Kornimate/medical-research-clean huggingface dataset:
endobronchial valve for emphysema palliation trial (vent) cost-effectiveness sub-study

Conditions: Emphysema; Chronic Obstructive Pulmonary Disease

Summary: the purpose of the vent cost-effectiveness sub-study is to gather healthcare utilization and quality of life information on patients enrolled in the vent study in order to analyze the relative cost-effectiveness of the endobronchial valve implant procedure.

therapeutic interventions in health care require the use of resources. since these resources are limited, it is important for clinical decision-makers to have economic information in addition to safety and efficacy data. in the economic environment of health care today, the incremental costs for a new therapeutic intervention must be offset by the value associated with better outcomes such as improved health and health-related quality of life and/or lower health care utilization costs over time. questions about the cost and effectiveness of medical care have generated considerable attention in medical outcomes research. in 1993, the department of health and human services appointed a multi-disciplinary group to recommend standards for the evaluation of health care. the panel's report suggested that standardized outcomes analyses be conducted to evaluate the cost-effectiveness of medical care. these analyses require preference-weighted measures of health-related quality of life. such measures are needed in order to adjust survival time for health-related quality of life.

Eligibility criteria:
inclusion criteria: * diagnosed by high-resolution computed tomography (hrct) with eligible heterogeneous disease distribution * forced expiratory volume in 1 second (fev1) \< 45% predicted * total lung capacity (tlc) \> 100% predicted * residual volume (rv) \> 150% predicted * post rehabilitation 6 minute walk test \> 140m * non-smoking for 4 months exclusion criteria: * prior lung transplant, lung volume reduction surgery (lvrs), median sternotomy, bullectomy or lobectomy * history of recurrent respiratory infections * evidence of large bullae (\> 30% of either lung) in a non-target lobe * fev1 \< 15% predicted * diffusing capacity of the lung for carbon monoxide (dlco) \< 20% predicted

Keywords: endobronchial valve endobronchial valve procedureebv ebv procedure endobronchial lung volume reduction lung volume reduction
prognosis and integrative assessment of aortic coarctation patients in china

Conditions: Coarctation of Aorta

Summary: this is a systemic research of chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.

the goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. risk factors associated with complications and prognosis are investigated and analyzed. identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. the findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.

Eligibility criteria:
inclusion criteria: * diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(asd), ventricular septal defect (vsd), patent ductus arteriosus( pda), patent foramen ovale (pfo); * patients who can cooperation with study procedures. exclusion criteria: * co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (hlhs), interruption of aortic arch (iaa), shone syndrome, moderate and severe mitral stenosis; * history of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
enhancing the effectiveness of cognitive behavioral therapy using non-invasive brain stimulation

Conditions: Depression; Anxiety; Stress Disorders, Post-Traumatic

Summary: the purpose of the proposed study is to examine if a repeated treatment of high definition transcranial direct current stimulation (hd-tdcs) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.


Eligibility criteria:
inclusion criteria: * all patients who have agreed to participate in virtual mental health treatment at health care sites throughout manitoba. eligible participants will be those enrolled in a range of mental health programs, including cbt, dbt, virtual hospital wards, and group-based treatment (e.g., cbtm, managing difficult emotions, etc). the target population will also include providers and decision makers offering virtual mental health programs. individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program or a provider/decision maker offering a virtual mental health program, and 2) located within manitoba exclusion criteria: * contraindication for mri (e.g., metallic implants and claustrophobia)
obalon us commercial registry

Conditions: Obesity

Summary: retrospective study of the data reported in the obalon us commercial registry

retrospective analyses of the safety and effectiveness data in the obalon us commercial registry reported by participating clinics through august 28, 2018 from patients who started the obalon therapy from january to december 2017 to represent the first year of commercialization. all patients included in the safety and efficacy analyses must have data through balloon removal and a starting bmi greater than or equal to 25, the definition of overweight and obese patients.

Eligibility criteria:
inclusion criteria: * started obalon balloon therapy between jan.-dec. 2017 * weight loss data through balloon removal * bmi \>25kg/m2
observational study to evaluate fluid resolution and effectiveness of brolucizumab for namd in portugal

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Summary: this study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for namd with brolucizumab in portugal.

naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given. the baseline visit will be used to assess eligibility and collect baseline characteristics information. the study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. if both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). the follow-up visits will take place at a frequency defined as per investigator's discretion. patients that have not received an intravitreal anti-vegf injection or visited an eye specialist for at least 6 months will be discontinued from the observation. retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. patients, already being treated with brolucizumab may also be included. here, retrospective data will be collected since the first brolucizumab injection.

Eligibility criteria:
inclusion criteria: 1. diagnosis of namd 2. male and female patients with ≥40 years of age at index 3. receipt of at least one injection of brolucizumab during the recruitment period 4. signed written informed consent exclusion criteria: 1. patients treated for rvo, dme, mcnv, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date 2. receipt of any anti-vegf treatment other than brolucizumab in the study eye at index date 3. central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at screening 4. any active intraocular or periocular infection or active intraocular inflammation in either eye at index date 5. patients who have been on anti-vegf treatment for longer than 3 years (before index date) 6. patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the smpc 7. any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation 8. patients participating in parallel in an interventional clinical trial 9. patients participating in parallel in any other nis generating primary data for an anti-vegf drug 10. retinal pigment epithelial rip/tear in the study eye at screening or baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to baseline 11. subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at screening

Keywords: beovu brolucizumab namd non-interventional trial fluid resolution
virtual mind-body exercises for people having pancreatic surgery

Conditions: Pancreas Disease

Summary: the purpose of this study is to find out if it is practical to provide 2 interventions, vmb exercise classes and euc (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or older * any pancreas disease (benign, pre-malignant, or malignant) and will be undergoing pancreatectomy * has at least one week to participate in the study prior to the anticipated surgery date * eastern cooperative oncology group (ecog) performance status 0 or 1 * english-speaking only exclusion criteria: * unable to give informed consent due to cognitive impairment or impaired decisionmaking capacity * cognitive impairment precluding response to study assessments * received neoadjuvant or any chemoradiation in the past 60 days * unwilling to accept random assignment * unwilling to commit to the 12-week study time period * unlikely to be compliant because of social factors that prevent patients from attending classes or doing home practice (e.g., unreliable internet, no access to a computer)

Keywords: exercises 22-070
comparison of insulin aspart produced by the nn2000 process to the current process in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by nn2000 process in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with type 1 diabetes * duration of diabetes for at least 12 months * treatment with insulin aspart for at least 3 months before trial start * body mass index (bmi) below 35.0 kg/m2 * hba1c below 12.0% exclusion criteria: * total insulin dosage more than 1.4 iu/kg/day * recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator) * known hypoglycaemia unawareness as judged by the investigator * known hypersensitivity or allergy
analysis of the availability of the treatments for ace-i and arb-induced angioedema

Conditions: ACE-I and ARB-induced Angioedema.

Summary: specific treatments for angiotensin-converting-enzyme inhibitor (ace-i) and angiotensin-receptor-blocker (arb)-induced angioedema exist. early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ed) stock them. the aim of this retrospective study was to define, for each patient with a confirmed ace-i or arb-induced angioedema, at which step of the care, the specific treatment was administered. the second objective was to analyse the availability of these treatment in the area around lyon, france and the factors that may influence it.


Eligibility criteria:
inclusion criteria: * every patient followed for the first time in our reference center for severe confirmed ace-i or arb-induced angioedema. data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit. * severe attack was defined either by its localization over the shoulder or by an severe abdominal attack. exclusion criteria: - patients which received no specific treatment (icatibant, c1-inhibitor concentrate) were excluded.

Keywords: angioedema emergency treatment treatment availability health equity
effects of pea proteins with different degrees of processing on postprandial metabolism in healthy adults

Conditions: Plasma Amino Acid Appearance and Disappearance; Postprandial Metabolic Events

Summary: the aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. in a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. it is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.

in a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying. during a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. each intervention arm will be separated by a washout period of at least 7 days.

Eligibility criteria:
inclusion criteria: * non-smoking * metabolically healthy * normal weight (bmi: 18,5 - 24,9 kg/m2) * written informed consent exclusion criteria: * pregnancy, lactation * hypo- or hypertension * underweight or overweight/obesity * food intolerances and allergies (especially milk protein, pea, celery) * malabsorption syndromes * gastrointestinal diseases * thyroid diseases * diabetes mellitus type 1 and type 2 * impaired kidney or liver function * anaemia * blood coagulation disorders * irregular menstrual cycle * endometriosis, severe menstrual problems * hormonal contraception * regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol) * hypersensitivity to paracetamol * body weight below 50 kg * alcohol abuse * glucose-6-phosphate dehydrogenase deficiency * gilbert's syndrome * vegan diet * eating disorders (especially anorexia nervosa, bulimia nervosa) * smoking * participation in another study

Keywords: postprandial metabolic events
psma pet and mri in gynecological cancers

Conditions: Gynecologic Cancer

Summary: the goal of this research is to determine the accuracy of psma positron emission tomography (pet) and multi-parametric magnetic resonance (mr) imaging to detect the presence of gynecological cancer cells in the body.

the investigators will evaluate a novel second-generation low-molecular-weight prostate specific membrane antigen (psma)-based positron emission tomography (pet) agent, 18f-dcfpyl, to determine the presence or absence of cancer, the accurate distribution of cancer and the normal biodistribution of psma in the abdomen and pelvis on pet imaging. psma, also known as folate hydrolase 1 and glutamate carboxypeptidase ii, is an enzyme associated with prostate cancer but has been also found to be expressed in the tumor neovasculature of many different types of non-prostate cancer tumors. psma-based 18f-dcfpyl pet demonstrates very high tumor-to-background ratio when studied in other tumors, including prostate tumors. mr imaging is a highly sensitive and specific imaging modality that can be used for gynecologic cancers. mr images can be obtained in conjunction with psma pet, adding additional anatomic and multi-parametric mri information without the need for a second imaging appointment.

Eligibility criteria:
inclusion criteria for healthy female controls n=12 (includes up to 6 dosimetry participants): * women with no suspected gynecological cancer. * no contraindications for mr or pet imaging. * greater than or equal to 18 years of age. * scheduled to undergo a hysterectomy and/or salpingo-oophorectomy inclusion criteria for female controls (dosimetry): * women with or without suspected gynecological cancer. * no contraindications for mr or pet imaging. * greater than or equal to 18 years of age. inclusion criteria for gynecological cancer patients (n=40): * women with known or suspected gynecological cancer * no contraindications for mr or pet imaging. * greater than or equal to 18 years * have had or are scheduled to undergo a hysterectomy and/or salpingo-oophorectomy exclusion criteria: * women that are pregnant or breast-feeding. * age \<18 * inability to provide informed consent on their own behalf * severe kidney dysfunction (gfr \<30 ml/min/1.73m2)

Keywords: uterine cancer ovarian cancer hysterectomy salpingo-oophorectomy
food challenge with barley starch as active comparator

Conditions: Allergy;Food; Allergy Wheat

Summary: aim of the present study is to verify in a double-blind placebo controlled food challenge (dbpcfc) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. scoring of symptoms during the challenges will be based on practall.


Eligibility criteria:
inclusion criteria: * age = 1-20 years * diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye) * response to cereal proteins confirmed within 2 months in an oral food challenge (ofc)\* or response to cereal proteins confirmed in an ofc more than 2 months ago but clinically verifiable and documented ongoing cereal allergy at the time of inclusion or diagnosis confirmed in an ofc with wheat performed as part of the study procedures. * voluntarily signed informed consent (including willingness to refrain from cereal containing foods for 1 week before intervention period and be exposed to cereal proteins in the test for eligibility) exclusion criteria: * complex food allergy which make elimination diet impossible to accomplish * patients experiencing unstable or exacerbated atopic disease, such as asthma, atopic dermatitis (ad), urticaria, or allergic rhinitis. * diseases and conditions that might affect safety. patients should not be challenged if they have chronic medical the event of anaphylaxis/treatment of anaphylaxis. examples of such conditions include unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease. * pregnancy should be ruled out by testing or based on history (e.g, before menarche) as appropriate * use of oral corticosteroids. inhaled and topical steroids or anti-inflammatory medications, such as calcineurin inhibitors or leukotriene antagonists and b-agonists, used at the lowest doses possible and on an established schedule by using fixed doses of medication to maintain a low and stable baseline of atopic disease. latter medication can usually be continued because their use is unlikely to significantly influence challenge outcomes and their withdrawal might result in exacerbations, affecting disease management and challenge interpretation. * use of antihistamines during the last 4 days before dbpc challenge or period of 5 half-lives of specific agent. * prolonged high dose steroids, omalizumab, or possibly other new drugs to control atopic disease upon decision of investigator. * aspirin/nonsteroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, alcohol, antacids and β-blockers upon the decision of the investigator * any chronic condition or its medication that affect immune system

Keywords: cereal allergy; barley starch, dbpc
prospective retinal and optic nerve vitrectomy evaluation (prove) study

Conditions: Glaucoma; Macular Pucker; Macula Hole; Vitreomacular Traction; Vitreous Opacities or Hemorrhage

Summary: since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. approximately 225,000 vitrectomies are performed annually in the united states and indications continue to expand. known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. although much has been written in the literature concerning acute rises in intraocular pressure (iop) in the immediate postoperative period, there is surprisingly little information on long term iop outcomes after vitrectomy. a recent report by chang given at the lxii (62) edward jackson memorial lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (oag) via oxidative stress exacerbated by removal of the crystalline lens. a second report by luk and colleagues reported similar conclusions in a modified cohort. both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. furthermore neither study accounted for natural history. finally, our analysis has not reproduced similar results. the primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. at 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.


Eligibility criteria:
inclusion criteria: * able to consent and comply for the duration of the study and imaging studies * media clarity sufficient for imaging studies * no previous treatment or surgery that might confound study results in the study or fellow eye * pars plana vitrectomy (ppv) indicated for epiretinal membrane (erm), macular hole (mh), vitreo-macular traction (vmt), and vitreous hemorrhage (vh) exclusion criteria: * unable to consent and/or comply for the duration of the study and imaging studies * history of the following conditions: glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (armd), prior ppv for retinal detachment, retained lens or dislocated intraocular lens * contralateral eye status post ppv or with advanced eye disease serious enough to warrant future ppv - contralateral eye with condition that may result in choroidal neovascular membrane

Keywords: vitrectomy glaucoma macula optic nerve ocular coherence tomography