Kornimate/medical-research-clean huggingface dataset:
prevalence of pulmonary embolism in patients with dyspnea on exertion (pedis)

Conditions: Pulmonary Embolism

Summary: pedis study is an observational, cross-sectional, multicenter italian study conducted in a consecutive series of patients who refer to the emergency departments (either spontaneously or sent by their attending physicians) for the recent (less than one months) development of exertional dyspnea. the general aim of the study is to assess the prevalence of pe in the overall population referring to the emergency departments without potential explanations for dyspnea

pedis study is an observational, cross-sectional, multicenter and no profit study. 600 consecutive patients referring to the emergency departments of the participating centers because they have developed one or more episodes of exertional dyspnea since less than one month will be enrolled. all eligible patients will be interviewed and examined by trained study physicians. the presence of already known potential explanations for the dyspnea will be assessed. in addition, symptoms of the lower extremities will be elicited, as well as the presence of risk factors for venous thromboembolism (vte). the presence or absence of pulmonary embolism will be assessed with the use of a validated algorithm based on pre-test clinical probability and d-dimer result. in patients in whom the pre-test clinical probability is low and the d-dimer result is negative, no further testing will be done, and pe will be considered excluded. in patients with high clinical probability, positive d-dimer result, or both, computed tomography (ct) pulmonary angiography will be performed the primary study objective is to evaluate prevalence of pe in the overall population

Eligibility criteria:
inclusion criteria: * age older than 18 and younger than 75 * recent (less than one month) development of exertional dyspnea * able to provide informed consent exclusion criteria: * anticoagulation required for other indications * contraindication to ct angiography (allergy to the contrast dye, severe renal failure \[creatinine clearance \< 30 ml/min\]) * involvement in simultaneous clinical trials * unable to provide their written informed consent

Keywords: dyspnea pulmonary embolism
mammography spect with rotating slant hole collimator

Conditions: Breast Cancer

Summary: the goal is to conduct a pilot study to determine the feasibility of the clinical use of rmssh spect imaging technology for breast imaging and to develop a standardized clinical protocol.

the goal of this protocol is to develop and evaluate a novel spect imaging technique for imaging the breast using rotating multi-segment slant-hole (rmssh) collimators. the motivation is the requirement of a low cost rmssh collimator and a conventional large-field-of-view (lfov) camera. it is believed that rmssh spect is particularly suitable for applications in breast imaging.

Eligibility criteria:
inclusion criteria: * women seen at johns hopkins avon division of breast imaging who have been diagnosed with breast cancer. exclusion criteria: * pregnant (or possibly pregnant) * lactating * unable to give consent * weights over 300 pounds * women who have already undergone definitive surgical treatment to their breast for breast cancer will not be eligible.
the effect of spa treatment on chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). an exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient must have chronic obstructive pulmonary disease * obstructive ventilation problem: tiffeneau index (expiratory volume in one second / slow vital capacity) \< 70% * expiratory volume in one second \< 80% of the theoretical value * reversibility \< 12% after inhalation of bronchodilators * smokers or ex smokers * available for study monitoring * has access to diagnostic, medical and therapeutic care according to the best, current criteria (see the recommendations of the french language pseumologist society) exclusion criteria: * the patient is participating in another study * the patient has participated in another study in the past 12 months * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is in military service (unavailable for monitoring) * patient is on parole or otherwise has their liberty restricted by administrative or judiciary decision * the patient is pregnant, or does not have contraception * the patient is breastfeeding * patient has neoplastic disease * patient has asthma * patient has another, evolving pulmonary disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection) * patient has a clinical history indicating asthma or another respiratory disease (in particular bronchiectasis, pneumoconiosis and other occupational diseases, history of pulmonary neoplasia, hiv, immunosuppressive therapy including corticosteroids in the long term * patient has respiratory insufficiency * hypereosinophilic patient (the number of polynuclear eosinophils is \> 0.5 giga/l; confirmed on 2 hemograms) * recent psychiatric trouble (less than 1 year) * takes illegal drugs * patient does not have pneumological care according to the standards set by the french language pneumologist society

Keywords: spa therapy
clinical study of the treatment of chiari malformation combined with type ii skull base depression

Conditions: Atlantoaxial Dislocation; Chiari Malformation; Basilar Invagination

Summary: the research background of this study is that chiari malformation (cm) is a congenital malformation in the foramen magnum region, often associated with syringomyelia, basilar depression, odontoid dislocation and other craniocervical junction deformities. the traditional surgical method for chiari malformation with skull basilar depression is simple decompression without fixation, so it cannot effectively maintain the stability of the cervical spine and reduce the compression of the brainstem and cervical cord, often resulting in poor curative effect and aggravated symptoms. the cervical spine is the most flexible and most mobile part of the spine, and the instability of the cervical spine will directly affect the quality of life of patients after surgery. subsequently, with the continuous advancement of technology and the continuous development and improvement of surgical methods, investigators can relieve spinal cord compression by using atlanto-occipital decompression and dissection followed by c1/2 lateral arthrolysis combined with occipitocervical fusion. so, is this surgical combination the most effective surgery for patients with chiari malformation and type ii skull basilar depression? how should doctors adjust to the best surgical approach to treat patients with chiari malformation and type ii skull basilar depression? these questions have long puzzled neurosurgeons. by conducting this research, investigators hope that participants can participate in it, and work with them to answer this question, and jointly promote the development and progress of doctors' careers, while benefiting more patients.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chiari malformation * combined with type ii skull base depression * clinical symptoms related to the disease * complete clinical imaging data * must be the first surgery exclusion criteria: * secondary cerebellar tonsillar hernia * severe atlantoaxial dislocation * osteochondroplastica * rheumatoid arthritis * down syndrome * refurbished case reoperation
rapamycin-eluting stents with different polymer coating to reduce restenosis (isar-test-3)

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (des). dess working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. at present, several des platforms have been developed and evaluated for clinical use. they differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with dess. based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in dess, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. this trial will compare the anti-restenotic efficacy of the permanent polymer (pp), biodegradable polymer (bp) and polymer-free (pf) rapamycin-eluting stents in patients with coronary artery disease. cypher stent (pp) is a stainless steel stent coated with sirolimus with use of permanent polymers while the isar stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, bp isar stent) but also coating without the need of polymer (pf isar stent) in the cath lab.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels. * written, informed consent by the patient or her/his legally-authorized representative for participation in the study. exclusion criteria: * target lesion located in the left main trunk or bypass graft. * in-stent restenosis. * cardiogenic shock. * malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. * known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel. * pregnancy (present, suspected or planned) or positive pregnancy test. * previous enrollment in this trial. * patient's inability to fully cooperate with the study protocol.
the non-specific immunological effects of providing oral polio vaccine to seniors in guinea-bissau

Conditions: Vaccine Reaction

Summary: opv is the live attenuated vaccine against polio virus. opv has been key in almost eradicating polio infection. intriguingly, opv has been associated with lower all-cause mortality and morbidity. these beneficial opv effects were seen in contexts with no circulating polio virus and thus have nothing to do with the specific effects of opv against polio infection. they have been coined "non-specific effects" (nses). such nses have also been observed for other live attenuated vaccines such as bcg vaccine and measles vaccine. the underlying immunological mechanisms are unknown. other live vaccines with beneficial nses have been shown to induce epigenetic changes leading to "trained immunity". they have also been associated with decreased inflammation. in the present study it will be investigates whether opv can induce trained immunity, reduce inflammation, and induce epigenetic modifications of the innate immune cells in senior citizens in guinea-bissau.

the aim is to study the non-specific immunological effects of providing a single dose of opv to seniors aged 50 and above in guinea-bissau: hypotheses 1. opv induces innate immune training (substudy a) 2. opv is associated with reduced systemic inflammation (substudy a) 3. opv induces epigenetic modifications of the innate immune cells (substudy b) setting: bandim health project (bhp)'s health and demographic surveillance system (hdss) in bissau. design: individually randomized trial in bhp's study area. participants will be randomized 1:1 to opv or placebo. to limit the amount of blood drawn from one single participant, two substudies with similar design will be conducted, with two different outcomes. the outcomes of the two substudies will be as follows: substudy a: immunological impact of opv. study the stimulation of cytokine production by heterologous stimuli as a biomarker of trained immunity induction and circulating biomarkers as a mirror of systemic inflammation induced by opv. substudy b: transcriptional and epigenetic reprogramming of immune cells by opv. study the transcriptional and epigenetic rewiring of immune cells induced by opv by single-cell atac-sequencing and rna-sequencing.

Eligibility criteria:
inclusion criteria: * male. * living in a household which had a bandim health project census visit conducted after 1 january 2017. * age above 50. * has a visible bcg scar. exclusion criteria: * previous adverse events to opv * suspicion of active viral/bacterial/hiv infection.

Keywords: oral polio vaccine trained immunity
abuja heart study: prospective epidemiological investigation of cardiovascular diseases

Conditions: Cardiovascular Diseases; High Blood Pressure

Summary: this is a multi-site prospective epidemiological investigation of cardiovascular disease (cvd) among abuja residents from the rural and metropolitan area.

sub-saharan africa continues to fight the battle of infectious diseases such as hiv/aids, tuberculosis and malaria. but given all the international efforts geared to curing and containing these diseases, and with progress made in various countries, sub-saharan africa is now heading into another type of epidemic, cardiovascular disease (cvd). predicted statistics have shown that cardiovascular diseases will become the leading cause of death in developing countries within the next 10 to 15 years, however relatively few population-based studies have examined cvd in africa . although control of communicable ,childhood ,and maternal diseases has benefited from an international efforts on clinical care, policy and implementation,such large scale effort are lacking for cvd and have left both policymakers and individuals with decisions on health issues without adequate information. prior to the commencement of the study,series of community meetings and focus groups discussions will be held to identify ways to enhance participation. an extensive examination will include a series of questionnaires dealing with lifestyle habits, medical history, social and cultural factors, physical assessments which include height, weight,central blood pressure assessment of arterial stiffness and autonomic function and laboratory measurements for cholesterol, other lipids, glucose ,c-reactive protein among others.

Eligibility criteria:
inclusion criteria: * some history of cardiovascular disease,plwha * patients have to agree to participate by signing a consent * 18 years and older exclusion criteria: * stroke

Keywords: abuja heart study nigeria cardiovascular diseases
effect of interval training on arterial stiffness in women with hypertension

Conditions: Arterial Stiffness

Summary: this study is aiming to assess the chronic effect of the interval training program on arterial stiffness in women with hypertension


Eligibility criteria:
inclusion criteria: * physically inactive * bmi 30-40 * stage 1 and 2 hypertension * elevated bp as systolic bp ≥130 mm hg and/or diastolic bp ≥85 mm hg measured at the brachial artery. exclusion criteria: * medications known to affect weight or appetite * any disease associated with exercise intolerance. * women were taking hormone replacement therapy
a clinical study in patients with overactive bladder with leakage of urine, to find out if the medicine, fesoterodine, works in those patients who did not have enough response to the medicine, tolterodine.

Conditions: Urinary Bladder, Overactive

Summary: patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency. sometimes patients do not have a satisfactory response, and may benefit from trying an alternative oral medicine. fesoterodine is related to tolterodine by producing the same active substance that acts on the bladder, but potentially at higher and more effective levels. so, a patient who has a poor response to tolterodine may still obtain a good response to fesoterodine. this study will help find out if this is what happens.


Eligibility criteria:
inclusion criteria: * diagnosis of overactive bladder with symptoms for at least 6 months. * moderate to severe incontinence episode frequency and subsequent sub-optimal response to tolterodine * women of child-bearing potential must not intend to become pregnant, be pregnant or producing breast milk at the time of study entry, and must use contraception exclusion criteria: * conditions or prior treatment that may also affect bladder function * clinically significant urinary tract infection (uti) * ongoing treatment with overactive bladder medications (these can be stopped at the first visit to allow entry into the study).

Keywords: bladder overactive overactive urinary bladder overactive bladder
volrustomig priming regimens exploratory phase ii platform study

Conditions: Non-small Cell Lung Cancer

Summary: purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

this is a platform, randomized, open-label, multicenter, global study. enrolled participants with stage iv non-squamous non-small cell lung cancer (nsq nsclc) who are treatment-naïve and have not received previous treatment for advanced or metastatic disease. these participants will be randomized in a 1:1 ratio to one of the two treatment arms: arm 1a and arm 1b. both arms will test a volrustomig dosing in combination with chemotherapy.

Eligibility criteria:
key inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 with no deterioration. * life expectancy greater than or equal to (\>=) 12 weeks. * adequate organ and bone marrow function. * body weight greater than (\>) 35 kilograms (kg) at screening and at randomization. * histologically or cytologically documented nsq nsclc. * absence of sensitizing epidermal growth factor receptor (egfr) mutations. * absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1l therapies. * at least one measurable lesion not previously irradiated that can be accurately measured at baseline as \>= 10 millimeter (mm) in the longest diameter. key exclusion criteria: * spinal cord compression. * history of primary active immunodeficiency. * active or prior documented autoimmune or inflammatory disorders. * mixed small-cell lung cancer and nsclc histology or sarcomatoid variant. * brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. a minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment. * prior chemotherapy or any other systemic therapy for stage iv nsclc. participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred greater (\>) 12 months from end of last therapy.

Keywords: solid tumor programmed cell death-ligand-1 tumor proportion score
prospective evaluation of the efficacy of budesonide/formoterol in bronchiolitis obliterans in ahsct

Conditions: Obstructive Airway Disease

Summary: the usual treatment for obstructive airway disease (oad) after allogeneic hematopoietic stem cell transplantation (ahsct) , which is related to graft versus host disease (gvhd), consists of intensification of systemic immunosuppressive therapy.

although it has not been evaluated prospectively, the usual treatment for obstructive airway disease (oad) after allogeneic hematopoietic stem cell transplantation (ahsct) , which is related to graft versus host disease (gvhd), consists of intensification of systemic immunosuppressive therapy. however, this treatment has a limited efficacy and is associated with a significant number of serious adverse effects, particularly infectious. alternative treatments are therefore necessary.we have retrospectively reported clinical and functional improvement in patients with oad following ahsct treated with inhaled budesonide/formoterol combination.these encouraging results need to be confirmed by the present randomised, prospective double-blind trial. this study is therefore designed to evaluate the efficacy of budesonide/formoterol versus placebo in patients with moderate to severe oad, not requiring initiation or intensification of systemic immunosuppressive therapy for extra thoracic gvhd. inclusion criteria modified according to amendment of 02/11/2009

Eligibility criteria:
inclusion criteria: * age ≥16 years. * previous normal pfts available. * absence of extrathoracic gvh disease justifying initiation or intensification of systemic immunosuppressive therapy. * respiratory signs present for less than 6 months. * ahsct recipients who have developed moderate to severe bronchiolitis obliterans, defined by reduction of fev1/vc below the 5th percentile of predicted normal or \< 80% of predicted, with fev1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist. ahsct recipients with fev1 \< 80% of predicted and ≥ 40% of predicted, not reversible after inhalation of short-acting beta-2 agonist and tlc ≥ 80% of predicted. * respiratory symptoms related to obstructive lung disease present for at least 6 months. * negative respiratory microbiology work-up. * informed consent signed by the patient or both parents of a minor. exclusion criteria: * extrathoracic graft versus host reaction justifying initiation or intensification of systemic immunosuppressive therapy. * use of inhaled bronchodilator and/or corticosteroid therapy at the time of inclusion. * known intolerance to inhaled bronchodilators and/or corticosteroids and/or lactose. * personal or donor history of asthma. * active smoking * fev1 \< 40% of predicted normal or ≥ 80% of predicted normal or po2 \< 50 mmhg. * documented respiratory tract infection. * pregnancy. * absence of effective contraception during the trial. * not covered by french national health insurance.

Keywords: obstructive airway disease bronchiolitis obliterans allogeneic hematopoietic stem cell transplantation bone marrow transplantation inhaled treatment budesonide formoterol