Kornimate/medical-research-clean huggingface dataset:
the effect of using musical and lighted baby crib mobile on newborns' pain and stress during blood draw

Conditions: Pain

Summary: it is widely recognized that the use of non-pharmacological methods in neonatal pain management is low both globally and in our country. nurses play a crucial role in managing pain through various techniques and in preventing its negative effects on newborns. toys with sounds, lights, and different features have been found to effectively capture infants' attention. consequently, it is anticipated that baby crib mobiles, which combine these attention-grabbing features, could serve as effective distractions during needle interventions, potentially reducing pain and stress. however, there is a lack of research on this specific application.

newborns often undergo needle procedures shortly after birth, such as vitamin k injections, hepatitis b vaccinations, screenings, and routine immunizations. depending on the baby's condition, these procedures may need to be repeated, and additional blood samples might be required. these painful procedures can cause significant stress for the newborn and may lead to neurocognitive, physiological, metabolic, and behavioral issues. pain experienced during these procedures can negatively impact the newborn's future reactions to pain. therefore, inadequate pain management can result in both immediate and long-term adverse effects. organizations such as the international neuropsychiatric pain group and the american academy of pediatrics advocate for reducing pain in infants during procedures, recommending non-pharmacological methods as the first line of management. these methods, aimed at providing analgesic effects by creating a relaxing environment, are important because they do not have side effects. some proven non-pharmacological techniques include breastfeeding, skin-to-skin contact, swaddling, music therapy, oral glucose, and pacifier use. music therapy is a widely used non-pharmacological method that helps reduce pain perception in newborns. studies have shown its effectiveness in various settings. for instance, research with premature newborns found that music therapy during central venous catheter placement reduced physiological and behavioral reactions. another study with 120 healthy newborns reported that having a musical baby crib mobile in vaccination rooms decreased pain levels and crying times. other studies have similarly highlighted the positive effects of listening to or singing lullabies during painful procedures.

Eligibility criteria:
inclusion criteria: * born between 38-42 weeks, * being 0-28 days, * absence of visual and auditory problems, * not using any pain reliever or sedative medication in the last four hours, * parents' willingness to participate in the study, * parents' knowledge of turkish, * parents' ability to read and write. exclusion criteria: * having a preterm birth, * having a disease that causes chronic pain, * having visual or auditory problems, * using any pain or sedative medication in the last four hours.
fycompa titration intervals and effects on retention rate

Conditions: Epilepsy

Summary: this study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. subjects will be randomized to either perampanel, standard titration interval rate (group a) or perampanel, slower titration interval rate (group b).

a total of 60 subjects with a confirmed diagnosis of either partial onset or primary generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day. subjects in this group will be designated group a. the remaining 30 subjects will also begin perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6 mg/day and will be designated group b.

Eligibility criteria:
inclusion criteria: 1. must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ich and gcp guidelines. 2. subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1. 3. subjects currently being treated with 1 to 3 antiepileptic medications with or without vns (does not count as an aed). 4. subjects aged 18 to 75. 5. subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications. 6. can be safely treated, in the opinion of the investigator, with fycompa. 7. able and agrees to follow the specified titration schedule. 8. subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary. exclusion criteria: 1. any history of non-epileptic or psychogenic seizures. 2. women who are currently pregnant, lactating or have plans to become pregnant in the immediate future. 3. subjects with active suicidal ideation or behavior as evidenced by positive answers on the columbia suicide severity rating scale (c-ssrs) or subject's with a history of suicidal ideation or attempt within 12 months. 4. subjects with a suicidal attempt in the 12 months prior to visit 1 5. any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study. 6. subjects with severe hepatic impairment or severe renal impairment or on hemodialysis. 7. any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome p450 (cyp3a).

Keywords: epilepsy epilepsy, partial onset epilepsy, generalized onset fycompa perampanel
a post market study to assess the spinal modulation dorsal root ganglion stimulator system in chronic post surgical pain

Conditions: Chronic Post Surgical Pain

Summary: 20-smi-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available axium neurostimulator in the management of chronic post surgical pain


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is able and willing to comply with the follow-up schedule and protocol 3. chronic post surgical pain for at least 6 months 4. failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. minimum baseline pain rating of 60 mm on the visual analog scale in the primary region of pain 6. subject is able to provide written informed consent 7. pain medication dosage has been stable for at least 30 days 8. patient has been included for implantation according to standard criteria from the dutch neuromodulation society exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months 5. subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. subjects with indwelling devices that may pose an increased risk of infection 8. subjects currently has an active infection 9. subject has participated in another clinical investigation within 30 days 10. subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. subject has been diagnosed with cancer in the past 2 years. 12. patient has no other exclusion criteria according to standard criteria from the dutch neuromodulation society
randomized clinical trial of bococizumab (pf-04950615; rn316) in subjects who are intolerant to statins

Conditions: Hyperlipidemia

Summary: this study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of bococizumab (pf-04950615; rn316) compared to placebo in subjects who are statin intolerant.


Eligibility criteria:
inclusion criteria: * hyperlipidemia * statin intolerant * fasting ldl-c \> = 70 mg/dl fasting tg \< = 400 mg/dl exclusion criteria: * pregnant or breastfeeding females * cardiovascular or cerebrovascular event or procedure within 90 days * severe or life-threatening adverse events with past use of statins * poorly controlled hypertension

Keywords: hyperlipidemia statin intolerance
lens - long-term eltrombopag observational study

Conditions: Purpura, Thrombocytopaenic, Idiopathic

Summary: a long term observational ocular safety study in adults who have received study medication (either active drug or placebo) in a phase ii or iii clinical study evaluating eltrombopag. the study will follow subjects for 2.5 years following their last ocular assessment on their prior treatment study (regardless of the therapeutic indication) and will describe long-term ocular safety with respect to changes in the lenses over time from all subjects.


Eligibility criteria:
inclusion criteria: subjects are eligible for enrolment in the study if they have previously participated in an eltrombopag study, either phase ii or iii, and meet all of the following criteria: * subject has signed and dated a written informed consent for this study. * subject has previously participated in a study evaluating eltrombopag, either phase ii or iii, and must have received at least one dose of study medication (either active drug or placebo). this excludes subjects from phase i studies (see section 5.1). * the prescribed follow-up ophthalmic assessment at 6 months post end of treatment should be completed as specified in the protocol for the previous study. * subject is able to understand and comply with protocol requirements and instructions. exclusion criteria: subjects meeting any of the following criteria must not be enrolled in the study: * subject has received surgery for cataracts and is aphakic or bilaterally pseudophakic. * in some countries (i.e. france), a subject is neither affiliated with nor a beneficiary of a social security category.

Keywords: thrombopoietin receptor agonist ocular safety hcv sb-497115-gr cit itp cataract eltrombopag olamine lens opacity
ezetimibe versus nutraceuticals in statin-intolerant patients

Conditions: Coronary Artery Disease

Summary: pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). the investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

background treatment with statins has a class i indication after percutaneous coronary intervention (pci), but is often discontinued by patients due to side effects. pharmacologic alternatives shown to be useful after pci include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). it remains unknown, however, which of these two therapeutic approaches is more effective after pci. purpose the primary objective of this study is to compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * angiographically-proven coronary artery disease * recent (\< 12 months) percutaneous coronary intervention * class i indication to receive statin treatment * previous (\< 12 months) withdrawn of a statin due to side effects * unwilling to receive treatment with an alternative statin * able to understand and willing to sign the informed consent form exclusion criteria: • women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before

Keywords: nutraceuticals statin
diagnosis and treatment of minor ischaemic stroke according to the etiology and pathogenesis

Conditions: Ischaemic Stroke

Summary: negligence or contempt of the etiology and pathogenesis of minor ischaemic stroke in the early diagnosis and effective treatment leads to more than 40-50% of patient with recurrent episodes, and 10% patient died. therefore, diagnosis and treatment of minor ischaemic stroke according to the etiology and pathogenesis is important. the 2007 korean modified toast type got some progress, but there exists two major disadvantages: imperfect diagnosis and pathogenesis of perforator artery infarction etiology; lack of typing according to the pathogenesis of large atherosclerotic infarction and taking measures of treatment according to the new types. recently, domestic professor gaoshan proposes new approach to diagnose and treat minor ischaemic stroke according to the etiology and pathogenesis of ciss typing, but the pathogenesis of hypoperfusion infarction with severe stenosis of large artery is unclear. is it low perfusion? or artery-artery embolization? or both? how to distinguish the pathogenesis of branch artery disease: by atherosclerosis? or hyalinosis? or both? how to check the validity of clinical types? this study take different interventions according to different types and observation of the long term clinical results of intervention( mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage), in order to clarify the new types can indeed solve the current problem of minor ischaemic stroke with high mortality, recurrence rate, disability rate and rate of cerebral hemorrhage and subarachnoid hemorrhage.


Eligibility criteria:
inclusion criteria: one of two conditions: 1. conscious patients with any of nihss score = 1,or 2. nihss ≤ 3 exclusion criteria: * patients over 80 years of age * patients with serious heart, lung, liver, kidney dysfunction or * severe systemic complications, * a known tumor, * pregnancy, * having a history of cerebral hemorrhage

Keywords: etiology pathogenesis minor ischaemic stroke types intervention
hematopoietic stem cell transplantation in type 1 diabetes mellitus

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem cell transplantation is able to induce prolonged and significant increases of c-peptide levels associated with absence of or reduction of daily insulin.

patients with type 1 dm depend on exogenous insulin administration for survival and for control of long-term complications. the best-established treatment is tight control of blood glucose achieved by frequent daily injections or continuous subcutaneous infusion of insulin, ie, intensive insulin therapy. although insulin therapy has developed enormously, even the most modern technologies do not allow the maintenance of normoglycemia. since the establishment of the autoimmune etiology of type 1 dm in the late 1970s, many clinical trials analyzing the effects of different types of immune interventions demonstrated that beta-cell preservation is an achievable target in different degrees. controlled trials and further biological studies are necessary to confirm the role of this treatment in changing the natural history of type 1 dm. this is a prospective pilot study which will enroll patients with type 1 diabetes mellitus within the first months of diagnosis, with clinical and laboratory findings. the donor stimulation will be with cyclophosphamide, filgrastim, and mesna. the cells will be recollected from peripheral blood by apheresis and refrigerated. the patients will receive a nonmyeloablative conditioning regimen with cyclophosphamide and fludarabine, and after this, the cells will be injected intravenously. they will receive a standard regimen of post-transplant prophylaxis. the duration of use of this prophylactic drugs scheme depends on the patient's recovery time. the reinfusion of stem cells will be completed after the last dose of cyclophosphamide, through a peripheral vein. lately, every three months, the c-peptide levels, glucose and insulin serum levels will be measured.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed in type 1 diabetes mellitus exclusion criteria: * patients with hiv * patients with hepatitis * patients with hematologic disease * patients with hearth failure * renal, hepatic or psychiatric disease * pregnant patients
baduanjin exercise for patients with gold 2-3 stable copd on pulmonary rehabilitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a disease with a very high morbidity and mortality rate. when the lung function drops lower and lower, patients will bear great affliction physically and mentally. how to improve the quality of life in patients with copd is a hot topic in the study of copd now. baduanjin, as one of the traditional chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for copd patients.

to investigate the efficacy of baduanjin exercise for patients with stable chronic obstructive pulmonary disease on phase ii\~iii. a prospective, randomized, controlled clinical trial was designed.

Eligibility criteria:
inclusion criteria: * aged from 40 to 80 years * diagnosed with stable chronic obstructive pulmonary disease * phase ii\~iii exclusion criteria: * the condition was serious or movement restrained by other diseases * in the acute exacerbation of chronic obstructive pulmonary disease * participants who have contraindications to exercise training * patients who have other serious acute, chronic organic disease or mental disorders
influence of acute respiratory distress syndrome (ards) and severe sepsis on srage levels in icu patients

Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome; Severe Sepsis; Septic Shock; Mechanical Ventilation

Summary: srage, the soluble form of the receptor for advanced glycation end products, is a novel marker of alveolar epithelial type i cell injury, but is also involved in acute systemic inflammation. the purpose of this observational prospective study is to determine whether srage could be used in an icu setting as a potential diagnostic and prognostic marker during ali/ards, regardless of associated severe sepsis or septic shock.

background: the receptor for advanced glycation end products (rage was recently identified as a promising new marker of alveolar type i cell injury. rage is a member of the immunoglobulin superfamily that acts as a multiligand receptor and is involved in propagating inflammatory responses. while the precise function of rage remains unclear, the elevated levels of rage, and its soluble isoform srage, correlate with severity of ali/ards in human and animal studies, and rage levels could reflect impaired alveolar fluid clearance. thus, it is possible that elevated levels of rage in ali/ards derive in part from rage's role in systemic inflammatory cascades rather than purely from its release from alveolar type i cells. design narrative: this observational prospective clinical study will describe and compare srage levels in the alveolar edema fluid and in the plasma from icu patients enrolled within the first 24 hours after onset of ali/ards and/or severe sepsis/septic shock, and from patients under mechanical ventilation (control group). edema fluid and plasma samples will be collected simultaneously on day 1, day 3, day 6, and day 28 (or at icu discharge), in order to describe kinetics of evolution of srage levels. undiluted pulmonary edema fluid samples will be collected in intubated patients only, and blood samples will be gathered from an indwelling arterial catheter. the concentrations of srage will be measured in duplicate by elisa.

Eligibility criteria:
inclusion criteria: * icu patients under mechanical ventilation * patients within the first 24 hours after onset of ali/ards according to the 1994 american-european consensus conference (aecc) * patients within the first 24 hours after onset of severe sepsis or septic shock according to the 1992 accp/sccm consensus conference exclusion criteria: * pregnancy * acute exacerbation of diabetes * dialysis for end-stage kidney disease * alzheimer's disease * amyloidosis * evolutive neoplastic lesion

Keywords: receptor for advanced glycation end products (rage) soluble rage (srage) acute lung injury (ali) acute respiratory distress syndrome (ards) severe sepsis septic shock alveolar epithelium mechanical ventilation intensive care unit (icu)
study to assess the efficacy and safety of meloxicam vs. diclofenac sr in patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: to assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg sr once daily over a treatment period of 8 weeks


Eligibility criteria:
inclusion criteria: - osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (nsaids) exclusion criteria: - none
the safety and effectiveness of transcatheter aortic valve raplacemet in intermediate risk patients with bicuspid aortic stenosis

Conditions: Aortic Valve Disease

Summary: previous trials have shown that tavr was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. however, patients with congenital bicuspid valve have been excluded in those trials. the purpose of this trial is to determine the safety and effectiveness of tavr in intermediate-risk patients with bicuspid aortic valve stenosis.


Eligibility criteria:
inclusion criteria: 1. severe, calcific bicuspid aortic stenosis. 2. heart team agrees the patient has a risk of operative mortality and has an sts \ 3. 3. the study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board (irb) of the respective clinical site. exclusion criteria: 1. ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath. 2. evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization. 3. severe aortic regurgitation (\>3+). 4. severe mitral regurgitation (\>3+).