Kornimate/medical-research-clean huggingface dataset:
association between vitamin d and the risk of uterine fibroids

Conditions: Gynaecological Disease; Vitamin D Deficiency; Uterine Fibroids

Summary: the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin d could reduce the risk of uterine fibroids in reproductive stage women.

a total of 1160 hypovitaminosis d patients (12 ng/ml ≤ serum 25-hydroxyvitamin d3 \< 20 ng/ml) without uterine fibroids will be randomly assigned in a ratio of 1:1 to two groups: intervention group and control group. the intervention group will receive 1600 iu/d of vitamin d3; the control group will receive regular follow-up. patients will be followed up at the same time points for 24 months. the outcome measure is the incidence of uterine fibroids in different groups.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in the study with informed consent; 2. females aged 35-50 who are confirmed with a normal, fibroid-free uterine structure, by means of transvaginal or abdominal ultrasonography; 3. serum25-hydroxyvitamin d3 \<20 ng/ml, ≥ 12ng/ml. exclusion criteria: 1. use of sexual hormone, mifepristone, gonadotropin-releasing hormone agonist (gnrha), or other medication which is likely to interfere with uterine fibroids within 3 months; 2. pregnancy, lactation, postmenopause, or planned pregnancy within two years; 3. allergic to vitamin d3; 4. suspected or identified as other tumors of genital tract; 5. history of hysterectomy or myomectomy; 6. history of osteoporosis or vitamin d deficiency taking vitamin d supplements within previous one month; 7. history of hyperparathyroidism, infectious diseases (tuberculosis, aids), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 8. alanine aminotransferase (alt) or aspartate transaminase (ast) more than 3 times of the normal upper limit, total bilirubin (tbil) more than 2 times of the normal upper limit; 9. creatinine levels ≥ 1.4 mg/dl (123μmol/l) or creatinine clearance ≤ 50 ml/min; 10. history of malignant tumors; 11. simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
pilot study on the effects of imoove in parkinson's disease patients

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is one of the most frequent causes of motor dysfunction in aging. it is therefore important to use rehabilitative therapeutic approaches that may prevent the development of motor complications when possible. imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold. the project is focused on quantifying the efficacy of imoove® as a treatment method for improving joint mobility, posture and autonomy in pd.

the pathogenesis of pd-related postural abnormalities is probably multifactorial as well as widely indefinite, and this could compromise treatment choices and efficacy. in addition to dystonia and rigidity, proprioceptive and sensorimotor disintegration as well as peripheral degenerative processes (myopathy, skeletal and soft tissue changes) have been proposed as causative factors of abnormal trunk postures. when the body is educated in the elispheric® movement it relearns the original vertebral motion, and postural control necessary for any action by the body, the professional can then perform effective vertebral reeducation. the elispheric® movements are created by a motorised plate. this unique technology impulses the body through a centrifugal force in three planes. this force trains the body in its natural spirals. the performance result is based on the fact that imoove restores the all freedom of movement, strength, precision and it works on the basic skeletal posture. it is an exploratory study, in order to verify if the project is adequate, to establish its feasibility and to obtain information that allows to determine the size of the sample of the definitive study, 30 consecutive pd outpatients will be recruited for the imoove® treatment.

Eligibility criteria:
inclusion criteria: * patients with parkinson's disease (diagnosed according to uk brain bank criteria); * age: 40-80 * medical treatment for parkinson's disease must be stable for at least two weeks prior to inclusion, and during the study. during the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.- exclusion criteria: * all the usual contraindications associated with physical medicine, rehabilitation and sport

Keywords: parkinson disease imoove elispheric movement
efficacy of optison echo contrast to detect thrombus in left atrial appendage

Conditions: Atrial Fibrillation

Summary: the investigators intend to determine if using optison echocardiography contrast increases sensitivity and specificity of detecting left atrial appendage thrombus in transesophageal echocardiography studies as opposed to standard 2d and 3d tee imaging without the use of echo contrast.

accurate determination of the presence or absence of left atrial appendage (laa) thrombus has a large impact on the clinical course of patients with atrial fibrillation or ischemic stroke and has large financial implications as well. misdiagnosing the presence of laa thrombus can lead to unnecessarily cancelled procedures (cardioversion and atrial fibrillation ablation) and potentially hazardous, unnecessary changes in clinical care (such as prolonged coumadin anticoagulation). missing laa thrombus can result in continuation of cardioversion or atrial fibrillation ablation procedures at a time when there is higher risk of subsequent embolic stroke. several of the patients with atrial fibrillation require transesophageal echocardiography (tee) performed prior to cardioversion or atrial fibrillation ablation procedures. there is opportunity to enroll most of these patients in our proposed study. there has been essentially no work published about the use of echo contrast materials in tee (other than agitated saline), particularly the use of optison. thus, the investigators will be exploring a new field in echocardiography and echo contrast.

Eligibility criteria:
inclusion criteria: * \> 18 years old * cognitively sound and able to provide informed consent * indicated for tee as a standard clinical procedure for evaluation of cardiac health status. exclusion criteria: * contraindicated for optison administration * known right-to-left or bi-directional cardiac shunts * hypersensitivity to perflutren, blood, blood products or albumen * women who are pregnant * removal of left atrial appendage * not able to provide informed consent

Keywords: atrial fibrillation stroke tee left atrial thrombus
more added value of therapeutic education in the management of patients with rheumatoid arthritis (etp-pr)

Conditions: Rheumatoid Arthritis

Summary: taking into account the recommendations of the health authority \[1\] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at nantes university hospital. step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; step 2: orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; step 3: final interview with a nurse said therapeutic education formative assessment to take stock. the main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.


Eligibility criteria:
inclusion criteria: * patient presenting at clinics for rheumatology or the rheumatology day hospital at the university hospital or hospitalized in the department of rheumatology * men or women * having signed the consent * major * affiliated to social security or covered by the cmu * patient with rheumatoid arthritis meeting the acr criteria * patient with rheumatoid arthritis stable for at least 6 months (change in das 28 \<1.2) exclusion criteria: * patient can not understand the information * patient confined to bed or chair, unable to care for himself or not doing with difficulty * pregnant patient * minors * adults under guardianship

Keywords: therapeutic education, rheumatoid arthritis
the effect of substitution of out-of-hours care from general practitioners to nurse practitioners

Conditions: Out-of-hours Care Services; Primary Healthcare

Summary: the aim of this study is to explore the effects of substitution in out-of-hours primary care. in consecutive stages an extra general practitioner (gp) is substituted by a nurse practitioner (np) aiming at replacing 3 out of 4 gps by nps. effects are measured in terms of feasibility and cost-efficiency.

out-of-hours care in the netherlands is under pressure. workload for gps during out-of-hours care is high and there are concerns about maintaining the quality of care. since 80% of the complaints shown in out-of-hours care is neither complex nor urgent not all patients necessarily have to be seen by a gp. a previous study (id: 80-82800-98-227) indicated that shifting care from gps to nps is possible in terms of safety and quality of care and resulted in cost savings due to less treatment. in that study 4 gps and 1 np provided care in the experimental condition and 5 gps provided care in the control condition. based on the results it is hypothesized that nps are competent to diagnose and treat at least 75% of the complaints shown in out-of-hours primary care. substituting more gps by nps in out-of-hours care will probably lead to more cost savings. in the current study care delivered and direct healthcare costs are compared between different team compositions. in the experimental condition care is provided by a team of nps and gps. the intervention starts with a team of 4 professionals in both the experimental (3 gps and 1 np) and the control (4 gps) condition; in consecutive stages an extra gp is substituted by an np aiming at replacing 3 out of 4 gps with by nps. control: 4 gps stage 1: experimental: 3 gps \& 1 np stage 2: experimental: 2 gps \& 2 nps stage 3: experimental: 1 gp \& 3 nps both feasibility and cost-efficiency will lead to recommendations on the optimal balance in a team between gps and nps.

Eligibility criteria:
inclusion criteria: * patients (with urgencylevel u2, u3, u4, or u5) requesting an appointment at the primary out-of-hours service during the weekend between 10am and 6pm. exclusion criteria: * none

Keywords: nurse practitioners primary healthcare emergency medical services substitution of care
prospective database for chronic myelogenous leukemia

Conditions: Leukemia, Myeloid, Chronic

Summary: prospective database for chronic myelogenous leukemia


Eligibility criteria:
inclusion criteria: * patients with cml

Keywords: cml
community empowerment to pilot a novel device for monitoring rescue medication use in urban children with asthma

Conditions: Asthma

Summary: background: pediatric asthma is the most common chronic illness among children and is associated with poor quality of life, activity restriction, school absences, and thousands of physician visits annually. the purpose of this study is to measure the effectiveness of using an innovative tracking system (caretrx) for the self-management of asthma, including daily and rescue medication use, among children and adolescents with pediatric asthma.

the primary study objective is to measure the effectiveness of using an innovative tracking system (caretrx) for the self-management of asthma, including daily and rescue medication use, among children with asthma. the study objectives will be achieved using a pre-post design for the participants. the investigators aim to enroll at least 26 participants for a 3-month intervention period. with this pilot study, the investigators hope to examine the impact of self-management behaviors on health outcomes including asthma symptoms and quality of life measures.

Eligibility criteria:
inclusion criteria: 1. youth with a primary diagnosis of persistent asthma according by nhlbi criteria 2. females or males between the ages of 6-17 years of age 3. youth or caregiver must have an android smart phone with operating system 4.3 or above and data plan for the duration of the study period exclusion criteria: 1. youth with other cardiac, pulmonary, or neuromuscular disorders that impact breathing 2. youth with documented developmental delays or impairments that would interfere with ability to use caretrx system
interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. combining interferon alfa and interleukin-2 may kill more tumor cells. purpose: phase ii trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

objectives: * evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. * assess the toxicity of this regimen. outline: patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. all patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. patients are assessed for response approximately 2 months after initiating therapy. patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. patients are followed for survival. projected accrual: 14 patients will be entered.

Eligibility criteria:
disease characteristics: * histologically proven renal cell cancer that is metastatic * no greater than 50% estimated hepatic replacement by tumor on ct or mri * no symptomatic involvement of the cns or a major nerve * measurable disease required * ineligible for treatment with low-dose interleukin-2 on another cmc protocol patient characteristics: age: * 18 and over performance status: * karnofsky 50%-100% life expectancy: * more than 3 months hematopoietic: * no coagulopathy (i.e., platelet count less than 80,000/mm3) hepatic: * ast and alt no greater than 5 times normal renal: * creatinine less than 4.0 mg/dl cardiovascular: * no symptomatic angina * no untreated coronary artery disease * no refractory arrhythmia * no abnormal left ventricular function pulmonary: * no dyspnea on minimal exertion other: * no site of ongoing bleeding * no systemic infection * no hiv antibody * no hbsag * no requirement for steroids * no psychiatric disease that precludes informed consent or protocol treatment * no second malignancy except: * basal cell skin carcinoma * carcinoma in situ of the cervix * not pregnant or nursing * effective contraception required of fertile women prior concurrent therapy: biologic therapy * no prior interleukin-2 chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified other * at least 28 days since prior treatment for renal cell cancer

Keywords: stage iv renal cell cancer recurrent renal cell cancer
pocket versus tunnel icrs for treatment of keratoconus

Conditions: Keratoconus

Summary: keratoconus is a corneal degenerative disease associated with loss of best-corrected visual acuity. the use of intrastromal corneal ring segment implants is indicated to regularize the cornea and to reduce aberrations.

keratoconus is a corneal degenerative disease characterized by corneal thinning and subsequent development of irregular astigmatism, diminution of vision and loss of best-corrected visual acuity. management of keratoconus includes halting disease progression through a corneal strengthening procedure called corneal collagen cross-linking (cxl) which usually results in stabilizing the condition but with no improvement in visual acuity or quality. intrastromal corneal ring segment (icrs) implantation is a well-established procedure for the management of moderate keratoconus with a corneal flattening effect that is associated with improvement of visual acuity and reduction of optical aberrations. the aim of the study is to evaluate and compare the visual, refractive and topographic outcomes of two different femtosecond laser assisted surgical techniques to create a corneal stromal pocket or a tunnel for implantation of icrs for the management of central keratoconus

Eligibility criteria:
inclusion criteria: 1. patients with progressive keratoconus with maximum keratometry (kmax) between 50-65 diopters 2. central keratoconus (keratoconus with steepest corneal point within the central 3 mm zone). 3. clear corneal with a minimum pachymetry of 400 μm. exclusion criteria: 1. corneal scars 2. patients with advanced keratoconus with kmax \> 65 diopters. 3. non-central keratoconus (para-central or peripheral keratoconus with steepest corneal point outside the central 3 mm zone). 4. previous corneal cross-linking and/or ocular surgery. 5. systemic diseases such as diabetes mellitus and autoimmune diseases

Keywords: keratoconus femtosecond laser-assisted icrs central keratoconus keraring
evaluate and understand preferences and representations in families of patients with regard to high-throughput sequencing technology for diagnostic purposes

Conditions: Rare Diseases

Summary: after the use of dna chips for diagnostic purposes, high-throughput sequencing (hts) is transforming the field of developmental diseases, from fundamental research to care. nonetheless, before hts can be transferred to everyday clinical practice, in particular for expert diagnosis using exome hts, it is necessary to anticipate the nature of the information to be given to patients and to parents in order to obtain consent for exome hts. the objective in terms of public health is to allow patients with rare diseases to benefit from innovative technologies in optimal conditions of information and accompaniment. the objectives of this project are to 1. evaluate the preferences of families of patients with development disorders as regard to suspicious and incidental findings from hts before its introduction for diagnostic purpose, 2. and then, following the exome analyses carried out for diagnostic purposes, describe, analyse and understand the experience, expectations and reactions of families and geneticists concerning the diagnostic trajectory in general and at the time the results of the hts were announced in particular a methodology that associated quantitative and qualitative approaches was chosen so as to combine the advantages and overcome the shortcomings of each: a quantitative study to investigate a large number of patients, which would ensure a certain representativeness of the population and allow sub-groups analyses to study the upstream phase concerning indications for high-throughput sequencing; and a qualitative study, which though it allows only a small number of patients to be investigated, makes it possible to describe, analyze and understand in depth the complex downstream phenomena of high-throughput sequencing results


Eligibility criteria:
quantitative study * inclusion criteria * parents of patients with development anomaly and/or intellectual deficiency with no etiological diagnosis * parents of patients consulting at the centres of reference in dijon or lyon * parents of patients who have not already benefited from hts * parents of patients who are fluent in french * non-inclusion criteria * persons without national health insurance cover * inability to answer the questionnaires qualitative study * inclusion criteria * persons who have provided written informed consent * parents of patients with a development anomaly * parents of patients consulting at the centres of reference in dijon or lyon * parents of patients who have already benefited from hts for diagnostic purposes * persons fluent in french * non-inclusion criteria * persons without national health insurance cover * cognitive impairment making it impossible for the person to understand the aims of the study
thiopurine methyltransferase polymorphisms evaluation

Conditions: Cancer

Summary: the purpose of the study is to determine the frequency of allelic variants in tpmt in the hispanic population and to compare the frequency in the hispanic population with the caucasian population.

relatively few studies have been performed evaluating the variant allele frequencies in spanish populations. to date, no studies evaluating the tpmt variant allele frequency in the hispanic population have been reported. hispanics are a growing part of the patient population treated in the united states. characterization of the proportion of patients with variant genotypes in this population is important since hispanic children represent a significant proportion of children being treated with thiopurines. a single 3 cc heparinized blood sample will be obtained for tpmt genotyping. the sample will be obtained either simultaneously with a clinical sample, at the time of an otherwise medically indicated intravenous catheter placement or scavenged from excess blood remaining following clinical laboratory testing.

Eligibility criteria:
inclusion criteria: * all hispanic children and adolescents diagnosed and treated at texas children's cancer center within the last 5 years for malignant diseases/cancer and non-malignant hematological disorders that necessitate chemotherapy * all hispanic children and adolescents who will be treated at texas children's center for malignant diseases/cancer and non-malignant hematological disorders that will necessitate chemotherapy. exclusion criteria: * any child or adolescent registering at texas children's cancer center and not requiring any form of therapy.

Keywords: cancer chemotherapy hematological disorder