Kornimate/medical-research-clean huggingface dataset:
phase ii study of intensity modulated radiotherapy in dose painting for sinus carcinomas after endoscopic surgery

Conditions: Tumor, Solid

Summary: the patient is randomized to one of the following groups: * experimental group: radiotherapy in painting dose on histoscannographic mapping * control group: standard pan-sinus radiotherapy


Eligibility criteria:
inclusion criteria: * patients \>18 years of age * patient with histologically confirmed nasosinus carcinoma * patient treated by endoscopic sinonasal surgery with histosurgical mapping within 2 months prior to radiotherapy * indication for radiotherapy treatment (photontherapy or protontherapy), without neoadjuvant chemotherapy (concomitant chemotherapy is permitted) * signature of informed consent prior to any specific study procedure * subject affiliated to a social security system exclusion criteria: * patient with not operated in place tumor * patient with distant metastases * patient treated with neoadjuvant chemotherapy * delay between surgery and radiotherapy greater than 8 weeks * other histologies (melanoma, sarcoma, lymphoma, etc.) * pregnant or breast-feeding woman or absence of contraception during genital activity * history of any other malignant disease in the last 3 years, except basal cell skin cancer, carcinoma in situ or superficial bladder tumor. any other solid tumor or lymphoma (without bone marrow involvement) must have been treated and show no sign of recurrence for at least 3 years. * simultaneous participation in another therapeutic clinical trial * patients deprived of their liberty, under guardianship, under curatorship, or subject to a legal protection measure, or unable to express their consent. * patients unable to undergo trial monitoring for geographical, social or psychopathological reasons

Keywords: imrt sinus nasal mucosal toxicity
exploring behavioral interventions to improve heart failure

Conditions: Heart Failure

Summary: the objective of this research is to compare tai chi versus resistance exercise, health education and usual care for changes in cardiac functional capacity measured for ability of the heart to pump by measuring ejection fraction (ef), end systolic and diastolic volumes in heart failure (hf) patients. also measured will be changes in physical function measured by walking speed and distance in the 6-min walk task, work performed during a bicycle task, and changes in daily physical activity. the investigators will compare groups for altered well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and quality of life. in addition the investigators will compare groups for altered vascular and pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to the bicycle task. also, the investigators will assess cardiac related hospitalization and death over a 12 month period by examining medical records.


Eligibility criteria:
inclusion criteria: 1. ability to perform a 6-minute walk task, with or without use of a cane or walker (must use the same walking assistance device during each session), and walk under 500 meters during task. 2. symptoms of chronic heart failure for at least 3 months. 3. clinically stable- defined as not having been hospitalized for a 3 month period, on stable doses of neurohormonal blocking agents and diuretics for at least 3 months. 4. acc/aha stages b and c 5. ability to perform light to moderate exercise (nyha functional class ii and iii) 6. presence of hf with an ejection fraction less than 40%, or diastolic dysfunction 7. ability to give informed consent 8. at least18 years of age exclusion criteria: 1. history of recent myocardial infarction (1 month) 2. angina not adequately managed with nitrates. 3. aortic or mitral stenosis 4. coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months. 5. severe copd 6. recent stroke or significant cerebral neurologic impairment. 7. active suicidality 8. currently participating in an exercise program. 9. currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics. 10. medications (steroids) and medical conditions affecting immune status not limited to grave's disease, rheumatoid arthritis, hashimoto's disease, sjogren's disease, lupus, multiple sclerosis

Keywords: tai chi
quantification and derivation of metabolic needs in children during burn rehabilitation

Conditions: Burns

Summary: the investigators are collecting information on the calorie needs of patients in the first year postburn. the investigators hypothesize that increased energy needs continue for up to a year following wound closure from burn injury.


Eligibility criteria:
inclusion criteria: * \>25% burn surface area * wounds present as 95% healed * admitted to shriners hospital cincinnati within 7 days of injury exclusion criteria: * \<5years old * \<25% burn injury * admitted greater than 7 days postburn

Keywords: nutrition assessment pediatric
study comparing test to aczone 5% and both to a placebo control in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: therapeutic equivalence and safety study

to evaluate the therapeutic equivalence and safety of test formulation and marketed reference listed drug (rld). to demonstrate the superiority of efficacy of the test and reference products over the placebo control in the treatment. to compare the safety of test, reference and placebo treatments.

Eligibility criteria:
inclusion criteria: * healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris * subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the investigator's global assessment (iga) (per table 1 below) exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation.
messenger ribonucleic acid (mrna) transfected dendritic cell vaccination in high risk uveal melanoma patients

Conditions: Uveal Melanoma

Summary: 1. rationale immunotherapy applying ex vivo generated and tumor antigen-loaded dendritic cells (dc) has now successfully been introduced in the clinic. a limited, but consistent, number of objective immunological and clinical responses have been observed. most of the successful results have been observed in patients with minimal residual disease, rather than patients with advanced metastatic disease. moreover, the investigators' preliminary results show that presence of tumor epitope specific t cells in biopsies taken from delayed type hypersensitivity (dth) reaction sites highly correlates with prolonged progression free survival (pfs). within uveal melanoma patients, a group with high risk of metastatic disease can be identified on basis of tumor specific genetic changes in loss of chromosome 3. at present no standard adjuvant or systemic treatment is available. applying dc-based immunotherapy in this group of high risk patients might reduce the risk of recurrence without interference in the current treatment guidelines. 2. objectives in this joint clinical study of radboud university nijmegen medical centre (runmc) and rotterdam eye hospital, the investigators aim to determine the in vivo immunological response induced in high risk uveal melanoma patients vaccinated with mrna-transfected dc. 3. study design this study is an open label non-randomized phase ii intervention study. 4. study population the investigators' study population consists of hla-a2 positive patients with a high risk uveal melanoma with proven expression of melanoma associated antigens tyrosinase and/or gp100. 5. main study endpoints this is an exploratory study aiming to demonstrate proof of principle. the first study endpoints are in vivo immunological response induced in high risk uveal melanoma patients vaccinated with mrna-transfected dc, administered i.v./i.d. and toxicity. secondary study endpoints are progression free survival, overall survival, and toxicity.


Eligibility criteria:
inclusion criteria: * histological documented uveal melanoma * hla-a2.1 phenotype (intervention arm) * non-hla-a2.1 phenotype (control arm) * melanoma expressing gp100 and/or tyrosinase * high risk genetic profile (loss of chromosome 3) determined by fish * interval since local treatment of uveal melanoma \< 12 months * no signs of liver metastasis determined by diagnostic ct-abdomen * normal serum ldh * no signs of cerebral metastases * bilirubin \< 25 micromol/l * who performance scale 0-1 * age 18-75 years * written informed consent * expected adequacy of followup * no pregnant or lactating women exclusion criteria: * history of second malignancy, except adequately treated basal cell carcinoma * serious active infections * autoimmune disease or organ allografts * concomitant use of immunosuppressive drugs * known allergy to shell-fish

Keywords: uveal melanoma chromosome 3 high risk immunotherapy adjuvant high risk genetic profile loss of chromosome 3
vessel wall imaging for diagnosis and monitoring of central nervous system (cns) vasculitis

Conditions: Vasculitis, CNS; Vasculitis, Cerebral

Summary: this is a prospective pilot study to determine the utility of mri and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.

this study will evaluate patients with suspected primary angiitis of the central nervous system (pacns), recruited during initial work-up by our multi-disciplinary team. given the low incidence of cns vasculitis and the fact that some patients are routed to a quaternary care center after initial work-up and diagnosis, evaluation of both groups will be useful to maximize the number of participants evaluated and to provide a representative sample of patients typically treated. during the study, participants will ultimately be deemed to have; 1. a specific clinical and pathologic subtype of pacns, 2. pacns not otherwise specified (nos) without pathologic or clinical proof of a specific subtype, or 3. an alternative diagnosis other than pacns. patients will undergo a standardized imaging and clinical examination at presentation and at pre-defined follow-up periods. imaging examinations will include an mri of the head, standard magnetic resonance angiogram (mra) of the head, and intracranial vessel wall imaging without and with iv gadolinium. patients will receive up to 4 imaging examinations at predefined intervals as part of this study. mri/mra/vessel wall features will be evaluated by 2 neuroradiologists. imaging findings will be correlated to clinical and any available laboratory or pathologic data. the target accrual is 10 patients for this pilot study.

Eligibility criteria:
inclusion criteria: 1. the patient is determined to have suspected pacns upon evaluation by a neurologist or rheumatologist or may have an established diagnosis of pacns of any duration as determined by a neurologist or rheumatologist. 2. ability to undergo routine clinical testing, including lumbar puncture performed for pacns to exclude potential alternative diagnoses (for initial suspected cases). 3. ability to provide informed consent. exclusion criteria: 1. less than 18 years of age. 2. any absolute contraindication to 3 tesla mri. 3. any absolute contraindication to gadolinium. 4. contraindication to lumbar puncture such as severe coagulopathy. 5. high risk carotid atherosclerotic plaque defined as either greater than 70% stenosis or known high risk plaque features such as intra-plaque hemorrhage. 6. medium or high risk factors for cardioembolic stroke based on the trial of org 10172 in acute stroke treatment (toast) criteria.
a study to describe the safety and immunogenicity of 20vpnc in infants in india and taiwan

Conditions: Pneumococcal Disease

Summary: the purpose of this study is to understand the safety and effects of a study vaccine (20vpnc) in infants and toddlers. this study is enrolling participants who are: * born after at least 36 weeks of pregnancy and about 2 months of age at the time of entering the study * have a bodyweight of at least 3 kg participants will receive either the study vaccine (20vpnc) or a licensed vaccine (13vpnc) as a 4-dose schedule as a shot in the muscle. participants will receive dose 1 on study day 1. dose 2 will be given 28-70 days after dose 1, and dose 3 will be given 28-70 days after dose 2. dose 4 will be given at 365-455 days (approximately 12-15 months) of age. participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. the study team will ask questions about the participant's health and take some blood samples during the visit.


Eligibility criteria:
inclusion criteria: * male or female infants born at ≥36 weeks of gestation and approximately 2 months of age at the time of consent * healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study * weight of 3.0 kg or greater at the time of randomization exclusion criteria: * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vpnc, 20vpnc, or any other diphtheria toxoid-containing vaccine. * major known congenital malformation or serious chronic disorder * other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study * previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
benefits and tolerance of exercise in patients with generalized and stabilized myasthenia gravis

Conditions: Myasthenia Gravis

Summary: the purpose of this study is to demonstrate that a 3 months physical exercise programme improves the quality of life of patients with generalized myasthenia gravis (mg) stabilized since at least 6 months under prednisone and/or azathioprine.

three centers randomized simple blind clinical trial whose objective is to assess the efficacy on qol improvement, and the tolerance of physical exercise over a period of 3 months in patients with generalized mg who have been stabilized since at least 6 months. during the 3 months pre-inclusion phase, the characteristics of mg will be collected. physical activity and performance will be assessed monthly. mgqol15 will be assessed at inclusion. patients will be randomized in either intervention arm or control arm. the intervention arm will consist of three sessions exercise per week during three months. the daily exercise will be performed on a rowing machine that will be adapted to the patient's own physical ability. physical activity will be measured with the help of an actimeter. once a month, mg evolution and tolerance to exercise will be assessed and mg treatment dose will be collected. exercise will be interrupted in case of mg exacerbation. quality of life and psychological status will be assessed at 3, 6 and 9 months. plasma levels of pro and anti-inflammatory cytokines will be measured at 3, 6 and 9 months in order to assess the effects of exercise on immune response. patients enrolled in the control arm will benefit from the same follow-up but will not have exercise.

Eligibility criteria:
inclusion criteria: 1. patient with generalized mg of stage ii or iii according to the mgfa classification, stabilized for at least 6 months. criteria for mg are either * positive dosage of ant-rach or musk auto-antibodies; * if absent, myasthenic symptoms decrement\> 10% in emng and test the positive prostigmine 2. patient ≥ 18 and ≤ 70 years old 3. patient having an health insurance 4. informed written consent exclusion criteria: 1. patients under particular protection 2. enrolment in another biomedical research in the last 3 months; 3. patients for whom physical practice is contra-indicated because of : * unstable coronary syndrome or myocardial infarction within the past 3 months * heart failure with systolic ejection fraction \< 50 % * respiratory failure defined by a vital capacity (cv) \< 70 % * stroke * other neuromuscular pathology * disabling rheumatologic disease (\> 80 % disability according to the barthel scale) * chronic pain or disabling orthopaedic conditions * hospitalization in the last 3 months for a serious medical or surgical condition * anemia (hematocrit \< 30%) 4. mgfa grade i, grade iv or v 5. severe cognitive impairment 6. mgqol-15 below 15/60

Keywords: myasthenia gravis physical exercise quality of life muscular performance fatigability
a pilot study of rosiglitazone in the treatment of gh secreting pituitary adenomas

Conditions: Pituitary Tumor

Summary: growth hormone secreting pituitary adenomas(ghomas) produce excessive gh, stimulating excessive insulin like growth factor 1(igf-1) synthesis in the liver, thus causing multiple systemic complications. the life expectancy of patients with untreated ghomas is shortened by ten years. the treatment goal of ghomas is to shrink the tumor volume and normalize gh and igf-1. under current treatment, only 50-70% of patients get remission. rosiglitazone is a widely used oral antidiabetic medicine. the investigator's preliminary data showed that rosiglitazone decreased the synthesis of gh and igf-1 in rat pituitary tumor cells gh3 and hepatocytes respectively. the investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with ghomas who have not been alleviated by other therapies.


Eligibility criteria:
inclusion criteria: * patients with ghomas confirmed by surgery * patients who did not get biochemical remission: gh nadir after oral glucose tolerance test（ogtt）\>1.0ug/l or igf-1 exceeds age matched normal range exclusion criteria: * patients who were allergic to rosiglitazone * patients with liver or kidney dysfunction, respiratory failure * patients with heart failure * patients with edema * patients with severe hyperlipidemia * patients with osteoporosis or a history of non traumatic fractures * patients with pregnancy and lactation * patients who had received radiation therapy within 3 years * patients who had participated in other clinical trials within 3 months * patients with other neoplastic diseases * patients with mental and neurological disorders * patients with other conditions which were believed not appropriate to take part in the clinical trial
leipzig exercise intervention in chronic heart failure and aging

Conditions: Heart Failure; Ageing

Summary: in both ageing and heart failure progressive exercise intolerance is observed. the leipzig exercise intervention in chronic heart failure and aging (leica) study aims to investigate how aerobic short-term training interventions affect exercise capacity, left ventricular systolic and diastolic function, biomarkers of heart failure, skeletal muscle metabolism, and endothelial function in chronis heart failure patients (chf-patients) and healthy subjects (hs) in two different age strata: above 65 years and below 55 years. aim of the trial is therefore to compare the effects of aerobic exercise training in young and old healthy subjects as well as in young and old heart failure patients. to our knowledge this study is the first to prospectively investigate age differences of training responses in both chf patients and age-matched healthy controls. because of the extensive clinical and molecular assessment the results of this trial will be made public in predefined substudies: * leica-echo * leica-biomarkers * leica-endothelium * leica-cardiopulmonary exercise function * leica-muscle

a total of 60 healthy subjects and 60 heart failure patients (in each group 30 \ 65 years) are prospectively randomized to either 4 weeks of aerobic ergometer training or control group. before and after the intervention period maximal exercise tolerance is determined by ergospirometry, endothelial function is measured by high-resolution a-mode ultrasound, left ventricular function by echocardiography including tissue doppler imaging, and thigh muscle mass is assessed by ct. skeletal muscle biopsies are obtained at both time-points and are analysed for inflammatory cytokines and markers of catabolism/anabolism.

Eligibility criteria:
inclusion criteria: group 1: healthy subjects * normal left ventricular ejection fraction (ef) \>55% * normal coronary artery disease (cardiac catheterization) group 2: chf patients * reduced left ventricular ejection fraction (ef) \<40% * stable clinical condition (nyha ii-iii) exclusion criteria: * cold * cardiac decompensation \<3 months * ventricular arrhythmias \>lown ivb * myocardial infarction \< 4 weeks * valvular heart disease \>ii° * insulin-dependent diabetes mellitus * arterial hypertension * orthopedic conditions prohibiting training participation

Keywords: heart failure ageing
a comparison of weighted vest exercise and strength training

Conditions: Mobility Limitations; Aging

Summary: the purpose of this study is to evaluate two types of exercise therapy designed to improve muscle power and mobility: weighted vest exercise vs. progressive resistance training.

muscle power, a separate physical attribute from strength, is an important determinate of physical functioning in the elderly, for example in avoiding impending falls, rising from a chair, and climbing stairs. muscle power, which declines with aging at a different rate than strength, has been shown in previous studies to improve through power training utilizing specially designed exercise equipment. however, weighted vest exercise could provide an acceptable, low cost, readily accessible alternative. the hypotheses being tested in this study are: 1) weighted vest exercise will improve lower extremity power when compared to age matched controls in a standardized progressive resistance training program; 2) improvements in lower extremity power enhance functional performance as shown by improved gait velocity, stair climbing, and chair rise time; and 3) weighted vest exercise in impaired older adults will improve self-reported function and disability. one hundred sixty-four men and women ages 65 and older, with some physical limitation but able to climb stairs independently, will be randomized to one of two 16-week exercise programs. the intervention group will participate in a weighted vest exercise protocol, consisting of chair-based and stair-climbing exercise, while the control group will participate in a standardized progressive resistance training program. participants in both programs will meet three times per week for 30-60 minutes per session, for a total of 16 weeks, at a research exercise gym, and will be under the direct supervision of research staff.

Eligibility criteria:
inclusion criteria: * community dwelling men and women aged 65 or older * ability to provide informed consent * impairment in physical performance, based on a score between 4 and 10 inclusive on the sppb (short physical performance battery), which evaluates standing balance, walking speed, and chair-rise time * score of 24 or greater on the folstein mini-mental status exam * exhibit independent stair-climbing ability exclusion criteria: * unstable acute or chronic disease * neuromusculoskeletal impairment interfering with independent stair climbing * abdominal aortic aneurysm * exertional angina * history of ventricular arrhythmia * inguinal or abdominal hernia * symptomatic valvular heart disease

Keywords: strength training power training exercise training functional performance tasks