Kornimate/medical-research-clean huggingface dataset:
cognitive behavioral therapy for copd

Conditions: COPD; Depression

Summary: the purpose of this study in patients with advanced copd and depression is twofold: 1. determine the feasibility and acceptability of a 6-session e-counseling intervention 2. determine the efficacy of the e-counseling intervention on depressive symptoms we hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.

chronic obstructive pulmonary disease (copd) is the third leading cause of the death in the us. although copd is mostly preventable, there is no cure. thus, care of patients with copd is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. these goals are highly consistent with core principles of palliative care. dyspnea is the most distressing symptom for patients. even optimal disease-directed treatment provides only partial relief from dyspnea. depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. psychosocial-behavioral therapy (pbt) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced copd. testing the use of novel technologies to provide efficacious interventions such as pbt to patients with advanced disease is critical for translational palliative care research

Eligibility criteria:
inclusion criteria: * copd (fev1/fvc \ 10pack-years) * depressed (phq-9 \>=10) * ability to speak, read and write english * willingness to use computer or study-issued tablet device exclusion criteria: * current non-nicotine substance abuse or dependence * psychotic disorder * active suicide ideation with intent and plan * alzheimer's/dementia * currently receiving any psychotherapy
biomarkers to differentiate bacterial from viral infections

Conditions: Infection, Bacterial; Infection Viral

Summary: antoine is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (sbi) in children aged from 7 days to 36 months. fever is a frequent cause of consultation in pediatric emergency departments. clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. the prevalence of severe bacterial infections (ibs) varies from 10 to 25% according to the studies. biological markers such as procalcitonin (pct) and c-reactive protein (crp) are commonly used in clinical practice. these markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of ibs. the use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. the diagnostic value of these new markers has been demonstrated by associating their dosage with that of crp for example. this is the case for ip-10, trail or mxa. however, very few pediatric studies have been carried out to date on these new biomarkers. however, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of ibs. 7 biomarkers were selected to be evaluated in this study. this study is designed to determine the best biomarkers combination for the sbi diagnosis on a cohort of 800 patients.


Eligibility criteria:
inclusion criteria: * febrile children: * between 7 days and 3 months old : fever \>38°c for more than 6 hours (late neonatal fever suspected) for which the physician prescribed venipuncture * between 3 months and 36 months old : fever ≥38,5°c for more than 6 hours and less than 7 days for which the physician prescribed venipuncture for suspected severe bacterial infection * patient with national health cover * consent form signed by at least one parent exclusion criteria: * children treated by antibiotherapy within the past 48h * children with congenital or acquired immunodeficiency syndrome or long-term immunosuppression treatment * vaccinated children within 48h by an inactivated vaccine or within 10 days for the mmr vaccines * children with a chronic disease * undergoing surgery within 7 days before inclusion

Keywords: severe bacterial infection acute infection infection viral biomarker combination diagnostic child
cone-beam computed tomographic (cbct) and regenerative endodontic treatment.

Conditions: Dental Trauma

Summary: dental trauma injuries during childhood may have an adverse impact on oral health throughout life. if trauma injuries causes pulpal necrosis, then the root stop forming. these teeth have consequently a questionable long-term survival. dental management of necrotic teeth with aberrant root formation represents a challenging clinical situation. the classical approach for treating these teeth includes apexification. both apexification with calcium hydroxide and mta do not achieve the goals of continued root development or restoration of pulp tissue functionality. in the last decades, a biological based approach referred as "revascularization", or "regeneration" has emerged as a biological treatment for necrotic pulps with aberrant root development. this treatment aims to regenerate pulp-like tissue within the root canal space after inducing an influx of stem cells from the apical papilla that results in reestablishment of pulp protective functions. there is evidence supporting the regeneration potential of dental tissues after regenerative endodontic treatment. however, root formation in traumatized immature teeth seems variable. the overall goal of this study is to gain knowledge about the treatment of immature necrotic teeth in young individuals due to dental trauma. the primary goal is to compare volumetric hard tissue formation between the mta apexification and the regeneration treatment.

a randomized controlled trial, employing 34 young individuals aged 6-18 years, with immature necrotic teeth will be included. the test group will be treated by the regeneration procedure and the control group by the application of an mta-plug. clinical and low-dose cone-beam computed tomography scans (preoperatively and at 18-months follow-up) will be retrieved. clinical data with information about tooth survival, absents of symptoms, resolution of infection and root development will be taken at every session.

Eligibility criteria:
inclusion criteria: * immature teeth and confirmed pulp necrosis caused by dental trauma. * teeth with apical opening larger that 1mm observed in the initial cbct. exclusion criteria: * extensive loss of coronal tissue that require restoration with a post that will occupy the space required for blood clot formation. * patients who had received antibiotic treatment during the previous 3 months.
efficacy and safety of ns2359 in adults with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of the study is to investigate if ns2359 is effective in the treatment of adhd in adult patients.


Eligibility criteria:
inclusion criteria: * patients with the diagnosis of attention deficit hyperactivity disorder (adhd), by dsm-iv, as manifested in clinical evaluation and confirmed by structured interview using the k-sads-e adult adhd module * patients with a cgi global severity (gs) score ≥4 (moderate impairment) * the patient provided written informed consent. * non-lactating women of childbearing potential that used adequate contraception (i.e. the use of oral contraceptives and practising a double-barrier form of birth control) and had a negative pregnancy test at screening. women of no childbearing potential who had been postmenopausal for less than 2 years must have a negative pregnancy test at screening. exclusion criteria: * any clinically unstable medical condition * clinically significant abnormal baseline laboratory values * mental retardation * organic brain disorders * non-febrile seizure disorder * patients with a history of an eating disorder including anorexia or bulimia nervosa * psychotic disorder of any type * patients with a ham-d (17 item) \>15 * patients currently (within the past 6 months) known to abuse or to be dependent on any drug, including alcohol or a positive urine drug screen for cocaine, heroin, or marijuana * treatment with stimulants was prohibited within 1 week prior to randomisation * treatment with antipsychotics/neuroleptics was prohibited for 8 weeks prior to randomisation * treatment with monoamine oxidase inhibitors was prohibited for 8 weeks prior to randomisation * treatment with tricyclic antidepressants, histamines and selective serotonin reuptake inhibitors was prohibited for 4 weeks (fluoxetine for 6 weeks) prior to randomisation * treatment with benzodiazepines, anticonvulsants (for behaviour) and lithium for 2 weeks prior to randomisation * patients with a history of bipolar disorder * patients using any concurrent medication for the treatment of adhd * patients that had previously participated in a ns2359 study * patients treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication * patients with a history of positive human immunodeficiency virus (hiv) test.

Keywords: adhd
the efficacy and safety of d745 added to d150 plus d759 therapy in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to prove that the group treated with d745 in combination added that the reduction of hba1c superior to placebo treated group added in combination.

the aim of this phase 3 study is to evaluate the efficacy and safety of additional combined d745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of d150 and d759

Eligibility criteria:
inclusion criteria: * between 19 years and 85 years old(male or female) * type 2 diabetes mellitus * bmi between 18.5kg/m2 and 40kg/m2 * agreement with written informed consent exclusion criteria: * type 1 diabetes mellitus or secondary diabetes mellitus * patients with complications of severe diabetes such as proliferative diabetic retinopathy * patients with genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * patients with abnormal laboratory test results according to the protocol * continuous or non continuous treatment insulin within 12 weeks prior to screening * chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening
protocol: phytomedicine-amargol®, clinical trial for efficacy proof on therapeutics

Conditions: Digestive System Disorders

Summary: this is a phase 3: efficacy study for amargol® a phytomedicine used for asymptomatic digestive complaints.

this study will be performed for proving the efficacy of amargol®, a phytomedicine product, under the brazilian law for registration and revalidation rdc 14/2010. amargol® indications are for non specific digestive complaints as laxative and anti-dyspeptic. is a mixture of 7 plant extracts: aloe ferox, angelica archangelica, alpinia officinarum, cinnamomum zeylanicum, gentiana lutea, commiphora myrrh and rheum palmatum. placebo controlled test

Eligibility criteria:
inclusion criteria: * 18-45 years old * 65-85 kg * healthy volunteers exclusion criteria: * chronic dyspeptics illness chronic congestive cardiac problems * pulmonary problems * diabetes, thyroid problems * pregnancy * bowel syndrome * hemorrhoids * colitis * allergies for any formula components.

Keywords: dyspepsia flatulence aerophagia constipation
european trial in atrial fibrillation(af) or flutter (afl) patients receiving dronedarone for the maintenance of sinus rhythm (euridis)

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: to assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (af/afl). to assess the efficacy of dronedarone versus placebo on af/afl-related symptoms. to assess the efficacy of dronedarone versus placebo on ventricular rate control in case of af/afl recurrence.

this is a double-blind, parallel arm, placebo-controlled, multicentre, multinational, phase iii study. to be eligible, patients must be in normal sinus rhythm at randomisation and must have an ecg-documented history of recent af/afl reverted to normal sinus rhythm by electrical, pharmacological or spontaneous conversion

Eligibility criteria:
inclusion criteria: * patients of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomization and with at least one ecg-documented af/afl episode in the last 3 months. exclusion criteria: * main criteria (non-exhaustive list, see protocol for details): women of childbearing potential without adequate birth control, pregnant women, breastfeeding women, congestive heart failure nyha class iii or iv, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.

Keywords: atrial fibrillation atrial flutter arrhythmia anti-arrhythmia agents
multidisciplinary approach to breast cancer through the study of altered transcriptomic and immune accompanied by the identification of extractable markers from the radiodiagnostic bioimaging

Conditions: Breast Cancer Patients

Summary: prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer


Eligibility criteria:
inclusion criteria: * clinical diagnosis of breast cancer. * patients 25 to 80 years of age exclusion criteria: * patients who refuse to participate in the study; * patients who do not fall within the age range mentioned above
intravitreal aflibercept injection for symptomatic macular edema from retinal artery macroaneurysms

Conditions: Macular Edema; Retinal Artery Macroaneurysm

Summary: phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.

baseline evaluation will consist of measurement of best-corrected etdrs visual acuity, complete eye exam, including iop measurement, color photos and intravenous fluorescein angiography, spectral domain oct and vitals. patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. follow up visits will be on day 7, 30, 60, 90, 120, 150 and 180. at each follow-up visit, best-corrected etdrs visual acuity, iop measurement and central foveal thickness (cft) by sdoct will be obtained. color photos and ivfa will be performed at month 3 and 6 visits. retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. cft \>310 microns 2. intraretinal or subretinal fluid on sdoct 3. increase in cft by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. decrease in vision by 5 or more letters frpm the previous visit associated with oct evidence of macular edema. 5. appearance of new hemorrhage on color photographs. final follow-up will be at six months. data collected will include, change in etdrs visual acuity from the baseline, change in cft, number of injections, number of eyes completely dry by sdoct, and number of eyes with a thrombosed ram by ivfa.

Eligibility criteria:
inclusion criteria: 1. symptomatic macular edema caused by ram in one of the eyes. if both eyes are involved, the eye with worse central foveal thickness will be enrolled in the study. 2. cft of 310 microns or more by spectral domain oct or lipid in the center of the fovea 3. best-corrected visual acuity of 73 to 24 letters. 4. willing and able to comply with clinic visits and study-related procedures. 5. willing to provide informed consent - exclusion criteria: 1. media opacity 2. pre-retinal fibrosis, retinal detachment, vitreo-macular traction 3. infectious keratitis, conjunctivitis, blepharitis or scleritis 4. any ocular surgery during the preceding 3 months. 5. aphakia or uncontrolled glaucoma 6. subfoveal hemorrhage 7. history of systemic or intravitreal anti-vegf injections, intravitreal steroid injection or implant, or laser treatment to ram within six months 8. any other ocular disease responsible for decrease in vision. 9. concomitant ocular disease that can cause increase in foveal thickness 10. ocular inflammation from any cause 11. recent (\<3 months) history of a thromboembolic event 12. pregnant or breast feeding women. 13. sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.

Keywords: 362.17
exair® versus native tissue repair for prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to compare safety and effectiveness of the exair prolapse repair system for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.


Eligibility criteria:
inclusion criteria: * female at least 18 years of age * subject has pelvic organ prolapse with leading edge at or beyond the hymen. at or beyond the hymen is defined as pop-q scores of ba ≥0 and bp ≥0 and c≥ -1/2 tvl * subject reports a bothersome bulge they can see or feel per pfdi-20 question 3, response of 2 or higher (i.e. responses of "somewhat", "moderately" or "quite a bit") * subject is willing to provide written informed consent * subject is willing and able to comply with the follow-up regimen exclusion criteria: * subject is pregnant or intends to become pregnant during the study * subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (uti), or tissue necrosis * subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical) * subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area * subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months) * subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (sle), marfan syndrome, ehlers danlos, collagenosis, polymyositis or polymyalgia rheumatica) * subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * subject has uncontrolled diabetes mellitus (dm) * subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit) * subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis) * subject is not able to conform to the modified dorsal lithotomy position * subject is currently participating in or plans to participate in another device or drug study during this study * subject has a known sensitivity to polypropylene * subject has had previous prolapse repair with mesh in the target compartment(s)

Keywords: pelvic floor disorder pelvic organ prolapse sexual dysfunction mesh pop transvaginal total repair uterine prolapse cystocele rectocele enterocele vaginal vault prolapse native tissue repair repair augmented with mesh pathological conditions, anatomical exair prolapse repair system vaginal mesh transvaginal mesh
a neoadjuvant study of nivolumab plus ipilimumab or nivolumab plus chemotherapy versus chemotherapy alone in early stage non-small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable nsclc. this study has multiple primary endpoints.


Eligibility criteria:
inclusion criteria: * early stage ib-iiia, operable non-small cell lung cancer, confirmed in tissue * lung function capacity capable of tolerating the proposed lung surgery * eastern cooperative oncology group (ecog) performance status of 0-1 * available tissue of primary lung tumor exclusion criteria: * presence of locally advanced, inoperable or metastatic disease * participants with active, known or suspected autoimmune disease * prior treatment with any drug that targets t cell co-stimulations pathways (such as checkpoint inhibitors) other protocol defined inclusion/exclusion criteria apply
microbiological profile of vap patients in respiratory icu

Conditions: VAP - Ventilator Associated Pneumonia

Summary: identification of the microbial profile of ventilator associated pneumonia causing microorganisms among respiratory icu patients .

ventilator-associated pneumonia (vap) is one of the common serious infectious diseases encountered in the intensive care unit (icu), which highly affects the healthcare cost and patient prognosis. all-cause of mortality associated with vap has been reported to range from 20% to 50%. the etiology of vap and their antimicrobial susceptibility pattern varies with different patient populations and types of icus. vap may be caused by a wide spectrum of bacterial pathogens, which may be polymicrobial and are rarely due to viral or fungal pathogens in immune-competent hosts. common etiologic agents are gram-negative bacilli such as pseudomonas aeruginosa, escherichia coli, klebsiella pneumoniae, and acinetobacter spp. and staphylococcus aureus among gram-positive cocci. due to the increased incidence of mdr organisms in intensive care units (icus), early and correct diagnosis of vap is mandatory for optimal antibiotic therapy. the frequency of specific mdr pathogens causing vap varies in hospitals, patient populations. also varies according underlying disease. this study will be conducted in respiratory intensive care unit, chest disease and tuberculosis department at assiut university hospitals.

Eligibility criteria:
inclusion criteria: 1. mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation. 2. age \> 18 years. exclusion criteria: 1. patients with clinical and radiological signs suggestive of pneumonia before intubation (community acquired pneumonia or hospital acquired pneumonia) 2. patients age ≤18 years old