Kornimate/medical-research-clean huggingface dataset:
life study - limiting chronotropic incompetence for pacemaker recipients

Conditions: Bradycardia

Summary: this study will compare how two different sensors inside the pacemaker may affect patients' quality of life.

the life study will estimate the prevalence of ci among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. changes in chronotropic response between ci patients randomized to either blended sensor or accelerometer will be compared. a sub-study will evaluate changes in functional capacity between ci patients randomized to either blended sensor or accelerometer.

Eligibility criteria:
inclusion criteria: * patients who meet current insigniatm plus pacemaker indications * patients who sign and date a patient informed consent prior to device implant * patients who remain in the clinical care of the enrolling physician exclusion criteria: * patients whose previous pacemaker had a minute ventilation sensor * patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker) * patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease * uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled) * patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., ddd or dddr) * patients whose life expectancy is less than 12-months due to other medical conditions * patients who have or who are indicated for an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy-defibrillator (crt-d) * patients who have active chronic leads that are either single-pass vdd, unipolar ventricular and atrial, non-is-1, and non-3.2mm unless the leads are replaced with bipolar leads that are is-1/3.2mm compatible * patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. each instance should be brought to the attention of guidant's clinical application research studies (cars) group to determine eligibility * patients who are younger than 18 years of age * patients who are pregnant * patients who are mentally incompetent and cannot sign a patient informed consent or participate in the study
90y transarterial radioembolization versus microwave ablation in small hepatocellular carcinoma with hypoalbuminemia

Conditions: Carcinoma, Hepatocellular

Summary: this clinical trial will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of small, early-stage hepatocellular carcinoma (hcc) who are candidates for both 90-yittrium therasphere transarterial radioembolization (90y) and microwave ablation (mwa). the study will determine whether treatment with 90y lowers the risk of disease progression within the first year after diagnosis. participants will be randomized to receive either first cycle 90y or mwa and then proceed with standard of care.

this study will compare 1-year outcomes in patients with hypoalbuminemia and a new diagnosis of early-stage hepatocellular carcinoma (hcc) who are candidates for both 90-yittrium therasphere transarterial radioembolization (90y) and microwave ablation (mwa). the study will focus on patients with solitary, small hcc, defined as a single tumor ≤ 3cm in diameter, and with hypoalbuminemia at the time of hcc diagnosis, defined as albumin \< 3.4 g/dl. participants will be randomized to receive either 90y or mwa as a first cycle liver-directed therapy. the study will enroll 50 participants randomized at a 1:1 ratio to 90y or mwa. after first cycle treatment, the participants will resume standard of care management for early-stage hcc. participants will undergo observational follow-up for 1-year after first cycle treatment to collect data on adverse events, response to treatment, time to retreatment, duration of response, and progression of disease staging.

Eligibility criteria:
inclusion criteria: * hcc diagnosis according to the liver imaging - reporting data system (li-rads) criteria as defined in the american association for the study of liver diseases 2018 hcc practice guidelines * eastern cooperative oncology group score 0 - 1 * child-pugh a - b * bilirubin \< 2.5 mg/dl * creatinine \< 2.0 mg/dl * no prior liver-directed therapy or systemic therapy for hcc * solitary, unresectable hcc ≤ 3cm * albumin level \< 3.4 g/dl at hcc diagnosis * tumor anatomical location and angiosome amendable to mwa and 90y exclusion criteria: * pregnant women * concurrent malignancy

Keywords: yttrium-90 hypoalbuminemia
rmt in patients with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: spinal cord injury (sci) is an involvement of the spinal cord, a nerve cord protected by the spine and extends from the base of the brain to the lumbar region. the spinal cord lesion causes complete or incomplete paralysis of voluntary mobility and absence, partial or total, of any sensitivity below the affected area; in addition, it also involves the lack of control over the sphincters of urination and intestinal evacuation, disorders of sexuality and fertility, alterations of the vegetative nervous system and risk of suffering other complications not less important as: bedsores, spasticity, kidney processes, ... the cervical and dorsal cord injury severely affects respiratory function due to paralysis and deterioration of the respiratory muscles. several types of respiratory muscle training (rmt) have been described to improve respiratory function for people with sci in the literature. despite the relatively small number of studies included in this review, the meta-analysis of the pooled data indicates that rmt would be effective in increasing respiratory muscle strength and also lung volumes for people with sci. more research is needed to obtain functional results after emr, such as dyspnea, cough efficacy, respiratory complications, hospital admissions due to respiratory complications and quality of life.


Eligibility criteria:
inclusion criteria: * diagnosis of acute spinal cord injury from c5 to t11 (ais a-b) * no tracheotomy user or invasive mechanical ventilation. * age between 18 years - 75 years. exclusion criteria: * not wanting to participate in the study. * not meet inclusion criteria * cognitive or psychiatric disorder that does not allow you to participate in the study.

Keywords: spinal cord injury rehabilitation respiratory muscle training quality of life
evaluation of the efficacy of oc-01 nasal spray on signs and symptoms of dry eye disease

Conditions: Dry Eye Disease

Summary: the objective of this study is to evaluate the safety and effectiveness of oc-01 nasal spray as compared to placebo on signs and symptoms of dry eye disease

this was a phase 2b, multicenter, randomized, double-masked, placebo controlled study designed to evaluate the safety and efficacy of oc 01 nasal spray in adult subjects with ded. the study randomized 182 subjects, at least 22 years of age, who had a physician's diagnosis of dry eye disease and met all other study eligibility criteria to receive an application of oc-01 or placebo twice daily (bid) for 4 weeks.

Eligibility criteria:
inclusion criteria: * have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1 exclusion criteria: * have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery within twelve months of visit 1 * have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with ded are allowed. * have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.) * have a known hypersensitivity to any of the procedural agents or study drug components * have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
interstitial lung diseases in primary sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: patients with pss seen in the division of rheumatology, the second affiliated hospital of zhejiang university, school of medicine (sahzu) during january 2016 to july 2018, were retrospectively reviewed. characteristics were analyzed.

patients with pss were retrospectively reviewed, and pss-ild and pss non-ild were identified. clinical data, laboratory parameters, pulmonary high-resolution ct (hrct), and pulmonary function tests (pfts) were collected. pss-ild patients were further categorized into subgroups according to hrct patterns or pfts.

Eligibility criteria:
inclusion criteria: * all patients with pss fulfilled the 2002 revised version of the european criteria proposed by the american-european consensus group * patient with pss evaluated with pulmonary hrct and/or pfts were included in the pss-ild group exclusion criteria: * patients with hepatitis c infection, past head and neck radiation treatment, sarcoidosis, acquired immunodeficiency syndrome, pre-existing lymphoma, graft-versushost disease, and use of anticholinergic drugs, igg4-related disease * patients with other connective tissue diseases (ctd) or other pulmonary diseases were further excluded, including those with pulmonary arterial hypertension, pulmonary infections, tuberculosis, chronic bronchitis, emphysema, asthma, chronic obstructive pulmonary disease, malignancies, pulmonary lesions related with environmental, occupational or medication exposures, or history of smoking
study evaluating the safety and efficacy of pf-03654746 in adult subjects with tourette's syndrome

Conditions: Tourette's Syndrome

Summary: the purpose of this study is to evaluate the safety and efficacy of an investigational compound designated pf-03654746 compared to placebo in the treatment of adults with tourette's syndrome. the study will also explore the pharmacokinetics of pf-03654746 in adults with tourette's syndrome.

the study was terminated 11-apr-2012 due to an internal reassessment of priorities by the sponsor. the decision to terminate was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * primary diagnosis of tourette's syndrome in english-speaking male or female adults 18 to 55 years of age who are in generally good health. * free of medications to treat tics for at least 6 weeks prior to randomization. * females of childbearing potential must use medically acceptable birth control for the duration of the study and for 28 days after study participation. exclusion criteria: * tic treatment including protocol-specified drugs, training in tic-suppressing behavioral techniques, habit reversal training or use of onabotulinum toxin a injection. * history or neurologic evidence of a secondary tic disorder, psychosis, bipolar disorder, tardive dyskinesia, untreated or unstable dsm-iv axis i disorder requiring treatment.

Keywords: tourette's syndrome in adults safety and efficacy randomized placebo control cross-over
testing an internet-based intervention for preventing eating disorders

Conditions: Eating Disorders

Summary: this study will examine the ability of an internet-based program to prevent college-aged women from developing eating disorders.

approximately 2% to 4% of college-aged women suffer from eating disorders (eds), and many more are at risk of developing them. a previous internet-based intervention called student bodies (sb), which focused on body image concerns, was effective in reducing risk factors for eds among college-aged women. however, the original sb program did not account for certain other risk factors, such as depression and compensatory behaviors like self-induced vomiting, over-exercising, or use of diuretics. image and mood (iam) is an enhanced version of the sb program and takes into account depressive symptoms and the use of compensatory behaviors. this study will examine whether iam will reduce ed risk factors in a large population of college women who are at high risk of developing eds. participation in this study will last 10 weeks. participants will be randomly assigned to either receive the iam program or be placed on a wait list. the iam program, which will be delivered through the internet, will provide information about nutrition, exercise, body image, and coping skills-including examples and exercises. it will also include an online message board monitored by a study psychologist. each week the iam participants will monitor their behavior, keep a journal about their experiences, and answer self-report questionnaires. assessments of eating disorder symptoms; weight and shape concerns; depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will be completed post-treatment and at 1- and 1.5-month follow-ups. those assigned to the wait list will complete these assessments and then receive the iam program after the last follow-up.

Eligibility criteria:
inclusion criteria for primary aim: * access to a computer with an internet connection * weight concerns scale score greater than or equal to 47 * presence of one additional risk factor, including a history of teasing, a history of depression, or low levels of compensatory behaviors (defined as less than four times per month) inclusion criteria for secondary aim: * access to a computer with an internet connection * weight concerns scale score greater than or equal to 47 exclusion criteria for both primary and secondary aims: * current diagnosis of an eating disorder * treated for an eating disorder within the past 6 months * currently receiving psychological treatment for an eating disorder or depressive disorder * started a new psychiatric medication within the past 2 months * exhibiting a level of psychopathology that would interfere with participation (e.g., acutely suicidal)

Keywords: bulimia nervosa binge eating binge-eating disorder
natural history of cardiac and respiration function in patients with muscular dystrophies on home mechanical ventilation

Conditions: Heart, Respiratory, Disease, Functional

Summary: muscular dystrophies are inherited disorders that affect skeletal muscle. cardiac and respiratory function may be affected in this group of diseases. the investigators sought to analyze the long term cardiac and respiratory function in patients with muscular dystrophies recquiring home mechnaical ventilation .

muscular dystrophies are neuromuscular disorders with disability and can affect respiratory muscle function and left ventricular function. medical management of patients with cardiomyopathy relies mainly on angiotensin-converting-enzyme inhibitors and beta blockers. respiratory management relies on home mechanical ventilation and couph assist. the investigators aim * to analyze cardiac and respiratory function over time in patients with muscular dystrophies followed at the home mechanical ventilation unit. * to determine the long term impact of the home mechanical ventilation on cardiac and respiratory events and to define the predictive factors associated. patients will be included retrospectively. tissue doppler imaging and tricuspid annular plane systolic excursion were used for the assessment of the right ventricle. left ventricular ejection fraction was used for the analysis of the left ventricle. respiratory function was assessed using the vital capacity, the maximal inspiratory pressure, the maximal expiratory pressure, the peak couph flow rate.

Eligibility criteria:
inclusion criteria: * age higher or equal to 18 years * duchenne muscular dystrophy * becker muscular dystrophy * sarcoglycanopathy * limb girdle muscular dystrophy * pompe disease * steinert disease * fsh disease * others myopathies exclusion criteria: * minor patient * sepsis condition

Keywords: cardiomyopathy echocardiography prognosis respiratory home mechanical ventilation vital capacity maximal inspiratory pressure maximal expiratory pressure
open-label study, to evaluate the safety and tolerability of zoledronic acid in patients with bone lesions secondary to multiple myeloma.

Conditions: Multiple Myeloma

Summary: to evaluate the safety and tolerability of intravenous zoledronic acid in the treatment of patients with multiple myeloma stage iii with bone lesions related to cancer.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 - 2. * confirmed diagnosis of durie-salmon stage iii multiple myeloma, with the following clinical characteristics: a. at least 1 osteolytic bone lesion demonstrable in a conventional x-ray film. b. the patient will have to be receiving treatment for primary neoplasia, at the time of the start of this trial. - ambulatory patients aged ≥ 18 years. exclusion criteria: * treatment with bisphosphonates in any moment during the last 12 months before visit 1. except for those patients that received only one dosis of bisphosphonates for any indication and when the administration has been 14 days before or older. * patients with an absence of a bone lesion clearly related to the primary cancer, and that is detectable in a conventional bone x-ray (simple film). * patients with a serum calcium level of ≤ 8 g/dl (2.00 mmol/l) or ≥ 12 mg/dl (3.00 mmol/l) * treatment with other investigational drugs within 30 days before inclusion in the trial. * serum creatinine levels of \> 3 mg/dl (265 umol/l). * total billirubin levels of \> 2.5 mg/dl (43 umol/l) * patients with a heart condition that has the nyha criteria for a grade iii and iv functional class other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bone lesions multiple myeloma zoledronic acid
treatment clinical practice in bipolar depression in spain

Conditions: Bipolar Depression

Summary: cross-sectional observational, non interventional, multicenter study of retrospective review of clinical records of ambulatory followed up bipolar patients in order to record epidemiological aspects of the course of the disorder, more specifically of bipolar depression episodes and the clinical practices carried out by psychiatrists in spain in bipolar depressive episodes


Eligibility criteria:
inclusion criteria: * diagnosed of bipolar disorder i or ii (dsm-iv-tr) in ambulatory follow-up * evolution of the bipolar diagnoses inferior to 10 years * having recorded in the patient's clinical history the clinical management of at least two bipolar depressive episodes exclusion criteria: * not having enough information recorded in the clinical history for the essential measurement variables * to have taken part in other study in the last 6 months

Keywords: bipolar depression treatment
investigating multimodally endothelial dysfunction in ocular and systemic disease

Conditions: Kidney Diseases; Diastolic Heart Failure; Small Vessel Disease; Glaucoma

Summary: to explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

in this interventional cohort study, the investigators aim to evaluate retinal vascular function as assessed by optical coherence tomography angiography, fundus photography and dynamic vessel analysis in patients who share microvascular involvement of their pathology (e.g. chronic kidney disease, cardiac decompensation, neuronal small vessel disease and glaucoma) and age-matched healthy controls. plasm and skin samples for comparative proteomics and transcriptomics are also taken.

Eligibility criteria:
inclusion criteria: * adult patients with a confirmed or suspect diagnosis of glaucoma based on intra-ocular eye pressure, visual field defect and structural optic nerve changes, regardless their age. * adult patients with chronic kidney disease regardless their age. * adult patients with heart failure with preserved ejection fraction (hfpef), regardless their age: symptomatic heart failure with left ventricle ejection fraction \> 50% and bnp \> 35 pg/ml (or nt-probnp\>125 pg/ml) or signs of diastolic dysfunction according to the european society of cardiology guidelines 2016 * adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age. * people without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age * capable and willing to participate (informed consent) exclusion criteria: * diabetes * personal medical history of retinal neovascularization. * unable or unwilling to give consent
epidemiological description of the kaposi's disease in france's southeast

Conditions: Kaposi's Disease

Summary: the purpose of this study is to evaluate the prevalence of the kaposi's disease in france's southeast on 10 years (from 2007 to 2017)

kaposi's disease is a multifocal disease with cutaneous expression in more than 95% of cases. there are 4 forms : mediterranean, endemic (sub-saharan africa), iatrogenic and epidemic (hiv) the physiological hypotheses to explain the disease are not clear. a proliferation of immunity cells in blood vessels and also an undetermined role of the human herpes virus 8 (hhv-8) could be involved. the treatment is complex and not standardized. there are a lot of different treatments. the purpose of this study is to evaluate the prevalence and described the characteristics and the treatment of the kaposi's disease in the france's southeast on 10 years, from 2007 to 2017.

Eligibility criteria:
inclusion criteria: * diagnosed patients with a kaposi's disease by biopsy from january 2007 to december 2017 exclusion criteria: * opposition to the use of personal data

Keywords: kaposi's disease hhv8 prevalence
evaluation of quality of life in women

Conditions: Quality of Life; Women Health; Social Interaction

Summary: 300 women will be evaluated in this study. their quality of life, level of physical activity, social functioning, levels of depression and musculoskeletal status will be assessed.

many factors affects quality of life in women. in the literature, factors affecting the quality of life such as diseases, working conditions and psychological factors of women have been investigated in different diseases. however, there was no study investigating the factors affecting quality of life for a sample of adult female individuals. therefore, the aim of our study is to investigate the effect of social, psychological and physical variables that we think may affect the quality of life in women.

Eligibility criteria:
inclusion criteria: * to be a volunteer exclusion criteria: * having severe musculoskeletal system disorders

Keywords: quality of life depression anxiety social function