Kornimate/medical-research-clean huggingface dataset:
rf lesion monitoring with 8mm intellatip mifi xp

Conditions: Atrial Flutter; Arrhythmia

Summary: abnormal heart rhythms or arrhythmias are often managed by a procedure in which a catheter is introduced into the heart. these catheters can then cauterize abnormally functioning portions of the heart muscle with the hope of returning the heart to a more effective rhythm. in the process of performing such a procedure, called a catheter ablation, an operator must be able to accurately sense electrical activity displayed on computer screens in different parts of the heart, provide sufficient localized energy to the abnormally behaving tissue (ideally without damaging uninvolved heart structures), and accurately reassess the electrical activity of the heart to ensure the spot in the heart has been cauterized. when sensing electrical activity of the heart, specialized catheters produce recordings on a computer screen known as electrograms (egm). to produce this recording conventional catheters commonly use a positive and negative electrode, from which the difference between the two provides the egm. the distance between the two electrodes varies from device to device. the greater the distance between them, the less accurate the measurement of local electrical activity becomes. this may result in poorly localized or excessive use of energy that could be damaging to normal heart structures or put the patient at risk for the return or development of additional arrhythmias. the intellatip mifi catheter has been constructed with a specialized sensing tip that uses "microelectrodes" that are relatively close in proximity (\<1 mm apart) with the hope of improving the sensing capability of the device. this study will analyze the signals obtained from this fda-approved catheter in people undergoing a catheter ablation procedure. the study will examine signals after the procedure is finished and will not prolong or differ the process from a standard ablation procedure. the goal of this study is to determine the ability of the microelectrodes to distinguish ablated, or cauterized versus non-cauterized tissue.

this trial is an operator-blinded, acute, single-visit observational trial in humans. enrollment will include 25 patients undergoing a radiofrequency ablation procedure in which ablation of the cavotricuspid isthmus is planned. electrogram characteristics of the small, imbedded pin electrodes will be compared to standard bipolar egms utilizing the ablation tip electrode and ring. absolute voltage, voltage reduction, and frequency spectra will be examined before, during, and after ablation. egm characteristics of standard and "ultra-local" recordings will be compared in their ability to accurately identify an effective rf lesion as defined below.

Eligibility criteria:
inclusion criteria: * any adult undergoing an atrial flutter ablation exclusion criteria: -
the wiser study: web based methods for enhancing resilience

Conditions: Burnout

Summary: this is a research study to find out if web-based resilience tools can increase well-being. enrolled participants will try out one or more brief positive psychology tools. the tools ask participants to reflect on positive experiences or to do an activity (e.g., write a letter of gratitude). the study is entirely online and participants will be prompted to participate via email or text messages. the study team is interested in the effects of the tools on stress, depression, and burnout in adults. a set of brief surveys are administered before and after using the tool, and again at follow-up periods (e.g., 1, 3, 6 and 12 months). surveys are collected electronically using the secure, hipaa-compliant survey software. there is no direct benefit to participants for participating in this research study aside from the potential to experience improvements in well-being. risks are minimal and include the potential to feel emotional or psychological distress when asked questions related to burnout.


Eligibility criteria:
inclusion criteria: * adults 18 and over are considered eligible for the study. a sub-sample will include employees (including but not limited to frontline caregivers, support staff and management) of the duke university health system, as well as external health systems. all participants will be invited to participate in one or more of the online tools. the investigators will allow the participation of any clinical areas/healthcare worker groups whose leaders express interest in building resilience. the investigators are targeting healthcare workers for recruitment in the study, but adults 18+ are eligible to participate in any of these tools. identification as a healthcare worker or not is part of data collection in every tool. exclusion criteria: * adults who are not proficient in english, do not have basic computer skills, or who have prohibitive vision or hearing disabilities will be excluded from this study as they will be incapable of full participation in the intervention and/or the survey process.

Keywords: burnout well-being behavioral health
health behaviors and time-of-day: older adult cognitive function

Conditions: Alteration of Cognitive Function; Ageing

Summary: this is a single-center, observational study design. enrolled participants will be typically, healthy older adults. participants will complete daily computerized measures, in addition to continuously wearing an actiwatch device. the study period will last 2 weeks. the objectives of the study are to examine the impact of sleep, pain, and circadian rhythm on practice-related learning in older adults at their preferred versus nonpreferred times of day.

participants will be asked to review the informed consent and consent to the study prior to any study procedure. there are four stages to this study: 1. a telephone interview, 2. an in-person interview and completion of questionnaires, 3. an in-home single night sleep recording, and 4. two weeks of computerized cognitive testing, subjective sleep and pain recordings, and wearing a actiwatch. during the telephone interview, participants will be asked question about their age, sleep, pain, and medical/mental health history. at a second visit, participants will complete a more in-depth interview of their physical health, mental health, sleep, and pain history. they will complete a brief test of their cognitive functioning. they will also complete 4 questionnaires about their time of day preference and mood. at the third visit, participants will visit the university of florida to be connected to a machine which will monitor their sleep. participants will return home to sleep while still connected to the machine and will return the machine to the university of florida the next day. participants will complete brief computerized daily questionnaires of sleep and pain and cognitive testing in the morning and evening, and and wear an actigraph (wristwatch-like device) that measures arm movements and ambient light for two weeks.

Eligibility criteria:
inclusion criteria: * age of 65 years and older * able to read and speak english * completion of morningness-eveningness questionnaire exclusion criteria: * significant medical or neurological disorder * major psychopathology * pain disorder other than fibromyalgia or osteoarthritis * sleep disorder other than insomnia * cognitive impairment * psychotropic or other medications known to alter sleep * unable to provide informed consent

Keywords: practice-related learning sleep pain circadian rhythm older adults
competency-based training in problem management plus: a randomized controlled trial

Conditions: Depression

Summary: the proposed study in nepal will evaluate if non-specialists participating in equip-based problem management plus training show greater competencies compared to non-specialists participating in standard problem management plus training. the proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.

there is increasing recognition of the high burden of psychological distress among populations around the world. increasingly, non-specialists (persons who do not have expertise in formal mental health training) are being used to deliver psychological services. there is a long history of successful implementation of psychological services by non-specialists in nepal. recently, a cluster randomized controlled trial of problem management plus showed modest benefit over enhanced care as usual in southeastern nepal. a recent initiative by the world health organization is being rolled out to improve the competencies of non-specialists participating in problem management plus and similar trainings. this initiative is ensuring quality in psychological services (equip). the proposed study in nepal will evaluate if non-specialists participating in equip-based problem management plus training show greater competencies compared to non-specialists participating in standard problem management plus training. the proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.

Eligibility criteria:
inclusion criteria: * no prior mental health professional training * literate in nepali exclusion criteria: * any prior mental health professional training

Keywords: training competency psychological treatment
a multicenter study on recombinant human thrombopoietin in management of itp in pregnancy

Conditions: Immune Thrombocytopenia; Pregnancy

Summary: the project was undertaking by qilu hospital of shandong university and other well-known hospitals in china. aims at evaluating efficacy and safety of rhtpo in management of itp in pregnancy.

the investigators are undertaking a multicenter, open-labeled, pilot study of 30 itp patients in pregnancy from qilu hospital of shandong university and other well-known hospitals in china. itp patients in pregnancy who failed to respond to prednisone, ivig and developed refractoriness to platelet transfusion will be given rhtpo intravenously at a dose of 300u/kg every day. dose will be tapered to 300u/kg every other day when platelet count rise over 50×10\^9/l. maintenance will be continued after delivery and the dose will be further reduced to 300u/kg per week. platelet count, bleeding and other symptoms will be evaluated before and after treatment. adverse events will be recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. subject is between 18-50 years old. 2. after 12 weeks gestation. 3. diagnosed with itp meeting the diagnostic criteria for immune thrombocytopenia. 4. patients who have no response or relapsed after corticosteroid or ivig. 5. patients developed refractoriness to platelet transfusion. 6. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 7. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received second-line itp-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. 4. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 6. patients who are deemed unsuitable for the study by the investigator.

Keywords: recombinant human thrombopoietin immune thrombocytopenia pregnancy
pilot study of pdl to treat bcc and sccis

Conditions: Basal Cell Carcinoma; Squamous Cell Carcinoma in Situ

Summary: this is a research study to find out more about the use of the pulsed dye laser in the treatment of basal cell carcinoma and early stage squamous cell carcinoma that has not invaded deep into the skin. the purpose of this study is to determine whether the use of the pulsed dye laser (pdl) can completely clear or regress basal cell carcinoma or early stage squamous cell carcinoma. pulsed dye laser is a type of laser that is commonly used to treat lesions on the skin that have a prominent blood vessel component. it has been used to treat broken blood vessels on the face, hemangiomas in children and adults, leg veins, port wine stains, and other lesions with a prominent vascular component.


Eligibility criteria:
inclusion criteria: * patients requiring surgical excision (conventional or mohs) for biopsy-proven basal cell carcinoma and biopsy-proven squamous cell carcinoma in situ that is clinically present at the pre-operative visit and measures greater than 0.4cm and less than 3cm in size. * lesions in the trunk, extremities, and scalp * presence of clinically identifiable residual tumor. * patients, males and females, aged 18-90 years. * willing to participate. * able to give informed consent. exclusion criteria: * age younger than 18 years * location of lesion not in the trunk, extremities, and scalp * fitzpatrick skin type v or vi. * prior history of known light sensitivity. * pregnancy * cognitive impairment * prisoner

Keywords: pulsed dye laser pdl basal cell carcinoma squamous cell carcinoma bcc scc 594nm laser
a 6-month randomised, double-blind, open arm comparator, phase iib, with azd9056, in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to confirm that azd9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. patients will receive background treatment with either methotrexate or sulphasalazine


Eligibility criteria:
inclusion criteria: * diagnosis of ra with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (esr) or c-reactive protein (crp). at least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion. be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation. exclusion criteria: * any other inflammatory disease in addition to ra that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. persistently abnormal liver function enzymes (blood test).

Keywords: rheumatoid arthritis
role of fcgamma receptors in immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia

Summary: immune thrombocytopenia (itp) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings. monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions. fcgamma receptors (fcγr), that are represented by activating receptors (fcγri, fcγriia, fcγriii) and an inhibiting one (fcγriib), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous. the aim of this study is to compare the expression of fcγr in patients with itp on circulating monocytes and on splenic macrophages.


Eligibility criteria:
inclusion criteria: itp group * patients who have provided written consent * patients over 18 years * patients with national health insurance * patients with itp, defined as thrombocytopenia \< 100 g/l, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy. control group * persons who have provided a written consent * persons over 18 years * persons with national health insurance * persons without autoimmune disease exclusion criteria: * patients under guardianship * pregnancy
a comparison of three surgical approaches to zygomaticomaxillary fractures

Conditions: Zygomatic Fractures

Summary: the study is a randomized controlled clinical trial, following the consolidated standards of reporting trials (consort) guidelines. the study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

the study is a randomized controlled clinical trial. twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used: group a: subtarsal approach group. group b: conventional transconjuctival approach group. group c: y- modification of the transconjuctival approach group.

Eligibility criteria:
inclusion criteria: * patients with zmc fractures requiring open reduction and internal fixation. * adult patients aged between 20 and 50 years with no gender predilection. exclusion criteria: * an existing laceration in the inferior and lateral periorbital site. * infection at the fracture line. * comminuted fracture with bone loss. * acute and chronic conjunctival diseases.
retrospective investigation of the impacts of prognosis for nasopharyngeal carcinoma patients

Conditions: Malignant Neoplasm of Other Specified Site of Nasopharynx

Summary: to investigate whether the additional induction chemotherapy (ic) to concurrent chemoradiotherapy (ccrt) was able to improve overall survival (os) and disease-free survival (dfs), and to clarify if stage-specified chemoradiotherapy regimens benefit the most for locoregionally advanced npc.

data of patients firstly diagnosed npc from jan 1st, 1998 to jun 1st, 2013 were downloaded from department of medical information, sun yat-sen university cancer center. patients were excluded if they had stage i or ii disease, no complete medical records, received treatment previously, or without concurrent chemoradiotherapy. follow-up data is updated on october 1st, 2015.the propensity score-matching (psm) method was adopted to balance observed covariates between both groups. propensity scores reflect the conditional probability that is intended to be uniform between patients received ccrt and ic+ccrt based on their baseline characteristics. matching was performed based on nearest-neighbor matching, and comparing between ccrt and ic+ccrt patients were matched within their respective risk groups.

Eligibility criteria:
inclusion criteria: 1. firstly diagnosed npc in sysucc from jan 1st, 1998 to jun 1st, 2013; 2. with complete medical records; 3. received radical rt. exclusion criteria: 1. distant metastasis patients at first diagnosis, 2. recurrent patients, 3. not finishing radiotherapy, missing medical data, death during rt, stage i or ii disease,received treatment previously, or without concurrent chemoradiotherapy were excluded.

Keywords: nasopharyngeal carcinoma induction chemotherapy concurrent chemoradiotherapy
study to assess real-world effectiveness of belimumab for treatment of adults with ln

Conditions: Lupus Nephritis

Summary: the purpose of the observe-ln study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active ln in multiple countries of interest. this study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.


Eligibility criteria:
inclusion criteria: * participants to provide a signed informed consent at the time of enrollment per protocol, * male or female aged 18 or over at initiation of belimumab, * participants received belimumab for the treatment of active ln prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab, * participants initiated belimumab 6 to 24 months prior to study enrollment, * accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy within the prior 24 months from belimumab initiation), * biopsy-confirmed diagnosis of active ln in the two-years prior to the initiation of belimumab * class iii (focal ln) with or without class v (membranous ln), * class iv (diffuse ln) with or without class v, * class v. exclusion criteria: * participants receiving renal replacement therapy at initiation of belimumab, * participant is concomitantly receiving another biologic at initiation of belimumab, * participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies), * participant is pregnant at the initiation of belimumab, * participant with a kidney transplant at the initiation of belimumab, * participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.

Keywords: belimumab lupus nephritis observe-ln renal function real world data
a study of the safety and pharmacokinetics of apixaban versus vitamin k antagonist (vka) or low molecular weight heparin (lmwh) in pediatric subjects with congenital or acquired heart disease requiring anticoagulation

Conditions: Thrombosis

Summary: to investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, 28 days to \< 18 years of age, inclusive * congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, kawasaki disease with coronary aneurysms, and pulmonary hypertension) * eligible participants include those who newly start anticoagulants and those who are currently on vka or lmwh or other anticoagulants for thromboprophylaxis * able to tolerate enteral medication \[eg, by mouth, nasogastric tube, or gastric tube\] * participants 28 days to \< 3 months must be able to tolerate oral/nasogastric tube (ngt)/gastric tube (gt) feeds for at least 5 days prior to randomization exclusion criteria: * recent thromboembolic events less than 6 months prior to enrollment * weight \< 3 kg * use of aggressive life-saving therapies such as ventricular assist devices (vad) or extracorporeal membrane oxygenation (ecmo) at the time of enrollment * artificial heart valves and mechanical heart valves * known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von willebrand disease, etc.) * active bleeding at the time of enrollment * any major bleeding other than perioperative in the preceding 3 months * known intracranial congenital vascular malformation or tumor * confirmed diagnosis of a gi ulcer * known antiphospholipid syndrome (aps). other protocol defined inclusion/exclusion criteria apply