Kornimate/medical-research-clean huggingface dataset:
ablation for icd intervention reduction in patients with cad

Conditions: Ventricular Tachycardia; Coronary Artery Disease; Implantable Cardioverter-Defibrillator

Summary: the aim of this study is to assess the role of ablation in appropriate icd interventions reduction in patients with coronary artery disease. the group will consist of 200 patients with implanted icd and appropriate intervention in the 3 months prior to enrollment. the patients will be randomized into ablation arm and conventional treatment. number of appropriate icd interventions is the primary endpoint of this study. all patients will have control follow-up visits every 3 months. the follow-up will be based on icd memory.


Eligibility criteria:
inclusion criteria: * coronary artery disease * icd implanted * appropriate icd intervention during the 3 months prior to enrollment * coronary angiography during the 6 months prior to enrollment * possible revascularization * age over 18 years * signed informed consent exclusion criteria: * age less then 18 years * pregnancy * active participation in other trial * heart failure (nyha iv) * contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access. * monomorphic, incessant, ventricular tachycardia * revascularization or other cardio-surgical procedure scheduled in the next 6 months

Keywords: ablation ventricular tachycardia coronary artery disease implantable cardioverter defibrillator interventions
healthy habits program for high cardiovascular risk patients: randomized controlled clinical trial

Conditions: Health Behavior; Motor Activity; Food Habits

Summary: the purpose of this study is to determine the effectiveness of a program to improve habits in a population with cardiovascular disease, comparing two different educational techniques (cognitive behavioral therapy group vs. informational workshops).


Eligibility criteria:
inclusion criteria: * patients who live in the catchment area of the health centers participating in the trial or that have their primary care physician in these centers. or * patients with a diagnosis of coronary heart disease, and / or transluminal angioplasty and / or coronary artery bypass grafting (cabg). these diagnoses must have occurred longer than six months from the time of inclusion. or * patients with a diagnosis of cerebrovascular accident (cva), transient ischemic attack (tia), carotid endarterectomy and / or carotid angioplasty. these diagnoses must have occurred longer than six months from the time of inclusion. or * patients with peripheral arterial disease with or without intermittent claudication, revascularization surgery, bypass placement of arterial and / or peripheral arterial angioplasty. these diagnoses must have occurred longer than six months from the time of inclusion. and * sedentary persons, defined as less than 90 minutes per week of moderate aerobic physical activity in their daily life (leisure, travel or work). exclusion criteria: - patients on chronic home monitoring and / or institutionalized before admission or living in a tertiary institution. or * moderate or severe limitation on functional capacity and / or mobility. or * patients with dementia. or * patients diagnosed with psychiatric illnesses that compromise patient autonomy. or * life expectancy less than 1 year. or * patients who do not want to take part in the program. or * patients who are participating in another research protocol at recruitment. or * patients with a diagnosis of intracranial hemorrhage secondary to aneurysmal rupture.

Keywords: cognitive therapy health education secondary prevention cardiovascular disease
quadricipital electrical stimulation in copd patients rehabilitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: quadricipital electrical stimulation added to respiratory rehabilitation in copd patients. quadricipital electrical stimulation (es) in chronic obstructive pulmonary disease (copd) patients has been demonstrated to improve both dyspnea and physical status. the aim of our study is to demonstrate that es added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients. design : 160 patients with severe copd will be randomly assigned to 2 groups : either rehabilitation program (group 1), either es and rehabilitation program (group 2). in both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. in group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week. subjects : copd patients with fev1 \ 80%, with dyspnea, in stable conditions, and 18 \> bmi \< 35 kg/m² . intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training. abbreviations : fev1 = forced expiratory volume in 1 sec; vc = vital capacity; tlc = total lung capacity; bmi = body mass index.


Eligibility criteria:
inclusion criteria: * subjects : copd patients with fev1 \ 80%, with dyspnea, in stable conditions, and 18 \> bmi \< 35 kg/m² exclusion criteria: * bmi 18 \ 35 kg/m² * pregnant women * peripheral neuropathy * cardio respiratory incremental test contra-indication * evolutive cancer * cardiac or cerebral pace maker, implanted cardio defibrillator * no informed consent given

Keywords: copd electrical stimulation rehabilitation exercise test
investigational study of oral fish oil in treating parenteral nutrition associated liver disease

Conditions: Liver Disease; Short Bowel Syndrome

Summary: the purpose of this study is to investigate the usefulness of oral fish oil(lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. the investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not

this is designed as a randomized placebo controlled trial of oral fish oil (lovaza) in normalizing parenteral nutrition associated liver disease.

Eligibility criteria:
inclusion criteria: * history of parenteral nutrition(pn)administration \>4weeks * pn associated liver disease from intestinal failure * ability to take full enteral feed * body weight equal or greater than 3kg * elevated alt level twice of that normal(alt\>84)at the time pn is weaned off exclusion criteria: * hemodynamic instability * renal failure * suspected congenital obstruction of the hepatobiliary system * diagnosis hepatitis a, b, or c * diagnosis of alpha 1-antitrypsin deficiency * diagnosis of cytomegalovirus infection * diagnosis of hiv * children in care

Keywords: oral fish oil lovaza omega-3-acid supplementation
using voice biomarkers to predict the likelihood of major depressive disorder

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is the leading cause of disability worldwide. depression and anxiety disorders are among the most prevalent of all mental disorders, with an estimated annual prevalence of 9.7% and 18.1% respectively. it has been known for the last 100 years that depression and anxiety both likely affect vocal acoustic properties. in 1921, emil kraepelin, characterized depressed patient's voices as having a lower pitch, lower volume, lower rate of speech, more monotony of prosody as well as more hesitations, stuttering, and whispering. mechanistically, it is possible that the neural circuitry involved in the pathophysiology of mood and anxiety disorders impinge upon the neural circuit involved in speech production, affecting qualities that include rate, prosody, speech latency and other paralinguistic features. thus, acoustic features of speech may be one of the more readily accessible biomarkers for these conditions. given this understanding, the investigators sought to develop a passive vocal biomarker instrument for depression and anxiety screening that could markedly expand access as well as standardize the quality of screening in primary care settings.


Eligibility criteria:
inclusion criteria: * adult males and or females over the age of 18 at the time of informed consent * access to a laptop, smartphone or tablet with a functioning microphone * stated willingness to comply with all study procedures and availability for the duration of the study * fluency in english * for depressed participant group: current diagnosis of depression * for non-depressed participant group: no current or prior diagnosis of depression exclusion criteria: * visual impairment that would make it difficult for the participant to follow the instructions * motor impairment that would make it difficult for the participant to follow the instructions * any known history of neurodegenerative or central nervous system disorders (e.g. ms, dementia, tbi, stroke, etc.) * any known history of major psychiatric disorder other than depression (e.g. bipolar disorder, schizophrenia, etc.) * any known history of substance abuse

Keywords: voice biomarkers speech analysis
changhai multimodal esophageal cancer cohort

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the burden of esophageal squamous cell carcinoma (escc) in china is substantial, with 85% of the cancers being in the progressive stage. the treatment for advanced escc are extremely limited, and immunotherapy, represented by pd-1 inhibitors, has demonstrated a promising application potential. however, the effectiveness of pd-1 inhibitors varies significantly among patients with different types of escc, and currently, there is no effective method to predict the response to pd-1 inhibitors. in this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for escc, integrating both pathological image features and clinical information of patients with escc, thereby enhancing the level of individualized and precise treatment for escc.


Eligibility criteria:
inclusion criteria: 1. availability of hematoxylin and eosin (h\&e) stained images, molecular data obtained through rna sequencing (rna-seq, dna-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, ajcc tumor, node, metastasis stage, specific location of oesophageal cancer occurrence, and history of reflux. 2. the sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites. exclusion criteria: 1. patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers; 2. cases involving combined adenocarcinoma affecting the gastroesophageal junction; 3. individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination; 4. subjects in whom postoperative pathology confirms an absence of residual malignant tissue.

Keywords: deep learning esophageal squamous cell carcinoma immune infiltration
european cystinosis cohort

Conditions: Cystinosis

Summary: cystinosis is a generalized lysosomal storage disease with a reported incidence of about 1:180,000 live births. there are estimated 110-140 cases in france (approximately 500 in western europe). the disease is caused by mutations in the ctns gene coding for cystinosin, a lysosomal carrier protein. the lysosomal cystine accumulation leads to cellular dysfunction in many organs. the first symptoms start at about 6 months of age. in the absence of specific therapy, end stage renal disease occurs between 6 and 12 years of age. survival beyond this age is associated with the development of extra-renal complications. renal transplantation and the availability of cystine-depleting medical therapy, cysteamine (eu/1/97/039/001, eu/1/97/039/003), have radically altered the natural history of cystinosis. cystinosis is a good example of a "paediatric" disease where patients now survive into adolescence and adulthood. these individuals have complex, multisystem problems that require on-going care. despite some progress in recent years there are still significant limitations in the knowledge of diagnostic and therapeutic procedures. a first european registry was launched in 2011, using the cemara application developed by the banque nationale de données maladies rares (bndmr, cnil authorisation number: 1187326), allowing the collection of data from france, belgium and italy. the objective of the current study is to translate this database into a cohort study that will allow and facilitate the collection of a wider range of data including clinical, and personal data such as quality of life data, from an increased number of european countries, improve the monitoring, data-management and analysis of the data, offer the possibility for patients to actively participate to and benefit from the study by developing a module in which patients will enter their own data on quality of life with a direct feed-back on the general results. this project is a unique opportunity for building a consensual european academic cohort not based on company driven, "drug-oriented" objectives. the cohort will collect clinical details to analyse patient outcomes thus providing audit of patient care \& clinical effectiveness. it will be possible, through the cohort, to indicate where improvements need to be made and ultimately improve care to the highest standards.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cystinosis (based on cystine dosage, presence of crystals at eye examination or molecular diagnosis) * signed informed consent exclusion criteria: * patients not able to give their informed consent. no other criteria (patients with associated disease should be enrolled).

Keywords: quality of life effects of treatments european study
his-bundle pacing vs. right ventricular apical pacing in patients with reduced ejection fraction

Conditions: His Bundle Pacing; Heart Failure, Systolic

Summary: the study compares standard right ventricle apical pacing with so called his-bundle pacing, for patients with slightly or moderately reduced ejection fraction and atrioventricular block requiring pacemaker therapy. the primary outcome is left ventricular ejection fraction measured after 6 months.

patients with reduced systolic ejection fraction (40≤ ejection fraction ≤55%) and pacemaker indication due to high degree av block are included. the study has a randomized double blinded crossover design. patients are implanted with a standard right ventricle lead and right atrial lead (if indicated), and in addition a his-bundle lead. randomization is performed as to which pacing modality is used during the first 6 months. after 6 months the pacing modality is changed. patients are blinded and endpoint adjudicators, including echocardiography staff, are blinded. device nurse and physician are not blinded. primary endpoint is difference in left ventricular ejection fraction after 6 months, paired comparisons are used and each patient is their own control. secondary endpoints include complications and safety of the device/electrode, and quality of life.

Eligibility criteria:
inclusion criteria: * av block ii or iii with high expected pacing need * left ventricular ejection fraction between 40% and 55% (inclusive) * willing to participate and sign informed consent exclusion criteria: * under 18 years old * pregnant * hypertrophic cardiomyopathy * cardiac sarcoidosis * cardiac amyloidosis * previous myocardial infarction within last 3 months * ventricular septum defect or other other left ventricular corrective surgery * congenital heart disease surgically corrected * atrial fibrillation with uncontrolled rate (if not planned for av node ablation)

Keywords: his bundle pacing conduction system pacing heart failure, systolic quality of life left ventricular ejection fraction
a study to evaluate the effects of bgf and gff on specific image based airway volumes and resistance in subjects with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of budesonide/glycopyrronium/formoterol fumarate (bgf) and glycopyrronium/formoterol fumarate (gff) on airway dimensions.

this is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to evaluate the effects of budesonide/glycopyrronium/formoterol fumarate (bgf), and glycopyrronium/formoterol fumarate (gff), on specific image based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease. in this study, airway dimension parameters will be calculated for each of the active compounds. this imaging methodology will allow an assessment of the extent of airway changes using a triple combination of budesonide/glycopyrronium/formoterol fumarate (bgf) and the dual combination glycopyrronium/formoterol fumarate (gff).

Eligibility criteria:
inclusion criteria: subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at visit 1. * copd diagnosis: subjects with an established clinical history of copd * screening clinical laboratory tests must be acceptable to the investigator. * screening ecg must be acceptable to the investigator * individual compliance: subjects must be willing to remain at the study center as required per protocol to complete all visit assessments * patients should be on scheduled maintenance treatment with one or more inhaled bronchodilator therapies. exclusion criteria: * as judged by the investigator, any evidence of significant diseases other than copd, i.e., disease or condition which, in the investigator's opinion makes it undesirable for the subject to participate in the trial. * spirometry performance: 1. subjects who cannot perform acceptable spirometry, i.e., meet ats/ers acceptability criteria. 2. repeatability: subjects who cannot perform technically acceptable spirometry in accordance with ats repeatability criteria * cancer: subjects who have cancer that has not been in complete remission for at least five years. * substance abuse: subjects, who in the opinion of the investigator, significantly abuse alcohol or drugs * subjects who in the opinion of the investigator are unable to abstain from prohibited medications including laba/lamas/ics

Keywords: copd
effect of pilocarpine in patients with xerostomia

Conditions: Xerostomia

Summary: the purpose of this study is to evaluate the effectiveness of a spray the basis of pilocarpine on salivary flow of patients with xerostomia, by radiation therapy, and primary sjögren's syndrome treated at the clinics hospital of faculty of medicine of ribeirão preto (hcfmrp-usp), and its impact on quality of life.

there will be two groups: group 1 (g1) - will use a spray with pilocarpine for three months and after a washout period of a month, use a spray without pilocarpine for another three months; group 2 (g2) - will use a spray without pilocarpine for three months and after a washout period of a month, use a spray with pilocarpine for another three months (in a randomized, controlled, duble blind and crossover study). participants will be submitted to ohip-14, xerostomia inventory (xi) and salivary flow measurement before the start of therapy - baseline (t0), one (t2), two (t3) and three (t4) months after starting the use of spray, after washout, crossover occurs and the same parameters are measured for the same periods (t0', t2', t3' and t4'), and is measured one hour after the saliva (t1 and t1') baseline.

Eligibility criteria:
inclusion criteria: * age equal or superior to 18 years; * both genders; * lucid and without diagnosis of any psychiatric disorder; * diagnosed with head and neck cancer and treated for a period of up to 5 years with radiotherapy where the major salivary glands (parotid, submandibular and sublingual) were included in the radiation field; * primary sjögren's syndrome with the diagnosis made by the american-european criteria. exclusion criteria: * sensitivity to pilocarpine * secondary sjögren's syndrome; * type ii diabetes mellitus; * aids; * pregnant or lactating women; * glaucoma; * uncontrolled asthma; * chronic obstructive pulmonary disease; * renal diseases; * severe cardiovascular diseases; * gastrointestinal disorders; * hepatic insufficiency.

Keywords: xerostomia pilocarpine quality of life
respiratory dysregulation and breathing training in anxious outpatients

Conditions: Anxiety

Summary: this study will explore respiratory dysregulation in anxious outpatients and examine the effect of breathing training with biofeedback for those anxious patients.

in clinic testing and outside the clinic testing, we will assess the prevalence of respiratory dysregulation in a sample of 60 non-psychotic, not currently alcohol or drug abusing veteran outpatients from our mhc (mental hygiene clinic) who experience episodic anxiety but who do not qualify and have never qualified for the diagnosis of pd (panic disorder). these patients will be compared to 30 patients who are not clinically anxious. of these 60 anxious patients, 30 will be randomly assigned to a 4-week course of breathing training assisted by feedback of end-tidal pco2 levels as an augmentation of their current treatment. they will be compared to 30 who simply will continue with their current treatment (tau). the breathing training group will receive clinical and physiological assessments immediately before the treatment period, four weeks after the end of the treatment period, and at a 4-month follow-up. the tau group will be assessed three times at equivalent intervals, and if they wish, may undergo breathing training after the third assessment. treatment will take place mainly in the first two years, giving us adequate time for follow-up and data analysis. we expect that this therapy will be especially effective for treating anxiety in the patients with substantial respiratory dysregulation.

Eligibility criteria:
inclusion criteria: * patients must be rated 2 or more on both q1 and q3, but they must not meet the full criteria for pd as determined by the anxiety disorders interview schedule for dsm-iv-lifetime version (adis). * in addition, they must be clinically stable enough that changes in the patients' anxiety levels can be attributed to the breathing training rather than to other new treatment initiatives during the training and 1-month evaluation periods or to spontaneous fluctuations in anxiety levels. thus, potential participants taking ssris or other antidepressants, or benzodiazepines have to have been on a stable dose of these medicines for at least the previous two months. exclusion criteria: * potential participants taking short-acting benzodiazepines such as alprazolam in excess of 2.0 mg/day or the equivalent on any day in the past month are excluded, because improvement might show up only in terms of reduction of medication dosage and not on the evaluation measures planned.

Keywords: anxiety breathing training respiratory dysregulation