Kornimate/medical-research-clean huggingface dataset:
evaluation of an environmental counsellor's home stay in children treated for asthma or allergic rhinitis via a standardized medical questionnaire randomized controlled superiority trial in parallel arms, multicentric (evalpce)

Conditions: Category 3 Study (Non-interventional Research)

Summary: assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.

asthma and allergic rhinitis are chronic diseases whose control is multifactorial (drug treatment, therapeutic education of the family and the child, consideration of a possible allergen...). when this control is not optimal, it leads to significant school absenteeism, pediatric emergency room visits and hospitalizations. environmental conditions at home play a role in asthma exacerbations and poor control of allergic rhinitis in children. mites, animal allergens, passive smoking, molds, cockroaches, household products, etc., are the main causes. the visit of a home environment advisor, who intervenes on medical prescription, makes it possible to evaluate the source of allergens and pollutants in the home and then to propose changes to the home. this position was created in france in 2009 by the ministry of the environment and is funded by the agence régional de santé (ars - regional health agency). the few studies carried out to assess the effectiveness of a home visit by an environmental advisor on exacerbations of these diseases are contradictory: some show an improvement in the quality of life of asthmatic children after a home visit (via the average reduction in the number of days with symptoms/year) as well as a reduction in asthma-related morbidity thanks to a reduction in exposure to indoor allergens. others have shown that it does not reduce the number of emergency room visits for asthma exacerbations. furthermore, it would appear that targeted allergen avoidance measures do not reduce drug treatment in asthmatics who are already on optimal pharmacological treatment. to our knowledge, there are no studies in france that use standardized medical questionnaires to assess disease control and quality of life before and after the visit of a home environmental consultant. for example, in angers and nantes, evaluation questionnaires are carried out with patients at 6 months and 1 year after a home visit, but the answers are not standardized and sometimes very subjective.

Eligibility criteria:
inclusion criteria: * patient under 18 years of age * with asthma or allergic rhinitis * for whom a home visit by an environmental consultant is prescribed exclusion criteria: * parental refusal to participate in the study * poor understanding of the french language not allowing to fill in the questionnaire * asthmatic child under 7 years old or child with allergic rhinitis under 6 years old (questionnaires not validated below these ages) * patient concerned by a current request for relocation

Keywords: asthma allergic rhinitis environmental consultant
hématologie adulte prevalence of adrenal insufficiency post-chemotherapy adrenocorticotropia in adult hematology

Conditions: Haematological Malignancy

Summary: a recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological is (68%) is onco-hematology. however, it is also the least studied population with no recent and significant prevalence study. a recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in hematology, objective a prevalence of biological is estimated at 16% at 3 months from the start of chemotherapy. the introduction of a substitution had led to an objective improvement in the quality of life estimated by eortc qlq-c30.

a recent meta-analysis involving 3753 patients treated with corticosteroids notes that the population with the highest prevalence of biological is (68%) is onco-hematology. however, it is also the least studied population with no recent and significant prevalence study. a recent multicenter study including patients followed up oncology who received dexamethasone for antiemetic purposes at cumulative doses well below the doses used in hematology, objective a prevalence of biological is estimated at 16% at 3 months from the start of chemotherapy. the introduction of a substitution had led to an objective improvement in the quality of life estimated by eortc qlq-c30. expected results are prevalence rate of biological adrenal insufficiency between 15 and 20% with improvement of the quality of life in the 2 months post-chemotherapy by hydrocortisone supplementation

Eligibility criteria:
inclusion criteria: * age\> 18 years * patient naive to any chemotherapy treatment, re-ceiving a 1st chemotherapy line of rchop, rcop, vtd, vd or mpt type from the adult hematology department * ps according to who = 0,1 and 2 exclusion criteria: * adrenal pathology, hypothalamus or pre-existing pituitary gland (including metastatic lesions) * long-term treatment with corticosteroids or in the previous 6 months * refusal or absence of informed consent
use babyguard® breast milk probiotics to verify the authenticity of the gut-breast axis hypothesis

Conditions: Intestinal Bacteria Flora Disturbance

Summary: in order to understand the life history of the breast milk flora, explore its composition, source of strains, and ability to colonize the baby's intestinal environment, to find out strains with the potential of probiotics in breast milk

this is a double-blind and randomized study. after being discharged from the hospital, the subject was notified to consume the babyguard breast milk probiotic daily for 1 month, and observe whether the mother's stool, breast milk and baby stool samples can find the same strain. the clinical diagnosis items of the bacterial strains of mother feces, breast milk and baby feces samples are evaluated by the doctor.

Eligibility criteria:
inclusion criteria: * at least 20 years old, pregnant women with non-high-risk pregnancy risk assessed by obstetricians and gynecologists, healthy mothers and infants with no abnormal obstetric examination results exclusion criteria: * pregnant women who have used oral or injectable antibiotics within three months before delivery, or women who need a cesarean section for any reason during pregnancy
double-dose valsartan monotherapy in hypertension treatment: an effectiveness and safety evaluation in chinese patients.

Conditions: Hypertension

Summary: to evaluate efficacy and safety of valsartan 160mg in chinese hypertensive patients.


Eligibility criteria:
inclusion criteria: * naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy: * all treatment-naive patients need to have 140mmhg≤mssbp\<180mmhg and 90mmhg≤msdbp\< 110mmhg at visit 1 * for patients on mono antihypertensive therapy, mssbp/msdbp should \<160/100mmhg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have mssbp≥140 mmhg and \<180mmhg and msdbp≥90 mmhg and \<110mmhg exclusion criteria: * severe hypertension * malignant hypertension * secondary hypertension * renal dysfunction(serum creatinine \> 2.0mg(176.8μmol/l)at visit 1) * hepatic disease * history of hypertensive encephalopathy or cerebrovascular accident within 6 months * history of myocardial infarction, coronary revascularization within 6 months * type 1 diabetes mellitus * patietns with hba1c \>8% at visit 1 * women in pregnancy and lactation * potentially fertile female patients not using effective contraceptive methods * be allergy to study drug. other protocol defined inclusion/exlusion criteria may apply

Keywords: hypertension valsartan
hiv prevention in very high risk men who have sex with men

Conditions: Risk Reduction Behavior

Summary: the purpose of this study is to pilot test an innovative program development project in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) hiv-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners).

this is an innovative program development project that will, over the next year, pilot test, in an open trial format an 8-session, individual, cognitive-behavioral therapy based, intervention on ten (10) hiv-infected men who have sex with men who report very high levels (\>10 episodes) of sexual transmission risk behavior (unprotected anal intercourse with serodiscordant partners). that is, to pilot test a novel prevention intervention designed to effect reductions in sexual transmission risk behavior among the riskiest men in the largest hiv risk group in the us. effecting even modest reductions in the mean number of risk acts in this group will likely have substantial public health significance through the number of averted new hiv infections. traditional secondary hiv intervention strategies (e.g., information, motivation, behavior change (imb)) models only have modest effects for hiv-positive msm and there is evidence to suggest that these effects tend to diminish over time.

Eligibility criteria:
inclusion criteria: * age 18 years old or older * self-reports as a man who has sex with men (msm) * self-reports being hiv-infected * reports engaging in 10 episodes or more of unprotected anal intercourse (receptive or insertive) in the past three months with male partners who are not hiv-infected or whose serostatus is unknown. * is capable of completing and fully understanding the informed consent process and the study procedures and assessments in english exclusion criteria: * unable or unwilling to provide informed consent

Keywords: hiv-infected msm hiv prevention
assessing the changes in markers of calcium vitamin metabolism of for breast cancer adjuvant (calciobs)

Conditions: Breast Cancer

Summary: this study is to assess hypercalciuria between j1 of the cure and 1 j1 6 of the cure of adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast cancer.

in view of the absence of data published on the changes of the vitamin and calcium metabolism in patients of a breast cancer receiving adjuvant chemotherapy combined with corticosteroids in antiemetic aiming and a basal calcium vitamin deficiency. a non randomized study evaluating the percentage of change in the vitamin and calcium balance and the occurrence of a hypercalciuria between initiation and the end of the adjuvant chemotherapy seems necessary, both from the scientific point of view, but also to estimate the usefulness of these markers in clinical practice track. this study is to assess hypercalciuria between j1 of the cure and 1 j1 6 of the cure of adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast cancer

Eligibility criteria:
inclusion criteria: * mammary adenocarcinoma to receive 6 cycles of adjuvant chemotherapy. * performance index according to who less than or equal to 1. * patient older than 18 years and older. * patient affiliated to a social security scheme or beneficiary of an equivalent french social protection system * the informed consent signed and before any procedures specific to the test screening. * pregnancy test negative for women and a means of contraception for women and men of reproductive age exclusion criteria: * the presence of metastatic disease. * other cancer (except basal-cell skin carcinoma and cancer of the cervix in situ treated adequately and curative) treated in the 3 previous years. * contraindications for the calcium and colecalciferol:-severe hypersensitivity to vitamin d or calcium supplementation or any of the excipients * pathology and/or conditions causing a hypercalcemia and/or hypercalciuria * calcium lithiasis - tissue calcification * hypervitaminosis d • presence of significant co-morbidities: uncontrolled endocrine disease. known disorders of the phospho-calcium balance in the last 3 years. osteopenia or osteoporosis proven treatment vitamin and calcium. * concomitant treatment with experimental products. * pregnant or nursing * legal incapacity or limited legal capacity. medical or psychological conditions, allowing the subject to complete the study or to sign the consent (art.) l.1121 - 6, l.1121 - 7, l.1211 - 8, l1211-9).
risk factors of minor head injury

Conditions: Minor Head Injury; Intracranial Bleeding; Traumatic Brain Injury

Summary: introduction and aims: the objective of this prospective study is to evaluate the risk factors of minor head injury in all consecutive patients of one year.

minor head injury (mhi)is one of the most common diagnoses in emergency rooms and traumatological outpatient departments. the aim of this study is to find clear evidence which risk factors are the most important in mhi patients to develop intracranial bleeding. we hypothetize that anticoagulation is one of the main risk factors for intracranial bleeding.

Eligibility criteria:
inclusion criteria: * minor head injury, dizziness, nausea, vomiting exclusion criteria: * no injury to the head

Keywords: minor head injury iintracranial bleeding traumatic brain injury cranial computed tomography anticoagulatory drugs
whish-2-prevent heart failure

Conditions: Physical Activity; Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Normal Ejection Fraction; Strength Training; Elderly; Women

Summary: the whish-2-prevent heart failure (hf) study is an ancillary study to the women's health initiative strong and healthy (whish) exercise pragmatic trial. the whish-2-prevent hf trial examines the intervention effect of physical activity (pa) on both incident hf and hf burden (recurrent hf and cvd death in those with hf) in a cost effective manner in elderly women. in addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of pa that leads to a reduced risk and burden of hf. the focus of the parent whish trial is on atherosclerotic cardiovascular disease and not heart failure.

a recently funded large pragmatic pa trial, women's health initiative strong and healthy (whish) trial based upon two decades of pa intervention experience using enhanced communication and behavioral techniques, has randomized 49,936 elderly women (average age 79) and will evaluate its intervention effect on the risk of atherosclerotic cvd. this translational intervention is aimed at reducing sedentary time and achieving or maintaining aerobic and strength enhancing pa levels currently recommended for cardiovascular benefit. the whish-2-prevent hf, represents the first and largest primary prevention exercise trial ever performed focusing on hf and will examine the intervention effect of pa , on both incident hf and hf burden (recurrent hf and cvd death in those with hf) in a cost effective manner in elderly women. in addition, it will allow a dose-finding analysis to better understand the type, intensity and frequency of pa that leads to a reduced risk and burden of hf. aim 1: test whether older women who are initially free of hf and randomized to a translational pa intervention will reduce the rate of incident hf compared to those not randomized to the translational pa intervention. h1: women free of hf randomized to the pa intervention will have reduced rates of incident hf compared to those not randomized. aim 2: test whether older women with and without hf at baseline randomized to a translational pa intervention will reduce the hf burden (number of acute hf hospitalizations and cvd death in those with antecedent hf) compared to those not randomized to the translational pa intervention. h2: women randomized to the pa intervention will have reduced hf burden compared to those not randomized exploratory aim 3: analyze the type, intensity and frequency of physical activity including skeletal muscle strengthening associated with a reduced risk of hf and hf burden in elderly women. h3: women who have low levels of sedentary behavior by either increasing or maintaining light intensity or moderate intensity physical activity will have reduced rates of hf compared to women who remain sedentary. those that add skeletal muscle strengthening will have additional benefits.

Eligibility criteria:
inclusion criteria: * alive, community dwelling, exclusion criteria: * dementia, need walking aide, reside in nursing home
fa clinical outcome measures

Conditions: Friedreich Ataxia; Neuro-Degenerative Disease

Summary: this multicenter natural history study aims to expand the network of clinical research centers in fa, and to provide a framework for facilitating therapeutic interventions. in addition, this study will lead to the development of valid yet sensitive clinical measures crucial to outcome assessment of patients with friedreich's ataxia. this study will support genetic modifier studies, biomarker studies, and frataxin protein level assessments by building a sample repository. this natural history study is no longer recruiting under this protocol nct03090789 but remains actively recruiting under the harmonized study (unifai) nct06016946.

friedreich's ataxia (fa) is a rare autosomal recessive degenerative disorder characterized by ataxia, dysarthria, sensory loss, diabetes and cardiomyopathy. the discovery of the abnormal gene in fa and its product (frataxin) has provided insight into possible pathophysiological mechanisms and novel approaches to treatments in this disease. while such methods for assessing disease progression may be useful, evaluation in clinical trials will require specific clinical outcome measures. this is a multicenter natural history study which aims to expand the network of clinical research centers specializing in friedreich's ataxia and to advance clinical care, research and therapeutic approaches in fa through the development and validation of clinical outcome measures. study sites aim to collect quantitative serial clinical data on patients with fa and expand the existing research network. in addition, the study will support various genetic modifier studies, biomarker studies, and frataxin protein level assessments in patients with fa, in carriers, and in controls. this study will recruit up to 2000 patients with friedreich ataxia worldwide, to be assessed annually for up to 15 years. all individuals with a genetic or clinical diagnosis of fa can participate. study participation involves yearly assessments of a core set of clinical measures and quality of life assessment measures in addition to optional collection of a cheek swab and/or blood sample.

Eligibility criteria:
inclusion criteria: 1. males or females age 4 to 80 years. 2. genetically confirmed diagnosis of fa (for carrier/control cheek swab and blood samples this is not required). 3. clinically confirmed diagnosis of fa, pending confirmatory genetic testing through a commercial or research laboratory (for carrier/control cheek swab and blood samples this is not required). 4. parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: 1) signs or symptoms of severe cardiomyopathy (such as congestive heart failure)

Keywords: friedreich ataxia neuro-degenerative disease
porous baseplate in total knee replacement

Conditions: Knee Osteoarthritis

Summary: this is a multi-centre single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the advance porous fixed bearing tibial baseplate and compatible femoral, patellar, and bearing components.

all patients will undergo post-operative model-based rsa to identify migration of the tibial baseplate with respect to the bone as well as migration of the patellar and femoral components with respect to the bone during the first 2 post-operative years. patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. peri-operative adverse events and other clinical complications will be captured as encountered.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating primary unilateral total knee arthroplasty * sufficient ligamentous function to warrant retention of the posterior cruciate ligament * aged 21 years or older * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent exclusion criteria: * active or prior infection * medical condition precluding major surgery * known medical condition limiting patient life expectancy to \< 2 years * expected to receive contralateral tka within 1 year * inflammatory arthropathy * prior patellectomy * pcl deficiency * major (\>25 degree) coronal plane deformity * bilateral coronal plane deformity requiring simultaneous bilateral tka * bone defects requiring augments, cones and/or stemmed implants * body mass index greater than 40
intratympanic stereoidal injections for facial nerve palsy

Conditions: Bell Palsy

Summary: bell's palsy is defined as a facial nerve palsy without any other known cause. the common practice for this disease consists of the use of oral steroids. such treatment can cause harm to people who have disabilities or prior conditions such as pregnancies, diabetes, obesity and/or high blood pressure. while the use of intratympanic injection for sudden sensory hearing loss is well rehearsed in many practices, similar management of facial nerve palsy due to bell's phenomenon is rare and a few researches have been conducted regarding the subject. in this research we suggest intratympanic injections for these patients as a treatment for bell's palsy.

bell's palsy is defined as a facial nerve paralysis without any other known diagnosis or cause .its' estimated occurrence is in 20 to 30 people per 100,000 people per year. the occurence is greater in patients older than 65 years old and lower in children younger than 13 years old. there are many estimated etiologies for bell's palsy, such as failure of the vasa nervosa, viral infections, ischemic neuropathies and auto immune reactions. of those, viral hypothesis is the most widely accepted. the prognosis for recovery for most patients is 80% to 90%. one series showed that only 17 out of 1505 patients demonstrated moderate to severe sequela and none had complete facial nerve paralysis. the common practice for the management of bell's palsy consists of oral steroids with or without the antiviral medications. a recent study made by the department of otorhinolaryngology and head and neck surgery in korea indicated that intratympanic injections could replace the use of oral steroids . another recent study by jong job lee et al. has shown that intratympanic injections have prolonged uptake in rats, in comparison to intraperitoneal injections.

Eligibility criteria:
inclusion criteria: adult patients 18 years old or more, diagnosed with bell's palsy who cannot receive oral steroid treatment for their condition, due to to pregnancy, diabetes, high blood pressure etc. exclusion criteria: * children under the age of 18. * patients who can receive oral steroid treatment for their condition. * patients with internal ear problems. \* patients who already recieved treatmetn for their condition.