Kornimate/medical-research-clean huggingface dataset:
the effect of the game on students' intramuscular injection skills

Conditions: Video Games; Students; Nursing; Infections; Intramuscular

Summary: today, error rates increase in intramuscular (im) drug administrations, which are frequently applied in clinical settings, due to many factors such as the increase in the number of students in nursing education, the low number of educators, insufficient clinical space and insufficient laboratory environments. this situation makes it inevitable to use different teaching methods in nursing education, especially in the acquisition and development of psychomotor skills. games, which are a type of virtual simulation methods; it is defined as a pedagogical tool that offers the student the widest possible learning opportunity, interesting, interactive media, and a teaching beyond entertainment. it is very important to acquire the necessary knowledge and skills in the management of intramuscular drug administration, which will constitute the majority of postgraduate applications of nursing students, by using today's technologies during their student life. another factor that is effective in psychomotor skill learning is; students' anxiety level. nursing students may experience anxiety while using the new technique, which negatively affects the learning process of the student. one of the reasons for the anxiety experienced by the students is that they have not reached enough professional knowledge and skills. it is observed that this level of anxiety increases especially in psychomotor skills. in the exams conducted for the evaluation of laboratory practices in nursing education, the student demonstrates the skills learned during the term. the level of anxiety he feels during this practice may also affect his performance. the general result of studies examining the relationship between test anxiety and academic performance is that there is a negative relationship between test anxiety and academic success. for this reason, it is very important to control students' anxiety. although the level of state anxiety increases from time to time, especially in the trainings carried out with simulation, it is one of the training methods that increases the self-confidence of the students by reducing their anxiety in the future. based on these reasons, this research; the aim of this study was to evaluate the effect of computer-assisted game on success and anxiety level in the development of intramuscular injection application skills in nursing education.


Eligibility criteria:
inclusion criteria: * being a first year nursing student * to be taking the basics of nursing course for the first time * to have at least 50 points from the im injection information form exclusion criteria: * graduated from health vocational high school * having a communication problem related to vision and hearing
a study is to understand the treatment patterns for immunotherapy agents and braf/mek inhibitors used in the treatment of advanced melanoma

Conditions: Melanoma

Summary: the goal of the study is to understand the treatment patterns for immunotherapy agents and braf/mek inhibitors used in the treatment of advanced melanoma


Eligibility criteria:
inclusion criteria: * patients must have ≥1 medical or pharmacy claim for nivolumab, ipilimumab, pembrolizumab, nivolumab+ipilimumab (on the same day), dabrafenib, vemurafenib, cobimetinib, trametinib, dabrafenib+trametinib (on the same day) and vemurafenib+cobimetinib (on the same day) * patients must have ≥6 months of continuous health plan enrollment prior to index date * patients must have ≥2 medical claims at least 30 days apart with a diagnosis for melanoma during the study period and ≥1 diagnosis for melanoma during the baseline period prior to or on the index date exclusion criteria: * patients with ≥1 claim for the agents of interest including immunotherapy agents and braf/mek inhibitors between the first diagnosis of metastatic disease and the day prior to the index date will be excluded * patients with a claim for acquired immunodeficiency virus (aids) anytime during the study period * patients under the age of 18 as of index date other protocol defined inclusion/exclusion criteria could apply
efficacy and safety of gemigliptin 50mg qd added in patients with type 2 diabetes inadequately controlled on glimepiride and metformin

Conditions: T2DM

Summary: after a screening, a 2-week, single-blind placebo run-in, 174 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily gemigliptin 50 mg or placebo to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.

subjects will visit the center on week 6, 12, 18 and 24 during the entire 24-week treatment period. total study duration will be approximately 26weeks and the subjects will be to practice exercise/diet control together.

Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes mellitus 2. adults aged ≥ 19 years old 3. patients with hba1c 7%\~11% at visit 1

Keywords: type 2 diabetes mellitus
an open-label extension trial to assess the safety of long-term treatment of rotigotine in advanced-stage parkinson's disease

Conditions: Advanced Stage Parkinson's Disease

Summary: the objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic parkinson's disease

this is the open-label extension to the randomized, double-blind, placebo-and active controlled sp515 (nct00244387) trial that assessed the efficacy and safety and tolerability of the rotigotine patch in subjects with advanced-stage idiopathic parkinson's disease that were not well-controlled on levodopa

Eligibility criteria:
inclusion criteria: * subjects who have completed four months of maintenance treatment in the sp515 (nct00244387) double-blind trial exclusion criteria: * subjects who had an ongoing serious adverse event from sp515 (nct00244387) double-blind trial that was assessed as related to study medication

Keywords: rotigotine neupro®
a follow-up study of patients with hbeag positive chronic hepatitis b treated with pegasys (peginterferon alfa-2a) in study ml22265

Conditions: Hepatitis B, Chronic

Summary: this multicenter, prospective, observational study will evaluate the one-year outcomes in hbeag positive chronic hepatitis b patients who had received pegasys (peginterferon alfa-2a) in arm a of study ml22265. data will be collected from each patient for up to one year post-therapy.


Eligibility criteria:
inclusion criteria: * patients who were randomized to study arm a of ml22265 and were treated and completed follow-up in the study, regardless of treatment response at any time point exclusion criteria: * patients unwilling to provide informed consent or abide by the requirements of the study
noninvasive intracranial pressure waveforms assessment in traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: in clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. this clinical condition demands effective investigation and early treatment. imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. one of the main causes of coma is intracranial hypertension (ih), with traumatic brain injuries (tbi) and cerebral hemorrhages being the major contributors to its development. ih increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. clinical studies show that adequate intracranial pressure (icp) control in tbi patients reduces mortality and increases functionality. unfortunately, the most accurate way to measure and evaluate the icp is through a catheter located inside the skull, and its perforation is required for this purpose. several studies have attempted to identify noninvasive solutions for icp monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. in vivo studies have identified excellent qualitative correlation with catheter icp recordings. however, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of tbi patients.


Eligibility criteria:
inclusion criteria: * moderate to severe traumatic brain injury with less than 24 hours. exclusion criteria: * primary decompressive craniectomy * brain death signs at admission * severe hemodynamic instability

Keywords: traumatic brain injury intracranial pressure intracranial compliance intracranial pressure waveforms neurological noninvasive monitoring
pilot-study for sas treatment in acute cerebral infarction: the pistacio trial

Conditions: Ischemic Stroke; Sleep Apnea Syndromes

Summary: sleep apnea syndrome (sas) is highly prevalent in acute stroke and it is related to worst outcome. we aim to assess if sas treatment, started immediately after acute ischemic stroke, impacts infarct growing and clinical prognosis.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke on brain mri * nihss 6-22 * thrombolysis exclusion criteria: * previous sas * previous stroke * auto-adaptative servo-ventilation contraindication
double-blind, randomized study evaluating the efficacy and safety of brivaracetam in adults with partial onset seizures

Conditions: Epilepsy

Summary: this study will evaluate the efficacy and safety of brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Eligibility criteria:
inclusion criteria: * subjects were 16 to 70 years, both inclusive. subjects under 18 years of age were only included where legally permitted and ethically accepted * subjects with well-characterized focal epilepsy or epileptic syndrome according to the international league against epilepsy (ilae) classification * subjects had a history of partial onset seizures (pos) whether or not secondarily generalized (type i seizures according to the ilae classification) * subjects had at least 2 pos whether or not secondarily generalized per month during the 3 months preceding visit 1 (v1) * subjects had at least 8 pos whether or not secondarily generalized during the 8-week baseline period * subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (aeds). vagal nerve stimulation (vns) was allowed and was not counted as a concomitant aed exclusion criteria: * history or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before visit 3 * history or presence of status epilepticus during the year preceding visit 1 or during baseline

Keywords: epilepsy brivaracetam partial onset seizures, adolescents & adults
sensory nerve function and exercise therapy response in chronic low back pain

Conditions: Chronic Low-back Pain

Summary: this observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. measures collected include sural sensory nerve conduction, quantitative sensory testing for pressure and heat pain thresholds, and psychosocial questionnaires. it is hypothesized that baseline sensory nerve dysfunction may be associated with reduced response to exercise therapy in chronic low back pain.

while exercise is commonly prescribed for chronic nonspecific low back pain (nslbp), patient responses are variable. differences in baseline sensory nerve function could plausibly contribute to exercise therapy outcomes. this cross-sectional quantitative observational study will investigate if baseline sensory nerve conduction amplitudes and quantitative sensory testing (qst) pain thresholds differ between matched nslbp patients later categorized as responders or non-responders to a 12-week standardized exercise regime. a sample of 50 nslbp participants with matched baseline pain and disability will undergo a tailored 12-week exercise intervention and 6-month follow-up. blinded assessors will perform post-intervention sensory nerve conduction and qst measures. it is hypothesized that exercise therapy responders will show greater improvements in sensory thresholds correlating with pain relief. results aim to elucidate neural factors associated with long-term exercise therapy outcomes in chronic low back pain.

Eligibility criteria:
inclusion criteria: * adults ages 20-60 years * nonspecific chronic low back pain \>3 months * baseline pain ≥6/10 and disability ≥40% exclusion criteria: * radicular leg pain * prior lumbar surgery * serious spinal pathology
evaluation of short-term safety and use patterns of an electronic nicotine delivery system

Conditions: Nicotine Dependence

Summary: electronic nicotine delivery systems (ends), commonly referred to as electronic cigarettes have gained in popularity over the last several years. the technology used to manufacture ends has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ends. these studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ends brands among tobacco cigarette smokers. this study will test a new generation ends, the njoy king bold (njoy, scottsdale, az). it is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. the cartridge inside contains 26 milligrams of nicotine. our primary objective is to evaluate the short-term effects of using the njoy kings ends on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. our secondary objective is to evaluate the subject's usage patterns for cigarettes and njoy king ends during a one-week period in which they can use each freely. the study includes three visits to the clinic spaced approximately one week apart. subjects who pass the screening visit will return to the clinic for visit 2 in which they will sample the njoy king ends for about 20 minutes before taking home enough to last till visit 3, one week later. they will be instructed to use as many or as few as they like during the week. subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. subjects will return to the clinic for visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. eligible subjects will then participate in two series of 10 puffs of njoy kings spaced one hour apart. during the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.


Eligibility criteria:
inclusion criteria: 1. healthy cigarette smokers 2. not trying or planning to quit 3. \>10 factory-produced cigarettes/day for previous year 4. breath carbon monoxide level of \>10 ppm at screening exclusion criteria: 1. pregnancy or lactation 2. abuse of drugs other than tobacco 3. use of any prescription psychoactive medications within 14 days 4. use of ends within 14 days 5. use of any nicotine replacement within 30 days
early intervention in remote autism (ipaad)

Conditions: Early Intervention in Remote Autism

Summary: the early start denver model (esdm) has shown its efficiency in the early management of asd. the study aims to evaluate the efficiency of a new type of management based on a semi-intensive center-based intervention (8h per week) coupled with a mooc (massive online open course: a teaching and learning intervention based on instrumental and interactive teaching situations) for remote parental training/supervision. the goal is to determine if compared to the esdm reference intervention (15h per week), this type of care can bring, a sufficient improvement in child development course and decreased symptoms of autism in young children, and if it could be, therefore, better suited to the needs of children and their family, bypassing the previously stated obstacles.


Eligibility criteria:
inclusion criteria: 1. diagnosis of asd based on the diagnosis and statistical manual of mental disorders, 5th edition (dsm-5) criteria; 2. diagnosis of asd on the autism diagnosis observation schedule (ados-2) and autism diagnosis interview (adir) for toddlers (we will include children above or equal to 13, which is the research cut-off); 3. aged between 15 and 36 months; 4. dq of 30 or above at the msel 5. sign informed consent form by both parents exclusion criteria: 1. a neurodevelopmental disorder with known etiology (e.g. fragile x syndrome, rett syndrom) 2. significant sensory or motor impairment 3. major physical problems such as a chronic serious health condition 4. history of a serious head injury and/or neurologic disease 5. seizures at time of entry 6. use of psychoactive medications (7 ) families unavailable for the intervention and the followup over a period of 12 months (8) impossibility for family to have access to the mooc

Keywords: autism asd esdm mooc
study of vir-2218 in patients with chronic hepatitis b in mainland china

Conditions: Hepatitis B, Chronic

Summary: this study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of vir-2218 in adults with chronic hbv infection in mainland china.


Eligibility criteria:
inclusion criteria: * male or female age 18 - 65; * weight ≥ 40 kg to ≤ 125 kg; * chronic hbv infection as defined by a positive serum hbsag for ≥ 6 months; exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; * significant fibrosis or cirrhosis; * history or evidence of drug or alcohol abuse; * history of intolerance to sc injection; * history of chronic liver disease from any cause other than chronic hbv infection; * history of hepatic decompensation;

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis
culturally adapted motivational interviewing with cbt and mindfulness based relapse prevention for substance use disorder in pakistan (camiab)

Conditions: Substance Use Disorder (SUD)

Summary: the study has both quantitative and qualitative components. the aim of study is to: 1. culturally adapt and integrate the existing motivational interviewing with cognitive behavioral therapy(micbt) and mindfulness based relapse prevention (mbrp) for people with substance use disorder (sud) in pakistan 2. test the feasibility and acceptability of the integrated intervention called camiab ('camiab' means success in urdu) in a randomized control trial (rct).

this study aims to culturally adapt the existing motivational interviewing with cbt (micbt) and integrate this with mindfulness-based relapse prevention (mbrp) intervention for people with sud and to test the feasibility, and acceptability of the intervention in a randomized control trial (rct). first phase will be cultural adaptation of intervention through focus groups and individual interviews with key stakeholders . phase two will be to test integrated micbt and mbrp on a small group of participants n=12. third phase will be a feasibility factorial randomized control trial with 260 participants with sud (n=65). participants will be recruited from primary care hospitals and drug rehabilitation centers in karachi, lahore, rawalpindi, hyderabad, and peshawar pakistan. intervention will take place weekly over a period of 12 weeks. the intervention will consist of individual as well as group sessions. assessments will be completed at baseline, after completion of intervention (12th week) and 24th week post randomization. all assessments will be administered by masked research assistants (ras), not involved in delivering intervention sessions. the therapists delivering the intervention will be trained and will be provided ongoing supervisions by a senior therapist.

Eligibility criteria:
inclusion criteria * participants with substance use disorder * meeting dsm-v criteria for substance use disorder * age 18 years and above * being able to understand spoken or written urdu * have undergone through the process of detoxification before study intervention exclusion criteria • any evidence of organic brain disease, clinically significant cooccurring medical illness or mental illness to the extent that can impede their ability to provide informed consent or engagement in the intervention.
onset prevention of urinary retention in orthopaedic nursing and rehabilitation

Conditions: Urinary Retention; Hip Fractures; Hip Arthritis

Summary: urinary retention (ur) is a common problem in older people undergoing hip surgery. untreated ur can lead to bladder distention and a permanent damage of the bladder, which can cause both physical and psychical suffering as well as increased costs for society. even if national and international practice guidelines are in place for handling ur within the health care system, many fail to comply with them. compliance to clinical practice guidelines are improved if different professions and managers collaborate as a team. in option (onset prevention of urinary retention in orthopedic nursing and rehabilitation) the investigators will coach multi-professional local facilitator teams in knowledge translation and implementation of ur practice as well as investigate the effects of such evidence-based practice in orthopedic nursing and rehabilitation. implementation of research-based knowledge in evidence-based practice within an organization is complex with several known interacting factors. in a health care system these factors can be the care context, knowledge (innovation) and how the organization facilitates such implementations. the implementation strategy of option utilize established theories of facilitation of knowledge implementation considering evidence and context with focus on leadership. the intervention consists of seminars and systematic support for implementation of ur-guidelines option combine studies of adherence to evidence based practice regarding ur for patients over 65 years old that has undergone hip surgery and the health economic aspects of it. option also contribute with improvements and increased knowledge regarding strategies to implement evidence based health care that can be used in other areas than ur and hip surgeries.


Eligibility criteria:
inclusion criteria: orthopaedic units in sweden performing hip surgery. - exclusion criteria: orthopaedic units in sweden not performing hip surgery -

Keywords: orthopedics implementation research utilization