Kornimate/medical-research-clean huggingface dataset:
long term observational study of a vagal nerve stimulation device in crohn's disease

Conditions: Crohn Disease

Summary: this will be an open label multicenter study of the safety and efficacy of an active implantable vns device in patients with crohn's disease.

patients who complete study spm-007 will be enrolled in this study at the time of the last visit of the preceding study. the assessments at the last visit of the preceding study will also be used as baseline measures for the current study. if the patient has previously discontinued spm-007 and greater than 30 days have elapsed since the final visit in spm-007, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies. the study will continue until the last patient entered has completed 24 months in this study. follow-up visits will occur at 3, 6, 12, 18 and 24 months. a final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 24 months on study. an interim visit must be performed a maximum of 1 month after any change in device settings. interim visits may also be performed at any time at the principal investigator's discretion; either between scheduled visits, or after the patient has completed the month 24 visit, if the study is still ongoing.

Eligibility criteria:
inclusion criteria: patients must have enrolled in study spm-007; including patients who either completed that study or withdrew before completion of that study. exclusion criteria: inability to provide informed consent significant psychiatric illness or substance abuse all patients will be excluded who have developed any of these exclusionary conditions during the smp-007 study, or in the interim between spm-007 and the day 0 of spm-010: * history of unilateral or bilateral vagotomy * history of recurrent vaso-vagal syncope episodes * known obstructive sleep apnea * known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block. * significant pharyngeal dysfunction or swallowing difficulties * clinically significant vocal cord damage or hoarseness * other implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators) * asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea * a greater than or equal to 40 pack-year smoking history * active peptic ulcer disease * patients with a limited life expectancy due to terminal illness

Keywords: vagus nerve stimulation
a dose escalation study of lenalidomide in relapsed or refractory b-cell chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; Leukemia, B-Cell, Chronic

Summary: the purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (mtedl) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory b-cell cll.


Eligibility criteria:
inclusion criteria: * documented diagnosis of b-cell cll that has relapsed after or is refractory to at least one prior regimen. the prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately) * ecog \< or = 2 * willing to agree to follow the pregnancy precautions. exclusion criteria: * pregnant or nursing women * systemic treatment for b-cell cll within 28 days of study start * central nervous system involvement * history of renal failure requiring dialysis * prior treatment with lenalidomide * alemtuzumab therapy within 56 days of initiating lenalidomide treatment * anc \< 1000 / ul * platelet count \< 50,000 / ul * calculated creatinine clearance \< 60 ml/min (cockroft-gault method) * ast or alt \> 3.0 x upper limit of normal * serum total bilirubin \> 2.0 mg/dl * neuropathy \> or = grade 2 * uncontrolled autoimmune hemolytic anemia or thrombocytopenia * richter's transformation (active)

Keywords: relapsed refractory fludarabine revlimid lenalidomide cll b-cell cll cc-5013 chronic lymphocytic leukemia
holmium laser vs bipolar enucleation of a large volume bph: a randomised controlled study

Conditions: BPH With Urinary Obstruction; Male

Summary: to compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large bph.

to compare safety and efficacy of bipolar plasmakinetic enucleation (bpep) versus holmium laser enucleation (holep) for management of large bph (\>80gm).

Eligibility criteria:
inclusion criteria: * patients suffering from luts secondary to infravesical obstruction from bph * failed medical treatment * international prostate symptom score (ipss) \> 13 * a peak urinary flow rate (qmax) \< 15 ml/sec * a prostate size ≥ 80 gm exclusion criteria: * presence of a urethral stricture * neurological disorder * bladder cancer * prostate cancer * previous history of bladder neck surgery or turp

Keywords: bph enucleation prostate luts ipss quality of life large prostate
study conducted in subjects with rheumatoid arthritis who have moderate to severe disease activity despite methotrexate therapy with or without other non biologic disease modifying antirheumatic drugs (dmards)for at least 12 weeks prior to screening

Conditions: Rheumatoid Arthritis

Summary: to compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus mtx with or without other disease modifying antirheumatic drugs therapy.


Eligibility criteria:
inclusion criteria: 1. subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 american college of rheumatology (acr) revised criteria for ra. 2. subject must have active rheumatoid arthritis despite methotrexate (mtx) therapy of ≥10 mg/wk for at least 12 weeks. the mtx dose must be stable for at least 4 weeks immediately prior to screening. exclusion criteria: 1. subjects who used any of the following systemic treatments during the washout periods given below: 1. oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline. 2. treatment with more than 1 nsaid within 14 days at baseline. 3. methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline. 4. subjects will be allowed to continue the following non biologic dmards: sulfasalazine, hydroxychloroquine, and leflumomide. all other non-biologic dmards (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic dmards must have been discontinued at least 2 months prior to week 1. 5. any biologic b cell depleting agent (eg, rituximab) within 2 years of week 1. 2. receipt of any live (attenuated) vaccine within 4 weeks prior to baseline. 3. receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Keywords: rheumatoid arthritis etanercept methotrexate dmards
study on the repeatability of cardiac output measurements dependence of temperature of injectate

Conditions: Heart Diseases

Summary: this study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. in accordance with our clinical practice, thermal indicator injections are synchronized with respiration. the impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested. the study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.

bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision. this study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. the reliability of the thermodilution measurements are tested a) in sedated, artificially ventilated cardiac surgical patients and b) in the same patients when postoperatively awake and spontaneously breathing. we further compare the use of room temperature and iced thermal indicator injections. the study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients. only patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.

Eligibility criteria:
inclusion criteria: * cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria - exclusion criteria: * acute cardiac surgery * preoperative arrythmias

Keywords: cardiac output thermodilution
dissecting the role of distal embolization of athero-thrombotic material in primary pci: the thromboticburden and microvascularobstruction (tobias) study.

Conditions: Acute Myocardial Infarction

Summary: demonstrate that fd-oct guidance is feasible and possibly results in reduction of frequency-domain optical coherence tomography-defined residual thrombus burden after thrombus-aspiration.


Eligibility criteria:
inclusion criteria: * st elevation myocardial infarction * ages eligible for study: \>18 years old * genders eligible for study: both (female sex with child-bearing potential excluded) exclusion criteria: * occluded (timi 0) or sub occluded (timi 1) proximal vessel of estimated diameter ≥3mm * intended use of thrombus aspiration
trajectories in insulin sensitivity across menstrual cycles in women with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: standardized longitudinal data collection of diabetes management relevant factors in women with t1d (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.


Eligibility criteria:
inclusion criteria: * living with type 1 diabetes * perimenopausal people with menstrual cycle * using a hybrid closed-loop system * signed digital informed consent exclusion criteria: * using hormonal therapy or contraception

Keywords: menstrual cycle trajectories women insulin sensitivity
the role of computerized training in post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: the purpose of this study is to determine whether a computerized training, "cognitive bias modification" targetting appraisals (cbm-app), can reduce dysfunctional appraisals of trauma in patients with post-traumatic stress disorder (ptsd), compared to a control condition. other outcomes measured include symptoms of ptsd and trauma-relevant dysfunctional cognitions. participants are recruited from inpatients with ptsd admitted to the clinic for psychosomatic medicine and psychotherapy, lwl university clinic of ruhr university of bochum.


Eligibility criteria:
inclusion criteria: * primary diagnosis of post-traumatic stress disorder according to icd-10 (f43.1), and dsm-5 (as assessed via clinician adminstered ptsd scale for dsm-5) * motivated and willing to take part in the study (including questionnaire measures, computer training, filling out questionnaires after discharge) * aged 18-60 years, male or female * fluent in german exclusion criteria: * substance abuse/ substance dependence currently or in the past six months * active suicidal thoughts or intentions * psychotic disorder (past or present) * learning disability/ intellectual impairment * red-green colour blindness
incidence and prevalence of juvenile dermatomyositis

Conditions: Juvenile Dermatomyositis

Summary: this is a descriptive, retrospective, multi-center, cross-sectional and observational epidemiological study of incidence and prevalence of juvenile dermatomyositis in alsace from 2000 to 2015. alsace is a french region with a low migratory flow


Eligibility criteria:
inclusion criteria: * age under 16 years * have a dermatomyositis according to the diagnostic criteria of bohan and peter of 1975 exclusion criteria: * refusal to participate in the study

Keywords: incidence prevalence epidemiology juvenile dermatomyositis inflammatory myopathy
chinese health ivvestigation of nurse aging

Conditions: Hot Flashes

Summary: climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.

hormone replacement therapy(hrt) is the main therapy to climacteric symptoms. but hrt also has a lot of disadvantages, such as cardiovascular disease, breast cancer .in our previous investigation,we found that doing exercise is helpful for climacteric symptoms.so we want to make a detailed investigation to research it.

Eligibility criteria:
inclusion criteria: - women aged 40-55 who has climacteric symptoms exclusion criteria: - women who have serious climacteric symptoms and other diseases which could interrupt the research.

Keywords: climacteric symptoms menopause nurses
using an online patient monitoring system to improve care for children with chronic conditions

Conditions: Attention Deficit Hyperactivity Disorder; Asthma; Autism Spectrum Disorder; Depression; Epilepsy

Summary: trivox health is an online system designed to make it easy for healthcare providers to monitor patients' disease symptoms and functioning over time and in between in-person visits (http://www.youtube.com/watch?v=vr1vcbx0ef4). using combined quality improvement and randomized clinical trial methods, we will evaluate the impact of trivox on the health outcomes, patient/family experience of care, and healthcare utilization for children and adolescents with attention deficit hyperactivity disorder (adhd), asthma, autism, depression, and epilepsy.

trivox health is a web-based patient management and monitoring system designed to track patients' disease symptoms and response to therapy over time. trivox health enables clinics to use electronic surveys to gather data remotely from multiple responders, including patients, parents/guardians, school personnel and ancillary providers, and view the responses in a timely manner via graphical, tabular, and narrative summary formats. this quality improvement (qi) initiative will implement trivox as the standard of care for all patients who receive care for adhd, asthma, autism, depression, and epilepsy within seven ambulatory specialties at boston children's hospital. patients and families will use trivox to report on patient health status and will complete clinically-retrivoxlevant questionnaires at routine intervals. providers will use the information collected through trivox to inform their clinical care of the patient/family. to evaluate the effectiveness of trivox, we will conduct a 24-month phased, cluster randomized controlled trial (rct) where we randomize providers to "active" vs. "delayed-start" to trivox use, with patients clustered by provider (within specialties) for analytic purposes. delayed-start providers will crossover to active trivox use after 12 months. patients/families will complete additional surveys in order to assess the system's actual or potential effects on patient/family-provider interactions, healthcare utilization and costs.

Eligibility criteria:
inclusion criteria: * pediatric patients with clinical diagnosis of adhd, asthma, autism, depression, and/or epilepsy * patient receives care for these diagnoses from providers in participating ambulatory clinics (primary care, adolescent medicine, developmental medicine, neurology, psychiatry) * patient's primary caregiver enrolled in trivox exclusion criteria: * none

Keywords: chronic disease patient portal health information technology patient provider communication quality improvement
a study of treatment patterns and clinical outcomes in first line recurrent/metastatic squamous cell carcinoma of the head and neck (1l r/m scchn) participants in europe

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: the purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \& neck (1l r/m scchn).


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: participants are included in cohort 1 - augment if they meet the following criteria: * adults18 years or older * diagnosis of histologically confirmed r/m scchn, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-jun-2017 and 31-june-2018. * prescribed 1l treatment for r/m scchn * treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants * have available for review one month of follow-up data available post initiation of 1l r/m scchn therapy * informed consent form (icf) signature/collection of living participants, as required by country regulation and local ethics committees participants are included in cohort 1 if they meet the following criteria: * adults 18 years or older * diagnosis of histologically confirmed r/m scchn, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-jan-2014 and 31-dec-2016. * prescribed 1l treatment for r/m scchn * treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants * have available for review one month of follow-up data post initiation of 1l r/m scchn therapy * informed consent form (icf) signature/collection of living participants, as required by country regulation and local ethics committees exclusion criteria: participants were excluded from either cohort if they meet the following criteria: * were enrolled in a cancer treatment-related clinical trial since the diagnosis of r/m scchn * recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).

Keywords: metastatic nivolumab recurrent scchn treatment patterns outcomes
immune memory evaluation in children following a primary vaccination with pneumococcal conjugate vaccines.

Conditions: Infections, Streptococcal

Summary: to evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

2 groups (60 per group), booster of pneumovax 23 after priming with prevnar or gsk biologicals' pneumococcal vaccine.

Eligibility criteria:
inclusion: * healthy children between 11-14 months old who received primary vaccination with prevnar or gsk biologicals' pneumococcal conjugate vaccine. exclusion: * children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs; * children having received any additional pneumococcal vaccine than in the primary study; * children with any disease that affect the immune system and history of seizures and/or allergic disease.
the investigation of therapeutic effect and platelet activity after ilib for ischemic stroke patient

Conditions: Ischemic Stroke

Summary: the aim of our study is to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient

background : this research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for ischemic stroke patient; the research will further explore the changes in platelet activity after treatment. the light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. pain control is indicated in such treatment, but still lacking evidence of neurological symptoms and functional improvement. purpose:this research is designed through randomization, control, and double-blind trial to therapeutic effect and platelet activity after intravenous laser irradiation of blood for ischemic stroke patient. furthermore, to establish a new way of clinical rehabilitation therapy. method: the investigators plan to recruit 20 patients who are between the ages of 20 to 80 years old. the participants are required to have clear conscious and be able to communicate. the patient with mild to moderate stroke ( nihss=1-15), which onset between one month to 2 years will be included. the treatment group will receive an intravenous helium-neon laser phototherapy. a vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. the power is set between 2.5 \~ 3.0mw, 60 minutes each time, once a day for five consecutive days each week, for 2 weeks (total 10 times in one course). the steps for the control group are the same, except that the output power is adjusted to zero intensity. this plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and platelet activity tests. at the same time, the clinical functions of patients will be evaluated, including nihss, mrs and stroke impact scale (sis).

Eligibility criteria:
inclusion criteria: * aged between 20 to 80 years old * able to speak and understand mandarin/taiwanese * no cognitive impairment * residual motor function impairment (mrs\>1) * mild stroke (nihss=1-4) or moderate stroke(nihss=5-15) * no psychological disease exclusion criteria: * severe stroke (nihss=16-42) * history of intracerebral hemorrhage and other major surgery * history of malignancy, chronic kidney disease * active infection * chronic hepatitis b or chronic hepatitis c * unstable angina or acute myocardial infarction within 6 months * severe cognition impairment * pregnancy

Keywords: ischemic stroke intravenous laser irradiation of blood platele activity