Kornimate/medical-research-clean huggingface dataset:
mri and lung function measures of benralizumab response in asthma

Conditions: Asthma

Summary: new treatments have been developed for asthma that are good at preventing asthma attacks and improving day-to-day symptoms. alongside the development of these new drugs, there are new ways of measuring how the lung is affected by asthma. in particular, investigators have developed ways of seeing how air moves in the lungs of people with asthma, using mri scanning. this study aims to see how quickly these new drugs result in changes in the way the lung is working, as seen in the mri scans and other breathing tests. this will help clinicians in the future to decide who is likely to respond to these new medicines, and once patients have started taking the drugs, will help clinicians to decide whether long term treatment is likely to benefit the people receiving them. in this study, the investigators plan to do extra breathing tests and mri scans on people who are receiving the drug as part of their usual clinical care. the study will not change an individual's treatment, but will give the investigators more information about the patients' illnesses and the way the patients' bodies respond to treatment.


Eligibility criteria:
inclusion criteria: * people with eosinophilic asthma meeting the national institute for health and clinical excellence (nice) criteria for benralizumab therapy based on eosinophil count and exacerbation rates will be offered the chance to participate in this study. exclusion criteria: * any medical illness that in the opinion of the investigator is likely to significantly impact on the response to benralizumab or the outcome of the mri and lung function testing. * non-concordance with routine asthma therapies (this would be assessed as a mandatory part of nice-based criteria). * any additional significant lung illness that would impact on likelihood of response to benralizumab. of note, trivial stable bronchiectasis that in the opinion of the patient's clinician is not clinically significant nor likely to result in either recurrent exacerbations or impairment of interpretation of investigation results will not be exclusion criteria. part of the initial inclusion regarding eligibility by nice criteria include an assessment of a likely eosinophilic asthmatic phenotype with probability of treatment response, and potential subjects with complex lung disease would be unlikely to be eligible. * current cigarette smoking, or cigarette smoking within the past 6 months * significant lifetime smoking history of ≥20 pack years * previous use of another biologic therapy targeting eosinophils within 6 months of enrollment * pregnancy, planning pregnancy, or breast feeding. women of childbearing potential must use effective contraception (concordant use of hormonal contraceptive, intrauterine device, total abstinence), and urine pregnancy tests will be performed before scans. * abnormal renal function (egfr \<30), to avoid risks from gadolinium chelate mri contrast agents.
pharmacokinetic and metabolism of [14^c] bms-986177 in healthy male participants

Conditions: Thrombosis

Summary: this is an adme study. human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (adme) of a study treatment. the goals of human adme studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.


Eligibility criteria:
inclusion criteria: * signed icf * healthy male * body mass index of 18.0 to 32.0 kg/m2, inclusive. * agreement to use approved contraception for 94 days post treatment * agreement to not donate sperm for 94 days post treatment exclusion criteria: * acute or chronic illness * gi disease current or recent * history of dizziness or recurring headaches * head injury within last 2 years * gi surgery * history or evidence of abnormal bleeding
a study of liquid certolizumab pegol as additional medication to methotrexate in the treatment of signs and symptoms of rheumatoid arthritis and in prevention of joint damage in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a 24 week study in which patients are given study medication and assessed for signs and symptoms of rheumatoid arthritis. x-rays are performed to assess the progress of joint damage during the study.


Eligibility criteria:
inclusion criteria: * patients must be at least 18 years old at the screening visit. * patients must have a diagnosis of adult-onset ra of at least six months duration but not longer than fifteen years as defined by the 1987 american college of rheumatology classification criteria. * patients must have active ra disease as defined by: * 9 tender joints at screening and baseline. * 9 swollen joints at screening and baseline. and fulfilling 1 of the following 2 criteria during the screening period: * 30 mm/hour esr (westergren), or crp \>15 mg/l. * patients must have received treatment with mtx (with or without folic acid) for at least 6 months prior to the baseline visit. the dose of mtx and route of administration must have been stable for at least 2 months prior to the baseline visit. the minimum stable dose of mtx allowed is 10 mg weekly. * patients must be willing to complete an x-ray of the hands and feet 24 weeks after randomization even if they are no longer receiving study treatment in the present study, provided they have not withdrawn their informed consent. exclusion criteria: * patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis). * patients must not have a secondary, non-inflammatory type of arthritis (e.g. oa or fibromyalgia) * female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug. * patients with a history of tuberculosis or positive chest x-ray for tuberculosis or positive * patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound). * patients with known human immunodeficiency virus (hiv) infection. * patients with an active malignancy of any type or a history of malignancy (except basal cell carcinoma of the skin that has been excised prior to study start). * patients with a current or recent history, as determined by the investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the patient's participation in the trial. * patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).

Keywords: rheumatoid arthritis certolizumab pegol, cimzia
evaluation of non specific symptoms and quality of life before and after surgery for mild primary hyperparathyroidism

Conditions: Primary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. a clinical score predicting clinical improvement at one year will be created.


Eligibility criteria:
inclusion criteria: * subjects with known moderate hpti will be considered for participation. patients with sporadic mild hpti defined by: * calcemia \> 2.6 mmol/l , pth \> 25 ng/l and creatininemia \< 160µmol/l or * calcemia between 2.5 and 2.6 mmol/l and pth \> 35 ng/l * calcemia ≤2.85 mmol/l * urine calcium level / 24 hours \< 10 mmol (400 mg), * decrease of the creatinin's clearance : 30% lower than normal population with the same age * patients younger than 50 * patients who can't be followed exclusion criteria: * familial hypercalcemia * multiple endocrinal neoplasia * treatment with lithium or thiazides * impossibility for the patient to complete the forms * impossibility to follow the patient * patient with serious disease which impact the quality of life
topical asp-1001 (contrast media formulation) and the acute response to nasal allergen challenge (nac)

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to see whether asp-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.


Eligibility criteria:
inclusion criteria: 1. males and females between 18 and 55 years of age. 2. history of grass and/or ragweed allergic rhinitis. 3. positive skin test to grass and/or ragweed antigen. 4. positive response to screening nasal challenge. exclusion criteria: 1. physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. pregnant or lactating women. 3. upper respiratory infection or sinusitis within 14 days of study start. 4. use of nasal steroids, antihistamines in the last 2 weeks. 5. fev1\<80% of predicted at screening for subjects with history of mild asthma 6. current smokers or recent ex-smokers 7. any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
comparison of non-invasive vs. invasive hemodynamic measurements

Conditions: Heart Failure，Congestive

Summary: comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

the conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. to overcome this challenge, a new technology to assess cvp non-invasively using an oscillometric method is being developed. it is called enclosed zone central venous pressure (ezcvp). a comparison study of ezcvp and cvp is needed to determine accuracy and reproducibility.

Eligibility criteria:
inclusion criteria: 1. adult age over 18 years. 2. arm circumference is 23 cm to 55 cm 3. subject will have an existing central venous catheter during their icu stay 4. subject or legally authorized representative (lar) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent 5. subject or lar is willing and able to comply with protocol procedures exclusion criteria: 1. finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff. 2. pregnant (self-reported) 3. upper extremity deep venous thrombosis currently being treated 4. severe skin disease involving the upper arm(s) 5. study investigator may exclude patients based on clinical judgement
comparison of 5 day embryo transfer with 2-3 day transfer in patients with previous in vitro fertilization failure

Conditions: Infertility

Summary: the purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous ivf failures

a total of 200 infertile women with at least two previous ivf failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment. the study protocol will be assessed by an independent institutional review board and royan ethics committee. ovarian stimulation protocol will include the use of a gnrh agonist (superfact; aventis pharma deutshlan, frankfurt, germany) administered in the long (down-regulation) protocol and the subsequent addition of fsh (gonal f, sereno, switzerland). embryos will be initially cultured in g1.v5 medium) vitrolife-sweden)tm on day 1 and 2, being transferred from this medium to g2.v5 ) vitrolife-sweden)tm on day 3. embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst. main outcome measures will be implantation, clinical pregnancy and live birth rates.

Eligibility criteria:
inclusion criteria: * age fewer than 40 * normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy * two previous or more failed ivf/icsi cycles exclusion criteria: * women with submucous myoma * women with intra mural or subserous myoma greater than 3 cm * women with endometriosis or endometrioma * hydrosalpinx

Keywords: infertility embryo transfer
arimidex in mccune albright syndrome

Conditions: McCune-Albright Syndrome

Summary: the primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with mccune-albright syndrome.


Eligibility criteria:
inclusion criteria: * informed written consent of parent/legal guardian and subject assent (as needed by local requirements) * females less than or equal to 10 years of age * diagnosed with mccune-albright syndrome * have progressive precocious puberty exclusion criteria: any one of the following is regarded as a criterion for exclusion from the study: * any prior treatment of mas associated with progressive precocious puberty with a third generation aromatase inhibitor (anastrozole, letrozole, exemestane) in which no clinical response was seen * concomitant treatment of precocious puberty associated with mas, with the exception of bisphosphonates for polyostotic fibrous dysplasia and lhrh analogues in the case of central precocious puberty * liver function tests at screening visit (ast, alt) \> or = 3x the upper limit of the reference range for age * known hypersensitivity to any component of study medication

Keywords: vaginal bleeding advanced bone age fibrous dysplasia mas mccune-albright syndrome
heat therapy versus exercise training in hypertension

Conditions: Hypertension; Cardiovascular Diseases; Arterial Hypertension

Summary: this is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated or stage 1 hypertension.

hypertension accounts for more cardiovascular disease related deaths than any other modifiable risk factor. while exercise training can be effective at reducing blood pressure in some individuals, many people do not respond to exercise training, and many more are unwilling to undergo regular exercise training. alternative options need to be explored. this is a clinical trial to determine whether 30 sessions of heat therapy in the form of hot water immersion is better than 30 sessions of traditional aerobic exercise training on blood pressure reduction in people with elevated blood pressure (hypertension). the investigators will evaluate known biomarkers of cardiovascular health. it is hypothesized that heat therapy will be superior to exercise training on blood pressure reduction.

Eligibility criteria:
inclusion criteria: * systolic blood pressure 120 mmhg or greater and less than 180 mmhg or diastolic blood pressure of 80mmhg or greater and less than 120mmhg exclusion criteria: * secondary hypertension; diagnosed cardiovascular disease other than hypertension; taking anti-hypertensive drugs; bmi of 35 or greater; fasting glucose greater than 125 mg/dl; women who are pregnant, nursing, or desiring to become pregnant.

Keywords: stage 1 hypertension arterial stiffness
0050-19-rmb ctil - vnotes compared to vh for vaginal apex prolapse

Conditions: Vaginal Prolapse

Summary: vnotes (transvaginal natural orifice transluminal endoscopic surgery) is a relatively new surgery for hysterectomy and uterosacral ligament suspension to treat vaginal prolapse. the investigators wish to run a randomized control trial comparing it to classic vaginal hysterectomy for the same indication.

the investigators will recruit 60 women with indication for surgery to treat uterine prolapse. 30 women will undergo vnotes surgery and 30 women will undergo classic vaginal hysterectomy. the investigators will compare outcomes of the surgeries such as surgery time, bleeding and clinical outcomes after 3 and 6 months post operation.

Eligibility criteria:
inclusion criteria: * women with vaginal prolapse * capable of having a surgery - assessed by an anesthesiologist * women who approve of having the surgery exclusion criteria: * bmi over 40 * women who have recurrent pid (pelvic inflammatory disease) * women with oncology records
prague registry of electric cardioversion

Conditions: Atrial Fibrillation; Atrial Flutter; Atrial Arrhythmia; Atrial Tachycardia

Summary: this single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.


Eligibility criteria:
inclusion criteria: * consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter exclusion criteria: * unstable patients with acute conditions requiring unplanned hospitalization

Keywords: anticoagulants anticoagulation cardioversion noac doac
prediction accuracy for langeal mask unique tm size in pediatric patient

Conditions: General Anaesthesia

Summary: the study aimed to know the accuracy for laryngeal mask unique tm size to malay pediatric race according to weight measurement recommended by manufacturer

sixty-six pediatric subjects aged between 1 - 10 years old underwent general anesthesia using laryngeal mask unique tm. laryngeal mask inserted using the size based on subject's weight. effectivity was confirmed if there is no air sound from patient's mouth, airway seal pressure ≥20 cmh2o, maximum inspiration pressure was ≤ 20 cmh2o, difference in expiration and inspiration tidal volume less than 5%, and there is no cuff appear in mouth.

Eligibility criteria:
inclusion criteria: * aged 1 -10 years old * malay race * scheduled for general anesthesia procedure with laryngeal mask exclusion criteria: - disagree to be included in the study
a study that provides long-term safety follow-up and examines long-term exposure to abiraterone acetate

Conditions: Metastatic Castration-resistant Prostate Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to collect follow-up safety data from participants in completed abiraterone acetate studies for a maximum duration of 9 years.

this is a nonrandomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), long-term safety follow-up study of abiraterone acetate in approximately 300 patients from other completed abiraterone acetate clinical studies. patients must have received at least 3 months of treatment with abiraterone acetate and a low-dose corticosteroid and, based on investigator assessment, may benefit from continued treatment. this study will consist of a screening period followed by open-label treatment of continued abiraterone acetate access. the patients will continue with the same abiraterone acetate and low-dose corticosteroid dosing regimen they were receiving in the previous abiraterone acetate clinical study until the investigator determines that the patient is no longer receiving benefit or the sponsor terminates the study. patients can be withdrawn from the study if an alternative access (eg, patient-assistance program or commercial source of abiraterone acetate) is available and feasible. each cycle of treatment will be 28 days. investigators will monitor and assess the patients for response to treatment or progression according to routine practice or as clinically indicated to determine whether continued treatment with abiraterone acetate is warranted. no efficacy data are being collected. safety will be monitored throughout the study for a maximum duration of 9 years. end-of-study assessments will be performed at least 30 days after the last dose of abiraterone or upon early withdrawal.

Eligibility criteria:
inclusion criteria: * currently participating in an abiraterone acetate clinical study considered complete and had received at least 3 months of treatment with abiraterone acetate tablets. exclusion criteria: * medical conditions that require hospitalization. * any condition or situation which, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.

Keywords: metastatic castration-resistant prostate cancer metastatic breast cancer abiraterone acetate low-dose corticosteroid treatment long-term access
non-eosinophilic biological effects of il-5

Conditions: Asthma

Summary: this study aims to investigate the role of il-5 in suppressing anti-viral immune responses in bronchial epithelial cells (becs) and in peripheral blood mononuclear cells (pbmcs) from 5 people with asthma.

il-5 has been shown to be present in higher levels in those with asthma, more so during viral infection. the investigators know from existing evidence that having increased levels of interferon (ifn) reduces asthma exacerbations and viral load. the investigators suspect that il-5 reduces the immune response during viral infection in bronchial epithelial cells (becs) and peripheral blood mononuclear cells (pbmcs) by reducing levels of ifn. the aim is to investigate if increased il-5 in stable eosinophilic asthma and asthma exacerbations suppresses anti-viral immunity in bronchial epithelial cells and in peripheral blood mononuclear cells directly via il-5 receptor signalling, suppressing rhinovirus induction of ifns. the investigators also will evaluate if anti-il-5 therapies suppress il-5 concentrations in stable and exacerbated asthma in vivo and whether suppression of il-5 in vivo restores deficient anti-viral immunity in becs and pbmcs, thereby protecting against asthma exacerbations.

Eligibility criteria:
must be eligible for the study 'mechanisms of adverse effects of long-acting beta-agonists in asthma' (maelaba) (19sm5101).

Keywords: interleukin 5 bronchial epithelial cells peripheral blood mononuclear cells peripheral dendritic cells interferon rhinovirus