Kornimate/medical-research-clean huggingface dataset:
does timing of vt ablation affect prognosis in patients with an implantable cardioverter-defibrillator?

Conditions: Ventricular Tachycardias

Summary: the purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (vts), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (icd) shock therapies and to evaluate if the timing of radiofrequency vt ablation affects the prognosis of icd recipients.

enrolled patients will remain in a first phase of the study until the first appropriate icd shock will be delivered. the objective of this first stage is to assess whether the burden of untreated non sustained vts or episodes treated with anti-tachycardia pacing is predictive of appropriate icd shocks. the second phase of the study will start after the first appropriate icd shock delivered for vt. patients will be then randomized to immediate vt ablation or to standard treatment, meaning waiting until next arrhythmic storm to perform a vt ablation procedure. the objective of this phase is compare the rate of worsening heart failure hospitalizations and deaths from any cause between the two groups.

Eligibility criteria:
inclusion criteria: * patients already implanted with icd (single-/dual -chamber, with or without cardiac resynchronization therapy) for primary or secondary prevention of sudden cardiac death exclusion criteria: phase a exclusion criteria: * general contraindication to transcatheter ablation * contraindication to antithrombotic therapy * patients chronically treated with class i and iii antiarrhythmic drugs phase b exclusion criteria: * patients developing first occurrence of incessant vts * patients receiving a shock for first occurrence of clinically verified ventricular fibrillation * patients with aetiology differing from ischemic heart disease for coronary artery disease and from non-ischemic dilatative cardiomyopathy

Keywords: icd shocks ventricular tachycardias ablation timing of ablation electrical storm arrhythmic storm
athlete's heart or arrhythmogenic right ventricular cardiomyopathy: contribution of exercise cardiovascular magnetic resonance (cmr)

Conditions: Arrhythmogenic Right Ventricular Cardiomyopathy

Summary: prospective, nonrandomized, single-center, comparative study to define if right ventricular (rv) contractile reserve assessed by exercise cmr helps to improve the differential diagnosis between pathological and physiological remodeling of the rv; ie. arrhythmogenic right ventricular cardiomyopathy (arvc) and athlete's heart.

comparison of the rv contractile reserve in 4 groups of patients: arrhythmogenic right ventricular cardiomyopathy (arvc) patients; endurance athletes with a dilated rv, endurance athletes with normal rv, untrained subject with normal rv. patients will come to the hospital for 3 visits (3 half days): * visit 1: clinical evaluation, rest ecg, rest echocardiography, cardio-pulmonary exercise test. * visit 2: exercise echocardiography, holter ecg monitor (48 yours) * visit 3: rest cmr and exercise cmr (ergocycle)

Eligibility criteria:
inclusion criteria: * men or women aged 18 years and older, * patients with confirmed arvc, but with no major rv dysfunction (rvef \>40%) * endurance athletes with dilated rv * endurance athletes with non-dilated rv * untrained healthy subjects with non-dilated rv * who signed a written free and informed consent: exclusion criteria: * patients with other cardiovascular disease; * contra-indication to cmr (in particular presence of a non-cmr compatible implantable cardiac defibrillator); * patients with permanent supraventricular arrhythmia; * patients unable to perform an exercise test on an ergocycle; * person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Keywords: arvc, athlete's heart, exercise, cmr, rv contractile reserve
clinical performance of bulk-fill composite using with adhesives with or without chlorhexidine

Conditions: Class II Dental Caries

Summary: this study aims to evaluate the clinical success of chlorhexidine-containing dentin bonding agent in primary molars with a 12-month follow-up. the research question is: is there a difference between the clinical evaluation results of deciduous teeth restored with dentin bonding agents containing and not containing chlorhexidine? a total of 40 patients aged 5-9 years with at least two dentin caries in primary molars were included in the study. the study involved a split-mouth design in which the standard bond and chlorhexidine-containing bond as the adhesive agents. bulk fill composite was used as the restorative material for the restoration of primary molars with class ii cavity. the evaluation of clinical success was performed by a calibrated observer according to the fdi criteria at months 3, 6, 9, and 12 after restoration.

this study aims to evaluate the clinical success of chlorhexidine-containing dentin bonding agent in primary molars with a 12-month follow-up. a total of 40 patients aged 5-9 years with at least two dentin caries (d1 level) in primary molars were included in the study. the study involved a split-mouth design in which ultradent pq1 bond and ultradent peak universal bond were used as the bonding agents and tetric n ceram bulk fill composite was used as the restorative material for the restoration of primary molars with class ii cavity. the evaluation of clinical success was performed by a calibrated observer according to the fdi criteria at months 3, 6, 9, and 12 after restoration.

Eligibility criteria:
inclusion criteria: (1) age between 5-9 years; (2) no systemic health problems (3) presence of at least one interproximal carious lesion not exceeding half of the dentin structure (d1 level) in the right and left sides of the mouth; (4) cooperation without issues (scoring 3 or 4 on the frankl scale); and (5) patient and parent's willingness to attend follow-up appointments throughout the study. exclusion criteria: * (1) the presence of pulp vitality with no clinical and/or radiological signs requiring endodontic treatment, (2) no previous treatment on the selected teeth, (3) radiographically, the caries should not extend to one-third of the pulp, indicating only the need for a class ii restoration, (4) the presence of adjacent teeth mesial and distal to the selected tooth and an opposing tooth in the oral cavity, (5) the absence of physiological or pathological root resorption.

Keywords: dentin bonding agents chlorhexidine antibacterial bonding bulk-fill composite
analysis of chronic neuropathic pain markers in patients treated with oxaliplatin

Conditions: Digestive Cancer; Gynecological Cancer

Summary: the role of oxidative stress in the development of oxaliplatin-induced peripheral neuropathy has been previously described in mice and in neuronal cell cultures (massicot 2013); clinical manifestations and pathophysiological mechanisms potentially involved have also been described in humans (andreas 2007) (attal 2009). the investigators team plans to conduct a translational clinicobiological research to explain the nature of the biochemical and molecular mechanisms of the development of oxaliplatin-induced painful neuropathy. to perform this project, the investigators propose to realize a pilot study in patients newly treated with oxaliplatin. this will be conducted in the oncology department of paris saint joseph hospital from may 2014 until the inclusion of 20 patients. the main objective of this pilot study is to evaluate the occurrence of acute and chronic neuropathic pain occurring in patients newly treated with oxaliplatin. the characterization of this pain is based on validated tests (cruccu 2010). moreover, the biochemical changes related to oxidative stress and those related to cellular lipid composition are characterized in these patients.


Eligibility criteria:
inclusion criteria: * patient newly traeted with oxaliplatin * patient suffering from any type of cancer treated with oxaliplatin * man or woman over 18 exclusion criteria: * patient with brain or leptomeningeal metastases * patient previously treated with cisplatin * patient addicted to alcohol * diabetic patient with peripheral neurological disorders * patient receiving calcium or magnesium salts intravenously * patient suffering from peripheral neuropathy * patient suffering from psychiatric disorders * patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.
effectiveness of online therapy to prevent burnout

Conditions: Burnout; Risk Reduction; Cognitive Change

Summary: this study aims to address the reliability and validity of the empowerment for participation (efp) batch of assessments to measure burnout risk in relation to the efficacy of online interventions to provide proactive rehabilitation using cognitive behavioral therapy (cbt) and floating to achieve improved mental health and wellbeing.

an empirical design using raw efp psychometric data to measure the effectiveness of online therapy to reduce the risk for burnout between a control group and an online therapy group. the aim is to test whether or not there is a statistically significant difference in the effectiveness on online therapy to reduce the risk for burnout compared to that of a control group. fifty participants were randomly selected. the rehabilitation and control group consisted of twenty-five normally distributed employees (n25) each. the rehabilitation group received therapy, and the control had not yet received any form of therapy. spss was used to analyze the data collected, a repeated measure anova, an ancova, a discriminant analysis, and a construct validity analysis were used to test for reliability and validity. the group was randomly selected from a list of employees within the my-e-health ecosystem. the group (n50) normally distributed group met all assumptions and consisted of a control group (n25) and a therapy group (n25). the post assessment value was used as the dependent variable. the burnout measure (30 questions) is obtained from the empowerment for participation (efp) batch of assessments (110 questions). all assessments and cbt were done digitally online and floating was done at a designated location. the full efp assessment is integrated into a digital ecosystem designed for this purpose and therapy. the online digital system is an integrity-based platform offering both the employee and caregiver a secure and encrypted ecosystem or secure data tunnel or channel between the therapists and patients.

Eligibility criteria:
inclusion criteria employees assessed on the efp burnout scale as having: * a moderate risk of burnout * a high risk of burnout * a burned out risk (mental health exhaustion) * employees with a current bunrout diagnosis from a hospital, outpatient or psychiatric cllinic * a fully employed person with a member organization * no other inclusion criteria. exclusion criteria: employees assessed on the efp burnout scale as having: * no evidence of burnout * low risk of burnout. * unemployed persons * no other exclusion critera was used.

Keywords: prevention mental health cognitive behavioral therapy interactive online therapy telehealth
histiocytic disorder follow-up study

Conditions: Histiocytosis; Langerhans Cell Histiocytosis; Erdheim-Chester Disease; Rosai Dorfman Disease; Xanthogranuloma; Malignant Histiocytoses

Summary: the purpose of the study is to describe the burden of chronic health conditions, psychological dysfunction, chronic pain, healthcare utilization, worse health-related quality of life, overall mortality, and cause-specific mortality among individuals with histiocytic disorders

background over the last decade, major advances have occurred in histiocytic disorders with the discovery of mapk-erk pathway mutations leading to targeted therapeutics using braf- and mek-inhibitors. however, there is a lack of large studies informing the burden of morbidity and mortality among people with histiocytosis. institutional studies in pediatric lch suggest that survivors suffer from long-term impairment of health related quality of life, cognitive dysfunction, pituitary dysfunction, and hearing difficulties in 20-50% cases. studies from the investigative team and others have also shown a high incidence of acute myeloid leukemia and other second primary malignancies in pediatric and adult lch. chronic medical conditions may arise as a function of the disease biology or due to cancer therapy, as seen in other hematologic malignancies. design retrospective cohort study aimed at determining the risk of chronic health conditions and cause-specific mortality in pediatric and adult patients with histiocytic disorders. the study will include patients from the histiocytosis association registry and other institutions including uab (n\~6000). the participants will complete a validated questionnaire capturing details of chronic health conditions, health related quality of life, cognitive/psychological function, and healthcare utilization. future directions the results from our study will be instrumental in formulating follow-up guidelines for histiocytic disorders and developing targeted survivorship programs to improve overall outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of histiocytic disorder at any age 1. langerhans cell histiocytosis, 2. erdheim-chester disease, 3. rosai-dorfman disease, 4. xanthogranuloma, 5. mixed histiocytosis 6. malignant histiocytosis (histiocytic sarcoma, langerhans cell sarcoma, interdigitating cell sarcoma) 7. hemophagocytic lymphohistiocytosis exclusion criteria: * none

Keywords: survivorship long-term targeted therapy second cancer
clinical evaluation of the snap wound care system in promoting healing in chronic wounds

Conditions: Lower Extremity Diabetic Leg Wounds; Lower Extremity Venous Leg Wounds; Lower Extremity Mixed Aetiology Leg Wounds

Summary: the purpose of this study is to evaluate a novel topical negative pressure (tnp) wound therapy device called the snap® (smart negative pressure) wound care system for the treatment of lower extremity diabetic, venous and mixed aetiology leg wounds.


Eligibility criteria:
inclusion criteria: * patient has diabetic foot ulceration, venous ulcer, or mixed aetiology ulcer with a surface area \<100 cm2 and \<10 cm in widest diameter on lower extremity, but larger than 1 cm2 (venous and mixed aetiology ulcers will be defined by clinical exam of treating physician. diabetic foot ulcers will be defined by clinical exam of the treating physician and as lower extremity ulcers in patients with a diagnosis of diabetes, but without venous stasis disease). * wound present for \>30 days. * patient has wound in location amenable to creation of airtight seal around wound using tnp dressings. * patient is able to comply with study protocol requirements. * patient is able to understand and provide written consent. exclusion criteria: * patient has evidence of wound infection in the opinion of the physician. * patient has a thick eschar that persists after wound debridement. * patient has an hba1c \>12%. * patient has ulcers due to inflammatory conditions such as pyoderma gangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinaemia, necrobiosis lipoidica, panniculitis, lupus erythematosus, scleroderma, or calcinosis. * patient has untreated osteomyelitis. * patient has any other condition that, in the opinion of the investigator, makes the patient inappropriate to take part in this study. * patient is allergic to the wound care device or occlusive dressing. * patient has exposed blood vessels. * patient is pregnant or pregnancy is suspected. * patient is actively participating in other clinical trials that may interfere with their participation in this study.
binocular peripheral myopic defocus using a clinical prototype device

Conditions: Myopia

Summary: kubota vision inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. in this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).


Eligibility criteria:
inclusion criteria: * spherical equivalent -0.50 to -5.50 diopters * visual acuity of at least 20/25 in each eye exclusion criteria: * history of ocular trauma or major eye surgery * active ocular infection * any prior history or participation in myopia control treatments within the past 3 months
create-1: a study to assess the efficacy and safety of axs-02 in patients with crps-1

Conditions: Complex Regional Pain Syndrome; Reflex Sympathetic Dystrophy

Summary: this is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of axs-02 in patients with crps-i.


Eligibility criteria:
key inclusion criteria: * male or female of at least 18 years of age * recently confirmed diagnosis of crps-1 (budapest criteria) * average pain intensity score of ≥ 5 (based on an 11-point scale \[0 - 10\]) * willing and able to provide written informed consent key exclusion criteria: * received chronic opioid therapy within 4 weeks * received a sympathetic nerve block within 3 weeks * active litigation or a pending workers' compensation decision * any other clinically significant medical or pain condition (eg, parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study

Keywords: bisphosphonate crps rsd non-opioid crps-1 acute on chronic pain chronic pain zoledronic acid
"effect of sonic activation assisted irrigation and apical enlargement on postoperative endodontic pain"

Conditions: Postoperative Pain; Endodontically Treated Teeth

Summary: the purpose of this randomized clinical trial is to evaluate the incidence of postoperative pain after retreatment after apical enlargement and sonic activation assisted irrigation. the presence of postoperative pain will assess after retreatment cases at 12, 24, 48, 72 hrs and 1 week.

the aim of this clinical study is to evaluate the intensity and duration of postoperative pain after apical enlargement and sonic activation assisted irrigation procedures. patients who have asymptomatic teeth required retreatment will include in this study and retreatment procedure will be applied to these teeth. one hundreds twenty asymptomatic teeth required retreatment will randomly participate into 4 treatment groups in terms of apical enlargement and sonic activation assisted irrigation procedure applied. the presence of postoperative pain will assess after 12, 24, 48, 72 hrs and 1 week. postoperative pain will be recorded by each patient by using visual analogue pain scale. before the treatments, the nature of the study, complications and associated risks will be totally explained and written informed consent will be obtained from all study participants. the local anesthetic will be applied before the treatment start. the routine retreatment procedure will be applied. different final irrigation solutions will be applied in accordance to the manufacturers' instructions. at the end of treatment, each patient will be given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. after one week the teeth will be examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Eligibility criteria:
inclusion criteria: -patients who were healthy volunteers and who have failed teeth required retreatment with periapical index score 3-5 score requiring root canal treatment for first time. patients who were not included the study who; * were pregnant or breast feeding during the duration of the study, * have systemic disease, have any pain and/or any facial swelling, abscess, * were immunocompromised, * were under 18 yrs. and over 65 yrs. age, * were taking antibiotics or corticosteroids within previous three days, * have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral, * have root canals that could not be well-treated with orthograde retreatment. exclusion criteria: -the patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.

Keywords: endodontics postoperative pain visual analogue pain scale
evaluate the safety and effectiveness of the biotrue oneday for astigmatism

Conditions: Astigmatism

Summary: comparing test lens for astigmatism soft contact lens (test) to 1-day control for astigmatism contact lenses (control).

this is a multicenter, randomized 1:1, parallel-group, bilateral, investigator-masked study at 13 investigative sites in the united states (us) in a population including chinese subjects (maternal and paternal grandparents born in china)

Eligibility criteria:
inclusion criteria: * subject must be of legal age (at least 18 or as defined by state law) on the date the icf is signed and have the capacity to provide voluntary informed consent. * subject must be able to read, understand and provide written informed consent on the irb approved icf and provide authorization as appropriate for local privacy regulations. * subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas. * subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. exclusion criteria: * subject has worn gas permeable (gp) contact lenses within last 30 days or polymethylmethacrylate (pmma) lenses within last 3 months. * subject has systemic disease affecting ocular health. * subject is using any systemic or topical medications that will affect ocular physiology or lens performance. * subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications. * subject has any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear