Kornimate/medical-research-clean huggingface dataset:
the use of remote magnetic navigation in catheter ablation of heart arrythmia

Conditions: Arrythmia

Summary: patients with several heart arrythmia can potentially be cured by catheterablation. for some arrythmias 95% of the patients are cured. also patients with atrial fibrillation are cured by catherablation even though the effect is not as impressive as for other cardiac arrythmias. about 70% of patients with paroxystic and persistant atrial fibrillation are cured. most of the remaining obtain a reduction of their symptoms. at conventional ablation of atrial fibrillation the catheters are manually navigated to the ideal anatomic position where to isolate the pulmonary veins from the left atrium. lately it has been possible to navigate the ablationcatheters using 'remote magnetic navigation' using a magnetic based navigation equipment, stereotaxis. the heartcentre of rigshospitalet had this stereotaxis equipment installed in the autumn of 2006. we will investigate the utility and safety of using this remote magnetic navigation/stereotaxis.

the purpose on this study is to show the utility and the safety by using the remote magnetic navigation of ablation catheters with the stereotaxis equipment at ablations of * atrial fibrillation, atrial flutter and other arrythmias * childrens arrythmias * arrythmias of patients with pacemaker or icd (implantable cardiac defibrillator)

Eligibility criteria:
inclusion criteria:following patients that need catheter ablation: * patients with atrial fibrillation * patients with artial flutter * patients with other tachy arrythmia * patients with paceaker/icd exclusion criteria: * patients with anamnestic psycosis or other conditions where information is impossible or insure to give * contraindication to magnetic ablation therapy

Keywords: stereotaxis arrythmia catheter ablation heart
evaluation of safety and efficacy of three flavors of supportan® drink in cancer patients in taiwan

Conditions: Cancer; Malnutrition (Calorie)

Summary: the goal of this clinical trial is to demonstrate safety and efficacy of supportan® drink (three flavors:tropical fruits, cappuccino, and pineapple-coconut), administered as oral nutritional supplement, that will be taken in addition to the patient's normal dietary intake to meet the daily nutritional targets. in cancer patients. the main questions it aims to answer are: primary efficacy endpoint 1. change in body weight from baseline to end of treatment at week 4 (week 4 -baseline) secondary efficacy endpoints 1. change in crp from baseline to week 2 and to end of treatment at week 4 (week 2 - baseline, week 4 -baseline) participants will be enrolled in one of three flavor group by his/her recruiting time. each subject needs visit hospital at baseline, week 2 and week 4 for checkups and test. and he/she needs take two bottles of supportan drink per day. during the study periods, subjects need write down his/her dietary records every day for evaluation.


Eligibility criteria:
inclusion criteria: 1. patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy; 2. patient with diagnosed cancer of any type (e.g., head and neck cancer, lung cancer, digestive tract cancer, breast cancer); 3. patient with or at risk of malnutrition defined as meeting malnutrition universal screening tool (must) with score ≥2; 4. capable of using oral nutritional supplementation; 5. written informed consent from patient. exclusion criteria: 1. patient with documented diagnosis of liver, kidney or heart disease in the hospital's electronic medical record (emr); severity of disease evaluated by investigator as not being suitable to participate in this study; 2. current alcohol or substance abuse as assessed by investigator; 3. patient had a stroke in the past year and is after investigator assessment judged as not yet clinically stable at the time of screening; 4. patients who are diagnosed with mental illness or depression assessed by the investigator as too severe for being suitable to participate in this study; 5. pregnant or breastfeeding woman; 6. allergic to any ingredient of the investigational products; 7. patients receiving or having received standard (not disease specific) oral nutritional supplements (ons), standard enteral formula/tube feeding or standard parenteral cancerspecific nutrition supplements in the last 3 days; 8. patients receiving or having received ons, enteral formula/tube feeding or parenteral nutrition with high fish oil or high epa/dha content (above 1 g/day) in the last 28 days; 9. current use of medication, food supplements or ons containing more than 500 mg of eicosapentaenoic acid (epa) and docosahexaenoic acid (dha)/day or fish oil capsules/supplements containing more than 500 mg epa and dha/day at screening; 10. transfusion of blood products within 1 week before screening; 11. surgery scheduled during the trial; 12. participation in other clinical trials using investigational drugs within 14 days before the start of the trial or during the trial.
safety, tolerability, and pharmacokinetic study of trk-250 for patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: trk-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (tgf-β1) protein, at the gene expression level. this study is a double-blind, randomized, placebo-controlled phase i study. the primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of trk-250 in subjects with idiopathic pulmonary fibrosis (ipf).


Eligibility criteria:
inclusion criteria: * clinical, radiographic, and histologic features consistent with the diagnosis of ipf * spo2 ≥90% at rest by pulse oximetry while breathing ambient air. * fvc ≥50% of predicted. * fev1 ≥50% of predicted. * ratio of fev1 to fvc ≥0.7. * dlco corrected for hemoglobin 30% to 79% of predicted, inclusive. exclusion criteria: * history of acute exacerbation of ipf or respiratory tract infection within 3 months prior to screening. * planned surgery during the study. * history of malignant tumor within 5 years prior to screening. * history of emphysema or clinically significant respiratory diseases (other than ipf). * other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases). * end-stage fibrotic disease expected to require organ transplantation within 6 months. * taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for ipf within 4 weeks prior to screening. (treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to screening and it is anticipated the dose will remain unchanged throughout enrollment.)

Keywords: trk-250 idiopathic pulmonary fibrosis
nursing perspective on burnout and medical errors in the intensive care unit during covid-19 pandemic

Conditions: Burnout, Professional; Medical Errors; Depression

Summary: the investigators plan to perform an observational study to evaluate the prevalence of burnout, depression and medical errors in a designated exclusive covid-19 patients hospital in malaysia, during the covid-19 pandemic. in addition, the relationship between burnout and depression with medical errors will be assessed. the population studied will be the nurses working in the intensive care unit, who are at higher risk due to the nature of their work at the frontlines of the pandemic.

during this unprecedented covid-19 pandemic crisis in the whole world, malaysia is also affected, with more than 5000 patients infected in the whole country as of 20th april, 2020. many intensive care unit nurses, who are at the frontlines of managing covid-19 patients, face increased workload, in addition to psychological stress from managing these patients, with stress also coming from being exposed to the risk of cross infection. hence, they are possibly at high risk of burnout and depression. in such a time of increased stress, the investigators also seek to find out the prevalence of medical errors made by intensive care unit nurses during this pandemic, and whether the medical errors are associated with burnout. factors associated with burnout, depression and medical errors will also be evaluated.

Eligibility criteria:
inclusion criteria 1. all nurses currently serving in the icu, sungai buloh hospital exclusion criteria 1. subjects who refuse to participate 2. subjects working in icu, sungai buloh hospital, for less than 1 month

Keywords: burnout depression medical errors intensive care unit nurses covid-19
doxorubicin (doxil) combined with rituxan, cyclophosphamide, vincristine and prednisone in newly diagnosed aggressive non-hodgkin's lymphomas

Conditions: Non-Hodgkin's Lymphoma

Summary: the current standard treatment for non-hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "r-chop." using r-chop therapy, complete disappearance of disease is expected in over 50% of people. one of the active drugs in the r-chop regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. the reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. this liposomally encapsulated form of doxorubicin called doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. doxil is fda approved for ovarian cancer. however its use in non-hodgkin's lymphoma is still investigational. by substituting doxil for doxorubicin in the r-chop regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. the purpose of this study is to see how well the combination of doxil, rituximab, cyclophosphamide, vincristine and prednisone (dr-cop) are in shrinking tumors in patients with non-hodgkin's lymphoma.


Eligibility criteria:
inclusion criteria: * pathologic diagnosis of non-hodgkin's lymphoma of b-cell origin: follicular large cell, diffuse large cell (including all b-cell variants), burkitt or burkitt-like lymphoma * all stages of disease * measurable or evaluable tumor parameter(s) * age greater than 17 years old * karnofsky performance status greater or equal to 50% * agc greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma) * bilirubin less or equal to 2.0; sgot less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma) * creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma) * lvef greater or equal to 45% * concurrent rt with or without steroids for emergency conditions secondary to lymphoma (i.e., cns tumor, cord compression)are permitted * men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy * signed informed consent exclusion criteria: * prior systemic cytotoxic therapy or rt for lymphoma * second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer * hiv seropositive * primary cns lymphoma * pregnant or nursing women * unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the pi
effects of early abuse on adult intimate relationships

Conditions: Hypoactive Sexual Desire Disorder; Female Sexual Arousal Disorder; Female Orgasmic Disorder; Major Depressive Disorder; Post-traumatic Stress Disorder

Summary: this study is designed to help us better understand the factors that affect the sexual lives of women who have been sexually mistreated during childhood. with this study we hope to learn about factors that may be promising targets for future treatments of sexual problems related to past sexual experiences. the investigators hypothesize that women who have experienced early sexual abuse are more likely to have sexual problems in adulthood than women who were not abuse in childhood.


Eligibility criteria:
inclusion criteria: * at least one involuntary sexual experience, defined as "unwanted oral, anal, or vaginal intercourse, penetration of the vagina or anus using objects or digits, or genital touching or fondling," before age 16 and no less than 2 years prior to enrollment. * currently sexually active or cohabiting in a potentially sexual relationship. * current sexual dysfunction, distress, or low sexual satisfaction exclusion criteria: * traumatic event in the previous three months * sexual abuse in the past two years * diagnosis of a psychotic disorder in the previous six months * significant suicidal or homicidal intent * currently receiving psychotherapy for sexual or abuse-related concerns * use of illicit drugs * in a currently abusive relationship

Keywords: childhood sexual abuse depression ptsd sexual function women
safety, tolerability and pharmacokinetics of lumateperone in pediatric patients with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: study iti-007-035 is a phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and pk of lumateperone for pediatric patients with autism spectrum disorder.


Eligibility criteria:
inclusion criteria: * male or female patients between 5 to less than 13 years of age * primary clinical diagnosis of asd with symptoms of irritability * abc-i subscale score of ≥12 at screening * cgi-s score of ≥3 at screening * body mass index (bmi) greater than the 5th percentile according to age- and gender-specific cdc clinical growth charts (2000) at screening * ability to swallow capsules exclusion criteria: * has a primary psychiatric diagnosis other than asd * reports suicidal ideation (type 3, 4 or 5 on the baseline/screening version of the c-ssrs) within 6 months prior to screening, or any suicidal behavior within 2 years prior to screening, and/or the investigator assesses the patient to be a safety risk to him/herself or others * clinically significant abnormality within 2 years of screening that in the investigator's opinion may place the patient at risk or interfere with study outcome variables * history of a clinically significant cardiac disorder and/or abnormal screening ecg or a qt interval corrected for heart rate using fridericia formula (qtcf) \> 460 msec at screening * patients with a history of orthostatic hypotension or who have orthostatic hypotension at screening * has a history of uncontrolled/disruptive behavior in the past 30 days that, in the investigator's opinion, would preclude the ability to participate in study procedures
assessing continuous glucose monitors in healthy children

Conditions: Diabetes Mellitus

Summary: continuous glucose monitors may be useful in the treatment of children with type 1 diabetes mellitus. the purpose of this study was to determine whether two fda-approved continuous glucose monitors, the continuous glucose monitoring system (cgms) and the glucowatch g2tm biographer (gw2b), are sufficiently accurate to use in future studies to characterize glucose levels in children.

the characterization of glucose levels in healthy children during day and nighttime is critical to the interpretation of glucose levels in diseases such as diabetes. this study was conducted by the direcnet study group to determine whether two fda-approved continuous glucose monitors are sufficiently accurate. the study was conducted at five clinical centers and enrolled approximately 20 healthy children (ages 7 to 17 years old) who did not have type 1 or type 2 diabetes nor a history of the disease in their immediate families. each participant was hospitalized for approximately 26 hours to assess the accuracy of the continuous glucose monitors compared with serum glucose determinations.

Eligibility criteria:
inclusion criteria * weight \>= 16.0 kg (35 lbs) * body mass index between the 10th to 90th percentile for age and sex * hba1c within normal limits * hematocrit within normal limits exclusion criteria * history of diabetes * history of positive islet cell antibody testing * family history of type 1 or type 2 diabetes in a sibling or parent * medication use of any type in the 7 days prior to study entry * skin abnormalities contraindicating device use

Keywords: continuous glucose monitoring devices blood glucose profiles in normal children blood glucose profiles in non-diabetic children
efficacy and safety of valsartan/amlodipine combination in hypertensive patients not controlled with amlodipine alone

Conditions: Hypertension

Summary: this study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication


Eligibility criteria:
inclusion criteria: * patients with uncomplicated, essential hypertension exclusion criteria: * severe hypertension * history of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm * liver, kidney, or pancreas disease * insulin dependent diabetes * allergy to certain medications used to treat high blood pressure other protocol-defined exclusion criteria may apply.

Keywords: hypertension, high blood pressure, valsartan, amlodipine
observational study for the evaluation of immune-mediated endocrinological adverse events in patients with hematological malignancies and subjected to treatment with immune-checkpoint inhibitors

Conditions: Hematological Malignancies

Summary: retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors


Eligibility criteria:
inclusion criteria: retrospective cohort * patients aged\> 18 years * cyto-histological diagnosis of mature lymphoproliferative syndrome of b or t lymphocyte origin * advanced stage of illness (relapsed or refractory) * patients undergoing treatment with immune anticheckpoint antibodies. * written informed consent prospective cohort * patients aged\> 18 years * cyto-histological diagnosis of mature lymphoproliferative syndrome of b or t lymphocyte origin * advanced stage of illness (relapsed or refractory) * patients who are candidates for therapy with anticheckpoint immune antibodies (it is specified that this therapy is completely independent of the subject's participation in the study). * written informed consent exclusion criteria: * severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.

Keywords: immune-checkpoint inhibitors endocrinological adverse events
efficacy and safety study of qaw039 in the treatment of patients with moderate to severe atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine whether qaw039 is safe and has beneficial effects in people who have moderate to severe atopic dermatitis (ad).


Eligibility criteria:
key inclusion criteria: * presence of atopic dermatitis confirmed by itchy skin condition in the past 12 months plus three, or more, of the following: * history of involvement of the skin creases (fronts of elbows, behind knees, fronts of ankles, around neck or around eyes) * personal history of asthma or hay fever * history of generally dry skin in the past year * onset before age of 2 years * visible flexural dermatitis * patients with an easi score of ≥15 at screening and stable ad (not currently experiencing an acute flare of their ad). * patients that have been treated with topical corticosteroids or topical calcineurin inhibitors on at least one occasion, or could not use topical drugs (due to contraindications, side effects, etc.) and are candidates for or have previously received systemic treatment. key exclusion criteria: * history of hypersensitivity to any of the study drugs (including local anesthesia) or to drugs of similar chemical classes (crth2 antagonists) * history of serious allergic reactions to any allergen, such as anaphylactic shock or life-threatening asthma, prior intubation, respiratory arrest, hospitalization due to asthma within the last 3 months or seizures as a result of asthma * history of clinically significant ecg abnormalities or screening/baseline ecg that demonstrated clinical significant abnormalities which could affect patient safety or interpretation of study results * history of long qt syndrome or whose qtc interval (frederica's) was prolonged (\>450 msec for males and females) at screening * use of topical prescription treatment (e.g., topical corticosteroids, calcineurin inhibitors, antibiotics, etc.) within two weeks prior to initial dosing of study drug. patient use of emollients was encouraged * exception: for local atopic dermatitis flares during this 2-week interval, mild topical corticosteroids may be taken short term (up to one week) * recent previous systemic treatment with phototherapy, systemic antihistamines, immunosuppressive agents (e.g., cyclosporine, mycophenolate, or oral tacrolimus, including therapeutic proteins) * patients on maintenance immunotherapy who either began their allergen specific immunotherapy regimen or had a clinically relevant change to their immunotherapy within one month prior to granting informed consent * patients on high-dose statin therapy (\>40 mg fluvastatin or 20 mg simvastatin, atorvastin, pravastatin, or rosuvastatin \[10 mg if asian\]) * excessive exposure to uv light in the three weeks prior to study start (screening), including tanning and sun beds and/or planning excessive sunbathing or beach holidays with associated sun bathing during the treatment period * history of hypertrophic scarring * body mass index \ 40 kg/m2

Keywords: atopic eczema skin diseases
examine national characteristics & outcome measures of gerd patients using the ppi acid suppression symptom (pass) test for response

Conditions: Gastroesophageal Reflux

Summary: to characterize the burden of disease in gerd patients of prescription therapy'


Eligibility criteria:
inclusion criteria: * signed informed consent, 18 years or older, diagnosis of gerd exclusion criteria: * peptic ulcer disease, upper gastrointestinal surgery, malignancy

Keywords: gerd