

Keywords: multiple sclerosis mitoxantrone methylprednisolone interferon beta1b relapse mri edss
clinical characteristics of importance to outcome in patients with spondyloarthritis

Conditions: Spondyloarthropathy

Summary: the objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (spa) treated with biologics. further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.

patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an active disease state, will be enrolled in this observational study. the overall aim is to investigate extra-articular manifestations, pain mechanisms and patient-reported outcomes and elucidate if these factors - independently or by interaction - influence treatment response after ≥ 3 months. patients will have a baseline visit, an eye examination and a follow up visit after ≥ 3 months. clinical examinations will be performed at both time points and include: 1. clinical examination (the spinal movement) 2. assessment of pain mechanisms by clinical evaluation (basdai, tender points,) and pain questionnaires (paindetect). 3. the sparcc enthesitis index will be used to enthesitis count. 4. interview and questionnaires regarding lifestyle, comorbidity, function and quality of life 5. blood samples 6. urine samples 7. stool samples clinical as well as patient-reported and observer-based outcomes will be described for the overall study population and the prognostic influence of extra-articular manifestations, comorbidity and pain mechanisms will be analysed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with spa * ≥18 years of age at time of consent * ability and willingness to give written informed consent and to meet the requirements of this protocol * patients must have a history of active disease and a basdai \>40 (10-100) or elevated c-reactive protein, despite current or previous nsaids therapy exclusion criteria: * age \< 18 years * no consent * pregnancy * active or latent tb * diagnosed human immunodeficiency virus * diagnosed hepatitis * current or past malignant disease * recurrent or chronic infection (viral, fungal or bacterial) * multiple sclerosis * heart failure (nyha class iii/iv)

Keywords: spondyloarthropathy ankylosing spondylitis spinal diseases spondylitis spondylarthritis psoriasis uveitis joint diseases
efficacy of azd3199 in chronic obstructive pulmonary disease (copd) patients

Conditions: COPD

Summary: the purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with azd3199 in moderate to severe copd.


Eligibility criteria:
inclusion criteria: * copd * current or exsmokers, 10 pack years exclusion criteria: * asthma * any clinically relevant abnormal findings at screening examinations * recent copd exacerbation

Keywords: copd efficacy safety inhalation
characteristics of adult patients with melanoma diagnosis <40 years age.

Conditions: Melanoma of Skin

Summary: the primary objective of the study is to analyse a local cohort of patients aged 18-39 years with melanoma diagnosis in order to determine the prevalence of the disease in this age group. secondary objectives are the following: * to identify risk factors associated with melanoma in young people. * to characterise the phenotype and dermoscopic features of melanoma in patients aged 18-39 years. * to analyse the relationship between the clinical and histopathological features of melanoma in young people. * to identify the mutational status of b-raf in the sample of patients analysed.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age \> 18 years and \< 40 years 3. diagnosis of cutaneous melanoma even non-primary exclusion criteria: -
oral viscous budesonide in anastomotic stricture after esophageal atresia repair (ovb in ea)

Conditions: Esophageal Atresia; Anastomotic Stenosis

Summary: the aim of this study is to perform a multicentre, prospective, randomized, placebo controlled, double-blinded study to demonstrate the potential and beneficial effects of ovb in the prevention of recurrence of anastomotic stricture in children operated for esophageal atresia with an anastomotic stricture.


Eligibility criteria:
inclusion criteria: * children aged \> 1 month to 3 years * operated for an esophageal atresia of all types except pure tef. * presence of an anastomotic stricture defined according to experts recommendations : * a relative esophageal narrowing at the level of the anastomosis, * demonstrated by a contrast study and/or an endoscopy * with significant functional impairment and associated symptoms requiring dilation. * symptoms include: feeding or swallowing difficulties, coughing and choking during feeds, food impaction, regurgitation/vomiting of undigested food, drooling. in very young patients: apnea and food refusal. * receiving an ongoing treatment by ppi 1 to 2 mg/kg die * informed parental consent exclusion criteria: * known immune deficiency * acute respiratory or intestinal infection * severe respiratory, cardiac or neurological condition precluding ovb or placebo swallowing * child fed exclusively via nasogastric tube or gastrostomy * absence of parental consent
remote assessment of cognition, insulin resistance and omega-3 fatty acid biomarkers in breast cancer survivors

Conditions: Breast Cancer; Obesity

Summary: majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and type 2 diabetes mellitus (t2dm). women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. omega-3 polyunsaturated fatty acids (pufas) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. the purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 pufas with insulin resistance and cognitive function in obese breast cancer survivors. due to the global pandemic caused by the coronavirus disease of 2019 (covid-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. the study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. upon receipt of blood samples and completion of all study questionnaires, participation will be complete.


Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer diagnosis * between 1-4 years post-breast cancer diagnosis * postmenopausal (at least 1 year post-menses) * ability to access and use internet resources, including zoom video calls * english speaking exclusion criteria: * diagnosis of type 2 diabetes mellitus * unwillingness to complete finger prick for blood collection

Keywords: chemotherapy cognitive impairment breast cancer survivor diet remote assessment
animal assisted mindfulness intervention (aami) for patients with acquired brain injury

Conditions: Acquired Brain Injury

Summary: the aim of this study is to investigate the effect of an animal assisted mindfulness intervention (aami) on patients with acquired brain injuries on their global severity of psychological distress. in addition, the effects on the patients' symptoms of depression, anxiety, perceived stress, mood, coping and mindfulness/self-compassion will be assessed. the study experimental condition consists of 6 weeks of intervention, containing 6 different modules. in every session, an animal will be present. in the control condition, the same program and same exercises will be used without the presence of or reference to animals. sessions take place two times a week for 6 weeks (leading up to a total of 12 experimental/control sessions), each lasting for about 60 minutes. 24 participants are planned to be included, 12 patients in each group.

it was estimated that a total sample of 24 participants (12 patients in each group) would provide enough power to detect a medium effect. since we had several dropouts, two additional groups (one intervention and one control) were started. this lead to the inclusion of 31 participants with a total sample size of 25 participants finishing the program.

Eligibility criteria:
inclusion criteria: * patients of rehab basel * acquired brain injury (abi); fim (functional independence measure) cut-off score defined as \> 60 * depressive or/and anxiety symptoms * psychological difficulties coping with the actual life situation * 18 years or older * willing to work with therapy animals * german speaking * willingness to participate/informed consent exclusion criteria: * communication and articulation is not possible * allergy to animals * aversion against animals * schizophrenic-related comorbidity * mobilization to "therapietiergarten" not possible
bruxism and underlying psichological factors

Conditions: Bruxism; Muscular Disorders, Atrophic; Temporomandibular Joint Disorders

Summary: the aim of this study was o determine the relationship between self-reported bruxism (sb) and some psychological factors (i.e: anxiety state-trait; stress reactivity index, beck depression inventory). a consecutive sample of 101 patients that reported at least 2 of the 6 items of bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory.

the bruxism self-reported index was that reported by pintado et al. pintado mr, anderson gc, delong r, douglas wh. variation in tooth wear in young adults over a two-year period. j prosthet dent. 1997;77:313-320. the muscular pain was assessed by the last version of the research diagnostic criteria reported by the schiffman et al in 2014 schiffman e, et al ; international rdc/tmd consortium network, international association for dental research; orofacial pain special interest group, international association for the study of pain. diagnostic criteria for temporomandibular disorders (dc/tmd) for clinical and research applications: recommendations of the international rdc/tmd consortium network\* and orofacial pain special interest group†. j oral facial pain headache. 2014 winter;28(1):6-27.

Eligibility criteria:
inclusion criteria: * self-reported bruxism exclusion criteria: * refused patients
comparison of the efficacy and safety of q8003 versus its individual components in bunionectomy patients

Conditions: Moderate to Severe Postoperative Pain

Summary: this is a randomized, double-blind, multicenter, fixed dose factorial study of q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe postoperative pain following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * patient is male or female and at least 18 years of age. * females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). non-pregnancy will be confirmed by pregnancy tests conducted at screening and pre-treatment. * patient is scheduled for bunionectomy surgery, meets the criteria of an asa class i to iii, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. * to be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point likert scale or at least 4 on the 11 point nprs scale). exclusion criteria: * in the opinion of the investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that, in the opinion of the investigator, would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. * used opiates continuously (including tramadol) for more than ten days in the past year. * hypersensitivity or poor tolerance to ibuprofen or short term opioids. * currently receiving any medications that are not at a stable dose (the same dose for \> 4 weeks prior to date of surgery). * was dosed with another investigational drug within 30 days prior to the screening visit or has previously received treatment with q8003. * current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). * current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).

Keywords: bunionectomy opioids