Kornimate/medical-research-clean huggingface dataset:
prospective, open-label tolerability and safety monitoring study of novantrone in a selected cohort of multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: the overall objective of this study is to collect data relevant to the tolerability of novantrone® therapy in patients with multiple sclerosis (ms) using dosing and monitoring recommendations specified in the package insert.

this phase iv, multicenter, prospective, open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available novantrone®. the patients will be assessed every 3 months during treatment followed by annual assessment for a total of five (5) years. the select cohort of ms patients enrolled will have secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting disease (i.e., patients whose neurological status is significantly abnormal between relapses). the overall objective of this study is to collect data relevant to the tolerability of novantrone® therapy in patients with multiple sclerosis (ms) using dosing and monitoring recommendations specified in the package insert.

Eligibility criteria:
inclusion criteria: * to be eligible for inclusion into this study, the subjects must fulfill all of the following criteria: * platelet count \>100,000 cells/µl * granulocyte count \> 2000 cells/µl * age 18-65 years * negative pregnancy test for female patients who are biologically capable of becoming pregnant, even if they are taking birth control * for patients of reproductive age, agreement to practice effective contraception throughout the study and for 6 months following the last administration of novantrone® * signed inform consent. exclusion criteria: * to be eligible for inclusion in this study the subjects must not meet any of the following criteria: * presence of cardiac risk factors: * history of congestive heart failure * lvef \< 50% determined by echocardiography or muga * previous treatment with novantrone®, other anthracenediones, or anthracyclines * prior mediastinal radiotherapy or total lymphoidal irradiation * ast, alt, bilirubin \> 2x upper limits of normal * severe untreated infection (including current urinary tract infection) * nursing or pregnant women)
detecting auricular points in mmg by a novel apd ( apd-mmg )

Conditions: Menstrual Migraine

Summary: this pilot study is designed to validate the diagnostic ability of a novel apd for auricular point detection among patients with menstrual migraine (mmg), as compared with an already commercialized device.

this pilot study is designed to evaluate the diagnostic ability of a novel apd for auricular point detection among patients with menstrual migraine (mmg), as compared with an already commercialized device. the investigators will test if the novel apd could provide a more reliable and quantifiable diagnosis of mmg-related auricular point than traditional devices currently available in the market; the study will also use the apd device to test whether the cutaneous electrical impedance detected from the corresponding auricular points by the novel device is the lowest in the reproductive organ and facial area in the mmg population. as a pilot study, 12 patients with mmg will be recruited from the school of chinese medicine, the university of hong kong. 12 healthy subjects will be recruited from the university community. auricular acupoint detection will be accomplished with the new device and a control device. the electrical impedance will be measured and recorded. patient's condition will also be evaluated by the visual analogue scale (vas) and the modified new england center of headache (nech) headache calendar. the specificity and sensitivity of the auricular point detection by the apd device will be calculated. cohen's kappa coefficient (κ) will be used to test the inter-methods reliability, test-retest reliability, and inter-tester reliability. moreover, the pearson correlation coefficient will be used to test the correlation between the electrical impedance of the auricular point and the pain intensity score.

Eligibility criteria:
inclusion criteria: * when attacks, average migraine pain severity \>=5 point measured by a 10-point vas scale; * diagnosed pure menstrual migraine without aura or menstrually related migraine without aura according to the international classification of headache disorders: 2nd edition; * provide written inform consent; * free of any other diagnosed psychological conditions; exclusion criteria: * with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease * pregnancy or lactation * participation in a clinical study that may interfere with participation in this study * history of or current tobacco, alcohol use * anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study * unable to provide written informed consent due to any reason.

Keywords: menstrual migraine auricular point diagnostic accuracy auricular point detection device
applying pulse wave analysis to predict intradialytic hypotension

Conditions: Intradialytic Hypotension

Summary: intradialytic hypotension (idh) is a common complication during hemodialysis in patients with chronic kidney disease and may increase the mortality. this study aimed to investigate whether pulse wave analysis could be the predictor of idh. in this study, patients under regular hemodialysis were enrolled from taoyuan chang gung memorial hospital. subjects were evaluated by pulse wave instrument, heart rate variability analyzer and constitution in chinese medicine questionnaire before hemodialysis. according to the definitions of idh, subjects in study group and control group were confirmed by the dialysis records. furthermore, repeated examinations were done for 3 hemodialysis to investigate the possible predictive factors for idh.

intradialytic hypotension (idh) is a common complication during hemodialysis in patients with chronic kidney disease and may increase the mortality. this study aimed to investigate whether pulse wave analysis could be the predictor of idh. in this study, patients under regular hemodialysis were enrolled from taoyuan chang gung memorial hospital. subjects were evaluated by pulse wave instrument, heart rate variability analyzer and constitution in chinese medicine questionnaire before hemodialysis. according to the definitions of idh, subjects in study group and control group were confirmed by the dialysis records. furthermore, repeated examinations were done for 3 hemodialysis to investigate the possible predictive factors for idh.

Eligibility criteria:
inclusion criteria: * patients under regular hemodialysis (3 times per week) in last 3 months exclusion criteria: * arrhythmia * artery-vein anastomoses on both arms * other conditions which might interfere the evaluation of pulse wave analysis and heart rate variability analysis

Keywords: intradialytic hypotension pulse wave analysis heart rate variability constitution in chinese medicine questionnaire
assessment of the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients with atrial fibrillation

Conditions: Atrial Fibrillation; Acute Coronary Syndrome; Thrombosis; Hemorrhage

Summary: atrial fibrillation (af) is a supraventricular arrhythmia characterized by uncoordinated and fast atrial activity, and coronary artery disease (chronic and acute coronary syndrome) is characterized by a generally atheromatous narrowing of the coronary arteries. angioplasty is necessary to restore arterial circulation in coronary artery disease. a dual anti-aggregating therapy is then initiated in these patients in parallel with treatment of af with anticoagulation. this triple therapy exposes the patient to an increased risk of hemorrhage. the combination of oral anticoagulation with antiplatelet inhibitor in long-term anticoagulated patients requiring stent placement has been studied in several recent trials (e.g. woest, pioneer af pci, redual pci and augustus). the results of these studies have formed the basis of the european recommendations of 2017 and 2020, whereby the therapeutic strategy depends on the risk of hemorrhage or ischemia. however, the hemorrhagic risk assessment factors included in the scores overlap with those for ischemic risk. it is therefore difficult to determine the predominant risk for each patient. thus, uncertainties persist as to the optimal duration of a triple therapy and the optimal recommended dose. in this study, the investigators aim to establish an inventory of the current practices by evaluating the incidence of hemorrhagic and ischemic events in post-angioplasty in anticoagulated coronary patients in the context of atrial fibrillation.


Eligibility criteria:
inclusion criteria: * patient on anti-coagulating therapy before or during hospitalization for atrial fibrillation * patient hospitalized in the cardiology ward admitted for acute or chronic coronary syndrome requiring coronary angioplasty * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * the subject is in a period of exclusion determined by a previous study * the patient has already been included into this study * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient pregnant, parturient or breast feeding

Keywords: dual anti-platelet therapy angioplasty
a 2-year, open-label, safety extension study of gevokizumab in subjects with pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: the study will evaluate the long-term safety of gevokizumab in treating active pg ulcers


Eligibility criteria:
inclusion criteria: * individuals who participated in a previous study of gevokizumab in pg * a clinical diagnosis of classic pyoderma gangrenosum * contraceptive measures adequate to prevent pregnancy during the study exclusion criteria: * clinical evidence of acutely infected pyoderma gangrenosum * history of allergic or anaphylactic reactions to monoclonal antibodies * history of recurrent or chronic systemic infections * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: pyoderma gangrenosum classic pyoderma gangrenosum
impact of acetaminophen on performance of guardian™ sensor (3) in adults

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the guardian™ sensor (3) (i.e., c algorithm and zeus algorithm) in subjects age 18 - 80 years.

the study is a multi-center, prospective, study without controls. the purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the guardian™ sensor (3) (i.e., c algorithm and zeus algorithm) in subjects age 18 - 80 years.

Eligibility criteria:
inclusion criteria: 1. individual is 18 - 80 years of age at time of enrollment. 2. subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis. 3. subject has adequate venous access as assessed by investigator or appropriate staff. exclusion criteria: 1. subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen 2. subject reports history of liver cirrhosis or liver problems that a health care provider told them they should not use acetaminophen because of liver disorder. 3. subject will not tolerate tape adhesive in the area of guardian™ sensor (3) placement as assessed by a qualified individual. 4. subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, staphylococcus infection). 5. subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to visit 1. (please note participation in an observational study is acceptable.) 6. subject is female of child-bearing potential and has a pregnancy screening test that is positive. 7. subject is female of child-bearing potential and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator. 8. subject is female and plans to become pregnant during the course of the study. 9. subject is breast feeding. 10. subject has a chronic heavy alcohol use as determined by investigator. 11. subject has a history of a seizure disorder. 12. subject has a hematocrit (hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents). 13. subject has a history of adrenal insufficiency. 14. subject is a member of the research staff involved with the study.
novapak prospective observational clinical trial

Conditions: Nasal Airway Obstruction

Summary: the novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with novapak nasal sinus packing and stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the novapak device under use as intended in the device indications.

the primary objective is to assess the safety of the novapak nasal sinus packing and stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by: * collecting all aes directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval * collecting all aes and calculating an overall rate and safety profile for the device the secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age. 2. subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., novapak). 3. after being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent. 4. mentally stable and able to follow the instructions for self-assessment/questionnaire completion. exclusion criteria: 1. subject has a shellfish allergy. 2. subject has known bleeding disorder or prescribed anticoagulants. 3. subject has craniofacial abnormalities that may interfere with access to the sinuses. 4. subject is immunocompromised (e.g., taking immunosuppressive medication). 5. subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
the impact of a patient education intervention for ambulatory oncology patients

Conditions: Gastro-intestinal Cancer; Lung Cancer; Head and Neck Cancer; Breast Cancer

Summary: this study will test the impact of newly created and available symptom management patient education brochures on symptom burden \[measured via the edmonton symptom assessment system (esas)\], health-related quality of life \[measured by the european organisation for research and treatment of cancer quality of life questionnaire (eortc qlq-30)\], patient satisfaction with care \[measured by the princess margaret hospital patient satisfaction questionnaire (pmh/psq-md 29) and the european organisation for research and treatment of cancer patient satisfaction with radiation or chemotherapy (eortc patsat35 rt/ct)\], self-efficacy, and knowledge at sunnybrook health sciences centre in toronto, canada. these brochures are designed for oncology patients in order to provide a response to symptom screening and are now a standard part of care. symptom screening occurs at each visit as patients are required to fill out esas, that asks about their experience with the occurence and severity of symptoms. the intent of the patient brochures are to acknowledge the screen, validate the symptom and provide knowledge of self-management strategies for symptoms. the brochures also provide information to patients about when and how to seek further help from their oncology team. the hope is that patients will experience a useful response to their screen with all levels of symptoms-from 0-10 in severity it is hypothesized that the addition of patient education symptom management pamphlets on 7 of the symptoms measured by esas (appetite, nausea and vomiting, depression, anxiety, fatigue, dyspnea and pain) will provide new and meaningful information which will build knowledge, validate the patient's experience of the symptom, lead to increased satisfaction with care, improved self efficacy in managing and accessing help for the symptom and therefore improved health related quality of life.


Eligibility criteria:
inclusion criteria: * receiving treatment at the odette cancer centre or breast cancer centre at sunnybrook hospital * over the age of 18 * english-speaking and able to read and complete a survey in english exclusion criteria (patients will be withdrawn from study in the event that...): * the patient is thought to be at risk to self or others, or be in need of immediate psychiatric assessment, in which case the patient will be referred urgently for assessment with psychosocial oncology or department of psychiatry * the patient wishes to discontinue the study * the patient is noted to be cognitively impaired during the course of the study such that he cannot complete a questionnaire reliably or physically impaired such that it is too burdensome

Keywords: odette cancer centre at sunnybrook health sciences centre toronto ontario
starting the conversation

Conditions: Stigma of Parents of Children With Mental Illness

Summary: the purpose of the study is to evaluate the group-based intervention "starting the conversation" as a webinar in germany. feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial (rct).

parents of children with mental illness often experience public and self-stigma, and keeping a child's mental illness secret is a common strategy to avoid stigma. both secrecy and disclosure have pros and cons for parents and their children. therefore, the decision whether, when, and to whom to disclose a child's mental illness is complex. interventions can provide guidance for systematic consideration and a well informed decision. the manualized peer-led group intervention "honest, open, proud" (hop) supports people with mental illness in their decision whether to disclose mental illness. research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. based on hop, "starting the conversation" (stc) was developed to systematically guide parents through their decision whether and how to disclose a child's mental illness. at the moment, there is no data regarding feasibility and efficacy of stc, but two pilot rcts of stc are currently underway, one in western australia and one in wisconsin, usa. the aim of the current study is to evaluate feasibility and efficacy of stc as a webinar in a pilot rct in german.

Eligibility criteria:
inclusion criteria: * parent with at least one child or adolescent that (i) is aged between 6 to 17 years (ii) has a current mental disorder according to icd-10 diagnosed by a psychiatrist or psychologist * age ≥ 18 years * positive screening for disclosure distress (1 item: "in general, how distressed or worried are you in terms of secrecy or disclosure of the mental illness of your child?", self-report, persons with a score ≥ 4 on a scale from 1-7 were included) * online informed consent * sufficient german language skills exclusion criteria: * intellectual disability of child (iq\<70, self-report)

Keywords: stigma parents of children with mental illness disclosure secrecy group intervention
this study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients.

Conditions: Arthritis Rheumatoid

Summary: this study is to investigate the effect of etanercept in early versus delayed referral for management of rheumatoid arthritis patients assessing real-world patient data entered in the iraq national center of rheumatology database between may 2012 and may 2017.


Eligibility criteria:
inclusion criteria: * diagnosed ra patients. * 18 years old and above. * did not receive pervious biological treatment. exclusion criteria: * had previous biological treatment * use etanercept for less than 1 year
effect of liraglutide on subclinical atherosclerosis in patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of the trail is investigate the effect of liraglutide 1.8mg as add-on to insulin for 6 months on carotid intima media thickness and cardiovascular risk factors in subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * age from 15 to 60 years * patients diagnosed with type 1 diabetes mellitus. * diabetes duration more than 1 year. * both genders. * c - peptide less than 0.3 nmol/l exclusion criteria: * patients with type 2 diabetes mellitus, lada (latent autoimmune diabetes in adults), mody (maturity-onset diabetes of youth), or other types of diabetes other than type 1 diabetes mellitus. * pregnant patients or desire to become pregnant in the next 6 months. * family history of medullary thyroid cancer or multiple endocrine neoplasia 2 * history of pancreatitis * familial hypercholesterolemia * use of adjunctive treatment to insulin (sglt-2 \[sodium-glucose cotransporter-2\] inhibitor, pramlintide, metformin) * start of treatment with statins, ezetimibe or psck9 (proprotein convertase subtilisin/kexin type 9) inhibitors, amlodipine, metoprolol in the last 6 months before the study. * bariatric surgery * use of medications (immunosuppressants, calcineurin inhibitors, mtor (mammilian target of rapamycin) inhibitors, corticosteroids, aspirin, or anticoagulants) * metabolic abnormalities (inborn errors of cholesterol storage metabolism, glycogen storage, abetalipoproteinemia, reye's disease, lcat (lecithin-cholesterol acyltransferase) deficiency)

Keywords: liraglutide diabetes mellitus, type 1 atherosclerosis