Kornimate/medical-research-clean huggingface dataset:
rate registry - registry of atrial tachyarrhythmia/atrial fibrillation (at/af) episodes in the cardiac rhythm management (crm) device population

Conditions: Atrial Fibrillation

Summary: the purpose of this registry is to produce a prospective, outcome-oriented registry to document the prevalence of at/af in the crm population by using the advanced at/af diagnostics in select sjm devices.


Eligibility criteria:
inclusion criteria: * patient is implanted with a crm device * patient has no documented history of af (3 months prior to enrollment) * patient is \>18 years of age * patient has life expectancy of \>24 months
zd1839 (iressa™) and concurrent chemo-radiation in patients with locally advanced non small cell lung cancer

Conditions: Non Small Cell Lung Carcinoma

Summary: the primary objective of the trial is to determine the maximum tolerated dose, if any, of the combination of daily zd1839 250 mg with carboplatin auc 2 and 60 gray (gy) irradiation and up to 45 mg/m2 paclitaxel.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed locally advanced stage iiia or iiib nsclc (without pleural effusion) * patients with apical tumours and supraclavicular nodes are acceptable if both can be easily encompassed in one radiation field * minimum life expectancy with treatment of 6 months * who performance status 0-1 exclusion criteria: * patients with previous malignancies other than nsclc * previous radiotherapy for nsclc * previous immunotherapy or chemotherapy * any unresolved chronic toxicity greater than ctc grade 2 from previous anticancer therapy * forced expiratory volume in 1 second (fev1) less than 1 litre (l) * absolute neutrophil count (anc) less than 1.5 x 109/l or platelets less than 100 x 109/l * serum bilirubin greater than 1.25 times the upper limit of reference range * alt or ast greater than 2.5 times the ulrr

Keywords: non small cell lung cancer
study of the effect of armodafinil treatment in healthy subjects with excessive sleepiness associated with jet lag disorder

Conditions: Excessive Sleepiness

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.


Eligibility criteria:
key inclusion criteria: * history of jet lag symptoms during the past 5 years. * the subject is in good health, as determined by a medical and psychiatric history, medical examination, clinical laboratory test results, and electrocardiography (ecg) and physical examination findings. * women of childbearing potential must be abstinent or use a medically accepted method of contraception, and must continue use of this method for the duration of the study (and for 30 days after participation in the study). * the subject is willing to comply with study restrictions and remain at the study center overnight, as required. * the subject must agree to refrain from alcohol use during the study. * the subject has a valid u.s. passport key exclusion criteria: * the subject has a history (past 12 months) or diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (osahs), shift work sleep disorder (swsd), or any other sleep disorder associated with excessive daytime sleepiness; or the subject has a history or current diagnosis of hypersomnia, insomnia, or sleep disorder. * the subject has any serious acute or chronic cardiovascular, pulmonary, gastrointestinal, neurological, endocrine or renal illness (including diabetes mellitus), hepatitis, asthma, chronic obstructive pulmonary disease (copd), or any other clinically relevant significant medical condition. * the subject has a history of any cutaneous drug reaction or drug hypersensitivity, or any clinically significant hypersensitivity reaction, or multiple allergies. * the subject has a history of deep vein thrombosis (dvt). * the subject has known human immunodeficiency virus (hiv). * the subject is pregnant or lactating. * the subject has used nicotine within the last 3 months. * the subject has a history of seizures, except for a single febrile seizure. * the subject has a psychiatric disorder that would affect participation in the study or full compliance with study procedures. * the subject has a clinically significant deviation from normal in clinical laboratory results, vital signs measurements, or physical examination findings. * the subject used any prescription or over the counter drugs disallowed by the protocol within 7 days of screening visit 2 (i.e., stimulants, hypnotics). * the subject has used an investigational drug within 1 month before the screening visit. * the subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion. * the subject has a known hypersensitivity to armodafinil or modafinil, or any other component of the study drug tablets.
bleeding pattern and user satisfaction during second consecutive mirena® in contraception and treatment of menorrhagia

Conditions: Contraception; Menorrhagia

Summary: the purpose of this study is to assess the bleeding pattern during the last 3 months of the first mirena® and the first year of the second mirena® use.

this study has previously been posted by schering ag, germany. schering ag has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * woman currently using mirena for contraception or menorrhagia with duration use between 4 years 3 months and 4 years 9 months and willingness to continue with the method. * normal size uterus at insertion, corresponding to sound measure of 6-10 cm. * clinically normal cervical smear result within 12 preceding months or at screening. * clinically normal breast examination findings. for patients \>/= 40 years at screening, a clinically normal mammography result within 12 preceding months or at screening is required. exclusion criteria: * menopausal symptoms impairing patient's quality of life or current estrogen therapy for menopausal symptoms. * known or suspected pregnancy. * any distortion of the uterine cavity, including congenital or acquired uterine anomalies and fibroids distorting the uterine cavity. * current or recurrent pelvic inflammatory disease. * abnormal uterine bleeding of unknown origin. * acute cervicitis or vaginitis not responding to treatment. * history of, diagnosed or suspected genital or other malignancy (excluding treated squamous cell carcinoma of the skin), and untreated cervical dysplasia. * any active acute liver disease or liver tumor.

Keywords: intrauterine system contraception menorrhagia
prospective registry study on the implementation of simultaneous postoperative radiochemotherapy for salivary gland carcinomas of the head and neck region

Conditions: Locally Advanced Salivary Gland Carcinoma

Summary: this is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in erlangen and elsewhere. the efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.


Eligibility criteria:
inclusion criteria: * salivary gland carcinomas of the major and minor salivary glands of the head and neck region * high-grade histology * successful oncological resection with curative intent * pt3-4 or pn1-3 or pn1(perineural sheath infiltration) or pt1-2 with scarce or positive resection margin * cm0 * indication for postoperative combined radiochemotherapy (guideline-compliant radiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 gy (depending on resection status), common chemotherapy regimens: paclitaxel 135mg/m² kof d1 and cisplatin 33mg/m² kof d1-3, q d22 or paclitaxel 135mg/m² kof d1, carboplatin auc 1.5 kof d1-3 or paclitaxel 50mg/m² kof, carboplatin auc2 d1,8,15, q d22 or paclitaxel 50mg/m²kof and cisplatin 30mg/m² kof d1,8,15, q d22, 4 cycles each). * patient age ≥18 years * who performance score ≤ 1 * signed patient information/consent form exclusion criteria: * distant metastases * other cancer in the last 5 years prior to study inclusion (with the exception of: adequately treated skin cancer (except melanoma) or lentigo maligno or adequately treated carcinoma in situ, in each case without evidence of active disease). * previous chemotherapy or radiotherapy for salivary gland carcinoma * previous radiotherapy in the head and neck area * pre-existing uncontrolled disease that constitutes a contraindication to simultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardial infarction within the last 6 months before the start of therapy, congestive heart failure, heart disease with new york heart association (nyha) iii or iv classification, active and therapy-resistant infection, pre-existing or concomitant immunodeficiency syndrome) * pregnancy and breastfeeding * fertile patients who cannot ensure effective contraception during and up to six months after combination therapy
proximal and distal approach gon rft in migraine

Conditions: Migraine Disorders; Headache Migraine Chronic

Summary: greater occipital nerve pulsed radiofrequency therapy is used in the treatment of migraine. this method is applied at the level of the proximal c2 vertebra and by approaching the nerve from the distal 1/3 medial of the occipital protuberant. the investigators aimed to compare the effectiveness of these two methods.

greater occipital nerve (gon) pulsed radiofrequency application is used in migraine headaches. the procedure is applied by approaching the occipital nerve trace with a radiofrequency needle, giving a pulsed radiofrequency current for 4 minutes, and then injecting 2.5 cc bupivacaine and saline. there are two types of applications. in the proximal/central approach, the injection is administered to the occipital nerve between the semispinalis capitis muscle and the obliquus capitis inferior, under ultrasound guidance, while in the distal approach, it is administered 1/3 cm medial to the occipital protuberant with a blind technique. the investigators aim to compare the treatment response at 1 and 3 months between two patient groups treated with both methods. for this purpose, the investigators planned to follow up with 60 patients. gon rf will be performed with a proximal approach to half of the patients and a distal approach to the other half. pain levels will be measured on the visual analogue scale (vas) in the 1st and 3rd months after the procedure. migraine disability index (midas) will be applied to the patients in the 1st week and 3rd month after the procedure. thus, it will be determined whether there is a difference between the approaches in terms of pain palliation. patients who have undergone the procedure will be found from their file records and called by phone, when they come to the control, face to face and 1-3. in the months, the scales will be filled by calling by phone.

Eligibility criteria:
inclusion criteria: * primary migraine hedache, first interventional treatment for headache exclusion criteria: * preganancy, malignancy

Keywords: greater occipital nerve block radiofrequency
cocaine-metyrapone interaction study - 1

Conditions: Cocaine-Related Disorders; Infusions, Intravenous

Summary: the purpose of this study is to examine the safety of two consecutive days of metyrapone (mrp) in subjects who may use cocaine concurrently.

to evaluate the safety of metyrapone (mrp) for using in an outpatient study in which participants would be given 2 750 mg doses of mrp per week. secondary study goals are to evaluate the possible efficacy of mrp as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. this study will utilize a double blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.

Eligibility criteria:
inclusion criteria: male or females between 18 and 45 yrs of age; cocaine dependence according to dsm-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments. exclusion criteria: additional criteria available during screening at the site.
delivery of anxiety disorder treatment in addictions centers

Conditions: Anxiety Disorders; Substance Use Disorders

Summary: anxiety disorders are highly prevalent among those with substance use disorders, but the majority of addictions treatment centers provide little to no evidence-based treatment for anxiety disorders. furthermore, tension reduction models suggest that treating anxiety should also improve substance use outcomes. this study is aimed at improving symptoms for people who have substance use and anxiety problems. the study is comparing regular intensive outpatient treatment for addiction to intensive outpatient treatment for addiction plus treatment for anxiety disorders. clinicians at a community addictions clinic will participate by receiving training in delivering cognitive behavioral therapy for anxiety disorders and will deliver the treatment to the patient participants. they will also complete some questionnaires. patient participants will be asked to complete a baseline assessment. those who are eligible will be randomly assigned to one of the two treatment groups. those who are assigned to addiction treatment as usual will continue their regular care at the matrix institute. participants who are assigned to also receive the anxiety treatment will be asked to participate in 6, 90-min treatment sessions and an orientation session. all participants will be asked to complete post-treatment and follow-up assessments. the assessments should take approximately 1 hour, and the follow-up assessment will be completed 6 months after treatment is over. it is hypothesized that those who get the additional anxiety disorder treatment will show greater improvement in anxiety and substance use outcomes than those who get intensive outpatient program without the anxiety disorder treatment.


Eligibility criteria:
inclusion criteria: * 18-60 years old * speak english * meet diagnostic criteria for at least one anxiety disorder * score at least an 8 on the oasis (see assessments), indicating at least moderate but clinically significant anxiety symptoms * be enrolled in the intensive outpatient program (iop) at the matrix institute (community partner) * meet diagnostic criteria for substance abuse or dependence exclusion criteria: * have unstable medical conditions * marked cognitive impairment * active suicidal intent or plan * active psychosis * unstable bipolar i disorder.

Keywords: anxiety disorders substance use disorders treatment effectiveness cognitive behavioral therapy
clinical utility of the speac® system: a case series

Conditions: Epilepsy

Summary: the primary objective is to collect preliminary data related to the clinical utility of the speac system in patients with a history of motor seizures. this trial is primarily an observational investigation. this protocol describes a series of observational case studies. each case study is intended to be interpreted independent from the other case studies. self-reported seizure frequency will be compared to observed seizure frequency using the speac system.


Eligibility criteria:
inclusion criteria: * subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement. * the subject's first reported seizure must be within the last 5 years. * male or female between the ages 22 and 99. * if female and of childbearing potential, subject must agree to not become pregnant during the trial. * can understand and sign written informed consent, or will have a parent or a legally authorized representative (lar) who can do so, prior to the performance of any study assessments. * subject or primary caregiver must be competent to follow all study procedures. * subject must be willing to use the seizure monitoring and alerting system for a long period of time (up to 90 days), for a minimum of 30 hours/ week. exclusion criteria: * the subject cannot be pregnant, or nursing. * the subject cannot be sensitive or allergic to adhesives or tapes.
bright ideas for pediatric palliative care: a problem-solving skills intervention to empower parent resilience

Conditions: Psychological Distress; Quality of Life

Summary: the goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright ideas problem solving skills training for parents of children in palliative care. the main questions it aims to answer are: * is bright ideas problem solving skills training feasible and acceptable for parents of children referred to pediatric palliative care? * does bright ideas reduce psychological distress in parents compared to parents receiving standard palliative care support? participants will: * participate in 6-8 sessions of the bright ideas program. * complete self report measures of psychological distress and well being. if there is a comparison group: researchers will compare bright ideas to standard palliative care support.


Eligibility criteria:
parent inclusion criteria: * parents or legal guardians of male and female children (ages 0-21) of any race or ethnicity and of any underlying medical diagnosis * child received at least one consult from the comfort and palliative care team within the past month * one parent or primary caregiver per child * able to speak, read, and write english or spanish, and give informed consent exclusion criteria: * parent age less than 18 years old * concurrent enrollment on another research study testing psychoeducational interventions for parents and/or patients * child has an estimated life expectancy of less than 4 months at time of study recruitment child inclusion criteria: * children 8-17 years of age whose primary caregiver has consented to participate * able to read and write english or spanish and assent exclusion criteria: • parent refusal to participate

Keywords: depressive symptoms anxiety post-traumatic stress
long-term follow-up study of male adults with hemophilia b previously treated with etranacogene dezaparvovec (csl222)

Conditions: Hemophilia B

Summary: the primary purpose of this study is to assess the long-term safety and efficacy in male adults with hemophilia b who were treated with csl222 (csl222) in parent studies csl222_2001 (nct03489291) or csl222_3001 (nct03569891).


Eligibility criteria:
inclusion criteria: received treatment with csl222 in study csl222_2001 or study csl222_3001, and completed participation in study csl222_2001 or study csl222_3001 or at least 5 years have passed since receiving csl222. exclusion criteria: not applicable
diagnostic value of heart-fatty acid binding protein and ischemia modified albumin as biochemical markers on non st segment elevation acute coronary syndrome at the emergency room.

Conditions: Acute Coronary Syndrome

Summary: early diagnostic of non st elevation coronary syndrome in patients admitted to the emergency room is difficult. two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia. the aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non st segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.

early diagnostic of non st elevation coronary syndrome (acs) in patients admitted to the emergency room is difficult. two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia. study objective: the aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non st segment elevation acs diagnosis in the first hour of management in emergency room. methods: in a prospective double blind study, initial heart fatty binding protein and ischemia modified albumin levels will be measured in consecutive patients admitted in the emergency room with chest pain and suspected non-st elevation acs. data including history, physical examination, serial 12-lead ecg and troponin-i measurement at 0 and 6 hours after admission will be collected by the treating physician blinded to the result of the markers. based on hospital diagnosis algorithm (troponin repeated measurements, treadmill test or other ischemia detection, coronarography if necessary) and follow-up at one month, patients will be classified as having or no non-st elevation acs by two independent physicians blinded to the results of markers. sensitivity, specificity, positive and negative predictive values will be determined for each marker and in combined analyses.

Eligibility criteria:
inclusion criteria: * all consecutive patients admitted in the emergency room with a primary complaint of chest pain evolving within 12 hours and suspected as acute coronary syndrome exclusion criteria: * patient younger than 18 years old, having an st elevation on a 12-lead ecg, having an evident traumatic cause of chest pain or having severe communication problems

Keywords: biological markers emergency service hospital heart fatty acid binding protein ischemia modified albumin
addressing diabetes together

Conditions: Diabetes

Summary: integration of diabetes prevention program (dpp) and diabetes self management program (dsmp) into wellconnect.


Eligibility criteria:
inclusion criteria: * adults 18 years or older * diagnosis of diabetes * enrolled in the dsmp or dpp exclusion criteria: * unable to provide consent
effect of radical prostatectomy on involuntary pelvic floor muscle contraction

Conditions: Lower Urinary Tract Symptoms

Summary: this study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction

radical prostatectomy may cause stress urinary incontinence (sui). that poses problem in terms of quality of life. there are many treatment options available for patients with sui, but the exact mechanism is not known. we compared, in continent and incontinent men post-radical prostatectomy, the correlation between the temporal course of pelvic floor activation during cough. simultaneously, recordings of electromyographic activity of external anal sphincter (eas emg) and external intercostal muscle (eic emg) during coughing will be made with a pair of pre-gelled electrodes. cough effort cause an involuntary pelvic contraction. intercostals muscles recording was chosen because they are one of the muscular components of cough initiation with diaphragm muscle. 24h pad-weighing test is used to quantify urinary incontinence. we will measure the latency between the onset of the eic emg and the eas emg (rt3), during a cough effort. we will also measure the duration of the contraction, the maximum eas emg activity and the area under the curve.

Eligibility criteria:
inclusion criteria: * follow in neuro-urology for lower urinary tract symptoms * radical prostatectomy exclusion criteria: * perineal radiotherapy * surgery for stress urinary incontinence

Keywords: radical prostatectomy urinary incontinence pelvic floor muscle reaction time