Kornimate/medical-research-clean huggingface dataset:
frequency doubling technology (fdt) mobile visual field testing

Conditions: Glaucoma

Summary: this is a single center, prospective study to evaluate the efficacy and reproducibility of frequency doubling technology (fdt)-based visual field devices compared to conventional humphrey visual field (hvf) perimetry. the investigators plan to enroll 500 patients in this study.

glaucoma is a leading cause of irreversible and preventable blindness world-wide. insufficient evidence exists to support routine screening for glaucoma in a primary care setting due to the relatively low prevalence of the disease (guirguis-blake, 2005 and moyer, 2013). frequency doubling technology (fdt)-based perimetry is a relatively inexpensive and portable visual field testing device with a short testing time that has shown reasonable efficacy, sensitivity and specificity in screening for glaucoma in clinic- and community-based settings (mansberger, 2005 and nomoto 2009). the aim of our study is to compare the efficacy and reproducibility of fdt perimetry platforms compared with humphrey visual field (hvf) perimetry (which is the gold clinical standard in clinics and hospitals) in detecting glaucomatous visual field defects.

Eligibility criteria:
inclusion criteria: * adult patients (18 and over) who speak english, spanish or creole, and are capable of providing informed consent and who have a humphrey visual field (hvf) test within the prior the 6 months preceding enrollment are eligible for enrollment in this non-invasive study. patients will be recruited from among patients at the bascom palmer eye institute clinics during their regularly scheduled clinic visits. no advertising will be used to recruit patients. exclusion criteria: * adults unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners and other vulnerable populations will be excluded from the study.
effect of thyroid hormone on post-myocardial infarction remodeling and prognosis in stemi patients

Conditions: Thyroid; Cardiac Remodeling, Ventricular; STEMI

Summary: this study aims to determine whether thyroid hormone levels are predictive of cardiac remodeling following myocardial infarction and the prognosis in patients with stemi receiving primary percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * with a confirmed stemi diagnosis * undergoing primary percutaneous coronary intervention (presenting \<12h after symptom onset) * patients agreed and provided informed consent exclusion criteria: * past history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass graft * past history of heart failure (lvef\<40%) or myocardiopathy or atrial fibrillation * past history of thyroid diseases, or were treated with amiodarone, dopamine, or corticosteroids before hospital admission * contraindicating to cardiac magnetic resonance imaging
effectiveness of osteopathic manipulative therapy in paediatric patients, with high frequency headache.

Conditions: Headache Disorders; Primary Headache Disorder

Summary: the aim of this study is to evaluate the effectiveness of osteopathic manipulative therapy, in supporting prophylactic medications in paediatric patients, with high frequency headache.

headache is one of the most common medical complaints in childhood, with migraine and tension-type headaches (tths) being the most frequent diseases. the prevalence of tension-type headache (tth) varies from 10% to 25% in school children and adolescents. therefore a range varying from 0,1% to 5,9% of this population presents chronic tension-type headache, occuring at least 15 days on a monthly basis. the tension-type headache is most likely multifactorial. in children, a connection seems possible between tension-type headache and psychosocial stress, psychiatric disorders, muscular stress, or oromandibular dysfunction. the treatment of tension-type headache covers a systemic approach that includes both pharmacologic and nonpharmacologic therapies, such as biobehavioural management, and patient and family education regarding lifestyle modifications to develop and/or maintain healthy habits. efficacy of these therapies is still unclear. complementary therapies could be a good support to pharmacologic treatment. osteopathic treatment results effective in some paediatric conditions, but in primary headache the possible efficacy is still unknown.

Eligibility criteria:
inclusion criteria: * diagnosis of primary high-frequency headache attacks. * no reduction or inconsistent reduction of attacks after two months of prophylactic treatment. exclusion criteria: secondary headache.

Keywords: headache disorders primary headache
maternal plasmatic regulatory t cells and th17 as possible diagnosis markers of acute chorioamnionitis

Conditions: Pathology of Pregnancy

Summary: the purpose of this study is to evaluate if regulator t cells (treg) and th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for pprom.

acute chorioamnionitis is the principal antecedent of premature birth and an important contributor to specific neonatal and other complications that may extend throughout subsequent life. the pprom is a high risk condition for developing chorioamnionitis. available biological markers have a low prognostic value. indeed, currently the diagnosis of intra-uterine infection relies only on placental cultures and anatomo-pathological exam after the delivery. moreover, pregnancy is an immunologic particular condition. indeed an immune tolerance is required with respect to the fetus and is mediated by treg lymphocytes, which suppressed th17 activity. recent studies have shown among women with frequent miscarriages, a balance between treg and th17, with a decrease in treg number and an increase in th17 number in decidua and blood. in case of infection, the immune pro-inflammatory response (th17) is restored in peripheric tissues and in blood in order to limit the extention of intra-uterine infection. this restoration of this pro-inflammatory response could be due to a modification of treg number ou tolerogenic activity. in this context, our hypothesis is that chorioamnionitis will lead to a decrease of treg proportion and an increase of th17 proportion in lymphocyte populations of maternal blood and placenta, with a back to values near than which is observed in beginning of pregnancy or in no pregnant women.

Eligibility criteria:
inclusion criteria: * informed consent signed * patient affiliated with a social security scheme * term pregnancy betwwen 24 and 34 weeks * pprom diagnosis * singleton pregnancy exclusion criteria: * delivery occured in 1 hour after admission * hemorragic praevia placenta or retro-placental hematoma * confirmed autoimmune or inflammatory disease * confirmed infectious disease by vih, vhc, and vhb

Keywords: pregnancy, chorioamnionitis, pprom, treg
cystic fibrosis and endothelial function: at rest and during exercise

Conditions: Cystic Fibrosis

Summary: perhaps one of the most disturbing aspects of cystic fibrosis (cf) is the associated premature death. oxidative stress has been observed in patients with cf and exercise intolerance has been shown to predict mortality in patients with cf, regardless of how healthy their lungs are. a critical barrier to improving the quality of life and longevity in patients with cf is our lack of knowledge regarding the different reasons why patients with cf cannot exercise to the level of their peers. we have collected preliminary data to support our central hypothesis that oxidative stress contributes to the impairment in blood vessel function at rest and during exercise which ultimately oxygen transport and delivery resulting in exercise intolerance. exercise is therapeutic medicine for patients with cf and this investigation represents a major breakthrough in the approach to begin understanding the physiological mechanisms which contribute to exercise intolerance in these patients.

the overall goals of this proposal are to provide mechanistic evidence that oxidative stress contributes to 1) endothelial dysfunction and 2) exercise intolerance in patients with cf. this study consists of two separate sub-studies, or protocols. protocol 1: aoc tested the effect of an antioxidant cocktail (aoc) on endothelial function at rest and during exercise in cf patients. protocol 2: bh4 tested the effect of tetrahydrobiopterin (bh4) on endothelial function at rest and during exercise in cf patients.

Eligibility criteria:
inclusion criteria: * diagnosis of cf and healthy controls * men and women (\> 18 yrs. old) * boys and girls (7 -17 yrs. old) * fev1 percent predicted \> 30% * resting oxygen saturation (room air) \>90% * patients with or without cfrd * traditional cf-treatment medications * ability to perform reliable/reproducible pfts * clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status) exclusion criteria: * children 6 yrs. old and younger * fev1 percent predicted \< 30% * resting oxygen saturation (room air) \< 90% * clinical diagnosis of heart disease * pulmonary artery hypertension * febrile illness within two weeks of visit * current smokers * currently pregnant or nursing * individuals on vaso-active medications (i.e. nitrates, beta blockers, ace inhibitors, etc.) * inability to swallow pills * patients with b. cepacia (only \~3% of our cf center patient population)

Keywords: cf, cystic fibrosis, exercise
transfer impedance in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study aims to determine whether respiratory system transfer impedance (ztr) may fill an important clinical function by providing a reproducible, valid, and sensitive measure of airway obstruction in people with cf.


Eligibility criteria:
inclusion criteria: * between the ages of 2 to 25 confirmed diagnosis of cystic fibrosis exclusion criteria:

Keywords: ztr transfer impedance cystic fibrosis pulmonary function test pft
effects of chronic right ventricular pacing in children with advanced atrioventricular block

Conditions: Congenital Complete Atrioventricular Heart Block; High Grade Atrioventricular Block; Postoperative Complete Heart Block

Summary: recent studies have shown that chronic stimulation of the right ventricle can cause deleterious effects to cardiac function and synchronicity. the occurrence and consequences of this phenomenon in children and young patients with cardiac pacemaker due to advanced atrioventricular block (avb) are still unknown. thus, our aims is to assess the chronic effects of cardiac pacing in children and young patients with advanced avb and its impact on clinical, functional and echocardiographic parameters.

this is a prospective cohort study that will include patients younger than 18 years-old at initial pacemaker implantation due to advanced avb. the design of the study will involve the following stages: 1. screening and enrollment: patients will be selected consecutively during ambulatory care at our institution or by the database of the surgical unity of cardiac pacing; 2. clinical and laboratory evaluation: patient history, clinical evaluation, serum levels of neurohormonal and inflammatory biomarkers of heart failure, clinical and laboratory investigation of autoimmune rheumatic diseases, quality of life (sf-36, chq-pf50) and six-minute walk test; 3. evaluation of ventricular function and cardiac synchronicity: tissue doppler (tdi) and real-time three-dimensional echocardiography (rt3de); 4. follow-up: patients will be monitored during 24 months. the main end-points are: * clinical and functional changes (nyha functional class) * heart failure hospitalization * quality of life * overall and cardiac mortality * cardiac resynchronization therapy and heart transplantation

Eligibility criteria:
inclusion criteria: * age \<18 years at initial pacemaker implantation * advanced av block with /without congenital heart defects * time under cardiac pacing superior than one year * unicameral or atrioventricular pacing in single right ventricle site * informed consent of the patient or responsible exclusion criteria: * bifocal or biventricular pacing * discontinuing use of the device for recovery of atrioventricular conduction * cardiac transplantation * inability to participate in the study procedures

Keywords: congenital complete atrioventricular heart block pacemaker cardiac pacing children heart failure ventricular dyssynchrony echocardiography quality of life six-minute walk test young adults
weight changes during and after pregnancy in women with gestational diabetes

Conditions: Gestational Diabetes Mellitus

Summary: gestational diabetes mellitus (gdm) is associated with short-term and long-term complications for infants and mothers. the management of gdm during pregnancy focuses on reducing risks to the infant associated with hyperglycemia. the postpartum management of gdm focuses on reducing maternal risk of developing type 2 diabetes (t2dm). a diagnosis of gdm identifies up to 31% of parous women who will eventually develop t2dm and approximately 50% of women diagnosed with gdm will develop t2dm in the first 5 years postpartum. the perceived risk of developing short-term and/or long-term complications of gdm may influence women's likelihood of engaging in diet modification, the mainstay of treatment of gdm, both during and after pregnancy. if sustained after delivery, diet modifications introduced as treatment for gdm could affect maternal weight changes during and after pregnancy, which could in turn affect t2dm risk. it is unknown if and how women with gdm differ in their perceived risk of developing t2dm, dietary choices, or weight gain (and retention) during versus after pregnancy. therefore, the project proposed in this application seeks to (1) characterize the perceived risk of developing t2dm among women with gdm during and after pregnancy, (2) characterize dietary choices of women with gdm during and after pregnancy, and (3) characterize weight changes of women with gdm during and after pregnancy as compared to women without gdm.


Eligibility criteria:
inclusion criteria for women with gdm: * patient is currently pregnant with a singleton pregnancy. * laboratory confirmed diagnosis of gdm between weeks 24-28 gestation. * patient is receiving routine prenatal care at vanderbilt university medical center. inclusion criteria for women without gdm: * patient is currently pregnant with a singleton pregnancy. * patient does not have gdm based on non-fasting and/or fasting gtt results. * patient is receiving routine prenatal care at vanderbilt university medical center. exclusion criteria for both cohorts: * diagnosis of type 1 or type 2 diabetes prior to pregnancy. * diagnosis of gdm prior to 20 weeks gestation. * patient does not speak english.
subthreshold stimulation versus suprathreshold stimulation in people with chronic low neck pain

Conditions: Pain; Trigger Point Pain, Myofascial

Summary: this trial will involve three groups. group 1 will receive subthreshold stimulation. group 2 will receive suprathreshold stimulation. group 3 will receive shame treatment.


Eligibility criteria:
inclusion criteria: * age from 40 to 65 years old participated in this study, 2 * having neck pain for more than 6 months with a grade five or greater on the visual analog scale * having one or more trigger points in the upper trapezius muscle, * a significant increase in neck muscle emg activity indicates the presence of tender points. exclusion criteria: * taking non-pharmacological therapies (e.g., acupuncture, physical therapy, osteopathy) * taking oral or intravenous pain therapy, intramuscular or subcutaneous injection of cortisone, or local anesthetics during the study period, * presence of any contraindication to electrical current including pregnancy, epilepsy, cardiac arrhythmia, cardiac surgery, implanted pacemaker or defibrillator, previous surgery in the spinal cord, infectious diseases of the spinal cord, malignant tumors with or without secondary blastomas in the spinal cord, severe radicular pain with acute paralysis in the extremities
smoking cessation for depression and anxiety treatment

Conditions: Smoking; Anxiety Disorders; Depression Disorders

Summary: the primary aim of this research study is to enhance smoking cessation outcome among smokers with elevated anxiety and depression. we are comparing two group treatment approaches: (1) an educational-supportive psychotherapy and standard smoking cessation treatment, and (2) an integrated smoking cessation, and anxiety and depression management treatment program (sdat). both treatments also utilize nicotine replacement therapy.


Eligibility criteria:
inclusion criteria: * ages 18-65 years old * capable of providing informed consent * willing to attend all study visits and comply with the protocol * daily smoker for at least one year * currently smoke an average of at least 6 cigarettes per day * report a motivation to quit smoking in the next 6 weeks of at least 5 on a 10-point scale * elevated anxiety or depression exclusion criteria: * use of other tobacco products * current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol * currently suicidal or high suicide risk * current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt * concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or depression * current or intended participation in a concurrent substance abuse treatment * current non-nicotine substance dependence * insufficient command of english to participate in assessment or treatment

Keywords: smoking cessation anxiety anxious depression depressed smoker stress
efficacy and safety evaluation of a regimen consisting of peginterferon lambda-1a + ribavirin + daclatasvir (lambda + rbv + dcv) in hcv genotype 1b treatment naïve patients or prior relapsers to peginterferon alfa + ribavirin (alfa + rbv) therapy

Conditions: Hepatitis C

Summary: the purpose of this study is to determine if treatment with pegylated interferon lambda-1a, given in combination with ribavirin and daclatasvir for 24 weeks, is as safe and effective as the standard treatment with pegylated interferon alfa-2a + ribavirin + telaprevir in subjects who are infected with chronic hepatitis c virus genotype 1b and have never received any prior anti-hcv treatment, or who have relapsed after an initial, successful treatment with pegylated interferon alfa + ribavirin


Eligibility criteria:
inclusion criteria: * patients chronically infected with hcv genotype-1b * naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines) * hcv rna viral load ≥100,000 iu/ml at screening * patients with compensated cirrhosis are permitted exclusion criteria: * infection with hepatitis c virus (hcv) other than genotype-1b * positive hepatitis b surface antigen (hbsag) or human immunodeficiency virus (hiv)-1/hiv-2 antibody test at screening * evidence of chronic liver disease caused by diseases other than chronic hcv infection * current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening * current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening * current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria * laboratory values: 1. hemoglobin \<12.0 g/dl (males) or \<11.0 g/dl (females) 2. platelets \<90,000/mm3 3. total serum bilirubin ≥2 mg/dl (unless due to gilbert's disease)
digital gait analysis in the home environment of patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of this study is the development of novel telemedical examination methods based on sensor-based gait analysis in patients with multiple sclerosis (ms). in a first step, the basic technical feasibility of measuring gait parameters in ms patients under standardized conditions in the clinic and in the home environment of the study participants will be investigated. in a subsequent two-week study phase, gait parameters (real-life monitoring) and standardized gait tests will be continuously recorded in the home environment of the study participants. the comparability of the collected gait parameters from standardized gait tests and real-life monitoring to clinical scales (e.g. edss) will investigate the medical applicability of gait analysis as a target parameter in ms patients. new algorithms for detecting indication-specific gait patterns from gait analysis in patients' daily lives and their possible changes over time (progression) will be explored and implemented into the study system. in addition, a patient app annotates the standardized gait tests and collects questionnaire-based data from the study participants during real-life monitoring. via a study tablet, the data of the gait analysis and the patient app are transmitted to a study platform (digital patient manager). the clinical assessment data (neurological examination, questionnaires) can be entered via a web front-end of the study platform and assigned to the patient via a pseudonym. a further aim of this study is to validate the technology used for its applicability in the home environment. by means of structured interviews after the study phase, the study participants will be asked about compliance and adherence. the following scientific questions will be investigated in this project: (a) is gait analysis a feasible and meaningful target parameter for ms centers? b) are gait parameters from real-life monitoring suitable biomarkers for the detection of ms symptoms? c) can gait parameters from standardized gait tests be compared with different testing environments (clinic / home environment)? d) how do gait parameters from standardized gait tests differ from gait data from real-life monitoring? e) how is the telemedical application for the collection of gait parameters evaluated by the patients? f) can disease progression be detected using sensor-based gait parameters from the home environment?


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis according to mcdonald criteria * expanded disability status scale (edss) 1-6 * age \> 18 years * ability to speak and read * ability to use an application running on a smart device * patient informed consent exclusion criteria: * severe difficulty walking with frequent falls * inability to walk at least 10 meters * permanent use of a wheelchair * severe spasticity * cognitive impairment with inability to give consent to protocol

Keywords: gait analysis home-monitoring