Kornimate/medical-research-clean huggingface dataset:
molecular diagnosis of systemic autoinflammatory diseases

Conditions: Inflammatory Disease; Genetic Disease; Somatic Mutation; Molecular Sequence Variation; Molecular Pathway Deregulation

Summary: systemic autoinflammatory diseases (saids) are a set of rare clinically and genetically heterogeneous conditions. the project proposes to identify novel genes and specific signatures in subgroups of patients with saids.

saids are characterized by long dormant periods with no or only minor clinical symptoms interrupted by febrile crises accompanied by serous and synovial membrane inflammation that spontaneously resolves. over the last decades, more than 50 genes encoding key components of the innate immune system have been identified to be involved in the pathophysiology of saids, with both germline and somatic mosaic variations. when disease-causing variations are identified, specific biotherapies are proposed depending on the involved gene and pathway. however, despite these scientific advances, most saids (70%) are of unknown etiology, the diagnosis is made with significant delay, and no targeted therapy can be suggested. this project aims to generate specific understanding and develop strategies for said patients with unknown etiology. the investigators aim to advance our understanding of saids pathophysiology, find the disease-causing gene variations and identify the involved cellular pathways that should accelerate correct diagnosis and personalize treatment.

Eligibility criteria:
inclusion criteria: * a patient presenting with a clinical and biological aseptic inflammatory syndrome associating one or more of the following signs: spontaneously resolving fever, abdominal (pain, diarrhea), locomotor (arthralgia, myalgia), thoracic (pain, pericarditis), cutaneous, sensory (uveitis, deafness), or renal (amyloidosis) involvement. exclusion criteria: * adult subject to legal protection measures (guardianship, curatorship, safeguard of justice).

Keywords: biomarkers
tele-stroke: prehospital identification of patients with suspected stroke using onsite mobile telemedicine - feasibility

Conditions: Stroke, Acute

Summary: observational study to investigate the technical feasibility, implementation into current diagnostic and treatment pathways and the diagnostic accuracy of the remote patient assessment by using mobile telecommunication ahead of hospitalization.

on-site, pre-hospital clinical assessment of patients with suspected acute stroke can accelerate further diagnostic and treatment pathways after patient arrival at the emergency room or the dedicated stroke center. interactive video and audio streaming connecting on-site paramedics to a stroke center based stroke physicians can help to overcome these hurdles. patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire may enable a pre-hospital decision on the need of expedited diagnostic and treatment procedures after arrival at the dedicated stroke center.

Eligibility criteria:
inclusion criteria: * any patient older or equal than 18 years with suspected acute stroke as per the first judgement of the paramedics on-site. * written informed consent by the patient, or legal representative (next-of kin) or informed consent by an independent physician not involved in the study exclusion criteria: -patients with symptoms not attributable to stroke in the emergency onsite ( observation of epileptic seizure, recent cerebral trauma, prior syncope or comatose state)
care pathways for colorectal cancer surgery

Conditions: Cancer

Summary: evaluate the care process and the quality of care for adult cancer patients who are admitted for colorectal surgery

this descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. this study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. in 4 countries (belgium, germany, france and the netherlands) 3 hospitals will participate (total number of hospitals is 12). they will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.

Eligibility criteria:
inclusion criteria: 1. all consecutive scheduled admissions starting september 2, 2013; 2. minimum age of 18 years; 3. elective admission for colorectal cancer surgery exclusion criteria: 1. emergency (not planned) admission for colorectal cancer surgery; 2. patients with severe dementia (dsm iv) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Keywords: surgery bowel rectum cancer nutrition
effect of over-the-counter toothpastes on chemotherapy-induced oral mucositis

Conditions: Mucositis; Neoplasms

Summary: the purpose of this study is to determine whether oral defense toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.

a pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with oral defense toothpaste. in this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. the first arm (test arm) will receive oral defense toothpaste and be required to brush three times per day, for 8 days. the second arm (control arm) will receive crest toothpaste and be required to brush three times per day, for 8 days. patients in the control arm will be provided magic mouth rinse, if needed. healing of oral mucositis lesions will be evaluated at days 1 and 8. quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 receiving chemotherapy * mucositis lesions not exceeding grade 2 exclusion criteria: * patients receiving high load chemotherapy * patients receiving radiation therapy * patients receiving oral antivirals, oral antifungals or oral antibacterials * patients experiencing oral candidiasis

Keywords: oral mucositis chemotherapy toothpaste
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for parkinson's disease

Conditions: Parkinson Disease

Summary: this trial will study the safety and efficacy of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for the treatment of parkinson's disease

this patient funded trial aims to study the safety and efficacy of intranasal installation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell (uc-msc) exosomes for the treatment of parkinson's disease. patients will receive a dose of 4 ccs of alloex, approximately 800 billion exosomes, between both nasal cavities. a second equivalent dose will be administered on the subsequent day. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur * anticoagulation medicine use

Keywords: parkinson's disease stem cell treatment
calcium and vitamin d intakes in children

Conditions: Hypocalcemia; Hypovitaminosis D

Summary: calcium (ca2+) and vitamin d (vitd) play an important role in child health. aims. the investigators evaluated the daily intake of ca2+ and vitd in healthy children; and the efficacy of ca2+ and vitd supplementation. daily ca2 + and vitd intake was evaluated in consecutive healthy children through a validated questionnaire. subjects with a daily ca2 + and vitd intake \< 70% of dietary reference intakes (dris) were invited to participate in prospective randomized trial with 2 groups of nutritional intervention: group 1, dietary counseling aiming to optimize daily ca2+ and vitd intake plus administration of a commercially available ca2 + and vitd supplementation product (colecalcium®, humana, milan, italy); group 2, dietary counseling alone. at the enrollment (t0) and after 4 months (t1) serum vitd levels were assessed.


Eligibility criteria:
inclusion criteria: * ambulatory healthy subjects (male and female, age range 3-17 years) consecutively observed at our department for routine clinical examination because vaccination program were considered eligible for the study. exclusion criteria * malnutrition (defined as a weight/height ratio \<5° centile); * presence of chronic systemic diseases (celiac disease, inflammatory bowel disease, food allergy, cystic fibrosis, malignancy, immunodeficiency, tuberculosis, genetic-metabolic disease, primitive bone disease, diabetes and endocrine disorder); * and use of systemic steroids in the previous 3 months.

Keywords: 25-hydroxyvitamin d dietary counseling pediatrics allergy bone metabolism
study evaluating the safety and efficacy of intravenous tigecycline to treat hospitalized japanese subjects

Conditions: Community-Acquired Infections

Summary: to purpose of this study is to assess the safety and tolerability of intravenous (iv) tigecycline in hospitalized subjects of japanese descent with community-acquired pneumonia (cap).

this is a multicenter, open-label study evaluating the safety and efficacy of tigecycline in the treatment of japanese subjects with cap. subjects with clinical signs and symptoms of cap who meet the eligibility requirements will be considered for enrollment. qualifying subjects will be assigned to receive tigecycline via iv administration for 7 to 14 consecutive days. the exact duration of administration of the study drug will be at the discretion of the investigator, based on the subject's condition. subjects will be followed for safety until the test-of-cure (toc) assessment 10 to 21 days after the last dose of therapy, and for efficacy until toc assessment.

Eligibility criteria:
inclusion criteria: * hospitalized japanese descent subjects known or suspected to have cap with a severity that requires iv antibiotic treatment. * chest radiograph within 48 hours before the first dose of iv test article showing the presence of a new infiltrate. * the presence of fever or hypothermia within 24 hours before the first administration of test article, and of at least two signs/symptoms of cap within 24 hours before the first administration of test article. exclusion criteria: * any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed. * hospital-acquired pneumonia, other lung disease including viral, fungal, or parasitic pneumonia, immunosuppressive conditions, and other illness, which affect evaluation of safety and efficacy of tigecycline. * known or suspected hypersensitivity to tigecycline or tetracyclines, or contraindication for these antibiotics.
left atrial appendage occlusion with watchman® device in patients with non-valvular atrial fibrillation and end-stage chronic kidney disease on hemodialysis

Conditions: Atrial Fibrillation; Heart Diseases; Renal Disease; Bleeding; Arrhythmias, Cardiac; Cardiovascular Diseases

Summary: atrial fibrillation (af) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (hd). stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (esckd) on hemodialysis.the risk of bleeding in these patients can be roughly 5-fold higher that without it. current guidelines recommend the use of oral anticoagulants (ao) to prevent stroke or systemic thromboembolism in high-risk patients with af. left atrial appendage occlusion (laao) reduces the risk of bleeding while allows thromboembolic stroke prevention. the aim of the study is to assess the procedural safety on stroke and bleeding prevention of laac in patients with non-valvular atrial fibrillation (nvaf) and esckd on hd.

atrial fibrillation (af) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (hd). stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (esckd) on hemodialysis.the risk of bleeding in these patients can be roughly 5-fold higher that without it. current guidelines recommend the use of oral anticoagulants (ao) to prevent stroke or systemic thromboembolism in high-risk patients with af. left atrial appendage occlusion (laao) reduces the risk of bleeding while allows thromboembolic stroke prevention.

Eligibility criteria:
inclusion criteria: * age\> 18 years. * stage v chronic kidney disease (gfr \<15 ml / min) in hemodialysis at the time of left atrial appendage closure. * history of atrial or valvular fibrillation (paroxysmal, persistent, permanent). * less moderate embolic risk (cha2ds2-vasc ≥2) or active oral anticoagulant therapy due to atrial fibrillation. * high associated hemorrhagic risk (hasbled ≥ 3) or a history of major bleeding (barc\> 2). * the patient has been informed of the characteristics of the study and has provided written informed consent. exclusion criteria: * life expectancy \< 2 years. * indication for oa different from nvaf. * severe pericardial effusion. * previous percutaneous closure of atrial septal defect. * intracardiac thrombus. * severe hepatic dysfunction with spontaneous inr (international normalized ratio) \> 1.5. * the patient refuses to participate in the study.

Keywords: left atrial appendage closure watchman device
effects of a ketogenic diet on body weight and cardiovascular risk factors

Conditions: Obesity

Summary: this pilot study is a randomized, controlled clinical trial to compare anthropometric and metabolic changes associated with six months of weight management by means of a very low carbohydrate diet or a calorically-restricted low fat diet. we hypothesized that the low fat diet would be associated with more weight loss and improvement of cardiovascular risk factors than the low carbohydrate diet.

low carbohydrate diets, including high-fat, 'ketogenic' diets, have moved to the forefront of popular diets promoted for weight loss in the united states. these diet plans have been aggressively marketed to millions of americans every year. however, there has been virtually no rigorous study of low carbohydrate, high fat diets either with regard to efficacy in promoting weight loss or effects on cardiovascular risk factors. because very low carbohydrate diets (i.e., the ketogenic diets) recommend increased intake of fat, and saturated fat, we hypothesized that following one of these diet plans could actually worsen important risk factors for cardiovascular disease. this is an issue of great importance because large numbers of people experiment with low carbohydrate diets despite not knowing their effects on blood pressure, plasma lipid levels, and glucose tolerance. therefore, we have proposed a clinical trial to test our hypothesis. in this study, we will compare the effects of three months of a ketogenic diet (as promoted by dr. robert atkins) with three months of a weight loss diet that conforms to the american heart association dietary guidelines in a group of 100 otherwise healthy obese subjects. during the course of the study, we will determine the effects of diet on 1) body weight, percent fat, and resting metabolic rate, 2) blood pressure, 3) plasma lipids, 4) measures of glucose tolerance, and 5) measures of psychological health and eating behaviors. this pilot study will provide the preliminary data needed to demonstrate the efficacy (or lack thereof) of a popular weight loss technique (i.e., the ketogenic diet) that is currently being criticized by professional organizations. armed with preliminary data, the investigators plan to further investigate the long-term anthropometric and metabolic effects of ketogenic diets with a larger sample.

Eligibility criteria:
inclusion criteria: * obese men and women with a bmi of 30-34 kg/m2, at least 18 years of age, who have had stable body weight (i.e., no gain or loss of \>5% of body weight) for the preceding six months, who have normal oral glucose tolerance, and who are able to commit to a six month study. exclusion criteria: * pregnancy, lactation, active medical or mental illness requiring treatment, recent (within 1 year) use of appetite suppressing compounds, previous use of the ketogenic diet.

Keywords: obesity weight loss diet fads
vy-aadc02 for parkinson's disease with motor fluctuations (restore-1)

Conditions: Parkinson's Disease

Summary: the objective of this study is to assess the safety of vy-aadc02 in participants with parkinson's disease (pd) with motor fluctuations.


Eligibility criteria:
key inclusion criteria: 1. males and females, 40 to 75 years of age (inclusive) 2. diagnosis of pd, consistent with united kingdom brain bank criteria 3. motor responsiveness to dopaminergic therapy, demonstrated by improvement in movement disorder society - unified parkinson's disease rating scale (mds-updrs iii score) 4. disease duration from diagnosis of ≥4 years 5. an average of ≥3 hours of off time (that is, periods of insufficient control of motor pd symptoms) per day over 3 consecutive days as confirmed by the pd diary 6. a stable, optimal regimen of parkinson's medications including levodopa for at least weeks prior to screening evaluation. participants must have a minimum duration of levodopa treatment of ≥1 year 7. in the judgment of the investigator, stable parkinson's features and symptoms for at least 4 weeks prior to screening evaluation 8. agrees to defer any elective neurological surgery, including deep brain stimulation or ablation procedure for pd, levodopa or apomorphine infusion, or the addition of new dopaminergic formulations until after the study is completed, if medically appropriate 9. ability to travel to study visits key exclusion criteria: 1. atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins, as determined by the investigator 2. montreal cognitive assessment (moca) score \<26 3. new or unstable psychiatric conditions (psychosis, depression) within 1 year of screening 4. brain imaging abnormalities in the striatum or other regions that would substantially increase risk of surgery 5. contraindication to magnetic resonance imaging (mri) and/or gadolinium-based contrast agents 6. prior brain surgery, infusion therapies or planned treatments that could complicate the study procedure or negatively impact study evaluations as determined from participant interview, screening mri, or medical records 7. history of malignancy other than treated carcinoma in situ within 3 years of screening evaluation 8. prior gene transfer, current treatment with any investigational agent (drug or device) within 2 months of screening evaluation, or participation or plans to participate in another research study 9. severe, biphasic and/or uncontrolled dyskinesia 10. disabling or uncontrolled impulse control disorders

Keywords: parkinson's disease (pd) aromatic l-amino acid decarboxylase aadc aav vy-aadc02 aav2-haadc ddc gene therapy levodopa dopamine neurosurgery nbib-1817 motor fluctuations
clinical study of triplea for treatment of alcohol addiction in outpatient care

Conditions: Alcoholism

Summary: the primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and triplea.

the study is a 12-month open-label and randomised comparison between the control group receiving only conventional treatment and the intervention group receiving conventional treatment enhanced with triplea. the studies have been designed to reflect as far as possible the conventional care for alcohol dependence. the triplea product is intended to strengthen the existing methods used during the assessment phase, treatment phase and aftercare of alcohol dependence.

Eligibility criteria:
inclusion criteria: * patients in care at addiction and neuropsychiatry uppsala university hospital and at nämndemansgården uppsala * 18 years or older * meets at least 2 of the criteria for addiction/substance syndrome according to diagnostic and statistical manual of mental disorders-5 (dsm-5) * ability to understand and communicate in swedish * ability to handle the technical equipment used in the study (alcoholometer and smartphone) * access to a fixed place (living, place for sleeping, place where the phone can be charged exclusion criteria: * schizophrenia * substance syndrome related to other substances than alcohol and nicotin * lowered lung function (not able to reach acceptable expiration volume for the alcoholometer function) * the patient is taken care of within the frame for the act on care of addicts * not suitable to participate according to the investigator * has not consumed any alcohol during the 4 weeks defined as baseline timeline follow back * normalized carbohydrate deficient transferrin (cdt) and phosphatidyl-ethanol (peth)-values in blood samples at visit 1

Keywords: alcohol abuse, alcoholometer, medical device, app
mindfulness, group therapy and psychosis; training decreases anxiety and depression

Conditions: Psychosis

Summary: the objective of this non-randomized, within-group comparison was to evaluate the addition of mindfulness as a new technique in an outpatient group therapy program for participants diagnosed with a psychotic spectrum disorder, alongside of cognitive behavioral therapy.

participants completed the patient health questionnaire-9 (phq-9), and the generalized anxiety disorder 7-item scale (gad-7), at admission and discharge. the first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment or treatment as usual (tau) against those who received tau. the second experiment compared age using matched scores from participants who received mindfulness training plus tau. participants attended group therapy for a five-week minimum, and were taught the mindfulness practices of breath, acceptance, observation, remaining non-judgmental, and letting go.

Eligibility criteria:
inclusion criteria: * all diagnostic statistical manual, fifth edition, (dsm-5) diagnoses that included a psychosis spectrum disorder exclusion criteria: * those lacking symptoms of psychosis

Keywords: mindfulness group therapy
efficacy study of neridronate to treat painful osteoarthritis of the knee with bone marrow lesions.

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee osteoarthritis (acr criteria) * radiographic diagnosis of knee osteoarthritis (kellgren/lawrence scale \>=2) * \>4 weeks but \ 30 mm on a 100 mm vas scale * bone marrow oedema of the affected knee on magnetic resonance exclusion criteria: * inflammatory arthritis * aseptic osteonecrosis of the knee * previous or current treatment with bisphosphonates * serum calcium or creatinine abnormalities