Kornimate/medical-research-clean huggingface dataset:
effectiveness of probiotics in adults with moderate to severe persistent asthma

Conditions: Asthma Patients

Summary: the objective of this study is to compare the effectiveness of probiotic as an adjuvant to standard therapy versus standard therapy alone in adult with moderate to severe persistent asthma in terms of 1. frequency of asthma exacerbations in terms of number of asthma attacks and severity of each episode. 2. improvement in pulmonary function tests as recorded by an increase in fev1 and fev1/fvc ratio. 5. hypothesis probiotics as an adjuvant to standard therapy is more effective as compared to the standard therapy alone in managing moderate to severe persistent bronchial asthma.

design of study this was a randomized controlled trial follow up protocol the patient was evaluated at the beginning of the study, and then again at one and three months following enrolment for a follow-up evaluation of the main and secondary outcomes. primary outcome to assess the frequency of exacerbations within 3 months. secondary outcome: to observe improvement in 1. fev1 and the fev1/fvc ratio. improvement in one step and more than 12% improvement in fev1 from baseline. improvement in asthma control test. sample size - the calculated sample size is 74 individuals (37 in each category i.e intervention \& control arm) sampling technique - simple random sampling sample selection inclusion criteria 1. patients of both genders between the ages of 18 and 80 years. 2. diagnosed cases of moderate to severe persistent asthma, as determined by act score and fev1/fvc ratio as per operational definition. exclusion criteria 1. patients with mild asthma. 2. pregnant females. 3. patients who have taken fiber supplement or probiotics during the last four weeks. 4. other pulmonary disorders, such as churg-strauss syndrome, allergic bronchopulmonary aspergillosis (abpa), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer. 5. asthma and chronic obstructive pulmonary disease overlap syndrome (acos).

Eligibility criteria:
inclusion criteria 1. patient of both genders between the ages of 18 and 80 years. 2. diagnosed cases of moderate to severe persistent asthma, as determined by act score and fev1/fvc ratio as per operational definition. exclusion criteria 1. patients with mild asthma. 2. pregnant females. 3. patients who have taken fiber supplements or probiotics during the last four weeks. 4. other pulmonary disorders, such as churg-strauss syndrome, allergic bronchopulmonary aspergillosis (abpa), chest wall deformities, bronchiectasis, pulmonary fibrosis, and lung cancer. 5. asthma and chronic obstructive pulmonary disease overlap syndrome (acos).

Keywords: asthma probiotics standard therapy adjuvant
impact of statins on cytokine expression in pneumonia

Conditions: Community Acquired Pneumonia; Cardiovascular Risk Factors

Summary: the investigators are conducting a study to determine the effects of a cholesterol-lowering medication, called simvastatin on pneumonia. people in the study will be in the hospital because they have pneumonia. the people will also have a medical condition like heart disease, diabetes, stroke or high cholesterol for which cholesterol-lowering medication has been shown to prevent future disease and/or death but are not taking a cholesterol-lowering medication when they go to the hospital. some people will get treated with antibiotics only and other people will get antibiotics and simvastatin while they are in the hospital. the study will compare the effects the combination of simvastatin and antibiotics has on people with pneumonia to treatment with antibiotics alone.


Eligibility criteria:
inclusion criteria: * at least 18 years of age, * chart documentation by a clinician of an initial working diagnosis of pneumonia within 24 hours of admission, * chest x-ray or other imaging evidence consistent with pneumonia within 48 hours of hospitalization, and * one of the following severity criteria: pneumonia severity index class iii or higher, at least 2/5 components of the curb-65, or icu level care within 24 hours of admission. * having one food and drug agency approved indication for statin therapy exclusion criteria: * prior treatment with one or more doses of a statin within 30-days prior to admission or during the current hospitalization. * hospitalization \> 24 hours at time of the diagnosis of pneumonia. * hospitalization \> 48 hours at time of study enrollment. * residence in a skilled nursing facility. * previously diagnosed human immunodeficiency virus infection with a current cd4 count \< 200 cells/mm. * immunosuppression * patient or family decision to limit medical care ("comfort measures only"). * known allergy to statin therapy. * active or planned pregnancy or breastfeeding. * inability to take oral medications at the time of study enrollment. * pre-existing liver disease or ast/alt \> 10% the upper limit of normal. * creatinine phosphokinase (cpk or ck) \> 50% above the upper limit of normal. * partial ileal bypass. * concurrent treatment with potential interacting drugs: ketoconazole, itraconazole, amiodarone, clarithromycin, erythromycin, cyclosporine, danazol, niacin, protease inhibitors, telithromycin, verapamil, gemfiborzil, ezetimibe (zetia), nefazodone. * transfer from an outside hospital.

Keywords: pneumonia statins cytokines
effect of paratracheal pressure on mask ventilation

Conditions: Ventilation

Summary: this study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.


Eligibility criteria:
inclusion criteria: * adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery exclusion criteria: * structural abnormalities or diseases in the face, neck, upper airway, or esophagus * increased risk of aspiration (pregnancy) * carotid artery stenosis, cerebrovascular disease
drains ablation post total hip arthroplasty : search for the least painful technique

Conditions: Total Hip Arthroplasty; Drain Insertion Site

Summary: comparison of ablation technique of drains


Eligibility criteria:
inclusion criteria: 1. patients admitted to the orthopedic surgery department for surgery for a total hip arthroplasty 2. signed inform consent form exclusion criteria: 1. drain in non-aspirating mode at the time of medical ablation prescription 2. administration of analgesic iii in the 12 hours preceding the inclusion
chronic coronary syndrome real practice and guidelines

Conditions: Coronary Arterial Disease (CAD)

Summary: evaluate adherence to the 2019 esc guidelines and standard care protocols for managing patients with the chronic coronary syndrome within the center

coronary artery disease (cad) refers to the presence of atherosclerotic plaques in the coronary arteries, which can be non-obstructive or obstructive. it represents a major cause of morbidity, mortality, hospitalization and health expenditure. the most recent european guidelines for the diagnosis and management of ccs delineate six common ccs scenarios: patients with suspected cad and stable angina symptoms and/or dyspnea; patients with new onset of heart failure or left ventricular dysfunction and suspected cad; asymptomatic and symptomatic patients with stabilized symptoms within one year after an acute coronary syndrome, or patients with recent revascularisation; asymptomatic and symptomatic patients beyond one year after initial diagnosis or revascularisation; patients with angina and suspected vasospastic or microvascular disease; asymptomatic subjects in whom cad is detected at screening. although these scenarios are heterogeneous, they are associated with an increased risk of acute events, and the stability of ccs patients over time depends on prompt diagnosis, optimal treatment and secondary prevention strategies, including lifestyle modifications, and pharmacotherapy.

Eligibility criteria:
inclusion criteria adult patients (18 years or older) with a confirmed or suspected diagnosis of ccs, fall within one of the following broad ccs categories: * patients with angina and/or dyspnea, and suspected coronary artery disease. * patients with new onset of heart failure or reduced left ventricular function. * patients within 1 year after an acute coronary syndrome or recent revascularization. * patients beyond 1 year after initial diagnosis or revascularization. * patients with anoca (e.g., microvascular angina, vasospastic angina). * asymptomatic subjects referred for screening for coronary artery disease. exclusion criteria: * patients with a recent acute coronary syndrome (defined as those within 1 month of a diagnosis of unstable angina, non-st-segment elevation myocardial infarction or st-segment elevation myocardial infarction)

Keywords: chronic coronary syndrome
methodological study of the effect of a lotion containing nature based microbial extract on atopic skin

Conditions: Atopic Dermatitis

Summary: the purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics finnish forest microbial biodiversity.

according of hygiene and biodiversity hypotheses, regular contact to nature biodiversity is beneficial for human health. without the contact, there is risk for immune system malfunction and related diseases like atopy, allergies and inflamed bowel diseases. regular contact to natural biodiversity, including environmental microbes, add immunological tolerance and train immune system to separate dangerous external stimuli from non-dangerous ones. this study aim at testing if it is safe to use microbial extract in lotion on daily basis on atopic skin. study participants are adults and they have atopic dermatitis diagnosis. participants use the lotion with microbial extract on other arm and placebo lotion (same lotion but microbial extract is replaced with safe coloring ingredient) on the other arm two times per day for 28 days. atopy medicines are not used on the study period and 14 days before the study. also, other moisturizers than test lotions are not used on test areas during the study. study is placebo controlled, randomized and double-blinded.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 * legally competence * fullfills hanifin \& rajka criteria for atopic dermatitis * commitment to the study exclusion criteria: * regular contact to farming environment * cancer or on going cancer treatments * use of immunosuppressive medicines * photo therapy, solarium or vacation abroad during the study * too severe eczema (not possible to keep pause from atopy medicines)

Keywords: biodiversity intervention allergy microbes
efficacy and safety trial of slitone(tm) birch in subjects with hayfever

Conditions: Allergy

Summary: the trial is performed to assess the efficacy and safety of slit one birch for treatment of birch pollen induced allergy

daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Eligibility criteria:
inclusion criteria: * a history of birch pollen allergy * positive skin prick test to birch * positive conjunctival test to birch * positive specific immunoglobulin e (ige) to birch exclusion criteria: * forced expiratory volume in 1 second (fev1)\<70% of predicted value * history of seasonal allergy interfering with study * history of symptomatic perennial allergy * history of emergency visit or admission for asthma in the previous 12 month
diabetes and psychological profile

Conditions: Type 1 or 2 Diabetes

Summary: this study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. the aim is to compare glycemic balance by measuring hba1c in diabetic patients (type 1 and 2) according to whether they have a type a or b psychosomatic profile evaluated by the bortner self-questionnaire.


Eligibility criteria:
inclusion criteria: * patients who have been given information about the research * patients with national health insurance * diabetic patients (type 1 or 2) * patients \> 18 ans exclusion criteria: * adult patients under guardianship or intellectually dependent * patients without national health insurance
drug eluting pantera lux catheter registry

Conditions: Coronary Artery Disease

Summary: all comers registry - evaluation of the safety and efficacy of the pantera lux paclitaxel releasing balloon for coronary arteries in daily clinical practice.

all patients are treated with the pantera lux paclitaxel releasing balloon. clinical follow ups at 1, 6 and 12 months after coronary intervention.

Eligibility criteria:
inclusion criteria: * signed patient informed consent / data release form * patient eligible for percutaneous coronary intervention (pci) * patient is older than 18 years of age exclusion criteria * patient has a known allergy against appropriate anticoagulation / antiplatelet therapy * patients with known allergy against paclitaxel or bthc * patients with a target lesion that was previously treated by brachytherapy * pregnant woman or lactating woman
a phase ii trial of leuprolide + flutamide + suramin in untreated poor prognosis prostate carcinoma

Conditions: Prostatic Neoplasm

Summary: one current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. survival was less in patients with high rather than low circulating androgen levels. thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. in this trial, we will pilot this concept.

the purpose of this study is to assess the potential for combined androgen blockage (leuprolide and flutamide), given with suramin (a growth factor inhibitor) to improve the clinical outcome(s) in a cohort of patients with bulky metastatic prostate cancer. combined androgen blockage is currently the standard of care for such individuals. suramin has shown reproducible activity in individuals with androgen independent disease. since these two approaches are independent of one another - on the molecular level, and in clinical results - it is hoped that the combination of these two approaches will result in improved response rates and in improved survival.

Eligibility criteria:
inclusion criteria: patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy. patients must be 18 years of age and an sgot/sgpt within 2 times of normal. patients must have stage d2 prostate carcinoma or state d1 disease with a gleason grade 7 or above (poorly differentiated). no other malignancy except curatively treated basal cell cancer of the skin. performance status ecog of 0-3. ability to give informed consent. no history of bleeding diathesis. patients with a history of peptic ulcer disease will be eligible if the ulcer is shown to be resolved by a barium study. no history of cerebrovascular event, either thrombotic or hemorrhagic. no current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. patient cannot be on calcium channel blockers such as nifedipine, diltiazem, or verapamil. no clinical or radiographic evidence of brain metastases. patients with extensive liver replacement (greater than 50%) by tumor will be ineligible. patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min. patients must have adequate hepatic function (bilirubin less than 1.5mg%). if the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy. patients must not have received chemotherapy. an absolute granulocyte count greater than 1,500; platelet count greater than 100,000; fibrinogen greater than 200 mg/dl; hgb greater than or equal to 9 gm/dl. reliability of the patient to take oral medication, go home and return for follow-up and treatment.

Keywords: bayesian hydroxy-flutamide combined androgen ablation prostate specific antigen
efficacy and safety of calcifediol vs placebo in subjects with vitamin d deficiency

Conditions: Vitamin D Deficiency; Vitamin D Insufficiency

Summary: this is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin d deficiency or insufficiency. its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (sgcs) compared to placebo.


Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age. * evidence of serum 25-oh-d levels \< 20 ng/ml or ≤ 10 ng/ml, for each cohort. * written informed consent. * for females of childbearing potential only: willing to perform pregnancy tests, must agree to use highly effective methods of birth control throughout the study. exclusion criteria: * subjects receiving any treatment with calcifediol, vitamin d analogues, vitamin complexes or vitamin d supplements. * subjects taking drugs that could modify vitamin d levels. * subjects taking calcium supplements. * uncorrected hypercalcaemia, known hypercalciuria or nephrolithiasis. * severe renal impairment. * subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypothyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism. * any present or previous malignancy. * known contraindications or sensitivities to the use of the ip or any of its components. * pregnant woman, breastfeeding woman or woman planning a pregnancy. * subject has received an ip within 30 days before the start of the screening or is currently enrolled in an investigational interventional study. * any condition that may jeopardise the clinical trial conduct according to the protocol. * employees of the investigator or clinical trial site, as well as family members of the employees or the principal investigator. * person committed to an institution by virtue of an order issued either by judicial or other authorities.

Keywords: vitamin d deficiency hypovitaminosis d vitamin d insufficiency
prediction of pcr by preoperative biopsy in breast cancer with ccr after neoadjuvant chemotherapy.

Conditions: Breast Neoplasm

Summary: the purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.

breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pcr) on mri will enrolled. the enrolled patients will undergo either us-guided multiple core needle biopsy or us-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). the patient will undergo subsequent wide excision of the tumor bed. histopathologic findings of the biopsy and the surgical specimen will be compared for pcr, and the ability of preoperative biopsies to predict pcr will be evaluated.

Eligibility criteria:
inclusion criteria: patients * with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (nac) * who received nac * with detectable lesion / clip marker on ultrasound * with ct1-t3 tumors * clinical and imaging complete or near-complete response on mri * with informed consent exclusion criteria: * multifocal cancer * residual microcalcification * contralateral breast cancer
music mindfulness study 2a.

Conditions: Mental Health Issue; COVID-19

Summary: mental health vulnerability due to stress is increased in people of african descent (pads) in america due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. however, the majority of these studies do not have an adequate representation of pads or other marginalized groups and are not designed to be culturally relevant or community based. music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. however, its role in stress management in pads engaged in meditation or mindfulness is seldom studied. this study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in pad community members with anxiety and depression during covid19. music mindfulness study: investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

investigators hypothesize that this intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care. participants will be screened, consented, and enrolled into either a 2-week pilot study (to test the feasibility of the experiment) or an 8-week full length study. the focus of this registration is the 8-week full length study. upon completion of the study, participants will be asked to take part in a focus group that will provide valuable feedback on their experience with the mindfulness intervention.

Eligibility criteria:
inclusion criteria: * symptoms of anxiety or depression assessed by phq9 (\>9) and gad7 (\>9) exclusion criteria: * component 2a * phq-9 \<9, gad7 \< 9 * regular meditation practice of at least once a week * has taken meditation course or intervention in the past year * any hospitalizations in the last 6 months * suicidal ideation, self-injurious behavior, or homicidal ideation at screening * active audio-visual hallucinations or other signs of psychosis * diagnosis of a seizure disorder or other neurological disorder that precludes outpatient participation * history of thyroid or cardiovascular disease * current substance use disorder

Keywords: mindfulness meditation music