Kornimate/medical-research-clean huggingface dataset:
prediga 2: spanish acronym of "educational and diagnostic project for gaucher and asmd"

Conditions: Gaucher Disease; Acid SphingoMyelinase Deficiency; ASMD; Niemann-Pick Diseases; Splenomegaly

Summary: the study of splenomegaly, and the follow-up of splenectomized patients, is one of the causes of referral of these patients to pediatric gastroenterology and oncohematology clinics, and adult internal medicine and hematology. it has been described that 0.3% of hospital admissions is for this reason. the study and management of splenomegaly is well described among the different medical specialties to which these patients arrive. after the application of the different algorithms and the different studies that are carried out, these splenomegaly are identified as being of hepatic, infectious, inflammatory, congestive, hematological origin and primary causes. despite these studies of splenomegaly, approximately 10-15% of these patients still remain undiagnosed. the objective of the present study is to increase the diagnostic sensitivity of these unknown splenomegalys, or unknown splenomegaly patients who remain in consultations, using the usual diagnostic clinical procedures of unknown splenomegaly and unknown splenectomy patients, where the investigators include the extraction of a blood sample for dry drop test (dbs), where the determination of the enzymatic/genetic activity will be carried out for gaucher disease (gd) and acid sphingomyelinase deficiency (asmd) , analysis of lisogl1 and lisosm.


Eligibility criteria:
inclusion criteria: * adult patients of both sexes. * patients who present signs, assessed instrumentally or with laboratory tests, of unknown splenomegaly, defined as a palpable spleen ≥ 1cm from the costal margin or diagnosed by ultrasound, magnetic resonance imaging (mri) or computed tomography (ct) of the spleen. * splenectomy patient with no diagnosis of the origin of the splenomegaly of unknown origin. * patients with splenomegaly or splenectomy without diagnosis but identified with itp (idiopathic thrombocytopenic purpura) * patient who gives his consent to participate in the study. exclusion criteria: * splenomegaly due to portal hypertension (documented by abdominal ultrasound or other instrumental test) due to liver disease * hematologic malignancy \[documented by positive physical exam + blood smear or fine needle aspiration (fna) or bone marrow biopsy\] * hemolytic anemia and/or thalassemia * patients who cannot meet the requirements of the protocol due to mental and/or cognitive alterations, uncooperative patients, educational limitations and understanding of written language * refusal of the patient to participate in the study
studying blood samples in women with breast cancer or a history of breast cancer

Conditions: Breast Cancer

Summary: rationale: studying samples of blood in the laboratory from patients with current or previous cancer may help doctors learn more about biomarkers related to cancer. purpose: this research study is looking at blood samples in women with breast cancer or a history of breast cancer.

objectives: primary * to compare peripheral blood (pb) concentrations of circulating endothelial cells (cec) in women with measurable, active breast cancer to pb concentrations of cec in a control population of women with a history of breast cancer who are currently without evidence of active disease. secondary * to compare in women with measurable breast cancer the relationship between pb concentrations of cec prior to and at 3 and 6 weeks following initiation of a new chemotherapy or hormonal therapy, and correlate these values with clinical response to treatment to determine if cec can be used as a tumor marker or indicator of disease burden. * to compare pb concentrations of cec to levels of plasma proteins associated with angiogenesis, including vascular endothelial growth factor, in women with active or a prior history of breast cancer. outline: peripheral blood and plasma samples are collected for analysis of circulating endothelial cells (cec) and angiogenic growth factor levels. blood samples from patients initiating a new chemotherapy or hormonal therapy for breast cancer are collected at baseline and at 3 and 6 weeks following the start of treatment. cec are quantified via flow cytometry and plasma angiogenic markers are assessed via elisa. projected accrual: a total of 100 patients with active, measurable breast cancer and 100 patients with a prior history of breast cancer will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * receiving treatment for measurable breast cancer at the arizona cancer center clinic * being followed for a prior history of breast cancer (with no evidence of active disease) at the arizona cancer center * hormone receptor status not specified patient characteristics: * menopausal status not specified * not pregnant or nursing prior concurrent therapy: * see disease characteristics

Keywords: breast cancer
monitoring of arrhythmias in patients treated with antipsychotics

Conditions: Death, Sudden, Cardiac; Arrythmia; Antipsychotics and Neuroleptics Toxicity

Summary: antipsychotics may be associated to life-threatening arrhythmias and sudden cardiac death. this is the fist study to estimated the arrhythmic burden using long-term monitoring by implantable loop recorder in patients treated with antipsychotics.

aims and objectives to estimate frequency of potential malign arrhythmias and cardiovascular outcome in a population with patients treated with antipsychotic drugs compared to healthy controls. background life expectancy is about 20 years shorter for patients with mental illness compared to the general population. increasing evidence suggest that antipsychotic drugs can cause cardiac arrhythmias and hence sudden death. however, the evidence as well as the incidence of rhythm disturbances in patients treated with antipsychotic drugs is insufficient reported. prolonged monitoring with external portable monitors is difficult for practical and technical reasons. in addition, long-term consistent and structured timing of clinical visits is often a challenge in this vulnerable patient group. in recent years, patients who have been suspected of rarely occurring arrhythmias, have been offered long-term monitoring using an 'implantable loop recorder' (ilr). however, no study has evaluated the arrhythmic burden in patients treated with antipsychotic drugs using ilr. methods and materials the study is a national joint project between departments of psychiatry and cardiology across denmark. after written informed consent and a baseline evaluation including echocardiography, ecg and biochemistry, an ilr will be implanted. during follow-up, arrhythmias will be monitored at regular clinical visits. cardiovascular endpoints will be monitored using danish national registries. expected outcome and perspectives the present study is the first to reveal arrhythmias among patients treated with antipsychotics using consistent long-term monitoring. the results will give valuable insights into possible mechanism of the observed early death and risk of sudden death in patients treated with antipsychotics.

Eligibility criteria:
inclusion criteria: * patients with smi defined according to icd-10 as: * f20.0-f20.9 schizophrenia * f22.0-f22.9 paranoid psychosis * f25.0-f25.9 schizo-affective psychosis * f28 other non-organic psychosis * f29 non-organic psychosis unspecified * f31.0-f31.9 bipolar affective disorder. * patients treated with or initiating antipsychotics with ≥ 0.5 daily defined dosage * \>18 years old and \<50 years. exclusion criteria: * patients not capable to understand the aim of the study as judged by investigator. * current in treatment with methadone. * left ventricular hypertrophy (echocardiographic septal thickness ≥1.3 cm for women and ≥1.4 cm for men, or lvm/bsa ≥109 g/m2 for women or ≥132 g/m2 for men). * heart failure (echocardiographic lvef \<35%). * ischemic heart disease (patient reported coronary bypass grafting or percutaneous coronary intervention. * congenital cardiovascular disease (patient reported).
study of spino-pelvic sagittal balance by vicon® optoelectronic system

Conditions: Kyphosis

Summary: spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. however, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. this prospective and controlled study try to assess the vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters


Eligibility criteria:
inclusion criteria: * male subjects * aged between 20 to 40 years * height between 165 to 190 centimeters * asymptomatic subjects from spinal point of view * bmi \< 30 kg/m² * affiliated to french social security * subjects having read the information note and signed informed consent exclusion criteria: * subjects with neurological, vestibular, rheumatological or orthopedic pathology which can influence walking and balance * subjects with known spinal pathology * subjects with visible morphologic spinal deformity * subjects with significant visual impairment (visual acuity \< 6/10) despite an optical correction port * subjects unable to walk without help * person placed under the safeguard of justice, guardianship or curatorship * subjects involved in other biomedical research during this study * subjects presenting an asymptomatic spinal pathology discovered at the inclusion on the spinal eos images.
mvx-onco-1 in patients with solid tumor

Conditions: Solid Tumor; Cancer

Summary: the objectives are to assess the safety and tolerability of 6 vaccine doses of mvx-onco-1, administered sub-cutaneously (injections and capsules implantations), in patients with advanced metastatic solid tumor in progression who are not or not any longer amenable to any standard therapy of their tumour disease.

endpoints: primary: to assess safety parameters including adverse and serious adverse events (incidence, causality, severity), local and systemic tolerance to the administered study treatment, changes in laboratory values and vital signs in patients with solid tumor; secondary: to measure some tumor responses in using imaging technique, serological tumor markers, immune monitoring and metabolic monitoring.

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years and older with advanced metastatic cancer in progression of various sites \[carcinoma of lung (either small cell or non-small cell), colon, breast, pancreas (exocrine or endocrine), stomach, oesophagus, head\&neck, thyroid, kidney, bladder, prostate, ovary, uterus (cervix or corpus); sarcoma of soft tissue, bone, uterus, melanoma; primary brain tumor\] where all recognized treatment are exhausted or not feasible. * life expectancy: estimate of at least 4 months. exclusion criteria: * have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 preceding weeks. * have received any chemotherapy treatment in the 4 preceding weeks. * serious concomitant health condition such as organ transplant requiring immunosuppressive drugs, severe psychiatric disorders. * history of second cancer within the last 2 years with the exception of basal cell carcinoma of skin and localized cervical carcinoma treated with curative intent. * patient with a systemic disease other than cancer, that is not controlled by usual medication. * therapeutic anticoagulation with coumarine or continues iv heparin. low-molecular weight heparin (lmwh) is permitted as long as treatment can be withheld several hours prior to subcutaneous implantation. * positive hiv-1, hiv-2, htlv-1, htlv-2, hepatitis b surface antigen, or hepatitis c antibody.

Keywords: cancer solid tumors gene therapy cell therapy encapsulation
evaluating the effectiveness of the dissemination of action schools! bc

Conditions: Physical Activity; Obesity; Physical Fitness

Summary: childhood obesity is a major public health threat. physical activity and healthy eating contribute to the maintenance of healthy weights. individually oriented behaviour change programs may not be able to overcome the influence of what has been called an obesogenic environment. action schools! bc (as! bc) used a socio-ecological approach to enhance opportunities for physical activity and healthy eating in elementary schools and created systemic change at the provincial level. as! bc helps elementary schools customize action plans, based upon their local context, to contribute to the health and well-being of children and the school community. pilot research showed that as! bc was an effective and feasible model. the provincial dissemination of as! bc has been launched and partners from across many sectors are involved to enhance the sharing of knowledge and increase the implementation of the as! bc model across british columbia. the dissemination provides an unprecedented opportunity for evaluating how changing the school environment can promoted healthy weights in children. the dissemination was evaluated using a cluster randomized design; 30 elementary schools (n = 1529 consented children) from four (out of five) provincial health authorities volunteered to participate. the primary goals of the research are: 1. to determine if the action schools! bc (as! bc) model is an effective approach to positively change school environments and health related behaviours of children from diverse geographical regions and cultural groups, and 2. to determine if the supports provided to schools or the community context influence the uptake and use of the as! bc model. this research will contribute to the science of obesity prevention and knowledge use as well as public health practice.


Eligibility criteria:
inclusion criteria: * student attends a school that has agreed to participate in the study * student's classroom teacher has agreed to participate in the study * student is in grade 4 or 5 at start of study * student participates in regular physical education classes at school * student's parents provide consent exclusion criteria: * student does not attend a school that has agreed to participate in the study * student's classroom teacher does not agree to participate in the study * student is not in grade 4 or 5 at start of study * student does not participate in regular physical education classes at school * student's parents do not provide consent

Keywords: physical activity healthy weight healthy eating physical fitness children school based community based obesity health promotion socio-ecological environment based
pain during vaccine administration

Conditions: Infant, Newborn, Pain

Summary: many painful interventions that cause pain and stress are applied to preterm babies in the neonatal intensive care unit for diagnosis and treatment. in neonatal care and reduction of acute interventional pain; non-pharmacological methods including behavioral, psychological and environmental regulations should be used. in the hepatitis b vaccine administered to preterm babies, stimulating the grasping reflex can make the preterm baby feel safe and calm. in the literature, there are many studies aimed at reducing pain in preterm newborns. however, no study has been found on the effect of grasping reflex stimulation on pain and crying in hepatitis b vaccine administration to preterm infants. this study was planned to examine the effect of grasping reflex on pain and crying duration in preterm infants with hepatitis b vaccine.


Eligibility criteria:
inclusion criteria: * 28-36 gestational week * no congenital malformation * follow up with a diagnosis of respiratory distress syndrome, * receive oxygen support with a nasal cannula or tube, * not receive mechanical ventilation support, * no contraindications for hepatitis b vaccine administration, * stable vital signs before vaccination, * not receive analgesic sedation treatment * whose parents give verbal and written consent to participate in the study. exclusion criteria: * infants of parents who did not give informed voluntary consent will not be included in the study. * decreased oxygen saturation levels * tachycardia just before the vaccine administration * invasive intervention in the right hand.
predicting risk factors for exacerbation of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: exacerbations of chronic obstructive pulmonary disease (copd) are unfavourable events in the course of disease for most copd patients. published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (hrql), disease progression, mortality, health care utilisation and costs. however, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. the identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.the pathogenesis of copd is still unclear, so there is no specific treatment at present .copd was considered to be the result of a combination of environmental and genetic factors. genetic factors play an important role in the acute exacerbation of copd.therefore, it is an urgent need to explore the heterogeneity of copd phenotype from the perspective of genes and to seek individualized prevention and treatment programs.this study is intended to provide a theoretical basis for the prevention, evaluation and development of individualized treatment plans for acute exacerbation of copd, thereby improving the prognosis of the disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease * aged \>= 40 years exclusion criteria: * spirometry can not be completed because of various reasons * asthma * pulmonary embolism * lung cancer * sequelae of tuberculosis * extensive bronchiectasis * interstitial lung disease * left cardiac insufficiency
lumbo-pelvic mobilization and stabilization with pilates method in low back pain and movement functionality

Conditions: Low Back Pain; Pain

Summary: lumbar pain is one of the most common injuries being the cause of morbidity in the individual generating occupational disability with strong personal, social and economic impact. as one of the methods of treatment, pilates is a method that has good results for the management of this dysfunction. however, it is not known exactly which approach pilates can bring better results for this population. therefore, the purpose of this study is to compare the effects of two types of pilates method interventions on non-specific chronic low back pain. a blinded randomized clinical trial, will be held. 28 patients divided randomly into two groups will be assessed, the mobilization pilates (mp) and the stabilization pilates (sp). both groups will be formed by individuals of both sexes and aged 21 to 41 years with chronic low back pain. both groups will receive 10 sessions of pilates methods twice a week, with each session taking an average of 50 minutes, therefore the mp will focus on a lumbo-pelvic mobilization exercises approach and the sp will focus on lumbo-pelvic stabilization exercises approach. at the beginning and end of the 5 weeks the individuals are evaluated to verify the presence of pain and disability with vas of pain and oswestry questionnaire, and also with the functional movement screen. data will be analyzed statistically.


Eligibility criteria:
inclusion criteria: * individuals of both sexes aged between 21 and 40 years; * self-reported low back pain for at least 3 months; * disability oswestry index greater than 10%. exclusion criteria: * diagnosis of pathognomonic low back pain caused by disc herniation with root involvement, inflammatory disorders, infections, osteoporosis, rheumatoid arthritis, fracture or tumor; * medical contraindication to the practice of pilates; * childbirth or gestation in the last 6 months; * be performing any type of treatment for low back pain is medicated, physiotherapeutic or alternative during the period of intervention; * change the level of physical or sports activity during the intervention period; * participants who miss two sessions in a row or four sessions alternately without retrieving them in the same week will automatically be excluded from the survey; or do not attend pre and post-test evaluation events.

Keywords: exercise movement techniques low back pain exercise
immunogenicity and safety study in infants of glaxosmithkline biologicals' infanrix hexa™ (dtpa-hbv-ipv/hib) vaccine

Conditions: Poliomyelitis; Tetanus; Acellular Pertussis; Haemophilus Influenzae Type b; Diphtheria; Hepatitis B; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Summary: this study evaluates the immunogenicity and safety of infanrix hexa™ (dtpa-hbv-ipv/hib) when administered as a primary vaccination course to indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.


Eligibility criteria:
inclusion criteria: all subjects must satisfy all the following criteria at study entry: * a male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination * documented administration of a hepatitis b vaccine dose at birth * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol * written informed consent obtained from the parent(s)/lar(s) of the subject * healthy subjects as established by medical history and clinical examination before entering into the study * born after a gestation period of at least 36 weeks exclusion criteria: the following criteria should be checked at the time of study entry. if anyexclusion criterion applies, the subject must not be included in the study: * child in care * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose * administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (hrv) vaccination which is allowed at any time during the study * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * evidence of previous diphtheria, tetanus, pertussis, hepatitis b, poliomyelitis and haemophilus influenzae type b (hib) vaccination or disease, with the exception of a birth dose of hepatitis b vaccine and oral poliovirus vaccine (opv) as per local standard of care * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination * family history of congenital or hereditary immunodeficiency * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine * major congenital defects or serious chronic illness * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period * acute disease and/or fever at the time of enrolment

Keywords: infanrix hexa™ primary vaccination india combination vaccine infants