Kornimate/medical-research-clean huggingface dataset:
outcome assessment of an active surveillance program for low risk prostate cancer: an observational study

Conditions: Prostate Cancer

Summary: the purpose of this research study is to monitor the feasibility and outcome of the active surveillance program for men with low risk prostate cancer.

the purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at the center for cancer prevention and treatment at st. joseph hospital. we hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (qol) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. in addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated. * psa \< 10 ng/ml within 1 month of program enrollment * clinical stage less than or equal to t2a * biopsy sampling with at least 10-12 cores * gleason score less than or equal to 3 + 3 * no more than 2 cores involved * no core more than 50% involved * eligible for definitive therapy * able to provide informed consent * able to complete a qol questionnaire * able to comply with the scheduled follow-up appointments exclusion criteria: * see inclusion criteria for eligibility

Keywords: prostate cancer active surveillance low risk prostate cancer
radiomics-based models for the prediction of pathological response to neoadjuvant therapy in gastric and gastroesophageal cancer

Conditions: Patients With Locally Advanced Carcinoma of the Stomach and Oesophagogastric Junction

Summary: identifying predictors of response to neoadjuvant therapy in gastric and gastro-oesophageal cancer early in the history of the disease would ensure optimal treatment planning. the study aims to apply radiomics for the prediction of response to neoadjuvant therapy.


Eligibility criteria:
inclusion criteria: * patients with locally advanced stomach cancer undergoing neoadjuvant chemotherapy and gastrectomy between january 2005 and august 2022 exclusion criteria: * siewert 1 tumors; * patients who have received neoadjuvant with the addition of a biological drug; * patients who have received radiotherapy; * patients without staging ct scan or with insufficient image quality in terms of phases performed, pixel spacing, slide thickness (mandatorily: \> 5 mm) or artefacts.

Keywords: stomach cancer esophagogastric junction. locally advanced carcinoma of the stomach radiomics
the use of ultra rice compared to iron drops consumed by anemic children

Conditions: Anemia; Iron Deficiency Anemia

Summary: background: how best to improve iron status among infants in low-income settings is of continued concern in many countries, including brazil objective: design: in a double blind, 5-mo, home-based trial in brazil, mildly anemic 6 - 24 month-old children (n=175) were randomly assigned to receive either ultra rice (urg) fortified with 23,4, mg fe as micronized ferric pyrophosphate (mfp) and a placebo solution of iron drops, or identical non-fortified rice (cg) and a solution of iron drops. parents were instructed on the correct dosage of iron drops and to feed their children (including whether and how much rice) as they normally would. iron status and hemoglobin (hb) were measured at baseline and at 5 mo.


Eligibility criteria:
inclusion criteria: * anemia exclusion criteria: * non anemic
corticosteroid lumbar epidural analgesia for radiculopathy

Conditions: Lumbosacral Radicular Pain

Summary: this is a research study of sp-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. the medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment. the purpose of the study is to measure how well a single injection of the experimental medication, sp-102, relieves pain. the study will also investigate the side effects of sp-102.


Eligibility criteria:
main inclusion criteria: * able and willing to read, write, and understand the english language and provide english language written informed consent prior to beginning any study procedures. * age 18 to 70 years (inclusive) at the screening visit. * a diagnosis of lumbosacral radicular pain (sciatica). * agrees to follow study-specific medication requirements. * if sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study. * has reviewed all study specific materials and has, in the opinion of the investigator, the abilities to understand and appropriately complete all study procedures. main exclusion criteria: * has radiologic evidence of a condition that would compromise study outcomes. * has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study. * has been diagnosed with insulin dependent diabetes mellitus. * presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments. * use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study. * has a body mass index ≥40 kg/m2.

Keywords: lumbosacral radicular pain sciatica leg pain
a multidimensional lifestyle intervention to reduce the risk of metabolic disorders in older workers in taiwan

Conditions: Metabolic Disorder

Summary: the study was aimed to evaluate the effectiveness of a multidimensional worksite intervention program to reduce the severity of metabolic disorders in older workers in taiwan.

the investigators conducted a quasi-experiment in older workers from three worksites in southern taiwan. * qualified subjects were assigned to the intervention or the reference group according to their availability to take part in study activities. * a researcher reviewed the health record and discussed with the subject about his/her health status. * subjects in the intervention group received lifestyle interventions. the activities included motivational presentations to increase awareness of own health problems and the role of lifestyle in the etiology of non-communicable chronic diseases. * subjects were organized into small groups to have biweekly meetings to share experiences, stimulate mutual encouragement and to overcome obstacles. * anthropometric and biochemical indicators were measured at baseline and endpoint (week 24).

Eligibility criteria:
inclusion criteria: * full-time worker * aged 50 years or older * willing to complete a screening questionnaire * sign a study consent exclusion criteria:

Keywords: older workers multidimensional intervention worksite health promotion taiwan
yan nian jiu zhuan fa improve chronic fatigue syndromes

Conditions: Chronic Fatigue Syndromes

Summary: this study is to disclose the mechanism of characteristic tao yin exercises regulate chronic fatigue syndromes based on brain-gut axis.explore the clinical manifestation of chronic fatigue syndromes, changes of neurotransmitter and central brain function. then provide some new methods of treating chronic fatigue syndromes.

this research will be conducted in shanghai university of traditional chinese medicine.then the clinical efficacy of yan nian jiu zhuan fa on chronic fatigue syndrome will be observed by examining gastrointestinal function, affecting the content of substances in plasma and analysing the central nerve response mechanism.

Eligibility criteria:
inclusion criteria: the occurrence of four or more of the following symptoms: * subjective memory impairment * tender lymph nodes * muscle pain * joint pain * headache * unrefreshing sleep * post-exertion malaise lasting for more than 24 hours exclusion criteria: * active, unresolved, or suspected medical disease * psychotic, melancholic or bipolar depression (but not uncomplicated major depression) * psychotic disorders * dementia * anorexia or bulimia nervosa * alcohol or other substance misuse * severe obesity.

Keywords: yan nian jiu zhuan fa
zileuton and exhaled nitric oxide in asthmatics

Conditions: Asthma

Summary: evaluate the additive role of zileuton 600mg qid to clinically stable asthmatics on advair 250/50 bid. since asthma is an endogenous inflammatory disease there usually is increased total exhaled, bronchial and alveolar nitric oxide which are markers of eosinophilic driven pathways of inflammation. the addition of zileuton which is a leukotriene synthesis inhibitor by itself or together with inhaled corticosteroids should reduce nitric oxide gas exchange.


Eligibility criteria:
inclusion criteria: * non-smoking * moderate to severe persistent asthmatics * clinically stable x 6 weeks on advair 250/50 bid for at least 12 months exclusion criteria: * no leukotriene synthesis inhibitors or receptor antagonists for 6 weeks

Keywords: asthma nitric oxide gas exchange lung function
study of sch 527123 in subjects with severe asthma (study p05109am1)

Conditions: Asthma

Summary: given the strong inhibition of sch 527123 on neutrophil migration to sites of inflammation, there is a theoretical reason for its use in patients with severe asthma where neutrophils are thought to play a significant role in the pathophysiology of the disease.


Eligibility criteria:
inclusion criteria: * subject must have severe asthma, be at least 18 to less than or equal to 70 years of age, of either sex, and any race. exclusion criteria: * subject who has been diagnosed with copd or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis).
the dynamics of human atrial fibrillation

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Summary: atrial fibrillation (af) is an enormous public health problem in the united states, affecting 2-5 million americans and causing rapid heart beats, stroke, heart failure or death. in this project, the applicant will develop a novel framework to better understand human af that builds on agreement between several concepts for the disease. the applicant will develop strategies to identify af patients who will best respond to each of several therapies, to guide personalized therapy.

the specific aim of this clinical study is to identify patients who will or will not respond to pvi, pvi plus other ablation or maze surgery based on locations of organized-to-disorganized areas and clinical profile. we will develop non-invasive ecgi and intracardiac recordings in our registry, then test them prospectively in an observational study. premise: identifying responders or non-responders to pvi alone, or pvi plus other ablation or maze surgery may enable patient-tailored therapy. this may raise overall success, reduce risks from unsuccessful procedures and improve resource utilization(58,128-130). this proposal will prospectively test in single-arm observations studies if patients who exhibit large organized af areas at planned ablation regions have higher procedural success than patients with smaller areas. we will use non-invasive ecgi indices of organized af, based on preliminary data(9, 84, 85). this project is significant because it will establish a deeper understanding of af and will develop strategies to identify af patients who will best respond to each of several therapies, to guide personalized therapy.

Eligibility criteria:
inclusion criteria: * referred for ablation or maze surgery at stanford medicine for persistent af (i.e. which requires cardioversion to terminate and/or lasts \>7 days) * per our clinical practice and guidelines (calkins et al., heart rhythm 2018), patients will have failed or be intolerant of \>or= 1 anti-arrhythmic drug. patients after maze surgery typically have failed prior endocardial ablation. exclusion criteria: * active coronary ischemia or decompensated heart failure * atrial or ventricular clot on trans-esophageal echocardiography * pregnancy (to minimize fluoroscopic exposure) * inability or unwillingness to provide informed consent * rheumatic valve disease (results in a unique af phenotype) * thrombotic disease or venous filters * prior chest surgery is a relative contraindication for maze surgery

Keywords: ablation arrhythmias, cardiac atrial fibrillation
analyse of tumour and constitutional dna for the study of the determinism in child neoplasia

Conditions: Pediatric Tumor; Familial Cancer; Solid Tumor, Childhood; Hematological Tumor

Summary: background. cancer is the leading cause of death by disease in children. most pediatric tumors differ from adult tumors in terms of biological and clinical characteristics. in children, the part of genetic determinism could be higher since the role of environmental factors may be less pronounced than in adults and that a young age at onset is a main feature of genetic cancer predisposition. recent studies suggested that a number of genetic predisposition remains to be characterized. methods. trio-based whole exome sequencing of germline dna from patients (children and adults diagnosed with cancers between 0 and 17 years) and parents will be performed prospectively in a multicentric study including 40 unselected cases of malignant tumor. participating hospitals will include the chu of montpellier, the chu de nice and the ap-hp. tumor analysis will include whole exome analysis and transcriptome for the identification of therapeutic target and contribute to confirm potential link between constitutive mutations and tumor phenotype (such as loss of expression, loss of heterozygosity). perspectives. this pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic dna and rna analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.


Eligibility criteria:
inclusion criteria: * the patient has a solid or haematological malignancy, either familial forms or isolated cases diagnosed between the ages of 0 and 17 years. * the minor patient and both biological parents are available to participate in the study or * the adult patient and one or both parents are available to participate in the study. * the patient's parents must have given their free and informed consent and signed the consent for the minor's participation in the study. * the patient's parent(s) must have given free and informed consent and the patient of legal age must have signed the consent for participation in the study. * the patient must be affiliated or beneficiary of a frrench social security scheme. exclusion criteria: * the patient's parents are under guardianship or trusteeship or under legal protection yes no * failure to obtain written informed consent from parents (for themselves and their minor child) after a period of reflection yes no * no affiliation to or beneficiary of a french social security scheme (for biological parents and the patient)

Keywords: pediatric oncology exome based trio cancer predisposition gene target therapies tumor exome transcriptome
reference range for abioscope® device with the psp assay in a generally healthy adult population

Conditions: Sepsis; Septic Shock; Healthy

Summary: this is a single center, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (psp) performed on abionic's abioscope device with the psp assay on generally healthy adults representative of the us population.


Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥ 18 years. 2. apparently healthy as determined by a subject questionnaire. exclusion criteria: 1) current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to: 1. heart disease 2. stroke 3. renal disease 4. liver disease 5. pancreatic disease 6. chronic obstructive pulmonary disorder 7. bleeding disorders 8. hypercalcitoninemia 9. hiv aids 10. receiving antibiotic therapy 11. suspected infection 12. immunosuppression 2) underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months. 3) current diagnosis of uncontrolled hypertension, hypotension, or diabetes. 4) diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment. 5 )experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care. 6) current diagnosis of cancer within the last 12 months. 7) received immunotherapy to stimulate or inhibit cytokines within the last 12 months. 8) hospitalization for more than 24 hours within the last 3 months. 9) reported as currently pregnant or nursing a child 10) unable or unwilling to provide the required blood sample for testing. 11) any other criteria that, in the opinion of the investigator, would render the participant unsuitable for inclusion in the trial.

Keywords: sepsis pancreatic stone protein immunoassay abionic healthy population point-of-care device
incretin effect on the immunological phenotype

Conditions: Type 1 Diabetes

Summary: assessment of the effect of incretin based therapies (liraglutide and saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

assessment of immunological effects of saxagliptin and liraglutide on immune cells of the peripheral blood.

Eligibility criteria:
inclusion criteria: -healthy subjects or patients with type 1 diabetes exclusion criteria: * pregnancy * treatment with glp-1-analoga (liraglutide, exenatide) * treatment with dpp4-inhibitor (sitagliptin, vildagliptin, saxagliptin) * chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)

Keywords: autoimmune disease diabetes type 1 incretin effect
a study of ¹²⁹xe mri to assess disease progression in patients with copd treated with or without azithromycin and standard-of-care medications

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will test whether daily use of azithromycin will reduce the rate of exacerbations and improve lung ventilation and perfusion assessed by xe-mri. the sensitivity of xe-mri to detect copd progression will be compared with standard clinical assessment measures including standard lung function tests, 6 minute walk test, and patient reported quality of life.


Eligibility criteria:
inclusion criteria: * current or former smokers with years ≥ 10 pack years * mmrc dyspnea score \> 1 * post-bronchodilator fev-1/forced vital capacity (fvc) \<0.70 at visit 1 or visit 2 * cohort a: gold stage 2-4 copd with a history of ≥ 2 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening * cohort b: gold stage 1 copd with a history of ≥1 moderate/severe exacerbations within a 12-month period in the 24 months prior to screening * receiving soc background drug therapy as per gold or british thoracic society (bts) guidance for copd for 12 weeks prior to screening visit 1 * on an eligible bronchodilator medication (laba ± lama) ± ics therapy for ≥12 weeks prior to visit 1 * chest x-ray or ct scan within 6 months prior to visit 1, or during the screening period (prior to visit 2), that confirms the absence of clinically significant lung disease besides copd * use of contraceptive measures exclusion criteria: * diagnosis of significant respiratory disease other than copd * comorbid conditions that may interfere with the evaluation of an investigational medical product * known sensitivity or allergy to azithromycin * a copd exacerbation and or pneumonia within 4 weeks prior to visit 1 * use of systemic corticosteroids within 4 weeks (oral or intravenous) or within 12 weeks (intramuscular im) prior to screening visit 1 * mri is contraindicated * any known arrhythmia, bradycardia or severe cardiac insufficiency * participant can not hold breath for 15 seconds * participant does not fit in the ¹²⁹xe vest coil used for mri * pregnant, lactating, or intending to become pregnant during the study or within 4 weeks after the last dose of the investigational medical product * history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results * for participants in cohort a: known significant hearing impairment as indicated by a score of ≥ 26 on the hearing handicap inventory in the elderly-screening questionnaire or as determined by the investigator * history of clostridium difficile (c. difficile) diarrhea clinically significant ecg changes, which in the opinion of investigator warrants further investigation or with a qtc interval \> 450 ms