Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety study of fsme-immun 0.5 ml in adult subjects previously vaccinated according to a rapid immunization schedule

Conditions: Encephalitis, Tick-Borne

Summary: the objective of this study is to investigate the immunogenicity and safety of fsme-immun 0.5 ml in two age strata (stratum a: 16 to 49 years, stratum b: \> 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). the third vaccination will be administered approximately 6 months after the first dose.


Eligibility criteria:
inclusion criteria: male and female subjects will be eligible for participation in this study if they: * understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age); * provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age); * are aged \>= 16 years (from the 16th birthday) at screening; * are clinically healthy, (i.e. the physician would have no reservations vaccinating with fsme-immun 0.5 ml outside the scope of a clinical trial); * have a negative pregnancy test result at the first medical examination (if female and capable of bearing children); * agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children); * agree to keep a subject diary. exclusion criteria: subjects will be excluded from participation in this study if they: * have a history of any previous tick-borne encephalitis (tbe) vaccination; * have a history of tbe infection; * have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, japanese b-encephalitis); * have a history of allergic reactions, in particular to one of the components of the vaccine; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions; * have a known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages); * have donated blood or plasma within 30 days of study entry; * have received a blood transfusion or immunoglobulins within 30 days of study entry; * are known to be hiv positive (an hiv test is not required specifically for the purpose of this study); * are simultaneously participating in another clinical trial including administration of an investigational product; * have participated in any other clinical study within six weeks prior to study entry; * are pregnant or breastfeeding (if female); * are a member of the team conducting this study or are in a dependent relationship with the study investigator. dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator. * have received any other vaccination within two weeks prior to study entry.
quality of life in patients with liver cancer treated with image-guided therapy

Conditions: Liver Cancer; Metastatic Cancer

Summary: rationale: gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future. purpose: this clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy.

objectives: * develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies. outline: this is a pilot, prospective, longitudinal study. patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. health and disease status and the development of other illnesses are assessed by medical record review. projected accrual: not specified

Eligibility criteria:
disease characteristics: * undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques: * x-ray * ultrasound * mri * ct scan * nuclear medicine imaging patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult primary liver cancer liver metastases
safety and efficacy of ledipasvir/sofosbuvir in adults with chronic hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) with or without ribavirin (rbv) in adults with chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * participants who failed treatment in study gs-us-334-0119 who meet relevant inclusion/exclusion criteria are eligible for retreatment in this study * chronic genotype 1 hcv infection * hcv treatment-naive * hcv rna \> 10,000 iu/ml at screening * absence of cirrhosis * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male key exclusion criteria: * pregnant or nursing female or male with pregnant female partner * infection with hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol * for hiv-1/hcv co-infected individuals: * opportunistic infection within 6 months prior to screening * active, serious infection (other than hiv-1 or hcv) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline * treatment with an antiretroviral (arv) regimen other than one of those listed in the study protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hcv genotype 1 hcv sustained virologic response direct acting antiviral combination therapy gs-7977 gs-5885 ribavirin sofosbuvir ledipasvir hepatitis c hepatitis c, chronic liver diseases virus diseases antiviral agents hcv/hiv co-infection
patient-reported outcome measures in wild-type and variant cardiac transthyretin amyloidosis

Conditions: Transthyretin Amyloidosis

Summary: specific, standardized, comprehensive, universally accepted patient-reported outcome measures (proms) are currently lacking for variant and wild-type cardiac amyloid transthyretin amyloidosis (v-attr/wt-attr). our goal is then to create two scores able to provide a cumulative assessment of cardiac involvement, peripheral neuropathy (in v-attr), and comorbidities, and their impact on the quality of life. in the setting of a nationwide collaboration involving 5 main italian referral centers for this condition (in ferrara, florence, pavia, pisa and messina), a panel will be created, including experts of attr cardiomyopathy, neurologists, geriatricians, health management specialists, as well as patients with either variant or wild-type attr cardiomyopathy (n=50). the most clinically relevant domains for patients (such as physical limitations, symptoms, self-efficacy and knowledge, social interference, quality of life, age-related issues, social and family environment, frailty, comorbidities) will be identified. two sets of 30 items (one for variant and another for wild-type attr cardiomyopathy) will be created in collaboration with patients. questions will be formatted for gender neutrality, clarity, interpretability, and possible foreign language translations. proms scores will be validated through administration to around 250 consecutive outpatients. score performance will be evaluated in terms of internal consistency, response to clinical changes, comparison with conventional clinical measures. the time needed for completion, the clarity of questions and the need for assistance from a family caregiver will be evaluated. this project will hopefully lead to the identification of disease-specific metrics that may serve as a clinically meaningful outcome in cardiovascular research, patient management, and quality assessment.


Eligibility criteria:
inclusion criteria: * diagnosis of cardiomyopathy due to attr amyloidosis, diagnosed by endomyocardial biopsy or on the basis of the algorithm for the non-invasive diagnosis of cardiac attr amyloidosis (gillmore et al., 2016). * clinical stability, defined as the lack of unscheduled hospitalizations and/or significant changes in cardiac therapies from at least 1 month. exclusion criteria: * lack of informed consent. * inability of understanding a written text in italian. * absence of the conditions of clinical stability, as defined above.

Keywords: amyloidosis transthyretin quality of life score cardiomyopathy
lumbar intervertebral disc herniation

Conditions: Lumbar Disc Herniation

Summary: the purpose of this study is to compare safety and outcomes of the following treatments of lumbar disc herniation: (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion. discectomy with posterior dynamic stabilization is proposed as the most effective treatment to improve range of motion, and to be similarly effective to discectomy alone and discectomy with internal fixation and fusion for other functional outcomes after surgery.

the purpose of this study is to compare outcomes of (1) discectomy with posterior dynamic stabilization with those of (2) discectomy alone or (3) discectomy with internal fixation and fusion. study aims are: 1. to demonstrate superiority of discectomy with posterior dynamic stabilization over discectomy alone and discectomy with internal fixation and fusion in range of motion at the operated level; 2. to demonstrate non-inferiority of discectomy with posterior dynamic stabilization compared to discectomy alone and discectomy with internal fixation and fusion in functional outcomes as measured by change in oswestry disability index; 3. to compare radiological, clinical, patient-reported and safety outcomes among the three surgical approaches.

Eligibility criteria:
inclusion criteria: * signed informed consent * age between 20 and 60 years inclusive * radiographic evidence of single level lumbar disc herniation * scheduled for single-level lumbar discectomy with or without fusion or dynamic stabilization * preoperative odi ≥ 30 * clinical symptoms consistent with lumbar disc herniation determined by history or physical exam: * radicular back or lower extremity pain and/or * decreased muscular strength and/or * abnormal sensation * involved disk at the spinal level between l2 and s1 * failed to gain adequate symptom relief from at least one month of adequate non-operative treatment, except in patients with severe symptoms that require immediate surgery (at surgeon's discretion) * absence of significant symptomatic adjacent segment disk herniation exclusion criteria: * cauda equine syndrome * previous spinal surgery, except previous discectomy at the same segment * patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease) * osteoporosis defined as t-score ≤ -2.5. bmd will be measured by dexa performed on lumbar spine * systemic infection such as aids, hiv, and active hepatitis * recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation * participation in a clinical trial of another investigational drug or device within the past 30 days

Keywords: lumbar disc herniation dynamic stabilization discectomy with posterior dynamic stabilization discectomy alone discectomy with internal fixation and fusion
evaluation of the a1cnow+ test kit

Conditions: Diabetes

Summary: the purpose of this study was to assure that consumers can successfully use the new version of a1cnow+ along with revised instructional materials.

the purpose of this study was to assure that consumers could successfully use the new version of a1cnow+ test kit along with revised instructional materials. the primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.

Eligibility criteria:
inclusion criteria: 1. adults (age 18 and older) approximately 80% being ≤55 years old 2. persons with: * known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site * no known diagnosis of diabetes - approximately 15% of subject population per site 3. individuals who are interested in performing a test using the kit at home 4. individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures) 5. individuals who are able to speak, read, and understand english 6. individuals able to read out loud the first 5 lines of the a1c test kit instructional materials to demonstrate ability to read the print (may use glasses, if needed) exclusion criteria: 1. individuals taking prescription anticoagulants (such as warfarin or heparin) or have clotting problems that may prolong bleeding. (taking plavix or aspirin daily is not excluded) 2. individuals with known rheumatoid arthritis or other condition causing significant impairment of manual dexterity 3. individuals with a known hemoglobin variant such as hbs or hbc 4. individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia) 5. individuals who have received a blood transfusion within the 4 months prior to the study. 6. persons with known infection with a bloodborne pathogen (e.g. hiv, hepatitis) 7. individuals working for a competitive medical device company 8. individuals who have participated in previous studies on the a1cnow+ product 9. persons missing a digit or partial digits on the hand 10. individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study: * significant visual impairment * significant hearing impairment * cognitive disorder * any other condition as per investigator's discretion
proposal for intraoperative administration of intravenous indocyanine green to evaluate position of the optic canal, position of the internal carotid arteries, tumor vascularization, and vessel encasement in endoscopic endonasal cranial base surgery

Conditions: Skull Base Neoplasms; Skull Neoplasms; Bone Neoplasm; Neoplasms; Bone Diseases; Musculoskeletal Disease

Summary: this study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.


Eligibility criteria:
inclusion criteria: * 18 years and above * patients undergoing an an eea for cranial base pathology that will require any of the following will be eligible for the study: optic canal decompression, intradural tumor dissection, dissection of tumor around the internal carotid artery. exclusion criteria: * less than 18 years of age * history of sulfa, iodide, or penicillin allergy * previous anaphylactic reaction to icg * women currently pregnant or nursing
the pain in intensive care unit: different rating system comparing

Conditions: Critical Illness

Summary: the purpose of this research is to find the best system for assessing the pain of critically ill patient in intensive care unit (icu). at first the investigators assess the sedation of the patient with the scale sedation-agitation scale (sas) or the delirium with the confusion assessment method, if the patient is too sedated or delirious the investigators consider him unable to use the visual analogic scale (vas). the investigators compare two different scales critical care pain observation tool (cpot) and behavioural pain scale (bps) which include no verbal items. each items has been evaluated in three different moments: before, during and after the nurses' care. the investigators compare the scales between them. then, every time the investigators value the score of these scales with the self-report of patients with the vas scale (when it is possible) and finally with the physiological parameters (blood pressure, heart rate and respiratory rate). in the end, the investigators compare two different classes of patient: the surgical and medical one. the investigators search for some differences in the perception of the pain between these two classes.

this study has specific aims: 1. to find the best method to evaluate the pain in critically ill patients; 2. to compare the perception of pain analysed trough cpot and bps; 3. to compare cpot and bps between medical and surgical patients.

Eligibility criteria:
inclusion criteria: * male and female * require of mechanical ventilation (mv) * hospitalization on icu \> 24 hours exclusion criteria: * age \< 18 years * tetraplegic * neuromuscolar disease * neuromuscolar blocking agents by continuous infusion * spontaneous breathing without mechanical ventilation (mv)

Keywords: pain icu mechanical ventilation cpot bps
different dyskinesias in parkinson's disease and their relation to levodopa pharmacokinetics

Conditions: Parkinson Disease; Dyskinesias

Summary: the purpose of this study is to study different kinds of dyskinesias in advanced parkinson's disease appearing at different levels of levodopa infusion dose. the hypothesis is that different dyskinesias (dystonia, chorea) correlate to different levels of levodopa concentrations, as detected in plasma.

by using duodenal infusion of levodopa/carbidopa, the plasma concentration of levodopa can be kept fairly constant. different doses, 10-20% higher or lower than the individually optimized dose will be used. motor performance is captured by video recordings to be compared to/correlated with plasma levodopa concentrations.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic parkinson's disease * ongoing treatment with duodopa * occurrence of dyskinesias, difficult to manage * age 30-90 years * hoehn \& yahr stage 3-5 at worst exclusion criteria: * treatment with dopamine agonist or glutamate antagonist * dementia * psychosis * treatment with typical neuroleptics

Keywords: dyskinesias duodenal levodopa infusion dose optimization pharmacokinetics pharmacodynamics
effect of single colonoscopy on colorectal adenomas detection

Conditions: Colonic Polyps

Summary: individualized colonoscopy withdrawal time is determined based on the different grade of physician experience and quality of bowel preparation.


Eligibility criteria:
inclusion criteria: 1. greater than the age of 40; 2. pathology and endoscopic data recorded available and detailed; 3. whole bowel staining endoscopy is not done. exclusion criteria: 1. not reach the ileocecal junction; 2. colorectal cancer; 3. familial adenomatous polyposis; 4. inflammatory bowel disease; 5. part of the bowel resection.
the safe fast track study

Conditions: Emergency Department; Non-specific Complaints

Summary: emergency departments (ed) internationally are treating an increasing number of patients. most require hospital services but some could be better cared for on alternative pathways. d-dimer has some unique properties. it is non-specific and is elevated in many acute condi- tions; but conversely remains normal in the absence of significant disease. previous studies have shown that having a normal d-dimer on arrival to the emergency department is associated with a very low risk of 30-day all-cause mortality. the investigators propose a multicenter randomized controlled trial using d-dimer to identify patients at low risk and test if providing this information will change time to discharge disposition by the treating physician.


Eligibility criteria:
inclusion criteria: * age 18 or above * able to provide oral and written informed consent in danish * blood tests ordered on arrival as part of standard of care * ambulatory on arrival or walking to the ambulance (i.e., stable independent gait) * normal vital signs (i.e., national early warning score \&lt; 3) exclusion criteria: * unstable condition requiring immediate care in the resuscitation area * triage level red (i.e., the most urgent patients) * trauma (minor and major) patients * high likelihood of requiring a d-dimer analysis on clinical indications during the current hospital contact (e.g., suspected venous thromboembolic disease) that will be ordered on arrival regardless of this study * previous participation in the study

Keywords: d-dimer fast track emergency
false lumen treatment for prevention of aortic growth using shape memory polymer - first-in-human study

Conditions: Aortic Dissection

Summary: to determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.


Eligibility criteria:
inclusion criteria: * ≥18 years of age. * a candidate for false lumen (fl) embolization with a type b dissection, and no prior primary entry tear/tl treatment, or * a candidate for fl embolization with a type b or type a dissection, in whom the primary entry tear/tl was treated in a previous procedure, and is now presenting with a fl requiring treatment. exclusion criteria: * an inability to provide informed consent. * enrolled in another clinical study other than a registry. * hyperacute or acute aortic dissection (\<15 days from symptom onset). * untreated or uncovered primary entry/reentry tear proximal to left subclavian artery (before fl treatment with the investigational product). * vascular disease, aortic rupture, and/or anatomy and/or dissection membrane condition that precludes the safe access and positioning of an introducer sheath and delivery (and expansion) of the investigational product into the fl. * prior treatment of the fl. * planned use of investigational devices to treat the primary entry tear and/or tl. * absence of/inability to create a reentry tear/fenestration adequately positioned and large enough to allow introducer sheath access into the fl. * planned use of fl embolic devices other than the investigational product. * prior abdominal aortic aneurysm (aaa) treatment. * planned concomitant major surgery (e.g., gastrointestinal surgery). * diagnosed or suspected congenital degenerative connective tissue disease (e.g., marfan's or ehler-danlos syndrome). * coagulopathy or uncontrolled bleeding disorder. * serum creatinine level \>2.5 mg/dl (within 90 days prior to the procedure). * cerebrovascular accident within 90 days prior to the procedure. * myocardial infarction and/or major heart surgery within 90 days prior to the procedure. * atrial fibrillation that is not well rate controlled. * unable or unwilling to comply with study follow-up requirements. * life expectancy of \<2 years postprocedure. * known hypersensitivity or contraindication to platinum, iridium, or polyurethane. * a condition that inhibits radiographic visualization during the study procedure and planned follow-up imaging. * history of allergy to contrast medium that cannot be managed medically. * uncontrolled comorbid medical condition, including mental health issues, that, in the opinion of the investigator, would adversely affect participation in the study. * participant is planning to become pregnant or is currently pregnant or lactating. for participants of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the study.